COMMISSION STAFF WORKING DOCUMENT on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells
Date: 2016-06-02
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, blood transfusion, cytology, health control, health risk, national implementing measure, organ transplantation, quality standard, safety standard, summarising

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 2.6.2016  SWD(2016) 127 final/2   CORRIGENDUM  This document corrects document SWD(2016) 127 final of 21.4.2016  Incorrect data sets in A.1.3, A.1.28, and A.1.30. of Annex 1 have been replaced and the Table of Contents amended accordingly.  The text shall read as follows: COMMISSION STAFF WORKING DOCUMENT on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells  {COM(2016) 223 final} {SWD(2016) 128 final}  
 
 
Table of Contents 
1.  

Introduction ..................................................................................................................................... 5 

2. 

Implementation of the EU tissues and cells legislation ................................................................... 5 

Designation of Competent Authority or Authorities Responsible for the Implementation of 

2.1. 
Directive 2004/23/EC .......................................................................................................................... 6 

2.2 

Obligations of Member States Authorities ............................................................................ 10 

2.2.1 

Supervision of human tissue and cell procurement ...................................................... 10 

 Accreditation/designation/authorisation/licensing of tissue establishments and tissue 
2.2.2. 
and cell preparation processes ..................................................................................................... 17 

2.2.3. 

Inspections and control measures ................................................................................ 22 

2.2.4 

Traceability .................................................................................................................... 30 

2.2.5 

Import/export of human tissues and cells .................................................................... 31 

2.2.6. 

Register of tissue establishments and reporting obligations ........................................ 37 

2.2.7. 

Notification of serious adverse events and reactions ................................................... 40 

2.3 

 Donor selection and evaluation ........................................................................................... 45 

2.3.1. 

Principles governing tissue and cell donation (Art. 12) ................................................. 45 

2.3.2. 

Consent, data protection and confidentiality ............................................................... 45 

2.3.3. 

Donor selection and evaluation. Procurement of tissues and cells .............................. 49 

2.3.4 

Donor testing ................................................................................................................. 53 

2.4 

 Quality and safety of tissues and cells .................................................................................. 57 

2.4.1 

Quality management, responsible person, personnel .................................................. 57 

2.4.2. 

Tissue and cell reception, processing, storage, labelling and packaging ...................... 60 

2.4.3. 

Distribution of tissues and cells for human application (Intra-community exchange) . 62 

2.4.4 

Relations between tissue establishments and third parties ......................................... 67 

Annex 1: Individual country responses to the survey on the implementation of the EU Tissues and 
Cells Directives conducted in 2012 and based on 2011 information ................................................ 70 

A.1.1. 

Survey response Austria ................................................................................................ 70 

A.1.2. 

Survey response Belgium .............................................................................................. 82 

A.1.3. 

Survey response Bulgaria .............................................................................................. 93 

A.1.4. 

Survey response Croatia .............................................................................................. 106 

2 

 
 
 
  
A.1.5. 

Survey response Cyprus .............................................................................................. 116 

A.1.6. 

Survey response Czech Republic ................................................................................. 126 

A.1.7. 

Survey response Denmark ........................................................................................... 137 

A.1.8. 

Survey response Estonia .............................................................................................. 148 

A.1.9. 

Survey response Finland .............................................................................................. 158 

A.1.10.  Survey response France ............................................................................................... 169 

A.1.11.  Survey response Germany ........................................................................................... 185 

A.1.12.  Survey response Greece .............................................................................................. 204 

A.1.13.  Survey response Hungary ............................................................................................ 223 

A.1.14.  Survey response Ireland .............................................................................................. 234 

A.1.15.  Survey response Italy .................................................................................................. 248 

A.1.16.  Survey response Latvia ................................................................................................ 263 

A.1.17.  Survey response Liechtenstein .................................................................................... 274 

A.1.18.  Survey response Lithuania........................................................................................... 283 

A.1.19.  Survey response Luxembourg ..................................................................................... 297 

A.1.20.  Survey response Malta ................................................................................................ 306 

A.1.21.  Survey response Netherlands ...................................................................................... 317 

A.1.22.  Survey response Norway ............................................................................................. 329 

A.1.23.  Survey response Poland .............................................................................................. 339 

A.1.24.  Survey response Portugal ............................................................................................ 351 

A.1.25.  Survey response Romania ........................................................................................... 366 

A.1.26.  Survey response Slovakia ............................................................................................ 377 

A.1.27.  Survey response Slovenia ............................................................................................ 386 

A.1.28.  Survey response Spain ................................................................................................. 396 

A.1.29.  Survey response Sweden ............................................................................................. 410 

A.1.30.  Survey response United Kingdom ............................................................................... 424 

3 

 
 
 
 
 
 
 
ABBREVIATIONS 

= European Commission 

ART   = assisted reproductive technologies 
ATMP  = advanced therapies medicinal products 
CMV   = cytomegalovirus 
DBM   = demineralised bone matrix  
EBV   = Epstein–Barr virus 
EBMT  = European Group for Blood and Marrow Transplantation 
EC  
ECDC  = European Centre for Disease Prevention and Control 
EEA   = European Economic Area 
EU 
 = European Union 
GMP   = good manufacturing practices 
GTP   = good tissue practices 
HBV   = hepatitis B virus 
HCV   = hepatitis C virus 
HSC   = haematopoietic stem cells 
HIV   = human immunodeficiency virus 
HFEA   = Human Fertility and Embryology Authority 
HLA   = human leukocyte antigen 
HTA   = Human Tissue Authority 
HTLV  = human T-cell lymphotropic virus 
IgM   = immunoglobulin M 
ISO   = International Organization for Standardization 
JACIE  = Joint Accreditation Committee-ISCT & EBMT 
NAT   = nucleic acid amplification test 
PBSC   = peripheral blood stem cells 
RATC = Rapid Alerts for Tissues and Cells 
SAE   = serious adverse event 
SAR   = serious adverse reaction 
SARE  = serious adverse reactions and events 
SOP   = standard operating procedures 

Member State and country codes: http://publications.europa.eu/code/en/en-370100.htm 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.  

INTRODUCTION 

This  Staff  Working  Document  accompanying  the  Report  from  the  Commission  to  the 
European  Parliament,  the  Council,  the  European  Economic  and  Social  Committee  and  the 
Committee of the Regions on the implementation of Directives 2004/23/EC, 2006/17/EC and 
2006/86/EC setting standards of quality and safety for human tissues and cells summarises the 
results  of  a  Commission  survey  on  the  implementation  of  the  EU  tissue  and  cell  legislation 
conducted in 2013. The data reported was from 2011.  

The implementation survey was answered by all Member States except Greece, and also by 
two  EEA  countries,  Liechtenstein  and  Norway.1  The  individual  country  responses  are 
included in Annex 1 to this document. Only Greece did not provide any information. Overall 
the cooperation with the Member States was satisfactory reflecting the very good interaction 
between the Commission services and the Member States in this area.  

This  document  addresses  only  the  implementation  of  the  EU  tissues  and  cells  legislation, 
whereas  the  outcome  of  the  verification  of  completeness  of  transposition  performed  by  the 
Commission is summarised in the overall Report on the implementation of the EU tissue and 
cell  legislation.  Information  on  the  application  of  the  principle  of  voluntary  and  unpaid 
donation (VUD) is presented in a separate Staff Working Document also accompanying the 
abovementioned Report. 

The implementation section of this document follows the structure of Directive 2004/23/EC, 
and includes three main chapters which address the obligations of Member States' authorities, 
donor selection and evaluation, and quality and safety of tissues and cells. 

2. 

IMPLEMENTATION OF THE EU TISSUES AND CELLS LEGISLATION 

The  implementation  survey  covers  a  broad  range  of  topics:  1.  designation  of  competent 
authorities,  2.  obligations  of  Member  States’  authorities,  3.  donor  selection  and  evaluation, 
and  4.  quality  and  safety  of  tissues  and  cells.  Each  sub-section  ends  with  comments 
summarising the main findings.  

Overall,  the  implementation  of  the  EU  tissues  and  cells  legislation  by  Member  States  is 
considered  adequate.  However,  a  number  of  Member  States  reported  difficulties  in  the 
interpretation, implementation or enforcement of some of its requirements.  

As  the  EU  legislation  in  the  tissue  and  cell  sector  does  not  provide  for  full  harmonisation, 
Member States had various approaches when implementing its provisions. These differences 
facilitate successful integration of the requirements into national legislation but in some cases 
they may limit the mutual acceptance of authorisations with consequences on the cross-border 
movement of tissues and cells. 

1   In a number of cases clarification requests were sent to Member States, as replies were incomplete or difficult 
to reconcile with other information available to the Commission. It is important to note that the hyperlinks 
contain the original replies of Member States, whilst the report reflects the updated information provided by 
Member  States.  This  can  lead  to  certain  discrepancies.  In  such  cases  this  report  contains  the  correct 
information.  

5 

 
 
                                                            
2.1.  Designation  of  Competent  Authority  or  Authorities  Responsible  for  the 
Implementation of Directive 2004/23/EC 
In the 2010 Communication on the application of Directive 2004/23/EC2 it was stated that all 
Member  States  had  designated  a  competent  authority  in  accordance  with  the  provision  laid 
down in Article 4(1), with 21 Member States having one competent authority responsible for 
all  types  of  tissues  and  cells  and  five  Member  States  (EL,  FI,  FR,  PT,  UK)  with  a  specific 
competent authority for reproductive tissues and cells. 

The 2013 survey revealed some organisational changes in the Member States (Table I, Figure 
1): 

 

In 15 Member States (AT, BE, BG, DE, DK, EE, FI, HR, HU, IE, LU, LV, MT, SI, 
SK) and Liechtenstein, there is only one competent authority; 

  Four Member States (CZ, ES, RO, UK) reported that two competent authorities were 
designated  in  their  countries.  In  the  Czech  Republic,  while  the  main  competent 
authority is responsible for tissue establishments’ authorisation and inspection, as well 
as vigilance, a second competent authority is in charge of granting import and export 
licences, European affairs and various aspects related to the national legislation. In the 
United  Kingdom  one  competent  authority  is  overseeing  the  traditional  tissues  and 
cells,  and  the  other  is  responsible  for  the  supervision  in  the  Assisted  Reproductive 
Technologies  (ART)  sector.  In  Romania  one  authority  is  mainly  responsible  for  the 
accreditation  of  the  tissue  establishments,  while  a  second  one  is  in  charge  of 
inspections and vigilance. In Spain, the organisation is similar to the one in the United 
Kingdom,  but  the  national  ART  competent  authority  has  only  a  consultative  role, 
whereas  the  authorisation,  inspection  and  vigilance  tasks  were  delegated  to  the 
regions; 

  Six  Member  States  (FR,  LT,  NL,  PL,  PT,  SE)  and  Norway  reported  that  three 
competent authorities were designated to oversee the tissues and cells field at national 
level;  

 

In  France,  Portugal  and  UK  one  of  the  competent  authorities  is  responsible  only  for 
the oversight of the ART sector;   

  Five Member States declared having regional competent authorities, namely DE, ES, 
FR,  IT  and  SK.  These  authorities  have  been  entrusted  with  tasks  like  accreditation/ 
authorisation/designation/licensing  of 
inspection  and/or 
vigilance.  In  Italy  regional  authorities  are  responsible  only  for  authorising  the  tissue 

tissue  establishments, 

2   http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0708:FIN:EN:PDF  

6 

 
 
                                                            
 
establishments. 

Fig. 1. Tissues and cells competent authorities in the reporting EU Member States and EEA 
countries 

In two Member States the designated competent authorities do not cover all the categories of 
tissues  and  cells  as  requested  by  the  Directives.  This  is  the  case  of  Poland3  and  Lithuania, 
where,  due  to  an  inappropriate  transposition  of  the  EU  legislation  in  the  ART  sector,  no 
competent authorities responsible for this particular field were reported. 

In addition to the oversight of the tissues and cells sector, in most of the Member States, the 
tissues and cells competent authorities are also supervising other sectors/activities (Figure 2).  

3   In 2015 Poland has adopted new legislation for the ART sector and is in process of implementing it. 

7 

 
 
 
 
                                                            
Table I. Tissues and cells national competent authorities 

8 

 
 
 
Fig. 2. Other responsibilities of tissues and cells competent authorities 

Several  Member  States  provided  clarifications  on  the  tasks  and  responsibilities  of  their 
national competent authorities. Germany and Ireland specified that they are also responsible 
for  advanced  therapy  medicinal  products  and  xenogenic  medicinal  products.  Furthermore, 
some  Member  States  reported  that  their  competent  authorities  are  also  responsible  for: 
cosmetic  products,  veterinary  products  (France,  Ireland);  tattoo  inks,  biocides,  ancillary 
products, human breast milk (France); clinical trials approval, protection of animals (Ireland); 
data collection and traceability (Italy); licensing of import-export activities (Czech Republic, 
Poland); licensing organisations that remove, store, and use human tissue for purposes outside 
direct  patient  treatment  (United  Kingdom/HTA);  public  health  regulation  (Malta);  policy 
development  and  implementation  (Denmark,  Ireland,  United  Kingdom);  providing  training 
programmes, international cooperation, relation with the media, research projects, transplant 
registries, promotion and education (Spain, Italy); enforcement (Ireland). 

Certainly  the  designation  of  the  competent  authority  or  authorities  in  the  field  of  human 
tissues  and  cells  for  human  application  is  a  prerogative  of  the  Member  States  and  EEA 
countries.  As  demonstrated  by  the  reported  data,  many  national  competent  authorities  are 
ministries  or  agencies  or  delegated  bodies  in  the  health  sector.  In  some  countries  the 
nominated  organisations  also  work  on  research,  education  or  labour  issues.  Some  countries 
with  federal  organisations  have  entrusted  some  important  responsibilities  (e.g.  authorisation 
and  inspection  of  tissue  establishments)  to  the  regional  authorities.  Whereas  some  Member 
States preferred to pool national capability in one large national competent authority usually 
responsible  for  several/all  healthcare  sectors,  other  countries  chose  to  develop  expertise  by 
creating/maintaining  distinct  organisations  dedicated  to  oversee  the  human  tissues  and  cells 
sector or a specific area of this sector (e.g. ART). Irrespective of organisational structure, the 
bi-annual  meetings  of  the  tissues  and  cells  competent  authorities  allow  for  sharing  best 
practices,  with  specialised  authorities  giving  significant  input  in  their  particular  area  of 
expertise and the others contributing with integrative standpoints within the broader context 
of  the  healthcare  sector,  especially  when  analysing  borderline  issues  like  those  with  the 
medical devices and medicinal products sectors.  

9 

 
 
 
 
Comments 

All Member States have appointed competent authorities for tissues and cells, which can be 
considered satisfactory. In some Member States more than one authority is responsible for the 
oversight of the tissue and cell sector. In these cases the division of tasks is based on the tissue 
types  concerned  (e.g.  separate  authority  for  the  ART  sector),  geographic  competences 
(federal/regional/local)  or  instruments  used  (e.g.  authorisation/inspection).  In  some  Member 
States  the  authorities  for  tissues  and  cells  are  also  responsible  for  the  oversight  of  other 
sectors  (e.g.  organs,  blood,  medicinal  products),  which  can be  beneficial  from  an  efficiency 
point of view. Ultimately it is for the Member States to decide on the organisational set-up of 
their  competent  authorities.  However,  Member  States  need  to  ensure  adequate  coordination 
and  communication  between  all  authorities  involved,  e.g.  to  discuss  borderline  issues  or 
ensure adequate follow-up in case of shortcomings.  

Irrespective  of  the  organisational  set-up  it  is  important  that  all  authorities  have  adequate 
resources at their disposal and are independent from industry, from the professional sector and 
other influences. In this respect it could be problematic if one and the same person works for a 
national competent authority and – at the same time – for a national tissue establishment.  

2.2  Obligations of Member States Authorities  

Directive 2004/23/EC contains a number of obligations for competent authorities. They relate 
to  (1)  the  supervision  of  procurement,  (2)  the  authorisation  of  tissue  establishments,  (3) 
inspections  and  control  measures,  (4)  traceability,  (5)  imports  and  exports,  (6)  reporting 
obligations and (7) notification of serious adverse events and reactions. The implementation 
of these obligations is set out in this section. 

2.2.1  Supervision of human tissue and cell procurement  

Under  Article  5  of  the  Directive  2004/23/EC,  the  competent  authority  or  authorities  must 
ensure  that  tissue  and  cell  procurement  and  testing  are  carried  out  in  conditions  accredited, 
designated, authorised or licensed for this purpose and that it complies with the requirements 
laid down in Directive 2006/17/EC.  

The survey showed that all reporting Member States authorise the conditions of procurement, 
as follows: 

  Twelve  Member  States  (BG,  CY,  CZ,  DE,  ES,  FI,  HR,  HU,  IE,  LU,  MT,  SI)  and 
Liechtenstein  authorise  the  conditions  of  procurement  by  inspecting  all  procurement 
centres;  

  Seven  Member  States  (AT,  DK,  IT,  PL,  PT,  SE,  UK)  reported  inspecting  some 

procurement centres; 

  Nineteen Member States (AT, BE, BG, CY, DE, DK, EE, HR, HU, IT, LT, LU, LV, 
MT,  NL,  PL,  PT,  SE,  UK)  and  Norway  evaluate  the  documentation  associated  with 
the procurement made available by the tissue establishment working with procurement 
centres.  

Additionally, Member States reported other practices:  

  Procurement sites have to be listed on the tissue establishment’s licence and inspected 

during routine inspections (Finland);  

10 

 
 
  Procurement  activities  are  evaluated  during 

the  product  evaluation,  where 

documentation has to include a description of the procurement conditions (France);  

  Procurement  centres  which  operate  through  a  third  party  agreement  with  a  licensed 
establishment  are  not  inspected  by  the  national  competent  authority  (United 
Kingdom). 

Estonia specified that only tissue establishments and healthcare professionals having contracts 
with  tissue  establishments  are  allowed  to  procure  tissues.  Ireland  reported  that  when 
procurement  occurs  in  Ireland,  the  activity  is  inspected  and  the  site  requires  a  tissue 
establishment  authorisation;  if  the  procurement  occurs  outside  Ireland,  the  relevant 
documentation  is  inspected  onsite  at  the  Irish  tissue  establishment.  Similar  to  Ireland,  in 
Belgium  procurement  can  be  carried  out  only  by  authorised  tissue  establishments.  Romania 
reported that one competent  authority is  responsible  for evaluating  the documentation  of all 
the  procurement  centres,  while  the  other  authority  is  responsible  for  their  inspection.  Spain 
informed that the task of supervising human tissue and cell procurement was entrusted to the 
regional competent authorities. 

In 2011, 20 Member States and Liechtenstein and Norway, granted 640 authorisations for the 
conditions  of  procurement  (Figure  3).  Six  Member  States  (FI,  IE,  LU,  LV,  PT,  SE)  did  not 
grant  any  authorisation  and  in  two  Member  States  (Greece  and  Italy)  such  data  were  not 
available. 

Fig. 3. Number of authorisations for conditions of procurement granted in 2011 

Most  of  the  Member  States  provided  the  number  of  centres  carrying  out  procurement 
activities in 2011. Of the 4825 procurement organisations carrying out procurement activities, 
most  of  them  are  dedicated  to  the  collection  of  haematopoietic  stem  cells,  followed  by 
procurement of replacement tissues and reproductive cells (Figure 4). It has to be underlined 
that  a  number  of  332  procurement  organisations  harvesting  cells  or  tissues  to  be  used  for 
advanced  therapy  medicinal  product  (ATMP)  manufacturing  were  also  reported.  A  detailed 
analysis  of  the  procurement  organisations  per Member  State  and  type of  tissues  procured is 
presented in Figures 5 - 8. 

11 

 
 
 
 
Fig. 4. Number of procurement organisations reported by the EU and EEA countries (2011 
data)  

Fig. 5. Number of centres carrying out procurement of replacement tissues (e.g. 
musculoskeletal, cardiovascular, ocular tissue, skin) in 2011 

12 

 
 
 
 
 
 
 
Fig. 6. Number of centres carrying out procurement of HSC (e.g. bone marrow, peripheral 
blood stem cells, cord blood) in 2011 

Fig. 7. Number of centres carrying out procurement of reproductive tissues and cells in 2011 

Fig. 8. Number of centres carrying out procurement of tissues and/or cells for ATMP 
manufacturing in 2011 

The  survey  revealed  that  all  reporting  Member  States  ensure  that  centres  carrying  out 
procurement of human tissues and cells centres comply with the requirements of Article 5 of 
Directive  2004/23/EC  and  its  implementing  Directive  2006/17/EC.  Their  approaches  vary, 
with  Member  States  only  inspecting  the  site/centre,  others  only  analysing  the  mandatory 
documentation  (Belgium,  Denmark),  and  most  of  them  performing  both  inspections  and 
analysis of the mandatory documentation (Fig 9). 

13 

 
 
 
 
 
 
Fig. 9. Member States’ approaches for ensuring that centres carrying out procurement of 
human tissues and cells comply with the EU legal requirements  

Additional procedures were also reported. In Sweden tissue establishments perform audits of 
the  procurement  centre(s)  and  the  audit  reports  are  examined  during  the  inspection  of  the 
tissue  establishment.  The  competent  authority  in  the  United  Kingdom  (HTA)  reported 
investigating  allegations  about  non-compliance  with  procurement  standards;  moreover,  to 
ensure continued compliance, correspondence is circulated to the sector (e.g. newsletter) and 
regular workshops are organised for updating the tissue establishments on the latest regulatory 
requirements.  

According to Article 5(1) of Directive 2004/23/EC Member States have to ensure that testing 
is carried out in conditions accredited, designated, authorised or licensed for this purpose. The 
survey showed that only in 10 Member States (CZ, DE, DK, HR, LU, MT, NL, RO, UK) and 
Liechtenstein and Norway, the tissues and cells competent authorities are also responsible for 
the accreditation/designation/authorisation or licensing of testing laboratories. In all the other 
Member States this is the competence of other authorities (Table II), as follows: 

  Ministry of Health (Cyprus, Slovenia); 

  Regional authorities (DE, ES, FI, HU, IT); 

  National accreditation organisations. 

14 

 
 
 
 
 
 
 
 
 
 
Country 

Name of the national accreditation organisation 

BE  

BG  

EE  

FI  

FR  

IE  

LV  

PL  

PT  

SE  

SK  

UK 

Scientific Institute for Public Health  

Bulgarian Service for Accreditation  

Estonian Accreditation Centre  

National Institute for Health and Welfare  

Comité Français d'Accréditation 

Irish National Accreditation Board  

Latvian National Accreditation Bureau  

National Chamber of Diagnostic Laboratories  

Direcao-General de Saude  

The Swedish Board for Accreditation and Conformity Assessment  

Slovak National Accreditation Service 

Clinical Pathology Accreditation (private organisation, providing a voluntary national 
accreditation service) 

Table II. National accreditation organisation responsible for the accreditation/designation/ 
authorisation or licensing of testing laboratories 

Additionally, Malta, Romania and Liechtenstein reported that in their countries the tissues and 
cells  competent  authorities  are  responsible  for  the  laboratories'  accreditation,  without  being 
responsible  for  inspecting  them.  Austria  reported  having  no  national  provisions  on 
accreditation of testing laboratories.  

The Member States' approaches for ensuring that tests required for donors are carried out only 
by  qualified  laboratories  accredited,  designated,  authorised  or  licensed  in  conformity  with 
Article 5(2) of Directive 2004/23/EC are shown in Figure 10. 

Concerning the inspection of the testing laboratories, while in the Czech Republic, Denmark 
and the United Kingdom the tissues and cells competent authorities are also responsible for 
the laboratories' accreditation, in Hungary, Portugal and Spain this task is not in their remit.  

Eleven  Member  States  also  provided  the  number  of  qualified  laboratories  in  their  countries 
(2011 data) (Figure 11).  

Overall, the answers to this section of the questionnaire showed that Member States pay strict 
attention  to  the  procurement  of  human  tissues  and  cells.  This  is  underlined  by  the  fact  that 
several countries allow procurement to be performed only by tissue establishments (BE, DE, 
EE, IT, SE) or authorise the conditions of procurement by inspecting all procurement centres 
(BG,  CY,  CZ,  DE,  ES,  FI,  HR,  HU,  IE,  LU,  MT,  SI  and  LI).  Additionally,  in  most  of  the 
responding countries, the documentation associated with the procurement is analysed during 
tissue establishments’ inspections.  

15 

 
 
Fig. 10. Member States approaches for ensuring that donors’ testing is carried out in 
conformity with Article 5.2 of the Directive 2004/23/EC 

Fig. 11. Number of qualified testing laboratories/Member State  
(Total number = 421 – 2011 data) 

Comments 

The  high  number  of  procurement  organisations  shows  that  this  activity  is  well  developed 
across the Union, particularly in the larger Member States with tradition in this field (e.g. DE, 
FR,  IT,  UK).  Furthermore,  beside  procurement  of  replacement  tissues,  haematopoietic  stem 
cells  and  reproductive  cells,  some  Member  States  also  reported  a  significant  number  of 
centres carrying out procurement of tissue and cells for ATMP manufacturing.  

testing, 

the  survey  showed 

Concerning 
the  reporting  countries 
accreditation/designation/authorisation  or  licensing  of  testing  laboratories  is  not  under  the 
competence  of  tissues  and  cells  authorities.  In  most  of  the  cases  the  national  accreditation 
organisations are also responsible for the inspection of the testing laboratories. However, only 
the  countries  in  which  tissues  and  cells  competent  authorities  are  also  responsible  for  the 

in  most  of 

that 

16 

 
 
 
 
accreditation/designation/authorisation  or  licensing  of  testing  laboratories  provided  data  on 
the number of qualified laboratories on their territory. Wherever accreditation and inspections 
are  undertaken  by  different  authorities,  a  good  communication  and  coordination  between 
respective authorities needs to be ensured. 

 Accreditation/designation/authorisation/licensing of tissue establishments and tissue 

2.2.2. 
and cell preparation processes 

Under  Article  6(1)  of  Directive  2004/23/EC,  Member  States  must  have  in  place  an 
appropriate  mechanism  to  ensure  that  all  tissue  establishments  where  activities  of  testing, 
processing,  preservation,  storage  and  distribution  of  human  tissues  and  cells  intended  for 
human  applications  are  undertaken  have  been  accredited,  designated,  authorised  or  licensed 
by a competent authority for the purpose of those activities.  

ocular 

tissues, 

All Member States reported that for replacement tissues and cells (e.g. musculoskeletal tissue, 
an 
cardiovascular 
accreditation/designation/authorisation/licensing  system  of  tissue  establishments  is  in  place. 
In  the  ART  sector,  25  Member  States  reported  having  an  accreditation,  designation, 
authorisation,  licensing  system  also  for  the  ART  tissue  establishments,  while  two  Member 
States (Lithuania, Poland) are still in the process of organising their national oversight system 
for this area. 

haematopoietic 

tissues, 

cells) 

skin, 

stem 

As  reported  by  the  Member  States,  inspections  play  a  key  role  in  the  accreditation/ 
designation/authorisation/licensing  process  which  varies  from  prior  compulsory  on-site 
inspections  to  desk-based  review  of  documentation  and  routine  inspections  (Figure  12).  In 
five  Member  States  (ES-ART  sector,  FR,  SE,  SK,  UK)  and  Norway  inspection  is  not  a 
tissue 
prerequisite  for 
establishments.  

the  designation,  authorisation,  accreditation,  or 

licensing  of 

Fig. 12. National requirements for accrediting/designating/authorising/licensing of tissue 
establishments 

Under Article 6(2), the competent authority or authorities must authorise the tissue  and cell 
preparation processes which the tissue establishment is entitled to carry out.  

Compared  with  the  2008  data  when  only  three  Member  States  were  conducting  inspections 
solely for the purpose of authorising preparation processes, this second survey reveals that 14 

17 

 
 
 
 
Member States are now organising such inspections (Figure 13). In the other Member States, 
in  the  absence  of  specific  authorisation  systems,  tissue  and  cell  preparation  processes  are 
either  authorised  by  reviewing  applications  of  the  submitted  documentation  or  during  a 
general inspection for the purpose of authorising a tissue establishment.  

Fig. 13. National systems for authorising tissue and cell preparation processes   
Two  Member  States,  Croatia  and  the  Netherlands,  reported  that  a  certification  of  the  tissue 
establishment to a quality system standard provided by an external entity is also required. In 
other  Member  States  (Cyprus,  France  and  Spain),  the  certification  by  an  external  entity  is 
optional, but recommended. In Italy there are different approaches depending on the type of 
tissues/cells:  whereas  haematopoietic  stem  cells  centres  are  inspected  in  collaboration  with 
JACIE and cord blood banks require ISO certification, for the other types of tissues and cells, 
no certification is required by law.  

to  2008  when  1716 

tissue  establishments  were  accredited/designated/ 
Compared 
authorised/licensed,  the  current  survey  showed  that  at  31/12/2011  a  total  of  2047  tissue 
establishments were accredited, designated, authorised or licensed in the EU (Figures 14 and 
15).  

18 

 
 
 
Fig. 14. Number of accredited/designated/authorised/licensed tissue establishments per type 
of human tissues and cells (2011 data) 

Fig. 15. Number of accredited/designated/authorised/licensed tissue establishments per type 
of human tissues and cells (comparative data) 

The  numbers  of  accredited/designated/authorised/licensed  tissue  establishments  per  country 
are  presented  in  Figure  16.  Only  one  Member  State,  namely  Malta,  reported  having  no 
authorised  tissue  establishments  on  their  territory.  Norway  provided  no  information  on  the 
number of tissue establishments. 

19 

 
 
 
 
Fig. 16. The number of accredited/designated/authorised/licensed tissue 
establishments/country (2011 data) 

Additionally in 2011, 1674 tissue establishments were authorised/re-authorised by competent 
authorities in 26 Member States (AT, BE, BG, CY, CZ, DE, DK, EE, FI, FR, HR, HU, IE, IT, 
LT, LU, LV, MT, NL, PL, PT, RO, SE, SI, SK, UK ) and Liechtenstein. Eighteen Member 
States (AT, BE, BG, CY, CZ, DE, FR, HR, HU, IE, IT, LV, MT, PL, RO, SI, SK, UK) and 
Liechtenstein 
tissue  establishments  were  pending  approval  of 
authorisation/re-authorisation at 31/12/2011.  

that  528 

indicated 

Information on the status of the tissue establishments (public vs. private) was provided by 25 
Member  States  and  Liechtenstein.  The  situation  is  summarised  in  Figures  17  and  18.  Two 
other countries, Spain and Norway, indicated that such data are not available. 

Fig. 17.Tissue establishments’ status (public vs. private)/country (2011 data) 

20 

 
 
 
 
 
Fig. 18.Tissue establishments’ status (public vs. private)/type of tissue (2011 data) 

Overall,  916  public  and  828  private  accredited/designated/authorised/licensed 
tissue 
establishments  were  reported.  As  shown  in  Figure  18,  only  in  the  ART  field  and  the  cord 
blood  sector  the  number  of  private  tissue  establishments  exceeds  the  number  of  the  public 
ones (69% and 59% respectively). Some interesting mixed models have emerged such as the 
tissue  sector  in  Italy,  where  the  private  sector  role  is  limited  to  that  of  a  third  party  for 
processing  or  storage,  with  all  donation,  promotion  and  distribution  activities  remaining  in 
public hands. 

Under Article 6(5), competent authorities may agree to the direct distribution of tissues and 
cells for immediate transplantation to a recipient. Six Member States (CY, DE, DK, LT, FR, 
PT) indicated that in 2011 tissues and/or cells were distributed under the direct agreement of 
an  competent  authorities.  In  most  of  the  cases,  these  were  HSC  (bone  marrow,  PBSC,  cord 
blood, donor lymphocyte infusion), but also ocular tissues (Denmark, Portugal), heart valves 
(Portugal), musculoskeletal tissue (Lithuania, Portugal) and amniotic membrane (Portugal). 

Comments 

The importance of the tissue and cell sector was demonstrated by its development in the last 
three  years,  with  an  almost  20%  increase  in  the  number  of  authorised  tissue  establishments 
compared  with  the  previous  survey.  In  two  areas  (musculoskeletal  tissues  and  reproductive 
cells)  a  significant  rise  in  the  tissue  establishments’  number  was  noted,  whereas  for  other 
types  of  tissues  and  cells  the  number  of  authorised  tissue  establishments  slightly  decreased. 
Additionally,  if  for  most  types  of  tissues  and  cells  the  public  sector  prevails,  in  the  field  of 
ART  approximately  60%  of  the  ART  establishments  belong  to  the  private  sector.  The 
development  of  the  private  sector  is  more  significant  in  some  Member  States  (e.g.  the 
Netherlands), while in others (e.g. BG, CZ, DE, RO) is due to the expansion of private ART 
establishments and cord blood banks. 

21 

 
 
 
Summing up, the answers concerning the accreditation/designation/authorisation/licensing of 
tissue  establishments  and  tissue  and  cell  preparation  processes  showed  that  this  core 
responsibility  is  well  implemented  across  the  Union.  However,  when  the  survey  was 
launched, two Member States were still in the process of transposing into national legislation 
the  requirements  for  safety  and  quality  in  the  ART  field,  and  one  Member  State  had  no 
operational competent authority and submitted no replies to the implementation questionnaire.  

The survey showed that the authorisation process  is quite heterogeneous, which  may hinder 
the process of mutual acceptance of authorisations between EU Member States. Even though 
half of the responding Member States require a prior on-site inspection, most of the countries 
grant a tissue establishment authorisation/accreditation/licence based on a desk-based review 
of  the  documentation.  Additionally,  depending  on  the  Member  State's  approach,  tissue 
establishments’  authorisations/accreditations/licences  are  granted  for  a  limited  or  unlimited 
time interval.  

A  combination  of  approaches  was  also  reported  for  authorising  tissue  and  cell  preparation 
processes.  Numerous  recent  technological  developments  which  generated  new  processing 
methodologies,  unheard  of  a  decade  ago  (e.g.  pre-cutting  of  corneas  with  the  transplant  of 
only  the  anterior  or  posterior  segment  to  one  patient,  decellularisation  of  skin  and  heart 
valves, new pathogen inactivation or sterilisation techniques) have increased the importance 
of  robust  preparation  process  authorisation.  As  suggested  by  some  Member  States,  a  more 
harmonised  procedure  and/or  establishing  an  EU  authorisation  template  for  preparation 
process authorisation may contribute to reaching mutual acceptance between Member States. 

While it is for Member States to decide which terminology to use for the initial permission to 
operate  as  a  tissue  establishment,  it  should  be  transparent  and  mutually  clear  for  competent 
authorities that the requirements of the EU legislation have been met in every Member State. 
The  differences  in  terminology  used  might  create  some  confusion,  in  particular  as  some  of 
these  terms  (e.g.,  accreditation)  are  also  used  to  describe  reviews  by  private,  non-
governmental entities.  

Overall, the survey shows that it is important that all Member States continue improving their 
practices  on  authorisation,  accreditation,  licensing  and  designation  according  to  the  EU 
legislation.  

2.2.3.  Inspections and control measures  

Under Article 7(1) of Directive 2004/23/EC, Member States must ensure that the competent 
authority  or  authorities  organise  inspections  and  that  the  tissue  establishments  carry  out 
appropriate control measures. 

As  reported  in  the  first  implementation  survey,  most  of  the  countries  have  comprehensive 
inspection systems place. Twenty-four Member States (AT, BE, BG, CY, DE, DK, EE, ES, 
FI, FR, HR, HU, IE, IT, LU, LV, MT, NL, PL, PT, RO, SE, SI, UK) and Liechtenstein and 
Norway confirmed the existence of such systems (Table III).  

22 

 
 
 
 
 
 
AT 

BE 

BG 

Austrian Agency for Health and Food Safety (AGES)                                      

Directorate General Inspection of FAMHP                                             

National Transplant Agency - Department "Registers, information, control and 
development of transplant"  

CY  Ministry of Health 
CZ 

Clinical Practice and Surveillance over Biological Material Processing (part of Inspection 
Division)                                           

DE 

DK 

EE 

ES 

FI 

FR 

Regional competent authorities in the German Länder supported by the Paul-Ehrlich-
Institute.  
 Danish Medicines and Medicines Authority  

State Agency of Medicines, Department of Biologicals within the structure of the agency.                                              

Regional competent authorities.                                                         

Fimea’s Inspectorate unit within the "Supervision and licenses Department"  

ANSM (INSBIO Department) - for non-reproductive tissues and cells. Regional agencies 
- for ART establishments  

HR  Ministry of Health - Service for Blood, Tissues and Cells Inspection                                  

HU 

IE 

IT 

LI 
LT 

Officers of the National Public Health and Medical Officer Service - Office of the Chief 
Medical Officer, Department of Health Administration  

Irish Medicines Board - Compliance department  

CNT - Tissue and Cell section. For HPC and cord blood banks inspections are carried out 
in collaboration with CNS.      
Arzneimittelkontrolle, for coordination and the Swissmedic inspectorate by agreement.                                                       
Legal and Supervisory Division of the National Transplant Bureau under the Ministry of 
Health of Lithuania  

LU  Ministère de la santé - Division de la médecine curative.                                                

LV 
MT 

State Agency of Medicines - Pharmaceutical activities compliance evaluation department  
Superintendence of Public Health                                             

NL 

Health Care Inspectorate         

NO 

Norwegian Board of Health Supervision                                         

PL 
PT 

National Centre for Tissue and Cell Banking                                         
DGS - Departamento da Qualidade na Saúde, for non-reproductive tissues. Ministry of 
Health' administrative body for Health Inspections (IGAS) in collaboration with CNPMA, 
for ART establishments. 

RO  Ministry of Health - State Sanitary Inspectorate  

SE 
SI 

SK 

UK 

The Health and Social Care Inspectorate  
Agency for Medicinal Products and Medical Devices  

In preparation 

HTA - Regulation directorate for tissue establishments handling non-reproductive tissues 
and cells and reproductive tissues. HFEA - Directorate of Compliance - for ART 
establishments 

Table III. Competent authorities responsible for inspections (2011 data) 

23 

 
 
 
 
One  Member  State,  Slovakia,  is  currently  developing/revising  the  inspection  system  at 
national level.  

inspections  performed 

Most Member States reported that tissue establishment inspection schemes overlap or interact 
with 
(mostly  blood,  organs,  medicinal 
products/advanced therapies (Figure 19). Only seven Member States (CY, HU, LT, LU, PL, 
PT,  SK)  and  Liechtenstein  indicated  having  in  place  national  inspection  schemes  dedicated 
only to tissue establishments.  

in  other 

sectors 

  19. Overlaps of the tissue establishment inspection schemes 

Twenty-five  Member  States  provided  data  on  the  staffing  of  inspection  departments  within 
the  national  competent  authorities  (Figure  20)  and  the  number  of  inspections  performed  in 
2011 (Figures 21a and 22a), as well as their outcome (Figures 21b and 22b).  

Fig. 20. Number of inspectors/Member State (numbers provided by FR, HU, RO and SE 
include also the inspectors in the regional authorities) 

24 

 
 
 
 
 
 
For  Spain,  where  inspection  was  entrusted  to  the  competent  authorities  in  the  autonomous 
regions,  no  data  on  either  staffing  or  the  number  of  inspections  performed  in  2011  were 
provided.  Germany  indicated  that  inspections  are  carried  out  by  the  regional  competent 
authorities of the German Länder, supported by the national competent authority and provided 
data only on the number of inspections performed in 2011. Additionally, France specified that 
for  the  ART  sector  the  regional  agencies  were  given  the  task  of  inspecting  the  ART 
establishments, but the national authority is responsible for ensuring the  appropriate training 
of  the  ART  inspectors  and  for  publishing  an  annual  report  on  these  inspections.  Several 
Member  States  pointed  out  that  inspections  are  carried  out  by  inspectors  of  the  national 
competent  authority  together  with  inspectors  from  the  regional  competent  authorities  (e.g. 
HU,  IT,  RO).  Sweden  reported  that  inspections  are  performed  by  the  national  competent 
authority  together  with  inspectors  from  the  regional  offices.  No  information  was  received 
from  Slovakia.  Two  Member  States,  France  and  the  United  Kingdom,  provided  data  on  the 
number of specialised inspectors for the ART establishments. 

Regarding staffing, 13 Member States (BE, DK, EE, HR, IE, LU, LV, MT, PL, PT, RO, SE, 
SI)  and  Liechtenstein  specified  that  inspectors  responsible  for  the  inspection  of  tissue 
establishments  are  also  in  charge  of  performing  inspections  in  other  sectors  (e.g.  blood, 
organs, medicinal products, sanitary inspections).  

Regarding  the  number  of  inspections  carried  out  in  2011,  a  number  of  542  inspections  of 
tissue establishments for non-reproductive tissues and cells was reported, as follows: 

  506 routine inspections; 

  Four inspections following the communication of a serious adverse reaction (SAR) or 

event (SAE), and; 

  32  other  inspections  (enforcement  inspections;  inspections  for  new  preparation 
processes; suspicion of illegal activities; verification of traceability and new activities; 
verification of corrective actions following a previous inspection; inspections due to a 
whistle-blower; inspection following moving to new premises). 

Regarding  the  outcome  of  these  inspections,  in  48  cases  (9%)  no  shortcomings  were  noted, 
minor  or  major  shortcomings  were  identified  in  331  (61%)  cases  and  150  cases  (28%) 
respectively,  whereas  in  five  cases  inspections  were  followed  by  either  suspension  (four 
cases) or revocation of authorisation and closure of the tissue establishment (one case) (Figure 
21b).  

25 

 
 
Fig. 21a. Number of authorised tissue establishments for non-reproductive tissues and cells 
and the number of inspections carried out in 2011 

Fig. 21b. Outcome of the 2011 inspections of authorised tissue establishments for non-
reproductive tissues and cells  

For the ART sector, 338 inspections were carried out in 2011 in 23 Member States as well as 
in Liechtenstein and Norway (Figure 22a). These included: 

26 

 
 
 
 
 
 
- 305 routine inspections; 

-  8  inspections  following  the  communication  of  a  serious  adverse  reaction  (SAR)  or  event 
(SAE) and; 

- 25 other inspections (e.g. following major organisational changes).  

The  outcome  of  these  inspections  was  as  follows:  in  63  cases  no  shortcomings  were  noted, 
minor or major shortcomings were identified in 243 cases and 131 cases respectively, whereas 
in  six  cases  inspections  were  followed  by  either  suspension  (three  cases)  or  revocation  of 
authorisation and closure of the tissue establishments (three cases) (Figure 22b).  

Fig. 22a. Number of authorised ART establishments and the number of inspections carried 
out in 2011  

Fig. 22b. Outcome of the 2011 inspections of authorised ART establishments  

27 

 
 
 
 
 
Besides  the  abovementioned  inspections,  in  2011  inspections  of  procurement  organisations 
outside the tissue establishments took place in 13 Member States (AT, BE, BG, CZ, DE, DK, 
FI, LU, MT, PL, PT, RO, SI) and Liechtenstein.  

Additionally, inspections of third parties were performed by 12 Member States (BE, BG, CZ, 
DE,  FR,  HR,  IT,  MT,  NL,  PL,  RO,  SI).  Most  of  the  Member  States  indicated  a  variety  of 
reasons for which third party inspections were not performed (e.g. no legal obligation, lack of 
inspection  capacity,  few  or  no  third  party  agreements,  third  parties  are  limited  to  testing 
laboratories which are licensed and inspected by other authorities, tissue establishments have 
to audit the third parties and the audit report is reviewed during routine inspections). 

Concerning the  implementation  of  Article  7(2),  23  Member  States  confirmed  respecting  the 
required time interval between two inspections (two years). Moreover, Hungary informed that 
tissue establishments are inspected every year. Sweden indicated that all tissue establishments 
were authorised in 2010, and inspected for the first time in 2010 and 2011; thereafter the time 
interval between inspections has not exceeded  two years. Four Member States (DK, HR, IT 
(only  for  the  HPC  and  ART  establishments)  and  NL)  reported  difficulties  to  fulfil  this 
requirement mainly due to staffing problems within the national inspectorates.  

In response to the requirement of Article 7(5) of Directive 2004/23/EC, in August 2010, the 
Commission  published  the  Operational  manual  for  competent  authorities  on  inspection  of 
tissue  and  cell  procurement  and  tissue  establishments  –  Guidelines  for  inspection 
(Commission  Decision  2010/453/EU4).  The  Manual  was  translated  in  all  the  official 
languages5. Even though the Manual is not legally binding, 22 Member States (AT, BE, BG, 
CY,  CZ,  DK,  EE,  ES,  FI,  HR,  HU,  IE,  IT,  LU,  LV,  MT,  NL,  PL,  PT,  RO,  SI,  SK),  and 
Liechtenstein  and  Norway  reported  using  this  Manual  at  national  level.  DE  reported  that 
according to the national legislation, the manual is not mandatory, but it is recommended as a 
guideline.  Four  Member  States  (DE,  LT,  SE,  UK)  reported  that  national  guidelines  were 
developed and are currently used at national level. 

Twenty-five Member States (AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, FR, HR, HU, IE, IT, 
LT,  LV,  MT,  NL,  PL,  PT,  RO,  SI  SK,  UK),  and  Liechtenstein  and  Norway,  sent  their 
inspectors to the training courses organised by the EU-funded projects EUSTITE6 and SOHO 
V&S7 and rated their usefulness and efficacy from good (three countries), to very good (ten 
countries) and essential (14 countries). 

Regarding  inspections  of  procurement  sites  in  third  countries  from  where  tissue  and  cell 
preparations were imported into the EU, only Germany and France indicated organising such 
inspections.  Germany  reported  that  the  inspection  in  the  third  country  was  a  requirement 
pursuant to section 72b of the German Medicinal Products Act, whereas France specified that, 
in some cases, the national competent authority was asked to verify the accuracy of the data 
provided by the exporting procurement centre to the French tissue establishments. 

As laid down in Article 7(6) and in agreement with the national competent authorities in three 
Member States (Bulgaria, Czech Republic, and Spain), joint inspections with other Member 

4  
5  
6  
7  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:213:0048:0050:EN:PDF  
http://ec.europa.eu/health/blood_tissues_organs/docs/manual_en.pdf 
http://ec.europa.eu/eahc/projects/database.html?prjno=2005204  
http://ec.europa.eu/eahc/projects/database.html?prjno=20091110  

28 

 
 
                                                            
 
States'  competent  authorities  were  organised.  Bulgaria  reported  that  a  joint  inspection  was 
performed  with  the  French  competent  authorities.  Spain  reported  that  the  inspectors  of  the 
HTA inspected the Transplant Service Foundation (Spain) in relation to distribution of skin to 
the United Kingdom. Additionally, the United Kingdom reported a case where a Regulation 
Manager  observed  an  inspection  in  Germany  in  2012  following  allegations  made  against  a 
German tissue establishment about procurement without consent.  

In line with the provisions in Article 7(7) of Directive 2004/23/EC, four Member States (CZ, 
FR, NL, UK) requested or organised inspections of a tissue establishment located in another 
EU country, in collaboration with the competent authority(ies) from that Member State. The 
Czech Republic indicated that the purpose of the inspection was to exchange information and 
regulatory  approaches,  whereas  for  France's  and  Netherlands'  competent  authorities  the 
objective was to substantiate the data provided by the tissue supplier in that Member State.  

Most of the Member States and Norway indicated an interest in developing joint inspections. 
Lack  of  resources  and  personnel  are  seen  as  the  main  obstacles  for  the  five  countries  (CY, 
DK, FI, LU and LI) who declared having no interest in organising such inspections.  

Comments 

The  analysis  of  the  replies  concerning  inspections  of  tissue  establishments  indicates  a  good 
implementation of the Directives’ requirements. If in most cases minor or major shortcomings 
were  recorded,  only  a  few  suspensions  and  revocations  of  authorisations  were  reported, 
showing  that  tissue  establishments  are  striving  to  comply  with  the  EU  quality  and  safety 
requirements.  Besides  suggesting  a  high  degree  of  compliance,  which  would  be  welcomed, 
the  small  number  of  suspensions/revocations  may  also  indicate  under-enforcement  (e.g.  in 
countries  which  have  never  reported  any  shortcomings).  No  data  on  the  number  of  tissue 
establishments that voluntarily ceased operations or were forced to cease operations for other 
reasons (e.g. economic) were provided. 

Concerning  the  time  interval  between  inspections,  several  Member  States  underlined  the 
difficulty of performing inspections every two years.  It was also suggested that instead of a 
fixed time interval, a risk-based approach may be equally valuable. The development of a risk 
assessment tool to prioritise inspections based on factors like the size of establishment, range 
of activity, experience of designated individuals responsible for oversight of the licence and 
compliance history was reported by some Member States.  

The  heterogeneous  practices  reported  (desk-based  vs.  on-site  inspections,  routine  vs.  non-
routine inspections), the discrepancies in the number of inspectors and their training/expertise, 
or  the  impossibility  to  provide  the  number  of  staff  in  charge  of  inspections  in  the  regional 
competent authorities may explain why an agreement on the mutual acceptance of inspections 
was not yet reached. Even though most of the Member States reported using the non-binding 
“Operational  manual  for  competent  authorities  on  inspection  of  tissue  and  cell  procurement 
and  tissue  establishments”  published  by  the  Commission  in  2010,  it  was  suggested  that  the 
current  practices  in  the  Member  States  should  be  further  analysed  and  addressed,  so  that 
shortcomings  identified  during  inspections  in  different  Member  States  (e.g.  classification  of 
minor,  major  and  critical  deficiencies)  result  in  similar  consequences  for  the  inspected 
establishment (e.g. indications for a revocation or suspension for similar deficiencies).  

Concerning  joint  inspections,  their  outcome  was  in  general  satisfying  and  in  particular 
allowed bringing expertise where this might be missing within their own Member State.  

29 

 
 
2.2.4  Traceability  

Member States must ensure that all tissue and cells procured, processed, stored or distributed 
on their territory can be traced from the donor to the recipient and vice versa. Additionally, 
Member  States  are  required  to  implement  a  donor  identification  system  which  assigns  a 
unique  code  to  each  donation  and  to  each  of  the  products  associated  with  it  (Article  8  of 
Directive 2004/23/EC and Article 9 and 10 of Directive 2006/86/EC).  

Twenty-three Member States (BE, BG, CY, CZ, DE, DK, FI, FR, HR, HU, IE, IT,  LT, LU, 
LV,  MT,  NL,  PL,  PT,  RO,  SI,  SK,  UK)  reported  that  a  donor  identification  system  was 
implemented in their countries. In most Member States, the unique code for each donation is 
assigned by the tissue establishment (BE, BG, CY, CZ, DK, EE, FI, FR, HR, HU, IE, LT, LU, 
LV, PL, PT), while in others by the procurement centre (DE, MT, SI, UK).  

Other approaches were also notified: 

  Portugal reported that the donation identification system in the ART sector underwent 
changes  since  the  last  reporting  exercise.  Since  the  1st  of  January  2013,  the  unique 
code for each donation has been allocated centrally by the ART competent authority 
(Conselho Nacional de Procriação Medicamente Assistida); 

  Slovenia and Portugal (for the ART sector) specified that a national database was put 

in place, providing for an automatic allocation of donation numbers;  

  Norway indicated that the donor identification is based on the national unique personal 

number identification system.  

Two Member States, Austria and Spain, as well as Liechtenstein, indicated having difficulties 
in  implementing  the  provisions  related  to  the  donor  identification  system.  Romania  notified 
that  the  unique  national  donor  identification  system  is  under  construction.  Austria  reported 
that the Federal Ministry of Health deferred the implementation of ISBT128 due to difficulties 
encountered during implementation, whereas in Spain and Liechtenstein, the requirements of 
Article  8  have  been  partially  implemented  (Art.  8.1),  awaiting  final  guidance  from  the 
Commission regarding the implementation of the Single European Code. 

Article  8  also  requires  tissue  establishments  to  keep  the  data  ensuring  full  traceability  for  a 
minimum of 30 years. This requirement is fulfilled by all the Member States which reported 
to the Commission. In 25 Member States (AT, BE, BG, CY, CZ, DE, DK, EE, ES, FI, FR, 
HR,  HU,  IE,  IT,  LT,  LU,  MT,  NL,  PL,  PT,  RO,  SE,  SK,  UK-HTA)  and  Norway  it  is 
mandatory to retain both paper and electronic records. For the ART sector, the UK (HFEA) 
indicated  that  records  can  be  electronic  or  paper  records.  In  Latvia,  Slovenia  and 
Liechtenstein this requirement is fulfilled only by keeping paper records.  

Member States have different approaches for ensuring the implementation of the provisions in 
Article 9 of Directive 86/2006/EC (e.g. data storage for 30 years). Most of the Member States 
(AT,  BE,  BG,  CY,  DE,  DK,  EE,  FI,  FR,  IE,  IT,  LU,  LV,  MT,  NL,  PL,  PT,  SE,  UK)  and 
Liechtenstein and Norway reported verifying this requirement during routine inspections. In 
the United Kingdom, this requirement is also checked at the initial licence application stage. 
Austria, Croatia and the Czech Republic ask the tissue establishments to include appropriate 
procedures  in  their  SOP.  Spain  specified  that  this  requirement  was  not  implemented  in  the 
ART sector. 

30 

 
 
 
Comments 

The  survey  showed  that  a  donor  identification  system  was  implemented  by  most  Member 
States,  with  the  unique  code  for  each  donation  being  assigned  predominantly  by  the  tissue 
establishments.  It  has  to  be  underlined  that  countries  which  reported  difficulties  in 
implementing  the  donation  identification  system  were  either  developing  a  central  allocation 
system or were waiting for the adoption of the implementing legislation introducing a Single 
European  Code  for  tissues  and  cells.  Moreover,  most  of  the  Member  States  reported  that 
detailed coding requirements and a harmonised implementation of the Single European Code 
for tissues and cells is desirable and actively supported the development by the Commission 
of the new coding requirements, adopted in 20158. Regarding data storage, almost all Member 
States  and  EEA  countries  comply  with  the  30  years  rule,  by  requesting  both  paper  and 
electronic records and by verifying this requirement during routine inspections. 

2.2.5 

Import/export of human tissues and cells  

Under Article 9(1) of Directive 2004/23/EC, Member States must take all necessary measures 
to  ensure  that  all  imports  of  tissues  and  cells  from  third  countries  are  undertaken  by  tissue 
establishments accredited, designated, authorised, licensed for the purpose of those activities 
and  that  imported  tissues  and  cells  can  be  traced  from  the  donor  to  the  recipient  and  vice 
versa. In 2008, only 11 Member States reported having clearly identified tissue establishments 
authorised to import tissues and cells.  

The current survey revealed that 16 Member States (AT, BE, BG, CY, CZ, DE, DK, EE, FI, 
FR, HR, PT, RO, SE, SI, UK), as well as Norway, have a register of tissue establishments that 
are explicitly authorised to perform import/export of tissues and cells from third countries and 
provided data on their number.  According to the  data provided by these countries for 2011, 
297 tissue establishments were authorised to import and 306 were authorised to export tissues 
and  cells  from/to  third  countries.  Compared  to  the  previous  report  (2008  data)  when  16 
Members  States  reported  importing  tissues  and/or  cells,  the  current  survey  shows  that  more 
countries (22) were importing tissues and/or cells in 2011 (Figure 23). 

8  Commission  Directive  (EU)  2015/565  of  8  April  2015  amending  Directive  2006/86/EC  as  regards  certain 
technical requirements for the coding of human tissues and cells, OJ L 93, 9.4.2015, p. 43–55  

31 

 
 
 
                                                            
Fig. 23. Countries importing human tissues and cells for human application (2011 data) 

Twenty-two  countries  indicated  that  imports  from  third  countries  were  carried  out  in  2011, 
but only 15 provided data on the type and volume of the imported tissues and cells (Figures 
24 and 25). Only nine Member States also collect data on the source of imports (BE, CZ, EE, 
ES,  FI,  HR,  IT,  SI,  UK/HFEA).  According  to  the  reported  data,  most  of  the  imports  were 
from  USA,  Australia,  Canada,  Israel,  and  Switzerland.  Other  countries  mentioned  were 
China/Hong  Kong,  Taiwan,  Russia,  Uruguay  and  Bosnia  Herzegovina.  Six  Member  States 
acknowledged importing tissues and cells, but could not provide data on the amount and type 
of  tissues  or  cells  imported,  and  one  Member  State  (Germany)  is  collecting  data  without 
distinguishing  between  tissues  and  cells  imported  from  third  countries  and  those  distributed 
from other EU Member States. Seven Member States (BG, CY, HU, LU, LV, RO, SK) and 
Liechtenstein reported that no imports of tissues and cells were carried out in 2011. 

32 

 
 
 
 
 
 Fig. 24. Type of tissues and cells imported (data reported for 2011 by 15 countries) 

Additionally, Germany reported that according  to section 8d of the German Transplantation 
Act (TPG), all tissues entering Germany (both from third countries and EU Member States) 
must be notified to the Paul Ehrlich Institute, irrespective of their source (e.g. an EU Member 
State  or  a  third  country).  In  2011,  45,073  units  of  tissues  and  cells  entered  Germany:  550 
ocular  tissue  (cornea),  2,550  cardiovascular  tissues  (heart  valves,  vessels,  and  pericardium), 
41, 648 musculoskeletal tissues (bone, cartilage, soft tissues), 325 reproductive cells (sperm), 
as well as 3,436,004 cm2 of skin. 

33 

 
 
 
 
Fig. 25. Volume of tissues and cells imported (units of tissues or cells; 2011 data) 

Due to the heterogeneous approach in recording data for the import of human tissues and cells 
it is still difficult to quantify the amount of imports into the Union.  

Under  Article  9(2),  Member  States  must  also  take  all  necessary  measures  to  ensure  that  all 
exports  of  tissues  and  cells  to  third  countries  are  undertaken  by  tissue  establishments 
accredited, designated, authorised or licensed for that purpose. Eighteen Member States (AT, 
BE, DE, DK, EE, ES, FI, FR, HR, IE, IT, MT, NL, PL, PT, SE, SI, UK) and Norway have a 
register of tissue establishments authorised to export tissues and cells to third countries. 

Fourteen Member States (AT, BG, CZ, EE, FI, HR, HU, LT, LU, LV, MT, RO, SI, SK) and 
Liechtenstein  and  Norway  reported  that  no  exports  of  tissues  and  cells  occurred  in  2011 
(Figure 26). 

Fig. 26. Tissue and cell exporting countries (2011 data) 

34 

 
 
 
 
Overall 12,152 units of tissues and cells were reported as exported to third countries. Of the 
11 countries exporting human tissue and/or cells in 2011,  four specified that information on 
the  country of  destination  is  not  collected  by  the  national  competent  authority  (CY,  IE,  SE, 
UK/HTA). The exporting countries, as well as the type and volume (in units) of tissues and 
cells exported, are shown in Figures 27 and 28. 

Fig. 27. Exporting countries - type of tissues and cells (data reported for 2011 by 11 
countries) 

Fig. 28. Volume of tissues and cells exported (units of tissues or cells; 2011 data) 

35 

 
 
 
  
Similarly to the data reported for imports, Germany specified that according to section 8d of 
the  German  Transplantation  Act  (TPG)  there  is  no  distinction  between  export  to  third 
countries  and  distribution  to  EU  Member  States,  therefore  all  tissues  and  cells  leaving 
Germany are reported to the Paul Ehrlich Institute on an annual basis. In 2011, 148,285 units 
were reported as sent to healthcare facilities outside Germany, as following: 188 ocular tissue 
(cornea,  limbal  cells),  2,131  cardiovascular  tissues  (pericardium),  144,373  musculoskeletal 
tissues (bone, cartilage, soft tissues), 130 other (amniotic membrane), 1,463 reproductive cells 
(sperm). Additionally, 2,825,092 cm2 of skin was also sent outside Germany. 

The competent authority or authorities may also authorise the import or export of tissues and 
cells in case of an emergency (Art 9.3b). Nine Member States (CY, DE, DK, HR, MT, NL, 
RO, SI, UK) and Norway, indicated that  direct distribution of tissues and cells  to a specific 
recipient was authorised in 2011 for haematopoietic stem cells and ocular tissues. 

Concerning the relation with self-sufficiency, the Member States approaches are different for 
import and export activities: 

  For exporting tissues and/or cells: 

o  BG, DK, ES, HR, IT, PL, PT, RO, SK reported that export of tissues and cells 
is authorised only after checking if local and/or national needs are fulfilled;  

o  Bulgaria  and  Latvia  indicated  that  exportation  is  authorised  based  on 

estimations performed on an annual basis; 

o  BE, CZ, DK, EE, HU, IT, PL, SE, SI, UK indicated that exportation of tissues 

and/or cells is authorised irrespective of national needs.  

  For importing tissues and/or cells: 

o  BG, DK, ES, HR, IE, IT, RO, and Norway reported that imports are authorised 

only after checking that local/national needs are not fulfilled;  

o  BG,  IE,  PL,  PT,  SE  and  Norway  specified  that  imports  of  tissues/cells  are 
authorised  based  on  estimations  showing  that  there  is  chronic  deficiency  of 
those tissues/cells.  

Some Member States (Italy, Poland) acknowledged having a strict approach regarding tissues 
and cells coming from other EU Member States, which are treated like those imported from 
third  countries.  The  United  Kingdom  informed  that  the  Human  Tissue  Authority  (HTA) 
provides specific online guidance for tissue establishments on import and export.  

Comments 

These  data  show  that  it  would  be  useful  for  competent  authorities  to  collect  more 
comprehensive  data  on  imports  and  exports  of  human  tissues  and  cells  through  the  tissue 
establishments' compulsory annual reports in accordance with Article 10(1), however, at this 
stage the reporting format is not harmonised.  

The data provided, even though incomplete and sometimes ill-defined, confirm that more and 
more  human  tissues  and  cells  -  such  as  skin,  bones,  ocular  tissues,  heart  valves,  and 
haematopoietic stem cells - are imported from third countries or are exported for the benefit of 
patients outside the European Union. It has to be noted that it is difficult to draw conclusions 

36 

 
 
 
regarding the volume of imports and exports of human tissues and cells due the absence of a 
harmonised framework for data collection in the Member States. It should be underlined that 
some level of harmonisation exists for such data due to the Eurocet9 project. However the fact 
that  some  countries  do  not  distinguish  between  distribution  within  the  European  Union  and 
import/export  from/to  third  countries  may  be  considered  an  important  hurdle  against  data 
collection and analysis. In some countries the differences between the legal framework under 
which  the  tissue  and  cell  legislation  was  transposed  (e.g.  transplantation  vs.  medicinal 
products legislation) may also contribute to the different datasets collected at national level.  

Furthermore,  mostly  due  to  their  more  stringent  quality  and  safety  requirements,  some 
countries  treat  tissues  and  cells  distributed  by  EU  Member  States  and  those  imported  from 
third  countries  in  the  same  way.  It  is  expected  that  the  recently  adopted  legal  requirements 
regarding  the  procedures  for  verifying  the  equivalent  standards  of  quality  and  safety  of 
imported tissues and cells10 will streamline the tissue and cells imports, and the collection of 
related data, guaranteeing the appropriate level of safety and quality across the Union. 

2.2.6.  Register of tissue establishments and reporting obligations  

Under  Article  10(1)  of  Directive  2004/23/EC,  tissue  establishments  must  keep  a  record  of 
their  activities  and  submit  an  annual  report  to  the  competent  authority  or  authorities,  which 
should be publicly available.  

Twenty Member States (AT, BE, BG, DE, EE, ES, FI, HR, HU, IE, IT, LT, MT, PL, PT, RO, 
SE, SI, SK, UK) and Liechtenstein and Norway, have created an annual report model on the 
activities  of  tissue  establishments  that  makes  the  reporting  of  the  yearly  activities  by  tissue 
establishments easier.  

All  the  reporting  Member  States  receive  annual  reports  from  their  tissue  establishments 
corresponding  to  activities  in  the  previous  year(s).  An  overview  of  the  number  of  tissue 
establishments providing data to the national competent authorities is presented in Figure 29.  

9 European Registry for Organs, Tissues and Cells, http://www.eurocet.org/ 
10  Commission  Directive  (EU)  2015/566  of  8  April  2015  implementing  Directive  2004/23/EC  as  regards  the 
procedures for verifying the equivalent standards of quality and safety of imported tissues  and cells Text with 
EEA relevance. OJ L 93, 9.4.2015, p. 56–68 

37 

 
 
 
                                                            
Fig. 29. Annual reporting by the tissue establishments (2011 data) 

It  should  be  emphasised  that  the  annual  reports  submitted  by  the  tissue  establishments  are 
essential in providing a suitable indication of the activities carried out in the field as well as 
reference data for assessing the needs and risks in the tissue and cell transplantation field. 

Only nine Member States (BE, BG, CZ, ES, IT, MT, PL, RO, SE) and Norway, had made the 
tissue establishments' reports publicly available in 2012. For the Member States which did not 
make the tissue establishments’ reports available, the main reasons were that at the moment of 
submitting  their  replies  to  the  implementation  survey,  legal  provisions  in  their  national 
legislation were absent (inappropriate transposition of Art. 10(1)) or  there was an insufficient 
capacity at competent authority level. 

Under  Article  10(2)  of  Directive  2004/23/EC,  the  competent  authorities  are  responsible  for 
maintaining a publicly accessible register of tissue establishments specifying the activities for 
which they have been accredited/designated/authorised/licensed. Twenty-five Member States 
and Norway indicated that they have a public register available (AT, BE, BG, CY, CZ, DE, 
DK, EE, ES, FI, FR, HR, HU, IE, IT, LT, LV, MT, NL, PL, PT, RO, SE, SI, UK). In most 
cases the annual reports and the register are accessible through the competent authorities' web 
pages (Table IV). Liechtenstein reported that there are no legal requirements in their national 
legislation  concerning  the  publicly  accessible  register  of  tissue  establishments.  Luxembourg 
informed  that  the  information  is  given  on  demand.  In  Slovakia,  this  register  is  under 
preparation. 

38 

 
 
 
Table IV. Publicly accessible national registers of tissue establishments (2011 data) 

39 

CountryLink to the national register of tissue establishmentsAThttp://www.basg.gv.at/arzneimittel/gewebe/register-29-gsg/ BEwww.fagg-afmps.beBGhttp://www.bgtransplant.bg/iat/transplantation.php?target_fCYwww.moh.gov.cyCZwww.sukl.cz/Rewievs and Lists/List of subjects from human tissues, cells and blood branch/List of holders of licence according the law on human TCDEhttp://www.pei.de/DE/infos/meldepflichtige/meldung-gewebe-8d-transplantationsgesetz/berichte-pei/berichte-meldung-8d-transplantationsgesetz-tpg-node.htmlDKhttp://laegemiddelstyrelsen.dk/da/service-menu/produktomraader/vaev-og-celler/register-over-godkendte-vaevscentre EEhttp://www.ravimiamet.ee/en/list-licensed-handlers-cells-tissues-and-organs-tissue-establishmentsEShttps://reports.ont.es/Autorizaciones.aspx For ART http://www.cnrha.msssi.gob.es/registros/centros/home.htm   FIhttp://www.fimea.fi/download/23600_FI_Lista_Suomessa_toimivista_kudoslaitoksista_10-7-2013.pdfFRhttp://ansm.sante.fr/var/ansm_site/storage/original/application/b9b896c06d8367834865273951775d4b.pdf   ;  http : //www.agence.biomedecine.fr/Autorisation-des-centres  ;    http : //www.agence.biomedecine.fr/Les-etablissements-autorises.73HRNon-reproductive tissues and cells: http://www.zdravlje.hr/ministarstvo/zdravstvene_ustanove_u_republici_hrvatskoj/ustanove_s_odobrenjem_za_obavljanje_djelatnosti_uzimanja_pohranjivanja_i_presadivanja_tkiva_i_stanica                                                 ART: http://www.zdravlje.hr/ministarstvo/zdravstvene_ustanove_u_republici_hrvatskoj/ustanove_s_odobrenjem_za_obavljanje_djelatnosti_medicinski_pomognute_oplodnje   HUhttps://www.antsz.hu/bal_menu/igazgatas/sejt_es_szovetbank_nyt.htmlIEhttp://www.imb.ie/EN/Blood-Tissues--Cells/Blood--Tissue-Establishments-.aspx?page=1&name=&orderby=name&orderascending=True&type=3&sitestatus=1&withdrawdate=IThttp://www.trapianti.salute.gov.it/cnt/cntHomeSezione.jsp?id=10&area=cnt-tessuti&menu=menuPrincipaleLINo registerLTwww.transplantacija.ltLUNo register. Information available on demand.LVhttp://www.zva.gov.lv/doc_upl/audu-sunu-20130726.pdf MThttps://ehealth.gov.mt/HealthPortal/public_health/healthcare_serv_standards/tissues_cells_organs.aspxNLhttp://www.farmatec.nl/doc/pdf/Internetoverzicht%20Wvkl-erkenningen%20en%20-vergunningen%20afgegeven%20vanaf%201%20juni%202007_18122.pdfNOhttp://www.helsedirektoratet.no/kvalitet-planlegging/bio-genteknologi/celler-og-vev/Sider/default.aspxPLhttp://www.kcbtik.pl/?Banki_Tkanek PThttp://www.dgs.pt/ms/8/default.aspx?pl=&id=5521&acess=0   (DGS); CNPMA: http://www.cnpma.org.pt/centros_lista.aspxROwww.transplant.ro  SEhttp://www.ivo.se/Tillstand-och-register/register/vavnadsinrattningar/Sidor/default.aspxSIhttp://www.slovenija-transplant.si/index.php?id=presajanje-tkiv SKNo register. Under preparation.UKhttp://www.hta.gov.uk/_db/_documents/Licensing_Reports_-_HA_201307021659.pdf http://guide.hfea.gov.uk/guide/AllClinics.aspx?x=A 
 
 
 
 
Under  Article  10(3)  of  Directive  2004/23/EC,  Member  States  and  the  Commission  should 
establish a network linking the national tissue establishment registers. Until now this network 
was  ensured  through  Eurocet7,  which  is  a  registry  of  national  tissue  establishments  and 
activity  reports  managed  by  the  Italian  Competent  Authority.  Twenty-three  Member  States 
acknowledged that they also report data to  Eurocet on a voluntary  basis (AT, BE,  BG, CY, 
CZ,  DE,  ES,  FI,  FR,  HR,  HU,  IT,  LT,  LU,  LV,  MT,  PL,  PT,  RO,  SE,  SI,  SK  UK).  Three 
Member States (Denmark, Ireland, and Netherlands) and EEA countries do not usually report 
their  data  to  Eurocet.  In  this  respect,  the  Danish  competent  authority  specified  that  data 
request for clinical information on tissues/cells is not part of their activities. Ireland informed 
that their competent authority (the Irish Medicines Board at the time) is not legally required to 
submit  data  regarding  tissues  and  cells  activity  to  the  Eurocet  registry  and  Netherlands 
declared that no raw data is readily accessible to the competent authority. 

Comments 

Overall, the Member States and the EEA countries comply with the requirements in Article 10 
of  Directive  2004/23/EC.  National  registers  of  tissues  establishments  are  made  available 
through  the  competent  authorities'  web  pages  and  also  via  the  Eurocet  page.  However,  the 
tissue establishments’ reports are not publicly available in all the reporting countries, mainly 
due  to  an  insufficient  transposition  of  this  provision  into  the  national  legislation  which 
resulted in several pre-infringement procedures through the EU Pilot platform. If the issue of 
making the annual reports provided by the tissue establishments public can be dealt with only 
at  national  level,  the  new  legal  provisions  for  the  application  of  the  Single  European  Code 
shall also satisfy the requirement in Art 10(3), by establishing the EU Tissue Establishment 
Compendium including all the tissues establishments with their contact details and the status 
of  their  accreditation/designation/authorised  or  licence.  By  updating  the  data  in  this 
Compendium,  the  tissues  and  cells  competent  authorities  demonstrate  full  transparency  and 
provide support to healthcare professionals searching for a tissue or cell provider within the 
Union. Moreover, the inclusion in the EU Tissue Establishment Compendium will reinforce 
the credentials of the EU tissue establishments in front of their partners and customers around 
the world. 

2.2.7.  Notification of serious adverse events and reactions  

Under  Article  11(1)  of  Directive  2004/23/EC,  Member  States  must  ensure  that  there  is  a 
system in place to report, investigate, register and transmit information about serious adverse 
events11 and  reactions12 which may  influence  the quality and safety  of tissues and cells and 
which  may  be  attributed  to  the  procurement,  testing,  processing,  storage  and  distribution  of 
tissues and cells. Serious adverse reactions observed during or after clinical application which 

11  According  to  Article  3(m)  of  Directive  2004/23/EC,  ‘Serious  adverse  event’  means  any  untoward 
occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells 
that  might  lead  to  the  transmission  of  a  communicable  disease,  to  death  or  life-threatening,  disabling  or 
incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity. 

12  According  to  Article  3(n)  of  Directive  2004/23/EC,  ‘Serious  adverse  reaction’  means  an  unintended 
response,  including  a  communicable  disease,  in  the  donor  or  in  the  recipient  associated  with  the 
procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating 
or which results in, or prolongs, hospitalisation or morbidity. 

40 

 
 
 
                                                            
 
may  be  linked  to  the  quality  and  safety  of  tissues  and  cells  should  be  also  reported.  The 
procedures  for  notifying  serious  adverse  events  and  reactions  were  adopted  in  Commission 
Directive 2006/86/EC. 

AT 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

ES 

FI 

FR 

HR 

HU 

IE 

IT 

LI 

LT 

LU 

LV 

MT 

NL 

NO 

PL 

PT 

RO 

SE 

SI 

UK 

Austrian Medicines and Medical Devices Agency (AGES) 

Federal Agency for Medicines and Health Products (FAMHP) 

Executive Agency for Transplantation (IAT) 

Ministry of Health 

State Institute for Drug Control (Pharmacovigilance Department) 

Paul Ehrlich Institute (PEI) 

Danish Health and Medicines Authority  

State Agency of Medicines  

National Transplant Organisation (ONT), the competent authorities of the autonomous regions 
and the National Group of Biovigilance.  

Finnish Medicines Agency (Fimea) 

Agence de la Biomedicine (ABM) 

Ministry of Health  

National Public Health and Medical Officer Service - Office of the Chief Medical Officer 
(NPHMOS-OCMO)  

Irish Medicines Board (IMB) - Tissue & Cell Vigilance  

National Transplant Centre (CNT) 

Amt für Gesundheit  

National Transplant Bureau under the Ministry of Health  

Direction de la Santé 

State Agency of Medicines - Senior expert of Pharmaceutical Activities Compliance Evaluation 
Department  

The Directorate for Health Care Standards of the Superintendence of Public Health  

Health Care Inspectorate (IGZ)  

Norwegian Directorate of Health  

National Centre for Tissue and Cell Banking (for tissue establishments), Poltransplant and 
National Centre for Tissue and Cell Banking (for procurement and transplantation).  

Instituto Português do Sangue e da Transplantação (for non-reproductive tissues and cells) and 
Conselho Nacional de Procriação Medicamente Assistida (CNPMA - for the ART sector)  

Ministry of Health – the State Sanitary Inspectorate  

Health and Social Care Inspectorate  

Agency of Medicinal Products and Medical Devices of the Republic of Slovenia 

HTA (for non-reproductive tissues and cells) and HFEA (for the ART sector) 

Table V. Organisations responsible for tissue and cell vigilance (2011 data) 

All reporting Member States except for Slovakia have a national vigilance system in place. In 
most  Member  States  vigilance  falls  under  the  responsibility  of  the  main  national  competent 
authority,  but  in  several  Member  States  this  is  either  delegated  to  the  regional  competent 

41 

 
 
 
authorities (DE, ES) or specific bodies (NL - Health Care Inspectorate). An overview of the 
organisations responsible for tissue and cell vigilance in the reporting EU and EEA countries 
is included in Table V.  

Only in 15 Member States (AT, BE, CZ, DE, DK, ES, FI, FR, HU, IE, LT, MT, NL, PT, SI) 
and  Liechtenstein  and  Norway,  were  dedicated  vigilance  officers  appointed.  In  the  other 
countries, this role is assigned to the tissues and cells inspectors. Additionally in  the United 
Kingdom,  for  the  ART  sector  the  HFEA  appointed  a  dedicated  vigilance  officer,  whereas 
HTA reported having a dedicated team of Regulation Managers in place who assess SAREs 
from establishments. A Regulation Officer acts as the administrator and data manager for the 
team and the reporting system is monitored by the team on a 24-hour basis, and any reports 
received are responded to within 24 hours. 

Regarding the compliance of tissue establishments in reporting SAR and SAE to the national 
competent  authorities,  the  percentage  of  the  tissue  establishments  complying  with  this 
requirement  (expressed  as  %  from  the  total  number  of  authorised  tissue  establishments  at 
national level) is shown in Figure 30. The relatively large group of establishments that do not 
report SARE data is a point that requires further attention. 

Fig. 30. SAR/SAE reporting to the national competent authorities (2011 data) 

In addition, Italy informed that tissue establishments are required to report SAR/SAE as they 
occur  and  the  competent  authority  compiles  the  annual  report.  However  the  tissue 
establishments  must  provide  detailed  information  to  transplant  centres  on  how  and  when  to 
report  SAR/SAE  and  this  is  reviewed  during  routine  inspection.  A  similar  approach  was 
reported  by  the  United  Kingdom  competent  authorities  (HTA  and  HFEA),  where  tissue 
establishments have to report SAR/SAEs within 24 hours of their discovery,  and not  via an 
annual report. 

Most of the Member States (AT, BE, BG, CY, CZ, DE, DK, ES, FR, HR, HU, IE, LT, LV, 
MT, PL, PT, RO, SE, SI, UK-ART sector) and Liechtenstein and Norway confirmed having 
in place a mandatory procedure for SAR/SAE reporting by the transplantation centres to the 

42 

 
 
 
 
distributing  tissue  establishments,  this  also  being  a  requirement  in  their  national  legislation. 
Members States not having such a procedure in place have different approaches: 

 

 

 

In  Estonia  and  Slovakia,  reporting  of  SAR/SAE  by  the  transplantation  centres  is 
obligatory by law;  

In  Finland,  Italy  and  Netherlands,  when  distributing  tissues  and/or  cells,  the  tissue 
establishments  are  responsible  for  providing  full  instructions  for  reporting  to  the 
transplantation centres; 

the  SAREs 

In  the  United  Kingdom,  for  non-reproductive  tissues  and  cells  and  reproductive 
tissues, 
in  HTA  standards. 
Establishments licensed by the HTA are required to have end-user agreements in place 
with  transplantation  centres,  which  include  the  requirement  to  report  SAREs,  and 
incident reporting is promoted and also monitored on inspection. 

is  outlined 

requirement 

reporting 

Regarding recalls, all countries require their tissue establishments to have a recall procedure. 
Only four Member States  (DK, EE,  FR and  UK) reported that  recalls were  issued by tissue 
establishments in their country for 2011. 

In accordance with Article 7(1) of Directive 2006/86/EC, Member States must submit to the 
Commission  an  annual  report  on  the  serious  adverse  reactions  and  events  notified  to  the 
competent  authority.  Most  of  the  Member  States  acknowledged  using  at  national  level  the 
template (based on the Annexes of Directive 2006/86/EC). In seven Member States (BE, DE, 
FR, NL, PT, SI, UK) and Norway, a template and guidelines developed at national level are 
used.  

Twenty-two Member States (AT, BE, BG, EE, ES, FI, FR, HR, HU, IE, IT, LT, LU, MT, NL, 
PL,  PT,  RO,  SE,  SI,  SK,  UK)  and  Norway  confirmed  giving  feedback  to  the  tissue 
establishments regarding SAR/SAE recorded at national level. 

Nineteen Member States (BE, BG, EE, ES, FI, FR, HR, HU, IE, LT, LU, MT, PL, PT, RO, 
SE, SI, SK, UK) and Norway reported giving feedback to the tissue establishments regarding 
SAR/SAE recorded at EU level. 

As regards communication of rapid alerts, 22 Member States (AT, BE, CY, DE, EE, ES, FI, 
FR,  HR,  HU,  IE,  LT,  LU,  LV,  MT,  NL,  PL,  PT,  SE,  SI,  SK,  UK)  and  Liechtenstein  and 
Norway  reported  that  a  system/procedure  is  in  place  at  national  level  for  notifying  tissue 
establishments and procurement sites in case of a national rapid alert or of a rapid alert issued 
via  the  EU  RATC  platform.  Five  Member  States  reported  not  having  such  a  system/formal 
procedure:  

  Bulgaria informed that the system is under construction and communication is done by 

email; 

  The Czech Republic reported using the already established system for pharmaceuticals 

or medical devices; 

  Denmark  reported  that  the  national  system  is  effective  in  notifying  the  tissue 

establishments which thereafter are responsible for contacting the POs; 

 

Italy  declared  that  no  written  procedure  was  formalised  and  rapid  alerts  are 
communicated by email on a case-by-case basis; 

43 

 
 
  Romania informed that a national procedure was under development, but the Ministry 
of  Health  is  responsible  for  communicating  the  alerts  issued  via  the  EU  RATC 
platform to the National Transplant Agency and the sanitary inspectors. 

Moreover, 21 Member States (AT, BE, CY, CZ, DE, DK, ES, FI, FR, HR, HU, IE, LT, MT, 
NL, PL, PT,  RO, SE, SI, UK)  circulate the alerts received via the tissues and  cells national 
vigilance  system,  when  relevant,  to  other  national  vigilance/alert  systems  (haemovigilance, 
pharmacovigilance, medical devices). 

Concerning training courses for the personnel in charge of vigilance at national/local level, 22 
Member States (AT, BG, CY, DE, DK, EE, ES, FI, FR, HR, HU, IE, IT, LT, LV, MT, NL, 
PL, PT, RO, SI, UK) and Norway welcomed the organisation of specific courses at EU level. 
The training course organised by the SoHO V&S project was ranked  as good (one Member 
State), very good (11 Member States) and excellent (ten Member States). Only five Member 
States  (BE,  CZ,  LU,  SE,  SK)  and  Liechtenstein  did  not  send  their  staff  to  these  courses, 
mostly because of lack of time or turnover of personnel. 

Comments 

The  importance  of  SARE  reporting  is  confirmed  by  the  interest  of  the  Member  States  in 
collaborating  with  the  Commission  to  improve  the  current  reporting  system  (e.g.  refine  the 
SARE reporting templates for improving collection of data in the ART sector) and to expand 
communication  with  other  countries  and  other  sectors  (e.g.  foster  cooperation  with  relevant 
third  countries  with  regard  to  SAR/SAE  reporting,  establishment  of  an  interface  for  SARE 
reporting  to  other  product  areas,  such  as  medical  devices  used  throughout  the  donation-
clinical application chain. Nevertheless, the aim of the annual reporting to the Commission is 
to identify the most frequent causes of SAR/SAE allowing for the development of appropriate 
corrective measures, which will ultimately make the medical application of human tissues and 
cells  safer.  In  this  context,  because  many  errors  are  not  always  reported  voluntarily  or  are 
discovered at a later stage and not reported in a timely manner, the corrective measures may 
not be made in a timely manner. Additionally, the “root causes” of these SARE/SAE should 
be correctly identified, analysed and reported with enough level of detail in order to allow for 
a complete description of the practices/factors which may lead to systematic errors. Moreover, 
underreporting and accurate data collection remain two objectives which need to be addressed 
at all levels, from clinical practitioners and tissue establishment staff to competent authorities.  

Something that has to be emphasised is the support of the Member States' authorities in the 
development of the Rapid Alerts for Tissues and Cells (RATC) launched by the Commission 
in February 201313, which allows national health authorities to exchange, in a timely manner, 
urgent  information  in  case  of  alerts  (including SAR/SAE)  relating  to  human  tissues  or  cells 
transferred between Member States. The first annual summary report of the RATC platform14 
published  in  August  2014  showed  an  increase  in  the  number  of  the  alerts  initiated  by  the 
national vigilance contact points, the platform providing wider possibilities of communication 
and  information  dissemination  with  the  choice  of  contacting  single  or  groups  of  national 
competent authorities. 

13 http://ec.europa.eu/dgs/health_consumer/dyna/enews/enews.cfm?al_id=1340  
14 http://ec.europa.eu/health/blood_tissues_organs/docs/ratc_report_2013_en.pdf  

44 

 
 
 
                                                            
2.3 

 Donor selection and evaluation  

Directives  2004/23/EC  and  2006/17/EC  contain  a  number  of  requirements  regarding  donor 
selection and evaluation. They relate to (1) principles governing tissue and cell donation, (2) 
consent,  data  protection  and  confidentiality  the  authorisation  of  tissue  establishments,  (3) 
donor selection and evaluation and procurement of tissues/cells, (4) testing of tissue and cell 
donors. 

2.3.1.  Principles governing tissue and cell donation (Art. 12) 

Under  Article  12(1)  of  Directive  2004/23/EC,  Member  States  must  endeavour  to  ensure 
voluntary  unpaid  donations  of  tissues  and  cells.  Donors  may  receive  compensation  strictly 
limited to making good the related inconveniences. In such cases, Member States must define 
the  conditions  under  which  compensation  may  be  granted.  Member  States  must  regularly 
submit  reports  on  these  measures  to  the  Commission.  On  the  basis  of  these  reports  the 
Commission will inform the European Parliament and the Council of any necessary measures 
it intends to take.  

The results  of the 2014  survey performed by the Commission  on  the implementation  of the 
principle  of  VUD  for  tissues  and  cells  in  the  Union  are  included  in  the  Commission  Staff 
Working Document on the implementation of the principle of voluntary and unpaid donation 
for human tissues and cells, accompanying the Report from the Commission to the European 
Parliament, the Council, the European Economic and Social Committee and the Committee of 
the  Regions  on  the  implementation  of  Directives  2004/23/EC,  2006/17/EC  and  2006/86/EC 
setting standards of quality and safety for human tissues and cells.   

In  a  nutshell,  the  latest  survey  shows  that,  overall,  Member  States  comply  with  Article  12, 
with most responding countries reporting that the principle of VUD is mandatory at national 
level.  However,  its  concrete  application  varies  across  the  Union,  with  considerable 
heterogeneity as regards practices vis-à-vis tissue and cell donors.  

2.3.2.  Consent, data protection and confidentiality  

Under  Article  13(1)  of  Directive  2004/23/EC,  the  procurement  of  human  tissues  and  cells 
shall  be  authorised  only  after  all  mandatory  national  consent  or  authorisation  requirements 
have been met.  

Regarding the consent system for living donation of tissues and cells, with the exception of 
Liechtenstein,  all  the  other  reporting  countries  have  an  opt-in  system  (explicit  consent) 
(Figure 31).  

Concerning the consent system for deceased donation of tissues and cells, an overview of the 
replies is shown in Figure 32. 

45 

 
 
Fig. 31. The consent systems for living donation of tissues and cells 

Fig. 32. The consent systems for deceased donation of tissues and cells 

Whereas,  the  consent  system  for  living  and  deceased  donation  is  different  in  17  countries 
(AT, BE, BG, CZ, FI, FR, HR, HU, IT, LV, PL, PT, SE, SI, SK, UK and Norway), only three 
Member  States  (Denmark,  Luxembourg  and  Spain)  have  different  consent  systems  for 
deceased tissue and organ donation. 

Irrespective of the consent system, in case of deceased donations, there are various options for 
who is allowed to authorise tissue donation (Figure 33). 

46 

 
 
 
 
Fig. 33. Persons allowed authorising deceased donation of tissues and cells  

Several Member States provided additional clarifications. In Netherlands, in case of a donor 
child  aged  12  or  below  the  consent  is  given  by  the  legal  guardian.  The  United  Kingdom 
specified  that  in  England,  Wales  and  Northern  Ireland  a  person  in  life  or  a  person's 
"nominated  representative"  can  give  consent,  but  there  is  no  mention  of  "nominated 
representatives" under the Human Tissue Act in Scotland.  

In all reporting Member States and EEA countries, the consent is verified during inspections 
by  various  means,  from  analysis  of  documentation  and  interviews  with  personnel  to 
interviews with living donors or relatives of deceased donors (Figure 34). 

Fig. 34. Verification of donors consent during inspections (2011 data) 

47 

 
 
 
 
Article  13(2)  of  Directive  2004/23/EC  requests  the  Member  States  take  all  the  necessary 
measures  to  ensure  that  donors  and  their  relatives,  as  well  as  any  persons  granting 
authorisation  on  behalf  of  the  donors  are  provided  with  the  appropriate  information.  All 
reporting  countries,  except  Ireland  and  Slovakia,  stated  that  only  trained  personnel  are 
allowed to provide such information. In Ireland, the requirement of Art 13(2), the information 
provided  to  donors  and  their  families  is  also  verified  during  inspections  together  with  the 
donor  files.  Additionally,  in  some  Member  States  (BG,  DE,  ES,  LT,  PL,  SE,  SK,  UK),  the 
information  for  donors  is  standardised  at  national  or  regional  level.  Germany  specified  that 
general information for donors is available due to national public awareness activities and is 
also provided by medical associations. For ART donors, in Spain the information is controlled 
at  regional  level  and  in  the  United  Kingdom  it  is  assessed  during  the  initial  application  for 
tissue establishment licence.  

Concerning  national  measures  taken  to  ensure  that  both  donors  and  recipients  remain 
unidentifiable  as  required  by  Art.14(1)  of  Directive  2004/23/EC,  several  approaches  were 
reported.  Many  Member  States  (CZ,  DE,  EE,  ES,  FI,  FR,  HR,  HU,  IE,  LT,  LV,  RO)  and 
Norway  stated  that  anonymity  is  ensured  by  the  application  of  the  data  protection  national 
legislation. In addition, anonymity is ensured by implementing the unique donor identification 
number (coding system) for both donor and recipient (AT, BE, BG, CY, IT, LU, MT, PL, SE, 
SI,  UK-HTA  and  LI).  Additional  methods  were:  control  measures  decided  by  tissue 
establishments  (Denmark);  verification  by  the  competent  authority  of  the  access  to 
information  and  of  the  procedures  put  in  place  by  the  tissue  establishment  to  ensure  the 
confidentiality (Portugal); providing third parties only with the tissue code (Slovakia). 

Member  States  and  EEA  countries  also  reported  on  the  measures  taken  to  ensure  that  the 
identity  of  the  recipient  is  not  disclosed  to  the  donor  and  vice  versa  required  under  Article 
14(3) of Directive 2004/23/EC. Besides applying the national requirements on data protection 
(CY,  DE,  EE,  ES,  FR,  HU,  IE,  LT,  LV,  NL,  RO,  SI),  introducing  the  unique  donor 
identification number (AT, FI, HR, IT, LU, MT, PL, SE, SK and LI, NO) is another method 
widely  used  for  ensuring  data  confidentiality.  Other  approaches  were  reported:  restricted 
access to the donor data (Bulgaria); requirements included in the tissue establishments' SOP 
and  inspected  by  the  competent  authority  before  granting  a  licence  (Czech  Republic); 
appropriate  procedures  put  in  place  by  both  tissue  establishments  and  organisations 
responsible  for  human  application  (Denmark);  validation  by  the  competent  authority  of  the 
procedures;  validation  by  the  competent  authority  of  the  procedures  established  at  tissue 
establishment  level  (Portugal);  with  the  exception  of  directed  donations,  information 
regarding  the  donor  identity  is  not  included  in  the  recipient  file  and  vice-versa  (United 
Kingdom). 

With regard to disclosure of donor data in case of gamete donation, the approaches taken by 
the  reporting  Member  States  and  EEA  countries  are  summarised  in  Figure  35.  The  special 
circumstances in which some countries (generally prohibiting the disclosure of gamete donor 
data) would allow disclosure include: 

  Children reaching 14 years old (Austria); 

  When  the  egg  donor  is  a  relative  of  the  woman  who  wishes  to  undergo  artificial 

insemination (Estonia); 

 

In case of a child born with a congenital disease (Spain); 

48 

 
 
  Children conceived through IVF procedures (Norway); 

  When donors express consent to disclose his/her data and only when the children born 
following  ART  procedures  with  donated  gametes  turn  18;  other  cases  following  a 
court decision (Portugal); 

  At the request of authorities (e.g. police, coroner office)(Romania); 

  Only to the child at adult age, but not to his/her parents)(Sweden); 

  To the medical staff only for medical reasons (Slovenia). 

Fig. 35. Disclosure of gamete donor data (2011 data)  

Comments 

Overall, the survey showed that regardless of the consent system, all responding countries put 
measures  in  place  for  verifying  donors’  consent.  On  the  other  hand,  only  in  a  few  Member 
States  is  this  checked  by  interviewing  the  living  donors  or  the  relatives  of  the  deceased 
donors. In addition only trained personnel are allowed to provide appropriate information to 
donors, but only  in a few countries  has  this information  been standardised  at national level. 
Concerning  donor  anonymity,  most  countries  rely  on  the  EU  and  national  data  protection 
legislation, but also on coding. In this context, the new requirements on the application of the 
Single European Code for tissues and cells may be considered an additional tool for ensuring 
that donor data are not disclosed to the recipient. 

2.3.3.  Donor selection and evaluation. Procurement of tissues and cells  

Under  Article  15  of  Directive  2004/23/EC,  donor  evaluation  and  selection  by  the  tissue 
establishments should be carried out in accordance with the provisions laid down in Annex I 
(donors  of  non-reproductive  tissues  and  cells)  and  III  (donors  of  reproductive  tissues  and 
cells) of Directive 2006/17/EC.  

49 

 
 
 
 
 
Compliance  with  these  requirements  is  verified  by  inspections  of  tissue  establishments, 
procurement  sites,  and  ART  establishments  by  audit  documentation,  standardised 
questionnaires  at  national  levels  and/or  regular  evaluation  of  medical  personnel  (Figure  36 
and 37). 

Furthermore, three Member States (Belgium, Germany, Italy) reported having more stringent 
criteria for donor selection:  

  Belgium  reported  having  one  additional  selection  criterion  -  “persons  that  have 

undergone documented or undocumented neurosurgery'';  

  Germany  informed  that  the  exclusion  criteria  are  adapted  to  the  donor  of  a  specific 

 

tissue;  
Italy reported that additional tests are required - NAT testing for HIV, HBV and HCV 
of HSC donors; toxoplasma IgM for amniotic membrane donors is mandatory; CMV 
IgM  for  heart  valve,  vessels  and  amniotic  membrane;  CMV  for  skin;  CMV, 
toxoplasma and EBV testing for HPC unrelated donors; serum archive for all donors.  

Fig. 36. Verifying the compliance of tissue establishments and procurement sites with the 
requirements of Annexes I and III of the Directive 2006/17/EC (2011 data)  

50 

 
 
 
 
Fig. 37. Verifying the compliance of ART establishments with the requirements of Annex II of 
the Directive 2006/17/EC (2011 data)  

A general concern that is expressed regularly by the  competent authorities is the absence of 
regulation focused on the protection of the living donor. 

In  most  Member  States,  the evaluation of  deceased donors  of tissues and cells  relies  on the 
medical records of the donor, the interview with the donor's family or a person who knew the 
donor  well  and  the  autopsy  report.  In  approximately  half  of  the  reporting  countries  an 
interview with the treating physician or with the general practitioner is also required (Figure 
38). One country (Liechtenstein) reported having only living donors. 

Moreover, other practices were also reported: 

  Belgium reported that a physical examination of the body is also required;  
 

In  Germany,  a  post  mortem  physical  examination  as  well  as  the  results  of  the 
laboratory tests required according to Annex II of Directive 2004/23/EC;  
  Liechtenstein reported that there are only living donors, for cord blood cells;  
  Slovakia informed that other examinations might be done in case they are needed;  
  The  United  Kingdom  reported  that  there  are  no  mandatory  sources  and  tissue 

establishments may use several sources to evaluate a donor. 

51 

 
 
 
 
Fig. 38 Evaluation of deceased donors of human tissues and cells (2011 data) 

Concerning the selection of donors of reproductive cells, four Member States indicated having 
more stringent criteria than those listed in Annex III to Directive 2006/17/EC: 

  Belgium - Testing for Treponema pallidum;  
  Czech Republic - HIV p 24 laboratory testing (NAT testing is not acceptable);  
  Portugal - age of the donor (maximum age for oocyte donors is 35 and for sperm is 45. 
For  ovocyte  donation  only  three  ovocyte  pick-ups  cycles  per  donor  are allowed.  For 
sperm donation, a donor can be used for the birth of eight living children);  

  United  Kingdom  –  age  of  donors.  HFEA  also  specified  that  posthumous  use  of 
gametes or embryos created using gametes from a donor who has since deceased may 
only  be  used  if  the  gamete  provider  has  been  screened  in  accordance  with  the 
requirements set out in the EU Directives. 

No Member State declared having more stringent criteria for autologous donation than those 
listed  in  Annex  I  to  Directive  2006/17/EC.  Furthermore,  no  Member  States  request  more 
information on the donation of tissues/cells than the mandatory one as laid down in the Annex 
to Directive 2004/23/EC. 

In  most  of  the  Member  States  compliance  with  the  requirements  for  tissues  and  cells 
procurement,  packaging  and  transport  is  verified  by  the  competent  authorities  when 
performing  inspections. Auditing of  tissue establishments and centres of human application, 
as  well  as  inspections  of  the  centres  of  human  application  have  been  reported  by  several 
countries  as  additional  measures  for  verifying  compliance  with  the  EU  procurement, 
packaging  and  transport  requirements  (Figure  39).  Other  Member  States  also  reported 
requesting written SOPs and approval licence (Czech Republic), authorisation of procurement 

52 

 
 
 
  
establishments pursuant to sec. 20b of the German Medicinal Products Act (Germany), more 
requirements  for  specific  tissues  and  cells  (Italy),  related  information  in  the  Tissue 
Establishment  Dossier  that  is  requested  prior  to  inspections  (Malta),  correct  procedures  in 
place at the initial application assessment stage, and follow up during two-yearly inspections 
(United Kingdom).  

Fig. 39. Verification of compliance with the EU requirements for procurement, packaging in 
Directive 2006/17/EC (2011 data) 

Comments 

In  summary, the survey  showed that  inspections are the most important  verification method 
used  by  the  Member  States'  competent  authorities  when  verifying  the  compliance  of  tissue 
establishments with the EU donor evaluation and selection requirements. Nevertheless it has 
to be underlined that a few countries rely only on the medical records of the donor and/or the 
autopsy  report  without  interviewing  the  donor’s  family  or  his/her  treating  physician/general 
practitioner, which may raise concerns. In relation to the selection of gamete donors, only two 
Member States (Portugal, United Kingdom) reported that the donor’s age was included among 
the selection criteria for oocyte donors. The use of selection criteria should be transparent and 
subject to continuous evaluation in order to minimise safety risks.  

Several  Member  States  have  called  for  an  enhanced  harmonisation  of  the  criteria  for  donor 
selection  and  evaluation,  stressing  the  importance  of  using  a  standardised  donor  evaluation 
procedure (e.g. consultation of all relevant sources for the medical and behavioural history of 
deceased donors).  

2.3.4  Donor testing  

Under Article 4 of Directive 2006/17/EC, the national competent authorities must ensure that 
donors of tissues and cells, except donors of reproductive cells, undergo the biological tests 
set  out  in  point  1  of  Annex  II.  Also,  Article  4(2)  of  Directive  2006/17/EC  requires  the 

53 

 
 
 
 
competent authorities to ensure that donors of reproductive cells undergo the biological tests 
set out in points 1, 2 and 3 of Annex III.  

An  overview  of  the  donor  testing  in  all  the  reporting  countries  is  shown  in  Figure  40  (for 
donors of non-reproductive tissues and cells) and Figure 41 (for donors of reproductive tissues 
and cells).  

Fig. 40. Testing of donors non-reproductive tissues and cells (2011 data) 

Fig. 41. Testing of donors of reproductive tissues and cells (2011 data) 

The  survey  confirms  that  all  reporting  countries  comply  with  the  mandatory  testing 
requirements laid down in Annex I to Directive 2006/17/EC. The other testing requirements 
such  as  testing  of  HTLV-1  antibody  for  donors  living  in  or  originating  in  high-prevalence 
areas  or  with  sexual  partners  origination  from  those  areas,  as  well  as  additional  testing 
depending on the donors’ travel and exposure history and the characteristics of the tissue and 
cell  donated (e.g. CMV, EBV, Toxoplasma gondii, malaria,  West Nile virus, Dengue fever, 
Chikungunya, Trypanosoma cruzi) are also performed.  

One practical concern for the implementation of such requirements is however the lack of  a 
common  view  on  high-prevalence  areas  for  these  diseases.  The  Commission  has  therefore 
asked  ECDC  to  elaborate  assessments  and  maps  for  use  by  the  Member  States'  competent 
authorities and tissue establishments across the Union. 

Compared to the 2008 data, many countries introduced more stringent testing requirements of 
donors of non-reproductive tissues and cells (Fig 38), as following: 

54 

Tests for donors of NON-reproductive tissues and cells/countryATBEBGCYCZDEDKEEESFIFRHRHUIEITLILTLULVMTNLNOPLPTROSESISKUKAnti-HIV 1 AbYYYYYYYYYYYYYYYYYYYYYYYYYYYYYAnti-HIV 2 AbYYYYYYYYYYYYYYYYYYYYYYYYYYYYYHIV AgYYYYYYYYNAT HIV 1YYYYYYYYYHBs AgYYYYYYYYYYYYYYYYYYYYYYYYYYYYYAnti HBc AbYYYYYYYYYYYYYYYYYYYYYYYYYYYYYNAT HBVYYYYYYYYAnti HCV-AbYYYYYYYYYYYYYYYYYYYYYYYYYYYyYNAT HCVYYYYYYYYYYTreponema PallidumYYYYYYYYYYYYYYYYYYYYYYYYYYYYYHTLV-1                             YYYYYYYNAT HTLV-1YYTests for donors of reproductive tissues and cells/countryATBEBGCYCZDEDKEEESFIFRHRHUIEITLILTLULVMTNLNOPLPTROSESISKUKAnti-HIV 1 AbYYYYYYYYYYYYYYYYYYYYYYYYYYYYYAnti-HIV 2 AbYYYYYYYYYYYYYYYYYYYYYYYYYYYYYHIV AgYYYYYYYYNAT HIV 1YYYYYHBs AgYYYYYYYYYYYYYYYYYYYYYYYYYYYYAnti HBc AbYYYYYYYYYYYYYYYYYYYYYYYYYYYYNAT HBVYYYYAnti HCV AbYYYYYYYYYYYYYYYYYYYYYYYYYYNAT HCVYYYYYNAT ChlamydiaYYYYYYYYYYYYYYYYTreponema PallidumYYYyYYYYYYYYYYYYYYYYYYYYYYYYHTLV-1                     YYYYYYYNAT HTLV1YY 
 
 
 
  NAT HIV: AT, BE, DK, ES, FI, FR, HR, PT; 
  NAT HBV: AT, BE, ES, FI, FR, HR, LT; 
  NAT HCV: AT, BE, DK, ES, FI, FR, HR, LT, PT. 

Regarding testing donors of reproductive cells, most of the reporting countries comply  with 
the requirements in Annex III to Directive 2006/17/EC, with some exceptions. Two Member 
States (Lithuania, Poland15) did not comply entirely because of inappropriate transposition of 
the  Directives  for the ART sector. Additionally, nine  Member States  (HU, IE, IT, LU, MT, 
RO, SE, SI, SK) and Liechtenstein do not perform NAT for Chlamydia as requested in Annex 
III to Directive 2006/17/EC. 

Three  Member  States  (Austria,  Belgium  and  Finland)  declared  that  more  stringent 
requirements  were  introduced  for  donors  of  reproductive  cells  (e.g.  mandatory  NAT  testing 
for HIV, HBV and HCV).  

Concerning  NAT  testing,  several  countries  specified  that  this  type  of  testing  is  mandatory 
only in specific circumstances: 

  Austria: only for deceased donations and living autologous donations;  
  Croatia: only for non-reproductive tissues and cells; 
  Denmark: for deceased donors; 
  Estonia: for donors of reproductive and non-reproductive tissues and cells NAT HIV 1 
and  NAT  HCV  tests  are  required  only  if  Anti-HIV  1  and  Anti  HCV-Ab  are  not 
performed; 

  Finland: for donors of non-reproductive tissues and cells; 
  France:  for  non-reproductive  tissues  and  cells,  and  only  NAT  HIV  for  egg  donation 
(immediately before the collection of the eggs as a second determination of the viral 
status of the donor) ; 

  Germany:  for  deceased  donors  (exceptions  for  cornea  and  skin),  in  addition  to 

serological testing; 

  Lithuania: only for HBV and HCV; 
  Portugal: only for non-reproductive tissues and cells. 

Countries  in  which  NAT  testing  is  not  obligatory  by  law,  have  different  approaches  toward 
introducing this type of testing: 

  Denmark  intends  to  make  NAT  testing  for  HIV,  HBV  and  HCV  mandatory  for  egg 

donors; 

  Estonia, Ireland and Romania encourage the use of NAT testing, but the cost-benefit 

has to be taken into account;  
In Hungary the NAT technique is performed, but it is not compulsory by law; 
In Latvia NAT is performed routinely for HIV, HBV and HCV, but is not mandatory 
by law; 
In  Cyprus  the  technique  is  performed  for  donors  of  reproductive  cells,  if  cells  are 
issued without retesting of donors after 180 days; 
In Poland NAT testing is used only for verification of questionable serological results; 

 
 

 

 

15 In 2015 Poland has adopted new legislation for the ART sector and is in process of implementing it. 

55 

 
 
                                                            
 
  Four Member States (IE, MT, NL, SE) and Norway declared having no plans to make 
NAT  testing  mandatory  (mainly  because  epidemiological  data  and  the  cost-benefit 
analysis do not motivate such a decision); 

  Slovenia reported that no discussion/decision was taken at national level regarding this 

 

issue; 
In the United Kingdom the Advisory Committee on the Safety of Blood, Tissues and 
Organs  (SaBTO)  has  recommended  NAT  testing,  in  particular  product  testing  rather 
than donor serum testing. Mandatory NAT testing is supported by HTA particularly in 
case of a treatment involving donation from multiple donors and where the donations 
are not stored and therefore cannot be retested at 180 days. 

Seven Member States (AT, DE, FI, HR, IE, IT, SI) and Norway expressed concerns regarding 
the  accuracy  of  tests  for  cadaveric  donors,  mainly  because  of  the  limited  number  of 
manufacturers  and  the  absence  of  validated  CE-marked  kits.  Therefore,  in  some  countries 
(e.g. Germany) the competent authorities recommend validating the assay systems before use 
on cadaveric samples. 

Nine Member States (CY, ES, HR, HU, IE, IT, LV, PT, SE) reported requesting international 
accreditation  for  testing  laboratories  (e.g.  ISO,  EFI).  In  Romania  the  accreditation  is  not 
mandatory, but nevertheless it is frequently used. 

Comments 

The  data  reported  show  that  most  of  the  EU  and  EEA  countries  comply  with  the  testing 
requirements  stipulated  in  Directives  2004/23/EC  and  2006/17/EC.  Several  countries  have 
introduced more stringent testing requirements such as NAT testing for HBV, HCV and HIV 
for  either  or  both  donors  of  non-reproductive  and  reproductive  tissue  and  cells,  whereas  in 
most Member States and EEA countries the use of this type of testing is not motivated by the 
cost-benefit analysis and/or the epidemiological context.  

Additional tests required by Member States are usually justified for local reasons, like e.g. the 
increased  prevalence  of a  certain  infectious  disease.  These  criteria  may  however  also  create 
barriers  for  exchanging  tissues  and  cells  between  Member  States.  Members  States  should 
therefore  have  at  least  mutual  transparent  view  on  the  tests  implemented  in  each  of  the 
Member States. 

Several of the testing requirements have been subject to discussion in the bi-annual competent 
authorities  meetings  and  their  relevance/value  and  use/feasibility  should  be  continuously 
assessed in order to keep the tests aligned with the changes in the underlying risks that they 
need to help address.  

An agreement at EU level on the compulsory use of NAT screening in certain circumstances 
based on new scientific data on its efficacy and cost-effectiveness may decrease even further 
the viral transmission risk.  

It should also be kept in mind that the application of (some) tests can have a major impact on 
the local availability of tissues and cells.  

It was noted in the discussions of the competent authority meetings that while the theoretical 
value of testing can  be high,  the effective value depends  largely on the implementation  and 
validation of these tests. Testing can therefore not be considered as the single pillar for safety 
of  tissues  and  cells  but  is  to  be  combined  with  deferral  criteria  and,  where  applicable, 

56 

 
 
inactivation  techniques.  It  is  only  the  combined  implementation  of  all  pillars  that  can 
minimise safety risks.  

2.4 

 Quality and safety of tissues and cells  

Directives  2004/23/EC  and  2006/86/EC  contain  a  number  of  provisions  concerning  quality 
and  safety  of  tissues  and  cells  intended  for  human  application.  They  refer  to  (1)  quality 
management,  responsible  person  and  personnel,  (2)  tissue  and  cell  reception,  processing, 
storage,  labelling and packaging,  (3) distribution of  tissues and cells  for human application, 
(4) relations between tissue establishments and third parties and (5) penalties applicable to in 
case of infringement of the national tissues and cells legislation. 

2.4.1  Quality management, responsible person, personnel 

Under  Article  16  of  Directive  2004/23/EC,  Member  States  must  take  all  the  necessary 
measures  to  ensure  that  all  tissue  establishments  put  in  place  and  keep  up  to  date a  quality 
system, including a minimum of documentation, which must also be available for inspection 
by the competent authorities. 

The  compliance  of  tissue  establishments  with  the  requirements  of  this  Article  is verified  by 
the national competent authorities when authorising and inspecting the tissue establishments 
and by performing internal or external audits (Figure 42). 

Fig. 42. Verification of compliance with the requirements of Art 16 (quality management) of 
Directive 2004/23/EC (2011 data) 

Article  17  of  Directive  2004/23/EC  requires  every  tissue  establishment  to  designate  a 
responsible  person  with  appropriate  qualifications,  who  should  fulfil  the  tasks  laid  down  in 
this Article. The verification methods employed by the competent authorities for ensuring the 
fulfilment of this legal obligation are presented in Figure 43. 

57 

 
 
 
 
 
Fig. 43. Verification of compliance with the requirements of Art 17 (responsible person) of 
Directive 2004/23/EC (2011 data) 

Besides  the  abovementioned  methods,  Sweden  reported  that  in  case  of  a  change  of  the 
responsible person, an application together with the CV of the new responsible person must 
be approved by the competent authority. 

Likewise,  Article  18  of  Directive  2004/23/EC  entails  that  tissue  establishment  personnel 
directly involved in all the activities, from procurement to distribution of human tissues and 
cells, should be properly qualified and should be provided with suitable training. A summary 
of the verification methods used by the competent authorities for ensuring appropriate training 
of the tissue establishments' personnel is shown in Figure 44. 

Some Member States reported additional procedures:  

 

Italy specified providing a non-mandatory training for the personnel directly involved 
in the activity of tissue establishments;  

  Malta  informed  that  during  inspections,  the  team  of  inspectors  asks  for  the 
documentation  concerning  the  training  of  the  personnel  directly  involved  in  the 
activities of tissue establishments;  

  Sweden  reported  that  during  the  inspections  interviews  with  the  personnel  directly 
involved in the activities of tissue establishments are conducted and that the possibility 
of participation to additional/advanced training courses is discussed. 

58 

 
 
 
Fig. 44. Verification of compliance with the requirements of Art 18 (personnel) of Directive 
2004/23/EC (2011 data) 

Twenty Member States (BE, BG, CY, DE, DK, EE, ES, FR, HR, HU, IE, IT, LV, MT, PL, 
PT,  SE,  SI,  SK,  UK)  and  Norway  reported  that  they  have  national/regional/local  training 
programmes  for  the  personnel  of  tissue  establishments.  Other  Member  States  reported  that 
their  personnel  is  trained  in  other  EU  countries  (AT,  CZ,  FI,  LT,  LV,  NL,  RO  and 
Liechtenstein) or in non-EU countries (Czech Republic, Netherlands, Romania). In addition, 
Poland mentioned that each tissue establishment designates a quality manager.  

Comments 

As all steps from tissue and cell donation until their distribution for medical application relies 
on  staff  professionalism,  all  personnel  should  be  appropriately  qualified  and  should  benefit 
from  appropriate  training.  The  present  survey  confirmed  that  Member  States  are  trying  to 
ensure  an  appropriate  level  of  training  for  the  tissue  establishments’  personnel,  and  the 
compliance  with  the  EU  training  requirements  is  systematically  checked  during  inspections 
and also before granting an authorisation/accreditation/licence to the tissue establishments. It 
has to be underscored that additional support on training of tissue establishments’ personnel 
was given through EU-funded projects such as European Quality System for Tissue Banking 
(EQSTB)16 and European Good Tissue Practices (EuroGTPs)17. The good practices on quality 
management, responsible persons and personnel developed by the EU-funded initiatives were 
also  included  by  the  Council  of  Europe  in  a  dedicated  Guide  to  the  quality  and  safety  of 
tissues and cells.  

16 http://ec.europa.eu/chafea/projects/database.html?prjno=2003209  
17 http://eurogtps.com/HOME/tabid/38/Default.aspx  

59 

 
 
 
 
 
                                                            
2.4.2.  Tissue and cell reception, processing, storage, labelling and packaging  

The  measures  taken  by  the  Member  States  and  EEA  countries  for  ensuring  that  tissue 
establishments  fulfil  the  requirements  in  Article  19  (Tissue  and  cell  reception)  of  Directive 
2004/23/EC and in Annex IV to Directive 2006/17/EC, are presented in Figure 45. 

Fig. 45. Verification of compliance with the requirements of Art 19 (tissue and cell reception) 
of Directive 2004/23/EC (2011 data) 

Article 20 of Directive 2004/23/EC obliges tissue establishments to include in their standard 
operating  procedures  all  processes  that  affect  quality  and  safety  thus  ensuring  that  they  are 
carried  out  under  controlled  conditions.  Detailed  requirements  concerning  tissue  and  cell 
processing  are  laid  down  in  Annex  II  to  Directive  2006/86/EC.  An  overview  of  the 
verification  methods  used  by  the  competent  authorities  for  ensuring  that  these  requirements 
are met is shown in Figure 46. 

Article 21 of Directive 2004/23/EC, as  well as Annex II  to Directive  2006/86/EC lay down 
the obligations of tissue establishments related to the tissues and cell storage conditions.  An 
outline  of  the  control  measures  used  by  the  competent  authorities  for  ensuring  that  these 
requirements are fulfilled is presented in Figure 47. 

Article 22 of Directive 2004/23/EC together with Annex II to Directive 2006/86/EC stipulate 
the  tissue  establishments’  obligations  related  to  labelling,  documentation  and  packaging  of 
human  tissues  and  cells.  A  synopsis  of  the  control  measures  applied  by  the  competent 
authorities for ensuring that these requirements are fulfilled is presented in Figure 48. 

60 

 
 
 
 
Fig. 46. Verification of compliance with the requirements of Art 20 (tissue and cell 
processing) of Directive 2004/23/EC (2011 data) 

Fig. 47. Verification of compliance with the requirements of Art 21 (storage of tissues and 
cells) of Directive 2004/23/EC (2011 data)  

61 

 
 
 
Fig. 48. Verification of compliance with the requirements of Art 22 (labelling, documentation 
and packaging) of Directive 2004/23/EC (2011 data) 

Due to their importance, Germany suggested that requirements for microbiological testing of 
the  source  materials  as  well  as  of  the  final  tissue  product  should  be  included  in  case  of  a 
potential revision of the legislation. It was underlined that microbiological testing for bacteria 
and fungi must be performed on the starting or incoming tissue itself, where possible. 

Additionally,  Poland  added  that  external  audits  are  not  obligatory,  but  some  of  the  tissue 
establishments  applied  for  and  received  ISO  accreditation.  The  JACIE  accreditation 
programme of procurement and transplantation centres as well as tissue establishments in the 
field of HSC started in 2013. 

Comments 

The  importance  of  inspections  is  highlighted  again  in  the  context  of  compliance  with  the 
reception, processing, storage,  labelling and packaging  requirements. It is  the most  frequent 
approach  to  control  their  implementation.  Mandatory  SOPs  are  also  required  during  the 
authorisation/accreditation/designation  or  licensing  process  in  most  of  the  responding 
countries.  

2.4.3.  Distribution of tissues and cells for human application (Intra-community exchange) 

Most  of  the  Member  States  and  EEA  countries  reported  having  cross-border  exchanges  of 
human tissues and cells distributed (either distributing or receiving to/from another Member 
State/EEA country or both).  

Eleven Member States (AT, BE, DE, DK, FR, HR, IT, LT, NL, PT, SE) and Norway declared 
having more stringent safety and quality requirements than the minimum ones required by the 
EU  tissues  and  cells  Directives.  Of  these,  some  (BE,  DK,  SE  and  Norway)  expect  that  the 
responsible  person  of  the  tissue  establishment  located  in  the  other  Member  State/EEA  will 
ensure the compliance with the more stringent requirements before releasing the products. If 

62 

 
 
 
needed,  the  competent  authority  from  the  receiving  country  is  informing  about  the  more 
stringent requirements the tissue establishment intending to distribute tissues and/or cells on 
their territory.  

Different  or  additional  requirements  by  Member  States  might  be  well  justified  for  local 
reasons, e.g. to address the increased prevalence of a certain disease. Members States should 
however  have  a  mutually  transparent  view  and  understanding  on  the  requirements 
implemented in each of the Member States. 

Article  23  of  Directive  2004/23/EC  requires  tissue  establishments  to  ensure  the  quality  of 
tissues  and  cells  during  distribution.  For  most  of  the  Member  States,  national  competent 
authorities  ensure  that  tissue  establishments  fulfil  the  requirements  of  this  Article  when 
granting authorisations, by inspections, audit or control of documentation (Figure 49). 

Fig. 49. Verification of compliance with the requirements of Art 23 (distribution) of the 
Directive 2004/23/EC (2011 data) 

In  most  of  the  reporting  countries  direct  distribution  of  tissues  and  cells  from  another  EU 
Member  State/EEA  country  to  organisations  responsible  for  human  application  (e.g. 
hospitals/clinics) on their territory is allowed. Four Member States (CZ, HR, PT and UK but 
only for gametes) and Liechtenstein reported that direct distribution is not allowed. An outline 
of the answers provide to this question is shown in Figure 50. 

63 

 
 
 
Fig. 50. Direct distribution of tissues and cells (2011 data) 

The other situations reported are detailed below: 

  Germany specified that before the first placing on the market, a certificate issued by 
the Paul-Ehrlich Institute is required (section 21a sub-section 9 AMG); the certificate 
shows that the products to be distributed in Germany have equivalent quality standards 
with the ones already on the market. In the case of non-equivalence, a “full marketing 
authorisation” (authorisation for tissue preparations regarding Section 21a AMG) must 
be obtained; 

  Latvia  informed  that  there  are  no  legal  provisions  regarding  distribution  to  Latvian 

hospitals from tissue establishments in another Member State; 

  Malta indicated that direct distribution to hospitals/clinics through brokers is possible 
only  after  notification  of  the  competent  authority  who  authorises  the  entry  if  the 
relevant documentation shows equivalence of standards; 
In the Netherlands, restrictions apply only for unprocessed tissues, which is done only 
via an authorised tissue establishment; 
In  Slovenia distribution  to  hospitals/clinics is  allowed,  but  with  special  authorisation 
issued for each case; 

 

 

  Spain indicated that only the distribution of products derived of human tissues such as 
demineralised  bone  matrix  (DBM)  and  lyophilized  products  may  be  distributed 
directly to hospitals/clinics; 
In the United Kingdom, direct distribution is allowed to end users, without requiring a 
licence, provided tissues and cells will not be stored for longer than 48 hours.  

 

Concerning  direct  distribution  of  specific  tissues  and  cells  to  a  recipient  (Article  6  of 
Directive 2006/17/EC), five Member States (FR, LT, MT, SI, SK) reported having authorised 
such  procedures  in  2011  for  haematopoietic  stem  cells  (France,  Lithuania),  musculoskeletal 
tissues (Lithuania, Malta) as well as gametes and embryos (FR).  

64 

 
 
 
 
Only 18 Member States (BE, BG, DE, EE, ES, FI, FR, HR, IE, IT, LT, NL, PT, RO, SE, SI, 
SK,  UK)  reported  that  data  related  to  the  cross-border  exchange  between  their  country  and 
another  Member  State/EEA  country  are  collected  at  national  level.  However,  the  data 
collected varies from one country to another, with some Member States providing data on the 
number and type of tissues distributed as well the country of destination/origin (BE, BG, DE, 
EE, FI, HR, IE, IT, LT, PL, PT), other only data on the number and type of tissues distributed 
(Netherlands,  Spain,  Sweden)  or  just  the  total  number  distributed  within  the  EU  (United 
Kingdom). Additionally, Germany collects data on tissues and cells entering and leaving their 
territory  with  no  distinction  between  import/export  from/to  third  countries  and  distribution 
within the EU.  

Overall,  for  2011,  18  countries  reported  that  59,375  units  of  human  tissues  and  cells  were 
distributed to other EU and EEA countries: 

  41,271  units  were  distributed  by  United  Kingdom.  Data  per  tissue  type  were  not 

reported; 

  16,461 units were distributed by 13 Member States (BE, BG, EE, ES, FI, IE, IT, LT, 

NL, PL, PT, SE, UK/HFEA) (Figure 51); 

  1,643 units of replacement tissues (musculoskeletal, ocular tissues and cardiovascular 
tissues) were distributed by France. It was specified that distribution of haematopoietic 
stem  cells  units  was  reported  to  EBMT.  Distribution  of  cryopreserved  sperm  to  one 
Member  State  (Spain)  for  patients  who  travel  abroad  for  egg  donation  was  also  was 
reported. 

Fig. 51. Volume of tissues and cells distributed for clinical application to another Member 
State or EEA country (units of tissues or cells – absolute and relative values; 2011 data) 

The  number  above  does  not  include  cord  blood  units,  cord  blood  segments  and  teeth  for 
autologous use transported for storage in another Member State (e.g. as reported by Slovenia). 

65 

 
 
  
One  Member  State  (Romania)  collects  data  on  distribution  of  tissues  and  cells  but  reported 
that no such products were distributed in 2011. Slovakia informed that data collection started 
only in December 2012, so 2011 data is not available. 

Information  on tissues and cells received from other  EU Member States  and EEA countries 
was also asked. For 2011 it was reported that 255,346 units of human tissues and cells were 
received from other EU and EEA countries: 

  238, 244 units were received by the United Kingdom;  
  4,480 units of replacement tissues (musculoskeletal, ocular tissues and cardiovascular 

tissues) were reported by France. Data per tissue type were not reported; 

  12,622 units were reported by 13 Member States (BE, BG, EE, ES, FI, IE, IT, LT, NL, 

PL, PT, SE, UK/HFEA) (Figure 52). 

Fig. 52. Volume of tissues and cells received for clinical application from another EU 
Member State or EEA country (units of tissues or cells – absolute and relative values; 2011 
data) 

Four Member States (HR, PL, RO, SK) informed that no tissues and cells were received from 
other EU or EEA countries in 2011.  

Slovenia  and Slovakia did  not  provide details  on the type of tissues and cells for which the 
authorisation was granted. 

In  addition,  only  nine  Member  States  (AT,  DE,  DK,  ES,  IE,  IT,  MT,  NL,  UK  for  non-
reproductive  tissues  and  cells)  and  Liechtenstein  and  Norway  reported  allowing  brokerage 
companies  for  either  distribution  in  EU  and/or  import/export  of  tissues  and  cells.  The  legal 
framework for the brokerage companies varies, as follows:  

  Authorisation by the national competent authority is required (Austria, Malta); 
  No  specific  legal  provisions,  but  the  competent  authority  informs  the  brokerage 
company  on  the  principles  of  tissues  and  cells  legislation  and  periodically  monitors 
their activities (Denmark); 

66 

 
 
 
  National  legislation  in  place  for  “brokering  of  medicinal  products”  (sec.  4  para.  22a 
German Medicinal Products Act), but no experience in implementing these regulations 
with regard to “classical tissues” (Germany); 

  Possibility  to  operate  under  a  third  party  agreement  with  a  public,  authorised  tissue 

establishment (e.g. currently occurring for processed bone products) (Italy);  

  Legislation  in  place,  according  to  which  a  broker  is  a  legal  entity  allowed  to  make 
financial  and  logistic  arrangements  between  seller  and  buyer  without  handling  the 
tissues  (handling  the  tissues  is  only  allowed  to  authorised  tissue  establishments) 
(Netherlands);  

  Authorisations for brokerage are provided by the regional authorities (Spain);  
  Brokers are considered intermediaries obtaining tissue for end-users, however most of 
them are licensed as they are engaged in an intermediate storage step. The competent 
authority's  role  is  to  authorise  and  monitor  them  through  inspection.  Currently  only 
one  broker  is  licensed  for  distribution  and  import/export,  without  storage  (United 
Kingdom). 

Three  Member  States  (Austria,  Germany,  Ireland)  as  well  as  Liechtenstein  and  Norway 
specified  that  even  though  brokers  are  allowed,  they  are  not  actively  supplying  healthcare 
professionals and other types of establishments.  

In the six Member States which indicated that brokers actively supply health professionals in 
their  country  (DK,  ES,  IT,  MT,  NL,  UK),  brokers  are  located  either  on  their  territory  (DK, 
ES,  IT,  MT,  UK)  or  in  another  country  (ES,  IE,  IT,  NL).  Spain  also  specified  that  the 
verification  of  compliance  with  the  safety  and  quality  requirements  is  performed  through 
analysis of the documentation provided by the broker. 

Comments 

As demonstrated by the Member States' replies, there are important cross-border movements 
of  human  tissues  and  cells  within  the  EU  and  EEA  countries.  This  may  be  considered  the 
result  of  the  quality  and  safety  standards  laid  down  in  Directive  2004/23/EC  and  its 
implementing  Directives,  which  have  created  the  framework  for  facilitating  transnational 
movements within the Union. However, it has to be underlined that like for import and export, 
data  collected  by  the  Member  States  probably  serve  different  purposes  and  use  various 
methodologies,  so  it  is  very  difficult  to  draw  a  clear  conclusion  on  the  volume  of  tissues 
exchanged  and  the  importance  of  EU  distribution  compared  to  import/export  in  this  sector. 
Additionally the more stringent requirements introduced by some Member States, as well as 
the different legal framework under which the EU tissues and cells legislation was transposed 
(e.g.  transplantation  vs. medicinal  products)  may  hamper  to  some  extent  the  flow  of  tissues 
and cells within the Union. 

2.4.4  Relations between tissue establishments and third parties  

Article 24 of Directive 2004/23/EC lays down the requirements between tissue establishments 
and  third  parties,  which  include  the  situations  when  a  written  third  party  agreement  is 
mandatory and the obligations of the tissue establishments when selecting the third parties, as 
well as their obligation to keep a complete lists of these agreements and to provide copies of 
the agreements upon request from competent authorities.  

67 

 
 
 
Only two Member States (Hungary, Luxembourg) reported that third party agreements are not 
included  in  their  national  legislation.  From  the  countries  allowing  third  parties  agreements, 
only  four  Member  States  (CY,  FI,  RO,  SK)  and  Liechtenstein  reported  that  no  third  party 
agreements were notified to the national competent authorities.  

Concerning the responsibilities entrusted to third parties, Member States reported that written 
agreements with third parties have been concluded for several activities within the donation-
distribution chain (Figure 53).  

Fig. 53. Tissue establishments’ written agreements with third parties (2011 data) 

Seven  Member  States  (BE,  BG,  DE,  EE,  FR,  LT,  PT)  and  Norway  reported  only  the 
circumstances  and  did  not  provide  detailed  data  on  activities  for  which  third  parties 
agreements can be concluded.  

Member States and EEA countries reported that third party agreements are checked (Art 6.2) 
by the competent authority(ies) mainly by inspection (AT, BE, BG, CZ, DE, DK, EE, ES, FR, 
HR,  IE,  IT,  LV,  NL,  PL,  PT,  SE,  UK  and  NO),  by  evaluating  the  contractual  agreements 
(Denmark, Latvia, Malta), but also when granting  authorisations/accreditations /designations 
or licences (BG, CZ, DE, EE, ES, FR, IE, NL, PL, PT, SE, SI, UK and NO).  

The  competent  authority  for  non-reproductive  tissues  and  cells  in  United  Kingdom  (HTA) 
specified having powers to enter and inspect third party premises, powers to direct a licensed 
establishment  to  put  in  place  a  third  party  agreement  with  a  supplier  of  goods  or  services 
where  it  considers  this  necessary.  The  HTA  equally  has  powers  to  direct  an  individual 
licensed establishment not to use a named supplier of either goods or services. Under extreme 

68 

 
 
 
circumstances the HTA may give details of suppliers from whom no  licensed establishment 
may receive goods or services. 

In  Italy, third parties  that carry  our critical steps such  as  processing  or storage  of tissues or 
cells on behalf of tissue establishments must have direct authorisations from the Ministry of 
Health, which are issued by the national competent authority (Centro Nazionale Trapianti) on 
the basis of inspections. In Sweden, a new third party agreement is considered a major change 
in  the  authorisation  of  a  tissue  establishment  and  it  requires  the  approval  of  the  competent 
authority (by document review).  

Comments 

The  fact  that  third  parties  may  be  involved  in  all  the  steps  of  the  chain  from  donation  and 
procurement  until  distribution  shows  the  importance  that  needs  to  be  given  to  the  written 
agreements  established  by  the  tissue  establishments  and  their  verification  by  the  national 
competent authorities. In this respect, it should be highlighted that Directive (EU) 2015/566 as 
regards the procedures for verifying the equivalent standards of quality and safety of imported 
tissues  and  cells18  provides  for  the  harmonisation  of  the  minimum  requirements  in  terms  of 
contents  of  written  agreements  between  importing  tissue  establishments  and  their  third 
country suppliers. 

2.4.5.  Penalties  

Under  Article  6(4)  of  Directive  2004/23/EC,  the  competent  authority  or  authorities  may 
revoke or suspend the accreditation/designation/authorisation/licence of a tissue establishment 
if it is found to no longer comply with the requirements of the Directives.   

Twenty-two  Member  States    (AT,  BE,  BG,  CY,  CZ,  DE,  EE,  ES,  FI,  FR,  IE,  IT,  LU,  LV, 
MT, NL, PL, PT, RO, SE, SI, UK) and Liechtenstein and Norway indicated that penalties for 
infringements of the national provisions pursuant to Directive 2004/23/EC were defined. Five 
Member States  (AT, CZ, DE, NL,  UK)  indicated that  such penalties were  already imposed, 
but only two Member States reported imposing penalties in 2011 (Germany – one fine; United 
Kingdom/HTA  – 11  penalties). The United Kingdom reported that the majority  of penalties 
were  imposed  following  inspections  where  shortfalls  against  regulatory  requirements  had 
been  identified;  penalties  imposed  included  conditions  or  directions  on  seven  licences, 
suspensions  of  specific  licensable  activities  on  three  licences  and  one  revocation,  but  none 
were followed by criminal sanctions. 

Comments 

The  penalties  foreseen  in  national  legislation,  their  criteria  for  implementation  and  their 
effective implementation can differ significantly between Member States. In order to ensure 
mutual trust between Member States, in particular for cross-border movements, some Member 
States  suggested  further  collaboration  and  coordination,  potentially  in  a  dedicated  EU 
initiative related to inspections and authorisations. 

18    Commission  Directive  (EU)  2015/566  of  8  April  2015  implementing  Directive  2004/23/EC  as  regards  the 
procedures for verifying the equivalent standards of quality and safety of imported tissues and cells Text with 
EEA relevance. OJ L 93, 9.4.2015, p. 56–68 

69 

 
 
 
                                                            
Annex  1:  Individual  country  responses  to  the  survey  on  the  implementation  of  the  EU 

Tissues and Cells Directives conducted in 2012 and based on 2011 information 

Note:  In  a  number  of  cases  clarification  requests  were  sent  to  Member  States  to  verify  the 
information included in their submission. It is important to note that while the original replies 
of  Member  States  are  shown  below,  the  text,  tables  and  figures  reflect  the  updated 
information  provided  by  Member  States  during  a  verification  process.  Where  there  are 
discrepancies,  the  text,  tables  and  figures  in  the  document  itself  contain  the  correct 
information. 

A.1.1. 

Survey response Austria 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

Federal Office for Safety in Health Care (BASG) / AGES Austrian 
Agency for Health and Food Safety 
Traisengasse 5 A-1200 Vienna Austria 
+43505550 
inspektionen@ages.at 
www.basg.gv.at 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Pharmaceuticals 
Medical devices 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
Federal Office for Safety in Health Care (BASG) and AGES The 
Federal Office for the Safetyin Health Care (BASG) / AGES was set 
up in January 2006 and is responsible for marketing authorisation of 
medicinal products in Austria and assessment of medicinal products 
and medical devices which are already on the market regarding 
efficacy, adverse reactions, production, shipment and storage. Fully 
owned by the Republic of Austria, BASG / AGES acts on behalf of 
the Republic as represented by the Federal Ministry of Health 
(BMG). The Federal Office for Safety in Health Care (BASG) is 
responsible for carrying out public services undertakings. BASG is 
directly subordinate to the Federal Ministry of Health (BMG). It 
consists of three members, which are appointed by the Federal 
Minister of Health. One of these members was delegated by the 
BMG, another by AGES; the third member is the head of BASG / 
AGES. AGES is thus connected closely to the BASG; it is 
represented by two members in the Federal Office and provides it 
with services, staff and facilities. The employees of BASG / AGES 
are responsible for carrying out public services undertakings and act 
on behalf of the Federal Office. The written decisions issued by the 
BASG are not subject to reversal change by the administration, thus 
making it the first and final authority.   The instituts of the Austrian 
Medicines and Medical Devices Agency:     Institute 
Pharmakovigilance (Head: Dr. Bettina Schade)     Institute OMCL 
(Head: Dr. Gerhard Beck)     Institut Marketing Authorisation & 
Lifecycle Management (Head: Dr. Christa Wirthumer-Hoche)     
Institute Inspections, Medical Devices & Haemovigilance (Head: 
DDr. Alexander Hönel) Head of the Austrian Medicines and 
Medical Devices Agency: Ao. Univ.-Prof. Dr. Marcus Muellner   

70 

 
 
 
 
The tasks concerning tissues and cells are mainly located at the 
Instituts Inspections, Medical Decives & Haemovigilance at the 
department Pharma and there at the group Blood & Tissues 
Inspections & Vigilance. The group Blood & Tissues Inspections & 
Vigilance consists of a team of inspetors (4), a vigilace team (3), and 
the head of the group.    
Not applicable 

Not applicable 

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
35 

32 

15 

36 

9 

Inspections of the site/centre 

No 

missing implementation in national law 
Analysis of the mandatory documentation requested from the tissue 
establishment 

missing implementation in national law 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art 4 Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

- 

Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 

71 

 
 
 
 
 
 
3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.4.1. Please specify why: 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
NAT HCV 
NAT Chlamydia 
Treponema Pallidum 
only for autologous donations NAT testing is not mandatory 
reproductive autologous: NAT testing not mandatory reproductive 
allogeneic: NAT testing mandatory deceased: NAT testing 
mandatory living autologous: NAT testing not mandatory living 
allogeneic: NAT testing mandatory 
Yes 

because there are no CE-marked kits for the testing of blood of dec 
No 

No 

No 

- 

Yes 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

Yes 
During inspections organised for this purpose 
2 

No 

57 

0 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

4.7.2. How many musculo-skeletal tissue establishments? 
4.7.6. How many cord blood tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 

4.8.1. How many skin tissue establishments? 

Musculo-skeletal tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
1 
1 
7 
1 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
1 

72 

 
 
 
 
 
 
4.8.2. How many musculo-skeletal tissue establishments? 
4.8.4. How many cardiovascular tissue establishments? 
4.8.5. How many HSC tissue establishments? 
4.8.6. How many cord blood tissue establishments? 
4.8.7. How many ART tissue establishments? 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.2. How many musculo-skeletal tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.9.6. How many cord blood tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.9.8 How many multi-tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.16.1.1. How many penalties have been imposed in 2011 (from 
01/01/2011-31/12/2011)? 
4.16.1.2. What were the reasons for imposing the penalties? Please 
describe. 
4.16.1.3. What kind of penalties were imposed? Please describe (e.g. 
suspension of authorisation, criminal penalty etc.) 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

16 
1 
3 
2 
4 
2 
Musculo-skeletal tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
9 
1 
2 
22 
5 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
10 
6 
1 
0 
6 
0 
0 
3 
14 
18 
14 
3 
none 

Tumor tissue (Glioblastoma multiforme) 1TE Subcutaneous adipose 
tissue 1TE 
0 

Yes 

Yes 
0 

- 

- 

A legally necessary certificate for tissue establishments, issued after 
each inspection, would be desireable in order to display the current 
status of authorization (comparable to a GMP-Certificate in the 
pharmaceutical area). 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 

Yes 

Austrian Agency for Health and Food Safety (AGES), Institute 

73 

 
 
 
 
 
 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conductedin 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4 Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 

Inspections, Medical Devices & Haemovigilance 
4 
Yes 

Blood 
Pharmaceuticals 
Advanced therapies 
40 

0 

2 (enforcement inspections) 

0 

11 

29 

2 

0 

2, Due to major changes in the TE additional inspections were 
performerd. 

18 

0 

0 

0 

1 

16 

0 

0 

74 

 
 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

2, Due to major changes in the TE additional inspections were 
performerd. 
General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  Desk based reviews are conducted if only minor changes in the TE 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses ;on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

took place. For routine inspections or for first inspections of a TE 
general system-oriented inspections are conducted. However there 
can be also a focus on special topics. Thematic inspections are 
triggered where major shortcomings are not solved or following 
SAE or SAR. 
Yes 

7 

Yes 

28 
No 
lack of inspection capacity 
Yes 

Yes 

4 

No 

No 

No 

No 

Yes 

more harmonisation and exchange of information on EU level in 
regard of inspections would be helpful (e.g. establishing a tissue & 
cells inspectors workin group) 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 

Yes 

2 

not recorded 

75 

 
 
 
 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 

6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc ) tissues from third countries. 

6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 

6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 

6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

Inspections at the importing establishments take place, the product is 
released by the Austrian establishment, SOPs and contracts are 
inspected to ensure the equivalent standards, the Austrian company 
has to perform audits at the site they are importing from 
Inspections at the importing establishments take place, the product is 
released by the Austrian establishment, SOPs and contracts are 
inspected to ensure the equivalent standards, the Austrian company 
has to perform audits at the site they are importing from 
Inspections at the importing establishments take place, the product is 
released by the Austrian establishment, SOPs and contracts are 
inspected to ensure the equivalent standards, the Austrian company 
has to perform audits at the site they are importing from 
Inspections at the importing establishments take place, the product is 
released by the Austrian establishment, SOPs and contracts are 
inspected to ensure the equivalent standards, the Austrian company 
has to perform audits at the site they are importing from 
Inspections at the importing establishments take place, the product is 
released by the Austrian establishment, SOPs and contracts are 
inspected to ensure the equivalent standards, the Austrian company 
has to perform audits at the site they are importing from 
Inspections at the importing establishments take place, the product is 
released by the Austrian establishment, SOPs and contracts are 
inspected to ensure the equivalent standards, the Austrian company 
has to perform audits at the site they are importing from 
Inspections at the importing establishments take place, the product is 
released by the Austrian establishment, SOPs and contracts are 
inspected to ensure the equivalent standards, the Austrian company 
has to perform audits at the site they are importing from 
Yes 

no data available, notification not required by national law 

No 

No 

F. Other 

only import is authorised - no estimations are performed  
No 

- 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 

No 

Yes 
The different, more stringent national laws of all member states can 
not be known. Product which are brought to other member states 
must fulfill the Austrian Cell and Tissue Safety Act.  
Yes 

If the tissues or cells have been released by a responsible person in 
the EU, the products can be used in Austria.  

During inspections records, SOPs are reviewed.  

Yes, no restrictions apply 

76 

 
 
 
 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) as 
a Competent Authority, in their authorisation/monitoring or 
inspection. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

No 

Yes 

For import/export of tissue and cells an authorisation by the CA is 
required. For the arrangement of transactions within the EU no 
authorisation is required. 
No 

- 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 

No 
No 

60-99% 

Data for 2009 were published, due to no national legislations there 
was no further publishing since then. Legislation was changed 
recently. The data of 2012 will be published.  
Yes 

http://www.basg.gv.at/arzneimittel/gewebe/register-29-gsg/ 
Yes 

update of register of TEs and their tasks was provided to EUROCET 
in July 2013 
- 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

8.7. Do you have any additional comments on reporting? 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.1.1. If no, why not? 

No 

9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
Please specify 'other'. 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

The Federal Ministry of Health deferred the implementation of 
ISBT128 on 16.12.2008 due to difficuties in the practical 
implementation in the area of tissues and cells. 
Other 

TE or procurement center 
Both paper records and electronic forms 

Needs to be specified in SOPs. Checking examples during routine 
inspections. 
- 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 

AGES (our CA) 
see 1.5 
Yes 

Yes 

77 

 
 
 
 
 
 
 
 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.2. Please specify why not. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient) 3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Yes 

Yes 

70-99% 

Yes 

it is regulated by national law 
Yes 

each TE receives a confirmation of the notification after submitting 
No 

currently there is no summary report of the Commission available 
Yes 
there were no recalls in 2011 

Yes 

all involved TE and procurement sites will be informed by email 

Yes 

all involved TE and procurement sites will be informed by email 

No 

leck of capacity, not mandatory 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Yes 

5 

- 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 

Explicit consent (opt-in) 

11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
Please specify 'other'. 

Before procurement of tissues or cells the donor has to be informed 
about the procedure, any risks, testings etc. and has to give his 
consent with his signature. 
Presumed consent (opt-out) 

Other 

People who object to donation of tissues or organs after death can 
sign up in register. Medical personnel has to counsel this register 

78 

 
 
 
 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity  of the receipient is not disclosed to the donor and vice 
versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 

11.10. Do you have any additional comments on consent and data 
protection? 

before any procurement of tissues or organs of deceased donors can 
take place. 
Yes 

Analysis of documentation 

Only trained personnel is allowed to provide such information 

Usually donors are traceable by a unique donor identification 
number. 

Usually donors are traceable by a unique donor identification 
number. 

No 

Parents will just get any necessary medical information or 
information regarding physical appearance of the sperm donor. 
However to the child the personal data of the sperm donor will be 
disclosed when he or she is 14 year old. 
- 

Inspections of TEs and procurement sites 
Audit of documentation 

No 

Medical records of the donor 

Inspections of ART centres 
Audit documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 
12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Inspection of tissue establishment 
Audit of tissue establishment 

No 

No 

No 

- 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 

Authorisation requirement 
Inspections 

79 

 
 
 
 
 
 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel trained? 
13.4.2.1. Please specify EU-countries. 
13.5. Any additional comments on quality management, responsible 
person, personnel? 

Internal audits 
External audits 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 
Mandatory trainings 
No 

EU countries 
EATB training, a.s.o. 
- 

14 Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 

14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.1.1. Please specify. 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 
- 

Yes 

Yes 

transport agreements, agreements with laboratories for laboratory 
testing,  agreements with clinical teams (procurement) 
during routine inspections 

- 

Yes 

The donation fo egg cells or embryos is not allowed.  Deceased 
donors have to be tested by NAT for HIV, HBV and HCV.  Of all 
the blood samples of donors samples have to be stored at the TE for 
30 years so that all laboratory tests can be repeated twice.  

80 

 
 
 
 
 
 
 
 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of  following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

ART provisions 

difficulties regarding the requirements on the premisis (air grade, 
monitoring of air grade) 
Directive 2006/17/EC 
Directive 2006/86/EC 
In the case of donations of autologous living donors or partner 
donations where test results are positive (HIV 1, 2, Hepatitis B, C 
etc.) the tissues or cells should not only be stored separately (Annex 
I 2.1.1, Annex III 2.3) but there should also be facilities in place to 
ensure separate processing to eliminate the risk of cross-
contamination and mix up. For deceased donors blood samples 
should be tested for HIV, Hepatits B and C genome by NAT. 
The paragraph "Annex I, D Facilities/Premises 4 (c)" should be 
explained and it should be clarified under which circumstances it 
applies. It should be defined which air quality for the environment is 
required if this paragraph is applicable.  

81 

 
 
 
 
 
A.1.2. 

Survey response Belgium 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7.  What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 

FAMHP: Federal Agency for Medicines and Health Products 
Eurostation building,  place Victor Horta, 40/40 B – 1060 Brussels  
00.32.2.524.80.00 
welcome@afmps-fagg.be 
www.fagg-afmps.be 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Pharmaceuticals 
Medical devices 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
The Federal Agency for Medicines and Health Products (FAMHP) 
(Law of 20/07/2006), a federal agency of public interest, is the 
competent authority in terms of quality, safety and efficacy of drugs 
and health Products.  Our activities are divided into three branches 
(DG) also called "pillars".  . PILLAR 1 "DG PRE authorization" 
manages all activities before the first authorization to market a drug 
or a health product  . PILLAR 2 "DG POST authorization" manages 
all activities after the first authorization to market a drug or a health 
product  . PILLAR 3 "DG inspection" ensures all inspection and 
control activities  
Not applicable 

/ 

Yes 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
27 TE's 

37 TE's 

23 TE's 

62 TE's 

15 TE's 

Analysis of the mandatory documentation 

No 

82 

 
 
 
 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art 4 Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Belgium: Scientific Institute for Public Health (WIV-ISP) 
Analysis of the mandatory documentation requested from the tissue 
establishment 

The following data are available for each laboratory: Agreement 
number,Issue Date, Validity Date, Name Director, Type of service 
for which the agreement is valid, Agreement valid for 5 year 
maximum. 
In Belgium, procurement is the responsibility of the TEs. There are 
no "procurement centers" in Belgium. “Procurement” is mentioned 
in the EU directive, but “procurement centers” are not mentioned 
nor defined  in the EU Directive. Therefore, the term “procurement 
center” should not be used in this questionnaire.  

Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
NAT Chlamydia 
Treponema Pallidum 
NAT testing is mandatory. 

No 

No 

No 

No 

HTLV-1 and NAT HTLV-1 should be asked in the questionnaire, 
not HTLV-2. In Belgium, for living donors, NAT tests may be 
replaced by serology 6 months after collection/procurement of 
tissues or cells. 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 
During routine inspections 

Yes 

Yes 

5 inspections as a prerequisite for the authorization  of TEs 

83 

 
 
 
 
 
 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
0 

0 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

4.7.2. How many musculo-skeletal tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.7. How many ART tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.2. How many musculo-skeletal tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 

Musculo-skeletal tissue establishments 
HSC tissue establishments 
ART tissue establishments 
Other tissue establishments 
1 
1 
23 
Cell Therapy 1 
ART tissue establishments 

3 
Musculo-skeletal tissue establishments 
HSC tissue establishments 
ART tissue establishments 
1 
1 
20 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Other tissue establishments 
3 
0 
15 
0 
4 
0 
6 
0 
16 
0 
7 
1 
62 
0 
Cell Therapy: 15 Keratinocytes: 3 Tympano-ossicular: 4 Amniotic 
membrane: 4 
Cell Therapy: 3 

0 

Yes 

84 

 
 
 
 
 
 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

No 
In 2011: three new applications for an authorisation have not 
resulted in the granting of an authorization 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 

Yes 

Directorate General Inspection of FAMHP 

5 inspectors Tissues & Cells, Blood 
Yes 

Blood 
40 

0 

0 

0 

40 

24 

0 

0 

0 

29 

0 

0 

0 

29 

85 

 
 
 
 
15 

establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  Every 2 years: a general system-oriented inspection or a thematic 

General system-oriented inspections 
Thematic inspections 

0 

0 

0 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 

inspection. Every 4 years: a general system-oriented inspection for a 
extension of the agreement.  
Yes 

65 

Yes 

1 
Yes 
1 
Yes 

Yes 

3 

No 

No 

No 

No 

Yes 

Yes 

69 

69 

86 

 
 
  
 
 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 

6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 

6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

The import of skin is restricted to the TEs authorized for skin 
tissues. The importing TEs are responsible for verifying the 
equivalent standards of quality and safety.  
The import of musculoskeletal tissues is restricted to the TEs 
authorized for musculoskeletal tissues. The importing TEs are 
responsible for verifying the equivalent standards of quality and 
safety.  
The import of ophtalmic tissues is restricted to the TEs authorized 
for ophtalmic tissues. The importing TEs are responsible for 
verifying the equivalent standards of quality and safety 
The import of cardiovascular tissues is restricted to the TEs 
authorized for cardiovascular tissues. The importing TEs are 
responsible for verifying the equivalent standards of quality and 
safety 
The import of HSC is restricted to the TEs authorized for HSC. The 
importing TEs are responsible for verifying the equivalent standards 
of quality and safety 

The import of cord blood is restricted to the TEs authorized for cord 
blood or HSC. The importing TEs are responsible for verifying the 
equivalent standards of quality and safety.  
The import of reproductive cells is restricted to a& limited number 
of TEs authorized for reproductive cells. The importing TEs are 
responsible for verifying the equivalent standards of quality and 
safety.  
Yes 

Import to Belgium  Type                           Units Country                                       
Hematopoietic stem cells        23           USA - Australia                                         
Musculo-skeletal tissue            159         USA 
Yes 

Export from Belgium: Hematopoietic stem cells: 41  USA; Cardiac 
valve: 1 New Zealand;  Cord blodd: 9 USA, Canada, Australia; 
Sperm: 9 Koweit 
No 

C. Export of tissues/cells is authorised irrespective of national needs 

No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 

Yes 

No 

By inspection 

Yes, no restrictions apply 

Yes 
The country that imports verifies that the criteria of quality and 
safety are in line with national legislation. 

All tissues and cells coming from another MS needs to be in line 
with the Belgium law 

87 

 
 
  
 
 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 

7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 

7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Yes 

Hematopoietic stem cells: 11 units , Ireland, Germany Sperm: 46 
(straw), The Netherlands, France, Spain, Danemark, Germany 
Embryo: 43, Spain, United Kingdom Cardiac valve: 170, France, 
germany, Luxembourg, Austria, The Netherlands, Lettonia, 
Slovenia,Switzerland  Ocular tissue: 33, ? Cord Blood: 35,The 
Netherlands, Spain, France, United Kingdom, Sweden, Denmark, 
Germany, Italy,Hungary 
Hematopoietic stem cells: 91, Germany,United kingdom, Spain, The 
Nederlands, Germany, Italy, Portugal, France Sperm: 7824 (straw), 
Denmark, Italy, Germany, France, Spain, The Nederlands Oocyte: 
760, The Nederlands Embryo: 28, Spain, United Kingdom Male 
gonad: 89, The Nederlands Cardiac valve: 128, Luxembourg, france, 
Germany, Switzerland Ocular tissue: 129, france, The Nederlands 
Cord blood: 2, Spain, Italy 
No 

No 

No 

Yes 

100% (all) 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site.  www.fagg-afmps.be 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

Yes 
www.fagg-afmps.be 
Yes 

www.fagg-afmps.be 
Yes 

Yes 

The data requested by Eurocet and that are reported in the annual 
report from each TE 

8.7. Do you have any additional comments on reporting? 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Yes 

Tissue establishment 

Both paper records and electronic forms 

 In the law and during inspection. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 

Yes 

88 

 
 
  
 
 
  
 
 
  
 
 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are welcome to upload 
the template if you wish. 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 

FAMHP 
Establishments responsible for the application of tissues and cells 
have to report to the biovigilance cell of the FAMHP and to the 
supplying tissue establishment serious adverse reactions and serious 
adverse events concerning to human tissues and cells. Tissue 
establishments have also to report the SARs and SAEs  including 
SARs in living donors and SAEs that may influence the quality and 
safety of thee tissues and cells. Furthermore, standard notification 
forms, definitions and instructions for use were elaborated and 
distributed by the FAMHP.  
No 

The template used in point 8.1 

Yes 

Yes 

100% 

Yes 

see point 10.2.1 
Yes 

When necessary specific information notes are distributed to all or 
the concerned part of the tissue establishments 
Yes 

When necessary specific information notes are distributed to all or 
the concerned part of the tissue establishments 
Yes 
No recalls in 2011.  

Yes 

When necessary specific information notes are distributed to all or to 
the concerned part of the tissue establishments 
Yes 

When necessary specific information notes are distributed to all or to 
the concerned part of the tissue establishments 
Yes 

N.A. 
Yes 

Medical devices 

No 

89 

 
 
10.15.2. If no, please specify why not. 

10.16. Do you have any additional comments on SARE reporting? 

We are convinced of the value of this training. We would have liked 
to send a new vigilance officer, but the selection procedure for this 
one still running. And for the current biovigilance officer the 
training was not useful  

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 

Explicit consent (opt-in) 

11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 

11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 

11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 

11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

The presumed consent is the basis, the explicit consent allows – in 
addition to the presumed consent - to express ones consent 
explicitly. 
Presumed (opt-out) and explicit (opt-in) consent 

The presumed consent is the basis, the explicit consent allows – in 
addition to the presumed consent - to express ones consent 
explicitly. 
No further authorisation is needed 

Yes 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 

A unique donor identification system is  implemented, assigning 
after procurement or (at the latest) at reception in the tissue 
establishment  a unique code to each donation and to each human 
body material collected in order to guarantee donor identification 
and traceability of all human body materiel.The identity of the donor 
may not be disclosed to third parties. Assigning of the identification 
code is the responsibility of the responsible person.  The inspector 
controls the information over the code during the inspection.  
The necessary steps are taken to ensure that in allogenic donation, 
data on the (s) recipient (s), including genetic data, which could 
identify the recipient cannot be accessed by third parties. The 
necessary steps are taken to ensure that in allogenic donation, the 
identity of the recipient is not disclosed to the donor or his family 
and vice versa. The inspector controls the different steps taken to 
respond to these obligation during the inspection  
No 

If yes instead of no. 

Inspections of TEs and procurement sites 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.3.1. If yes, please specify. 

Inspections of ART centres 

Yes 

One extra selection criterium: “persons that have undergone 

90 

 
 
  
 
 
  
 
 
documented or undocumented neurosurgery 
Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
Other 
A physical examination of the body  
Yes 

Test for Treponema Pallidum 
No 

No 

Inspection of tissue establishment 

12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Please specify 'other'. 
12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.5.1. Please specify. 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Inspections 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

Authorisation requirement 
Inspections 

Inspections 

Yes 

The TE has a training for his personnel. It is checked during the 
inspection. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

Inspections of tissue establishments 

Inspections of tissue establishments 

91 

 
 
  
 
 
  
 
 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

Inspections of tissue establishments 

Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities?  Agreements between institutions and third parties must comply with 

Yes 

Yes 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.1.1. Please specify. 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 

16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

the Belgian legislation. Agreements with third parties must specify 
the terms of cooperation and responsibility, as well as the protocols 
to be followed to meet the performance requirements. 
The agreement between the TE and the third party are seen during 
the inspections of tissue establishments and if needed, an inspection 
takes place of the third party. Copies of the agreements have also to 
be sent to the FAMHP. 

Yes 

NAT Tests for HIV1, HBV and HCV. 
Import-export 

How to force a TE in an other EU member state to meet the extra 
Belgian law requirements if that TE distributes tissues or cells 
directly to a hospital in Belgium 
Directive 2006/17/EC 

Annexes II and III: the requirement “HTLV-I antibody testing must 
be performed for donors living in or originating from high-incidence 
areas or with sexual partners originating from those areas or where 
the donor’s parents originate from those areas;” For some tissues 
/cells this requirement should be modified, because unnecessary (see 
ECDC document). 

92 

 
 
  
 
 
  
 
 
 
 
 
A.1.3. 

Survey response Bulgaria 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

Please specify 'other': 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 

Bulgarian Executive Agency for Tansplantation  
1202 Sofia, Bulgaria, 112 Bratia Miladinovi Str. 
tel.: +359 2 813 50 10, fax: +359 2 931 61 51 
iat@bgtransplant.bg 
www.bgtransplant.bg 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Human organs 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
The Executive Agency for Transplantation is a public body, second 
rank budget operator. The overall budget: 312000 Euro Number of 
staff of the Executive Agency for Transplantation - 30 positions 
Executive Director - 1 Deputy Executive Director-1 General 
Secretary -1 Security Officer of information -1 General 
Administration : Department "Financial,-economic and 
administrative activity "- 6 positions Specialized Administration:  
Department "Registers, information, control and development of 
transplant"-20 positions Staff working on EU affairs and legal 
matters: 5 persons but not fully engaged in the EU activity Number 
of fully engaged inspectors-2 Number of Senior experts - 3. Their 
responsibilities also  include inspection activities. Number of Junior 
experts - 3. Their responsibilities also  include inspection activities. 
Vigilance officers - We have not such a position. This activities is 
also included in the responsibilities of all experts and inspectors. 
Not applicable 

There are no Regional CAs. It is a centralized system by Executive 
Agency for Transplantation. 

Yes 
By inspecting all procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
Other 
The authorisation is given by Ministry of Health for hospitals and by 
Regional Health Inspections for outpatient health establishments. 
5 

5 

13 

26 

We couldnt provide the data. ATMP is out of our competence. It is 
within the scope of Drug Agency. 

93 

 
 
 
 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

This accreditation is done by Bulgarian Service for Accreditation.  
Analysis of the mandatory documentation requested from the tissue 
establishment 

We could not provide such data because we do not maintain such 
registry but every TE is obliged to have a contract agreement only 
with qualified accredited laboratories. We inspect the relevant 
documentation at site 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
NAT testing is mandatory for Chlamydia in case of reproductive 
tissues and cells. It is recommended that HIV1/2, HBV and HCV are 
tested via NAT. 

No 

Yes 

CMV antibody, EBV antibodies and Toxoplasma antibodies are 
required in immunosuppressed patients. Testing for antibodies to 
HTLV-I is performed for donors who were born or lived in areas 
with high risk or have sexual partners originating from those 
regions, as well as the donor's parents are from such regions. When 
Anti HBc is positive and HBsAg is negative, TEs are obliged to 
conduct additional studies to assess the risk and to establish 
eligibility for clinical use. Scientifically validated algorithm for 
testing is applied for the exclusion of active infection with 
Treponema pallidum. Non-reactive specific or non-specific test can 
allow tissues to be released. When performing a non-specific test 
positive result will not prevent the taking or release if a specific 
Treponema test is negative. Donors by whom Treponema specific 
test is positive, require a thorough risk assessment to determine 
eligibility for clinical use. In some circumstances, further studies are 
carried out according to the medical record of the donor and the 
characteristics of the donations (E.g. RhD, HLA, malaria, CMV, 
toxoplasma, EBV, Trypanosoma cruzi. 
Yes 

Testing for antibodies to HTLV-I is performed for donors who were 
born or lived in areas with high risk or have sexual partners 

94 

 
 
  
 
 
originating from those regions, as well as the donor's parents are 
from such regions. Further testing for malaria, CMV, RhD, 
Tripanosoma cruzi are required if a history of foreign travel or the 
presence of other risk factors for these diseases. The anonymous 
donor is performed genetic screening for common autosomal 
recessive genetic disease in ethnicity, which requires it, or ancestry 
with genetic problems. Genetic screening is performed after written 
informed consent of the donor. Recipients are fully informed about 
the risks of transmission of genetic diseases and the measures to 
reduce the risk of them. 
No 

3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

14 

Yes 
During routine inspections 
By review of a submitted application with supporting documentation 
There were no licenses suspended. 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.6. How many cord blood tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.6. How many cord blood tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.9.8.  How many multi-tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 

There were no licenses revoked. 

No 

Cord blood tissue establishments 

1 
Multi-tissue establishments 

1 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
2 
11 
1 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
0 
1 
0 
1 
2 
5 
1 
5 
2 

95 

 
 
  
 
 
 
 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 

24 
1 
2 
None 

Yes 

No 

Yes 

In the Department "Registers, information, control and development 
of transplant" there is a unit of two fully engaged inspectors. In 
addition there are 3 senior and 2 junior experts whose 
responsibilities include inspections. 
7 
Yes 

Organs 
Hospitals 
10 

0 

2 

1 

9 

0 

0 

0 

0 

96 

 
 
 
 
  
 
 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct? 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.14.1. Could you please explain why? 

5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 

18 

3 

2 

3 

12 

3 

0 

0 

0 

General system-oriented inspections 
Thematic inspections 
It depends on the risk assessment of the TE activities. 
Yes 

9 

Yes 

4 
Yes 
2 
Yes 

Yes 

5 

No 

Yes 

The Bulgarian TE for this period was subsidiary of French TE. 
French competent authorities asked Bulgarian competent authorities 
for conducting a joint general inspection. 
No 

No 

Yes 

97 

 
 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 

6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 

6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 

6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 

6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 

6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 

6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 

Yes 

0 

1 

We don't have specific procedure for skin but the import of skin 
should meet the general requirements for diceased donors according 
to our Law of the Transplatation of Organs, Tissues and Cells and 
two ordinances: Ordinance  6 on establishing medical standards for 
organ transplants, tissues and cells and Ordinance  13 on the terms to 
be met by the quality of tissues and cells under international 
exchanges for the needs of the Republic of Bulgaria. 
We don't have specific procedure for musculo-skeletal tissues but 
the import of bone, tendons, fascia should meet the general 
requirements for diceased donors according to our Law of the 
Transplatation of Organs, Tissues and Cells and two ordinances: 
Ordinance  6 on establishing medical standards for organ transplants, 
tissues and cells and Ordinance  13 on the terms to be met by the 
quality of tissues and cells under international exchanges for the 
needs of the Republic of Bulgaria. 
We don't have specific procedure for ophtalmic tissues but their 
import should meet the general requirements for diceased donors 
according to our Law of the Transplatation of Organs, Tissues and 
Cells and two ordinances: Ordinance  6 on establishing medical 
standards for organ transplants, tissues and cells and Ordinance  13 
on the terms to be met by the quality of tissues and cells under 
international exchanges for the needs of the Republic of Bulgaria. 
We don't have specific procedure for cardio vascular tissues but their 
import should meet the general requirements for diceased donors 
according to our Law of the Transplatation of Organs, Tissues and 
Cells and two ordinances: Ordinance  6 on establishing medical 
standards for organ transplants, tissues and cells and Ordinance  13 
on the terms to be met by the quality of tissues and cells under 
international exchanges for the needs of the Republic of Bulgaria. 
We don't have specific procedure for haematopoietic stem cells 
(HSC)  but their import should meet the general requirements for 
living donors according to our Law of the Transplatation of Organs, 
Tissues and Cells and two ordinances: Ordinance  6 on establishing 
medical standards for organ transplants, tissues and cells and 
Ordinance  13 on the terms to be met by the quality of tissues and 
cells under international exchanges for the needs of the Republic of 
Bulgaria. 
We don't have specific procedure for cord blood but their import 
should meet the general requirements for living donors according to 
our Law of the Transplatation of Organs, Tissues and Cells and two 
ordinances: Ordinance  6 on establishing medical standards for 
organ transplants, tissues and cells and Ordinance  13 on the terms to 
be met by the quality of tissues and cells under international 
exchanges for the needs of the Republic of Bulgaria. 
We don't have specific procedure for cord blood but their import 
should meet the general requirements for living donors according to 
our Law of the Transplatation of Organs, Tissues and Cells and two 
ordinances: Ordinance  28 on activities of assisted reproduction and 

98 

 
 
  
 
 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

Ordinance  13 on the terms to be met by the quality of tissues and 
cells under international exchanges for the needs of the Republic of 
Bulgaria. 
No 

No 

No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
B. Export of tissues/cells is authorised based on estimations 
performed on an annual basis 
D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
E. Import of tissues/cells is authorised based on estimations showing 
that there is chronic deficiency of those tissues/cells 
After the assessment and the written conclusions made by the head 
of the public multi-tissue bank we release or not tissues and cells for 
import or export.. 
No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 

No 

7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 

7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 

99 

Yes 
We try immediately to fulfil the stringent quality and safety 
measures established by other MS 

We demand licensing, authorisation or accreditation of the local CA; 
contract agreements between TEs; relevant SOPs for the activities 
the TE apply for; documentations verifying the qualification of the 
staff donation, procurement, testing, processing, preservation, 
storage and distribution of human tissues and cells, etc. 
Yes, but only via an authorised TE in my MS 

No 

Yes 

Great Britain, Cord blood, 314 distributed units Belgium, Cord 
blood, 520 distributed units Greece, Cord blood, 61 distr. units 
Germany, CB, 13 distributed units Great Britain, fragment from 
umbilical cord, 175 distributed units Belgium, fragment from 
umbilical cord, 336 distributed units Greece, fragment from 
umbilical cord, 54 distributed units Greece, Teeth, 6 teeth Germany, 
Bones, 843 units Germany, Tendons, 407 Germany, Skin, 6 
Germany, Fascia, 12 Netherlands, Skin, 93 Italy, Bones, 15 Italy, 
Tendons, 12 Italy, Fascia, 4 
No 

No 

No 

 
 
  
 
 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 

100% (all) 

Yes 

8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

8.7. Do you have any additional comments on reporting? 

Yes 
http://www.bgtransplant.bg/iat/registers%20and%20statistics.php?ta
rget_f=statistics.htm 
Yes 

http://www.bgtransplant.bg/iat/registers%20and%20statistics.php?ta
rget_f=%D0%A2%D1%8A%D0%BA%D0%B0%D0%BD%D0%B
8%20%D0%B8%20%D0%BA%D0%BB%D0%B5%D1%82%D0%
BA%D0%B8.html  ;  
http://www.bgtransplant.bg/iat/registers%20and%20statistics.php?ta
rget_f=%D0%90%D1%81%D0%B8%D1%81%D1%82%D0%B8%
D1%80%D0%B0%D0%BD%D0%B0%20%D1%80%D0%B5%D0
%BF%D1%80%D0%BE%D0%B4%D1%83%D0%BA%D1%86%
D0%B8%D1%8F.html 
Yes 

http://www.bgtransplant.bg/iat/transplantation.php?target_f=%D0%
9B%D0%B5%D1%87%D0%B5%D0%B1%D0%BD%D0%B8%20
%D0%B7%D0%B0%D0%B2%D0%B5%D0%B4%D0%B5%D0%
BD%D0%B8%D1%8F%20%D0%B8%D0%B7%D0%B2%D1%8A
%D1%80%D1%88%D0%B2%D0%B0%D1%89%D0%B8%20%D
0%B4%D0%B5%D0%B9%D0%BD%D0%BE%D1%81%D1%82%
D0%B8%20%D0%BF%D0%BE%20%D1%82%D1%80%D0%B0
%D0%BD%D1%81%D0%BF%D0%BB%D0%B0%D0%BD%D1
%82%D0%B0%D1%86%D0%B8%D1%8F%20%D0%BD%D0%B
0%20%D1%82%D1%8A%D0%BA%D0%B0%D0%BD%D0%B8
%20%D0%B8%20%D0%BA%D0%BB%D0%B5%D1%82%D0%
BA%D0%B8.html 
Yes 

During the years we have submited all kind of data which they 
required from us. 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Yes 

Tissue establishment 

Both paper records and electronic forms 

This requirement is laid down in our law for transplatation and we 
check this obligation during every inspection. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/86) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation.  We have special Ordinance  10 on the conditions and procedure for 

Executive Agency for Transplantation. 

Yes 

100 

 
 
  
 
 
  
 
 
  
 
 
reporting, recording and transmission of information on SAR/E and 
barring, withdrawal and destroying tissues and cells.  (1) Medical 
specialist who observed or suspected SAE/SAR is required to fill 
immediately report according to Annex No 1 and submit it to the 
responsible person assigned to a hospital. (2) The responsible person 
immediately label all the tissues and cells taken from the donor with 
"quarantine" and notifies the head of the TE and the Executive 
Agency for Transplantation, providing them with all the information 
regarding the case.  (3) The head of the TE is required to report 
immediately to all relevant health establishments. (4) All the notified 
health establishments shall promptly labeled "quarantine" all tissues 
and cells derived from the same donor, and place them in a 
designated container marked "quarantine". (5) The responsible 
person of the TE notified the already established committee of the 
TE investigating the case. (6) The committee shall hold a hearing 
within three days where it analyzes the causes, circumstances and 
the outcome related to suspected serious adverse reaction and 
produces a report. (7) In case of occurred serious adverse reaction 
commission is obliged to propose measures in order to solve and 
prevent the issue and write them down in the report which is then 
submitted to the responsible person, the head of the TE and the 
person under Art. 10, para. 5 from the Ordinance mentioned above.. 
(8) The responsible person notifies within 7 days the Executive 
Agency for Transplantation about the results actions from the 
investigation of the committee and the undertaken by sending a copy 
of the notice under par. 1 and report under par. 6 from above 
mentioned ordinance. (9) The head of the TE shall immediately 
notify all concerned health establishments for confirming results of 
SAE/R. (10) When the committeefinds out that a SAE/R can affect 
the quality and safety of the retrieved tissues and cells, the 
responsible person and the Executive Agency for Transplantation 
take immediate actions to block, recall and destroy tissues and cells 
under quarantine. (11) When the committee finds that the SAE/R 
can not influence the quality and safety of the retrieved tissues and 
cells, the responsible person releases them from quarantine. 
Yes 

Yes 

No 

It is a matter of our budget. 
100% 

Yes 

The procedure follows the items described in p. 10.1.2. 
Yes 

We inform only the concerned TE regarding relevant SAR/SAE. 
Yes 

We inform only TEs which provide the activities as the recorded 
SAR/SAE. 
Yes 
0 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/86 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 

101 

 
 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.2. If no, please specify why not. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.2. If no, please specify why not. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 

10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

No 

It is still under construction. For now we are using only email 
correspondence. 
No 

For now we are using email correspondence with short desctiption in 
case of relevant activities of the TEs. Because part of the 
information is confidential. 
Yes 

We fulfil all data which can be extracted from our registries and 
transfer it to the EUROCET nomenclature. 
No 

Yes 

5 

The vigilance officers are engaged in other activities as experts. 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 

Explicit consent (opt-in) 

Explicit written consent system 

Presumed (opt-out) and explicit (opt-in) consent 

Presumed consent:  According to the Bulgarian Law of the 
Transplantation of Organs, Tissues and Cells: (1) Shall not be 
admitted retrieving organs, tissues and cells for implantation if the 
person has expressed dissent in writing thereof during his/her 
lifetime. (2) Not admitted shall be taking of organs, tissues and cells 
from a corpse of a person under 18 years of age or of a person under 
judicial disability, except by the written consent of his/her parents, 
guardian or trustee. (3) Not admitted shall be taking of organs, 
tissues and cells for implanting from a corpse of a person with 
unknown identity. (4) If the corpse is subject to a forensic expertise 
the taking of organs, tissues and cells from him/her shall be 
performed upon a permit in writing by a forensic expert, who shall 
not participate in transplantation activities. Explicit consent: Taking 
of organs, tissues and cells from the person, who passed away, may 
be performed if the following requirements are met: 1. in the health 
insurance book of the person, in the cases where there is such, there 
is not a registered dissent of the person for taking organs, tissues and 
cells after his/her death; 2. the name of the person has not been 
entered in the official register of the Executive Agency for 
Transplantations under Art. 39, para 1, item 2; 3. the forthcoming 
taking of organs, tissues or cells obligatorily is announced and there 
is no dissent in writing presented within reasonably short term from 
his/her: a) spouse or parent; b) child; c) brother or sister. (2) The 
manner of ascertainment and certification of the circumstances under 
para 1 shall be determined by an ordinance of the Minister if Health.  
First degree relatives (including spouse) 

11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 

Yes 

102 

 
 
 
 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

Analysis of documentation 

Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 

According to the Bulgarian Law of the Transplantation of Organs, 
Tissues and Cells: Prohibited is the spreading of data allowing the 
identification of the donor or of the recipient. 
The information is official secret. Only restricted access is allowed. 

No 

The information is official secret. Only restricted access is allowed. 

Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 
Regular evaluation of medical personnel 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Standardised questionnaires at national level 
Inspections of ART centres 
Regular evaluation of medical personnel 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 

Authorisation requirement 
Inspections 

103 

 
 
  
 
 
  
 
 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 

13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 

13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Yes 

According to Bulgarian Law for Transplantation of Organs, Tissues 
and Cells:  Art. 4 (7) the personnel shall be trained within every two 
years;  Art. 11 (5) p. 17 BEAT organizes training on quality and 
safety in carrying out transplantation activities for responsible 
persons and personnel engaged in procurement, testing, processing, 
labeling, storage, transportation and distribution of organs, tissues 
and cells. 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities?  According to our Law of Transplantation of Organs, Tissues and 

Yes 

Yes 

Cells: Art. 15a. (new - SG 71/06, in force from 01.01.2007) (1) The 
tissue establishments shall conclude written contracts between them, 
in case they carry out jointly activities related to taking, treatment, 
processing, storing and/or implantation of organs, tissues and cells. 
(2) The tissue establishments shall conclude written contracts with 
third parties for providing goods and services, which can influence 
the quality and the safety of the organs, tissues or the cells. (3) The 
tissue establishments shall create and maintain a register of the 
contracts concluded under para 1 and 2. (4) The tissue 
establishments shall send copies of the contracts under para 1 and 2 
to the Executive Agency for Transplantation in 7-days term from 
their conclusion.  
Authorisation requirements,  Inspections of TE,  All third-party 
agreements shall be registered within 7 days from their contracting 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

104 

 
 
  
 
 
  
 
 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 

16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 

and stored in official registries of CA (BEAT),  TEs shall maintain 
registries themselves. 

No 

Import-export 

Import-export:  Directive 2004/23/EC Art. 9 p. 3 (c) "The competent 
authority or authorities shall take all necessary measures to ensure 
that imports and exports of tissues and cells referred to in 
subparagraphs (a) and (b) meet quality and safety standards 
equivalent to those laid down in this Directive."  What kind of 
"necessary measures" should be fulfiled to ensure that imports from 
third countries met the requirements of EU T&C Directives? 
Directive 2004/23/EC 

We suggest the following: Directive 2004/23/EC Art. 9 p. 3 (c) "The 
competent authority or authorities shall take all necessary measures 
to ensure that imports and exports of tissues and cells referred to in 
subparagraphs (a) and (b) meet quality and safety standards 
equivalent to those laid down in this Directive." In Art. 9 p.3 it 
should be included the following text: ... shall take all necessary 
measures: Inspection at site by CA of MS or written declaration by 
CA of the third country which ensures that they fulfil all 
requirements for safety and quality of all the three EU T&C 
Directives ... 

105 

 
 
  
 
 
 
 
 
A.1.4. 

Survey response Croatia 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 
2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 

Ministry of Health 
Ksaver 200a, 10000 Zagreb, Croatia 
+385 1 460 7671 
vanja.nikolac@miz.hr 

Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
1.Regulation (proposing laws and strategic documents, enacting sub-
laws) 2. Monitoring of activities 3. Managemet of capital 
investitions in the field 
No 
Ministry of Health is a central state administration body. Activities 
are financed from the state budget. Additionaly, for the costs of 
authorization TE are paying fee. Two units share responsibility for 
T&C.  1. Health Protection Directorate    1.1. Service for Blood, 
Tissues and Cells Inspection (1 head od Service and 2 inspectors)  2. 
Institute for transplantation and biomedicine (head of Institute – 
assistant of Minister) 2.1. Service for transplantation (3 employees) 
2.2. Service for biomedicine (3 employees)  
Not applicable 

no regional CA 

Yes 
By inspecting all procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
10 

4 

4 

non-partner ART: 0,  partner ART: 13 

0 

Inspections of the site/centre 
Analysis of the mandatory documentation 

106 

 
 
  
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
Please specify 'other': 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 

2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.4.1. Please specify why: 

3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.7.1. Please specify. 
3.8. Do you have any additional comments on testing? 

Yes 

1 

Inspections of the laboratories 
Analysis of the mandatory documentation requested from the tissue 
establishment 
Other 
Inspections of the TEs 
Laboratory is authorised for blood donors’ testing from 2005.  
Testing cca 100 000 blood donors per year. In process for the 
authorisation for T&C donors’ testing, according to the new 
legislation (enacted in June 2013.) Tests: Minimum testing 
requirements    - HIV 1 i 2 – Anti-HIV-1,2 – Hepatitis B – HBsAg 
iAnti-HBc – Hepatitis C – Anti-HCV – Syphilis - NAT  HIV 1, 
HBV i HCV. Additional tests  - HTLV-I -  ABO - RhD - HLA 
antigens and antibodies 

Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
NAT is mandatory for non-reproductive tissues and cells but not for 
reproductive tissues and cells. NAT for reproductive T&C is not 
foreseen since only partner donation occurs. For non-partner 
donation CA will propose NAT testing to scientific bodies for 
consideration.  
Yes 

Limited number of manufacturers and tests which are validated for 
deceased donors, short period of validation, relatively small number 
of  examinees. 
Yes 

HTLV 1, Anti HBs, Malaria, CMV, Toxoplasma, EBV, 
Tripanosoma cruzi 
Yes 

HTLV 1, Anti HBs, Malaria, Toxoplasma, Tripanosoma cruzi 
Dengue fever, CMV, WEB  
Yes 

ISO 15 189 for each method performing 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 

Yes 

107 

 
 
  
 
 
  
 
 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 
4.6.1. What is the relation between the indpendent certification(s) 
(e.g. ISO, JACIE, FACT) and the CA authorisation of the tissue 
establishments? (more than 1 answer possible) 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

4.7.1. How many skin tissue establishments? 
4.7.2. How many musculo-skeletal tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.1. How many skin tissue establishments? 
4.8.2. How many musculo-skeletal tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.4. How many cardiovascular tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Yes 

1 TE;  8 ART centers 

Yes 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
0 

0 

Yes 

Mandatory for authorisation 

Skin tissue establishments 
Musculo-skeletal tissue establishments 
ART tissue establishments 
1 
3 
3 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
1 
3 
Cardiovascular tissue establishments 
HSC tissue establishments 
ART tissue establishments 
1 
1 
3 
Cardiovascular tissue establishments 
HSC tissue establishments 
ART tissue establishments 
1 
1 
1 
0 
1 
2 
0 

No 

Yes 

Service for Blood, Tissues and Cells Inspection 

108 

 
 
 
 
 
 
  
 
 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 

1 head of Service and 2 inspectors 
Yes 

Blood 
Organs 
Pharmaceuticals 
Advanced therapies 
Hospitals 
0 

1 

licensing inspections (4)  

0 

3 

1 

0 

1 

4 

0 

0 

licensing inspections (8) 

0 

0 

8 

0 

109 

 
 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

0 

8 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  Report(s) of previous inspection(s): number and qualification of 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.7.1. Why not? 

5.7.2. How do you prioritise tissue establishments to be inspected? 

5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

non-conformities Report(s) of SAREs Report(s) of activities 
Complexity of activity Various data collected due to everyday close 
communication 
No 

Unit dedicated to T&C’ inspection was established in the end of 
2009. Licensing inspections have started in second half of 2010. 
Decision based on: Number of tissue types processing Number of 
tissues of each type processing/distributing Method of processing 
Report(s) of previous inspection(s): number and qualification of 
non-conformities Report(s) of SAREs Various data collected due to 
everyday close communication 
0 

No 

Procurement rarely takes a place outside TEs since TEs are 
established only in the main (biggest) hospitals which are 
concurrently main  procurement sources. Program for countrywide 
tissue procurement, foreseeing larger number of procurement-only 
hospitals is under  development. 
Yes 
1 
Yes 

Yes 

5 

No 

No 

No 

No 

Yes 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 

Yes 

110 

 
 
  
 
 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 

Please specify 'other': 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

0 

0 

Importation from a third countries is prohibited except for 
emergency. 

Importation from a third countries is prohibited except for 
emergency. 

Importation from a third countries is prohibited except for 
emergency. 

Importation from a third countries is prohibited except for 
emergency. 

Importation from a third countries is prohibited except for 
emergency. Whenever is possible JACIE accreditation is required. 

Importation from a third countries is prohibited except for 
emergency. Whenever is possible FACT-NetCord accreditation is 
required. 
There are no procedures for importation of reproductive cells. 

Yes 

57 corneas from USA 

No 

No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
F. Other 
Import is authorised, additional to point D, only in emergency 
situations. 
1. waiting lists for:  a) transplantation (corneas, heart valve)  b) 
procedures including use of tissues (e.g. hip prostheses revision) 2. 
donor registers for matching tissues  
Yes 

57 corneas  

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 

Yes 
Authorised TE is responisible for compliance check 

111 

 
 
  
 
 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Yes 

NA 

By inspection  

No 

No 

Yes 

No T/C distributed to other MS 

No T/C distributed to other MS 

No 

No 

No 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site.  ART: 

No 
No 

60-99% 

Insuficient administrative capacity of CA 
Yes 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

http://www.zdravlje.hr/ministarstvo/zdravstvene_ustanove_u_republ
ici_hrvatskoj/ustanove_s_odobrenjem_za_obavljanje_djelatnosti_me
dicinski_pomognute_oplodnje  T&C: 
http://www.zdravlje.hr/ministarstvo/zdravstvene_ustanove_u_republ
ici_hrvatskoj/ustanove_s_odobrenjem_za_obavljanje_djelatnosti_uzi
manja_pohranjivanja_i_presadivanja_tkiva_i_stanica  
Yes 

HSC, ART, TISSUES 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
Yes 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 

112 

 
 
  
 
 
  
 
 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Tissue establishment 

Both paper records and electronic forms 

TE are responsible for ensurance of data storage 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 

Ministry of Health 
Responsible person from TE or procurement/application center 
informs CA . CA is responsible for monitoring of investigation 
process, data distribution and corrective actions implementation.  
Yes 

Yes 

No 

Insuficient administrative capacity of CA 
100% 

Yes 

Responsible person from transplantation center reports to the 
responsible person of TE and to CA in written or electronic form or 
by phone,  without delay.  
Yes 

SAREs are presented and discussed at Ministry’s Expert Committee 
(regular and ad hoc) 
Yes 

SAREs are presented and discussed via e-mail communication or at 
regular Ministry’s Expert Committee meetings in the case not 
affecting  national users. In cases affecting national users ad hoc 
meetings can be convened  
Yes 
0 

Yes 

CA notifies responsible persons in TE, in written and 
electronic/phone form. Ministry’s Expert Committee proposes 
measures, which Ministry imposes.  
Yes 

CA notifies responsible persons in TE, in written and 
electronic/phone form. Ministry’s Expert Committee proposes 
measures, which Ministry imposes.  
Yes 

113 

 
 
  
 
 
10.13.1. If yes, please specify what data. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

HSC, ART, TISSUES 
Yes 

Pharmacovilance 
Medical devices 
Yes 

4 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
Please specify 'other'. 

Other 

Yes 

Explicit consent (opt-in) 

Explicit consent (opt-in) 

Presumed consent (opt-out) 

No further authorisation is needed 

11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

Deceased donors: Presumed consent system is in place, no need for 
verification Living donors: Analysis of documentation  
Only trained personnel is allowed to provide such information 

All stakeholders are obliged to protect personal data according to the 
special legislation.  

Establishment of coding system according to which only TE can 
connect data of recipient with donor data. 
Yes 

Inspections of TEs and procurement sites 
Audit of documentation 
Regular evaluation of medical personnel 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 
Audit documentation 
Regular evaluation of medical personnel 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
Other 
family and close friends 

114 

Please specify 'other'. 

 
 
  
 
 
  
 
 
12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Audit of the centre of human application 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
Authorisation requirement 
13.1. How do you ensure that tissue establishments in your country 
Inspections 
have in place a quality system respecting the provisions of the 
Internal audits 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
External audits 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 

13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 

13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Yes 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 

115 

Professional society meetings Pre-accession instruments (TAIEX, 
IPA)  

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 

 
 
  
 
 
  
 
 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 

Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 

14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 
15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.1.1. Please specify. 

16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 

16.2.1. For all selected options in question 16.2., please provide a 
short description. 

16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

A.1.5. 

Survey response Cyprus 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 

1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 

Yes 

Yes 

For the cessation of activity, procurement of cord blood and testing 
By inspection 

Yes 

• prohibition of third countries tissue importation, • mandatory 
unpaid donation,  • requirement for international accreditation for 
HSC banks, CB banks and testing laboratories, • mandatory NAT 
testing for T&C donors  
ART provisions 
Import-export 
Vigilance 
Authorisation-accreditation-licensing of TEs 
Inspections 
ART provisions –problems in fulfiling requirements for personel, 
quality system and facilities Vigilance – insufficient number of CA 
employees Authorisation-accreditation-licensing of TEs¸and 
inspections – insufficient number of inspectors, in 2011 was one 
inpector for blood, tissues and  cells and ART Import-export- vague 
EU legislation allowing broad interpretations  
Directive 2004/23/EC 

Ministry of Health, Cyprus 
1, Prodromou and 17, Chilonos str, Nicosia 1449, Cyprus 
22605600 
cgregoriadou@moh.gov.cy, emakrigiorgi@moh.gov.cy, 
cstylianou@mphs.moh.gov.cy 
www.moh.gov.cy 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
3 inspectors/vigilance officers, no separate budget (Ministry of 
Health)  

Not applicable 

N/A 

116 

 
 
  
 
 
  
 
 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
Please specify 'other': 

2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 

Yes 
By inspecting all procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
3 

0 

3 

0 

0 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

Ministry of Health, under different legislation 
Analysis of the mandatory documentation requested from the tissue 
establishment 
Other 

licensed laboratories only under the Licensing of Clinical 
Laboratories Law 
Under a different inspection and licensing system. there are 136 
licensed clinical laboratories, 2 EFI accredited laboratories 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
We require this testing if tissues or cells will be issued without 
retesting of donors after 180 days of collection 

117 

 
 
 
 
  
 
 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.7.1. Please specify. 
3.8. Do you have any additional comments on testing? 

No 

No 

No 

Yes 

ISO, EFI 
Licensed Testing Laboratories under the Clinical Laboratories Legis 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

3 

Yes 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
2 

0 

Yes 

Optional, but TEs are encouraged to get a certification 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 
4.6.1. What is the relation between the indpendent certification(s) 
(e.g. ISO, JACIE, FACT) and the CA authorisation of the tissue 
establishments? (more than 1 answer possible) 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.7. How many ART tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.7. How many ART tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.6. How many cord blood tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 

Yes 

118 

ART tissue establishments 

1 
ART tissue establishments 

1 
Cord blood tissue establishments 

1 
Ocular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
0 
3 
2 
0 
1 
5 
0 
8 
2 

 
 
 
 
 
 
 
 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 

No 

Yes 

Inpectors 

3 
No 

11 

0 

2 for new processes not licensed 

0 

4 

0 

0 

0 

1 for new process   

6 

0 

0 

0 

4 

119 

 
 
  
 
 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

0 

0 

0 

0 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  General system for licensing and re issue of license, and every year, 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.17.1. Could you please explain why not? 
5.18. Do you have any additional comments on inspections? 

thematic for new process applications, desk based for import only 
Yes 

16 

No 

Procurement for autologous cord blood banks occurs only outside 
licensed tissue establishments. Clinics were cord cord blood is 
procured need to be licensed under the Private Clinic Act 
No 
Third parties are usually testing laboratories. Clinical laboratories 
have to be licensed by a different legislation in order for TEs to have 
a third party agreement 
Yes 

Yes 

5 

No 

No 

No 

No 

No 

Lack of resources 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 

Yes 

3 

120 

 
 
  
 
 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

1 

no skin is imported 

no bone is imported 

FDA licence, AATB valid acredidation 

no cadio vascular tissues are imported 

no haematopoietic cells are imported 

cord blood procured in third countries is imporetd for processing and 
storage. 

no gametes are imported 

No 

Yes 

2  Donations of Peripheral stem cells 

No 

F. Other 

only export of highly matched stem cell donations  
Yes 

Patient's own gametes or embryos due to relocation 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 

No 

No 

No 

No 
SOPs review and records 

Yes, but only via an authorised TE in my MS 

121 

 
 
  
 
 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

No 

No brokers were licensed yet 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.1.1. If no, why not? 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 

use the Eurocite templates 
100% (all) 

No 
No 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site.  www.moh.gov.cy 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

Yes 

Tissues, HPCs, ART 

Interested parties can view these reports at the Ministry of Health 
offices 
Yes 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Yes 

Tissue establishment 

Both paper records and electronic forms 

Through inpections 

Yes 

Same  
Inspectors act as vigilance officers 
Yes 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

Inspectors act as vigilance officers 
100% 

In the legislation for tissues and cells 

Yes 

Yes 

No 

122 

 
 
 
 
  
 
 
  
 
 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.2. Please specify why not. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.2. Please specify why not. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

No 

Only for those concerned 
No 

only if involved 
Yes 
0 

Yes 

Through the responsible person of TE via email, mail, tel 

Yes 

As above if affected 

No 

Not required 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Yes 

5 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 

Yes 

Explicit consent (opt-in) 

Mostly living donation for HPCs and Gametes 

Explicit consent (opt-in) 

First degree relatives (including spouse) 
Other relatives 

11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 

Analysis of documentation 
Interviews with personnel 
Interviews with living donors 
Only trained personnel is allowed to provide such information 

Assignement of unique codes 

Penalty if any information regarding donors or recipients is 
disclosed in legislation 

123 

 
 
  
 
 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

No 

Financial and imprisonment sentences in legislation 

Inspections of TEs and procurement sites 
Audit of documentation 
Regular evaluation of medical personnel 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 
Audit documentation 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Authorisation requirement 
Inspections 
External audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Yes 

ISO training programmes 

124 

 
 
  
 
 
  
 
 
13.5. Any additional comments on quality management, responsible 
person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 

14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 
16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 

Yes 

No 

Usually with testing laboratories  

No 

Vigilance 
Inspections 

Need ongoing inspectors/vigilance european training programs as 
personel may change sectors 
Directive 2004/23/EC 
Directive 2006/17/EC 
Directive 2006/86/EC 
Please take into account suggestions of the 1st Informal Competent 
Authorities meeting in 2012 
Please take into account suggestions of the 1st Informal Competent 
Authorities meeting in 2012 
Please take into account suggestions of the 1st Informal Competent 
Authorities meeting in 2012 

125 

 
 
  
 
 
  
 
 
 
 
 
 
 
A.1.6. 

Survey response Czech Republic 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 
1.1.7.What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The  NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 
1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
Please specify 'other': 

1.3. National Competent Authority 3? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 
Please specify 'other': 
2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 

State Institute for Drug Control 
Srobarova 48 100 41 Prague 10 Czech Republic 
+420 272185111 
posta@sukl.cz 
www.sukl.cz 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Pharmaceuticals 
Medical devices 
Other 
Regulation of prices and reimbursements of pharmaceuticals 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Yes 
Ministar of Health of the Czech Republic 
Palackeho namesti 4 128 01 Prague 2 Czech Republic 
+420 224971111 
mzcr@mzcr.cz 
www.mzcr.cz 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
Regulation of prices and reimbursements of pharmaceuticals 
Other 

Licencing of import and export ,contacts with EC, preparation of 
legal matters in national legislation 
No 
State Institute Survaillance Branch Inspection Division Clinical 
Practice and Survaillance over Buiological Material Proccessing (2 
inspectors), Pharmacovigilance Department  

Not applicable 

NA 

Yes 
By inspecting all procurement centres 
Other 
Approval licence issued by State Institute for Drug Control 
102 

45 

126 

 
 
 
 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
Please specify 'other': 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
Please specify 'other': 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation systems for 
testing laboratories? 

67 

35 

4 

Inspections of the site/centre 
Other 

Approval licence issued by State Institute for Drug Control 
Yes 

26 

Inspections of the laboratories 
Other 

Approval licence issued by State Institute for Drug Control 
26 

No 

Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
NAT testing is not allowed by the Czech national legislation 

No 

Yes 

HTLV for donor living in or originate from high incidence areas 
(sexual partners, parents) 
Yes 

HTLV for donor living in or originate from high incidence areas 
(sexual partners, parents) 
No 

127 

 
 
 
 
3.8. Do you have any additional comments on testing? 

No 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

86 

Yes 
During routine inspections 
By review of a submitted application with supporting documentation 
0 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

0 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

4.7.3. How many ocular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.2. How many musculo-skeletal tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.9.8.  How many multi-tissue establishments? 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 

Ocular tissue establishments 
HSC tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
2 
1 
7 
2 
Multi-tissue establishments 

2 
Musculo-skeletal tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
2 
4 
1 
Adipose tissues- 2 TE Distribution - 2 TE 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
10 
0 
1 
0 
2 
0 
0 
1 
3 
28 
5 
0 
0 

128 

 
 
 
 
 
 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.16.1.1. How many penalties have been imposed in 2011 (from 
01/01/2011-31/12/2011)? 
4.16.1.2. What were the reasons for imposing the penalties? Please 
describe. 
4.16.1.3. What kind of penalties were imposed? Please describe (e.g. 
suspension of authorisation, criminal penalty etc.) 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 

1 storage of TCs, 2 distribution,  2 adipose tissues 

0 

Yes 

Yes 
0 

NA 

NA 

No 

Yes 

Clinical Practice and Survaillance over Biological Materila 
Processing (part of Inspection Division) 
2 
Yes 

Blood 
Pharmaceuticals 
Advanced therapies 
78  

0 

3 - suspection of illegal activities (procurement, processing and use) 
concerning TC without any licence reguested by the law 

0 

72 

6 

0 

0 

129 

 
 
 
 
 
 
9 

3 

0 

0 

was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  According to the AIDE MEMOIRE of the inspection (standard 

General system-oriented inspections 

0 

0 

6 

0 

0 

3 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.13.1. Could you please explain why? 

5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.14.1. Could you please explain why? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 

inspection protocol) 
Yes 

8 

Yes 

92 
Yes 
28 
Yes 

Yes 

3 

Yes 

To share experience, to get more information about the regulatory 
approach in another MS 
Yes 

At the request of another NCA 
No 

130 

 
 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

No 

Yes 

No 

Yes 

17 

16 

TE has written SOPs for import including verifying quality and 
safety requirements according to the Czech law 

TE has written SOPs for import including verifying quality and 
safety requirements according to the Czech law 

TE has written SOPs for import including verifying quality and 
safety requirements according to the Czech law 

TE has written SOPs for import including verifying quality and 
safety requirements according to the Czech law 

TE has written SOPs for import including verifying quality and 
safety requirements according to the Czech law 

TE has written SOPs for import including verifying quality and 
safety requirements according to the Czech law 

TE has written SOPs for import including verifying quality and 
safety requirements according to the Czech law 

Yes 

PBSC 82, BMSC 2, DLI 6 (SI, DE, USA, UK, CAN) 

No 

No 

C. Export of tissues/cells is authorised irrespective of national needs 
F. Other 
Import of TCs is authorised irrespective of national needs, upon the 
request of TE 
No 

Rules for import/export of TCs are the same in case of 3rd countries 
and EU MS, the same approval licence 

131 

 
 
 
 
 
 
No 
TEs can provide distrobution by their own or by approved 
distributor, both inspected 

No 

No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No. 

No 

No 

No 

No 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.1.1. If no, why not? 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site.  www.sukl.cz/Rewievs and Lists/List of subjects from human tissues, 

Yes 
Available on website of each TE 
No 

Content of annual report is established in legislation 
60-99% 

Not requested by national legislation 
Yes 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

cells and blood branch/List of holders of licence according the law 
on human TC 
Yes 

Detailed information of TE, upon the request of EUROCET 
No. 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Yes 

No. 

Tissue establishment 

Both paper records and electronic forms 

Established in written SOPs of TEs, requested by national legislation 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

State Institute for Drug Control 
See above - Pharmacovigilance Department 

Yes 

132 

 
 
 
 
 
 
 
 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.2. Please specify why not. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.2. Please specify why not. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.2. If no, please specify why not. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.2. If no, please specify why not. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.2. If no, please specify why not. 
10.16. Do you have any additional comments on SARE reporting? 

Yes 

Yes 

Yes 

<50% 

Yes 

SAR - TE - State Institute for Drug Control, requested by national 
legislation 
No 

System has not been established yet,  no reports. 
No 

System has not been established yet,  no reports. 
Yes 
0 

No 

System has not been established yet,  no RA yet. in case of RA is 
possible to use established RA system for pharmaceuticals or 
medical devices 
No 

System has not been established yet, no RA yet, in case of RA is 
possible to use established RA system for pharmaceuticals or 
medical devices 
Yes 

Requested data (no SAR/SAE reported) 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
No 

No specialised vigilance officer for TCs 
No. 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 

Explicit consent (opt-in) 

No further authorisation is needed 
Other 

Written informed consent for each donation, requested by national 
legislation. 
Presumed consent (opt-out) 

133 

 
 
 
 
tissue donation? (more than 1 answer possible) 
Please specify 'other'. 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

National Register for Persons Withagreeing with Post-mortem 
Removal of Organs and Tissues, responsible person verifies 
information from this register before procurement 
Yes 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 

Established in written SOPs of TEs, inspected by NCA berofe TE 
licencing, requested by national legislation 

Established in written SOPs of TEs, inspected by NCA berofe TE 
licencing, requested by national legislation 
No 

Established in written SOPs of TEs, inspected by NCA berofe TE 
licencing, requested by national legislation 
No 

Inspections of TEs and procurement sites 
Other 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Approval licence from NCA  
No 

Approval licence from NCA for procurement centers 
Inspections of ART centres 
Other 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
Yes 

HIV p 24 laboratory testing, NAT is not acceptable 
No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Other 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.5.1. Please specify. 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 

134 

 
 
 
 
Tissues and Cells, 2011)) 
12.8.1. Please specify. 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Written SOPs, approval licence 
No. 

Authorisation requirement 
Inspections 
Internal audits 
External audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel trained? 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
No 

EU countries 
Non-EU countries 
No 
No 
No request for personnel training in EU, Non-EU countries 

13.4.2.1. Please specify EU-countries. 
13.4.2.2. Please specify non EU-countries. 
13.5. Any additional comments on quality management, responsible 
person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

Inspections of tissue establishments 
Internal audits of tissue establishments 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
No 

Yes 

Yes 

Laboratory testing, storage, distribution, procurement Written 
agreements Issued in the approval licence of TE 
Approval licence, inspected before approval, inspected every 2 years 

No. 

No 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 

135 

 
 
 
 
 
 
 
 
 
 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

ART provisions 
Import-export 
Vigilance 
Some ART refuse regulation Special approval licence for 
distributors Access into the DB  
No shortcomings 

136 

 
 
 
 
 
A.1.7. 

Survey response Denmark 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 

Danish Health & Medicines Authority 
Axel Heides Gade 1 2300 Copenhagen S Denmark 
+45 7222 7400 
sst@sst.dk 
www.@sst.dk 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
Development and implementation of national legislation, 
formulation of national health policies, etc.  
No 
In Denmark, the Danish Health and Medicines Authority is the 
supreme authority in healthcare and regulatory control of medicines. 
We assist and advise the Ministry of Health as well as other 
authorities with the administration of healthcare services and inform 
Danish citizens on health issues. It is also our responsibility to 
ensure the availability of effective and safe medicines, medical 
devices and new therapies and to promote their proper use. We are 
here to create the best possible framework for the healthcare system 
to prevent and treat illness, suffering and functional limitations for 
the individual. We give advice on the Danish regions healthcare 
plans. We follow health conditions through monitoring and 
evaluation and endeavour to be at the cutting edge of professional 
knowledge within the healthcare area. We have the responsibility for 
education, authorisation, registration and supervision of Healthcare 
professionals. There are approximately 700 employees devided 
between 10 departments and with resides at 4 addresses. 
Not applicable 

The National Competent Authority has primary responsibility for all 
aspects of TE Directives. Regional Competent Authorities are not 
present in Denmark.  

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
Seven. 

Forty-seven 

Thirty-five 

Forty 

137 

 
 
 
 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 

2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Ten 

Analysis of the mandatory documentation 

Yes 

Nine testing laboratories in Denmark.  

Inspections of the laboratories 

There are nine within Denmark. These were first authorised in 2007. 
HIV Ag/Ab  NPU19649; Anti-HCV  NPU12033, HBsAg  
NPU02349 ; Anti-HBc  NPU02346; Ultrio Plus NAT  NPU26888; 
Syfilis NPU12993; HCV RNA  NPU14475; HIV RNA NPU26884; 
HBV DNA  NPU12183                                                
Testing of donors is regulated as a tissue establishment in Denmark.  

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
NAT Chlamydia 
Treponema Pallidum 
See 3.5 below as well. NAT testing is mandated nationally for 
deceased donors. Established by national scientifi committee several 
years to be beneficia in minimizing infection transmission. We 
intend to make NAT testing for HIV, HBV og HCV mandatory for 
egg donors    
No 

Yes 

NAT testing is mandated nationally for deceased donors.  
No 

No 

Testing laboratories should be included in Eurocet registry with 
authorised analyses listed with IUPAC numbers. 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 

Thirteen 

Yes 

Yes 

No 

138 

 
 
 
 
 
 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

0 

0 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.9. Please specify the type of tissues/cells and how many. 

4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.2. How many musculo-skeletal tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 

Other tissue establishments 

It is only possible to continue if accepting one pending in 4.7 
Other tissue establishments 

To accept Other tissue establishment in 4.8 is the only way to be 
able to continue this questionaire 
Musculo-skeletal tissue establishments 

1 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
13 
0 
1 
0 
1 
0 
4 
1 
3 
2 
12 
14 
3 
0 
Corneas 5 

No 

Establishing and promoting an EU template for authorization will 
assist in the distribution of tissues/cells and encourage mutual 
recognition between Member States.  

Yes 

Inspection department of the Danish Medicines and Medicines 
Authority. 
1.5 whole time equivalents are dedicated to the tissue/cells sector. 
There are 16 inspectors in the inspection department for all types of 
GXP.   
Yes 

139 

 
 
 
 
 
 
 
 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 

Blood 
Organs 
Pharmaceuticals 
Advanced therapies 
Medical devices 
9 

0 

0 

0 

7 

2 

0 

0 

0 

9 

0 

0 

0 

7 

2 

0 

0 

0 

140 

 
 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  Routine inspections are typically planned for two year intervals and 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.7.1. Why not? 
5.7.2. How do you prioritise tissue establishments to be inspected? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.17.1. Could you please explain why not? 

5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 

subsequently evaluated on a risk based approach with current 
information.  
No 

Resources. 
Risk based approach and evaluation of current information.  
Eleven 

Yes 

1 
No 
Not practical or justified on the curent information.  
Yes 

Yes 

4 

No 

No 

No 

No 

No 

Complexities of auditing TE's in third countries and priorities to 
fulfill requirements at national level.    
The frequency of inspections should be based on a risk assessment 
scheme instead of a required 2 years frequency 

Yes 

9 

9 

By the routine inspection of the SOP's according to generic 
principles. 

141 

 
 
 
 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

Not specific. 

Not specific. 

Not specific. 

Not specific. 

Not specific. 

Not specific. 

Yes 

Corneas 6 

No 

No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
C. Export of tissues/cells is authorised irrespective of national needs 
D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
Advised by the tissue establishment. 

Yes 

Corneas 6 

None. 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 

No 

No 

Yes 
Responsible Person shall demonstrate they have established any 
supplementary national requirements of the receiving EU country, 
and demonstrate they meet them.  
Yes 

Response to enquiries by sending the TE information on our national 
requirements.  

Inspection of the procedures for distribution 

Yes, no restrictions apply 

142 

 
 
 
 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) as 
a Competent Authority, in their authorisation/monitoring or 
inspection. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.8.1. Where are the brokers located? 
7.9. Do you have any additional comments on distribution? 

No 

Yes 

Specific legislation not specified at this time. Our CA informs the 
brokerage company on the principles of TE legislation and 
periodically monitors their activities. 
Yes 

Your country 
Suitable draft legislation for brokerage companies should be 
developed to ensure quality, safety and traceability.   

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.1.1. If no, why not? 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

No 
Yes 

Report format and style varies slightly from year to year. 
100% (all) 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.2. If no, why not? 

8.7. Do you have any additional comments on reporting? 

http://laegemiddelstyrelsen.dk/da/service-
menu/produktomraader/vaev-og-celler/register-over-godkendte-
vaevscentre  
Yes 

http://laegemiddelstyrelsen.dk/da/service-
menu/produktomraader/vaev-og-celler/register-over-godkendte-
vaevscentre 
No 

Data request for clinical information on tissues/cells is not part of 
our work activities.    
Individual reports (see 8.3) on activities of a TE are not deemed 
beneficial.  

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

None. 

Yes 

Tissue establishment 

Both paper records and electronic forms 

Verification by routine inspections of tissue establishments. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

Danish Health and Medicines Authority. 
The vigilance coordinator has responsibility for the receipt, 
management and assessment of SAR/E's to our Agency. In 
collaboration with internal colleagues a strategy is developed to 

143 

 
 
 
 
 
 
 
 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.2. Please specify why not. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.2. Please specify why not. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.2. If no, please specify why not. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.2. If no, please specify why not. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

investigate probable cause and implement corrective actions as 
appropriate. The vigilance officer is fluent with the protocol and 
procedures of the RATC system, when applicable.   
Yes 

Yes 

Yes 

<50% 

Yes 

we have a procedure for ART 
No 

Low statistics at this time. 
No 

Resources. 
Yes 
Two, sperm straws, genetic. 

No 

Our national system is effective for notifying the TE's, which 
thereafter have responsibility for contacting the procurement 
centre/s. 
No 

Our national system is effective for notifying the TE's, which 
thereafter have responsibility for contacting the procurement 
centre/s. 
No 

Resources. 
Yes 

Medical devices 

Yes 

4 

A technical report of the SAR/E's at EU level, with 
recommendations/corrective actions, would be a useful tool to issue 
direct to tissue establishments.  

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 

Explicit consent (opt-in) 

Different types of consent must be complied with (e.g. for donation, 

144 

 
 
 
 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.4.1. If no, please describe the difference. 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

for treatment, for storage, etc) 
Explicit consent (opt-in) 

First degree relatives (including spouse) 

No 

Different perspectives apply here. 
Analysis of documentation 

Only trained personnel is allowed to provide such information 

This is the responsibility of the TE and different control systems 
apply. 

This is the responsibility of the TE and the treatment clinic to 
ensure. by their own hospital procedures.  
Yes 

None. 

Inspections of TEs and procurement sites 
Audit of documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 
Audit documentation 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
No 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 

Authorisation requirement 

145 

 
 
 
 
  
 
 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

Inspections 
Internal audits 

Authorisation requirement 
Inspections 

Inspections 

Yes 

An independent organization performs a one day course, which is 
available for all types of tissue establishments.  
None.  

Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

None. 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

15.2. Any additional comments on third party agreements? 

Yes 

Yes 

Examples of circumstances are where; a) infectious marker testing is 
performed at a different testing centre, b) the TE arranges 
responsibility for stored tissue/cells and traceability data to a third 
party, if they should close, c) another third party performs 
specialized processing on behalf of the TE, d) the TE has an IT 
system and the software updates, the storage of data (ie patient files, 
lab results, materials in contact, etc  are performed by an 
independent third party, e) the TE uses the courier services of a third 
party to fulfill distribution requirements.  f) another TE in a different 
EU country performs earlier specified activities 
(donation/procurement/testing) and our TE continues with later 
specified activities.    
A specific evaluation of the contractual agreements (see 15.1.1.1 
above) to ensure details and responsibilities of both parties are 
specified, and agreement is signed and dated. This evaluation is 
performed at routine inspections and are specified in the TE dossier 
prior to the visit.  
None.  

146 

 
 
 
 
 
 
 
 
16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.1.1. Please specify. 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 

16.2.1. For all selected options in question 16.2., please provide a 
short description. 

16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 

16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

Yes 

NAT testing for deceased donors, specified in a guidance document.  
Testing provisions 
Distribution provisions 
Import-export 
Inspections 
Status of testing laboratories in other countries and some national 
requirements are different in Europe Distribution; Interpretation is 
different across Europe. Import-eksport: Issues are being addressed 
in working group Inspections: The 2 year interval is a challenge to 
fulfill 
Directive 2004/23/EC 
Directive 2006/17/EC 
Directive 2006/86/EC 
Identify proposals for further consideration, review these in a 
working group to develop recommendations, then present the 
information to CA/Commission meetings.  
Identify proposals for further consideration, review these in a 
working group to develop recommendations, then present the 
information to CA/Commission meetings.  
Identify proposals for further consideration, review these in a 
working group to develop recommendations, then present the 
information to CA/Commission meetings.  

147 

 
 
 
 
A.1.8. 

Survey response Estonia 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 
Please specify 'other': 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 

State Agency of Medicines 
Nooruse 1, 50411 Tartu, Estonia 
+372 737 4140 
info@ravimiamet.ee 
http://www.ravimiamet.ee/ 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
State Agency of Medicines is a governmental body under the 
Ministry of Social Affairs. Its main responsibility is the protection 
and promotion of public and animal health, through the supervision 
of medicines for human and veterinary use. Among other goals State 
Agency of Medicines aims to ensure that cells, tissues and organs 
used in the treatment of humans in Estonia are proven to be safe and 
of high quality.  Department of Biologicals is a part of State Agency 
of Medicines. The staff consists of three persons who are all 
involved in EU affairs, legal matters and biovigilance. The 
inspections can also be carried out by all members of the department 
with the help of a senior inspector whose main focus is 
pharmaceutical manufacturing. As Department of Biologicals is a 
part of the State Agency of Medicines, it gets funded by the agency, 
which is funded by approximately ten percent by the government.  
Not applicable 

No Regional Competent Authority(ies)  

Yes 
Other 

In Estonia only tissue establishments and special medical care 
providers in contract with tissue establishments are allowed to 
procure tissues. Tissue establishment is responsible for the 
procurement and conditions and documentation associated with 
procurement in the tissue establishment are inspected. 
Two tissue establishments renewed their licences. 

There were three tissue establishments responsible for procurement 
of “traditional tissues and cells” in 2011. 

There were two tissue establishments responsible for procurement of 
haematopoietic stem cells in 2011. 

There were  five tissue establishments responsible for procurement 
of gametes, embryos and other reproductive tissues in 2011. 

0. 

148 

 
 
 
 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 

2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

Laboratories are accredited by Estonian Accreditation Centre. 
Analysis of the mandatory documentation requested from the tissue 
establishment 

- East-Tallinn Central Hospital Ltd. - 25.06.2012 (first accred. 
18.12.07) Detailed description - 
http://www.eak.ee/dokumendid/pdf/kasitlusala/L199.pdf - North 
Estonia Medical Centre Ltd Laboratory (03.06.2010) Detailed 
description – 
http://www.eak.ee/dokumendid/pdf/kasitlusala/L232.pdf - - 
Quattromed HTI Laborid Ltd - 20.05.2009 (first accred. 20.05.04) 
Detailed description - 
http://www.eak.ee/dokumendid/pdf/kasitlusala/L159.pdf - - Tartu 
University Clinics United Laboratories - 03.02.2010 (first accred. 
03.02.05) Detailed description - 
http://www.eak.ee/dokumendid/pdf/kasitlusala/L167.pdf - West 
Tallinn Central Hospital Ltd Laboratory of Clinic of Diagnostics 
26.02.2009 (first accred. 26.02.04) Detailed description - 
http://www.eak.ee/dokumendid/pdf/kasitlusala/L155.pdf 

Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT HCV 
NAT Chlamydia 
Treponema Pallidum 
The use is encouraged, but the resources of tissue establishments and 
the cost-benefit has to be taken into account. 

No 

Yes 

Anti-HTVL-I for donors coming from high risk areas or whose 
sexual partners come from high risk areas. 
Yes 

- Anti-HTVL-I for donors coming from high risk areas or whose 
sexual partners come from high risk areas. - Trichomoniasis 

149 

 
 
  
 
 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

No 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

5. 

Yes 
During routine inspections 
During inspections organised for this purpose 
0. 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

0. 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

Other tissue establishments 

None. 
Other tissue establishments 

None. 
Other tissue establishments 

None. 
ART tissue establishments 
Multi-tissue establishments 
0 
3 
3 
0 
No tissues requiring special direct agreement were distributed. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 

Yes 

No 

Yes 

State Agency of Medicines, Department of Biologicals within the 
structure of the agency. 
3 in the Department of Biologicals (all multi-functional) and also 1 
from another department of the agency (department for supervision 
over medicinal products; support to tissue establishment 
inspections). 
Yes 

150 

 
 
  
 
 
 
 
 
 
  
 
 
5.2.1. If yes, please specify. (more than 1 answer possible) 

Please specify other. 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 

Blood 
Organs 
Advanced therapies 
Others 
General inspection process has been established on the level of the 
State Agency of Medicines, the agency supervises tissues and cells 
and pharmaceuticals. 
4 

0 

0 

0 

3 

1 

0 

0 

4 

2 

0 

1 - Inspection of premises and conditions prior to first authorisation 
(new ART site). 

0 

0 

2 

0 

0 

0 

151 

 
 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  Depends on the results of the last inspection and/or changes in the 

General system-oriented inspections 
Thematic inspections 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 

facilities and handling practices in the tissue establishment. 
Yes 

6 - including inspections prior to first authorisations. 

No 

Authorised tissue establishments in Estonia are themselves 
responsible for fulfilling the conditions for procurement. 
No 
State Agency of Medicines is not obligated to inspect third parties 
on routine basis. Also, laboratories performing the donor testing are 
accredited by Estonian Accreditation Centre. 
Yes 

Yes 

4 

No 

No 

No 

No 

Yes 

Yes 

6. Only authorized tissue establishments are allowed to 
import/export tissues from/to third countries. 

6 

There are currently no tissue establishments authorized to handle 
skin in Estonia. 

Only authorized tissue establishments are allowed to import tissues 
from third countries. 

152 

 
 
  
 
 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 

6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

Only authorized tissue establishments are allowed to import tissues 
from third countries. 

Only authorized tissue establishments are allowed to import tissues 
from third countries. 

Only authorized tissue establishments are allowed to import tissues 
from third countries. 

There are currently no tissue establishments authorized to handle 
cord blood in Estonia. 

Only authorized tissue establishments are allowed to import tissues 
from third countries. 

Yes 

19 unrelated bags of HPC. Countries of origin: 15 from Germany, 2 
from Finland, 2 from Israel. 249 sperm straws. Country of origin: 
Denmark.  
Yes 

26 units of cord blood. Countries of destination: 25 to Lithuania, 1 to 
United Kingdom. 

No 

C. Export of tissues/cells is authorised irrespective of national needs 
F. Other 
Import of tissues/cells is authorised irrespective of national needs. 
No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 

Yes 

No 

Yes 
Tissue establishments themselves are responsible for meeting the 
quality and safety measures established by Member States they want 
to export to. 
No 

The conditions of transport are in the responsibility of the tissue 
establishment and the means of establishing the proper conditions 
are controlled during routine inspections. 
Yes, but only via an authorised TE in my MS 

26 units of cord blood. Countries of destination: 25 to Lithuania, 1 to 
United Kingdom. 

19 unrelated bags of HPC. Countries of origin: 15 from Germany, 2 
from Finland, 2 from Israel. 249 sperm straws. Country of origin: 
Denmark. 
No 

153 

 
 
  
 
 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

No 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

100% (all) 

No 
Yes 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

8.7. Do you have any additional comments on reporting? 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 

Yes 

http://www.ravimiamet.ee/rakkude-kudede-ja-elundite-2012-aasta-
k%C3%A4itlemisandmete-kokkuv%C3%B5te 
Yes 

http://www.ravimiamet.ee/en/list-licensed-handlers-cells-tissues-
and-organs-tissue-establishments 
Yes 

State Agency of Medicine completes forms for tissues, HPC and 
ART. 

Tissue establishment 

Both paper records and electronic forms 

Tissue establishments have a legal obligation to store the data and 
they will have to demonstrate a reasonable storage/backup system 
for the documents during inspections. 

9.5. Do you have any additional comments on traceability? 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

State Agency of Medicines 
State Agency of Medicines is a governmental body under the 
Ministry of Social Affairs. Its main responsibility is the protection 
and promotion of public and animal health, through the supervision 
of medicines for human and veterinary use. Among other goals State 
Agency of Medicines aims to ensure that cells, tissues and organs 
used in the treatment of humans in Estonia are proven to be safe and 
of high quality. 
Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 

Yes 

Yes 

154 

 
 
  
 
 
  
 
 
  
 
 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.2. If no, how do you ensure that SAR/SAE are reported to the 
TEs? 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 

10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

100% 

No 

There is no mandatory procedure but the transplantation centre is 
required by the law to report SAR/SAE  to the TE concerned. 
Yes 

Vigilance activities are reported biannually on the website of State 
Agency of Medicines. 
Yes 

EU level serious adverse reactions and adverse events will be 
included in the biannual overview, if Estonia was directly 
concerned. 
Yes 
Four cases of hyperviscosity of apheresis product (HPC). 

Yes 

Tissue establishments concerned will be informed by e-mail and 
over the phone. 
Yes 

Tissue establishments concerned will be informed by e-mail and 
over the phone. 
No 

We complete the SANCO “Serious Adverse Reaction(s) and 
Event(s)“ questtionnaire. 
No 

Yes 

4 

Explicit consent (opt-in) 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 

Yes 

Analysis of documentation 

No further authorisation is needed 

Donor has to explicitly agree to donate. This is separate for each 
donation. 
Explicit consent (opt-in) 

155 

 
 
  
 
 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

Only trained personnel is allowed to provide such information 

Handling of the documentation is based on the data protection act 
and only authorized persons are allowed to access the data. 

Handling of the documentation is based on the data protection act. 

Yes 

The personal data of a donor shall not be disclosed upon artificial 
insemination, except in the case where the ovum donor is a relative 
of the woman who wishes to undergo artificial insemination. 

Inspections of TEs and procurement sites 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Autopsy report 
Other 
Any other relevant tests. 
No 

No 

No 

Inspection of tissue establishment 

Please specify 'other'. 
12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 

Authorisation requirement 
Inspections 

156 

 
 
 
 
  
 
 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 

Yes 

A competent person shall have the following qualifications: 1) an 
academic degree in medicine or biology or specialities relating to 
biology acquired in a university or a foreign qualification equal 
thereto; 2) at least two years of practical work experience in the field 
of handling cells, tissues and organs. 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Inspections of tissue establishments 
Other 

Short description of storage conditions is mandatory for 
authorisation. 
Inspections of tissue establishments 
Other 

Short description of labelling and packaging procedures is 
mandatory for authorisation. 

Yes 

Yes 

This corresponds to the article 24 in 2004/23/EC - e.g. donor testing, 
transport of the material etc. 
During inspections of tissue establishments. List of third parties 
performing the contractual services related to the tissue handling and 
the nature of these services is added to the application for 
authorisation. 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
Please specify 'other'. 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
Please specify 'other'. 

14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

No 

No difficulties 

No difficulties. 

No shortcomings 

157 

 
 
  
 
 
  
 
 
  
 
 
A.1.9. 

Survey response Finland 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 
Please specify 'other': 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 

Finnish Medicines Agency 
P.O. Box 55, FI-00034 FIMEA, FINLAND 
+358 29 522 3341 
registry@fimea.fi / personal addresses: firstname.lastname@fimea.fi 
www.fimea.fi 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
The Finnish Medicines Agency (Fimea) is the national competent 
authority for regulating pharmaceuticals. As a central administrative 
agency operating under the Ministry of Social Affairs and Health it 
promotes the health and safety of the population by regulating 
medicinal, blood and tissue products, and by developing the 
pharmaceuticals sector.  Fimea’s organisation is structured around 
three core processes: Supervision and licenses, Assessment of 
medicinal products, and Assessment of pharmacotherapies. The 
Supervision and licenses -process includes Inspectorate unit and 
Laboratory unit.  The Inspectorate is responsible for authorisation 
and inspection of tissue establishments, and for vigilance functions. 
About 20 inspectors/experts are working in the Inspectorate. Two 
senior inspector are responsible for the authorisation and inspection 
of tissue establishments, and for vigilance actions. In addition, the 
Assessment of medicinal products -process provides medical 
expertise at need (mostly in vigilance). Legal expertise is provided 
by the process of internal services.  
Not applicable 

No decentralised systems nor regional competent authorities for 
tissues and cells.  

Yes 
By inspecting all procurement centres 
Other 
Procurement sites are listed on each TE license and inspected as a 
part of routine TE inspection.  
None. Almost all Finnish TEs and their procurement sites were 
authorized year 2007-2008. 
5 

5 

No separate procurement sites for gametes and embryos. All 23 
fertility clinics (TEs) are responsible also for procurement of 

158 

 
 
 
 
 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 

2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 

2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.4.1. Please specify why: 

3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 

gametes and embryos. 
1 

Inspections of the site/centre 

No 

Regional authorities and The National Institute for Health and 
Welfare (THL) are responsible for licensing of all clinical 
microbiology laboratories in Finland. THL keeps the registry of 
laboratories. 
Analysis of the mandatory documentation requested from the tissue 
establishment 

In Finland any licensed clinical microbiology laboratory can perform 
donor testing. THL is a national registration authority and keeps the 
registry. Exact number of donor testing laboratories was not 
available during survey. The estimate is 20-30 laboratories (clinical 
laboratories of university hospitals and central hospitals as well as 
some private laboratories). 

Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
NAT Chlamydia 
Treponema Pallidum 
The Finnish Medicines Agency will update the Administrative 
Regulation 3/2012 in 2013. The Finnish Medicines Agency is 
introducing more stringent protective testing requirements: viral 
PCR tests required for living and deceased donors -except donors of 
reproductive cells). The more stringent national requirements are 
being notified (Commission Directive 98/34/EC; the notification 
identification is 2013/0349/FIN). 
Yes 

All allogenic donors (both living and deceased) should be tested as 
carefully (both serology and PCR). 
Yes 

159 

 
 
  
 
 
3.5.1. Please specify. 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Risk groups (HTLV, malaria, etc) 
Yes 

Risk groups (HTLV, malaria, etc) 
No 

Yes 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

Yes 
During routine inspections 
0 

No 

0 

2 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.2. How many musculo-skeletal tissue establishments? 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.2. How many musculo-skeletal tissue establishments? 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 

Musculo-skeletal tissue establishments 
Other tissue establishments 
1 
mesenchymal stem cells (ATMP) 
Other tissue establishments 

All TEs were authorised by 31.12.2011 
Musculo-skeletal tissue establishments 
Other tissue establishments 
1 
mesenchymal stem cells 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
1 
0 
22 
1 
2 
0 
1 
0 
11 
0 
1 
0 
10 
13 

160 

 
 
  
 
 
 
 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 

1 
0 
1: mesenchymal stem cells (for ATMP) 

0 

0 

Yes 

No 

Yes 

Fimea’s organisation is structured around three core processes: 
Supervision and licenses, Assessment of medicinal products, and 
Assessment of pharmacotherapies. The Supervision and licenses -
process includes Inspectorate unit and Laboratory unit.The 
Inspectorate is responsible for authorisation and inspection of tissue 
establishments, and for vigilance functions.  
2 
Yes 

Blood 
Advanced therapies 
17 

0 

0 

0 

17 

0 

0 

0 

161 

 
 
 
 
  
 
 
0 

0 

0 

8 

was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  On-site inspections are carried out at least every four years. Desk-

General system-oriented inspections 
Desk based reviews 

0 

0 

8 

0 

0 

0 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 

based inspections can be used at the time of an intermediate 
evaluation between on-site inspections, if there have been no 
significant changes in TE.  
Yes 

59 

Yes 

11 
No 
In Finland there are quite a few third parties which act as suppliers 
of critical services to TEs. So far inspections of the TE have 
indicated no non-compliance with the written agreement by a third 
party.  
Yes 

Yes 

4 

No 

No 

162 

 
 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.17.1. Could you please explain why not? 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 

No 

No 

No 

Limited HR 

Yes 

16 

16 

No importation of skin 

Authorised TE is responsible for import procedures. Procedures are 
inspected douring routine TE inspection. TEs report number of 
import/export tissues and cells annually. 

Authorised TE is responsible for import procedures. Procedures are 
inspected douring routine TE inspection. TEs report number of 
import/export tissues and cells annually. 
No importation of cardio vascular tissues 

Authorised TE is responsible for import procedures. Procedures are 
inspected douring routine TE inspection. TEs report number of 
import/export tissues and cells annually. 

Authorised TE is responsible for import procedures. Procedures are 
inspected douring routine TE inspection. TEs report number of 
import/export tissues and cells annually. 
Authorised TE is responsible for import procedures. Procedures are 
inspected douring routine TE inspection. TEs report number of 
import/export tissues and cells annually. 

Yes 

HSC: 7 grafts from USA, 1 graft from Israel. 

No 

No 

F. Other 

HSC: HLA match criteria 
No 

163 

 
 
  
 
 
Yes 
All grafts must fulfill minimum requirements. In exceptional cases, 
Fimea  can grant permission to import/export graft nor fulfilling the 
requirements (health reasons, benefits outwigjt the risks). 
No 

Authorised TE is responsible for ensuring that the other TE fulfill 
the requirements.  

Yes, but only via an authorised TE in my MS 

HSC: 4 grafts to Germany and Sweden Amniotic membrane: 14 
grafts to Ireland 

HSC: 79 grafts from Germany, 1 from UK, 1 from Portugese, 1 from 
France Sclera: 15 from Netherlands Tendons: 63 from Netherlands 
Sperms: Denmark 
No 

6.16. Do you have any additional comments on import/export? 

No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Yes 

No 

No 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

100% (all) 

No 
Yes 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

http://www.fimea.fi/download/21482_Kudoslaitostoiminta_Suomess
a_vuonna_2011.pdf 
Yes 

http://www.fimea.fi/download/23600_FI_Lista_Suomessa_toimivist
a_kudoslaitoksista_10-7-2013.pdf 
Yes 

All 
The role of EUROCET should be clarify (mandatory or non-
mandatory reporting). 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 

Yes 

Tissue establishment 

164 

 
 
  
 
 
  
 
 
 
 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 

9.5. Do you have any additional comments on traceability? 

Both paper records and electronic forms 

During inpections particular attention is paid to the identification 
systems, traceability and registries (IT systems and paper 
documentation). 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

Fimea 
Fimea’s organisation is structured around three core processes: 
Supervision and licenses, Assessment of medicinal products, and 
Assessment of pharmacotherapies. The Supervision and licenses -
process includes Inspectorate unit and Laboratory unit. 
Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.2. If no, how do you ensure that SAR/SAE are reported to the 
TEs? 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

Yes 

Yes 

100% 

No 

TEs give instructions to the transplantaion centers.  

Yes 

Annual summary is published.  
Yes 

We give feedback to those TEs which are involved in particular 
event.  
Yes 
0 

Yes 

We notify TEs by phone or e-mails. 

Yes 

We notify TEs by phone or e-mails. 

No 

We already provide data regarding SAR/SAE to the Comission.  
Yes 

Haemovigilance 
Pharmacovilance 

165 

 
 
  
 
 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Medical devices 
Yes 

4 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 

Explicit consent (opt-in) 

Donors must give informed written consent to the removal of an 
organ or tissue. Before giving written consent, donors must be 
provided with an explanation of the significance of the procedure for 
themselves and the recipients, and be informed that their consent can 
be withdrawn. 
Presumed consent (opt-out) 

First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Yes 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 

Coding systems for donors. Restrict access to registries.  

Coding systems for donors. Restrict access to registries.  

Yes 

11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

Inspections of TEs and procurement sites 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Autopsy report 
No 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 

No 

No 

166 

 
 
  
 
 
  
 
 
Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 

Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Authorisation requirement 
Inspections 
Internal audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel trained? 
13.4.2.1. Please specify EU-countries. 
13.5. Any additional comments on quality management, responsible 
person, personnel? 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
No 

EU countries 
ESHRE EATB etc. 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.2. Any additional comments on third party agreements? 

Yes 

No 

167 

 
 
  
 
 
  
 
 
  
 
 
  
 
 
16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.1.1. Please specify. 

16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

Yes 

Tissue Act 101/2001: No donor or assignee of a donor may be 
promised or paid a fee for the removal and use of an organ or tissue 
as laid down in this Act, or for the donation of a cadaver. 
No difficulties 

No difficulties.  

Directive 2006/17/EC 

All allogenic donors (both living and deceased) should be tested as 
carefully (both serology and PCR).   Oocyte and sperm donors (non-
partner) should have same test requirements (if there is no 
quarantine: PCR-tests for HIV, HBV, HCV and Chlmaydia) 

168 

 
 
 
 
 
A.1.10. 

Survey response France 

1. Public information 
1.1. Name of National Competent Authority 
(NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 
answer possible) 

Please specify 'other': 

1.1.7. What are the role/tasks of the NCA? (more 
than 1 answer possible) 
Please specify 'other': 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 
answer possible) 

Please specify 'other': 

1.2.7. What are the role/tasks of the NCA? (more 
than 1 answer possible) 

Please specify 'other': 

1.3. National Competent Authority 3? 
1.3.1. Name of National Competent Authority 3: 
1.3.2. Address of NCA 3: 
1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 
answer possible) 
1.3.7. What are the role/tasks of the NCA? (more 
than 1 answer possible) 

Please specify 'other': 

Ministry of health 

14, avenue duquesne  75700 PARIS France  
00 33 1 40 56 50 61 
genevieve.liffran@sante.gouv.fr  
www.sante.gouv.fr 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
cosmetic products, tatoo ink, biocides, ancillary products, milk breast,  medicinal 
products, medicinal products (human , paediatric, veterinary medicinal products) 
Other 

The ministry of health draws rules and regulations according to the law applying to 
the activities on organs, tissues and cells. It designs the strategic orientations of these 
areas.It manages the health alerts. 
Yes 
Agence nationale de sécurité du médicament et des produits de santé (ANSM) 
143/147, Boulevard Anatole France 93285 SAINT DENIS CEDEX 3 FRANCE 
00 33 1 55 87 40 41 
fewzi.teskrat@ansm.sante.fr  
www.ansm.sante.fr 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
cosmetic products, tatoo ink, breast milk,  microorganisms and toxins,biocide 
products, all kinds of medicinal products (including ATMPs), cellular 
products,contraceptive products,contact lenses 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
 drawing decisions ,   recall of products, suspension of authorization, revok of the 
authorisation, managing rapid alert system,regulatory discussion at national and 
european level under the supervision of the health Ministry . 
Yes 
Agence de la biomédecine (ABM) 
1, avenue du stade de france  93212  LA PLAINE SAINT DENIS  FRANCE 
00 33 1 55 93 65 09 
francoise.merlet@biomedecine.fr 
www.agence-biomedecine.fr 
Reproductive tissues and cells 
Human organs 
Inspection 
Vigilance 
Other 
The Agence de la biomedecine is under the authority of the Ministry of health. In the 
reproductive tissues and cells  it has inspection and vigilance missions . It  also 
provides the ministry of health with expertise in order to improve the quality and 

169 

 
 
1.4. National Competent Authority 4? 
1.5. Please give a short description of the legal 
status and organisation of the National Competent 
Authority(ies) (e.g. departments, staffing, number 
of senior and junior inspectors, staff working on 
EU affairs and legal matters, vigilance officers, 
budget, independence from government etc.). 

1.6. In case of MS with federal or decentralised 
systems, please indicate the roles/tasks of the 
Regional Competent Authority(ies). (more than 1 
answer possible) 
1.7. Could you please describe the 
competence/mandate of the Regional Competent 
Authority(ies) and their relation with the National 
Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of 
procurement"? 
2.1.1. How do you authorise the "conditions of 
procurement"? (more than 1 answer possible) 
Please specify 'other': 

2.1.2. How many such authorisations were granted 
in 2011 (01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement 
centres in which procurement of "traditional tissues 
and cells" (skeletal tissues, cardiovascular tissues, 
skin, ocular tissues, amniotic membrane, pancreatic 
islet, hepatocytes, adipose tissue etc.) were carried 
out in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement 
centers in which procurement of haematopoietic 
stem cells (bone marrow, PBSC, cord blood etc.) 
were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement 
centers in which procurement of gametes, embryos 
and other reproductive tissues were carried out in 
2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement 
centers in which procurement of tissues/cells for 
ATMP manufacturing were carried out in 2011 
(01/01-31/12/2011). 
2.3. How do you ensure that procurement centres 
comply with the requirements laid down in Art. 5 

safety in the fields of organs, tissues, reproductive and non reproductive cells 
procurement, donation and use. It plays an essential role in the promotion and the 
development of these activities .It has an operational task in allocation of appropriate 
organs or cells in the purpose of transplantation.                           
No 
The Health Ministry is in charge of drafting the general policy of public health 
according to the legal framework applying to the activities on organs, tissues and cells 
(ethical, medical and legal aspects). It also defines the main orientations for the 
development of these activities .It implements policies for improving the quality and 
the health security regarding health cares,  health products and medical trials.  The 
"Agence nationale de sécurité du médicament et des produits de santé (ANSM)" is 
responsible for the evaluation, authorisation, inspection and control of whole health 
products and establishments which process them (for more information: 
http://www.ansm.fr)  The Agence de la biomedecine (ABM) provides expertise in 
order to improve the quality and safety in four fields : organ procurement, assisted 
reproduction, embryology and genetics, and haematopoietic stem cells. It plays an 
essential role in the promotion and the development of these activities. It also has 
operational tasks in allocation of organs and HSC to the matched recipient in vue of 
transplantation. Given its expertise in these fields, the ABM is the CA for all medical 
and scientific aspects relating to these issues.  It should be pointed out that in the 
vigilance field, ANSM is the competent authority for biovigilance and materio 
vigilance in relation with the Agence de la biomédecine whereas ABM is fully 
competent for ART vigilance. 
Accreditation, authorisation, licensing of TEs 
Inspection 

The regional competent authorities (Agences régionales de santé : ARS) are in charge 
of authorization and inspection of procurement and transplantation of organs, tissues 
and cells establishments, including hematopoietic stem cells (HSC) and Assisted 
Reproductive Techniques (ART) centres. ABM provides the regional agencies with an 
expertise advice in the process of the authorisation. 

Yes 

Other 

These conditions are evaluated during the product evaluation where procurement 
conditions are described in the dossier. 
4 

168 authorized procurement centers  (among these 168,  22 authorized procurement 
centers don't perform this procurement activity) 

32 bone marrow collection and apheresis centres and 9 cord blood banks. 

In France, in 2011, 104 IVF centres (composed of a biological unit and a clinical unit 
in an unique site in an establishment for health) and 95 labs for insemination (just a 
biological site) have performed ART activities.  

 Data not available because the procurement site  authorizations  are not linked to the 
regulatory status of the final  product. (cell/tissues/ATMP)  

Inspections of the site/centre 
Analysis of the mandatory documentation 

170 

 
 
 
 
of Directive 2004/23/EC and its implementing 
Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, 
licensed) ? (more than 1 answer possible) 
2.4. Are you also responsible for the accreditation, 
designation, authorisation or licensing of 
laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this 
activity? 

2.5. How do you ensure, as CA for T&amp;C, that 
tests required for donors are carried out only by 
qualified laboratories accredited, designated, 
authorised or licensed Art. 5(2))? (more than 1 
answer possible) 
Please specify 'other': 

2.6. Please provide data on qualified laboratories 
accredited, authorised or licensed in your country 
(e.g. number, year of 
accreditation/authorisation/license, which donor 
tests are performed etc.). 
2.7. Do you have any additional comments on 
procurement? 

No 

In 2020, all the French laboratories must be fully accredited by the comité français 
d'accréditation (COFRAC), designed as the national accreditation body in France 
(2008 decree). 
Analysis of the mandatory documentation requested from the tissue establishment 
Other 

Only medical laboratories authorized by regional health competent authorities realize 
the donor qualification . 
We have about 200 accredited qualified laboratories but   It's impossible to provide 
precise data about the ones which perform donor testing : there are private or public  
laboratories  : some of them depend on hospitals (private and public), Some of them 
depend on blood transfusion establishments. Sometimes these establishments have 
agreements   with private accredited laboratories which carry out  the donor tests  
HSC donors procurement centres associated to the national registry are accredited by 
the WMDA. HLA labs performing HLA typing on donors and CB units are EFI 
accredited. Regarding ART, there are two separate processes : the first one is the legal 
framework of authorisation and inspection by the regional competent authorities for 
both clinical and biological activities, the second one is the legal accreditation process 
required for all the French laboratories and validated by Cofrac on all their activities 
including biological ART activities. About testing of gametes donors, the tests are not 
performed in the reproductive lab where the donors are recruited but by medical labs 
wich all are in the process of accreditation. 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for 
donors of non-reproductive tissues and cells in 
your Member State. (more than 1 answer possible) 

Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
HTLV-2 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
Nat testing is not mandatory for ART patients ; it is performed according to the 
medical context and the general recommendations. However for egg donation, NAT 
HIV is mandatory immediately before the collection of eggs as a second 
determination of the viral status of the donor. 

3.2. Please specify laboratory tests required for 
donors of reproductive tissues and cells in your 
Member State. (more than 1 answer possible) 

3.3. If NAT testing is not mandatory in your 
country, could you please indicate whether you 
intend to make it mandatory or to encourage its 
use? Please specify why or why not (e.g. number 
of additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the 
available tests and test procedures for deceased 
donors? 
3.5. Are any other laboratory tests required for 
donors of non-reproductive tissues and cells in 

No 

Yes 

171 

 
 
 
 
your Member State? 
3.5.1. Please specify. 
3.6. Are any other laboratory tests required for 
donors of reproductive tissues and cells in your 
Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation 
systems for testing laboratories? 
3.8. Do you have any additional comments on 
testing? 

For cells qualification : -cytomegalovirus virus '-Epstein -Barr -Toxoplasma gondii   
Yes 

Actually, required testing differs between ART couples or non partner donor. For 
ART couples (both male and female partners, even if gametes from donors are used) : 
Anti HIV1 and 2, Anti HCV, anti HBS, Anti HBC, Ag HBV and treponema pallidum. 
If necessary : Nat HCV, Nat HIV, or HTLV depending on the context and for women, 
Rubella and toxo For gamete donors, the same and in addition : Anti CMV and Nat 
HIV 
No 

no 

No 

Yes 

Yes 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
0 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, 
authorisation, accreditation or licensing for all 
types of tissue establishments under your 
responsability? 
4.2. Is inspection a prerequisite for the designation, 
authorisation, accreditation or licensing of tissue 
establishments? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 
answer possible) 
4.4. Following inspections/controls (Art. 6.4, 
Directive 2004/23/EC), how many 
authorisations/accreditation/licenses were 
suspended in 2011? 
4.5. Following inspections/controls (Art. 6.4, 
Directive 2004/23/EC), how many 
authorisations/accreditation/licenses were revoked 
in 2011? 
4.6. Do you require TEs to be certified by an 
external entity to a quality system standard (e.g. 
ISO, JACIE, FACT)? 
4.6.1. What is the relation between the indpendent 
certification(s) (e.g. ISO, JACIE, FACT) and the 
CA authorisation of the tissue establishments? 
(more than 1 answer possible) 
Please specify 'other': 

Optional, but TEs are encouraged to get a certification 
Other 

Yes 

1 

Cord blood unit must be USA IND qualified for the shipment (NMDP sponsor) 

Musculo-skeletal tissue establishments 

Musculo-skeletal tissue establishments 

2 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation 
pending approval at 01/01/2011 (more than 1 
answer possible): 
4.7.2. How many musculo-skeletal tissue 
establishments? 
4.8. Tissue establishments with authorisations 
pending approval by 31/12/2011 (more than 1 
answer possible): 
4.8.2. How many musculo-skeletal tissue 
establishments? 
4.9. Tissue establishments first time authorised 
between 01/01/2011 and 31/12/2011 (more than 1 
answer possible): 
4.9.2. How many musculo-skeletal tissue 
establishments? 
4.10. All tissue establishments authorised by 
31/12/2011 (more than 1 answer possible): 

1 

1 

Musculo-skeletal tissue establishments 

Skin tissue establishments 
Musculo-skeletal tissue establishments 

172 

 
 
 
 
 
 
4.10.1.1. How many public skin tissue 
establishments? 
4.10.1.2. How many private skin tissue 
establishments? 
4.10.2.1. How many public musculo-skeletal tissue 
establishments? 
4.10.2.2. How many private musculo-skeletal 
tissue establishments? 
4.10.3.1. How many public ocular tissue 
establishments? 
4.10.3.2. How many private ocular tissue 
establishments? 
4.10.4.1. How many public cardiovascular tissue 
establishments? 
4.10.4.2. How many private cardiovascular tissue 
establishments? 
4.10.5.1. How many public HSC tissue 
establishments? 
4.10.5.2. How many private HSC tissue 
establishments? 
4.10.6.1. How many public cord blood tissue 
establishments? 
4.10.6.2. How many private cord blood tissue 
establishments? 
4.10.7.1. How many public ART tissue 
establishments? 
4.10.7.2. How many private ART tissue 
establishments? 
4.10.8.1. How many public multi-tissue 
establishments? 
4.10.8.2. How many private multi-tissue 
establishments? 
4.11. How many tissues and cells were distributed 
under the direct agreement of the Competent 
Authority according to Art. 6(5) during 2011? 
Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the 
national provisions pursuant to the Directive been 
defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on 
accreditation, authorisation, designation and 
licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections 
and control measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of 
the CA in charge of inspections. 

Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
10 

0 

17 

7 

16 

1 

12 

1 

36 

2 

9 

0  

42 IVF centres  

62 IVF centres and 92 IUI labs  

16 

0 

1402 (bone marrow + PBSC + cord blood + lymphocytes) 

Yes 

No 
Actually, in the field of reproductive cells, 104 IVF centres and 92 IUI labs are 
authorised and had an ART activity in 2011.  Among the IUI labs, near 100% are 
private.  Among the IVF centres, it is about 40% which have a public status. Some of 
them have both status private and public (different status between the  clinical unit 
and the biological unit).  A legal provision set that only the public or if private, non 
profit establishments, are authorised to manage non parner donors. 

Yes 

   The CA in charge of inspection of TE (non reproductive tissues and cells) is ANSM. 
The division in charge of inspections is "INSBIO" (inspection of biological products). 
For ART, the regional agencies are in  charge of inspection. The ABM must publish a 
mandatory annual report on inspections performed by the regional agencies, according 

173 

 
 
 
 
 
 
5.1.2. If yes, please specify staffing (how many 
inspectors). 

5.2. Does the inspection scheme interact or overlap 
with the inspection scheme of other activities, for 
example blood, pharmaceuticals, etc. (e.g. same 
inspector team, common training, common 
documentation, etc.)? (more than 1 answer 
possible) 
5.2.1. If yes, please specify. (more than 1 answer 
possible) 
Please specify other. 

5.3. How many routine inspections of tissue 
establishments for non-reproductive tissues/cells 
were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues 
establishments for non-reproductive tissues/cells 
were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or 
reactions, or suspicion thereof ? 
5.3.2. How many other type of inspections of 
tissues establishments for non-reproductive 
tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number 
of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number 
of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number 
of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number 
of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number 
of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number 
of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted 
in ART establishments (from 1/1/2011 to 
31/12/2011)? 

to their inspection reports they send to ABM. 
4 inspectors in ANSM. Regarding ART, there are 22 regional agencies with at least 2 
inspectors trained in ART per agency in order to inspect every two years all the ART 
centres. 
Yes 

Others 

Common trainings about the general inspection practises, the frame of the inspection 
report , the common inspection procedures ,the graduation of the  shortcomings based 
on a risk approach  etc.... 
27 

0 

0 

0 

27 

8 

0 

0 

0 

32 

174 

 
 
5.4.1. How many inspections were conducted in 
ART establishments following serious adverse 
events or reactions, or suspicion thereof (from 
1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were 
conducted on ART establishments (from 1/1/2011 
to 31/12/2011) (e.g. due to a whistle-blower)? 
Please specify. 
5.4.3. Outcome of inspections of ART tissue 
establishments carried out in 2011 (01/01/2011 to 
31/12/2011): What was the number of inspections 
carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried 
out in ART establishments where minor 
shortcomings were noted? 
5.4.5. What was the number of inspections carried 
out in ART establishments where major 
shortcomings were noted? 
5.4.6. What was the number of inspections carried 
out in ART establishments followed by suspension 
of authorisation? 
5.4.7. What was the number of inspections carried 
out in ART establishments followed by closure of 
respective establishements? 
5.4.8. What was the number of other inspections of 
ART establishments? Please specify. 
5.5. Which type of routine inspections do you 
conduct? (more than 1 answer possible) 

5.6. How do you decide which type of routine 
inspection to conduct? 

5.7. Until 2011, did you implement the requirement 
concerning the time interval between two 
inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice 
between 2008-2011 (01/01/2008-31/12/2011)? 

5.9. Did you perform/conduct inspections of 
procurement sites outside tissue establishments? 
5.9.2. If no, why not? 

1 

0 

0 

32 

32 

0 

0 

0 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 
The type of routine inspection is decided according a risk based inspection 
programme. Regarding ART, routine inspections are planned every two years 
according to a national inspection programm. However the lack of ressources leads to 
real difficulties to respect the interval of two  years between two inspections.  
Yes 

In the field of reproductive cells the TEs inspected twice were TEs with major 
shortcomings.   14 TEs were inspected twice. The total number of inspections was 
163. 
No 

The agences régionales de santé (ARS) are in charge of the inspection of the 
procurement establishments. ANSM, time to time, inspect procurement 
establishments when there is doubt about the  quality and safety of the products. 
Regarding ART, centers carry out both procurement and clinical applications of 
gametes and embryos. The regional agencies must inspect the ART centres for  both 
clinical and biological activities. 

                                It depends on the kind of implemented process of tissues and cells                                         
No 

5.10. Did you carry out inspections of third parties?  Yes 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational 
Manual for Competent Authorities on inspection of 
tissue and cell procurement and tissue 
establishments - Guidelines for inspections 
(Commission Decision 2010/453/EU)? 
5.11.1. If no, which guidelines/regulations are used 
for inspections at national level? 

5.11.2. If no, please provide a hyperlink to these 

For inspections ,we use the national good tissues and cells practices (the 27th october 
2010 ANSM decision), ISO norms, GMP, aide memoire , decree and ministerial 
orders. Regarding ART, routine inspections are based on the control of the 
compliance with the regulations in force in France and particularly with the rules of 
ART good practices  in ART (published by decree in 2010). A large place is given to 
traceability.A national guide is available for inspection in ART. 
http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000023086655. 

175 

 
 
guidelines/inspections. 

5.12. Did you send any of your inspectors to the 
training courses organised by EU-funded projects 
(e.g. EUSTITE, SOHO V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness 
and efficacy of these training courses on a scale 
from 1 to 5 (1 = not important, 2 = sufficient, 3 = 
good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a 
tissue establishment in another MS in collaboration 
with the NCA in that MS (Art 7(6))? 
5.13.1. Could you please explain why? 

5.14. Did you receive/organise an inspection of a 
tissue establishment in your country at the request 
of another MS in collaboration with the NCA in 
that MS (Art 7(6))? 
5.15. Did you organise any inspections of 
procurement centres or tissue establishments in 
third countries from which tissues and/or cells 
were imported in your country (as recorded by 
31/12/2011)? 
5.15.1. If yes, please specify why. 

5.16. Have you asked another MS, or have you 
been requested by any other MS, on the results and 
control measures of your inspections, as part of an 
enquiry/investigation? 
5.16.1. If yes, please specify. 
5.17. Would you be interested in developing joint 
inspections? Joint inspections should be 
understood as inspections of tissue establishments 
conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third 
countries. 
5.18. Do you have any additional comments on 
inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue 
establishments that are explicitly authorised to 
perform import/export of tissues and celles from/to 
third countries? 
6.2. Please specify the number of tissue 
establishments authorised to import tissues and 
cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue 
establishments authorised to export tissues and 
cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in 
place for verifying the equivalent standards of 
quality and safety for importation of skin from 
third countries. 

6.5. Please specify which procedures you have in 

Good practices in ART : 
http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000022809674&
dateTexte=&categorieLien=id  National guide for ART centres inspection : 
http:/www.agence-biomedecine.fr/Referentiel-inspection-AMP 
Yes 

5 

Yes 

In some cases , French national CAs needs to know the accuracy of the data provided 
by the MS,  suppliers (distributors) of tissues and cells. 
No 

Yes 

In some cases , the French national CAs needs to know the accuracy of the data 
provided by the procurement establishment or provided by the tissue establishments,  
importer of tissues and cells 
Yes 

Some European member states (poland, Danemark, Portugal, Estonia, etc) 
Yes 

There is a need of organizing a legal framework in the field of joint inspections 
especially when tissues and cells are imported within EU countries.  

Yes 

tissues:1 ; HSC: all  the 36 HSC centers           

  tissues :5; HSC :all the 36 centres,         

1. through the import/export authorisation procedure where the CA authorizes the 
product based on the assessment of the data provided by the importer in the dossier 
submitted to the CA 2. through the documents accompanying each import and sent to 
the importing TE ; 3. through inspections of the supliers of tissues and cells in third 
countries. Currently no product authorization has been granted for this type of tissues 
imported from a third country . 
the same as 6.4 Currently no product authorization has been granted for this type of 

176 

 
 
 
 
place for verifying the equivalent standards of 
quality and safety for importation of musculo-
skeletal (bone, tendons, fascia etc.) tissues from 
third countries. 
6.6. Please specify which procedures you have in 
place for verifying the equivalent standards of 
quality and safety for importation of ophtalmic 
(cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in 
place for verifying the equivalent standards of 
quality and safety for importation of cardio 
vascular tissues from third countries. 
6.8. Please specify which procedures you have in 
place for verifying the equivalent standards of 
quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord 
blood) from third countries. 
6.9. Please specify which procedures you have in 
place for verifying the equivalent standards of 
quality and safety for importation of cord blood 
from third countries. 
6.10. Please specify which procedures you have in 
place for verifying the equivalent standards of 
quality and safety for importation of reproductive 
cells (sperm, egg cells) from third countries. 

6.11. Did you import tissues/cells from 3rd 
countries during 2011 (01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning 
the number/volume of imported tissues and cells 
by country of origin. 
6.12. Did you export tissues/cells from 3rd 
countries during 2011 (01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning 
the number/volume of exported tissues and cells by 
country of destination. 
6.13. Are you aware of any significant changes in 
2012 which may invalidate the 2011 data on 
imports/exports of tissues/cells between your 
country and other third countries? 
6.14. What is the relation between import/export of 
tissues and cells and self-sufficiency? (more than 1 
answer possible) 
Please specify 'other': 

6.15. Did you authorise direct imports of 
tissues/cells to hospitals/clinics in your country? 
6.16. Do you have any additional comments on 
import/export? 

tissues imported from a third country . 

the same as 6.4 Currently no product authorization has been granted for this type of 
tissues imported from a third country . 

the same as 6.4 Currently no product authorization has been granted for this type of 
tissues imported from a third country . 

 through the import/export authorization procedure where the CA authorizes the 
product based on the assessment of the data provided by the importer in the dossier 
submitted to the CA. An authorization is granted on a case by case basis for this type 
of cells..   

the same as 6.8  

Import of reproductive cells in France from third country or EU MS must be 
individually authorised by the ABM. A specific file with available data on the 
conditions of the procurement, donation, testing,etc is submitted to ABM by the 
French ART centre requesting an authorization. ABM makes its decision on a case by 
case basis depending on the data provided and the respect of French legal and ethical 
principles during the whole process. 
Yes 

tissue : 0 ; HSC = 283 ; Reproductive cells = 4. the data per country of origin are not 
available. 

Yes 

     tissues = 0  ; HSC = 64    Reproductive cells = 7  ( the data per countries of 
destination are not available)    

No 

F. Other 

No tissues are imported from  a third country  - imported cells are  based on HLA 
compatibility. 
No 

In the field of HSC, import and export are necessary to comply with the medical need 
for matching between donor and recipient. 75% of HSC are imported in France.  
Direct import by hospital or clinics are not allowed in France. 

Yes 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of 
tissues and cells? 
7.1.1. If yes, how do you address the possible more 
stringent quality and safety measures established 
by other Member States? Please specify. 
7.1.2. If yes, do you have more stringent quality 
and safety measures than in other Member States? 
7.1.2.1. How do you address this difference for 
tissues and cells coming from a MS with minimum 

The problem is that when a 6.2 authorisation is granted by another Member-state we 
don't know how they have performed  their assessment ,which were their safety 
criteria....... In the field of HSC, international registries follow WMDA standards. 
Yes 

Based on the european directive, member states need to recognize authorization 
granted by the other member states. 

177 

 
 
 
 
quality requirements? Please specify. 
7.2. How do you ensure that tissues establishments 
fulfil the requirements of Art. 23 of Directive 
2004/23/EC regarding quality of tissues and cells 
during distribution? Please specify. 
7.3. Do you allow direct distribution to 
hospitals/clinics in your MS from TEs in another 
MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the 
recipient of specific tissues and cells (Art. 6, 
Directive 2006/17/EC)? 
7.4.1. If yes, how many authorisations were given 
in 2011 (01/01/2011 to 31/12/2011)? 
7.4.2. If yes, for which tissues/cells? 

7.5. Do you collect data regarding the cross-border 
exchange of tissue/cells between your country and 
other EU MS? 
7.5.1. Please provide us with data (country of 
destination, type of tissue/cell and number of units 
distributed) concerning distribution to other MS in 
2011 (01/01/2011-31/12/2011). 

7.5.2. Please provide us with data (country of 
origin, type of tissue/cell and number of units 
distributed) concerning distribution to other MS in 
2011 (01/01/2011-31/12/2011) 

7.6. Are you aware of any significant changes in 
2012 which may invalidate the 2011 data on cross-
border exchanges of tissues/cells between your 
country and other EU MS? 
7.7. Do you allow brokerage companies for either 
distribution in EU and/or import/export of 
tissues/cells? In this context, a brokerage company 
means a body that arranges transactions between a 
supplier (tissue establishment/company selling 
tissues or cells) and a buyer (a tissue 
establishment/a hospital or clinic/an individual) 
without undertaking activities of processing, 
preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on 
distribution? 

-through the evaluation of the file of the TE authorization submitted to the NCAs and 
which contains data about distribution such as the requirements to provide a 
description of the organization set up to ensure the distribution ; - also through 
inspections on site carried out on the basis of the good tissues and cell practices.  
No 

Yes 

For HSC = 607  ;  For reproductive cells = 49 

HSC = Bone marrow, PBSC, cord blood and lympho  ;  Reproductive cells = gametes, 
embryos. 
Yes 

-  for tissues (skin ,bones ,vessels etc...) : 1643 distributions to others MS. - For HSC, 
see EBMT:  exchanges within the UE or the world according to the needs of 
matching. - For reproductive cells, the main part of exchange is represented by export 
of cryopreserved sperm to Spain, in order to obtain an ART with donated eggs. We 
know that this represents a very  small part of the patients who travel abroad for egg 
donation.  
-    For tissues (skin ,bones ,vessels etc...) : 4480 distributions from others MS  -    For 
HSC, see EBMT. Exchanges within the UE or the world according to the needs of 
matching.   -  in 9 cases, autorizations are given by ABM for import gametes from a 
EU MS, probably because of the legal restrictions about embryo transfers in 
Switzerland and Germany. In other few cases,  authorisations are given because 
patients intend to move while gametes or embryos are cryopreserved.     
No 

No 

No 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template 
on the activities of tissue establishments in your 
Member State? (Article 10(1)). If yes, please 
upload the template. 
8.1.1. If no, why not? 
8.2. How many tissue establishments submitted 
annual reports of their activities during 2011. 
Please provide an estimation. (1 answer possible) 
8.3. Are these reports publicly available? (Article 
10(1)) 
8.4. Do you publish a national annual report of the 
consolidated activities of all tissue establishments 
in your country? 

in progress. 
100% (all) 

Yes 

No 

178 

 
 
  
 
 
8.4.1. Please insert the link to the published 
national annual report. 

8.5. Is there a publicly accessible register of 
authorised tissue establishements in place? (Article 
10(2)) 
8.5.1. If yes, please provide us with the link to the 
register's web site. 

8.6. Do you provide data regarding tissues and 
cells activities to the EUROCET registry (non-
mandatory reporting)? 
8.6.1. If yes, what data are provided to 
EUROCET? Please specify. 

8.7. Do you have any additional comments on 
reporting? 

http://ansm.sante.fr/var/ansm_site/storage/original/application/79a989c66ec609a6c7a
60db3464f9636.pd  ;    http : //www.agence.biomedecine.fr/AMP   ; http : 
//www.agence.biomedecine.fr/CSH    
Yes 

http://ansm.sante.fr/var/ansm_site/storage/original/application/b9b896c06d836783486
5273951775d4b.pdf   ;  http : //www.agence.biomedecine.fr/Autorisation-des-centres  
;    http : //www.agence.biomedecine.fr/Les-etablissements-autorises.73 
Yes 

Data about tissues and cells etablishment activities, about the processed products and 
about the  authorised ART centers and activities performed, activities and results 
(pregnancies, children...) in partner and non partner donation. 

Yes 

Tissue establishment 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) 
implemented in your country? 
9.2. Who assigns the unique code for each 
donation? (only 1 answer possible) 
9.3. How is the data storage for traceability 
purposes organised in your tissue establishements 
(Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data 
storage requirement is respected (Directive 
2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on 
traceability? 

Both paper records and electronic forms 

by inspections Only electronic files in HSC centres and national registry in ABM 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in 
place (for the reporting of serious adverse events 
and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of 
its organisation. 

10.2. Annual reporting (Article 6.4, Dir. 
2006/86/EC). Do you use the SAR/E (to the CA 
(2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are 
welcome to upload the template if you wish. 

ABM is leading the Assisted Reproductive Techniques (ART)  vigilance system, in 
relation with ANSM  -  ANSM for biovigilance  (including organs, tissues and cells) 
in relation with ABM 
In tissues and cells field other than reproductive At the top of the system there's the 
ANSM which coordinates the actions of the stakeholders who play a part in the 
biovigilance system. ANSM receives all the notifications of adverse  events/reactions 
and takes the adequate safety measures. Then, in each public or private tissues or cells 
establishment, there is a local biovigilant correspondent who sends the dedicated form 
of  adverse events/reactions to the ANSM.An assessment is performed for each report 
by the local biovigilant,the ANSM assessors in link with the Agence de la 
biomedecine.Based on the  findings,corrective actions are implemented locally or 
nationally.       The ART VS is organised according to 2 levels : - National level : 
Agence de la biomedecine × Leads the national ART VS × Designs methods and tools 
(documents, grading scale, I.S. etc.) × Collects adverse event and reactions (AER) × 
Analyses AER × Coordinates investigation and monitor corrective measures × 
Implements national guidelines × Reports to Ministry of Health and professionals × 
Coordinates nationally with other VS - Local level : ART clinical centers and lab × 
Identify a local correspondent for ART VS (mandatory) × ART professionals inform 
the CLA of AER × The CLAs  notify the ABM and coordinates locally with other VS  
No 

The principles included in the common Approach Document developed for the 
Annual reporting to the EC  were already in place in the french proceedings. No, 
ABM does not use the SAR/E templates developped by EC since it is not really 
appropriate for reproductive cells and embryos 

179 

 
 
  
 
 
  
 
 
10.3. Do you use the Common Approach 
Document developed for the Annual reporting to 
the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in 
charge of collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 
2011 the SAR/SAE data as requested (please 
provide the % from the total number of TEs 
authorised in your country). 
10.6. Do you have a mandatory procedure for the 
transplantation centres when reporting SAR/SAE 
to the TEs which distributed the tissues/cells (Art 
11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding 
SAR/SAE recorded at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding 
SAR/SAE recorded at EU level? 
10.8.1. Please specify. 
10.9. Do you require your TEs to have a recall 
procedure? 
10.10. How many recalls related to safety and 
quality of tissues/cells were issued in your country 
in 2011? Please specify the number and which 
tissues were recalled and why (e.g. missing 
consent, quality defects etc). 
10.11. Do you have in place a system/procedure to 
notify Tissue Establishments and procurement sites 
in case of a national rapid alert? 
10.11.1. If yes, please give a short description of 
the system/procedure. 

10.12. Do you have in place a system/procedure to 
notify Tissue Establishments and procurement sites 
when a rapid alert is issued via the EU RATC 
platform? 
10.12.1. If yes, please give a short description of 
the system/procedure. 

10.13. Do you provide data regarding SAR/SAE to 
the EUROCET registry (non-mandatory 
reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via 
these tissues and cells national vigilance system 
also to other national vigilance/alert systems? 
10.14.1. If yes, please specify which of the 
following systems are usually contacted. (more 
than 1 answer possible) 

Please specify 'other'. 
10.15. Did you send a vigilance officer/contact 
point to the trainings organised by the EU-funded 
project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness 

Yes 

Yes 

100% 

Yes 

http://ansm.sante.fr/var/ansm  
site/storage/original/application/bcef203df79ae53c65ff2277f9bc52f5.pdf In each ART 
center, the local ART vigilance correspondant notifies the SARE using a specific 
form. Information related to SARE collected are defined by law. 
Yes 

Only if the SAR/SAE could impact their own activities. 
Yes 

Only if the SAR/SAE could impact their own activities. 
Yes 

see annual biovigilance report (www.ansm.sante.fr) 

Yes 

All procurements sites and TE must designate a local biovigilance correspondant and 
both state their coordinates (mail and fax). In case of alert, one is sent by mailing list 
and depending on its  severity, coupled with a fax. In the field of ART, any alert could 
be communicated through a specific and secure I.S. 
Yes 

All procurements sites and TE must designate a local biovigilance correspondant and 
both state their coordinates (mail and fax). In case of alert, one is sent by mailing list 
and depending on its  severity, coupled with a fax. In the field of ART, any alert could 
be communicated through a specific and secure I.S. 
No 

.. 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Other 
nosocomial infection surveillance 
Yes 

4 

180 

 
 
and efficacy of these trainings on a scale from 1 
(insufficient) - 2 (sufficient)  3 (good) - 4 (very 
good) to 5 (essential)? 
10.16. Do you have any additional comments on 
SARE reporting? 

In France not only severe SARE are collected but also SARE. The national ART VS 
requires also to notify all AR related to ART activities not only those related to the 
quality of reproductive cells. We  consider the notification templates presented in the 
tools I the 2006/86 EUTCD is not appropriate for ART 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell 
donation do you have in place within your Member 
State? 
11.1.1. Please specify your choice of consent 
system for living tissue/cell donation. 

Explicit consent (opt-in) 

11.2. What consent system for deceased tissue/cell 
donation do you have in place within your Member 
State? 
11.3. According to your national legislation, in 
case of deceased donations, please specify who is 
giving the authorisation for the tissue donation? 
(more than 1 answer possible) 
11.4. Is the consent system for deceased tissue 
donation the same as for organs? 
11.5. How is this consent verified during 
inspections? (more than 1 answer possible) 

11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of 
donors are provided with the appropriate 
information, as requested by Art. 13(2)? (more 
than 1 answer possible) 
11.7. What measures are in place to ensure that 
both donors and recipients remain unidentifiable 
when access is given to third parties (Art. 14(1)). 
Please specify. 
11.8. Please specify what measures are in place to 
ensure that the identity of the receipient is not 
disclosed to the donor and vice versa. 

11.9. Does your national legislation allows 
disclosure of donor data in case of gametes 
donation? 
11.9.1. If no, please specify the circumstances and 
measures in place. 

It is a legal requirement for donation of soho. We think that it's the best way to 
guarantee the donor's freedom and will  because the condition of this consent is a clear 
information provided  to  the donor,particualrly regarding all the medical 
consequences of his donation. 
Presumed consent (opt-out) 

No further authorisation is needed 

Yes 

Analysis of documentation 
Interviews with personnel 
Interviews with relatives of deceased donors 
Only trained personnel is allowed to provide such information 

It's a principle set in the French bioethical Law: the article L.1211-5  (code de la santé 
publique) lays down that "no information allowing to identify at the same time the one 
who donated an element or a product of his body and the one who received it cannot 
be revealed". 
there are two measures : 1) the first one mentionned above lays down that no 
information allowing to identify at the same time the one who donated an element or a 
product of its body and the one who received it cannot be revealed". 2) the second one 
is mentionned in the article R.1211-19 of the french health code (code de la santé 
publique) which states that "traceability is ensured by a codification which is also uses 
to guarantee the anonymity of the two persons involved in a procurement and a 
transplantation. 
No 

An anonymous code is allocated as the donor is recruited at the ART center level and 
this code will be kept during the whole procedure untill gametes are distributed. No 
information concerning  the donor (position, hobbies etc...) is given to the recipients 
in order to avoid to reveal potentially identifying data. Staff dealing with recruitement 
of donors are specifically trained. Registries of  donors and donations are strictly kept 
at a local level and have validated protection against intrusion and are controlled by 
the CNIL and during inspections. 

11.10. Do you have any additional comments on 
consent and data protection? 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements 
related to the evaluation and selection of donors 
(except donors of reproductive cells) are respected 
in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 

Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 

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Standardised questionnaires at national level 
Inspections of ART centres 
Audit documentation 

No 

Interview with the donor's family or a person who knew the donor well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation centre, ART centre) 
Audit of the centre of human application 

12.2. How do you ensure that all requirements 
related to the evaluation and selection of donors of 
reproductive cells are respected in your country 
(Art 15 (1), Annex III of Directive 2006/17/EC)? 
(more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor 
selection than those listed in Annex I of the 
Directive 2006/17/EC? 
12.4. What sources are required in your MS for the 
evaluation of a deceased donor of tissues/cells? 
(more than 1 answer possible) 

12.5. Do you have more stringent criteria for 
selection of donors of reproductive cells than those 
listed in Annex III of the Directive 2006/17/EC? 
12.6. Do you have more stringent criteria for 
autologous donation than those listed in Annex I of 
the Directive 2006/17/EC? 
12.7. Do you require more information on the 
donation of tissues/cells than the mandatory one as 
laid down in the Annex of Directive 2004/23/EC 
(Art 15(3)? 
12.8. How do you ensure that all requirements 
regarding tissues and cells' procurement, packaging 
and transport are complied with by tissue 
establishments in your country (Art 15(1), Annex 
IV of Directive 2006/17/EC? (more than 1 answer 
possible)(For this question "audit" means a 
documented review of procedures, records, 
personnel functions, equipment, materials, 
facilities, and/or vendors in order to evaluate 
adherence to the written SOP, standards or 
governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance 
for the Transplantation of Organs, Tissues and 
Cells, 2011)) 
12.9. Do you have any additional comments on 
selection, evaluation and procurement? 

Authorisation requirement 
Inspections 
Internal audits 
External audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments 
in your country have in place a quality system 
respecting the provisions of the Directive 
2004/23/EC Art 16.1? (more than 1 answer 
possible). (For this question "audit" means a 
documented review of procedures, records, 
personnel functions, equipment, materials, 
facilities, and/or vendors in order to evaluate 
adherence to the written SOP, standards or 
governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance 
for the Transplantation of Organs, Tissues and 
Cells, 2011)). 
13.2. How do you ensure that tissue establishments 
have a responsible person fulfilling the 
requirements of Art. 17(1)? (more than 1 answer 
possible) 
13.3. How do you ensure an appropriate training 
for the personnel directly involved in the activities 
of tissue establishments? (more than 1 answer 
possible) 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 

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13.4. Do you have national/regional/local training 
programmes for the personnel of tissue 
establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality 
management, responsible person, personnel? 

Yes 

ABM organizes different trainings for health professionals  working in the fields of 
organs, tissues and HSC procurement and transplantation .It has experimented this 
year a learning management  system. It also organises different trainings on quality 
management, legal and ethical aspects in ART or also for midwives involved in ART 
activities.  The programs are available on the website of ABM.  Moreover ABM 
proposes  several annual meetings for the different kinds of health professionals  
working  in organs, tissues and HSC  procurement and transplantation and in ART(for 
example the   annual meeting of the correspondents in ART vigilance during the 
national congress in ART).       

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments 
in your country fulfill the requirments of the Art. 
19 (Tissue and cell reception) of Directive 
2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.2. How do you ensure that tissue establishments 
in your country fulfill the requirements of the Art. 
20 (Tissue and cell processing) of Directive 
2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments 
in your country fulfill the requirements of Art. 21 
(tissue and cell storage conditions) of Directive 
2004/23/EC? (more than 1 answer possible) 

SOPs for all processes affecting quality and safety are mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with storage of tissues and cells are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with labelling and packaging  are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 
All the questions are related to the presence of procedures and not on their contents, 
what is assessed regarding the quality of the tissues and cells procured, processed and 
controlled. 

14.4. How do you ensure that tissue establishments 
in your country fulfill the requirements of Art. 22 
(labelling, documentation and packaging) of 
Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, 
processing, storage, labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed 
in your national legislation? 
15.1.1. If yes, have tissue establishments in your 
Member State notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 

Yes 

Yes 

15.1.1.2. How are third party agreements 
controlled (Art 6.2) by the Competent 
Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party 
agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent 
quality and safety requirements than those 
requested by the EU legislation in this field (e.g. 
restrictions concerning the donation/use of certain 
tissues/cells, mandatory unpaid donation etc.)? 
16.1.1. Please specify. 

When third parties provide good or services which might have an impact on the 
quality and safety of the products.The agreement clearely states the responsabilities  
of each part of the agreement and particularly it describes the tasks entrusted with the 
third party and the way it has to carry out them . 
 At the beginning through the dossier submitted for the authorization of tissue 
establishment and after that through inspections. 

HSC centres have an agreement with FDA. ABM has an agreement with a transport 
company for CB unit shipments. 

Yes 

Because quality and safety are directly linked with the conditions of recrutment of 
donors, the French law set ethical provisions. Among them : -  the recruitment of 
donors must be managed through a non profit organisation which can evaluate the 

183 

 
 
  
 
 
 
 
 
 
16.2. Has your Member State encountered any 
difficulties in implementing the requirements in the 
EU Tissues and Cells Directives? Please choose 
from the options below. 

16.2.1. For all selected options in question 16.2., 
please provide a short description. 

16.3. In your opinion, in which of the following 
Directives are there shortcomings (if any)? (more 
than 1 answer possible) 
16.3.1. How would you suggest to solve these 
issues in Directive 2004/23/EC? 

16.3.2. How would you suggest to solve these 
issues in Directive 2006/17/EC? 
16.3.3. How would you suggest to solve these 
issues in Directive 2006/86/EC? 

needs at a national level and organize on a non-profit basis the promotion and the  
evaluation of the donors;   - payment of donors for donation is totally forbidden.  - 
except in the cases of duly justified therapeutic interest, donation is anonymus and it's 
done for all the patients who need a transpalntation : for this reason the private 
autologous cord blood  banks are not authorized in France Key principles should be 
reasserted at the UE level: the products of the human body should not be a source of 
financial gain. Some compensation practices relate to payment and leads to ethical  
abuses. 
ART provisions 
Testing provisions 
Import-export 
Vigilance 
Inspections 
Terminology not appropriate for the field of reproductive cells. Difficulties to strictly 
apply the periodicity of two years between two inspections of the same ART center. 
The French system of ART vigilance takes care of women exposed to complications 
of ovarian hyperstimulation and surgical collection of eggs which are not taken into 
account in the European  system as they don't have consequences on the quality of 
reproductives cells.   D.2006-17 : the requirements for testing have to be revised for 
both partner and non partner donations (genetics and virological testing) D 2006-86 : 
the requirements about quality of air in the facilities should be discussed in the context 
of ART (class D classification cannot be applied for ART field due to some processes 
contrainst)   
Directive 2004/23/EC 
Directive 2006/17/EC 
Directive 2006/86/EC 
 1) In  the tissues and cells field  There is a need :  - to extend the scope of the 
directive to the tissues and cells collected and transplanted back to the same patient, 
within the same surgical procedure, after being subject to a manipulation at   the 
surgical unit or in the patient’s room so that the cells or tissues are not intended to be 
used for the same essential function; -to clarify  the legal status of the dehydrated 
human placenta and the status of certain products for which it's difficult to determine 
which is the relevant legal field ( directive 2004/23 ; medical device directives ; 
ATMP regulation ) -to extend the scope of the inspection organized, at the request of 
the competent authorities of another member-state whenever there are grounds for 
suspecting non compliance with the  principles of the directive; - to add a provision 
which excludes a competent authority which is as the same time a tissue establishment 
; -to change the frequency of the inspection of tissue establishment  (between two 
inspections the intervall should not exceed 3 years (instead of two years)  -to 
harmonize the  process  assesment for tissues and cells to avoid as much as possible 
the differences on the quality of the tissues and cells prepared in the different 
meember-states via a  standardized format of dossier and via guidelines -to develop 
rules and guidelines applying to ATMP with hospital exemptions -to apply the 
international santards (FACT,JACIE,AABB) in all cord blood banks 
(private/public,autologous/allogenic)  2) In the field of ART threis a need to foresee a 
specific technical directive for reproductive tissues and cells . 
 - the requirements for testing have to be revised for both partner and non partner 
donations (genetics and virological testing)   
- In order to guarantee the harmfulness and the therapeutic efficiency of the tissues 
and cells ,by providing that in certain cases the CA can require the implementation of 
clinicals trials for new tissues and cells products results.   - the requirements about 
quality of air in the facilities should be discussed in the context of ART (class D 
classification cannot be applied for ART field due to some processes contrainst) -   to 
harmonize the  process  assesment for tissues and cells to avoid as much as possible 
the differences on the quality of the tissues and cells prepared in the different 
meember-states via a  standardized format of dossier and via guidelines      

184 

 
 
 
 
A.1.11. 

Survey response Germany 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

Paul-Ehrlich-Institut,  Bundesinstitut für Impfstoffe und 
biomedizinische Arzneimittel 
Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany  
+49 6103 77 0 
pei@pei.de 
www.pei.de 
Non-reproductive tissues and cells 
Blood and blood components 
Pharmaceuticals 
Other 
Other biomedicinal products such as sera, vaccines, allergens, 
advanced therapy medicinal products and xenogenic medicinal 
products 
Inspection 
Vigilance 
Other 
Marketing authorisation of tissue products and their vigilance 
including tissue vigilance inspections 
No 
The Paul-Ehrlich-Institut is the “Federal Institute for Vaccines and 
Biomedicines”, thus a higher competent authority of the Federal 
Republic of Germany. It reports to the “Bundesministerium für 
Gesundheit” (Federal Ministry of Health). The Paul-Ehrlich-Institut 
is the National Competent Authority for Tissues and Cells. Most of 
its activities relate to the various duties laid down in German and 
European medicinal product legislation, such as for example the 
approval of clinical trials and the marketing authorization of 
particular groups of medicinal products. The legal responsibilities of 
the Paul-Ehrlich-Institut relate to biological medicinal products such 
as vaccines for humans and animals, medicinal products containing 
antibodies, allergens used for therapy and in diagnostics, plasma-
derived medicinal products and medicinal products for gene therapy, 
somatic cell therapy and xenogeneic cell therapy, i.e. for processes 
in the latest forms of biomedical treatment. Product responsibilities 
extend to blood and blood products for transfusion medicine and as 
well as tissue and cell products. The Paul-Ehrlich-Institut´s 
organization entails 7 product-related divisions performing research 
and regulatory activities. The division “Safety of Medicinal Products 
and Medical Devices” performs tasks related to pharmacovigialnce, 
hemovigilance and tissue vigilance. The sections “EU-
Cooperation/Biological Medicinal Products”, “Legal Affairs”, 
“Clinical Trials”, “Microbial Safety”, “Viral Safety” and 
“Biostatistics”, for example, provide support for assessment and 
regulation of all vaccines and biomedicines. The division 
“Administration” provides administrative support. For further details 
see the Annual Report of the Paul-Ehrlich-Institut 
(http://www.pei.de/DE/institut/jahresberichte/jahresberichte-
node.html). As a public body, the Paul-Ehrlich-Institut is subject to 
the principles of national budget law (laid down mainly in the 
Constitution), a number of other relevant laws, and the Annual 
Budget Act. The Paul-Ehrlich-Institut receives an annual budget 
from the government that is not affected by the amount of collected 
fees. The Paul-Ehrlich-Institut´s budget and finance plan are divided 
into types of expenditure for personnel expenses, tangible expenses 
(including expenses for consumables, facility management, staff 
training, travels etc.) and investment expenses. For further details 

185 

 
 
 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 

Please specify 'other': 

1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 

see the Annual Report of the Paul-Ehrlich-Institut 
(http://www.pei.de/DE/institut/jahresberichte/jahresberichte-
node.html).   
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
The Regional Competent Authorities in the German Länder are 
basically entrusted with the task of supervising and continuously 
monitoring the compliance with legal provisions. For this purpose, 
they grant authorisations.  
There is a splitted competence between the National Competent 
Authority (PEI) and the Regional Competent Authorities of the 
Länder. Generally spoken, the Regional Competent Authorities are 
responsible for activities in matters of Article 5 and 6 of the 
Directive 2004/23/EC well as for granting import authorizations, 
Article 9 of the Directive 2004/23/EC. Furthermore, it is their 
regional responsibility to continuously monitor the compliance with 
legal provisions. In case of noncompliance, they also have the power 
to impose penalties/sanctions. The PEI is responsible for the 
marketing authorisation of tissue products as well as for the 
fulfilment of pharmacovigilance duties . Both, the Regional 
Competent Authorities and the PEI work together, e.g. in the field of 
inspections.  The German Federal Government as well as the Paul-
Ehrlich-Institut have no authority to issue directives opposite the 
Länder.  For further information regarding the Regional Competent 
Authorities of the Länder see annex.  

Yes 
By inspecting all procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
226 

345 

983 

208 

234 

Inspections of the site/centre 
Analysis of the mandatory documentation 

Yes 

207   In Germany, the Regional Competent Authorities are 
responsible for this authorisation. 
Inspections of the laboratories 
Analysis of the mandatory documentation requested from the tissue 
establishment 

186 

 
 
 
 
possible) 
Please specify 'other': 

2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 

2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.4.1. Please specify why: 

3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 

Other 
Authorisation of the laboratories  by inspection of the laboratories 
and analysis of the mandatory documentation in the laboratories. 
173   The performed donor tests in the qualified laboratories depend 
on the scope of the authorisation. Most of the laboratories provide 
the following tests:  HIV1, HIV2 (including NAT-tests), Hepatitis B, 
Hepatitis C (including NAT-tests), HTLV-1/2, Treponema pallidum, 
Chlamydien.  Laboratories also provide the subsequent mentioned 
tests: - Hepatitis A  - CMV (including NAT-test) - Epstein-Barr-
Virus - Toxoplasma - Malaria - Rubella - Trypanosoma cruzi  - 
Parvovirus B 19 (including NAT-test) - Gonorrhoea (including 
NAT-test) - RV - VZV - HSV (including NAT-test) - Measles 
(including NAT-test) - RhD - HLA-typing - blood-typing 
No. 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
NAT testing is not mandatory by German law, however, it is an 
additional requirement imposed by the national competent authority. 
According to current scientific knowledge viruses can be transmitted 
by cardiovascular and highly blood supplied tissues (e.g. HBV and 
HCV). Therefore, the competent authority PEI requires in addition 
to serological testing and as a further safety measure HIV-, HBV-, 
and HCV-NAT for deceased donors (exceptions for cornea and skin) 
. Since for cardiovascular and highly blood contaminated tissues 
effective virus inactivation is not possible (preservation of tissue 
morphology necessary) the advantage of NAT is apparent (reduction 
of diagnostic window period). 
Yes 

All assay systems intended to be used for the detection of infections 
with HIV, HCV and HBV used in the European Union have to 
comply with the requirements of Directive 98/79/EC and with the 
Common Technical Specifications (CTS). The CTS require 
investigations on the sensitivity and specificity of the assays which 
are fulfilled for all devices bearing the CE-mark. These 
investigations are to be carried out using serum and plasma. In 
general, the CE-marked assays are not validated for the use of 
cadaveric specimens. After death, rapid changes due to autolysis, 
haemolysis, bacterial growths etc. occur in the blood specimens. The 
latter complicate the determination of infection markers and may 
eventually lead to unspecific reactions and, as a consequence, to 
false-positive results or to loss of reactivity and false-negative 
results. In addition, the pre-mortal administration of blood and blood 
products may lead to significant dilution effects of the blood which 
could also diminish sensitivity. Therefore, the Paul-Ehrlich-Institut 
as competent authority recommends validating the assay systems 
before use on cadaveric samples. 
No 

187 

 
 
 
 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

No 

No 

Commission Directive 2006/17/EC requires HTLV-I antibody 
testing for donors living in, or originating from, high-incidence areas 
or with sexual partners originating from those areas or where the 
donor’s parents originate from those areas.  Since it is very difficult 
to determine what a HTLV-I high-incidence area is and more data 
on prevalence are available than data on incidence, the Commission 
Directive should be amended in regard of replacing the references 
“high-incidence” to references “high-prevalence”. The competent 
authority completely agrees with this science-based specification.  
Additional testing referred to medical directives or guidelines (e.g. 
of the German Federal Medical Association / 
“Bundesärztekammer"), e.g. aminotransferase for bone tissue banks 
as state of the scientific and technical knowledge.  

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

98 

Yes 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
3 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

0 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

4.7.1. How many skin tissue establishments? 
4.7.2. How many musculo-skeletal tissue establishments? 
4.7.3. How many ocular tissue establishments? 
4.7.4. How many cardiovascular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 

Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
ART tissue establishments 
Other tissue establishments 
1 
58 
19 
2 
12 
113 
16 (e.g. chondrozytes, reproductive tissue, fetal tissue, amnion) 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 

188 

 
 
 
 
 
 
4.8.1. How many skin tissue establishments? 
4.8.2. How many musculo-skeletal tissue establishments? 
4.8.3. How many ocular tissue establishments? 
4.8.4. How many cardiovascular tissue establishments? 
4.8.5. How many HSC tissue establishments? 
4.8.7. How many ART tissue establishments? 
4.8.8. How many multi-tissue establishments? 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.2. How many musculo-skeletal tissue establishments? 
4.9.3. How many ocular tissue establishments? 
4.9.4. How many cardiovascular tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.9.8.  How many multi-tissue establishments? 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.16.1.1. How many penalties have been imposed in 2011 (from 
01/01/2011-31/12/2011)? 

1 
39 
14 
2 
9 
87 
0 
10 (e.g. chondrocytes, reproductive tissue, fetal tissue, amnion) 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
17 
5 
2 
4 
37 
2 
34 (e.g. arms, hands, amnion) 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
2 
9 
23 
96 
8 
6 
3 
3 
22 
29 
2 
11 
14 
105 
2 
8 
1 

2 

4 

Yes 

Yes 
In 2011 there has been one penalty imposed under the 
Transplantation Act.   

189 

 
 
 
 
4.16.1.2. What were the reasons for imposing the penalties? Please 
describe. 

4.16.1.3. What kind of penalties were imposed? Please describe (e.g. 
suspension of authorisation, criminal penalty etc.) 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

Please specify other. 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 

The statistics do not specify the infringement. It cannot be said, 
whether the infringement was in relation to organs or tissues and 
cells. Beside, there are no specific statistical data available relating 
to infringements against tissue regulation.  
The penalty imposed was a financial penalty. 

No. 

Yes 

The Regional Competent Authorities in the German Länder are  
entrusted with the task of inspections; they are supported by the 
Paul-Ehrlich-Institute.  For further information see answer 1.7. 
No further data available.  
Yes 

Blood 
Pharmaceuticals 
Advanced therapies 
Medical devices 
Others 
Whole salers, brokers, pharmacies and GCP/GLP-
Surveillance/License 
56 

0 

8 

16 

46 

9 

1 

0 

4 

32 

190 

 
 
 
 
0 

0 

0 

1 

8 

34 

13 

establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  Risk-based approach referred to the outcome of the last inspection. 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.11.1. If no, which guidelines/regulations are used for inspections at 
national level? 
5.11.2. If no, please provide a hyperlink to these 
guidelines/inspections. 

General system-oriented inspections 
Thematic inspections 

Not mandatory, but recommended as a guideline, additional 
guideline as aide memoire. 
 Aide memoire «Surveillance of procurement establishments and 
laboratories » (No. 07122501),  
https://www.zlg.de/arzneimittel/deutschland/qualitaetssystem.html 
(no open resource) 
Yes 

50 
Yes 
63 
No 

Yes 

Yes 

62 

4 

5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.15.1. If yes, please specify why. 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 

4 

No 

No 

Yes 

Required pursuant sec. 72b of the German Medicinal Products Act. 
Yes 

191 

 
 
inspections, as part of an enquiry/investigation? 
5.16.1. If yes, please specify. 

5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 

6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 

6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 

Requirements, conditions and data basis of an import licence granted 
by HTA (UK) for a tissue preparation of a US tissue.  Information to 
other MS because of tissue import from the Ukraine and USA 
conducted by a German holder of import license.   
Yes 

No. 

Yes 

37 

Ocular, limbal  1 Cardiovascular, pericardium 1 Musculoskeletal, 
bone, femoral 17 Musculoskeletal, soft tissue 2 Musculoskeletal, 
bone, preparation 2 Musculoskeletal, cartilage 32 Skin 3 
Reproductive, sperm 13  Note:  In Germany, there is no 
authorisation for export of tissues and cells, but the export of tissue 
and cells has to be notifed annually by the tissue establishments.   
Import authorisation and certification pursuant sec. 72b of the 
German Medicinal Products Act, granted by the Regional 
Competent Authorities,  product-related marketing authorisation 
pursuant sec. 21a or sec. 21 of the German Medicinal Products Act, 
granted by the Paul-Ehrlich-Institut. 
See answer 6.4. 

See answer 6.4. 

See answer 6.4. 

See answer 6.4. 

See answer 6.4. 

Import authorisation and certification pursuant sec. 72b of the 
German Medicinal Products Act, granted by the Regional 
Competent Authorities. 

Yes 

The notification requirement according to section 8d of the German 
Transplantation Act (TPG) does not distinguish between import 
from third countries and import from member states of the European 
Union. The following table contains all tissues which were notified 
to the Paul-Ehrlich-Institut as being “imported” to Germany during 
2011:  Ocular, corneal 550 Cardiovascular, heart valves 128 
Cardiovascular, vessels 12 Cardiovascular, membrane, pericardium 
2410 Musculoskeletal, bone, complete 7914 Musculoskeletal, bone, 
femoral 1680 Musculoskeletal, bone, preparation 14056 
Musculoskeletal, soft tissues 17822 Musculoskeletal, cartilage 176 

192 

 
 
 
 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 

6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

Skin (area in square centimeter) 3436004 Skin (number of pieces) 2 
Reproductive, sperm 325  
Yes 

The notification requirement according to section 8d of the German 
Transplantation Act (TPG) does not distinguish between export to 
third countries and export to member states of the European Union. 
The following table contains all tissues which were notified to the 
Paul-Ehrlich-Institut as being “exported” from Germany during 
2011:  Ocular, corneal 185 Ocular, limbal 3 Cardiovascular, 
membrane, pericardium 2131 Musculoskeletal, bone, complete 8985 
Musculoskeletal, bone, femoral 2850 Musculoskeletal, bone, 
preparation 119407 Musculoskeletal, soft tissues 12951 
Musculoskeletal, cartilage 180 Membrane, amniotic 130 Skin (area 
in square centimeter) 2825092 Reproductive, sperm 1463 
No 

F. Other 

There is no information about this issue. 
Yes 

31 (e.g. bone marrow stem cells, peripheral blood stem cells, coord 
blood, cardiac valves) 
No. 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 

Yes 
Certification by the Paul-Ehrlich-Institut before the first placing on 
the market pursuant to sec. 21a para. 9 of the German Medicinal 
Products Act:  Before issuing the certificate, the PEI examines 
whether the processing of the tissue preparations meet the 
requirements with respect to the removal and processing procedures 
including the donor selection procedures and the laboratory test 
methods, and whether the quantitative and qualitative criteria for the 
tissue preparations meet the requirements of the German Medicinal 
Products Act and its ordinances. The competent higher federal 
authority issues the certificate if the authorisation certificate or 
another certificate from the competent authority of the country of 
origin demonstrates the equivalence of the requirements pursuant to 
the German regulation and the proof of authorisation in the Member 
State of the European Union or in another State Party to the 
Agreement on the European Economic Area is submitted.   
Yes 

In Germany human tissue preparations are regarded as medicinal 
products (according to section 4 number 30 of the Medicinal 
Products Act; German Medicinal Product Act; AMG). Accordingly, 
authorizations for the manufacturing and placing on the market of 
tissue preparations are required. Industrially produced tissue 
preparations are regulated as pharmaceutical medicinal products, 
tissue preparations not produced using industrial processes, 
produced with methods well established and known in the EU,  
having functions or being associated with adverse reactions known 
from public literature are regulated according to the framework of 
Directive 2004/23/EC. Therefore, in Germany there are two different 
marketing authorizations depending on the classification of the 
product based on the AMG:  1.) authorization for “classical” human 
tissue preparations (regulated as medicinal products) according to 
section 21a AMG and  2.) marketing authorization according to 
section 21 AMG (regulated as medicinal products according to 

193 

7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 

 
 
 
 
Directive 2001/83/EC).  “Classical” human tissue preparations 
subject to authorization according to section 21a AMG which are 
intended to be placed on the market in a member state of the 
European Union shall require a certificate according to section 21a 
sub-section 9 AMG prior to the first placing on the market in 
Germany. Before issuing the certificate, the competent higher 
federal authority, Paul-Ehrlich-Institut, shall examine whether the 
processing of the tissue preparations meets the requirements with 
respect to the removal and processing procedures including the 
donor selection procedures and the laboratory examinations, and 
whether the quantitative and qualitative criteria for the tissue 
preparations meet the requirements of the AMG and its ordinances. 
Without the above mentioned marketing authorisation, authorisation 
or certification , respectively, the placing of human tissue 
preparations on the German market is not permitted.   
Authorisation pursuant sec. 20c of the German Medicinal Products 
Act and inspections, granted by the Regional Competent Authorities.  
The tissue establishments are supervised by the Regional Competent 
Authorities of the Länder. Technical requirements for processing, 
storage and distribution must be defined in the quality management 
system which is checked during the supervision.   
Other 

Before the first placing on the market a certificate, which is issued 
by the Paul-Ehrlich-Institut, is required (section 21a sub-section 9 
AMG). The certificate shall ensure that only equivalent products are 
introduced into the purview of the AMG (see answer 7.1.1.). 
Otherwise, in the case of non-equivalence, a “full marketing 
authorization” (authorization for tissue preparations regarding 
Section 21a AMG) must be obtained. 
No 

Yes 

Ocular, limbal 3 Cardiovascular, pericadium 2.410 Cardiovascular, 
heart valves 110 Cardiovascular, vessels 12 Musculoskeletal, bone, 
complete 7.914 Musculoskeletal, bone, femoral 1.647 
Musculoskeletal,, soft tissues 17.822 Musculoskeletal, bone, 
preparation 14.059 Musculoskeletal, cartilage 208 Skin (area in 
square centimetre) 3.287.339 Skin (number of pieces) 61.511 
Reproductive, sperm 325  Note:  In Germany, the country of 
destination has not to be notifed by the tissue establishments.   
Ocular, corneal 1 Cardiovascular, pericadium 2.131 
Musculoskeletal, bone, complete 8.985 Musculoskeletal, bone, 
femoral 2.844 Musculoskeletal,, soft tissues 12.951 Musculoskeletal, 
bone, preparation 128.392 Musculoskeletal, cartilage 177 Skin (area 
in square centimetre) 2.825.092 Skin (number of pieces) 967 
Reproductive, sperm 1.007 Note:  In Germany, the country of origin 
has not to be notifed by the tissue establishments.  
No 

Yes 

New definition “brokering of medicinal products” (sec. 4 para. 22a 
German Medicinal Products Act), notification of trade activities 
without conducting wholesale distribution to the Regional 

7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 

7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
Please specify 'other'. 

7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 

7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 

7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) as 
a Competent Authority, in their authorisation/monitoring or 
inspection. 

194 

 
 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Competent Authorities acc. to sec. 52c of the German Medicinal 
Product Act. No experiences in implementing these regulations with 
regard to “classical tissues”. Interdiction of commerce for “classical” 
tissues acc. to sec. 17 of the German Transplantation Act 
(Transplantationsgesetz – TPG), no commerce for germ cells due to 
the German Embryo Protection Law (Embryonenschutzgesetz - 
ESchG).  
No 

No.  

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

No 
Yes 

60-99% 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site.  www.pharmnet-bund.de 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

Yes 

http://www.pei.de/DE/infos/meldepflichtige/meldung-gewebe-8d-
transplantationsgesetz/berichte-pei/berichte-meldung-8d-
transplantationsgesetz-tpg-node.html 
Yes 

1. Donation of ocular tissues, skin, heart valves, blood vessels, 
musculoskeletal tissues and placenta.  2. Procurement of cm² of skin 
retrieved.  3. Storage at 01/01/ 00:00, procession, discarding, 
distribution and storage at 31/12 24:00 of the above tissues (no. 1) 
completed by ovarian and testicular tissues (units).The 
musculoskeletal tissues are subdivided in whole or part of 
supporting bone (units), tendons / ligaments (units), cartilage (units), 
bone filling material (units) and other musculoskeletal (units) (i.e. 
ear ossicles). 4. Import- and Export of the above mentioned tissues 
(no.3)  
The Register of tissue establishments is based on the German 
Transplantation Act (sec. 8f TPG) and was established in 2011 at the 
German Institut for Medicinal Documentation and Information 
(Deutsches Institut für Medizinische Dokumentation und 
Information – DIMDI). It is a publicly accessible register of tissue 
establishments specifying the acitivities for which they have been 
authorised by the Regional Competent Authority; it contains also the 
contact details of the tissue establishments. Due to the fact that 
DIMDI hosts this register since end of 2011, the data in the registry 
do not yet contain the whole dataset of tissue establishments that 
existed in Germany in the implied period of time.  Final 
transplantation data cannot be provided because this is not part of 
the notification requirement according to section 8d para. 3 of the 
German Transplantation Act (TPG). Beside, there is no obligation 
pursuant to Article 10 of the Directive 2004/23/EC.  

8.7. Do you have any additional comments on reporting? 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 

Yes 

Procurement centre 

Both paper records and electronic forms 

195 

 
 
 
 
 
 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 

9.5. Do you have any additional comments on traceability? 

Tissue establishments and organisations responsible for human 
application are required by law to retain the data for 30 years, in an 
appropriate and readable storage medium (sec. 41 AMWHV, sec. 15 
para. 2 German Transplantation Act). The tissue establishments have 
to provide a solution for the case of closing the establishment in 
respect to storage of remained tissues as well as the data for 
purposes of traceability (e.g. by contract with another tissue 
establishment) (sec. 20c para. 7 German Medicinal Products Act, 
sec. 41 AMWHV). These aspects are part of the surveillance of 
inspections by the Regional Competent Authorities. 
No. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of its organisation. 

The vigilance of tissue products is in the competence of the National 
Competent Authority (PEI) insofar tissue products require a 
marketing authorisation pursuant to sec. 21a or sec. 21 of the 
German Medicinal Products Act.  The surveillance of the vigilance 
system of the procurement and tissue establishments (SOPs, 
reporting channels) is in the responsibility of the Regional 
Competent Authorities. 
Section 63i of the German Medicinal Products Act / documentation 
and notification obligations in respect of tissue preparations and 
tissues: (1) The holder of a marketing authorisation or authorisation 
for tissue preparations pursuant to section 21a, shall keep documents 
on all suspected serious incidents or serious adverse reactions in the 
Member States of the European Union or in the States party to the 
Agreement on the European Economic Area or in a third country, as 
well as on the number of recalls. (2) The holder of a marketing 
authorisation or authorisation for tissue preparations pursuant to sub-
section 1 shall, furthermore, document every suspected serious 
incident and every suspected serious adverse reaction and shall 
report them to the competent higher federal authority immediately, 
or at the latest within 15 days of acquiring this knowledge. The 
report shall contain all  necessary information, especially the name 
or firm and address of the pharmaceutical entrepreneur, name and 
number or code of the tissue preparation, date and documentation of 
the emergence of the suspicion of the serious incident or the serious 
adverse reaction, date and place where the removal of the tissue took 
place, enterprises or facilities supplied as well as information on the 
donor. The incidents or reactions reported pursuant to sentence 1 are 
to be examined with respect to their causes and effects and 
subsequently evaluated and the results together with the measures to 
trace and protect both the donor and the recipient reported 
immediately to the competent higher federal authority. (3) In the 
case of tissue preparations and tissues which are not subject to 
marketing authorisation or authorisation, the tissue facilities shall 
notify the competent authority, immediately, of every suspected 
serious incident and every suspected serious adverse reaction. The 
notification shall contain all necessary information such as the name 
or firm and address of the donation or tissue facility, name and 
number or code of tissue preparation, date and documentation of the 
emergence of the suspected serious incident or the serious adverse 
reaction, date on which the tissue preparation was manufactured as 
well as information on the donor. Sub-section 2 sentence 3 shall 
apply mutatis mutandis. The competent authority shall transmit the 
notifications pursuant to sentences 1 and 2 as well as the 
notifications pursuant to sentence 3 to the competent higher federal 
authority. (4) The holder of a marketing authorisation or 
authorisation for tissue preparations within the meaning of sub-
section 1 shall submit, to the competent higher federal authority, on 

196 

 
 
 
 
the basis of the obligations contained in sub-section 1, an updated 
report on the safety of the medicinal product immediately upon 
request or, where recalls, confirmed or suspected serious incidents or 
serious adverse reactions are involved, at least once a year. Sentence 
1 shall not apply to parallel importers. (5) Section 62 sub-section 6 
shall apply mutatis mutandis to tissue facilities; Section 63b sub-
section 3 shall apply mutatis mutandis to the holder of an 
authorisation for tissue preparations. (6) A serious incident within 
the meaning of the foregoing provisions is any undesired event in 
connection with the procurement, testing, processing, preserving, 
storage or supply of tissues preparations which could lead to the 
transmission of an infectious disease, the death of a patient, a life-
threatening state, disability or invalidity of patients, the need for or 
prolongation of hospitalisation or disease. A serious incident is also 
any incorrect identification or confusion of germ cells or 
impregnated egg cells within the framework of medically-assisted 
insemination measures. (7) A serious adverse reaction within the 
meaning of the foregoing provisions is an unintended reaction, 
including an infectious disease in the donor or recipient in 
connection with the procurement of tissues or the transplanting of 
tissue preparations, which is fatal or life-threatening or leads to 
disability or invalidity or requires hospitalisation or the prolongation 
of existing hospitalisation or causes or prolongs a disease.  
Yes 

No 

The tissue establishments are requested to use the notification form, 
which is available on the PEI homepage. 
Yes 

<50% 

Yes 

According to the German Transplantation Act (TPG) there is an 
obligation for transplantation centers/ transplant doctors to report 
SARs to the Regional or National Competent Authority. They are 
asked to use the notification form available on the PEI homepage. 
No 

At present there is no established feedback, but the PEI is planning 
to publish an annual tissue vigilance report. 
No 

At present there is no established feedback, but the PEI is planning 
to include this issue in an annual tissue vigilance report. 
Yes 
0 

Yes 

The German competent authorities established a reporting system to 
inform the qualified person in each tissue establishment responsible 
for quality and safety of the medicinal products. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.3.1. If no, please specify what guidelines you use. 

10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.2. Please specify why not. 

10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.2. Please specify why not. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 

197 

 
 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Yes 

The German competent authorities established a reporting system to 
inform the qualified person in each tissue establishment responsible 
for quality and safety of the medicinal products. 
No 

There is no obligation and no benefit for this procedure. 
Yes 

Haemovigilance 
Medical devices 
Yes 

4 

Cooperation with relevant third countries with regard to SARE 
reporting (e.g. USA, case Cryolife), Establishment of an interface 
for SARE reporting to other product areas, e.g. industrial tissue 
products in terms of the Directive 2001/83/EG or ATMP in terms of 
the Regulation (EC) 1394/2007 SOHO V&S Vigilance Guidance for 
Competent Authorities is helpful and should be updated if necessary.  

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 

Explicit consent (opt-in) 

Please specify 'other'. 

In the case of living donation the explicit consent of the donor is 
mandatory. 
Explicit consent (opt-in) 

First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Friends 
Other 
Section 4 of the Transplantation Act regulates the removal of organs 
with the consent of persons other than the donor: In cases where the 
physician who is supposed to remove the organ has neither written 
evidence of consent nor written evidence of objection by the 
potential donor, the latter's next-of-kin shall be asked whether he or 
she is aware of a declaration of donation on the part of the potential 
donor. If the next-of-kin has no knowledge of such a declaration 
either, removal under the provisions set forth in Section 3, paragraph 
1 numbers 2 and 3 as well as paragraph 2 shall only be admissible if 
a physician has informed the next-of-kin about a possible organ 
removal and has obtained his or her consent. In making the decision, 
the next-of-kin shall respect the presumed wishes of the potential 
donor. The physician shall inform the next-of-kin of this 
requirement. The latter may agree with the physician that his or her 
consent may be withdrawn within a specific, agreed deadline. 
Within the meaning of this Act, next-of-kin are, in the following 
order of priority: 1. the spouse, 2. children of full age, 3. the parents 
or, in so far as the potential donor was a minor at the time of death 
and the custody for his or her person was exercised at that time by 
only one parent, by a guardian or curator, then the person exercising 
this custody, 4. sisters and brothers of full age, 5. grand-parents. 
Next-of-kin are only authorised to make a decision pursuant to 
paragraph 1 if personal contact between the former and the potential 
donor existed in the two years preceding the potential donor's death. 

198 

 
 
 
 
The physician shall determine this fact by questioning the next-of-
kin. In the case of several next-of-kin of equal rank, it is sufficient 
for one of them to be consulted under the terms of paragraph 1 and 
take a decision; however, an objection on the part of any of them is 
noteworthy. If a prior-ranking next-of-kin cannot be reached within 
an appropriate period of time, the consultation and decision of the 
next-of-kin of lower rank who can be reached next shall be 
sufficient. A person of full age who has evidently had an especially 
intimate personal relationship with the potential donor until the 
latter's death shall be of equal rank to the next-of-kin; such a person 
shall be on a par with the next-of-kin. In the event that the potential 
donor had delegated the decision regarding organ removal to a 
specific person, this person shall take the place of the next-of-kin. 
Yes 

Analysis of documentation 
Interviews with personnel 
Other 
Surveillance of SOPs, contracts between procurement and tissue 
establishments. 
Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 
Other 

General information is also available within the national schemes on 
public awareness as well as information made available by medical 
associations. 
According to Section 14 of the Transplantation Act are those persons 
involved in the disclosure or passing on of information pursuant to 
relevant sections of the Transplantations Act are not authorised to 
disclose the personal data of either the organ donor or the organ 
recipient. The personal data compiled within the framework of the 
Transplantation Act may not be processed or utilised for any purpose 
other than those stipulated in the Act. They may be processed and 
utilised for court proceedings the subject matter of which is the 
violation of any prohibition to disclose data pursuant to sentence 1 
or 2. These provisions shall, in the case of the donation of semen, be 
without prejudice to the right of the child to have access to 
knowledge about his or her own parentage. In the case of a bone 
narrow transplantation, by way of derogation from sub-section 2, the 
identity of the tissue donor and that of the tissue recipient or of the 
relative in question may be mutually revealed if the tissue donor and 
the recipient or his or her legal representative have explicitly agreed 
to do so. 
See answer to question 11.7. 

Yes 

No.  

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 

Please specify 'other'. 

11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
Please specify 'other'. 

11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 

11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 

Inspections of TEs and procurement sites 
Audit of documentation 
Other 

Authorisation of procurement establishments pursuant sec. 20b of 
the German Medicinal Products Act, surveillance of SOPs, quality 
management system and the training of the personnal (see sec. 33, 
34 und 35 Arzneimittel- und Wirkstoffherstellungsverordnung / 
AMWHV, TPG-GewV). The determination of donor eligibility and 
the data from laboratory tests are carried out according to pre-

199 

 
 
 
 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.3.1. If yes, please specify. 

12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Please specify 'other'. 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 

established SOPs in accordance with good professional practice (sec. 
33 AMWHV).  
Inspections of ART centres 
Audit documentation 
Other 

See question 12.1. (other) 
Yes 

Donor selection: The exclusion criteria are adapted to the donor of a 
specific tissue (for example donor for heart valves or vessels or 
cornea). Therefore, the donor selection criteria are sometimes more 
specific or stringent, respectively. As criteria for donor selection, the 
medical history of bacterial and protozoic diseases which can lead to 
chronically persistent infections, including tuberculosis, brucellosis, 
leprosis, melioidosis, Q fever, chlamydiosis, salmonellosis and 
tularaemia, should be considered by manufacturers. In this 
connection, specific attention should be paid on tick / arthropode 
borne diseases such as borreliosis, bartonellosis, rickettsiosis, 
trypanosomiasis, leishmaniasis, babesiosis and ehrlichiosis. The risk 
to transmit these infectious agents with specific tissues has to be 
assessed and negative effects for the recipient have to be excluded. 
Manufacturers are advised to refer to the German Guidelines on 
Hemotherapy, as published by the Federal Medical Association 
(Bundesärztekammer) in order to revise the donor questionnaire and 
to consider restrictions for specific tissue preparations.  
Procurement: Manufacturers are asked to provide a detailed 
procedure for the preparation and disinfection of the donor’s skin. 
So far, in many cases this is not possible due to a multitude of 
different procurement sites with non-supervised disinfection 
procedures. Manufacturers are asked to revise all applied 
procedures. A standardized procedure for skin disinfection should be 
provided to all procurement sites by the tissue organisation or 
establishment in future. They should follow the recommended 
standards of practice used for surgical patients and should account 
for the elimination of bacterial spores as well as vegetative 
microorganisms and therefore include suitable disinfectants, their 
concentration and duration of exposure.  
Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
Other 
Post mortem physical examination as well as the results of the 
laboratory tests required according to Annex II of Directive 
2004/23/EC. 
No 

No 

No 

Inspection of tissue establishment 
Other 

200 

 
 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.8.1. Please specify. 

12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Authorisation of procurement establishments pursuant sec. 20b of 
the German Medicinal Products Act. 
No. 

Authorisation requirement 
Inspections 
Internal audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
Please specify 'other'. 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

Yes 

Authorisation requirement 
Inspections 
Other 
Notification of changes, reservation of authorisation  
Authorisation requirement 
Inspections 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 

Local training of the personnel by the tissue establishment or other 
providers. 
No. 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
The requirements for microbiological testing of the source materials 
as well as of the final tissue product should be included:  
Microbiological testing for bacteria and fungi must be performed on 
the starting or incoming tissue itself, where possible; otherwise 
testing of a substitute like tissue or cell material closely related to the 
procured tissue or rinsing / transport solution has to be performed. 
Testing methods should be able to detect relevant aerobic and 
anaerobic bacteria, as well as fungi, and have to take into account 
possible specific contaminations of the tissue, for instance with 
fastidious microorganisms such as Neisseria sp. or Mycobacterium 
sp. Preferably, a representative sample of the tissue itself should be 
tested using appropriate media, incubation conditions and 

201 

 
 
 
 
 
 
temperatures. Other suitable samples may be taken from transport or 
washing solutions. In-process microbiological testing should be 
performed at relevant manufacturing steps, for instance after a stage 
of decontamination or inactivation, after washing or change of 
storage solution. For in-process control tests large amounts of spent 
storage solutions or cell culturing medium, or other suitable sample 
material should be used.  Suitable microbiological control tests have 
to be applied on each batch of a final tissue or cell preparation. 
Whenever possible, a tissue or cell sample should be tested after 
final packaging, otherwise immediately prior to this step. In addition 
or in exceptional cases as an exclusive sample, spent storage or 
culturing medium or final washing solutions may be used for final 
testing. Every effort should be made to take representative samples.  
Tests for the detection of mycoplasmas should be performed as late 
as possible during the manufacturing process.  If risk factors are 
present, it is desirable to perform additional tests for the detection of 
specific infectious agents. The need for endotoxin/pyrogen testing 
should be evaluated for each type of tissue or cell preparation. It 
depends on the intended route of administration, the usual endotoxin 
content of a preparation and the possible impact on the recipient.  
Sampling and testing methods have to be validated to show the 
representativeness of the sample and the suitability of the selected 
methods.  Microbiological safety of tissues and cells should follow 
the concept of a risk-based approach. It is based on donor selection, 
the absence of initial contamination or surveillance of incoming 
bioburden in combination with the absence of specific 
microorganisms, respectively, and the therapeutic use of the 
preparation. This is supplemented by control and monitoring of the 
manufacturing process and the final preparation, and validated 
methods of disinfection, decontamination or inactivation of 
microorganisms during processing of tissues and cells. Treatment of 
tissues with antibiotics and antimycotics cannot be regarded as a safe 
procedure for elimination of viable microorganisms in cells and 
tissue preparations. Some microorganisms may survive the antibiotic 
treatment, but may be inhibited in growth and not detected by 
microbiological testing due to the sampling error, and can recover 
when conditions change. Therefore, if possible due to the nature of 
the starting material, a treatment with antimicrobial substances 
should not be performed, or should at least be restricted to a 
validated time as short as possible with subsequent processing steps 
without the use of such substances.  

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities?  On the authority of the tissue establishments. 
15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

Yes 

Yes 

They are controlled in the context of the authorisation of the tissue 
establishment and the regular inspections. 
No.  

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.1.1. Please specify. 

16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 

Yes 

The German legislation has restrictions on the certain use of gametes 
and embryotic stem cells which fall under Article 4 para. 3 of 
Directive 2004/23/EC and are not covered by the scope of Art. 168 
para. 4 letter a of the Treaty. 
Testing provisions 
Import-export 

202 

 
 
 
 
 
 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 

16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

Other 
For further details see letter from German Federal Ministry of Health 
from 3th June 2013.  
Directive 2004/23/EC 
Directive 2006/17/EC 
Directive 2006/86/EC 
Article 28 should be amended by requirements for an approach for 
microbiological testing on incoming material, in-process and final 
product samples. 
Directive 2006/17/EC should be amended by an article on 
microbiological testing on tissue as incoming material, in-process 
controls and final product testing, similar to Article 4 (laboratory 
tests required for donors) and corresponding annex. 
Directive 2006/86/EC should be amended by an article on 
microbiological testing on tissue as incoming material, in-process 
controls and final product testing, similar to Article 4 (laboratory 
tests required for donors) and corresponding annex. 

203 

 
 
 
 
 
A.1.12. 

Survey response Greece 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
Please specify 'other': 
1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
THE PROCESS OF IDENTIFYING A SUITABLE 
HEMATOPOETIC STEM CELL DONOR FOR A  PATIENT IN 
A NEED FOR TRANSPLANT 
1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer possible) 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
Please specify 'other': 
1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible)* 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
Please specify 'other': 
1.3. National Competent Authority 3? 
Yes No 
1.3.1. Name of National Competent Authority 3 
1.3.2. Address of NCA 3: 
1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 answer possible) 
Non-reproductive tissues and cells 
Reproductive tissues and cells 

HELLENIC TRANSPLANT ORGANISATION & BONE MARROW 
DEPARTMENT 
5, ANASTASIOU TSOHA STREET, ATHENS, 115 21 , GREECE 
0030 2016471200, 0030 2132027000 
eom@eom.gr  
www.eom.gr  

Yes 

Yes 

Yes 
Yes 
Yes 

Search 

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Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
Please specify 'other': 
1.3.7. What are the role/tasks of the NCA? (more than 1 answer 
possible 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
Please specify 'other': 
1.4. National Competent Authority 4? 
Yes No 
1.4.1. Name of National Competent Authority 4: 
1.4.2. Address of NCA 4: 
1.4.3. Telephone (central access point): 
1.4.4. E-mail (central access point): 
1.4.5. Website: 
1.4.6. The NCA is responsible for? (more than 1 answer possible)  HTO is a non profit organisation granted from  the Ministry of Health. 

It has three departments: solid organs department- 5 employees                                                                                                                                                            
bone marrow  department -5 employees                                                                                                                          
administrative  economical department - 3 employees   and two  
lawyers working on legal matters  

Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
Please specify 'other': 
1.4.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
Please specify 'other': 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) 
(e.g. departments, staffing, number of senior and junior 
inspectors, staff working on EU affairs and legal matters, 
vigilance officers, budget, independence from government etc.). 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent 
Authority(ies). (more than 1 answer possible) 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
Not applicable 
Please specify 'other': 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation 
with the National Competent Authority(ies) for tissues and cells: 
2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 

Periodically we have inspectors from the Ministry of Health  

Not applicable  

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Yes No 
2.1.1. How do you authorise the "conditions of procurement"? 
(more than 1 answer possible) 
By inspecting all procurement centres 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement 
that is available in the tissue establishment 
working with procurement centres 
Other 
Please specify 'other': 
2.1.2. How many such authorisations were granted in 2011 
(01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" 
(skeletal tissues, cardiovascular tissues, skin, ocular tissues, 
amniotic membrane, pancreatic islet, hepatocytes, 
adipose tissue etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone 

marrow, PBSC, cord blood etc.) were carried out in 2011 (01/01-
31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other 
reproductive tissues were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP 
manufacturing were carried out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 
2004/23/EC and its implementing Directive 2006/17/EC (e.g. 
trained personnel, conditions accredited, designated, 
authorised, licensed) ? (more than 1 answer possible) 
Inspections of the site/centre 
Analysis of the mandatory documentation 
Other 
Please specify 'other': 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor 
testing? 
Yes No 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 

2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&C, that tests required for 
donors are carried out only by qualified laboratories 
accredited, designated, authorised or licensed Art. 5(2))? (more 
than 1 answer possible) 
Inspections of the laboratories 
Analysis of the mandatory documentation requested from the 
tissue establishment 
Other 
Please specify 'other': 

Yes 

Yes 
Yes 

1)University hospital  of  Alexandroupolis- Corneas department  2)   
Ofthalmiatreio of  Athens 
1)Biometics Dental  2)Iamex  Endolysi 3) Optimum Orthopedics 

Sceletical tissues  

1) EVAGGELISMOS HOSPITAL UNIT 2) AGHIA SOFIA 
HOSPITAL UNIT 3) RIO HOSPITAL 4) PAPANIKOLAOU 
HOSPITAL 5) ATTIKON HOSPITAL 6) AGHIOS SAVVAS 
HOSPITAL 7) LAIKO HOSPITAL 8) HELLENIC CORD BLOOD 
HOSPITAL OF ATHENS  9)HELLENIC CORD BLOOD HOSPITAL 
OF THESSALONIKI 

Yes 

Yes 
1)G. GENNIMATAS HOSPITAL 2) ELENA VENIZELOU 
HOSPITAL 3) EVAGGELISMOS HOSPITAL 4) IPPOKRATEIO 
THESSALONIKIS HOSPITAL 5) GENERAL HOSPITAL OF 
LARISSA 
HTO  

Yes 

6 LABORATORIES (ANTI -HIV, ANTI HTLV I + II, CMV/ ANTI 
CMV, HBS-Ag, ANTI- HBC, ANTI HCV, TREPONEMA 

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year of accreditation/authorisation/license, which donor tests are 
performed etc.). 
2.7. Do you have any additional comments on procurement? 
3. Testing (Art. 4, Annexes I, II and III of Directive 
2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. 
(more than 1 answer possible) 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
HTLV-2 
NAT HTLV-2 
3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. 
(more than 1 answer possible) 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
HTLV-2 
NAT HTLV-2 
NAT Chlamydia 
Treponema Pallidum 
3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it 

PALLIDUM) 

Yes 

Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 
Yes 

NAT TESTING NOT MANDATORY. UNTIL NOW NAT TEST IS 
MANDATORY FOR BLOOD DONATION. WE TEND TO 
EXTEND THE USE OF THIS METHOD TO TISSUE & CELL 
DONORS. 

mandatory or to encourage its use? Please specify why or why not 
(e.g. number of additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and 
test procedures for deceased donors? 
Yes No 
3.4.1. Please specify why: 

Yes 

Safety reasons , Quality & Traceability 

3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 

Yes No 
3.5.1. Please specify. 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State 
Yes No 
3.6.1. Please specify. 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 

No 

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Yes No 

Yes 
EUROPEAN FEDERATION FOR IMMUNOGENETICS (EFI)                                                                                                   
ELOT/ EN/ ISO 15015189:2007(2012) 

3.8. Do you have any additional comments on testing? 
4. Accreditation, designation, authorisation or licensing of 
tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue 
establishments under your responsability? 
Yes No 
4.1.1. Why not? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
Yes No 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 

4.3. Are preparation processes authorised? 

Yes No 
4.3.1. How are they authorised? (more than 1 answer possible) 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting 
documentation 
4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were suspended in 2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 
Yes No 
4.6.1. What is the relation between the indpendent certification(s) 
(e.g. ISO, JACIE, FACT) and the CA authorisation of the tissue 
establishments? (more than 1 answer possible) 
Mandatory for authorisation 
Optional, but TEs are encouraged to get a certification 
Inspections are conducted jointly by the CAs and independent 
certifying body 
No relation 
Other 
Please specify 'other': 

4bis. Overview of tissue/cells establishments authorised by the 
NCA 
(Establishments authorised for only one type of tissue should be 
included under the appropriate categories 
3.6.1.-3.6.7.; establishments authorised for more than one type of 
tissue, should be included under "multi-tissue" 
establishments" - category 3.6.8.) 
In questions XX – XX please select the appropriate type(s) of 
tissue establishments in your country and then provide 
the requested numbers. 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 

Yes 

Yes 
1) BIOMETICS DENTAL  2) IAMEX ENDOLYSI 3) OPTIMUM 
ORTOPEDICS 4) OPTHALMIATREIO OF ATHENS 5) 
UNIVERSITY HOSPITAL OF ALEXANDROUPOLIS 

Yes 

Yes 
Yes 

1)   OTHALMIATREIO OF ATHENS     2) UNIVERSITY 
HOSPITAL OF ALEXANDROUPOLIS 

− 

No 

Yes 

Yes 

Yes 
Yes 
Yes 

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Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
4.7.1. How many skin tissue establishments? 
4.7.2. How many musculo-skeletal tissue establishments? 
4.7.3. How many ocular tissue establishments? 
4.7.4. How many cardiovascular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.6. How many cord blood tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval 
by 31/12/2011 (more than 1 answer possible): 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
4.8.1. How many skin tissue establishments? 
4.8.2. How many musculo-skeletal tissue establishments? 
4.8.3. How many ocular tissue establishments? 
4.8.4. How many cardiovascular tissue establishments? 
4.8.5. How many HSC tissue establishments? 
4.8.6. How many cord blood tissue establishments? 
4.8.7. How many ART tissue establishments? 
4.8.8. How many multi-tissue establishments? 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 
01/01/2011 and 31/12/2011 (more than 1 answer possible): 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
4.9.1. How many skin tissue establishments? 
4.9.2. How many musculo-skeletal tissue establishments? 
4.9.3. How many ocular tissue establishments? 
4.9.4. How many cardiovascular tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.9.6. How many cord blood tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.9.8. How many multi-tissue establishments? 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more 
than 1 answer possible): 
Skin tissue establishments 
Musculo-skeletal tissue establishments 

Yes 
Yes 

1 
1) ASKLIPIEION HOSPITAL 
OCULAR 2 

4 
2 

Yes 
Yes 
Yes 

Yes 
Yes 

8 
17 
20 

4 
2 

None 

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Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
4.10.1.1. How many public skin tissue establishments 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue 
establishments? 
4.10.2.2. How many private musculo-skeletal tissue 
establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the 
direct agreement of the Competent Authority according to Art. 
6(5) during 2011? Please provide number(s) per type tissues/cells. 
4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
Yes No 
4.16.1. Have penalties already been imposed? 
Yes No 
4.16.1.1. How many penalties have been imposed in 2011 (from 
01/01/2011-31/12/2011)? 
4.16.1.2. What were the reasons for imposing the penalties? 
Please describe. 
4.16.1.3. What kind of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty etc.) 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 
5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
Yes No 
5.1.1. If yes, please specify the CA/Department of the CA in 
charge of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.1.3. If no, please specify why not. 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example 
blood, pharmaceuticals, etc. (e.g. same inspector team, common 
training, common documentation, etc.)? (more than 1 answer 
possible) 
Yes No 

Yes 

Yes 

NA 
1 

None 

2 

One public  

CORNEAS: 345 , HEMATOPOETIC STEM CELL: 78,     
HELLENIC CORD BANK OF ATHENS : 2                       

Yes 

No 

Yes 
A team fron the Ministry of Health authorized  for inspections  

Yes  
It depend upon the type of tissue  

No 

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5.2.1. If yes, please specify. (more than 1 answer possible) 
Blood 
Organs 
Pharmaceuticals 
Advanced therapies 
Medical devices 
Hospitals 
Accreditation organisations (e.g. JACIE) 
Others 
Please specify other. 
5.3. How many routine inspections of tissue establishments for 
non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 
to 31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues 
establishments for non-reproductive tissues/cells were conducted 
in 2011 (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, 
or suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on 
ART establishments (from 1/1/2011 to 31/12/2011) ( 
e.g. due to a whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments 
carried out in 2011 (01/01/2011 to 31/12/2011): What was the 
number of inspections carried out where no shortcomings were 
observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 

Two corneas 

Every two years 

Every six months  

Onr year 

Two inspecrions  

Three inspections  

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5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more 
than 1 answer possible) 
General system-oriented inspections 
Thematic inspections 
Desk based reviews 
5.6. How do you decide which type of routine inspection to 
conduct? 
5.7. Until 2011, did you implement the requirement concerning 
the time interval between two inspections (Art. 7.3.)? 
Yes No 
5.7.1. Why not? 
5.7.2. How do you prioritise tissue establishments to be 
inspected? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
Yes No 
5.9.1. If yes, how many? 
5.9.2. If no, why not? 
5.10. Did you carry out inspections of third parties? 
Yes No 
5.10.1. If yes, how many? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell 
procurement and tissue establishments - Guidelines for 
inspections (Commission Decision 2010/453/EU)? 
Yes No 
5.11.1. If no, which guidelines/regulations are used for 
inspections at national level? 
5.11.2. If no, please provide a hyperlink to these 
guidelines/inspections. 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO V&S)? 
Yes No 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 
= sufficient, 3 = good, 4 = very good, 5 = essential)? 
1 2 3 4 5 
5.12.2. Why not? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in 
that MS (Art 7(6))? 
Yes No 
5.13.1. Could you please explain why? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
Yes No 
5.14.1. Could you please explain why? 
5.15. Did you organise any inspections of procurement centres or 

According to the date of the request from the T.E 

Two corneas 

Yes 
Two in public tissue and none yet in private establishment   

No 

Because we request a private contact between the T.E and the 3r d 
parties which reassures the safety and the quality system according to 
the Greek  law  

Yes 

Yes 
 4 

No 

Yes 

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tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
Yes No 
5.15.1. If yes, please specify why. 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control 
measures of your inspections, as part of an enquiry/investigation? 
Yes No 
5.16.1. If yes, please specify. 
5.17. Would you be interested in developing joint inspections? 
Joint inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more 
Member States' Competent Authorities on their territory or in 
third countries. 
Yes No 
5.17.1. Could you please explain why not? 
5.18. Do you have any additional comments on inspections? 
6. Import/export (Article 9 Directive 2004/23/EC) 
Import/export refers to the exchange of tissue/cells with non-EU 
Member States 
6.1. Do you have a register of authorised tissue establishments 
that are explicitly authorised to perform import/export of tissues 
and celles from/to third countries? 
Yes No 
6.2. Please specify the number of tissue establishments authorised 
to import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised 
to export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 
6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) 
tissues from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from third 
countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than cord 
blood) from third countries. 
6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
Yes No 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 

No 

No 

No 
We are not ready yet 

No 

DIRECTIVE 2008 & PRESIDENTIAL LAW 26/2008 

DIRECTIVE 2008 & PRESIDENTIAL LAW 26/2008 

No 

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6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
Yes No 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on imports/exports of 
tissues/cells between your country and other third countries?* 
Yes No 
6.13.1. If yes, please specify. 
6.14. What is the relation between import/export of tissues and 
cells and self-sufficiency? (more than 1 answer 
possible) 
A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
B. Export of tissues/cells is authorised based on estimations 
performed on an annual basis 
C. Export of tissues/cells is authorised irrespective of national 
needs 
D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
E. Import of tissues/cells is authorised based on estimations 
showing that there is chronic deficiency of those 
tissues/cells 
F. Other 
Please specify 'other': 
6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
Yes No 
6.15.1. If yes, please specify the number of cases and for which 
type of tissues/cells. 
6.16. Do you have any additional comments on import/export? 
7. Distribution/intra community exchanges (Article 23 
Directive 2004/23/EC) 
For this question, distribution should be understood as cross-
border exchanges of tissues/cells, and not between 
tissue establishments and centres of human application within the 
same MS. 
7.1. Do you have intra-community exchanges of tissues and cells? 
Yes No 
7.1.1. If yes, how do you address the possible more stringent 
quality and safety measures established by other 
Member States? Please specify. 
7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
Yes No 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding 
quality of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your 
MS from TEs in another MS? (only 1 answer possible). 
Yes, no restrictions 
apply 
Yes, but only via an 

No 

Yes 

Yes 

Yes 

THERE IS A WAITING LIST FOR HCC & OCULAR 

NO 

YES 
WE REQUEST FROM THE OTHER MS TO FOLLOW STRICTLY 
THE DIRECTIVE GUIDELINES 

NO 
WE INSIST TO FOLOOW THE DIRECTIVES GUIDELINES 

BY INSPECTIONS 

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authorised TE in my MS 
No  /    Other 
Please specify 'other'. 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
Yes No 
7.4.1. If yes, how many authorisations were given in 2011 
(01/01/2011 to 31/12/2011)? 
7.4.2. If yes, for which tissues/cells? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
Yes No 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011) 
 7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of 
tissues/cells between your country and other EU MS? 
Yes No 
7.6.1. Please specify. 
7.7. Do you allow brokerage companies for either distribution in 
EU and/or import/export of tissues/cells? 
In this context, a brokerage company means a body that arranges 
transactions between a supplier (tissue 
establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) 
without undertaking activities of processing, preservation or 
storage. 
Yes No 
7.7.1. Please describe the legal requirements and your role (if 
any) as a Competent Authority, in their authorisation/monitoring 
or inspection. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
Yes No 
7.8.1. Where are the brokers located? 
Your country Another country 
7.8.2. If the broker is located in another country, how 
easy/difficult is it to ensure that safety and quality requirements 
are met? 
7.9. Do you have any additional comments on distribution? 
8. Register of tissue establishments and reporting obligations 
(Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the 
activities of tissue establishments in your Member State? 
(Article 10(1)). If yes, please upload the template. 
Yes No 
8.1.1. If no, why not 

8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an 
estimation. (1 answer possible) 
100% (all) 60-99% 50-69% <50% 
8.3. Are these reports publicly available? (Article 10(1)) 
Yes No 
8.3.1. If yes, please insert the link(s) to the report(s). 

NO 

NO 

YES 
DONATION TWO CORD BLOOD UNITS TO UK IN 2011 

PBSC: 2011 78,                                                                     CORNEAS: 
345                                                                  SCELETICAL TISSUES: 
519 

NO 

NO 
ACCORDING TO  THE DIRECTIVES 

NO 

NO 
WE DO NOT HAVE AT THE MOMENT A TEMPLATE FOR EACH 
ASCTIVITY BUT WE KEEP DATA BASE IN PAPER FORM 
FROM THE T.E. 

50-69% 

YES 
www.eom.gr / www.eae.gr 

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8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
Yes No 
8.4.1. Please insert the link to the published national annual 
report. 
8.4.2. If no, why not? 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
Yes No 
8.5.1. If yes, please provide us with the link to the register's web 
site. 
8.5.2. If no, why not? 
8.6. Do you provide data regarding tissues and cells activities to 
the EUROCET registry (non-mandatory reporting)? 
Yes No 
8.6.1. If yes, what data are provided to EUROCET? Please 
specify. 
8.6.2. If no, why not? 
8.7. Do you have any additional comments on reporting? 
9. Traceability (Article 8, Directive 2004/23/EC; and Directive 
2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented 
in your country? 
Yes No 
9.1.1. If no, why not? 
9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
National Competent Authority 
Regional Authority 
Tissue establishment 
Procurement centre 
Other 
Please specify 'other'. 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer 
possible) 
Only paper records Only electronic forms Both paper records and 
electronic forms 
9.4. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/89/EC, Art. 9)? 
Please specify. 
9.5. Do you have any additional comments on traceability? 
10. Notification of serious adverse events and reactions 
(Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions 
(Article 11(1))? 
Yes No 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its 
organisation. 
10.1.3. If no, why not? 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates 
developed to the Annual reporting ot the EC also at national 
level? 
Yes No 
10.2.1. If no, what template do you use? You are welcome to 
upload the template if you wish. 
10.3. Do you use the Common Approach Document developed 

NO  

NO DUE TO FINANCIAL REASONS 

NO 

NO DUE TO FINANCIAL REASONS 

YES 
HSC & CORNEAS DATA 

YES 

YES 

BOTH PAPERS AND ELECTRONICS FORMS 

WE KEEP THEM IN A SEPARATE LOCKED SPACE  WITH 
LIMITED ACCESS 

YES 
HTO 
HTO IS AN NON PROFIT ORGANISATION GRANTED FROM 
THE MINISTRY OF HEALTH. 

YES 

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for the Annual reporting to the EC also at national level? 
Yes No 
10.3.1. If no, please specify what guidelines you use. 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
Yes No 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % 
from the total number of TEs authorised in your country). 
100% 70-99% 50-69% <50% 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs 
which distributed the tissues/cells (Art 11.2)? 
Yes No 
10.6.1. If yes, please provide a brief description. 

10.6.2. If no, how do you ensure that SAR/SAE are reported to 
the TEs? 
10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
Yes No 
10.7.1. Please specify. 

10.7.2. Please specify why not. 
10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
Yes No 
10.8.1. Please specify. 
10.8.2. Please specify why not. 
10.9. Do you require your TEs to have a recall procedure? 
Yes No 
10.9.1. If no, please specify why not. 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please specify 
the number and which tissues were recalled and why (e.g. missing 
consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
Yes No 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.11.2. If no, please specify why not. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a 
rapid alert is issued via the EU RATC platform? 
Yes No 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.12.2. If no, please specify why not. 
10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
Yes No 
10.13.1. If yes, please specify what data. 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and 
cells national vigilance system also to other national 
vigilance/alert systems? 
Yes No 

YES 

NO 
DUE TO THE STUFF LIMITATION 

<50% 

YES 
WE DISTRIBUTE THE SURVEY FORMS TO BE COMPLETED 
BY THE T.E.'s 

YES 
WE GIVE SOME DIRECTIONS FOLLOWED BY INSPECTIONS 
TO THE T.E.'s 

YES 

YES 

NO 

DUE TO THE STUFF LIMITATION 

NO 

DUE TO THE STUFF LIMITATION 

NO 

YES 

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10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 
Haemovigilance 
Pharmacovilance 
Medical devices 
Other 
Please specify 'other'. 
10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO 
V&S? 
Yes No 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 
(insufficient) - 2 (sufficient) 3 (good) - 4 (very good) to 5 
(essential)? 
1 2 3 4 5 
10.15.2. If no, please specify why not. 
10.16. Do you have any additional comments on SARE 
reporting? 
11. Consent and personal data protection (Article 13 and 14, 
Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
Presumed consent (opt-out) Explicit consent (opt-in) 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 

11.2. What consent system for deceased tissue/cell donation do 
you have in place within your Member State? 
Presumed consent (opt-out) Presumed (opt-out) and explicit (opt-
in) consent 
Explicit consent (opt-in) 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Friends 
No further authorisation is needed 
Other 
Please specify 'other'. 
11.4. Is the consent system for deceased tissue donation the same 
as for organs? 
Yes No 
11.4.1. If no, please describe the difference. 
11.5. How is this consent verified during inspections? (more than 
1 answer possible 
Analysis of documentation 
Interviews with personnel 
Interviews with relatives of deceased donors 
Interviews with living donors 
Other 
Please specify 'other'. 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 

YES 

NO 

 Explicit consent  

WE KEEP CONSENT FORMS FOR EACH TYPE OF TISSUE TO 
BE COMPLETED 

explicit  consent 

YES 

YES 

YES 

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13(2)? (more than 1 answer possible) 
Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 
Other 
Please specify 'other'. 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is 
given to third parties (Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice 
versa. 
11.9. Does your national legislation allows disclosure of donor 
data in case of gametes donation? 
Yes No 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 
12. Selection, evaluation and procurement (Article 15 Directive 
2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 
Audit of documentation 
Regular evaluation of medical personnel 
Other 
Please specify 'other'. 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells 
are respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
Standardised questionnaires at national level 
Inspections of ART centres 
Audit documentation 
Regular evaluation of medical personnel 
Other 
Please specify 'other'. 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
Yes No 
12.3.1. If yes, please specify. 
12.4. What sources are required in your MS for the evaluation of 
a deceased donor of tissues/cells? (more than 1 answer possible) 
Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
Other 
Please specify 'other'. 
12.5. Do you have more stringent criteria for selection of donors 
of reproductive cells than those listed in Annex III of the 
Directive 2006/17/EC? 
Yes No 
12.5.1. Please specify. 
12.6. Do you have more stringent criteria for autologous donation 

YES 

WE KEEP AN ANONIMITY FOR TWO YEARS 

WE GIVE CODE SYSTEM 

YES 
YES 
YES 

YES 

YES 
YES 

YES 

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than those listed in Annex I of the Directive 2006/17/EC? 
Yes No 
12.6.1. If yes, please specify. 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the 
Annex of Directive 2004/23/EC (Art 15(3)? 
Yes No 
12.7.1. If yes, please specify. 
12.8. How do you ensure that all requirements regarding tissues 
and cells' procurement, packaging and transport are complied 
with by tissue establishments in your country (Art 15(1), Annex 
IV of Directive 2006/17/EC? (more than 1 answer possible) (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, 
and/or vendors in order to evaluate adherence to the written SOP, 
standards or governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Audit of the centre of human application 
Other 
12.8.1. Please specify. 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 
13. Quality management, responsible person, personnel (Article 
16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your 
country have in place a quality system respecting the provisions 
of the Directive 2004/23/EC Art 16.1? (more than 1 answer 
possible). (For this question "audit" means a documented review 
of procedures, records, personnel functions, equipment, materials, 
facilities, and/or vendors in order to evaluate adherence to the 
written SOP, standards or governments laws and regulations 
(from Council of Europe Guide to the Safety and Quality 
Assurance for the Transplantation of Organs, Tissues and Cells, 
2011)). 
Authorisation requirement 
Inspections 
Internal audits 
External audits 
Other 
Please specify 'other'. 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? 
(more than 1 answer possible) 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Other 
Please specify 'other'. 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 

YES 
ACCORDING TO  THE DIRECTIVES 

NO 

YES 
YES 
YES 

YES 

YES 
YES 
YES 

YES 
YES 
YES 
YES 

YES 
YES 
YES 

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Mandatory trainings 
Other 
Please specify 'other'. 
13.4. Do you have national/regional/local training programmes 
for the personnel of tissue establishments? 
Yes No 
13.4.1. If yes, please specify. 
13.4.2. If no, in which country(ies) is your personnel trained? 
EU countries Non-EU countries 
13.4.2.1. Please specify EU-countries. 

13.4.2.2. Please specify non EU-countries. 
13.5. Any additional comments on quality management, 
responsible person, personnel? 
14. Reception, processing, storage, labelling and packaging (Art 
19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your 
country fulfill the requirments of the Art. 19 (Tissue and cell 
reception) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
Other 
Please specify 'other'. 
14.2. How do you ensure that tissue establishments in your 
country fulfill the requirements of the Art. 20 (Tissue and cell 
processing) of Directive 2004/23/EC? (more than 1 answer 
possible) 
SOPs for all processes affecting quality and safety are mandatory 
for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
Other 
Please specify 'other'. 
14.3. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 21 (tissue and cell storage 
conditions) of Directive 2004/23/EC? (more than 1 answer 
possible) 
SOPs for procedures associated with storage of tissues and cells 
are mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
Other 
Please specify 'other'. 
14.4. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 22 (labelling, 
documentation and packaging) of Directive 2004/23/EC and 
Annex IV of Directive 2006/17/EC? (more than 1 answer 
possible) 
SOPs for procedures associated with labelling and packaging are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 
Other 
Please specify 'other'. 

YES 

NO 

EU countries  
EUSTITE, FACT NETCORD ,                                                           
JACKIE 

YES 
YES 
YES 
YES 

YES 

YES 
YES 
YES 

YES 

YES 
YES 
YES 

YES 

YES 
YES 
YES 

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14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 
15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your 
national legislation? 
Yes No 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
Yes No 
15.1.1.1. Under which circumstances and for which 
responsibilities? 
15.1.1.2. How are third party agreements controlled (Art 6.2) by 
the Competent Auhtority(ies) in your MS? 
Please specify. 
15.2. Any additional comments on third party agreements? 
16. General comments - implementation 
16.1. Do you have at national level more stringent quality and 
safety requirements than those requested by the EU 
legislation in this field (e.g. restrictions concerning the 
donation/use of certain tissues/cells, mandatory unpaid donation 
etc.)? 
Yes No 
16.1.1. Please specify. 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and 
Cells Directives? Please choose from the options below. 
ART provisions 
Procurement provisions 
Testing provisions 
Storage provisions 
Distribution provisions 
Import-export 
Vigilance 
Authorisation-accreditation-licensing of TEs 
Inspections 
Traceability 
Other 
No difficulties 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are 
there shortcomings (if any)? (more than 1 answer possible) 
Directive 2004/23/EC Directive 2006/17/EC Directive 
2006/86/EC 
No shortcomings 
16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 
16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

YES 

YES 
CONTRACT 

BY DOCUMENTATION PAPER 

NO 

YES 

YES 
YES 

STRUCTIONAL DIFFICULTIES & COMMUNICATION 
PROBLEMS 

NO 

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A.1.13. 

Survey response Hungary 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? 
(more than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more 
than 1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 

National Public Health and Medical Officer Service - Office of the 
Chief Medical Officer (NPHMOS-OCMO) 
2-6 Gyali ut, Budapest, H-1097, Hungary 
+36-1-476-1100 
igazgatas@oth.antsz.hu; tisztifoorvos@oth.antsz.hu 
http://www.antsz.hu 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Pharmaceuticals 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
National Public Health and Medical Officer Service - Office of the 
Chief Medical Officer (NPHMOS-OCMO) is responsible for the 
professional management, coordination and control of public health, 
epidemiology, health development (protection and maintenance of 
health, health education) and health administration activities, as well 
as the supervision (licencing and control) of healthcare. NPHMOS is 
directed by the Chief Medical Officer who fulfils his tasks under the 
direct supervision of the minister responsible for health. Department 
of Health Administration of NPHMOS-OCMO fulfils the CA tasks, 
there are about fifty officers in the country that can conduct 
inspections of TEs and other health care providers as well. 
Not applicable 

Not applicable. 

Yes 
By inspecting all procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
17 

9 

15 

20 

NA. 

Inspections of the site/centre 

No 

223 

 
 
 
 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 

2.5. How do you ensure, as CA for T&amp;C, that tests required 
for donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
Please specify 'other': 

2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and 
test procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.7.1. Please specify. 

3.8. Do you have any additional comments on testing? 

National Authorities are district institutes of public health under the 
direction of the government offices 
Other 

Laboratories must be licenced as health care providers, they have to 
comply professional requirements prescribed by legal rules. 
Authorized authorities inspect and control if they fulfil the legal 
requirements. 
Our databases do not contain all of data to answer this question, so we 
cannot give exact numbers. 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HCV-Ab 
Treponema Pallidum 
NAT testing can be done, but not compulsory.   

No 

Yes 

If it is necessary: RhD, HLA, malaria, CMV, Toxoplasma, EBV, 
Trypanosoma cruzi 
Yes 

Neisseria gonorrhoeae, Herpes genitalis, CMV, Chlamidia 
trachomatis, Trichomonas vaginalis 
Yes 

Using an international accreditation system is not mandatory for each 
laboratory 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments 
under your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses were 
suspended in 2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 

No 
0 

Yes 

10 

0 

224 

 
 
  
 
 
  
 
 
2004/23/EC), how many authorisations/accreditation/licenses were 
revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.3. How many ocular tissue establishments? 
4.7.4. How many cardiovascular tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.6. How many cord blood tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.3. How many ocular tissue establishments? 
4.9.4. How many cardiovascular tissue establishments? 
4.9.6. How many cord blood tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more 
than 1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue 
establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) 
during 2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors). 

Ocular tissue establishments 
Cardiovascular tissue establishments 
1 
1 
Cord blood tissue establishments 

2 
Ocular tissue establishments 
Cardiovascular tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
1 
2 
2 
1 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
2 
0 
2 
0 

1 
0 
2 
0 
1 
0 
4 
2 
7 
10 
0 

No 

Yes 

Officers of the National Public Health and Medical Officer Service - 
Office of the Chief Medical Officer, Department of Health 
Administration conducts inspections of tissue establishments. Those 
of our officers working in large cities of the country, inspect TEs 
located in the area, participating of medical supervisors if needed 
There are about fifty officers in the country that can conduct 
inspections of TEs and other health care providers as well. At least 

225 

 
 
 
 
 
 
  
 
 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for 
non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 
to 31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, or 
suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a 
whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 

two officers take part in an inspection, and one medical supervisor, 
the latter ones do not belong to the NPHMOS-OCMO, they are called 
upon for a single inspection by the NPHMOS-OCMO 
No 

10 

0 

0 

6 

3 

0 

0 

0 

2 

2 

0 

0 

1 

0 

0 

0 

0 

4 

226 

 
 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 
1 answer possible) 
5.6. How do you decide which type of routine inspection to 
conduct? 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.7.1. Why not? 

5.7.2. How do you prioritise tissue establishments to be inspected? 

5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? 
Joint inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised 
to import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised 
to export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for 

General system-oriented inspections 

In Hungary general system-oriented inspections are the common type 
of inspections 
No 

According to Hungarian legislation inspections are carried out 
„regularly”. In practice inspections are carried out yearly.  
General inspections by central arrangement, tissue establishments 
under licencing process, inspection due to patient complaint. 
However, inspections can be conducted more frequent than two years, 
due to some changing in activity of the TEs or other causes.  
Most of TEs were inspected at least twice between 2008-2011. 

No 

Each procurement site had to possess a cell or tissue establishment 
licence in 2011, even if it operated as a procurement site. 
No 
Because each establishment, which persuits activity connected with 
cells or tissues, must be a licenced tissue establishment. 
Yes 

Yes 

5 

No 

No 

No 

No 

Yes 

No 

0 

0 

NA. 

227 

 
 
  
 
 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 
6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) tissues 
from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from third 
countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than cord 
blood) from third countries. 
6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

NA. 

NA. 

NA. 

NA. 

NA. 

NA. 

No 

No 

No 

C. Export of tissues/cells is authorised irrespective of national needs 

No 

No 
Inspections of the tissue establishments 

Yes, but only via an authorised TE in my MS 

No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in 
EU and/or import/export of tissues/cells? In this context, a 
brokerage company means a body that arranges transactions 
between a supplier (tissue establishment/company selling tissues or 
cells) and a buyer (a tissue establishment/a hospital or clinic/an 
individual) without undertaking activities of processing, 
preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

No 

No 

No 

228 

 
 
  
 
 
  
 
 
Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 

No 
No 

60-99% 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web 
site. 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/89/EC, Art. 9)? Please specify. 

Yes 

The Hungarian law changed this summer, tissue establishments shall 
submit to the competent authority an annual report on these activities 
and this report shall be publicly available. The reports should be sent 
by 31 January next year. 
Yes 

https://www.antsz.hu/bal_menu/igazgatas/sejt_es_szovetbank_nyt.ht
ml 
Yes 

- tissues data - HPC data - ART data  

Tissue establishment 

Both paper records and electronic forms 

30 years data storage requirement is prescribed for all health care 
providers – including tissue establishments – in the Act XLVII of 
1997 on the Handling and Protection of Medical and Other Related 
Data 

9.5. Do you have any additional comments on traceability? 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of its organisation. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

National Public Health and Medical Officer Service - Office of the 
Chief Medical Officer (NPHMOS-OCMO) 
In case of serious adverse event or reaction the tissue establishment 
notifies the NPHMOS-OCMO, the NPHMOS-OCMO notifies the 
affected transplant institutes and the National Institute for Quality- 
and Organizational Development in Healthcare and Medicines. In 
case of serious adverse event or reaction the transplant institute 
notifies the NPHMOS-OCMO. The NPHMOS-OCMO performs the 
needed actions. 
Yes 

Yes 

Yes 

100% 

Yes 

In case of serious adverse event or reaction the transplant institute 

229 

 
 
  
 
 
  
 
 
10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please specify 
the number and which tissues were recalled and why (e.g. missing 
consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued 
via the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 
10.14. Do you notify alerts communicated via these tissues and 
cells national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

notifies the NPHMOS-OCMO. Legal rule determines the form of the 
report. The NPHMOS-OCMO then performs the needed actions. 
Yes 

If NPHMOS-OCMO receives a report on SAR/SAE from a health 
care provider, NPHMOS-OCMO performs the needed actions 
including notifying the affected tissue establishment. 
Yes 

If NPHMOS-OCMO receives a report on SAR/SAE from a EU 
member state, NPHMOS-OCMO performs the needed actions 
including notifying the affected tissue establishments. 
Yes 
0 

Yes 

In case of national rapid alert NPHMOS-OCMO performs the needed 
actions including notifying the affected tissue establishments and 
procurement sites. 
Yes 

In case of rapid alert from the EU, NPHMOS-OCMO performs the 
needed actions including notifying the affected tissue establishments 
and procurement sites. 
Yes 

All data. 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Yes 

5 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 

Explicit consent (opt-in) 

Basically, only a person with legal capacity may donate tissues, 
except for some circumstances. 
Presumed (opt-out) and explicit (opt-in) consent 

Primely presumed consent (opt-out) system is the sole system in 
Hungary, but every person can declare an objection in written form. 
Tissues may only be removed from cadaver donors if the deceased 
did not make a declaration opposing donation during his lifetime. A 
person with legal capacity may make a declaration in writing, or 
verbally at his attending physician in case of inability to, or 
significant difficulty in making a written declaration. A person with 
restricted legal capacity may make an opposition  declaration without 
his legal representative’s involvement. Such opposition declaration 

230 

 
 
  
 
 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
Please specify 'other'. 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third 
parties (Art. 14(1)). Please specify. 

11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice 
versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

may  be made on behalf of a person with no legal capacity by his 
legal representative.  
Other 

If the deceased is under age and no opposition declaration can be 
found, the organ or  
Yes 

Analysis of documentation 
Interviews with living donors 
Only trained personnel is allowed to provide such information 

Name of the donor cannot be recorded on the labelling of the tissue, 
only an identity number. The institution that removes the tissue from 
the donor, must apply the privacy rules of the health law. The 
competent authority controls if the institution applies the legal rules.   
Legal rule determines that that the identity of the recipient is not 
disclosed to the donor and vice versa. The competent authority 
controls if the institution applies the legal rules. 
Yes 

No 

Inspections of ART centres 

Medical records of the donor 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
Inspections of TEs and procurement sites 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 
12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, 
standards or governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

No 

No 

No 

Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 

231 

 
 
  
 
 
  
 
 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). 
(For this question "audit" means a documented review of 
procedures, records, personnel functions, equipment, materials, 
facilities, and/or vendors in order to evaluate adherence to the 
written SOP, standards or governments laws and regulations (from 
Council of Europe Guide to the Safety and Quality Assurance for 
the Transplantation of Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, 
responsible person, personnel? 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 

Yes 

Personnel of health care providers, including tissue establishments, 
have to take part in regular training programmes. Training 
programmes can be organized by medical universities, national 
professional institutes, health care providers. 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage 
conditions) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 

SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and 
safety requirements than those requested by the EU legislation in 
this field (e.g. restrictions concerning the donation/use of certain 
tissues/cells, mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 

No 

No 

Other 

The implementation of the Directive has only been completed this 
summer, as the IT system of NPHMOS-OCMO had to be developed. 
The Hungarian law (Decree 18 of 1998 of the Minister of Health) 
changed this summer (from 01.07.2013), tissue establishments shall 
submit to the competent authority an annual report on these activities 
and this report shall be publicly available. The reports should be sent 
by 31 January next year. 

232 

 
 
  
 
 
  
 
 
  
 
 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

No shortcomings 

233 

 
 
 
 
 
A.1.14. 

Survey response Ireland 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 

1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 
answer possible) 

Please specify 'other': 

1.1.7. What are the role/tasks of the NCA? (more than 
1 answer possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status 
and organisation of the National Competent 
Authority(ies) (e.g. departments, staffing, number of 
senior and junior inspectors, staff working on EU 
affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised 
systems, please indicate the roles/tasks of the Regional 
Competent Authority(ies). (more than 1 answer 
possible) 
1.7. Could you please describe the 
competence/mandate of the Regional Competent 
Authority(ies) and their relation with the National 
Competent Authority(ies) for tissues and cells: 

Irish Medicines Board 
Irish Medicines Board,  Kevin O Malley House, Earlsfort Centre,  Earlsfort 
Terrace, Dublin  2, Ireland  
00353 -1- 6764971 
compliance@imb.ie 
www.imb.ie 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
Vetinary Products, Cosmetic Products, Advanced Therapy Medicinal Products, 
Clinical Trials approval, Protection of Animals.  
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
Overseeing recalls, Advice to the Government, International Representation, 
Enforcement.  
No 
There are four (4) departments directly involved in carrying out IMB's reglatory 
functions:  1:Compliance (Inspections and audits, Market compliance and 
enforcememt),  2: Human Products Authorisation and Registration (licensing of 
medicines for human use, designation and monitoring of notified bodies for 
medical devices, registration of medical devices)  3: Human products monitoring 
(monitoring of safety of medicines for human use, blood and blood components, 
tissues and cells and medical devices),  4: Vetinary Sciences (licensing and safety 
of medicines for human use, scientific animal protection).  There are three (3) 
departments which provide cross organisational support: 1: Finance and corporate 
affairs, 2: human resources, 3: IT management and an office of the Chief 
Executive.   Overall there are approximately 300 staff working in the Irish 
Medicines Board.  In the Compliance department there are currently 
approximately 21 inspectors working accross different specialities including 
GMP, GDP, GCP, Blood ,Tissues & Cells and Organs (BTO). There is a 
dedicated team for Tissues & Cells inspection comprised of the BTO manager, 
two BTO inspectors and a BTO scientific officer.  The BTO manager and  BTO 
inspectors represent the competent authority at an EU level through participation 
in European Commission competent authority meetings, EU working groups and 
the development of best practice guidance in the field of Tissues and Cells.  The 
human products monitoring department is made up of pharmacovigilance, 
medical devices vigilance and human products vigilance assessment, comprising 
of approximately 40 staff, there is 1 dedicated Tissue & Cells vigilance officer.   
The Irish Medicines Board is 85% Self funded through licensing, inspection fees, 
The remainder is funded by the Irish Department of Health.  
Not applicable 

Not applicable  

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"?  Yes 

234 

 
 
 
 
 
2.1.1. How do you authorise the "conditions of 
procurement"? (more than 1 answer possible) 
2.1.2. How many such authorisations were granted in 
2011 (01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement centres 
in which procurement of "traditional tissues and cells" 
(skeletal tissues, cardiovascular tissues, skin, ocular 
tissues, amniotic membrane, pancreatic islet, 
hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers 
in which procurement of haematopoietic stem cells 
(bone marrow, PBSC, cord blood etc.) were carried out 
in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers 
in which procurement of gametes, embryos and other 
reproductive tissues were carried out in 2011 (01/01-
31/12/2011). 
2.2.4. Please provide the number of procurement 
centers in which procurement of tissues/cells for 
ATMP manufacturing were carried out in 2011 (01/01-
31/12/2011). 
2.3. How do you ensure that procurement centres 
comply with the requirements laid down in Art. 5 of 
Directive 2004/23/EC and its implementing Directive 
2006/17/EC (e.g. trained personnel, conditions 
accredited, designated, authorised, licensed) ? (more 
than 1 answer possible) 
2.4. Are you also responsible for the accreditation, 
designation, authorisation or licensing of laboratories 
performing donor testing? 
2.4.2. Which National Authority is in charge of this 
activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests 
required for donors are carried out only by qualified 
laboratories accredited, designated, authorised or 
licensed Art. 5(2))? (more than 1 answer possible) 
Please specify 'other': 

2.6. Please provide data on qualified laboratories 
accredited, authorised or licensed in your country (e.g. 
number, year of accreditation/authorisation/license, 
which donor tests are performed etc.). 
2.7. Do you have any additional comments on 
procurement? 

By inspecting all procurement centres 

none 

 4 

6 

9 

1 - cartilage for extraction of chondrocytes for use in ATMP (processing 
performed in another EU Member State) 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

Irish National Accreditation Board (INAB) 

Analysis of the mandatory documentation requested from the tissue establishment 
Other 

All laboratories that perform tests required for donors are listed on each Tissue 
Establishment's Authorisation. Each laboratory is required to be accredited by the 
Irish National Accreditation Board. 
11 testing laboritories in Ireland who perform tests required for donors; testing at 
time of donation performed  as per Directive requirements: AntiHIV1, AntiHIV2, 
HBsAG,Anti HBc, Anti- HCV-Ab, HTLV - 1 and 2 (when required) Treponema 
Pallidum must be excluded  
Where procurement occurs in Ireland, the activity is inspected and the site 
requires a Tissue Establishment Authorisation. If the procurement occurs outside 
Ireland, inspection of relevant documentation occurs onsite at the Irish Tissue 
Establishment. 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors 
of non-reproductive tissues and cells in your Member 
State. (more than 1 answer possible) 

3.2. Please specify laboratory tests required for donors 
of reproductive tissues and cells in your Member State. 
(more than 1 answer possible) 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 

235 

 
 
 
 
3.3. If NAT testing is not mandatory in your country, 
could you please indicate whether you intend to make it 
mandatory or to encourage its use? Please specify why 
or why not (e.g. number of additional cases detected, 
cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available 
tests and test procedures for deceased donors? 
3.4.1. Please specify why: 

3.5. Are any other laboratory tests required for donors 
of non-reproductive tissues and cells in your Member 
State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors 
of reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation 
systems for testing laboratories? 
3.7.1. Please specify. 

3.8. Do you have any additional comments on testing? 

NAT testing would be encouraged by the NCA; However, a national decision 
would be required and currently no plans in place. 

Yes 

Post mortem testing may be compromised due to hemolyis, autolysis or bacterial 
contamination which could lead to the detection of false negatives / positives. 
There are currently no CE marked comercially available tests on the market. 
However, no post mortem procurement of tissues and cells occurs in Ireland 
Yes 

HTLV-1 testing of donors living in or originating from areas of high prevalence 
as per Directive 
Yes 

HTLV-1 testing of donors living in or originating from areas of high prevalence 
as per Directive. NAT chlamydia tesing is obligatory for non partner sperm 
donations as per Directive. 
Yes 

Yes, in Ireland, the Irish National Accreditation Board accredit such laboratories 
to the International Standard for Medical Testng Laboratories ISO15189. 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
Yes 
4.1. Do you have a system of designation, 
authorisation, accreditation or licensing for all types of 
tissue establishments under your responsability? 
4.2. Is inspection a prerequisite for the designation, 
authorisation, accreditation or licensing of tissue 
establishments? 
4.2.1. How many inspections were performed in 2011 
for authorising/accrediting/licensing/designating TEs? 

Yes 

No applications for Tissue Establishment Authorisation were received in 2011. 
All existing Tissue Estalishments had been authorised in 2011. 3 inspections were 
performed in relation to applications to vary /change the existing Tissue 
Establishment Authorisations. Routine (two yearly) inspections of tissue 
establishments were also performed. 
Yes 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
none 

4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer 
possible) 

4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external 
entity to a quality system standard (e.g. ISO, JACIE, 
FACT)? 

none 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending 
approval at 01/01/2011 (more than 1 answer possible): 
4.7.2. How many musculo-skeletal tissue 
establishments? 
4.7.4. How many cardiovascular tissue establishments? 
4.8. Tissue establishments with authorisations pending 

Musculo-skeletal tissue establishments 
Cardiovascular tissue establishments 
1 

1 
Cardiovascular tissue establishments 

236 

 
 
  
 
 
 
 
approval by 31/12/2011 (more than 1 answer possible): 
4.8.4. How many cardiovascular tissue establishments? 
4.9. Tissue establishments first time authorised 
between 01/01/2011 and 31/12/2011 (more than 1 
answer possible): 
4.9.2. How many musculo-skeletal tissue 
establishments? 
4.10. All tissue establishments authorised by 
31/12/2011 (more than 1 answer possible): 

4.10.2.1. How many public musculo-skeletal tissue 
establishments? 
4.10.2.2. How many private musculo-skeletal tissue 
establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue 
establishments? 
4.10.6.1. How many public cord blood tissue 
establishments? 
4.10.6.2. How many private cord blood tissue 
establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue 
establishments? 
4.10.8.1. How many public multi-tissue 
establishments? 
4.10.8.2. How many private multi-tissue 
establishments? 
4.11. How many tissues and cells were distributed 
under the direct agreement of the Competent Authority 
according to Art. 6(5) during 2011? Please provide 
number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national 
provisions pursuant to the Directive been defined 
(Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on 
accreditation, authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and 
control measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the 
CA in charge of inspections. 
5.1.2. If yes, please specify staffing (how many 
inspectors). 
5.2. Does the inspection scheme interact or overlap 
with the inspection scheme of other activities, for 
example blood, pharmaceuticals, etc. (e.g. same 
inspector team, common training, common 
documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer 
possible) 

5.3. How many routine inspections of tissue 
establishments for non-reproductive tissues/cells were 
conducted in 2011 (from 1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments 

1 
Musculo-skeletal tissue establishments 

1 

Musculo-skeletal tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
1 

2 

2 
none 

none 

1 

none 
9 

3 

1 

None  

Yes 

No 

Yes 

The compliance department of the Irish Medicines Board are in charge of 
inspections.  
1 Blood, Tissues and Organs Manager, 2 Blood, Tissues and Organs Inspectors, 1 
Blood, Tissues and Organs Scientific Officer. 
Yes 

Blood 
Organs 
Advanced therapies 
6 

none 

237 

 
 
 
 
  
 
 
for non-reproductive tissues/cells were conducted  in 
2011 (from 1/1/2011 to 31/12/2011) following serious 
adverse events or reactions, or suspicion thereof ? 
5.3.2. How many other type of inspections of tissues 
establishments for non-reproductive tissues/cells were 
conducted in 2011 (from 1/1/2011 to 31/12/2011) (e.g. 
due to a whistle-blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were 
observed? 
5.3.4.  Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where minor shortcomings were 
noted? 
5.3.5. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where major shortcomings were 
noted? 
5.3.6. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number of 
inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number of 
inspections carried out that were followed by closure? 
5.3.8. Outcome of inspections of TEs for non-
reproductive tissues/cells conducted in 2011 
(01/01/2011 to 31/12/2011): What was the number of 
other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in 
ART establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or 
reactions, or suspicion thereof (from 1/1/2011 to 
31/12/2011)? 
5.4.2. How many other type of inspections were 
conducted on ART establishments (from 1/1/2011 to 
31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.4.3. Outcome of inspections of ART tissue 
establishments carried out in 2011 (01/01/2011 to 
31/12/2011): What was the number of inspections 
carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out 
in ART establishments where minor shortcomings were 
noted? 
5.4.5. What was the number of inspections carried out 
in ART establishments where major shortcomings were 
noted? 
5.4.6. What was the number of inspections carried out 
in ART establishments followed by suspension of 
authorisation? 
5.4.7. What was the number of inspections carried out 
in ART establishments followed by closure of 
respective establishements? 

none 

none 

5 

5 

none 

none 

none 

4 

none 

There were three (3) inspections performed which reviewed applications to vary 
the existing Tissue Establishment Authorisations of two ART clinics.  

none 

6 

1 

none 

none 

238 

 
 
5.4.8. What was the number of other inspections of 
ART establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? 
(more than 1 answer possible) 
5.6. How do you decide which type of routine 
inspection to conduct? 

5.7. Until 2011, did you implement the requirement 
concerning the time interval between two inspections 
(Art. 7.3.)? 
5.8. How many TEs were inspected at least twice 
between 2008-2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of 
procurement sites outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational 
Manual for Competent Authorities on inspection of 
tissue and cell procurement and tissue establishments - 
Guidelines for inspections (Commission Decision 
2010/453/EU)? 
5.12. Did you send any of your inspectors to the 
training courses organised by EU-funded projects (e.g. 
EUSTITE, SOHO V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and 
efficacy of these training courses on a scale from 1 to 5 
(1 = not important, 2 = sufficient, 3 = good, 4 = very 
good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the 
NCA in that MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another 
MS in collaboration with the NCA in that MS (Art 
7(6))? 
5.15. Did you organise any inspections of procurement 
centres or tissue establishments in third countries from 
which tissues and/or cells were imported in your 
country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been 
requested by any other MS, on the results and control 
measures of your inspections, as part of an 
enquiry/investigation? 
5.17. Would you be interested in developing joint 
inspections? Joint inspections should be understood as 
inspections of tissue establishments conducted jointly 
by two or more Member States' Competent Authorities 
on their territory or in third countries. 
5.18. Do you have any additional comments on 
inspections? 

3 - There were three (3) inspections performed which reviewed applications to 
vary the existing Tissue Establishment Authorisations of two (2) ART clinics.  
General system-oriented inspections 

All routine TE inspections comprise of a detailed on-site review of the quality 
system and processes along with a review of any issues or serious adverse events / 
reactions (SAE/R's) that may have occured since the last inspection. Routine 
inspections are performed on-site no less than once every two years as per 
Directive.  
Yes 

19 

No 

Where procurement occurs in Ireland, the activity is inspected and the site 
requires a tissue establishment authorisation. If the procurement occurs outside of 
Ireland, inspection of the relevant documentation occurs onsite at the irish tissue 
establishment  
No 
Performing external auditing is mandatory to all TEs and is reviewed as part of 
the routine IMB inspection 
Yes 

Yes 

5 

No 

No 

No 

No 

Yes 

The NCA would encourage the development of joint inspections, however, a 
controlled approach to their development is needed, specifically, with respect to 
the joint inspection of sites outside of the EEA.  

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue 
establishments that are explicitly authorised to perform 

No 

239 

 
 
 
 
import/export of tissues and celles from/to third 
countries? 
6.2. Please specify the number of tissue establishments 
authorised to import tissues and cells from third 
countries (recorded by 31/12/2011). 
6.3. Please specify the number of tissue establishments 
authorised to export tissues and cells from third 
countries (recorded by 31/12/2011). 
6.4. Please specify which procedures you have in place 
for verifying the equivalent standards of quality and 
safety for importation of skin from third countries. 
6.5. Please specify which procedures you have in place 
for verifying the equivalent standards of quality and 
safety for importation of musculo-skeletal (bone, 
tendons, fascia etc.) tissues from third countries. 

6.6. Please specify which procedures you have in place 
for verifying the equivalent standards of quality and 
safety for importation of ophtalmic (cornea, sclera, etc) 
tissues from third countries. 

6.7. Please specify which procedures you have in place 
for verifying the equivalent standards of quality and 
safety for importation of cardio vascular tissues from 
third countries. 

6.8. Please specify which procedures you have in place 
for verifying the equivalent standards of quality and 
safety for importation of haematopoietic stem cells 
(HSC) (other than cord blood) from third countries. 

7 

7 

The importation of skin is not performed in Ireland.  

TE's that wish to import Tissues and Cells on a routine basis from a site outside 
the EEA are required to list this activity on their TE authorisation.In authorising 
this routine import, the IMB performs a detailed review of the documentation 
supplied by the tissue establishment including the national accreditation status of 
the third country site and the service level agreement (SLA) between both parties. 
TE's that wish to import tissues and cells on a non routine basis, must notify the 
IMB of their intent to import using IMB documentation and will document this 
import as a planned deviation. TE's that wish to import Tissues and Cells on a 
routine basis from a site outside the EEA are required to list the exporting site on 
their TE authorisation. In authorising this non - routine import, the IMB performs 
a detailed review of the documentation supplied by the tissue establishment 
including the national  and international accreditation status of the third country 
site and the service level agreement (SLA) between both parties. A follow up 
review this non routine import is perfomed onsite as part of the routine Irish TE 
inspection. 
TE's that wish to import Tissues and Cells on a routine basis from a site outside 
the EEA are required to list this activity on their TE authorisation.In authorising 
this routine import, the IMB performs a detailed review of the documentation 
supplied by the tissue establishment including the national accreditation status of 
the third country site and the service level agreement (SLA) between both parties. 
TE's that wish to import tissues and cells on a non routine basis, must notify the 
IMB of their intent to import using IMB documentation and will document this 
import as a planned deviation. TE's that wish to import Tissues and Cells on a 
routine basis from a site outside the EEA are required to list the exporting site on 
their TE authorisation. In authorising this non - routine import, the IMB performs 
a detailed review of the documentation supplied by the tissue establishment 
including the national  and international accreditation status of the third country 
site and the service level agreement (SLA) between both parties. A follow up 
review this non routine import is perfomed onsite as part of the routine Irish TE 
inspection. 
TE's that wish to import Tissues and Cells on a routine basis from a site outside 
the EEA are required to list this activity on their TE authorisation.In authorising 
this routine import, the IMB performs a detailed review of the documentation 
supplied by the tissue establishment including the national accreditation status of 
the third country site and the service level agreement (SLA) between both parties. 
TE's that wish to import tissues and cells on a non routine basis, must notify the 
IMB of their intent to import using IMB documentation and will document this 
import as a planned deviation. TE's that wish to import Tissues and Cells on a 
routine basis from a site outside the EEA are required to list the exporting site on 
their TE authorisation. In authorising this non - routine import, the IMB performs 
a detailed review of the documentation supplied by the tissue establishment 
including the national  and international accreditation status of the third country 
site and the service level agreement (SLA) between both parties. A follow up 
review this non routine import is perfomed onsite as part of the routine Irish TE 
inspection. 
TE's that wish to import Tissues and Cells on a routine basis from a site outside 
the EEA are required to list this activity on their TE authorisation.In authorising 
this routine import, the IMB performs a detailed review of the documentation 
supplied by the tissue establishment including the national accreditation status of 
the third country site and the service level agreement (SLA) between both parties. 

240 

 
 
TE's that wish to import tissues and cells on a non routine basis, must notify the 
IMB of their intent to import using IMB documentation and will document this 
import as a planned deviation. TE's that wish to import Tissues and Cells on a 
routine basis from a site outside the EEA are required to list the exporting site on 
their TE authorisation. In authorising this non - routine import, the IMB performs 
a detailed review of the documentation supplied by the tissue establishment 
including the national  and international accreditation status of the third country 
site and the service level agreement (SLA) between both parties. A follow up 
review this non routine import is perfomed onsite as part of the routine Irish TE 
inspection. 
TE's that wish to import Tissues and Cells on a routine basis from a site outside 
the EEA are required to list this activity on their TE authorisation.In authorising 
this routine import, the IMB performs a detailed review of the documentation 
supplied by the tissue establishment including the national accreditation status of 
the third country site and the service level agreement (SLA) between both parties. 
TE's that wish to import tissues and cells on a non routine basis, must notify the 
IMB of their intent to import using IMB documentation and will document this 
import as a planned deviation. TE's that wish to import Tissues and Cells on a 
routine basis from a site outside the EEA are required to list the exporting site on 
their TE authorisation. In authorising this non - routine import, the IMB performs 
a detailed review of the documentation supplied by the tissue establishment 
including the national  and international accreditation status of the third country 
site and the service level agreement (SLA) between both parties. A follow up 
review this non routine import is perfomed onsite as part of the routine Irish TE 
inspection. 
TE's that wish to import Tissues and Cells on a routine basis from a site outside 
the EEA are required to list this activity on their TE authorisation.In authorising 
this routine import, the IMB performs a detailed review of the documentation 
supplied by the tissue establishment including the national accreditation status of 
the third country site and the service level agreement (SLA) between both parties. 
TE's that wish to import tissues and cells on a non routine basis, must notify the 
IMB of their intent to import using IMB documentation and will document this 
import as a planned deviation. TE's that wish to import Tissues and Cells on a 
routine basis from a site outside the EEA are required to list the exporting site on 
their TE authorisation. In authorising this non - routine import, the IMB performs 
a detailed review of the documentation supplied by the tissue establishment 
including the national  and international accreditation status of the third country 
site and the service level agreement (SLA) between both parties. A follow up 
review this non routine import is perfomed onsite as part of the routine Irish TE 
inspection. 
Yes 

7 TE's inported tissues and cells in 2011. 4 non ART establishments and 3 ART 
establishments.  2 PBSC's 1 Donor Lymphocyte 4 Cord Blood 34 Bone  11 
Pericardium 20 Amnion  14 Sclera 168 Corneas 2040 imports of gametes and 
embryos from 3 ART clinics.   
Yes 

export of 734 units to a country outside the EEA.  

No 

D. Import of tissues/cells is authorised only after checking that local/national 
needs are not fulfilled 
E. Import of tissues/cells is authorised based on estimations showing that there is 
chronic deficiency of those tissues/cells 
Tissues and Cells are imported to Irish Tissue Establishments in cases where 
Ireland does not provide the resources for patients (e.g procurement of post 

241 

6.9. Please specify which procedures you have in place 
for verifying the equivalent standards of quality and 
safety for importation of cord blood from third 
countries. 

6.10. Please specify which procedures you have in 
place for verifying the equivalent standards of quality 
and safety for importation of reproductive cells (sperm, 
egg cells) from third countries. 

6.11. Did you import tissues/cells from 3rd countries 
during 2011 (01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by 
country of origin. 

6.12. Did you export tissues/cells from 3rd countries 
during 2011 (01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by 
country of destination. 
6.13. Are you aware of any significant changes in 2012 
which may invalidate the 2011 data on imports/exports 
of tissues/cells between your country and other third 
countries? 
6.14. What is the relation between import/export of 
tissues and cells and self-sufficiency? (more than 1 
answer possible) 

6.14.1. If A or D were selected, please explain how you 
quantify local/national needs. 

 
 
6.15. Did you authorise direct imports of tissues/cells 
to hospitals/clinics in your country? 
6.16. Do you have any additional comments on 
import/export? 

mortem bone, patient specific bone marrow) 
No 

The development of guidance by the European working group for import/ export 
of Tissues and Cells is required and the IMB is participating in this working goup. 

It is the responsibility of the TE to perform distribution of tissues and cells in 
compliance with the requirements of the Directive.  

Yes, no restrictions apply 

No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues 
and cells? 
7.2. How do you ensure that tissues establishments 
fulfil the requirements of Art. 23 of Directive 
2004/23/EC regarding quality of tissues and cells 
during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics 
in your MS from TEs in another MS? (only 1 answer 
possible). 
7.4. Have you authorised direct distribution to the 
recipient of specific tissues and cells (Art. 6, Directive 
2006/17/EC)? 
7.5. Do you collect data regarding the cross-border 
exchange of tissue/cells between your country and 
other EU MS? 
7.5.1. Please provide us with data (country of 
destination, type of tissue/cell and number of units 
distributed) concerning distribution to other MS in 
2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, 
type of tissue/cell and number of units distributed) 
concerning distribution to other MS in 2011 
(01/01/2011-31/12/2011) 

Yes 

No 

Allogenic Peripheral Blood Stem Cells - 4 units distributed within the EEA 

Bone Marrow Allogenic - 9 Accepted from within EEA Peripheral Blood Stem 
Cells Allogenic - 14 Accepted from within EEA Bone - 21 Accepted from within 
EEA Sclera - 4 Accepted from within EEA Amniotic Membrane - 3 Accepted 
from within EEA Heart Valves - 13 Accepted from within EEA Donor 
Lymphocyte - 1 Accepted from within EEA Tendons - 5 Accepted from within 
EEA Corneas - 5 Accepted from within EEA     
No 

No 

Yes 

Another country 
There are no Irish brokers actively supplying healthcare professionals / 
establishments in Ireland. However, as no restrictions apply to the distribution of 
tissues and cells to Ireland from brokers within the EU, it is difficult to control the 
quality and safety requirements, specifically with respect to the reporting of 
SAE/R's traceability and recall notifcation.  
The development of guidance in the control of distribution across the EU and 
directly to health care professionals and recipietns is required.  

7.6. Are you aware of any significant changes in 2012 
which may invalidate the 2011 data on cross-border 
exchanges of tissues/cells between your country and 
other EU MS? 
7.7. Do you allow brokerage companies for either 
distribution in EU and/or import/export of tissues/cells? 
In this context, a brokerage company means a body that 
arranges transactions between a supplier (tissue 
establishment/company selling tissues or cells) and a 
buyer (a tissue establishment/a hospital or clinic/an 
individual) without undertaking activities of 
processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.8.1. Where are the brokers located? 
7.8.2. If the broker is located in another country, how 
easy/difficult is it to ensure that safety and quality 
requirements are met? 

7.9. Do you have any additional comments on 
distribution? 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on 
the activities of tissue establishments in your Member 
State? (Article 10(1)). If yes, please upload the 
template. 
8.2. How many tissue establishments submitted annual 
reports of their activities during 2011. Please provide 

100% (all) 

Yes 

242 

 
 
 
 
 
 
an estimation. (1 answer possible) 
8.3. Are these reports publicly available? (Article 
10(1)) 
8.4. Do you publish a national annual report of the 
consolidated activities of all tissue establishments in 
your country? 
8.4.2. If no, why not? 

8.5. Is there a publicly accessible register of authorised 
tissue establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the 
register's web site. 

8.6. Do you provide data regarding tissues and cells 
activities to the EUROCET registry (non-mandatory 
reporting)? 
8.6.2. If no, why not? 

8.7. Do you have any additional comments on 
reporting? 

No 

No 

This is currently being progressed. Our stakeholders will be consulted in this 
regard as any annual activity data may be sensitive particularly in the ART field. 
Yes 

http://www.imb.ie/EN/Blood-Tissues--Cells/Blood--Tissue-Establishments-
.aspx?page=1&name=&orderby=name&orderascending=True&type=3&sitestatus
=1&withdrawdate= 
No 

The IMB are not legally required to submit data regarding tissues and cells 
activity to the EUROCET registry. It is felt that the submission of data requires 
resources not currently available to the IMB. In addition, the IMB have not 
established agreements with their TE's to submit their data to a publicly accessible 
registry.  

Yes 

Tissue establishment 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) 
implemented in your country? 
9.2. Who assigns the unique code for each donation? 
(only 1 answer possible) 
9.3. How is the data storage for traceability purposes 
organised in your tissue establishements (Art 8(4))? 
(only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage 
requirement is respected (Directive 2006/89/EC, Art. 
9)? Please specify. 
9.5. Do you have any additional comments on 
traceability? 

Both paper records and electronic forms 

This area is reviewed as part of the inspection process. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place 
(for the reporting of serious adverse events and 
reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its 
organisation. 

Yes 

Irish Medicines Board - Tissue & Cell Vigilance  
Blood Tissues and Organs Vigilance Officer is responsible for the receipt and 
analysis of SAE/Rs and provides information to BTO inspectors for follow up 
during inspections of TEs. 
Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). 
Do you use the SAR/E (to the CA (2006/76 art 6.4)) 
templates developed to the Annual reporting ot the EC 
also at national level? 
10.3. Do you use the Common Approach Document 
developed for the Annual reporting to the EC also at 
national level? 
10.4. Do you have a dedicated vigilance officer in 
charge of collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 
2011 the SAR/SAE data as requested (please provide 
the % from the total number of TEs authorised in your 
country). 
10.6. Do you have a mandatory procedure for the 
transplantation centres when reporting SAR/SAE to the 
TEs which distributed the tissues/cells (Art 11.2)? 

Yes 

Yes 

100% 

Yes 

243 

 
 
  
 
 
  
 
 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding 
SAR/SAE recorded at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding 
SAR/SAE recorded at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall 
procedure? 
10.10. How many recalls related to safety and quality 
of tissues/cells were issued in your country in 2011? 
Please specify the number and which tissues were 
recalled and why (e.g. missing consent, quality defects 
etc). 
10.11. Do you have in place a system/procedure to 
notify Tissue Establishments and procurement sites in 
case of a national rapid alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to 
notify Tissue Establishments and procurement sites 
when a rapid alert is issued via the EU RATC 
platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 

10.14. Do you notify alerts communicated via these 
tissues and cells national vigilance system also to other 
national vigilance/alert systems? 
10.14.1. If yes, please specify which of the following 
systems are usually contacted. (more than 1 answer 
possible) 

Please specify 'other'. 
10.15. Did you send a vigilance officer/contact point to 
the trainings organised by the EU-funded project 
SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and 
efficacy of these trainings on a scale from 1 

In accordance with this legislation, the IMB has established a reporting system for 
the notification of suspected Serious Adverse Reactions (SARs) and Serious 
Adverse Events (SAEs) associated with human tissues and cells.    All Tissue 
Establishments are required, through the Responsible Person (or designee), to 
notify the IMB of and provide a report analysing the cause of and ensuing 
outcome of:    •Any serious adverse events and reactions which may influence the 
quality and safety of tissues and cells and which may be attributed to the 
procurement, testing, processing, storage and distribution of tissues and cells;  
•Any serious adverse reaction observed during or after clinical application which 
may be linked to the quality and safety of tissues and cells  The reporting 
requirements to the IMB are inclusive of:  - In the case of assisted reproduction, 
any type of gamete or embryo misidentification or mix-up, which shall be 
considered a serious adverse event;  - ‘Near miss’ reports where the event was 
detected prior to transplantation.    All reports are submitted using the IMB Guide 
to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events 
(SAEs) associated with Human Tissues and Cells together with the IMB Adverse 
Reaction / Event Report Form – Human tissues and Cells . These documents may 
be dowloaded and posted into the IMB or submitted via an on-line form available 
on the IMB website 
Yes 

An annual report of all SAE/Rs reported is issued to all Tissue Establishments.  
Yes 

Information on SAR/SAEs recorded at EU level are provided if they directly 
impact TE's in Ireland and for learning purposes. 
Yes 

No recalls have been performed in Ireland to date.  

Yes 

The IMB provide national rapid alert information to all affected sites through 
email notification and issue guidance on the required management procedures.  
Yes 

The IMB provide rapid alert information to all affected sites through email 
notification and issue guidance on the required management procedures.  
No 

This is primarily a resource issue. This information is already provided on an 
annual basis to the EC and would be a doubling of effort. 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Other 
organ vigilance system (also managed by IMB) 
Yes 

5 

244 

 
 
(insufficient) - 2 (sufficient)  3 (good) - 4 (very good) 
to 5 (essential)? 
10.16. Do you have any additional comments on SARE 
reporting? 

Explicit consent (opt-in) 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell 
donation do you have in place within your Member 
State? 
11.1.1. Please specify your choice of consent system 
for living tissue/cell donation. 
11.2. What consent system for deceased tissue/cell 
donation do you have in place within your Member 
State? 
11.3. According to your national legislation, in case of 
deceased donations, please specify who is giving the 
authorisation for the tissue donation? (more than 1 
answer possible) 
11.4. Is the consent system for deceased tissue donation 
the same as for organs? 
11.5. How is this consent verified during inspections? 
(more than 1 answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of 
donors are provided with the appropriate information, 
as requested by Art. 13(2)? (more than 1 answer 
possible) 
Please specify 'other'. 

Analysis of documentation 

Other 

Yes 

Consent to be revised as part of the development of a national Human Tissues 
Act. Until its completion - Explicit consent (opt in)  
Explicit consent (opt-in) 

First degree relatives (including spouse) 

11.7. What measures are in place to ensure that both 
donors and recipients remain unidentifiable when 
access is given to third parties (Art. 14(1)). Please 
specify. 
11.8. Please specify what measures are in place to 
ensure that the identity of the receipient is not disclosed 
to the donor and vice versa. 
11.9. Does your national legislation allows disclosure 
of donor data in case of gametes donation? 
11.9.1. If no, please specify the circumstances and 
measures in place. 

11.10. Do you have any additional comments on 
consent and data protection? 

Inspection of donor file, health and lifestyle questionnaires, information provided 
to donors and their families and practice (as per S.I 158 of 2006 - Schedule 1 - 6 ).  
All TEs are required to comply with Data Protection Legislation here in Ireland. 
A unique identifcation number is given to both donors and recipients and applied 
to all documentation relating to the transplantation procedure.  

All TEs are required to comply with Data Protection Legislation here in Ireland. 
A unique donor code is appied at donation and is used within the TE at all times. 

No 

There is no legislation in Ireland in this area. No donor sperm is procured here in 
Ireland. All donor sperm is obtained from another EU Member state. The donor 
disclosure rules in that MS would have to be applied to these donors. 

Inspections of TEs and procurement sites 
Audit of documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related 
to the evaluation and selection of donors (except 
donors of reproductive cells) are respected in your 
country (Art. 15(1), Annex I Directive 2006/17/EC)? 
(more than 1 answer possible) 
12.2. How do you ensure that all requirements related 
to the evaluation and selection of donors of 
reproductive cells are respected in your country (Art 15 
(1), Annex III of Directive 2006/17/EC)? (more than 1 
answer possible) 
12.3. Do you have more stringent criteria for donor 
selection than those listed in Annex I of the Directive 
2006/17/EC? 
12.4. What sources are required in your MS for the 
evaluation of a deceased donor of tissues/cells? (more 
than 1 answer possible) 
12.5. Do you have more stringent criteria for selection 

Inspections of ART centres 
Audit documentation 

No 

No 

Interview with the donor's family or a person who knew the donor well 
Medical records of the donor 

245 

 
 
  
 
 
  
 
 
No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation centre, ART 
centre) 

of donors of reproductive cells than those listed in 
Annex III of the Directive 2006/17/EC? 
12.6. Do you have more stringent criteria for 
autologous donation than those listed in Annex I of the 
Directive 2006/17/EC? 
12.7. Do you require more information on the donation 
of tissues/cells than the mandatory one as laid down in 
the Annex of Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements 
regarding tissues and cells' procurement, packaging and 
transport are complied with by tissue establishments in 
your country (Art 15(1), Annex IV of Directive 
2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of 
procedures, records, personnel functions, equipment, 
materials, facilities, and/or vendors in order to evaluate 
adherence to the written SOP, standards or 
governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance for 
the Transplantation of Organs, Tissues and Cells, 
2011)) 
12.9. Do you have any additional comments on 
selection, evaluation and procurement? 

Authorisation requirement 
Inspections 
Internal audits 
External audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in 
your country have in place a quality system respecting 
the provisions of the Directive 2004/23/EC Art 16.1? 
(more than 1 answer possible). (For this question 
"audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, 
facilities, and/or vendors in order to evaluate adherence 
to the written SOP, standards or governments laws and 
regulations (from Council of Europe Guide to the 
Safety and Quality Assurance for the Transplantation 
of Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments 
have a responsible person fulfilling the requirements of 
Art. 17(1)? (more than 1 answer possible) 
13.3. How do you ensure an appropriate training for the 
personnel directly involved in the activities of tissue 
establishments? (more than 1 answer possible) 
13.4. Do you have national/regional/local training 
programmes for the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 

Yes 

It is the responsibility of the tissue establishments to develop their own internal 
training processes as per Article 18 of Directive. This is reviewed on inspection. 
The TEs define the qualification and training of personnel. 

13.5. Any additional comments on quality 
management, responsible person, personnel? 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in 
your country fulfill the requirments of the Art. 19 
(Tissue and cell reception) of Directive 2004/23/EC 
and Annex IV of Directive 2006/17/EC? (more than 1 
answer possible) 
14.2. How do you ensure that tissue establishments in 
your country fulfill the requirements of the Art. 20 
(Tissue and cell processing) of Directive 2004/23/EC? 
(more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in 
your country fulfill the requirements of Art. 21 (tissue 
and cell storage conditions) of Directive 2004/23/EC? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 

SOPs for procedures associated with storage of tissues and cells are mandatory 
for authorisation 
Inspections of tissue establishments 

246 

 
 
  
 
 
  
 
 
(more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in 
your country fulfill the requirements of Art. 22 
(labelling, documentation and packaging) of Directive 
2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.5. Any additional comments on reception, 
processing, storage, labelling and packaging? 

SOPs for procedures associated with labelling and packaging  are mandatory for 
authorisation 
Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
Yes 
15.1. Are third party agreements foreseen/allowed in 
your national legislation? 
15.1.1. If yes, have tissue establishments in your 
Member State notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 

Yes 

15.1.1.2. How are third party agreements controlled 
(Art 6.2) by the Competent Auhtority(ies) in your MS? 
Please specify. 
15.2. Any additional comments on third party 
agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent 
quality and safety requirements than those requested by 
the EU legislation in this field (e.g. restrictions 
concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any 
difficulties in implementing the requirements in the EU 
Tissues and Cells Directives? Please choose from the 
options below. 
16.2.1. For all selected options in question 16.2., please 
provide a short description. 
16.3. In your opinion, in which of the following 
Directives are there shortcomings (if any)? (more than 
1 answer possible) 

The import and export of tissues and cells -  For service providers - e.g 
maintenance, testing, suppliers -   For sites performing prescribed activities on 
behalf of the Tissue Establishment e.g. donation, procurement, processing etc. 
Agreements must be established in accordance with Article 24 of Directive and 
are reviewed as part of inspection process.  

No 

Distribution provisions 
Vigilance 

Distribution provisions - There is difficulty in controlling the distibution of tissues 
and cells to healthcare professionals / establishments from other EU Meber States.  
No shortcomings 

247 

 
 
  
 
 
  
 
 
 
 
A.1.15. 

Survey response Italy 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer 
possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer 
possible) 
1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.3. National Competent Authority 3? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, 
staff working on EU affairs and legal matters, vigilance officers, 
budget, independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent 
Authority(ies). (more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

Ministry of Health.  However, the National Transplant Centre as a 
technical institution of the Ministry, carries out most of the operational 
activities of the Competent Authority. 
National Transplant Centre Via Giano della Bella, 34 00162 Rome Italy 
+39 06 49904040 
cnt@iss.it 
http://www.trapianti.salute.gov.it 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Human organs 
Inspection 
Vigilance 
Other 
Activity data collection (donation and transplantation); traceability 
(allocation of donation numbers for tissue donations); training;  
Yes 
National Blood Centre 
Via Giano della Bella, 27 00162 Rome Italy 
+39 06 49904953 
direzione.cns@iss.it 
http://www.centronazionalesangue.it 
Non-reproductive tissues and cells 
Blood and blood components 
Inspection 
Vigilance 
No 
CNT is a technical instrument of the Ministry of Health and is organised 
as an independent unit within the Higher Institute of Health (Istituto 
Superiore di Sanità).  It was instituted by a law that provides the legal 
basis for its activities including the promotion and co-ordination of 
organ donation and transplantation.  Its annual budget is allocated by the 
government in the context of that law and includes funds for the 
implementation of Law no. 191 which is the Italian transposition of 
Directive 2004/23/EC. The centre includes the following sections 
(departments): Medical (organs); Tissues and Cells; Informatics; 
International Relations; Communications; Administration. A small 
number (3) of senior staff work on EU legislative affairs (including the 
Director) and a similar number support the Ministry in the development 
of Italian legislation.  There are 6 inspectors for tissues and cells who 
also manage the vigilance activities.  There is also a team of experts 
from the field that are trained by CNT to assist on inspections.  The 
Centre leads and participates in many EU -funded projects in the field of 
transplantation and assisted reproduction. 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
The Regional Authorities are responsible for authorising Tissue 
Establishments and for suspending or revoking that authorisation. They 
do this on the basis of an initial evaluation of regional minimal 
structural and organisational requirements.  Their subsequent activity is 
subject to insepction to verify compliance with the national legislation 
that transposes the EU Directives.  For tissues and HPCs, these 
inspections are carried out by CNT/CNS on a national basis and the 
results are submitted to the regional authorities.   In 2010, the Ministry 
of Health indicated that for ART, the inspections should be carried out 
by the regional authorities with the support of CNT; this regional ART 
centre inspection programme started in 2011. 

248 

 
 
 
 
2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? 
(more than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 
(01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out 
in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in 
which procurement of tissues/cells for ATMP manufacturing 
were carried out in 2011 (01/01-31/12/2011). 

2.3. How do you ensure that procurement centres comply with 
the requirements laid down in Art. 5 of Directive 2004/23/EC 
and its implementing Directive 2006/17/EC (e.g. trained 
personnel, conditions accredited, designated, authorised, 
licensed) ? (more than 1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor 
testing? 
2.4.2. Which National Authority is in charge of this activity? 

2.5. How do you ensure, as CA for T&amp;C, that tests required 
for donors are carried out only by qualified laboratories 
accredited, designated, authorised or licensed Art. 5(2))? (more 
than 1 answer possible) 
Please specify 'other': 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are 
performed etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 
1 answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 
1 answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement centres 
In general, authorisation for procurement is integrated into the tissue 
establishment inspection scheme and is not granted separately. 
372 centres 

63 procurement centres of bone marrow; 83 procurement centres for 
PBSC, 279 procurement centres for cord blood 

195 (excluding centres that carry out only intra-uterine insemination 
(IUI) 

13 authorised ATMP manufacturers (clinical trials) with procurement at 
their own hospitals.  Some may have procurement in other hospitals for 
whom they manufacture but the numbers of these procurement centres 
are not available. 
Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

Testing laboratories operate within the national healthcare system and 
are authorised for their activities by the Regional Health Authorities 
Analysis of the mandatory documentation requested from the tissue 
establishment 
Other 

Reliance on the system in place for diagnostic laboratory authorisation. 
Not possible to provide.  See 2.4 

No 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
NAT testing for HIV, HCV and HBV is mandatory for donors of HPCs 
(bone marrow, PBSC, cord blood) in line with the national blood 
legislation.  It is not mandatory for tissues or gamete donor, except for 
living tissue donors where the serology test is not repeated at 180 days).  
It is, nonetheless, routinely carried out by tissue banks.  There are no 
plans to make it mandatory. HTLV testing is carried out only on donors 

249 

 
 
 
 
3.4. Do you have concerns on accuracy of the available tests and 
test procedures for deceased donors? 
3.4.1. Please specify why: 

3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.7.1. Please specify. 
3.8. Do you have any additional comments on testing? 

with identified risk as specified in Directive 2006/17/EC. Chlamydia is 
a required test for gamete donors but it is not performed by NAT. 
Yes 

Many centres use kits that are not certified for use with cadaveric 
samples.  
Yes 

Depending on the type of donor, the type of tissues/cells or the donor 
history, testing may be required for CMV, toxoplasma, West Nile Virus, 
Chikungunya etc. Obviously, blood grouping and HLA typing are 
required for certain donors and bacteriology testing of tissues/cells is a 
requirement for all types of donations. 
No 

Yes 

For HLA testing laboratories: EFI or ASHI accreditation 
No 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments 
under your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 

Yes 

Yes 

4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were suspended in 2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 
4.6.1. What is the relation between the indpendent certification(s) 
(e.g. ISO, JACIE, FACT) and the CA authorisation of the tissue 
establishments? (more than 1 answer possible) 

Please specify 'other': 

Tissues: 13;       HPC: 3 inspections at TEs for bone marrow and PBSC 
and 11 inspections at cord blood banks;       ART: 11                            
Please note: many centres are given a preliminary 
authorisation/accrediation etc. before inspection on the basis of a 
documentary review. 
Yes 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
0 

0 

Yes 

Mandatory for authorisation 
Inspections are conducted jointly by the CAs and independent certifying 
body 
No relation 
Other 
Please note that we selected 'other' in order to be able to add this 
explanatory note.  The situation is different for tissues and ART 
compared with HPC. HPC centres are inspected in collaboration with 
JACIE. For cord blood banks ISO certification is mandatory. For tissues 
and other types of cells, there is no relation with any independent 
certification system and no such certification is required by legislation. 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

Musculo-skeletal tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 

250 

 
 
 
 
 
 
4.7.2. How many musculo-skeletal tissue establishments? 
4.7.4. How many cardiovascular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.6. How many cord blood tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval 
by 31/12/2011 (more than 1 answer possible): 

4.8.2. How many musculo-skeletal tissue establishments? 
4.8.4. How many cardiovascular tissue establishments? 
4.8.5. How many HSC tissue establishments? 
4.8.6. How many cord blood tissue establishments? 
4.8.7. How many ART tissue establishments? 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 
01/01/2011 and 31/12/2011 (more than 1 answer possible): 

4.9.5. How many HSC tissue establishments? 
4.9.6. How many cord blood tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more 
than 1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue 
establishments? 
4.10.2.2. How many private musculo-skeletal tissue 
establishments? 

4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue 
establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 

Other tissue establishments 
1 
1 
69 
16 
195 
1 
We assume this refers to the 'other' category  Pancreatic islets: 1 
Musculo-skeletal tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
1 
1 
66 
9 
188 
1 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Other tissue establishments 
3 
1 
7 
We assume this refers to the 'other' category Pancreatic islets: 1 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
5 
0 
4 

0 (although there is 1 private musculo-skeletal processing facility that is 
inspected and authorised to process tissue as a third party for public 
banks. 
7 
0 
3 
0 

11 
0 
3 
0 
6 
1 
8 
0 
Pancreatic islets: 2 Amniotic membrane: 1 

Not applicable 

251 

 
 
establishements and how many. 
4.11. How many tissues and cells were distributed under the 
direct agreement of the Competent Authority according to Art. 
6(5) during 2011? Please provide number(s) per type 
tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in 
charge of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common 
training, common documentation, etc.)? (more than 1 answer 
possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for 
non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 
1/1/2011 to 31/12/2011) following serious adverse events or 
reactions, or suspicion thereof ? 
5.3.2. How many other type of inspections of tissues 
establishments for non-reproductive tissues/cells were conducted 
in 2011 (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where no 
shortcomings were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by closure? 

0 

Yes 

No 
No 

Yes 

Tissue and Cell section of CNT.  For HPC and cord blood banks, these 
inspections are carried out in collaboration with CNS 
6 inspectors although all of these individuals also have other 
responsibilities.  There is also a team of tissue bank expert inspectors, a 
team of HPC centre expert inspectors and 2 teams of ART centre 
inspectors (one regional team and one national team) who work in this 
field or in related fields and have been trained by CNT to assist in 
inspections on an ad-hoc basis. 
Yes 

Blood 
Accreditation organisations (e.g. JACIE) 
CB:10; HPC: 3;Tissues:13 

0 

1 cord blood bank inspection to verify traceability and new activity. 1 
tissue bank inspection to verify corrective actions following a previous 
inspection 1 third party processor to review plans for a new preparation 
process. 
Tissues: 2;HPC: 0;CB: 2 

Tissues: 2;HPC: 3;CB: 9 

Tissues: 9; HPC: 3; CB:9   We have understood this to mean those 
where 'major' and/or 'critical' non-compliances were noted, according to 
the EC Operational Manual. 

0 

0 

252 

 
 
 
 
 
 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of other inspections carried out? Please 
specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, or 
suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on 
ART establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a 
whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments 
carried out in 2011 (01/01/2011 to 31/12/2011): What was the 
number of inspections carried out where no shortcomings were 
observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective 
establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more 
than 1 answer possible) 

5.6. How do you decide which type of routine inspection to 
conduct? 

5.7. Until 2011, did you implement the requirement concerning 
the time interval between two inspections (Art. 7.3.)? 
5.7.1. Why not? 

5.7.2. How do you prioritise tissue establishments to be 
inspected? 

5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 

5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 

See question 5.3.2 

11 

0 

0 

0 

0 

11 

0 

0 

See 5.4.2 above 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 
General system-oriented inspections are the normal type of inspection 
conducted.  They are carried out for the first certification of the centre 
and normally for subsequent routine inspections also. On rare occasions 
thematic inspections are carried out, either when the centre has already 
had a number of general system-oriented inspections and it is decided 
that it will be more fruitful to choose a specific topic on which to focus 
or when a particular issue has arisen in relation to e.g. importation, a 
change in processing or a vigilance incident in the period prior to the 
routine inspection. Desk-based reviews are carried out when there is a 
large number of centres to be inspected for the first time.  They are used 
to help prioritise the order of inspections and to allow preliminary 
certification until a site inspection can be conducted. 
No 

This was achieved, plus or minus a few months, for tissue banks where 
the number of banks is only 31.  It has not been possible for HPC 
centres due to the high number of centres (> 100).  CNT received the 
mandate to inspect ART centres only in 2011.  Although a small number 
of centres have been inspected twice, there is a very high number of 
centres(more than 200 excluding centres that do only IUI) and it is 
likely that the 2 year cycle will not be possible to maintain. 
Using desk-based review of questionnaires, by the size of the banks and, 
for HPCs, depending on the timing of JACIE inspections as the CA 
inspection is carried out jointly with JACIE. 
Tissues:  20.             HPC: 0 but a system of interim documentary 
review was implemented at two years following release of certification 
by the CA.  
Yes 

HPC only: 3 
Yes 

253 

 
 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell 
procurement and tissue establishments - Guidelines for 
inspections (Commission Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 
= sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in 
that MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 
31/12/2011)? 
5.16. Have you asked another MS, or have you been requested 
by any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? 
Joint inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments 
that are explicitly authorised to perform import/export of tissues 
and celles from/to third countries? 
6.2. Please specify the number of tissue establishments 
authorised to import tissues and cells from third countries 
(recorded by 31/12/2011). 

6.3. Please specify the number of tissue establishments 
authorised to export tissues and cells from third countries 
(recorded by 31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 

6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) 
tissues from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from third 
countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 

6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than cord 
blood) from third countries. 

in 2011: 1 
Yes 

Yes 

4 

No 

No 

No 

No 

Yes 

No 

No 

At this time, any tissue establishment that is certified by CNT as being 
compliant with the safety and quality requirements is also allowed to 
import or export in compliance with our specific decree on 
Import/export.  A specific authorisation will be implemented to allow 
maintenance of the EU TE compendium. 
to third countries? as 6.2 

Inspectors review the agreements that the tissue establishments have 
with the third country supplier.  They also review a selection of donor 
records that have been reviewed by the importing Italian TE and any 
other documents associated with the importation. 
Inspectors review the agreements that the tissue establishments have 
with the third country supplier.  They also review a selection of donor 
records that have been reviewed by the importing Italian TE and any 
other documents associated with the importation. 
Inspectors review the agreements that the tissue establishments have 
with the third country supplier.  They also review a selection of donor 
records that have been reviewed by the importing Italian TE and any 
other documents associated with the importation. 
Inspectors review the agreements that the tissue establishments have 
with the third country supplier.  They also review a selection of donor 
records that have been reviewed by the importing Italian TE and any 
other documents associated with the importation. 
Inspectors review the compliance of protocols adopted for HSC 
importation by national (IBMDR, Italian Bone Marrow Transplantation) 
and international (WMDA, World Marrow Donor Association) 
standards .They also review a selection of donor records that have been 

254 

 
 
 
 
6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 

6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of 
origin. 

6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 

6.13. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on imports/exports of tissues/cells 
between your country and other third countries? 
6.14. What is the relation between import/export of tissues and 
cells and self-sufficiency? (more than 1 answer possible) 

Please specify 'other': 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

reviewed by the importing Italian TE and any other documents 
associated with the importation. 
Inspectors review the compliance of protocols adopted for HSC 
importation by national (IBMDR, Italian Bone Marrow Transplantation) 
and international (WMDA, World Marrow Donor Association) 
standards .They also review a selection of donor records that have been 
reviewed by the importing Italian TE and any other documents 
associated with the importation. 
Inspectors review the agreements that the art centers have with the third 
country art centers. They also review documents associated with the 
importation. 

Yes 

Tissues: Not collected centrally though could be obtained from the 
importing banks HPC:Australia 1 PBSC and 5 CB, Canada 2 BM, 6 
PBSC, China/Hong Kong 1 BM, Israel 4 BM and 15 PBSC, 1 BM and 1 
PBSC, Taiwan 1 CB, USA 55 BM, 63 PBSC and 26 CB, Switzerland 1 
BM, 1 PBSC and 1 CB. ART: not known but only imported by couples 
for their own use (the law prohibits non-partner gamete donation and 
use). 
Yes 

We assume this intends to mean that we export to third countries.   
Tissues: 357 corneas (at this time we do not record centrally the country 
of destination so this includes both EU and non-EU countries.   ART: 
CNT has had responsibility for import/export of gametes and embryos 
only since January 2013 so we have no data for 2011.   HPC: 64; 
Australia 1 CB, Croatia 1 PBSC and 1 CB; Israel 4 BM and 15 PBSC 
and 1 CB, Canada 1 PBSC and 1CB, Chile 1 CB, Russia 1 PBSC, South 
Africa 2 CB, Switzerland 2 PBSC and 2 CB, Turkey 1 CB, USA 4 BM, 
6 PBSC and 20 CB. 
No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
C. Export of tissues/cells is authorised irrespective of national needs 
D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
F. Other 
Other - import of tissues/cells is allowed only when the same time of 
product is not available within the country from another bank. For HPC 
import/export depends on the HLA compatibility between donor and 
recipient, characteristics of the donor and of the cellular product (for 
cord blood units). 
For A, tissue banks are asked to check with the other banks for that type 
of tissue (usually by email or fax) to know if there are unmet requests 
for that type of tissue or cell product before it is exported.  For D, there 
needs to be a specific request from a clinical user who confirms that the 
product needs to be imported. 
No 

Tissues and cells coming from other EU Member States are managed in 
a manner equivalent to those coming from third countries. We have a 
recently adopted Decree on Import/Export.  Additionally, for HPC 
import/export an authorisation from the Ministry of Health must be 
obtained. 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and 
cells? 

Yes 

255 

 
 
 
 
7.1.1. If yes, how do you address the possible more stringent 
quality and safety measures established by other Member States? 
Please specify. 

7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding 
quality of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your 
MS from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011). 

7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011) 

7.6. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on cross-border exchanges of 
tissues/cells between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in 
EU and/or import/export of tissues/cells? In this context, a 
brokerage company means a body that arranges transactions 
between a supplier (tissue establishment/company selling tissues 
or cells) and a buyer (a tissue establishment/a hospital or 
clinic/an individual) without undertaking activities of processing, 
preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if 
any) as a Competent Authority, in their authorisation/monitoring 
or inspection. 

7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.8.1. Where are the brokers located? 
7.8.2. If the broker is located in another country, how 
easy/difficult is it to ensure that safety and quality requirements 
are met? 

Our decree requires that imports, even from EU MS, enter via an 
authorised Italian TE which must verify quality and safety.  Any 
additional requirements need to be stipulated in the quality agreement 
between the tissue establishment in Italy and that in the other MS. 
Yes 

See 7.1.1 For HPC it is necessary to carry out the NAT test for HIV, 
HBV and HCV. 

Through the control of the documentation relating to the donor and the 
product. 

Yes, but only via an authorised TE in my MS 

No 

Yes 

We understand this question to refer to distribution from Italy to other 
EU MS. For tissues, 357 corneas were sent out of Italy. At this time we 
do not record centrally the countries of destination so this will include 
EU and non-EU countries. For HPCs: Total 84: Austria 1 BM, 2 PBSC, 
Belgium 3 CB, Czech Republic 1 BM, Denmark 1 BM and 3 CB, 
France 7 BM, 6 PBSC and 16 CB, Germany 3 BM, 10 PBSC and 5 CB, 
Greece 1 PBSC and 2 CB, Netherlands 3 CB, Poland 1 PBSC, Portugal 
1 CB, Slovakia 1 CB, Slovenia 1 CB, Spain 2 BM, 2 PBSC and 3 CB, 
Sweden 1 PBSC, UK 1 BM, 4 PBSC and 4 CB.    
We understand this to mean distribution from EU MS into Italy. The 
numbers are not centrally available at this time for tissues. For HPC, 
Total: 429:  Austria 2 CB, Belgium 2 CB, Cyprus 3 PBSC, Denmark 1 
PBSC, France 6 BM, 6 PBSC and 9 CB, Germany 106 BM, 240 PBSC 
and 7 CB, Greece 1 CB, Ireland 1 PBSC, Netherlands 1 CB, Poland 2 
BM, 7 PBSC, Portugal 3 BM, 12 PBSC, Spain 10 CB, Sweden 1 CB, 
UK 6 BM, 3 PBSC. 
No 

Yes 

For tissues, such companies are only allowed to operate under a third 
party agreement with an authorised tissue establishment (which must be 
public sector).  This happening currently only for processed bone 
products. They can organise the importation on behalf of the TE and can 
also store and transport on behalf of the TE.  The TE must take 
responsibility for ensuring equivalent quality and safety and for taking 
orders from clinical users and allocating products to them for 
distribution.  The TE must also take responsibility for traceability and 
vigilance. 
Yes 

Another country 
See 7.7.1 above for the limitations that are put on their activities.  They 
are actively supplying only in this context.  Any activities outside of an 
agreement with a TE are not legal.   Please note: having selected 
'Another country' above, it was not possible to also select 'Your 
country'.  Some of these distributors also operate in Italy. 

256 

 
 
7.9. Do you have any additional comments on distribution? 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the 
activities of tissue establishments in your Member State? (Article 
10(1)). If yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 
answer possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 

100% (all) 

Yes 

8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web 
site. 
8.6. Do you provide data regarding tissues and cells activities to 
the EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please 
specify. 
8.7. Do you have any additional comments on reporting? 

Yes 
They are available on the Eurocet Registry website at www.eurocet.org 
and on the CNT website. 
No 

The data are published on the Eurocet platform and the CNT website 
and presented at conferences, congresses etc. 
Yes 

http://www.trapianti.salute.gov.it/cnt/cntHomeSezione.jsp?id=10&area
=cnt-tessuti&menu=menuPrincipale 
Yes 

CA details TE detaila Activity data 

Regarding 8.1, our reply referred only to tissue banking procurement, 
processing and distribution activity.  The following is information 
regarding tissue donation, and HPC activity reporting. Tissues: For 
donation, each donation is entered electronically on the national 
computer software (SIT) managed by CNT.  These data are available on 
the system in real time and it generates the annual donation data.  Every 
3 months each tissue bank completes a standard form with activity data 
and each Regional Tranpsplant Centre provides data on tissue 
transplants.  The form completed by the banks is attached.  HPC: For 
HPCs data on transplants are inserted in EBMT's informatic software 
(Promise).  This system sends a quarterly report to GITMO (the Italian 
Bone Marrow Transplant Group) who forwards it to CNT.  For donation 
activity of cord blood, each cord blood bank reports on a quarterly basis 
to CNT and CNS (the Excel form used is attached). ART: the ART 
centres enter their activity data directly into an informatic system 
managed by the National ART Registry. An annual report is produced 
by the Registry. 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented 
in your country? 
9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
Please specify 'other'. 

Other 

Yes 

9.3. How is the data storage for traceability purposes organised 
in your tissue establishements (Art 8(4))? (only 1 answer 
possible) 
9.4. How do you ensure that the 30 years data storage 
requirement is respected (Directive 2006/89/EC, Art. 9)? Please 
specify. 
9.5. Do you have any additional comments on traceability? 

Verified during inspection 

No 

For tissues: National CA;  For HPC: IBMDR (Italian Bone Marrow 
Donor Registry) for unrelated donors; for autologous and related 
donors, codes are allocated by TEs.  For ART: allocated by TEs. 
Both paper records and electronic forms 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

CNT for tissues and ART.   CNT in collaboration with CNS for HPC 
and cord blood. 

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10.1.2. If yes, please provide a short description of its 
organisation. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you 
use the SAR/E (to the CA (2006/76 art 6.4)) templates developed 
to the Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are welcome to 
upload the template if you wish. 
10.3. Do you use the Common Approach Document developed 
for the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 

10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed 
the tissues/cells (Art 11.2)? 
10.6.2. If no, how do you ensure that SAR/SAE are reported to 
the TEs? 
10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.2. Please specify why not. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please specify 
the number and which tissues were recalled and why (e.g. 
missing consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.2. If no, please specify why not. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued 
via the EU RATC platform? 
10.12.2. If no, please specify why not. 

10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and 
cells national vigilance system also to other national 
vigilance/alert systems? 
10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy 
of these trainings on a scale from 1 (insufficient) - 2 (sufficient)  
3 (good) - 4 (very good) to 5 (essential)? 

There are three slightly different systems in place for Tissues, HPC and 
ART.  In each case the centres are informed regarding how they should 
notify using forms that are based on those in the annexes of Directive 
2006/86/EC. The TEs are responsible for informing clinical users, 
procurement centres and third parties on how to notify SARE and what 
to notify.  Their procedures for doing this are reviewed during routine 
inspections. 
No 

We use the templates in the annexes to Directive 2006/86/EC. 

Yes 

No 

The role is shared by the inspector team although one inspector takes 
the lead for tissues and ART and one for HPC. 
100% 

No 

By ensuring that TEs when distributing tissues and cells provide full 
instructions for reporting. 
Yes 

At this time we do not produce an annual SARE report but we do 
provide summaries during training courses for TE professionals and at 
professional society meetings. 
No 

Until now, there has not been an EC Annual Report to share with the 
TEs.  Once available (2013), it will be shared. 
Yes 
0 

No 

Up to now, we communicate by email on a case-by-case basis.  This has 
not yet been formalised in a written procedure. 
No 

Up to now, we communicate by email on a case-by-case basis.  This has 
not yet been formalised in a written procedure. 
No 

this data is not requested or reported by Eurocet. 
No 

Yes 

4 

258 

 
 
10.16. Do you have any additional comments on SARE 
reporting? 

Regarding question 10.5, we entered 100% in order to be able to 
continue compiling the questionnaire.  However, the TEs are not 
required to provide an annual SARE report. They report SARE as they 
occur and the CA compiles the annual report.  The TEs must provide 
detailed information to transplant centres on how and when to report 
SARE.  They manage the interaction with the transplant centres.  The 
way they do this is reviewed during routine inspection. See 10.1.2 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do 
you have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same 
as for organs? 
11.5. How is this consent verified during inspections? (more than 
1 answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third 
parties (Art. 14(1)). Please specify. 

Yes 

Explicit consent (opt-in) 

Living donor must sign a consent form. 

Presumed (opt-out) and explicit (opt-in) consent 

Explicit for cornea; presumed for other tissues.  However, normal 
practice is always to consult the family to establish a 'lack of objection'. 
First degree relatives (including spouse) 
Non-marital partners 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 

11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice 
versa. 
11.9. Does your national legislation allows disclosure of donor 
data in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and 
data protection? 

For tissues and HPC, an anonymous donation number must be used. The 
requirements for maintenance of anonymity are defined in national 
guidelines against which inspectors inspect.  For ART, no non-partner 
donation is allowed by law. 
See 11.7 

No 

No non-partner donation of gametes is allowed by the national 
legislation (Law No. 40).   
No 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of 
reproductive cells) are respected in your country (Art. 15(1), 
Annex I Directive 2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 

Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 
Audit of documentation 
Other 
For tissues and HPC, detailed requirements are specified in national 
guidelines. 
Inspections of ART centres 
Audit documentation 

12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection 
than those listed in Annex I of the Directive 2006/17/EC? 
12.3.1. If yes, please specify. 

Yes 

NAT testing for HPC donors for HIV, HBV and HCV is required. - 
toxoplasma IgM for amniotic membrane (in case of positivity the tissue 
cannot be used for transplant);  - CMV IgM for hear valves and vessels 
and amniotic membrane, in case of positivity CMV DNA must be 
performed, if negative the donor is suitable. - CMV for skin: if positive 
the result must be communicated to the centre that has requested the 
tissue for clinical use  CMV,toxoplasma and EBV testing for HPC 

259 

 
 
 
 
 
 
12.4. What sources are required in your MS for the evaluation of 
a deceased donor of tissues/cells? (more than 1 answer possible) 

12.5. Do you have more stringent criteria for selection of donors 
of reproductive cells than those listed in Annex III of the 
Directive 2006/17/EC? 
12.5.1. Please specify. 
12.6. Do you have more stringent criteria for autologous 
donation than those listed in Annex I of the Directive 
2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues 
and cells' procurement, packaging and transport are complied 
with by tissue establishments in your country (Art 15(1), Annex 
IV of Directive 2006/17/EC? (more than 1 answer possible)(For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, 
and/or vendors in order to evaluate adherence to the written SOP, 
standards or governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
12.8.1. Please specify. 

12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

unrelated donors Serum archive for all donors Chlamydia testing for 
gamete donors  
Interview with the donor's family or a person who knew the donor well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
Yes 

Only partner donation is permitted 
No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Other 

Audits are included in the sense that the CA inspection verifies that 
internal audits are performed as part of the quality management of the 
TE. Other: for tissues, national guidelines define the requirements in 
more detail, including for specific tissues. 
No 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your 
country have in place a quality system respecting the provisions 
of the Directive 2004/23/EC Art 16.1? (more than 1 answer 
possible). (For this question "audit" means a documented review 
of procedures, records, personnel functions, equipment, 
materials, facilities, and/or vendors in order to evaluate 
adherence to the written SOP, standards or governments laws 
and regulations (from Council of Europe Guide to the Safety and 
Quality Assurance for the Transplantation of Organs, Tissues and 
Cells, 2011)). 
Please specify 'other'. 

Authorisation requirement 
Inspections 
Internal audits 
External audits 
Other 

13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? 
(more than 1 answer possible) 
13.3. How do you ensure an appropriate training for the 
personnel directly involved in the activities of tissue 
establishments? (more than 1 answer possible) 
Please specify 'other'. 
13.4. Do you have national/regional/local training programmes 
for the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

Please note that the external audits refer only to the field of HPCs. 
Internal audits are a requirement of the quality system and are verified 
during inspection.  The authorisation is performed by the Regional 
Health authority and is verified during the CA inspection.For tissues, 
national guidelines are issued that include requirements for specific 
tissues.  
Inspections 

Inspections 
Other 

Non-mandatory training 
Yes 

CNT organises basic and advanced training courses for personnel of 
tissues banks and for personnel of ART centres. For HPC CNT 

260 

 
 
 
 
13.5. Any additional comments on quality management, 
responsible person, personnel? 

participates in national and regional courses for professionals in the 
field; the courses are organised by the professional societies. 
No 

Inspections of tissue establishments 
Internal audits of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your 
country fulfill the requirments of the Art. 19 (Tissue and cell 
reception) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your 
country fulfill the requirements of the Art. 20 (Tissue and cell 
processing) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.3. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 21 (tissue and cell storage 
conditions) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.4. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 22 (labelling, 
documentation and packaging) of Directive 2004/23/EC and 
Annex IV of Directive 2006/17/EC? (more than 1 answer 
possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 

No 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your 
national legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) by 
the Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and 
safety requirements than those requested by the EU legislation in 
this field (e.g. restrictions concerning the donation/use of certain 
tissues/cells, mandatory unpaid donation etc.)? 
16.1.1. Please specify. 

16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 

Yes 

Yes 

- for processing of tissues - for storage of tissues, HPC, gametes or 
embryos  - for gamma sterilisation of tissues - for tissue or cell 
transportation - for monitoring and management of liquid nitrogen 
facilities 
Reviewed during routine inspections 

Third parties that carry our critical steps such as processing or storage of 
tissues or cells on behalf of TEs must have a direct authorisation from 
the Ministry of Health.  These authorisations are issued on the basis of 
an inspection by CNT. 

Yes 

More stringent requirements for receiving tissues/cells from EU 
Member States.  Some more stringent requirements for testing and 
serum archiving as mentioned above. 
Procurement provisions 
Testing provisions 
Inspections 
Procurement: where tissues/cells - notably cord blood for 
autologous/family use - is procured but then sent to another EU country 
(as banking is not allowed in Italy) the CA does not verify the 
compliance of the conditions of procurement as there is no TE in Italy 
where this could be performed - we rely on the CA of the receiving MS 
to confirm this through document review at the receiving TE. Testing: 
the tissue and cell CA is not competent to inspect and verify the 
compliance of testing laboratories with the requirements. Inspections: 
with the high number of centres - particularly HPC and ART centres - 
and the number of inspectors trained and available to conduct 

261 

 
 
 
 
 
 
 
 
16.3. In your opinion, in which of the following Directives are 
there shortcomings (if any)? (more than 1 answer possible) 

16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 

16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 
16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

inspections, it has not been possible to conduct site inspections at every 
centre and at an interval of every two years. 
Directive 2004/23/EC 
Directive 2006/17/EC 
Directive 2006/86/EC 
See comments sent on June 2nd 2013 in reply to request from Sanco on 
potential shorcomings in the current tissues and cells directives and 
resubmitted now in an email to Ioana Siska. 
We would have comments on this directive but they would depend on 
which comments are accepted for the mother directive. 
We would have comments on this directive but they would depend on 
which comments are accepted for the mother directive. 

262 

 
 
 
 
 
A.1.16. 

Survey response Latvia 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 

State  Agency  of  Medicines of the Republic of Latvia 
15 Jersikas Street, Riga, LV-1003 
+371 67078424 
info@zva.gov.lv 
www.zva.gov.lv 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
State  Agency  of  Medicines is the state institution under 
supervision of the Ministry of Health of the Republic of Latvia,  that 
carries out evaluation, marketing authorisation, monitoring, control 
and regulation of distribution of medicines and medical devices in 
Latvia. It is a state  agency not financed from the state budget 
(agency's budget is formed from  service  fees). There are 13 
departments and 144  employees (www.zva.gov.lv). 2 senior 
inspectors for blood, tissues, cells, and organs, including vigilance in 
the Agency. Legal department consists of  4 employees. EU matters 
- no dedicated staff. 
Not applicable 

No regional authority. 

Yes 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
0 

0 

0 

0 

0 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

263 

 
 
 
 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.7.1. Please specify. 

3.8. Do you have any additional comments on testing? 

Latvian National Accreditation Bureau 
Analysis of the mandatory documentation requested from the tissue 
establishment 

6, information available on www.latak.lv 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
In practice NAT HBV, NAT HCV, NAT  HIV1 are being performed  
routinely. 

No 

Yes 

On certain circumstances tests for HTLV-1;  RhD; HLA; malaria;  
CMV; toxoplasma; EBV; Trypanosoma cruzi should be considered. 
Yes 

On certain circumstances tests for HTLV-1;  RhD; malaria;  CMV; 
Trypanosoma cruzi should be considered. 
Yes 

Most testing laboratories are accredited according to EN ISO 15189  
and /or EN ISO 17025 standards. 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

0 

Yes 
During routine inspections 
By review of a submitted application with supporting documentation 
0 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 

0 

264 

 
 
  
 
 
  
 
 
Cord blood tissue establishments 

1 
Other tissue establishments 

,,1  ( mononuclear stem cells) 
ART tissue establishments 

1 
Musculo-skeletal tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
1 
0 
0 
1 
0 
1 
1 
0 
0 

2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.6. How many cord blood tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

Placental tissues 

0 

Yes 

No 
Penalties:  - The Criminal law:Section 139. Illegal Removal of 
Tissue and Organs from a Human Being (1) For a person who 
commits illegal removal of tissue or organs from a deceased human 
being in order to use such for medical purposes, where commission 
thereof is by a medical practitioner, the applicable punishment is 
deprivation of liberty for a term not exceeding four years or 
temporary deprivation of liberty, or community service, or a fine, 
with deprivation of the right to engage in the practice of medical 
treatment for a term not exceeding five years. (2) For a person who 
commits illegal removal of tissue or organs from a living human 
being in order to use such for medical purposes, where commission 
thereof is by a medical practitioner, the applicable punishment is 
deprivation of liberty for a term not exceeding seven years, with 
deprivation of the right to engage in the practice of medical 
treatment for a term not exceeding five years.  - State Agency of 
Medicines has powers to suspend or revoke authorization issued to 
tissue establishment if it no longer fullfils requirements of 
implementing national provisions.   

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Yes 

State Agency of  Medicines.  Pharmaceutical activities compliance 
evaluation department is responsible  for inspections. 

265 

 
 
 
 
 
 
 
 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 

2 inspectors (senior experts). 
Yes 

Blood 
Organs 
Pharmaceuticals 
Advanced therapies 
0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

,,1 inspection related to establishment authorization 

0 

0 

0 

0 

0 

266 

 
 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  Type for routine Inspections  is selected  depending on the particular 

General system-oriented inspections 
Thematic inspections 

0 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 

situation and information available to NCA. 
Yes 

0 

No 

Currently there are no procurement sites outside tissue 
establishments. 
No 
None of  authorized tissues establisments declared  contracts with 
3rd parties (except laboratories, please  also see answer  to 2.4). 
Yes 

Yes 

4 

No 

No 

No 

No 

Yes 

No 

0 

0 

None, because not relevant so far. If Agency would be receiving 
such request for imports equivalency of standards will be evaluated 
on case by case basis. 
None, because not relevant so far. If Agency would be receiving 
such request for imports equivalency of standards will be evaluated 

267 

 
 
  
 
 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 

Please specify 'other': 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

on case by case basis. 

None, because not relevant so far. If Agency would be receiving 
such request for imports equivalency of standards will be evaluated 
on case by case basis. 
None, because not relevant so far. If Agency would be receiving 
such request for imports equivalency of standards will be evaluated 
on case by case basis. 
None, because not relevant so far. If Agency would be receiving 
such request for imports equivalency of standards will be evaluated 
on case by case basis. 

None, because not relevant so far. If Agency would be receiving 
such request for imports equivalency of standards will be evaluated 
on case by case basis. 
None, because not relevant so far. If Agency would be receiving 
such request for imports equivalency of standards will be evaluated 
on case by case basis. 

No 

No 

No 

B. Export of tissues/cells is authorised based on estimations 
performed on an annual basis 
F. Other 
No special conditions regarding sufficiency for authorization of 
imports 
No 

No 
By inspecting  the  SOPs and records regarding distribution, 
labelling. 

No provisions regarding distribution from TE in another MS to 
Latvian hospitals 
No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
Please specify 'other'. 

Other 

7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

No 

No 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 

268 

 
 
  
 
 
  
 
 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.1.1. If no, why not? 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

No 

EUROCET template is being used. 
100% (all) 

No 
No 

It is still under implementation 
Yes 

http://www.zva.gov.lv/doc_upl/audu-sunu-20130726.pdf  
Yes 

ART data activity Tissues data activity   

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Yes 

Tissue establishment 

Only paper records 

Procedures ( SOP) are in place in tissue establishments, checked 
during inspection. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

State Agency of Medicines 
Senior expert of Pharmaceutical Activities Compliance Evaluation 
Department is responsible of data collection, documentation, 
analysis, corrective and preventive actions. Also for issue of RATC 
(if necessary) at a national level or communication to EU RATC 
platform, coordination of actions to be taken if RATC issued by 
another member state affects tissues and cells procured, processed or 
distributed in Latvia. 
Yes 

Yes 

No 

As the number of tissue establishments in the country is small, this 
task is assigned to one of inspectors. 
100% 

Yes 

All establishments using human tissues and  cells  for human 
application have to report any SAR/SAE - relevant information  to 
tissue establishments engaged in the donation, procurement, testing, 
processing, storage and distribution of human tissues and cells in 
order to facilitate traceability and ensure quality and safety. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 

10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded  No 

269 

 
 
  
 
 
  
 
 
at national level? 
10.7.2. Please specify why not. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.2. Please specify why not. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

No SAR/SAE was reported so far 
No 

Still under implementation. If Latvia is affected by alert issued at EU 
level then TEs are contacted. Please also see answer to 10.1.2. 
Yes 
0 

Yes 

According to SOP if the rapid alert is issued then all tissue 
establishments potentially affected are identified and contacted by 
phone and in writing. Depending on the information feedback the 
follow up measures are decided. 
Yes 

According to SOP if the rapid alert is issued via EU RATC platform  
then all tissue establishments potentially affected are identified and 
contacted by phone and in writing. Depending on the information 
feedback the follow up measures are decided. 
No 

Still under implementation.  
No 

Yes 

4 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 

Explicit consent (opt-in) 

According to national provisions in this case the explicit consent( 
opt-in) is mandatory 
Presumed (opt-out) and explicit (opt-in) consent 

For deceased donors consent is checked in the Citizens Register 
where any person during life can provide information whether 
he/she allows or prohibits donation of tissues/cells after death. 
According to national provisions if there is no information in the 
Citizens Register (neither authorization, nor  prohibition) then it is to 
be considered as presumed consent but in this case first degree 
relatives have option to inform in writing the medical establishment 
regarding the deceased persons will on donation expressed during 
his/her life. 
First degree relatives (including spouse) 

11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 

Yes 

Analysis of documentation 
Interviews with personnel 

270 

 
 
  
 
 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 

11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 

11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 

11.10. Do you have any additional comments on consent and data 
protection? 

Only trained personnel is allowed to provide such information 

Law on protection of personal data contains provisions for handling 
personal data, incl. obligation to get authoriztion for handling of 
such data. Systems and Pprocedures must are in place that ensure 
that  information provided to third parties is in coded/anonymized 
form. If  personal information has to be provided to third party then 
provisions of the Law applies   . 
Law on protection of personal data contains provisions for handling 
personal data, incl. obligation to get authoriztion for handling such 
data. Procedures are in place that ensure that  information is in 
coded/anonymized form. In the Regulations there are provisions 
prohibiting disclosure of such data therefore tissue establishments 
are obliged to implement appropriate systems and procedures. 
No 

Law on sexual and reproductive health paragraph 14  provisions 
ensures that donor data should  not be dislosed:  14. Secrecy of 
Medical Impregnation  (1) It is prohibited to disclose any data on 
potential parents to a gamete donor.  (2) Potential parents may only 
obtain information regarding a gamete donors genetic and 
anthropometric data.   

Inspections of TEs and procurement sites 
Audit of documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 
Audit documentation 
Regular evaluation of medical personnel 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 

271 

 
 
  
 
 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Authorisation requirement 
Inspections 
Internal audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Yes 

13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

Each  tissue establishment  has local training  programmes  for their 
personnel. 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities?  Donor testing 
15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

Yes 

Yes 

Tissue establishments  provide copies of agreements  with third 
parties at the request of the competent authority for evaluation. 
During inspections agreements are reviewed and practices checked 
against their requirements.   

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 

No 

272 

 
 
  
 
 
  
 
 
  
 
 
  
 
 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 

16.2.1. For all selected options in question 16.2., please provide a 
short description. 

16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 

16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

ART provisions 
Testing provisions 
Distribution provisions 
Import-export 
Vigilance 
Traceability 
ART provisions       -  very specific area therefore we think it should 
be regulated separately from other types or general tissues and cells 
Testing provisions  -   in small countries it is not always possible to 
perform testing  for rare diseases Distribution provisions   -  if many 
entities are involved in procurement, transportation and other 
activities it is very difficult to delineate responsibilities of each 
involved party. Also provisions for direct distribution could be 
elaborated  in more detail. Import-export - provisions could be 
elaborated  in more detail.              Vigilance      -  low awareness at 
tissue establishments level     Traceability    -   if many entities 
(located in different countries) are involved in different activities 
with tissues/cells (e.g., procurement, testing, processing, banking) it 
is very difficult to evaluate the integrity of traceability when 
inspecting only local entity.  Other    (direct distribution, 
authorization for direct application) - criteria and conditions could 
be elaborated  
Directive 2004/23/EC 
Directive 2006/17/EC 
Explain and define requirements for brokers, import/export. Also 
harmonize with provisions of organ directive 2010/53/EU where 
possible  
Elaborate detailed provisions regarding criteria for direct use/direct 
distribution 

273 

 
 
 
 
 
A.1.17. 

Survey response Liechtenstein 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 
2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 

Amt für Gesundheit 
Aeulestrasse 51 9490 Vaduz Liechtenstein 
00423 236 73 25 
pharminfo@llv.li 

Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Pharmaceuticals 
Medical devices 
Other 
 reimbursement of pharmaceuticals and medical devices, public 
medical  office, health  prevention and promotion 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
The office of Public Health is a part of the Liechtenstein 
Administration which is dependent of the government. It consists of 
6 departments and  secretariat and legal support.The staff consists of 
18 persons. For the issues of pharmaceuticals, medical devices, 
human tissues and cells and blood including vigilance two persons 
are in charge. More information can be found at the 
http://www.llv.li/amtsstellen/llv-ag-home.htm. 
Not applicable 

not applicable 

Yes 
By inspecting all procurement centres 

1 

0 

1 

2 

0 

Inspections of the site/centre 

Yes 

1 

274 

 
 
  
 
 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Analysis of the mandatory documentation requested from the tissue 
establishment 

Labor Risch, authorisation for microbiolog. , serolog. diagnostic for 
blood, blood products or tissues and cells,  by Swissmedic, valid till 
02.11.2014 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT testing is not mandatory due to the requirements of dir. 
2006/17/EU, annex II and III 

No 

No 

No 

No 

Yes 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

Yes 
During routine inspections 
0 

No 

2 

0 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.7. How many ART tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.6. How many cord blood tissue establishments? 

1 

ART tissue establishments 

2 
Cord blood tissue establishments 

275 

 
 
  
 
 
  
 
 
 
 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 

ART tissue establishments 

2 
Cord blood tissue establishments 
ART tissue establishments 
1 
0 
0 
2 
0 

Yes 

No 

Yes 

Arzneimittelkontrolle, for coordination and the Swissmedic 
inspectorate by agreement 
3 Swissmedic inspectors 
No 

0 

0 

0 

none 

none 

none 

none 

none 

none 

276 

 
 
 
 
  
 
 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct? 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 

2 

0 

0 

none 

2 

none 

0 

0 

n/a 

General system-oriented inspections 

based on inspection results 
Yes 

n/a 

Yes 

1 
No 
n/a 
Yes 

Yes 

4 

No 

No 

No 

No 

No 

277 

 
 
Competent Authorities on their territory or in third countries. 
5.17.1. Could you please explain why not? 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

no ressources 

No 

0 

0 

na 

na 

na 

na 

na 

na 

not legal 

No 

No 

No 

F. Other 

na 
No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 

No 
n/a 

No 

No 

No 

278 

 
 
  
 
 
  
 
 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) as 
a Competent Authority, in their authorisation/monitoring or 
inspection. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

Yes 

The legal requirements are based on the  standards of  dir 
2004/23/EG 

No 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 

No 
No 

<50% 

Due to data protection legislation it is not possible to publish 
activities of only 2 ART tissue establishments, in a tiny country the 
anonymity would not be given; no annual report is requested for the 
establishment with blood cord activities. 
No 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.2. If no, why not? 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.2. If no, why not? 
8.7. Do you have any additional comments on reporting? 

no legal basis 
No 

 no contact 

No 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.1.1. If no, why not? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
Please specify 'other'. 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

we are waiting for the new European code for tissues and cells 
Other 

see 9.1.1. 
Only paper records 

legal requirement, ensured by inspections 

Yes 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 

Amt für Gesundheit 
one person resposnible for vigilance 
Yes 

Yes 

Yes 

279 

 
 
  
 
 
  
 
 
  
 
 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.2. Please specify why not. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.2. Please specify why not. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.2. If no, please specify why not. 
10.16. Do you have any additional comments on SARE reporting? 

<50% 

Yes 

by legislation 
No 

Should we? 
No 

Should we? 
Yes 
0 

Yes 

by fax and Phone 

Yes 

if necessary by fax and phone 

No 

no contact 
No 

No 

lack of time 

Presumed consent (opt-out) 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
Please specify 'other'. 

not regulated 

Presumed consent (opt-out) 

First degree relatives (including spouse) 
Other 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 

see art. 88 f-90  of Gesundheitsverordnung, LR 811.011, 
www.gesetze.li  
Yes 

Analysis of documentation 

Only trained personnel is allowed to provide such information 

ID numbers are generated 

280 

 
 
  
 
 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

see 11.7 

No 

not allowed 

Inspections of TEs and procurement sites 

No 

Other 

Inspections of ART centres 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 
Please specify 'other'. 
12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Inspection of tissue establishment 

No 

No 

there are only living donors, for  cord blood cells 
No 

Inspections 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 

Inspections 

Inspections 

281 

 
 
  
 
 
  
 
 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel trained? 
13.4.2.1. Please specify EU-countries. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

No 

EU countries 
The Swissmedic inspectors have their own training programm.They 
participated in the EUSTITE training and PIC/s quality circles. 

Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

Inspections of tissue establishments 

Inspections of tissue establishments 

Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 
16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

Yes 

No 

No 

Other 

many activities are not applicable in Liechtenstein. 

Directive 2004/23/EC 
Directive 2006/17/EC 
Directive 2006/86/EC 
I do not know if there are shortcomings as already mentioned many 
activities do not take place in Liechtenstein. 

282 

 
 
  
 
 
  
 
 
  
 
 
  
  
 
 
 
A.1.18. 

Survey response Lithuania 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer 
possible) 
1.1.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 

1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer 
possible) 
1.2.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 
Please specify 'other': 
1.3. National Competent Authority 3? 
1.3.1. Name of National Competent Authority 3: 
1.3.2. Address of NCA 3: 

1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 answer 
possible) 
Please specify 'other': 
1.3.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 
1.4. National Competent Authority 4? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior 
inspectors, staff working on EU affairs and legal matters, 
vigilance officers, budget, independence from government 
etc.). 

National Transplants Bureau under the Ministry of Health of the Republic of 
Lithuania 
2, Santariskiu street  LT  08661 Vilnius  Lithuania   
+ 370 52 79 6096 
info@transplantacija.lt 
www.transplantacija.lt 
Non-reproductive tissues and cells 
Human organs 
Inspection 
Vigilance 
Other 
Coordination of all national activities in the field of donation and 
transplantation of human organs, tissues and cells; responsibility for crafting 
all necessary legislating acts regulating the field of HOTC donation and 
transplantation; maintenance of the National Register of Donors and 
Recipients for HOTC 
Yes 
Ministry of Health of the Republic of Lithuania 
Ministry of Health of the Republic of Lithuania Vilnius str. 33, LT-01506 
Vilnius, Lithuania Tel. (+370 5) 268 5110 Fax. (+370 5) 2661402 
+37052685110 
ministerija@sam.lt 
www.sam.lt 
Reproductive tissues and cells 

Other 

- 
Yes 
State Health Care Accreditation Agency under the Ministry of Health 
Jeruzalės str. 21, LT-08420 Vilnius Tel. (+370) 5 261 51 77, Fax. (+370) 5 
212 73 10 
(+370) 5 261 51 77 
vaspvt@vaspvt.gov.lt 
http://www.vaspvt.gov.lt/en 
Medical devices 
Other 
- 
Accreditation, authorisation, licensing of TEs 

No 
1. National Transplant Bureau(NTB) is a National Competent Authority in 
charge of the implementation of quality and safety standards related to 
donation,  procurement, testing, processing, preservation, storage, 
distribution and transplantation of human tissues, cells and organs. It is also 
engaged in inspection  procedures for tissue banks and in supervising 
procedures for tissues, cells and organs procurement, transportation and 
transplantation. NTB is a State budgetary institution with staff of 25: 
administration 5 persons (director, deputy director, administrator, chief 
accountant, accountant);  Transplants Coordination Division with 10 
specialists (1 senior specialist for organs, 1 senior specialist for tissues and 
cells also acting as a vigilance officer, and  the rest  transplant coordinators); 
Legal and Supervisory Division with Head of division and 4 specialists (2 of 
them inspectors); Public Communications Division  with Head and 4 
specialists. Budget for the year 2013 is 283 thousand EUR; of which 204,5 
thousand euros will be spent on salaries. 2. Family health division of the 
Ministry of Health is responsible for the preparation of the bill on artificial 

283 

 
 
1.6. In case of MS with federal or decentralised systems, 
please indicate the roles/tasks of the Regional Competent 
Authority(ies). (more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of 
the Regional Competent Authority(ies) and their relation 
with the National Competent Authority(ies) for tissues and 
cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of 
procurement"? (more than 1 answer possible) 
2.1.2. How many such authorisations were granted in 2011 
(01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement centres in 
which procurement of "traditional tissues and cells" (skeletal 
tissues, cardiovascular tissues, skin, ocular tissues, amniotic 
membrane, pancreatic islet, hepatocytes, adipose tissue etc.) 
were carried out in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in 
which procurement of haematopoietic stem cells (bone 
marrow, PBSC, cord blood etc.) were carried out in 2011 
(01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in 
which procurement of gametes, embryos and other 
reproductive tissues were carried out in 2011 (01/01-
31/12/2011). 
2.2.4. Please provide the number of procurement centers in 
which procurement of tissues/cells for ATMP manufacturing 
were carried out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply 
with the requirements laid down in Art. 5 of Directive 
2004/23/EC and its implementing Directive 2006/17/EC 
(e.g. trained personnel, conditions accredited, designated, 
authorised, licensed) ? (more than 1 answer possible) 
2.4. Are you also responsible for the accreditation, 
designation, authorisation or licensing of laboratories 
performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 

2.5. How do you ensure, as CA for T&amp;C, that tests 
required for donors are carried out only by qualified 
laboratories accredited, designated, authorised or licensed 
Art. 5(2))? (more than 1 answer possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are 
performed etc.). 

fertilization and transposition of EU Directives. 3. State Health Care 
Accreditation Agency under the Ministry of Health is responsible for the 
accreditation, licencing and supervision of comformity to licencing 
conditions. 
Not applicable 

Not applicable 

Yes 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement centres 
1 

3 

2 

0 

0 

Analysis of the mandatory documentation 

No 

  State Health Care Accreditation Agency under the Ministry of Health  
(VASPVT) www.vaspvt.gov.lt 
Inspections of the laboratories 
Analysis of the mandatory documentation requested from the tissue 
establishment 

There are 4 licensed laboratories, which perform donor tests: 1) laboratory 
of the Vilnius University Hospital Santariskiu Klinikos, licensed in 1999; 2) 
laboratory of the Hospital of Lithuanian University of Health Sciences 
Kauno klinikos, licensed in 2000; 3) laboratory of Klaipda University 
Hospital, licensed in 1990; 4) National Public Health Surveillance 
Laboratory, licensed in 2005. 

2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of 
non-reproductive tissues and cells in your Member State. 
(more than 1 answer possible) 

Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 

284 

 
 
 
 
  
 
 
3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more 
than 1 answer possible) 
3.3. If NAT testing is not mandatory in your country, could 
you please indicate whether you intend to make it mandatory 
or to encourage its use? Please specify why or why not (e.g. 
number of additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests 
and test procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of 
non-reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems 
for testing laboratories? 
3.7.1. Please specify. 
3.8. Do you have any additional comments on testing? 

NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
HTLV-2 
Anti-HIV 1 
Anti-HIV 2 
Treponema Pallidum 
NAT testing is mandatory for  HCV, HBV. It is not mandatory for HTLV as 
Lithuania is not high prevalence area. NAT HIV could be mandatory to 
avoid ,,window  period mistakes as it could shorten it  from 15 to 10-12 
days. But it will prolong the time of donor testing from 6 to 7.5 hrs that 
means in some cases (when we have multiorgan donor) organs could  be 
lost. AntiHIV-1,2 and Ag HIV is enough to  prove the negative results. From 
Lithuania's long practice in testin of the donated blood by NAT method there 
were no one case positive with HIV. 
No 

Yes 

Syphilis RPR, CMV IgM, CMV IgG, EBV IgG, Toxo IgG, Anti HTLV-1 
No 

Yes 

ISO 

Yes 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue 
establishments under your responsability? 
4.2. Is inspection a prerequisite for the designation, 
authorisation, accreditation or licensing of tissue 
establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer 
possible) 
4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity 
to a quality system standard (e.g. ISO, JACIE, FACT)? 

No 

0 

1 

0 

Yes 
By review of a submitted application with supporting documentation 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending 
approval at 01/01/2011 (more than 1 answer possible): 
4.7.8. How many multi-tissue establishments? 
4.8. Tissue establishments with authorisations pending 
approval by 31/12/2011 (more than 1 answer possible): 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 
01/01/2011 and 31/12/2011 (more than 1 answer possible): 
4.9.8.  How many multi-tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 
(more than 1 answer possible): 

Multi-tissue establishments 

1 
Multi-tissue establishments 

0 
Multi-tissue establishments 

1 
Cord blood tissue establishments 
Multi-tissue establishments 

285 

 
 
  
 
 
 
 
4.10.6.1. How many public cord blood tissue 
establishments? 
4.10.6.2. How many private cord blood tissue 
establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.11. How many tissues and cells were distributed under the 
direct agreement of the Competent Authority according to 
Art. 6(5) during 2011? Please provide number(s) per type 
tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national 
provisions pursuant to the Directive been defined (Article 
27)? 
4.17. Do you have any additional comments on 
accreditation, authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and 
control measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in 
charge of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common 
training, common documentation, etc.)? (more than 1 answer 
possible) 
5.3. How many routine inspections of tissue establishments 
for non-reproductive tissues/cells were conducted in 2011 
(from 1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for 
non-reproductive tissues/cells were conducted  in 2011 
(from 1/1/2011 to 31/12/2011) following serious adverse 
events or reactions, or suspicion thereof ? 
5.3.2. How many other type of inspections of tissues 
establishments for non-reproductive tissues/cells were 
conducted in 2011 (from 1/1/2011 to 31/12/2011) (e.g. due 
to a whistle-blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where no 
shortcomings were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 

0 

1 

1 
0 
All together - 36 (35 units of PBSC (every time 500 ml) and 1 unit of 
m/sceletal tissue) 

No 

Yes 

Legal and Supervisory Division of the National Transplant Bureau under the 
Ministry of Health of Lithuania in charge of inspections of non-reproductive 
tissues and cells 
1 (2) 
No 

1 

0 

0 

1 

0 

0 

0 

0 

1, just desk based inspection before TE getting licensed  

286 

 
 
 
 
  
 
 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of other inspections carried out? 
Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, 
or suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted 
on ART establishments (from 1/1/2011 to 31/12/2011) (e.g. 
due to a whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments 
carried out in 2011 (01/01/2011 to 31/12/2011): What was 
the number of inspections carried out where no 
shortcomings were observed? 
5.4.4. What was the number of inspections carried out in 
ART establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in 
ART establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in 
ART establishments followed by suspension of 
authorisation? 
5.4.7. What was the number of inspections carried out in 
ART establishments followed by closure of respective 
establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? 
(more than 1 answer possible) 
5.6. How do you decide which type of routine inspection to 
conduct? 
5.7. Until 2011, did you implement the requirement 
concerning the time interval between two inspections (Art. 
7.3.)? 
5.8. How many TEs were inspected at least twice between 
2008-2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement 
sites outside tissue establishments? 
5.9.2. If no, why not? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual 
for Competent Authorities on inspection of tissue and cell 
procurement and tissue establishments - Guidelines for 
inspections (Commission Decision 2010/453/EU)? 
5.11.1. If no, which guidelines/regulations are used for 
inspections at national level? 

5.11.2. If no, please provide a hyperlink to these 
guidelines/inspections. 

5.12. Did you send any of your inspectors to the training 
courses organised by EU-funded projects (e.g. EUSTITE, 
SOHO V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and 
efficacy of these training courses on a scale from 1 to 5 (1 = 

0 

0 

0 

0 

0 

0 

0 

0 

0 

Desk based reviews 

We are entitled to conduct only desk based reviews 

Yes 

1 

No 

We were not entitled to perform such inspections between 2008-2011 
No 
We were not entitled to perform such inspections between 2008-2011 
No 

1. For routine inspections: Law on public administration of the Republic of 
Lithuania. 2. The National Transplant Bureau Director's Order NoT1-37 
about non-routine inspections of tissue banks and T&C&O procurement 
organizations : ,,Asmens  sveikatos prie~ikros /staigs, teikian is ~mogaus 
audinis, lstelis ir organs bei ia ~mogaus gauts audinis ir lstelis pagamints 
produkts, skirts naudoti ~monms,  donorysts, /sigijimo, iatyrimo, 
apdorojimo, konservavimo, laikymo ir paskirstymo paslaugas, neplaninis 
patikrinims atlikimo taisykls" 
1. http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_id=123381 ; 2. 
http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_id=432986&p_query
=&p_tr2=2  
Yes 

5 

287 

 
 
not important, 2 = sufficient, 3 = good, 4 = very good, 5 = 
essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA 
in that MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS 
in collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement 
centres or tissue establishments in third countries from 
which tissues and/or cells were imported in your country (as 
recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been 
requested by any other MS, on the results and control 
measures of your inspections, as part of an 
enquiry/investigation? 
5.17. Would you be interested in developing joint 
inspections? Joint inspections should be understood as 
inspections of tissue establishments conducted jointly by two 
or more Member States' Competent Authorities on their 
territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue 
establishments that are explicitly authorised to perform 
import/export of tissues and celles from/to third countries? 
6.2. Please specify the number of tissue establishments 
authorised to import tissues and cells from third countries 
(recorded by 31/12/2011). 
6.3. Please specify the number of tissue establishments 
authorised to export tissues and cells from third countries 
(recorded by 31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 

6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) 
tissues from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from 
third countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than 
cord blood) from third countries. 
6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from 
third countries. 
6.11. Did you import tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 

No 

No 

No 

No 

Yes 

No 

0 

0 

No procedures yet as Lithuania doesn't import skin from third countries. If in 
the future TEs will perform import of skin, they should follow requirements 
of Health Care Minister Order No V-397; (21 May 2007);  No V-188 (13 
March 2009); No V-463 (22 June 2004); No V-401 (22 May 2007); No V-
364 (14 May 2004) 
The Health Care minister Order No V-463 (22 June 2004)  and other orders 
(see above) 

The Health Care minister Order No V-463 (22 June 2004)  and other orders 
(see above) 

The Health Care minister Order No V-463 (22 June 2004)  and other orders 
(see above) 

The Health Care minister Order No V-463 (22 June 2004)   

Same procedures as for other tissues and cells (see above) 

no (importation is not allowed) 

Yes 

288 

 
 
  
 
 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of 
origin. 
6.12. Did you export tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 
which may invalidate the 2011 data on imports/exports of 
tissues/cells between your country and other third countries? 
6.14. What is the relation between import/export of tissues 
and cells and self-sufficiency? (more than 1 answer possible) 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for 
which type of tissues/cells. 
6.16. Do you have any additional comments on 
import/export? 

4x500 ml PBSC from USA 

No 

No 

C. Export of tissues/cells is authorised irrespective of national needs 
E. Import of tissues/cells is authorised based on estimations showing that 
there is chronic deficiency of those tissues/cells 
Yes 

PBSC, 32 cases (including cases from EU countries) or only 4 cases from 
third country (USA) 

Yes 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and 
cells? 
7.1.1. If yes, how do you address the possible more stringent 
quality and safety measures established by other Member 
States? Please specify. 
7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
7.1.2.1. How do you address this difference for tissues and 
cells coming from a MS with minimum quality 
requirements? Please specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding 
quality of tissues and cells during distribution? Please 
specify. 

Yes 

Quality and safety measures should be the same. If we do not perform the 
test required in another MS, we should do it before export.  

Quality and safety measures should be the same. If no, there is upon the 
specialists who decide if they will transplant such tissues/cells or not. 

Health Care Minister's Order No V-1010 Chapter X (about distribution of 
T&C): X. AUDINIr, LSTELIr PASKIRSTYMAS  57. Apdoroti audiniai ir 
lstels neturi bkti paskirstomos, kol neatitinka viss aio Apraao nustatyts 
reikalavims. 58. Paskirstymas atlikus audinis, lstelis /sigijim: 58.1. 
Kiekvienam audinis, lstelis gabenimui turi bkti skirtas lydraatis, kuriame 
pateikiama ai informacija: 58.1.1. donorysts data (ir laikas, jeigu galima); 
58.1.2. perspjimas apie pavojs; 58.1.3. bet kokie priedai (jeigu tokie 
naudojami); 58.1.4. autologins donorysts atveju  nurodant, kad audiniai, 
lstels skirti tik autologiniam naudojimui; 58.1.5. tikslins donorysts atveju 
nurodomas recipientas. 58.2. Jei audinius, lsteles gabena tarpininkas, 
kiekvienas gabenamas konteineris turi bkti pa~enklintas pateikiant toki 
informacij: 58.2.1. nuorod, kad konteineryje gabenami audiniai, lstels; u~raa 
Elgtis atsargiai; 58.2.2. /staigos, ia kurios gabenamas konteineris, pavadinim 
(adres, telefono numer/) ir asmen/, / kur/ galima kreiptis kilus problemoms; 
58.2.3. /staigos, / kuri gabenamas konteineris, pavadinim (adres, telefono 
numer/) ir asmen/, / kur/ galima kreiptis, kad jis paimts konteiner/; 58.2.4. 
gabenimo prad~ios dat ir laik; 58.2.5. gabenimo slygs techninius 
reikalavimus, svarbius audinis, lstelis kokybei ir saugai; 58.2.6. audinis, 
lstelis produkts atveju pridti /raa Neavitinti; 58.2.7. jei ~inoma, jog audiniai, 
lstels teigiamai reaguoja / atitinkam u~kre iamos ligos ~ymen/, pridti u~raa 
Biologinis pavojus; 58.2.8. autologinis donors atveju pridti u~raa Tik 
autologiniam naudojimui; 58.2.9. laikymo slygs techninius reikalavimus 
(tokius kaip Neaaldyti). 59. Paskirstymas recipientui arba sveikatos 
prie~ikros /staigai: 59.1. Galutinis paskirstoms audinis, lstelis ~enklinimas: 
59.1.1. Ant pirmins audinis, lstelis talpos bktina nurodyti ai informacij: 
59.1.1.1. audinis, lstelis tip; 59.1.1.2. audinis, lstelis identifikavimo numer/ 
(prireikus, siuntos arba partijos numer/); 59.1.1.3. Audinis banko 
identifikavimo duomenis; 59.1.1.4. galiojimo dat; 59.1.1.5. autologins 
donorysts atveju reikia u~raayti nuorod (Tik autologiniam naudojimui) ir 
nurodyti donoro / recipiento tapatyb; 59.1.1.6. tikslins donorysts atveju 
etiketje reikia nurodyti numatom recipient; 59.1.1.7. kai ~inoma, kad 
audiniai, lstels teigiamai reaguoja / atitinkam u~kre iamos ligos ~ymen/, 
bktina pridti u~raa BIOLOGINIS PAVOJUS. 59.1.2. Jeigu / pirmins talpos 

289 

 
 
  
 
 
etiket negalima /raayti jokios 51.1 punkte nurodytos informacijos, j reikia 
pateikti atskirame lape, pridedamame prie pirmins  talpos. `is lapas 
pridedamas prie pirmins  talpos taip, kad bkts u~tikrinta, jog jie liks kartu. 
59.1.3. Etiketje arba lydraa iuose turi bkti nurodyta ai informacija: 59.1.3.1. 
audinis, lstelis apraaymas (apibr~tis) ir, jei taikoma, matmenys; 59.1.3.2. jei 
taikoma, morfologiniai ir funkciniai duomenys; 59.1.3.3. audinis, lstelis 
paskirstymo data; 59.1.3.4. su donoru atlikti biologiniai tyrimai ir js 
rezultatai; 59.1.3.5. laikymo rekomendacijos; 59.1.3.6. talpos, pakuots 
atidarymo taisykls ir kita reikiama informacija, susijusi su manipuliavimu; 
59.1.3.7. galiojimo datos po atidarymo / manipuliavimo; 59.1.3.8. praneaimo 
apie nepageidaujamas reakcijas ir (arba) reiakinius taisykls; 59.1.3.9. 
cheminis med~iags liku is, kurie gali bkti kenksmingi (pvz., antibiotiks, 
etilinoksido ir kt.), buvimas. 59.2. Gabenimo konteinerio iaors ~enklinimas: 
59.2.1. Gabenant pirmin talpa turi bkti pakrauta / gabenimo konteiner/, kur/ 
bktina ~enklinti, nurodant bent jau ai informacij: 59.2.1.1. Audinis banko, ia 
kurio gabenama, identifikavimo duomenis, /skaitant adres ir telefono 
numer/; 59.2.1.2. u~ audinis, lstelis naudojim ~monms atsakingos /staigos 
(ar organizacijos), kuriai gabenama, identifikavimo duomenis, /skaitant 
adres ir telefono  numer/; 59.2.1.3. nuorod, kad pakuotje yra ~mogaus 
audiniai, lstels, bei u~raa ELGTIS ATSARGIAI; 59.2.1.4. kai reikia 
persodinti lsteles, pavyzd~iui, kamienines lsteles, turi bkti u~raaas 
NE`VITINTI; 59.2.1.5. rekomenduojamos gabenimo slygos (pvz., laikyti 
aaltai, neapversti ir kt.); 59.2.1.6. saugos taisykles ir (arba) aaldymo bkd (kai 
taikoma). 59.3. Siekiant ialaikyti reikiamas audinis, lstelis savybes turi bkti 
nurodytos svarbios gabenimo slygos, pavyzd~iui, temperatkra ir trukm. 59.4. 
Talpa ir (arba) pakuot turi bkti saugi ir u~tikrinti, kad nustatytomis slygomis 
audiniai, lstels ialaikys reikiamas tolesniam naudojimui savybes. 
Yes, but only via an authorised TE in my MS 

Yes 

32 

PBSC, musculo/sceletal 
Yes 

From Lithuania to Irland PBSC - 1x500ml;  

From Germany to Lithuania PBSC 28x500ml; from UK to Lithuania PBSC 
2x500ml; from Poland to Lithuania m/s -1 unit  

No 

No 

No 

7.3. Do you allow direct distribution to hospitals/clinics in 
your MS from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient 
of specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.4.1. If yes, how many authorisations were given in 2011 
(01/01/2011 to 31/12/2011)? 
7.4.2. If yes, for which tissues/cells? 
7.5. Do you collect data regarding the cross-border exchange 
of tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, 
type of tissue/cell and number of units distributed) 
concerning distribution to other MS in 2011 (01/01/2011-
31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on cross-border exchanges of 
tissues/cells between your country and other EU MS? 
7.7. Do you allow brokerage companies for either 
distribution in EU and/or import/export of tissues/cells? In 
this context, a brokerage company means a body that 
arranges transactions between a supplier (tissue 
establishment/company selling tissues or cells) and a buyer 
(a tissue establishment/a hospital or clinic/an individual) 
without undertaking activities of processing, preservation or 
storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the 
activities of tissue establishments in your Member State? 
(Article 10(1)). If yes, please upload the template. 

Yes 

290 

 
 
  
 
 
8.2. How many tissue establishments submitted annual 
reports of their activities during 2011. Please provide an 
estimation. (1 answer possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the 
consolidated activities of all tissue establishments in your 
country? 
8.4.1. Please insert the link to the published national annual 
report. 
8.5. Is there a publicly accessible register of authorised 
tissue establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's 
web site. 
8.6. Do you provide data regarding tissues and cells 
activities to the EUROCET registry (non-mandatory 
reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please 
specify. 
8.7. Do you have any additional comments on reporting? 

60-99% 

No 
Yes 

www.eurocet.org 

Yes 

www.transplantacija.lt 

Yes 

All the data regarding T&C (except ART) activities filled in the attached 
forms as requested by EUROCET.  

Yes 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) 
implemented in your country? 
9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
9.3. How is the data storage for traceability purposes 
organised in your tissue establishements (Art 8(4))? (only 1 
answer possible) 
9.4. How do you ensure that the 30 years data storage 
requirement is respected (Directive 2006/89/EC, Art. 9)? 
Please specify. 

Tissue establishment 

Both paper records and electronic forms 

The Order of Health Care minister No V-397 (Lietuvos Respublikos 
sveikatos apsaugos ministro 2007 m. gegu~s 21 d. /sakymas Nr. V-397 "Dl 
mirusio ~mogaus  audinis ir gyvo ~mogaus audinis ir lstelis donorysts, 
/sigijimo, iatyrimo, apdorojimo, konservavimo, laikymo, paskirstymo slygs 
bei tvarkos apraao tvirtinimo"  }in., 2007, Nr. 132-5393):  34. Informacija 
apie donorus, siekiant visiako atsekamumo, saugoma 30 mets po js audinis, 
lstelis klinikinio panaudojimo arba galiojimo laiko pasibaigimo. 

9.5. Do you have any additional comments on traceability? 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for 
the reporting of serious adverse events and reactions (Article 
11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its 
organisation. 

Yes 

National Transplant Bureau under the Ministry of Health 
See the answers to the question 1.1.7. and to 1.2. National Transplant Bureau 
performs the vigilance role according to the Order of Health Care Minister 
No  V-401 (2007 m. gegu~s 22 d. /sakymas Nr. V-401 "Dl praneaims apie 
nepageidaujamas reakcijas ir (ar) reiakinius, susijusius su audinis ir lstelis 
/sigijimu,iatyrimu,  apdorojimu, laikymu, paskirstymu ir transplantacija, 
tvarkos apraao patvirtinimo"  (}in., 2007, Nr.58-2253; 2010, Nr. 138-7081). 
TE, PO and Transplant centers  should report to CA about SARE, should 
investigate and take measures. CA submit annual reports to Health Care 
Ministry and to European Commission. 
Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do 
you use the SAR/E (to the CA (2006/76 art 6.4)) templates 
developed to the Annual reporting ot the EC also at national 
level? 
10.3. Do you use the Common Approach Document 
developed for the Annual reporting to the EC also at national 
level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the 

Yes 

Yes 

70-99% 

291 

 
 
  
 
 
  
 
 
total number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the 
transplantation centres when reporting SAR/SAE to the TEs 
which distributed the tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please 
specify the number and which tissues were recalled and why 
(e.g. missing consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify 
Tissue Establishments and procurement sites in case of a 
national rapid alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 

10.12. Do you have in place a system/procedure to notify 
Tissue Establishments and procurement sites when a rapid 
alert is issued via the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 

10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues 
and cells national vigilance system also to other national 

Yes 

The Health Care Minister's Order No V-401 (2007 m. gegu~s 22 d. 
/sakymas Nr. V-401 "Dl praneaims apie nepageidaujamas reakcijas ir (ar) 
reiakinius, susijusius  su audinis ir lstelis /sigijimu, iatyrimu, apdorojimu, 
laikymu, paskirstymu ir transplantacija, tvarkos apraao patvirtinimo"  (}in., 
2007, Nr.58-2253; 2010, Nr. 138- 081)), article 4.3, which says exactly, that 
institution should report about SARE to TE which distributed T&C :  4. 
Praneaan ioji /staiga privalo taikyti SVP, skirtas informacijai apie /sigytus ir 
transplantuotus audinius ir lsteles iasaugoti, irnedelsdama praneati apie visas  
nepageidaujamas reakcijas aioms /staigoms: 4.1. Nacionaliniam organs 
transplantacijos biurui; 4.2. /staigai, gavusiai audinius, lsteles ir organus, 
susijusius su nepageidaujama reakcija, skirtus transplantacijai, jeigu juos 
paskirst praneaan ioji /staiga; 4.3. /staigai, paskirs iusiai audinius, lsteles ir 
organus, susijusius su nepageidaujama reakcija, jeigu juos paskirst kita 
/staiga. 
Yes 

We communicate with all TEs in case of SARE reported at national level 
and give them feedback according to the same Health Care Minister's Order 
No V-401  (see above) and according to the Order of the Director of 
National Transplant Bureau T1-44, 11 October 2010 ,,Dl keitimosi 
informacija apie pavojingus  nepageidaujamus reiskinius ir reakcijas 
~mogaus audinis ir lastelis donorysts, /sigijimo, iatyrimo, apdorojimo, 
konservavimo, laikymo ir paskirstymo srityje  tvarkos apraao"  
Yes 

We inform our TEs in cases of SARE recorded at EU level if these cases 
could be relevant to them according to both Orders mentioned above. 
Yes 
0 

Yes 

The Order of the Director of National Transplant Bureau No T1-44, 11 
October 2010 ,,Dl keitimosi informacija apie pavojingus nepageidaujamus 
reiskinius ir  reakcijas ~mogaus audinis ir lastelis donorysts, /sigijimo, 
iatyrimo, apdorojimo, konservavimo, laikymo ir paskirstymo srityje tvarkos 
apraao", which stays that  information about national rapid alert should be 
communicated to all TEs, POs, Transplant centers, Health Care Ministry and 
other related Competent Authorities 
Yes 

The Order of the Director of National Transplant Bureau No T1-44, 11 
October 2010 ,,Dl keitimosi informacija apie pavojingus nepageidaujamus 
reiskinius ir  reakcijas ~mogaus audinis ir lastelis donorysts, /sigijimo, 
iatyrimo, apdorojimo, konservavimo, laikymo ir paskirstymo srityje tvarkos 
apraao" Article 2(2), which  stays that information from RATC should be 
communicated to all TEs, POs, Transplant centers, Health Care Ministry and 
other related Competent Authorities. 
No 

it was not requested from EUROCET yet 
Yes 

292 

 
 
vigilance/alert systems? 
10.14.1. If yes, please specify which of the following 
systems are usually contacted. (more than 1 answer possible) 
10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO 
V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and 
efficacy of these trainings on a scale from 1 (insufficient) - 2 
(sufficient)  3 (good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE 
reporting? 

Haemovigilance 
Medical devices 
Yes 

4 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
Explicit consent (opt-in) 
11.1. What consent system for living tissue/cell donation do 
you have in place within your Member State? 
11.1.1. Please specify your choice of consent system for 
living tissue/cell donation. 

11.2. What consent system for deceased tissue/cell donation 
do you have in place within your Member State? 
11.3. According to your national legislation, in case of 
deceased donations, please specify who is giving the 
authorisation for the tissue donation? (more than 1 answer 
possible) 
11.4. Is the consent system for deceased tissue donation the 
same as for organs? 
11.5. How is this consent verified during inspections? (more 
than 1 answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by 
Art. 13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors 
and recipients remain unidentifiable when access is given to 
third parties (Art. 14(1)). Please specify. 

The Transplant Law, Article 10(2) specifies that consent for living donation 
should be given by person him/herself in written form: 10 straipsnis. 
Transplantavimo ia gyvo donoro tvarka 1. Transplantacijai audiniai, lstels ir 
organai gali bkti imami ia gyvo asmens tik recipientui gydyti ir kai nra 
mirusio asmens tinkams audinis, lstelis ar organo  bei kits efektyvis gydymo 
alternatyvs. 2. Imti audinius, lsteles bei organus ia gyvo veiksnaus donoro 
leid~iama tik gavus jo raatiak sutikim. Donoras turi teis ataaukti savo 
sutikim. 
Explicit consent (opt-in) 

First degree relatives (including spouse) 

Yes 

Analysis of documentation 

Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 

These rules are described in 3 Acts: I. The Order of Health Care Minister No 
V-1010 (7 December 2007), Art 9(6): 9.6. Visi duomenys, /skaitant bendrj 
informacij, sulyginami su Apraao taikymo sritimi, kuriais gali naudotis tre 
iosios aalys, turi bkti anoniminiai, kad nei  donorai, nei recipientai nebkts 
identifikuoti. `iam tikslui Audinis bankas turi u~tikrinti, kad: 9.6.1. bkts 
pritaikytos duomens apsaugos priemons ir apsaugos /renginiai, neleid~iantys 
papildyti, iatrinti arba pakeisti duomens donors bylose arba /raauose  apie 
donorysts sustabdym bei perkelti informacij; 9.6.2. bkts nustatyta tvarka, 
padedanti panaikinti duomens neatitikimus; 9.6.3. nebkts informacijos 
atskleidimo be leidimo atvejs, tuo pa iu metu garantuojant transplantants 
siet/. II.Government Decree on Registry (Dl }mogaus audinis, lstelis  ir 
organs donors bei recipients registro  /steigimo ir jo nuostats patvirtinimo 
(}in., 2000, Nr. 72-2230, 2012, Nr. 115-5834), chapter VI article 38 and 39: 
38. Registro duomenys vieaai neskelbiami, iaskyrus nurodytuosius 39 
punkte. 39. Vieaai gali bkti pateikiami tik apibendrinti, suvestiniai registro  
duomenys.  III.  in Transplant Law Art 3(4):  3 straipsnis. }mogaus audinis, 
lstelis ir organs donors bei recipients registras 1. Transplantacijos atvejai ir 
duomenys apie donorus ir recipientus atskirais sraaais turi bkti /raaomi / 
}mogaus audinis, lstelis ir organs donors bei recipients  registr. 2. }mogaus 
audinis, lstelis ir organs donors bei recipients registr steigia ir jo nuostatus 
tvirtina Lietuvos Respublikos Vyriausyb. 3. Kad bkts iasaugotas donors bei 
recipients konfidencialumas, naudojimosi }mogaus audinis, lstelis ir organs 
donors bei recipients registro duomenimis  tvark nustato Sveikatos apsaugos 
ministerija. 4. U~ }mogaus audinis, lstelis ir organs donors bei recipients 
registro duomens konfidencialum atsako visi fiziniai ir juridiniai asmenys, 

293 

 
 
  
 
 
11.8. Please specify what measures are in place to ensure 
that the identity of the receipient is not disclosed to the 
donor and vice versa. 

11.9. Does your national legislation allows disclosure of 
donor data in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures 
in place. 
11.10. Do you have any additional comments on consent and 
data protection? 

kurie naudojasi aio  registro duomenimis. 
Transplant Law Art 3 (3,4) and Art 5: 3. Kad bkts iasaugotas donors bei 
recipients konfidencialumas, naudojimosi }mogaus audinis, lstelis ir organs 
donors bei recipients registro duomenimis  tvark nustato Sveikatos apsaugos 
ministerija. 4. U~ }mogaus audinis, lstelis ir organs donors bei recipients 
registro duomens konfidencialum atsako visi fiziniai ir juridiniai asmenys, 
kurie naudojasi aio  registro duomenimis. 5 straipsnis. Donoro, recipiento 
duomens konfidencialumas Informacija apie donoro ir recipiento sveikatos 
bkkl, taip pat visa kita asmeninio pobkd~io informacija, tarp js ir duomenys 
apie asmens tapatyb, yra  konfidenciali ir suteikiama tik Pacients teisis ir 
~alos sveikatai atlyginimo /statymo  ir kits teiss akts nustatyta tvarka.  Also 
see above (question 11.7) 
No 

0 (gametes donation is not allowed) 

Audit of documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of 
reproductive cells) are respected in your country (Art. 15(1), 
Annex I Directive 2006/17/EC)? (more than 1 answer 
possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.3. Do you have more stringent criteria for donor selection 
than those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the 
evaluation of a deceased donor of tissues/cells? (more than 1 
answer possible) 

Reproductive cells donation is not allowed 
No 

Audit documentation 
Other 

Interview with the donor's family or a person who knew the donor well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Audit of tissue establishment 

12.5. Do you have more stringent criteria for selection of 
donors of reproductive cells than those listed in Annex III of 
the Directive 2006/17/EC? 
12.6. Do you have more stringent criteria for autologous 
donation than those listed in Annex I of the Directive 
2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the 
Annex of Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding 
tissues and cells' procurement, packaging and transport are 
complied with by tissue establishments in your country (Art 
15(1), Annex IV of Directive 2006/17/EC? (more than 1 
answer possible)(For this question "audit" means a 
documented review of procedures, records, personnel 
functions, equipment, materials, facilities, and/or vendors in 
order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe 
Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your 
country have in place a quality system respecting the 

Authorisation requirement 
Inspections 

294 

 
 
  
 
 
  
 
 
provisions of the Directive 2004/23/EC Art 16.1? (more than 
1 answer possible). (For this question "audit" means a 
documented review of procedures, records, personnel 
functions, equipment, materials, facilities, and/or vendors in 
order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe 
Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? 
(more than 1 answer possible) 

13.3. How do you ensure an appropriate training for the 
personnel directly involved in the activities of tissue 
establishments? (more than 1 answer possible) 

13.4. Do you have national/regional/local training 
programmes for the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel 
trained? 
13.4.2.1. Please specify EU-countries. 
13.5. Any additional comments on quality management, 
responsible person, personnel? 

Internal audits 
External audits 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
No 

EU countries 

Czech Republic, Spain 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your 
country fulfill the requirments of the Art. 19 (Tissue and cell 
reception) of Directive 2004/23/EC and Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your 
country fulfill the requirements of the Art. 20 (Tissue and 
cell processing) of Directive 2004/23/EC? (more than 1 
answer possible) 
14.3. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 21 (tissue and cell 
storage conditions) of Directive 2004/23/EC? (more than 1 
answer possible) 
14.4. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 22 (labelling, 
documentation and packaging) of Directive 2004/23/EC and 
Annex IV of Directive 2006/17/EC? (more than 1 answer 
possible) 
14.5. Any additional comments on reception, processing, 
storage, labelling and packaging? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are mandatory 
for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your 
national legislation? 
15.1.1. If yes, have tissue establishments in your Member 
State notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 

Yes 

Yes 

According Directive Art 24 and according Health Care Minister's Order No 
V-1010: 5.10. Audinis bankas sudaro raatiakus susitarimus su tre iosiomis 
aalimis kiekvien kart, kai vykdoma iaorin veikla, kuri veikia audinis, lstelis, 
apdorots kartu  su tre ija aalimi, kokyb ir saug, ypa  aiomis aplinkybmis: 
5.10.1. kai Audinis bankas patiki vien ia audinis, lstelis apdorojimo etaps tre 
iajai aaliai; 5.10.2. kai tre ioji aalis teikia prekes ir paslaugas, kurios daro 
poveik/ audinis, lstelis kokybs ir saugos garantijai, taip pat ir js 
paskirstymui; 5.10.3. kai Audinis bankas teikia paslaugas sveikatos 
prie~ikros /staigai, kuri neturi licencijos Audinis banko veiklai; 5.10.4. kai 
Audinis bankas paskirsto tre isjs aalis apdorotus audinius, lsteles. 5.11. 
Audinis bankas vertina ir atrenka tre isias aalis, remdamasis js galimybmis 
atitikti Apraae nustatytus reikalavimus. 5.12. Susitarimai tarp Audinis banko 
ir tre isjs aalis tiksliai nustato tre isjs aalis atsakomyb ir iasami veiklos tvark. 

295 

 
 
  
 
 
  
 
 
15.1.1.2. How are third party agreements controlled (Art 6.2) 
by the Competent Auhtority(ies) in your MS? Please specify. 

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality 
and safety requirements than those requested by the EU 
legislation in this field (e.g. restrictions concerning the 
donation/use of certain tissues/cells, mandatory unpaid 
donation etc.)? 
16.1.1. Please specify. 

16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please 
provide a short description. 
16.3. In your opinion, in which of the following Directives 
are there shortcomings (if any)? (more than 1 answer 
possible) 

5.14. Nacionalinio transplantacijos biuro praaymu Audinis bankai privalo 
pateikti susitarims su tre iosiomis aalimis kopijas.  
According Health Care Minister's Order No V-1010: 5.14. Nacionalinio 
transplantacijos biuro praaymu Audinis bankai privalo pateikti susitarims su 
tre iosiomis aalimis kopijas. 

Yes 

Mandatory unpaid donation. Commercial donation is forbidden. According 
Transplant Law Art.11(1): 11 straipsnis. Komercinis sandoris neleistinumas 
1. Gyvo ar mirusio ~mogaus audiniai, lstels ir organai negali bkti civilinis 
komercinis sandoris objektas. Taip pat draud~iama skelbti apie ~mogaus 
audinis,  lstelis ir organs poreik/ arba js prieinamum, siekiant finansins arba 
panaaios naudos.  
ART provisions 
Other 

The Law on ART has not been approved since 2001 due to differences of 
political parties views 
No shortcomings 

296 

 
 
  
 
 
 
 
 
A.1.19. 

Survey response Luxembourg 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 

Ministère de la Santé 
Villa Louvigny - allée Marconi L-2120 LUXEMBOURG 
+352 2478 5505 
Ministere-Sante@ms.etat.lu 
http://www.ms.public.lu/fr/ 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
Ministry of Health with the Directorate of Health - Governemental 
Institution 

Not applicable 

/ 

Yes 
By inspecting all procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
none 

5 

0 

1 

0 

Inspections of the site/centre 
Analysis of the mandatory documentation 

Yes 

3 

Inspections of the laboratories 

297 

 
 
 
 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Analysis of the mandatory documentation requested from the tissue 
establishment 

laboratories accreditated according our general legislation on 
laboratories; all donor tests as foreseen in the directives 

/ 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
HTLV-2 
Treponema Pallidum 
/ 

No 

No 

No 

No 

/ 

Yes 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 
0 

No 

0 

0 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.2. How many musculo-skeletal tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.2. How many musculo-skeletal tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 

Musculo-skeletal tissue establishments 

0 
Musculo-skeletal tissue establishments 

0 
Other tissue establishments 

298 

 
 
 
 
 
 
 
 
and 31/12/2011 (more than 1 answer possible): 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 
4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 

/ 
Musculo-skeletal tissue establishments 
ART tissue establishments 
0 
1 
0 
1 
/ 

Yes 

No 

Yes 

Division de la médecine curative 

2 
No 

1 

0 

0 

0 

0 

0 

0 

0 

0 

299 

 
 
 
 
  
 
 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct? 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.2. Why not? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.17.1. Could you please explain why not? 
5.18. Do you have any additional comments on inspections? 

1 

0 

0 

0 

0 

0 

0 

0 

0 

General system-oriented inspections 
Desk based reviews 
/ 
Yes 

1 

Yes 

> 1 
No 
not appropriate 
Yes 

No 

not possible 
No 

No 

No 

No 

No 

no time 
/ 

300 

 
 
 
 
6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

No 

0 

0 

/ 

/ 

/ 

/ 

/ 

/ 

/ 

No 

No 

No 

F. Other 

no import/export 
No 

No 
audit 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 

No 

No 

No 

Yes, no restrictions apply 

301 

 
 
  
 
 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

No 

No 

/ 
100% (all) 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.1.1. If no, why not? 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.2. If no, why not? 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

information given on demand 
Yes 

/ 
No 

No 
No 

ART 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Yes 

/ 

Tissue establishment 

Both paper records and electronic forms 

Yes 

Direction de la Santé 
/ 
Yes 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.2. If no, how do you ensure that SAR/SAE are reported to the 
TEs? 

not enough personnal 
100% 

on case by case 

Yes 

No 

No 

302 

 
 
  
 
 
  
 
 
  
 
 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.2. If no, please specify why not. 
10.16. Do you have any additional comments on SARE reporting? 

Yes 

case by case 
Yes 

case by case 
Yes 
0 

Yes 

email - fax - telephone 

Yes 

email - fax - telephone 

Yes 

if then ART 
No 

No 

no time 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.4.1. If no, please describe the difference. 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

coding 

coding 

Yes 

No 

Explicit consent (opt-in) 

the person must give his or hers authorization 

Explicit consent (opt-in) 

First degree relatives (including spouse) 

organs = opt out system 
Analysis of documentation 

Only trained personnel is allowed to provide such information 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 

303 

 
 
  
 
 
  
 
 
Inspections of TEs and procurement sites 
Audit of documentation 

Inspections of ART centres 
Audit documentation 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 

12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Authorisation requirement 
Inspections 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel trained? 
13.4.2.1. Please specify EU-countries. 
13.5. Any additional comments on quality management, responsible 
person, personnel? 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 

EU countries 
/ 

No 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 

Inspections of tissue establishments 
Internal audits of tissue establishments 

304 

 
 
  
 
 
  
 
 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

No 

No 

No difficulties 

/ 

No shortcomings 

305 

 
 
  
 
 
  
 
 
 
 
 
A.1.20. 

Survey response Malta 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 

2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 

Superintendence of Public Health, Ministry for Health, Malta 
SLH-OPD- Level 1 St. Lukes Square, Gwardamangia PTA1010 
(+00356) 25953326/8 
healthstandards.sph@gov.mt 
https://ehealth.gov.mt/HealthPortal/public_health/publichealthregula
tion/introduction.aspx   and  
https://ehealth.gov.mt/HealthPortal/public_health/healthcare_serv_st
andards/tissues_cells_organs.aspx  
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Other 
Public Health Regulation, Health Care Standards, Health 
Promotion/Disease Prevention and Environmental Health 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
The National Competent Authority is the Superintendent of Public 
Health. The Superintendence has three directorates under its remit-  
1.The Health Care Standards Directorate which is accountable to the 
Superintendent of Public Health in managing issues related to the 
regulation of subtances of Human Origin. There is just one person 
responsible for this area, the Director who is a consultant in Public 
Health and is responsible for regulatory matters related to SOHO, 
inspections, authorisations, related EU and legal matters and SOHO 
vigilance. 2. The Health Promotion/Disease Prevention Directorate 
3. The Environmental Health Directorate. The Medicines Authority 
also falls under the Superintendence from the technical point of view 
Not applicable 

Not applicable- There are no regional Competent Authorities. 

Yes 
By inspecting all procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
Provisional Authorisations were given to two cord blood companies 
in 2011. These have now been fully authorised in 2013 together with 
another new cord blood procurement organisation. 
0 

2 

0 

0 

306 

 
 
 
 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 

2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Inspections of the site/centre 
Analysis of the mandatory documentation 

Yes 

Cord blood procurement organisations in Malta store cord blood in 
tissue/cell establishments abroad and in such cases the testing is 
done by the mother company abroad 
Analysis of the mandatory documentation requested from the tissue 
establishment 

0 

Nil 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
There is no intention to make it mandatory. The prevalence of 
HIV/Hep B etc in Malta is low and a cost-benefit analysis does not 
warrant its introduction 

No 

No 

No 

No 

Nil 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

2 

Yes 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC),  Nil 

307 

 
 
 
 
 
 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

Nil 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.6. How many cord blood tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.9. Please specify the type of tissues/cells and how many. 

4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 

Cord blood tissue establishments 

2 procurement organisations 
Other tissue establishments 

Two cord blood procurement organisations 
Other tissue establishments 

Two cord blood procurement organisations which have now been 
authorised. 
Other tissue establishments 

Nil 

2 cord blood procurement organisations which were in the process of 
being authorised and were then authorised in 2012 
Nil 

Yes 

No 
Nil 

Yes 

The Superintendence of Public Health 

1 expert on tissues and Cells and two GMP inspectors 
Yes 

Blood 
Organs 
Advanced therapies 
Hospitals 
Nil 

Nil 

nil 

0 

308 

 
 
 
 
 
 
 
 
0 

Nil 

Nil 

Not applicable 

2 cord blood procurement organisations 

was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  Depending on the nature of the organisation- whetehr it is a 

General system-oriented inspections 
Desk based reviews 

0 

0 

0 

0 

0 

0 

0 

0 

0 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 

procurment organisation with storage of tissues/cells in 
establishments in Eu or EEA Member States, the nature of tissues 
and cells collected and the nature of processes. 
Yes 

0 

Yes 

2 
Yes 
1 
Yes 

309 

 
 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 

6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 

6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 

6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 

6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 

Yes 

5 

No 

No 

No 

No 

Yes 

 Malta has to rely on the help of other inspectors from EU member 
states to assist the local inspectors during the inspections  

No 

0 

0 

Notification of the import to the Competent Authority who verifies 
the equivalence of standards and a requirement of cerification by the 
responsible person of the exporting tissue establishment stating the 
equivalence of standards 
Notification of the import to the Competent Authority who verifies 
the equivalence of standards and a requirement of cerification by the 
responsible person of the exporting tissue establishment stating the 
equivalence of standards 
Notification of the import to the Competent Authority who verifies 
the equivalence of standards and a requirement of cerification by the 
responsible person of the exporting tissue establishment stating the 
equivalence of standards. No such importations have as yet taken 
place. 
Notification of the import to the Competent Authority who verifies 
the equivalence of standards and a requirement of cerification by the 
responsible person of the exporting tissue establishment stating the 
equivalence of standards. No such imporations have as yet taken 
place. 
Notification of the import to the Competent Authority who verifies 
the equivalence of standards and a requirement cerification of the 
responsible person of the exporting tissue establishment stating the 
equivalence of standards. No such imporations have as yet taken 
place. 
Notification of the import to the Competent Authority who verifies 
the equivalence of standards and a requirement cerification of the 
responsible person of the exporting tissue establishment stating the 
equivalence of standards. No such importations have as yet taken 

310 

 
 
 
 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

place. 
Not applicable. Importation of gametes is not allowed in Malta 

Yes 

Skin- from Netherlands 

No 

No 

F. Other 

Import is considered when the tissues/cells are not avalable locally at 
all. 
Yes 

Demineralised bone matrix 

Nil 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
Please specify 'other'. 

Other 

7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.4.1. If yes, how many authorisations were given in 2011 
(01/01/2011 to 31/12/2011)? 
7.4.2. If yes, for which tissues/cells? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) as 
a Competent Authority, in their authorisation/monitoring or 
inspection. 

7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.8.1. Where are the brokers located? 
7.9. Do you have any additional comments on distribution? 

No 
They have to be certified by the responsible person of the tissue 
establishment distributing them. 

Direct distribution to hospitals/clinics through brokers after 
notification of the Competent Authority who authorises the import if 
the relevant documentation shows equivalence of standards 
Yes 

One 

Demineralised bone martix 
No 

No 

Yes 

The Competent Authority has to be notified regarding each and 
every importation, requests further information, analyses the 
information provided and only gives authorisation for importaion 
after equivalence of standards is verified  
Yes 

Your country 
Nil 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 

Yes 

311 

 
 
 
 
 
 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 

8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

8.7. Do you have any additional comments on reporting? 

100% (all) 

Yes 
https://ehealth.gov.mt/HealthPortal/public_health/healthcare_serv_st
andards/tissues_cells_organs.aspx 
Yes 

https://ehealth.gov.mt/HealthPortal/public_health/healthcare_serv_st
andards/tissues_cells_organs.aspx 
Yes 

https://ehealth.gov.mt/HealthPortal/public_health/healthcare_serv_st
andards/tissues_cells_organs.aspx 
Yes 

Data on procurement of cord blood and distribution of any imported 
tissues (such as imported skin or bone matrix for clinical application 
in Malta). 
Nil 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 

Yes 

9.5. Do you have any additional comments on traceability? 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

Procurement centre 

Both paper records and electronic forms 

By randomly checking that donations till now can be traced and 
overseeing that procurement organisations have adequate data 
backup sytems and checking that they also have in place a system 
wherby data can be stored even in case of closure of the 
establishment. 
Nil 

The Superintendence of Public Health  
The Superintendence of Public Health is made up of three 
directorates-  (1) The Directorate for Health Care Standards (2) the 
Health Promotion and Disease Surveillnace Directortyae and the 
Environmental Health Directorate. The Vigilance sytem is taken 
care of by the Health Care Standards Directorate. The same 
directorate also takes care of the haemovigilance system and 
vigilance and surveillnce related to organ transplants. 
Yes 

Yes 

Yes 

100% 

Yes 

Transplantation centres have to report to the Tissue establishments 
which distributed the tissues/cells. The tissue/cell establishments 

312 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

 
 
 
 
 
 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

Please specify 'other'. 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

then investigate the issue and report to the Competent Authority. 
Transplantation centres are also obliged to inform the Competent 
Authority when such SAR/SAEs occur. 
Yes 

An annual report consolidated report is posted on the website 
Yes 

An annual report consolidated report is posted on the website 
Yes 
Nil 

Yes 

The same directorate responsible for Vigilance and Surveilance 
system for Tissues/Cell is also responsible for the national rapid alert 
sytem. The system also communicates with rapid alert sytems for 
blood and other substances of human origin. It can also send alerts to 
the Malta Medicines Authority whhich is responsible for 
Pharmacovigilance and to the MCCAA which is the Competent 
Authority responsible for Medical Devices. 
Yes 

The same directorate responsible for Vigilance and Surveilance 
system for Tissues/Cell is the Directorate that receives the alerts 
through the RATC platform and is also responsible for the national 
rapid alert sytem. The system also communicates with rapid alert 
sytems for blood and other substances of human origin. It can also 
send alerts to the Malta Medicines Authority whhich is responsible 
for Pharmacovigilance and to the MCCAA which is the Competent 
Authority responsible for Medical Devices. The alert can be also 
cascaded to tissue establishments and procurement sites and also to 
end users like hospitals and transplantation centres. 
Yes 

Cord blood procurement data. 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Other 
End users, transpnt centres including the organ tranplant centre. 
Yes 

5 

Nil 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 

Explicit consent (opt-in) 

It is considered that the donor has a right to decide whether to donate 
or not. 
Explicit consent (opt-in) 

313 

 
 
 
 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 

11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

First degree relatives (including spouse) 
Other relatives 

Yes 

Analysis of documentation 

Only trained personnel is allowed to provide such information 

The donors and recipients are given a unique identifier number. 

The identity of the donor is not revealed to the recipient and all 
precautions are taken so that any material is given a unique identifier 
number that can only be traced back by the procurement 
organisation or tissue establishment as the the traceability 
requrements dictate and in the case of a need for look-back 
procedures in investigations or by the Competent Authority during 
investigations. 
No 

Not applicable as gamete donation is not permitted in Malta. 

Data Protection is ensured through the Data Protection Act of 2001. 

Audit of documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Audit documentation 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Other 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 

314 

 
 
 
 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.8.1. Please specify. 

12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Related information is also requested in the Tissue Establishment 
Dossier that is requested prior to inspections. This dossier and the 
documentation therein is inspected by the Licensing Authority prior 
to the onsite inspection. 
Nil 

Authorisation requirement 
Inspections 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
Please specify 'other'. 

Authorisation requirement 
Inspections 

13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

Authorisation requirement 
Inspections 
Other 
At inspection, the inspectorate team asks for documentation of 
training for the personnel directly involved in the activities of tissue 
establishments. 
Yes 

The training undergone depends on the type of personnel. The 
Tissue Establishment has to have a Quality Manual that defines the 
job description and the qualifications and training required by the 
personnel. It has to define how the training is to be provided, the 
proficiency testing of the personnel and the documentation of such 
training/proficiency tests and competencies of the personnel. 
Nil 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

Nil 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

Yes 

Yes 

Cord blood procurement organisations have third party agreements 

315 

 
 
 
 
 
 
 
 
15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

with clinical teams responsible for procurement. 
The procurement organisation/tissue establishment has to have a 
documented list of third parties with which it has agreements and 
has to have documented copied of the agreement. The agreements 
have to define the responsibilities of both parties with definition of 
SOPs for all the processes and control measures that could affect the 
quality and safety of the tissues and cells. 
Nil 

No 

No difficulties 

Not applicable 

No shortcomings 

316 

 
 
 
 
 
 
 
A.1.21. 

Survey response Netherlands 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
Please specify 'other': 
1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer possible) 

1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.3. National Competent Authority 3? 
1.3.1. Name of National Competent Authority 3: 

1.3.2. Address of NCA 3: 
1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 answer possible) 

1.3.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
Please specify 'other': 
1.4. National Competent Authority 4? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, 
budget, independence from government etc.). 

Ministry of Health, Welfare and Sport (Ministerie voor 
Volksgezondheid, Welzijn en Sport, VWS) 
P.O. Box 20350 2500 EJ Den Haag  The Netherlands 
+ 31 70 340 7911 
- 
www.minvws.nl 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Accreditation, authorisation, licensing of TEs 
Other 
policy making 
Yes 
Health Care Inspectorate (Inspectie voor de Gezondheidszorg, IGZ) 
P.O Box 2680   3500 GR Utrecht The Netherlands   
+ 31 (0)88-120 5000 
meldpunt@igz.nl 
www.igz.nl 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Inspection 
Vigilance 
Yes 
Dutch Transplantation Foundation (Nederlandse Transplantatie 
Stichting, NTS) 
P.O.Box 2304 2301 CH Leiden The Netherlands 
+ 31 (0)71 5795 777 
info@transplantatiestichting.nl 
http://www.transplantatiestichting.nl/ 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Human organs 
Other 

donor registry, patient waiting list, allocation of organs and tissues. 
No 
NCA1 Ministerie van Volksgezondheid, Welzijn en Sport ( VWS, 
Ministry of Health, Welfare and Sport); responsible for policy making; 
divisions Public Health, Curative Care, Long-term Care; staffing: total 
4200 fte’s, 8 dedicated to EU (legal) affairs; budget ca € 18 billion;  
NCA2 Inspectie voor de GezondheidsZorg (IGZ, Health Care 
Inspectorate); independent part of ministry of Health, Welfare and 
Sport; departements: Cure, care, pharmaceutical products (including 
organs, tissues, cells, and blood); budget € 60 million; staffing: total 
500, 300 dedicated to inspections, specific tissues and cells; staff for 
international/European inspection and vigilance: 2 senior, 1 junior, 1 
support, 1 legal. NCA3 Nederlandse TransplantatieStichting (NTS, 
Dutch Transplantation Foundation); legally assigned as Organcenter, in 
charge of donor registry, patient waiting list, allocation of organs and 
tissues;  budget € 30 million; staffing: total 65;  

317 

 
 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? 
(more than 1 answer possible) 
2.1.2. How many such authorisations were granted in 2011 
(01/01-31/12/2011)? 

2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out 
in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were 
carried out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more 
than 1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor 
testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required 
for donors are carried out only by qualified laboratories 
accredited, designated, authorised or licensed Art. 5(2))? (more 
than 1 answer possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are 
performed etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

Not applicable 

N/a 

Yes 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement centres 
18 TE; Conditions of procurement were inspected and granted at each 
inspection of TE, except when at inspections for authorisations for 
import and distributions.  
38 

11 

80 

1 

Inspections of the site/centre 
Analysis of the mandatory documentation 

Yes 

51 

Inspections of the laboratories 
Analysis of the mandatory documentation requested from the tissue 
establishment 

43 donor test labs for 2006/17 tests; 8 donor test labs for 2006/17 tests 
plus HLA typing. In the Netherlands accreditation of donor test labs 
started in 2011. 

no 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 

318 

 
 
 
 
 
 
3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and 
test procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

We do not plan to make NAT mandatory; 180 days quarantaine in case 
of living donors is regarded sufficient. 

No 

Yes 

Donor is tested for HTLV, depending on the country of origine. 
Yes 

The non-partner donor is tested for HTLV, depending on the country 
of origine. 
No 

no 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments 
under your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

18 

Yes 
During routine inspections 
During inspections organised for this purpose 
0 

4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were suspended in 2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 
4.6.1. What is the relation between the indpendent certification(s) 
(e.g. ISO, JACIE, FACT) and the CA authorisation of the tissue 
establishments? (more than 1 answer possible) 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval 
by 31/12/2011 (more than 1 answer possible): 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 
01/01/2011 and 31/12/2011 (more than 1 answer possible): 

4.9.2. How many musculo-skeletal tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more 
than 1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 

0 

Yes 

Mandatory for authorisation 

Other tissue establishments 

0; no authorisations pending approval at 01/01/2011. 
Other tissue establishments 

0; no authorisations pending approval at 31/12/2011. 
Musculo-skeletal tissue establishments 
HSC tissue establishments 
ART tissue establishments 
1 
1 
16 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
0 
1 

319 

 
 
 
 
 
 
4.10.2.1. How many public musculo-skeletal tissue 
establishments? 
4.10.2.2. How many private musculo-skeletal tissue 
establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) 
during 2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.16.1.1. How many penalties have been imposed in 2011 (from 
01/01/2011-31/12/2011)? 
4.16.1.2. What were the reasons for imposing the penalties? 
Please describe. 
4.16.1.3. What kind of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty etc.) 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in 
charge of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for 
non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 
to 31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues 
establishments for non-reproductive tissues/cells were conducted 
in 2011 (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 

0 

15 

0 
1 
0 
11 
0 
3 
0 
79 
0 
5 
0 

Yes 

Yes 
0 

N/a 

N/a 

4.6, 4.6.1: JACIE, FACT, only for (HP)stemcells; 

Yes 

Health Care Inspectorate 

2 senior inspectors,1  junior inspector, 1 supporting staff member 
Yes 

Blood 
Organs 
Advanced therapies 
11 

0 

1; due to a whistle-blower. 

0 

13 

320 

 
 
 
 
 
 
0 

0 

0 

0 

24 

10 

shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, or 
suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on 
ART establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a 
whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments 
carried out in 2011 (01/01/2011 to 31/12/2011): What was the 
number of inspections carried out where no shortcomings were 
observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more 
than 1 answer possible) 
5.6. How do you decide which type of routine inspection to 
conduct? 
5.7. Until 2011, did you implement the requirement concerning 
the time interval between two inspections (Art. 7.3.)? 
5.7.1. Why not? 
5.7.2. How do you prioritise tissue establishments to be inspected?  Criteria: - external certification; - previous shortcomings (type and 
numer); -notifications (events, reactions, alerts, and field signals); - 
size of TE (numer of tissues distributed or processed); - type of activity  
33 

General system-oriented inspections 

Understaffed. 

N/a 

No 

24 

20 

0 

0 

0 

0 

0 

5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell 
procurement and tissue establishments - Guidelines for 

No 

This is regarded the responsibility of the TE.  See 2.1.1: documentation 
associated with (conditions of) procurement is inspected at the TE 
working with the procurement centres. 
Yes 
2 
Yes 

321 

 
 
inspections (Commission Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 
= sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.13.1. Could you please explain why? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.16.1. If yes, please specify. 
5.17. Would you be interested in developing joint inspections? 
Joint inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised 
to import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised 
to export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 
6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) tissues 
from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from third 
countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than cord 
blood) from third countries. 
6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 

Yes 

3 

Yes 

In case of shipment of tissues to the Netherlands. 
No 

No 

Yes 

NL requested clarifications of a license issued in another MS. 
Yes 

no 

No 

12 

Unknown 

Aide-memoire for importing. 

Aide-memoire for importing. 

Aide-memoire for importing. 

Aide-memoire for importing. 

Aide-memoire for importing. 

Aide-memoire for importing. 

Aide-memoire for importing. 

322 

 
 
 
 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on imports/exports of tissues/cells 
between your country and other third countries? 
6.14. What is the relation between import/export of tissues and 
cells and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which 
type of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

Yes 

No data. 

Yes 

skin 5453, bone 4830, cornea 48, HPSC unrelated 1 (bonemarrow) 14 
(periphere blood), 4 (cord blood), embryo 8. ART 2011 not available 
yet. 
No 

F. Other 

Export of post-mortal tissues and scarce tissues is restricted. 
Yes 

One (1) case of direct import of an embryo. 

See activities and conclusions of the Working Group Import of Tissues 
and Cells. 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells?  Yes 
7.1.1. If yes, how do you address the possible more stringent 
quality and safety measures established by other Member States? 
Please specify. 
7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your 
MS from TEs in another MS? (only 1 answer possible). 
Please specify 'other'. 

Other 

Yes 

This is responsibility of the authorised distributor/TE. 

For safety reasons more stringent measures are regulated in The 
Netherlands in order to control the distribution of unprocessed tissues 
from other MS. 
On site inspections of TE's. 

7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 

7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in 
EU and/or import/export of tissues/cells? In this context, a 
brokerage company means a body that arranges transactions 
between a supplier (tissue establishment/company selling tissues 
or cells) and a buyer (a tissue establishment/a hospital or clinic/an 
individual) without undertaking activities of processing, 

Yes,  but FOR UNPROCESSED TISSUES only via an authorised TE 
in our MS. 
No 

Yes 

Distributed to EU (none NL; no data on country of destination): skin 
9830, bone 16821, tendon 99, cornea 182, sclera 15, amnion 10, heart 
valve 27, blood vessel 5, HPSC 4 (bone marow), 15 (periphere blood), 
7 (cord blood), lymfocyt 1, semen (donor) 156, semen (partner) 963, 
oocyt (autologeous) 745, embryo 8.  
Not available. 

No 

Yes 

323 

 
 
 
 
preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) 
as a Competent Authority, in their authorisation/monitoring or 
inspection. 

7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.8.1. Where are the brokers located? 
7.8.2. If the broker is located in another country, how 
easy/difficult is it to ensure that safety and quality requirements 
are met? 
7.9. Do you have any additional comments on distribution? 

In the Netherlands, a broker is a legal entity, in the field of tissues only 
allowed to make financial and logistic arrangents between seller and 
buyer without handling the tissues. Handling the tissues is only 
allowed to authorised TE's. 
Yes 

Another country 
Unknown, yet to be determined. 

no 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.1.1. If no, why not? 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 
answer possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 

This is the responsibility of the TE. 
<50% 

No 
No 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web 
site. 

8.6. Do you provide data regarding tissues and cells activities to 
the EUROCET registry (non-mandatory reporting)? 
8.6.2. If no, why not? 
8.7. Do you have any additional comments on reporting? 

Following from the Act of Freedom of Information, annual reports 
from TE's are already publicly available. 
Yes 

http://www.farmatec.nl/doc/pdf/Internetoverzicht%20Wvkl-
erkenningen%20en%20-
vergunningen%20afgegeven%20vanaf%201%20juni%202007_18122.
pdf 
No 

no raw data readily accessible;  
No 

Yes 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented 
in your country? 
9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

No 

National Competent Authority 

Both paper records and electronic forms 

On site inspections. 

Yes 

Health Care Inspectorate (IGZ) 
See question 1.5. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its 
organisation. 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to 
the Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are welcome to 
upload the template if you wish. 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 

Yes 

No 

For annual SAR/E - report we use descriptive set-up (text, tables and 
figures) instead of a specific template.  
Yes 

324 

 
 
 
 
 
 
 
 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.2. If no, how do you ensure that SAR/SAE are reported to the 
TEs? 
10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.2. Please specify why not. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please specify 
the number and which tissues were recalled and why (e.g. missing 
consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued 
via the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and 
cells national vigilance system also to other national 
vigilance/alert systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

70-99% 

No 

1. The reporting of SAR/E's are incorporated in the instructions for use 
of the tissue-product. 2. On-site inspections. 
Yes 

Feedback is given for single notifications if necessary, and on a general 
level in the national annual report for SAR/E. 
No 

Already publicly available on SANCO website. 
Yes 
0 

Yes 

Part of specific standard operating procedure of the Health Care 
Inspectorate. 
Yes 

Part of specific standard operatnig procedure of the Health Care 
Inspectorate. 
No 

This is not deemed necessary. 
Yes 

Haemovigilance 
Medical devices 
Other 
Organs, clinical trials. 
Yes 

Please specify 'other'. 
10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting?  No 

3 

Explicit consent (opt-in) 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do 
you have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 

Political decision. 

Explicit consent (opt-in) 

Please specify 'other'. 
11.4. Is the consent system for deceased tissue donation the same 
as for organs? 

First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Other 
Guardian, in case of child of 12 years of age or older.  
Yes 

325 

 
 
 
 
11.5. How is this consent verified during inspections? (more than 
1 answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third 
parties (Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice 
versa. 
11.9. Does your national legislation allows disclosure of donor 
data in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 

Legally regulated in Dutch Act on Safety and Quality of SoHO 
(WVKL). 

Legally regulated in Dutch Act on Safety and Quality of SoHO 
(WVKL). 

Yes 

No 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 
Audit of documentation 
Regular evaluation of medical personnel 
Standardised questionnaires at national level 
Inspections of ART centres 
Audit documentation 
Regular evaluation of medical personnel 
No 

12.5. Do you have more stringent criteria for selection of donors 
of reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues 
and cells' procurement, packaging and transport are complied with 
by tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, 
and/or vendors in order to evaluate adherence to the written SOP, 
standards or governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

Interview with the donor's family or a person who knew the donor well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 

No 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your 
country have in place a quality system respecting the provisions of 
the Directive 2004/23/EC Art 16.1? (more than 1 answer 
possible). (For this question "audit" means a documented review 
of procedures, records, personnel functions, equipment, materials, 
facilities, and/or vendors in order to evaluate adherence to the 
written SOP, standards or governments laws and regulations (from 
Council of Europe Guide to the Safety and Quality Assurance for 

Authorisation requirement 
Inspections 

326 

 
 
 
 
 
 
the Transplantation of Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel trained? 

13.4.2.1. Please specify EU-countries. 

13.4.2.2. Please specify non EU-countries. 

13.5. Any additional comments on quality management, 
responsible person, personnel? 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 

No 

EU countries 
Non-EU countries 
Unknown; location of training of the personnel of TE's is not notified 
or registred at the level of national competent authority. 
Unknown; location of training of the personnel of TE's is not notified 
or registred at the level of national competent authority. 
No 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your 
country fulfill the requirments of the Art. 19 (Tissue and cell 
reception) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your 
country fulfill the requirements of the Art. 20 (Tissue and cell 
processing) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.3. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 21 (tissue and cell storage 
conditions) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.4. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 22 (labelling, 
documentation and packaging) of Directive 2004/23/EC and 
Annex IV of Directive 2006/17/EC? (more than 1 answer 
possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

No 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 

SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 

SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 
15.1.1.2. How are third party agreements controlled (Art 6.2) by 
the Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and 
safety requirements than those requested by the EU legislation in 
this field (e.g. restrictions concerning the donation/use of certain 
tissues/cells, mandatory unpaid donation etc.)? 
16.1.1. Please specify. 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are 
there shortcomings (if any)? (more than 1 answer possible) 

Yes 

Yes 

One case in 2012 concerning storage. 

- agreements between TE and third parties are requirement for 
authorisation of TE. - on-site inspection of TE or third party. 
No 

Yes 

Distribution of unprocessed tissue from other MS to the Netherlands. 
Inspections 

- inspection interval; selection of sites to be inspected. 

Directive 2004/23/EC 
Directive 2006/17/EC 

327 

 
 
 
 
 
 
 
 
16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 
16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

Directive 2006/86/EC 
We refer to the outcome and report of the PCAM in Vienna, November 
2012. 
We refer to the outcome and report of the PCAM in Vienna, November 
2012. 
We refer to the outcome and report of the PCAM in Vienna, November 
2012. 

328 

 
 
 
 
 
A.1.22. 

Survey response Norway 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 

1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 
1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer possible) 

1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.3. National Competent Authority 3? 
1.3.1. Name of National Competent Authority 3: 
1.3.2. Address of NCA 3: 
1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 answer possible) 

1.3.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.4. National Competent Authority 4? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? 
(more than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 

Norwegian directorate of health 
Norwegian directorate of health P.b 7000 St.Olavs plass NO-0130 
Oslo Norway 
+47 81020050 
postmottak@helsedir.no  
www.helsedirektoratet.no 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Medical devices 
Other 
Gene modified micro organisms 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Yes 
Norwegian board of health supervision 
Calmeyers gate 1 P.b 8128 NO-0032 Oslo Norway 
+47 21529900 
postmottak@helsetilsynet.no 
www.helsetilsynet.no 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Inspection 

Yes 
Norwegian medicines agency 
pb. 63 Kaldbakken NO-0901 Oslo Norway 
+47 22897700 
post@legemiddelverket.no 
www.legemiddelverket.no 
Non-reproductive tissues and cells 
Pharmaceuticals 
Accreditation, authorisation, licensing of TEs 
Inspection 
No 
The national competent authorities are organised under the norwegian 
ministry og health and care services. The inspectors are independent 
from govermental control.  

Not applicable 

There are no regional competent authorities for TE 

Yes 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
14 

329 

 
 
 
 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more 
than 1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required 
for donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and 
test procedures for deceased donors? 
3.4.1. Please specify why: 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 
3.7. Do you request/use international accreditation systems for 

11 

0 

10 

1 

Inspections of the site/centre 
Analysis of the mandatory documentation 

Yes 

15 

Inspections of the laboratories 
Analysis of the mandatory documentation requested from the tissue 
establishment 

Number: 15, Year of accreditiation: 2008-2013, tests: HCV, HBV, 
Tp, HIV, HTLV-1, HTLV-2 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
HTLV-2 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
HTLV-2 
NAT Chlamydia 
Treponema Pallidum 
NAT is not mandatory according to cost-benefit analysis and 
epidemiological situation in Norway. 

Yes 

Shortcomings of available tests for deseased donors  
No 

Yes 

required tests for gonorrhea and chlamydia for non partner donation 
No 

330 

 
 
  
 
 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments 
under your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 
4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses were 
suspended in 2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses were 
revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 

No 

0 

Yes 
By review of a submitted application with supporting documentation 
0 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 (more 
than 1 answer possible): 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) 
during 2011? Please provide number(s) per type tissues/cells. 

0 

Other tissue establishments 

Approvals given in Norway are not time limited 
Other tissue establishments 

Approvals given in Norway are not time limited 
Other tissue establishments 

Approvals given in Norway are not time limited 
Other tissue establishments 

Approvals given in Norway are not time limited 

Approvals given in Norway are not time limited 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for 
non-reproductive tissues/cells were conducted in 2011 (from 

Yes 

No 

Yes 

Nowregian board of health supervision 

2 
Yes 

Blood 
Pharmaceuticals 
Advanced therapies 
Medical devices 
Accreditation organisations (e.g. JACIE) 
0 

331 

 
 
  
 
 
 
 
 
 
  
 
 
1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 
to 31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, or 
suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a 
whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 
1 answer possible) 
5.6. How do you decide which type of routine inspection to 
conduct? 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 

0 

0 

0 

0 

0 

0 

0 

0 

9 

0 

0 

2 

7 

0 

0 

0 

0 

General system-oriented inspections 
Thematic inspections 
Based on review of documentation, risk assessement and history of 
deficiencies 
Yes 

0 

332 

 
 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? 
Joint inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised 
to import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised 
to export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 
6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) tissues 
from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from third 
countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than cord 
blood) from third countries. 

No 

Not relevant 
No 
Not relevant 
Yes 

Yes 

4 

No 

No 

No 

No 

Yes 

Yes 

5 

0 

National regulation of quality and standards equivalent to EU 
standards 

National regulation of quality and standards equivalent to EU 
standards 

National regulation of quality and standards equivalent to EU 
standards 

National regulation of quality and standards equivalent to EU 
standards 

National regulation of quality and standards equivalent to EU 
standards 

333 

 
 
  
 
 
6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which 
type of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

National regulation of quality and standards equivalent to EU 
standards 

National regulation of quality and standards equivalent to EU 
standards 

Yes 

Not available 

No 

No 

D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
E. Import of tissues/cells is authorised based on estimations showing 
that there is chronic deficiency of those tissues/cells 
National list of patients in need of tissues and cells or transplantation 

Yes 

1, tendonse 

Yes 
Distribution conditions shall comply with national regulations.  

TE with import license must ensure, and document, comliance with 
national regulations.  

Licensing and inspection 

Yes, but only via an authorised TE in my MS 

Yes 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent 
quality and safety measures established by other Member States? 
Please specify. 
7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in 
EU and/or import/export of tissues/cells? In this context, a 
brokerage company means a body that arranges transactions 
between a supplier (tissue establishment/company selling tissues or 
cells) and a buyer (a tissue establishment/a hospital or clinic/an 
individual) without undertaking activities of processing, 
preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) 
as a Competent Authority, in their authorisation/monitoring or 
inspection. 
7.8. Are brokers actively supplying health 

Yes 

No 

No 

No 

No 

Distribution license for DBX 

334 

 
 
  
 
 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

50-69% 

Yes 
By contacting Norwegian directorate of health 
Yes 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web 
site. 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.2. If no, why not? 
8.7. Do you have any additional comments on reporting? 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.1.1. If no, why not? 

No 

9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

http://www.helsedirektoratet.no/kvalitet-planlegging/bio-
genteknologi/celler-og-
vev/Documents/ÅRSRAPPORT%20celler%20og%20vev%202011.p
df 
Yes 

http://www.helsedirektoratet.no/kvalitet-planlegging/bio-
genteknologi/celler-og-vev/Sider/default.aspx 
No 

Lack of accordance with eurocet scheme 

Identification of donor is determined by national unique personal 
number identification system 
Tissue establishment 

Both paper records and electronic forms 

License and inspections 

No 

Yes 

Norwegian directorate of health 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation.  www.cellerogvev.no 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are welcome to 
upload the template if you wish. 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.3.1. If no, please specify what guidelines you use. 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 
10.7. Do you give feedback to the TEs regarding SAR/SAE 

Procedures according to national regulations 
Yes 

National regulations 
Yes 

We use ordinary mail. 

<50% 

Yes 

No 

335 

 
 
  
 
 
  
 
 
  
 
 
recorded at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.1. Please specify. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please specify 
the number and which tissues were recalled and why (e.g. missing 
consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued 
via the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and 
cells national vigilance system also to other national vigilance/alert 
systems? 
10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Feedback are given to TE who reports. 
Yes 

Feedback are given to relevant TE's 
Yes 
0 

Yes 

Rapid alert information are sendt to relevant TE's 

Yes 

Rapid alert information are sendt to relevant TE's 

No 

Not yet implemented 
No 

Yes 

4 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 

Written conscent 

Explicit consent (opt-in) 

Presumed consent (opt-out) 

First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Friends 
Yes 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third 
parties (Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice 
versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 

National regulations 

Personal identification is replaced with donor code 

No 

IVF children have right to know identification of donor 

336 

 
 
  
 
 
Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 

place. 
11.10. Do you have any additional comments on consent and data 
protection? 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
Inspections of TEs and procurement sites 
12.1. How do you ensure that all requirements related to the 
Audit of documentation 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 
Audit documentation 

No 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, 
standards or governments laws and regulations (from Council of 
Europe Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

Authorisation requirement 
Inspections 
Internal audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). 
(For this question "audit" means a documented review of 
procedures, records, personnel functions, equipment, materials, 
facilities, and/or vendors in order to evaluate adherence to the 
written SOP, standards or governments laws and regulations (from 
Council of Europe Guide to the Safety and Quality Assurance for 
the Transplantation of Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 

13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 

13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 
13.5. Any additional comments on quality management, 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Yes 

Sentralised competence centres 

337 

 
 
  
 
 
  
 
 
  
responsible person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) 
of Directive 2004/23/EC? (more than 1 answer possible) 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage 
conditions) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 
15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and 
safety requirements than those requested by the EU legislation in 
this field (e.g. restrictions concerning the donation/use of certain 
tissues/cells, mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 

Yes 

Yes 

Documention of third party agreement 

Licensing and inspection 

No 

No difficulties 

TE's mainly comply with national regulations 

Directive 2004/23/EC 

The required interval between two inspections are to short. We would 
prefer intervals of three/four years.   

338 

 
 
 
 
  
 
 
  
 
 
 
 
 
A.1.23. 

Survey response Poland 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 
1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer possible) 

1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.3. National Competent Authority 3? 
1.3.1. Name of National Competent Authority 3: 
1.3.2. Address of NCA 3: 
1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 answer possible) 
1.3.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.4. National Competent Authority 4? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

National Centre for Tissue and Cell Banking  
ul. Chalubinskiego 5, 02-004 Warsaw, Poland  
+48 22 621 75 43  
sekretariat@kcbtik.pl; artur.kaminski@wum.edu.pl;  
www.kcbtik.pl  
Non-reproductive tissues and cells 
Inspection 
Vigilance 
Yes 
Polish Transplant Coordinating Center - Poltransplant  
Al. Jerozolimskie 87, 02-001 Warsaw, Poland  
+ 48 22 622 58 06   
transpl@poltransplant.org.pl  
www.poltransplant.org.pl 
Non-reproductive tissues and cells 
Human organs 
Inspection 
Vigilance 
Yes 
Department of Mother and Child, Ministry of Health  
ul. Długa 38/40, 00-241 Warsaw, Poland  
+48 22 53 00 383   
dep-md@mz.gov.pl  
www.mz.gov.pl  
Reproductive tissues and cells 
Vigilance 

No 
National Centre for Tissue and Cell Banking (KCBTiK – Krajowe 
Centrum Bankowania Tkanek i Komorek) is a budgetary unit 
submitted to the minister competent to do with health matters. The 
tasks of the National Centre for Tissue and Cell Banking include, in 
particular: 1) organization of a co-operation between tissue and cell 
banks; 2) performance of reference and consultative functions; 3) 
supervision and inspection of tissue and cell banks in respect of the 
merits; 4) keeping a register of tissue and cell banks; 5) organizing 
the trainings with regard to recovery, collection, testing, processing, 
sterilization, storage and distribution of cells and tissues; 6) keeping 
the list of persons who completed the trainings with regard to 
recovery, collection, testing, processing, sterilization, storage and 
distribution of cells and tissues; 7) exercising substantive 
supervision over the activity of recovery teams; 8) management of 
SAREs.  Polish Transplant Coordinating Center is responsible for: 1) 
procurement and transplant centers of biovital tissues and cells , 2) 
HSC import and export, 3) management of SAREs in the field of 
HSC.  Department of Mother and Child has no assigned status of the 
NCA. However it deals with matters related to ART in Poland. 
Not applicable 

There are no Regional CAs in Poland.  

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement that is 

339 

 
 
 
 
2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

available in the tissue establishment working with procurement 
centres 
3 

154 

120 

no data 

27 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

National Chamber of Diagnostic Laboratories  
Analysis of the mandatory documentation requested from the tissue 
establishment 

59 

In 2012 there were 15 on site inspections of  procurement centers. 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
NAT testing is used for verification of doubtfull serological results  

No 

No 

No 

No 

Due to the lack of the regulation regarding ART in Poland the panel 

340 

 
 
 
 
of obligatory laboratory tests required for donors of reproductive 
tissues and cells is not formally established.  

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.1.1. Why not? 

No 

Designation of tissue and cell establishments is done by Minister of 
Health  
Yes. Review of submitted documentation and on-site inspection is 
always required. 
5 

Yes 
During routine on-site inspections and by review of a submitted 
application with supporting documentation 
0 

0 

No 

4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.3. How many ocular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.5. How many HSC tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.3. How many ocular tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue establishments? 
4.10.4.2. How many private cardiovascular tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private tissues/cells 

Ocular tissue establishments 
HSC tissue establishments 
1 
4 
HSC tissue establishments 

1 
Ocular tissue establishments 
HSC tissue establishments 
1 
4 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
2 
1 
1 
0 
4 
0 
2 
0 
18 
0 
3 
6 
2 
1 
- pancreatic islets bank - 1  

- chondocytes and osteoblasts bank - 1  

341 

 
 
 
 
 
 
establishements and how many. 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 

0 

Yes 

No 
Tissue and cell establishments are authorised every five years (the 
Designation of the Minister of Health is valid for 5 years). 
Inspections for designation follows application prepared by applying 
tissue establishment. At least every two years each tissue 
establishment is subjected to on-site inspection. 

Yes 

National Centre for Tissue and Cell Banking  

6 
No 

11 

3 

0 

0 

3 

3 

0 

0 

0 

0 

0 

342 

 
 
 
 
 
 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

0 

0 

0 

0 

0 

0 

0 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  On-site inspections are always carried out in 2-year period sheme 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 

and after SARE reporting.  
Yes 

23 

Yes 

2 
Yes 
3 
Yes 

Yes 

5 

No 

No 

No 

No 

Yes 

343 

 
 
  
 
 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 

6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 

6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 

6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 

6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

No 

0 

0 

Regulation of Minister of Health on exportation and importation of 
cells tissues and organs (Dz.U. 2010, Nr 75, poz. 485) : - donation 
procedure, donor selection criteria, laboratory testing, processing, 
storage, distribution and transportation conditions  
Regulation of Minister of Health on exportation and importation of 
cells tissues and organs (Dz.U. 2010, Nr 75, poz. 485) : - donation 
procedure, donor selection criteria, laboratory testing, processing, 
storage, distribution and transportation conditions  
Regulation of Minister of Health on exportation and importation of 
cells tissues and organs (Dz.U. 2010, Nr 75, poz. 485) : - donation 
procedure, donor selection criteria, laboratory testing, processing, 
storage, distribution and transportation conditions  
Regulation of Minister of Health on exportation and importation of 
cells tissues and organs (Dz.U. 2010, Nr 75, poz. 485) : - donation 
procedure, donor selection criteria, laboratory testing, processing, 
storage, distribution and transportation conditions  
Regulation of Minister of Health on exportation and importation of 
cells tissues and organs (Dz.U. 2010, Nr 75, poz. 485) : - donation 
procedure, donor selection criteria, laboratory testing, processing, 
storage, distribution and transportation conditions  
Regulation of Minister of Health on exportation and importation of 
cells tissues and organs (Dz.U. 2010, Nr 75, poz. 485) : - donation 
procedure, donor selection criteria, laboratory testing, processing, 
storage, distribution and transportation conditions  
There is no regulation regarding ART in Poland 

Yes 

HSC:  9 (USA), 2 (Australia) 

Yes 

HSC:  1 (Australia),  1 (Croatia)  

No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
C. Export of tissues/cells is authorised irrespective of national needs 
E. Import of tissues/cells is authorised based on estimations showing 
that there is chronic deficiency of those tissues/cells 
Based on current request for particular type of tissue graft from 
hospitals in Poland.  
No 

According to law regulations each procedure of crossing of Polish 
border of tissues and cells is recognised as import or export. In 
general there is no differences between other member states and 

344 

 
 
7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 

third countries.   

Yes 
No in general. According to law regulations each procedure of 
crossing of Polish border of tissues and cells is recognised as import 
or export. In general there is no differences between other member 
states and third countries.  The authorisation of tiissue establishment 
by adequate CA is an important part of verification. Each tissue or 
cel graft is distibuted to Polish hospitals with the involment of 
designated by Polish Minister of Health tiissue establishment. 
Yes 

- document of accredidation, designation, licencing of tissue 
establishment by adequate CA; - direct contact with CA from other 
MS (t.e. country of origin); - procedures of donation, donor selection 
criteria, laboratory testing, procurement, processing, storage, 
distribution and transportation conditions.  
Verification of document of accredidation, designation, licencing of 
tissue establishment by adequate CA; - direct contact with CA from 
other MS (t.e. country of origin); - procedures of donation, donor 
selection criteria, laboratory testing, procurement, processing, 
storage, distribution and transportation conditions.  
Yes, but only via an authorised TE in my MS 

No 

Yes 

- ocular tissue: 1 (Germany)  - heart valves: 20 (Germany)  - HSC: 
126 (Germany), 8 (Great Britain), 1 (Cyprus), 2 (Czech Republik), 2 
(France), 1 (Spain), 1 (Italy) 
0 

No 

No 

No 

7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.1.2.1. How do you address this difference for tissues and cells 
coming from a MS with minimum quality requirements? Please 
specify. 

7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 

7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 

Yes 
http://www.kcbtik.pl/?Zestawienia  
Yes 

http://www.kcbtik.pl/?Zestawienia  
Yes 

100% (all) 

345 

 
 
 
 
  
 
 
8.5.1. If yes, please provide us with the link to the register's web site. 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

8.7. Do you have any additional comments on reporting? 

http://www.kcbtik.pl/?Banki_Tkanek  
Yes 

- consolidated activities for tissue and cells regarding donation, 
procurement, processing, storage and distribution   

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 

Yes 

9.5. Do you have any additional comments on traceability? 

Tissue establishment 

Both paper records and electronic forms 

Based on review of writen procedure in place regarding set of data 
and adequate (30 years) period of storage. Procedures and data 
archivisation is reviewed during each on-site inspection.  
Poland has implemented ISBT 128 coding system in tissue and cell 
establishments. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of its organisation. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 

10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

Both National Centre for Tissue and Cell Banking and Polish 
Transplant Coordinating Center  
National Centre for Tissue and Cell Banking for tissue 
establishments, Poltransplant and National Centre for Tissue and 
Cell Banking for procurement and transplantation. System is based 
on EUSTITE project deliverables. Management of SAREs by tissue 
bank was discussed during training courses organised in Poland. 
Each tissue establishment by implementing quality system 
managment is responsible for implementation SARE SOP. National 
Centre for Tissue Banking receives SARE notificantions from tissue 
establishments. If described case is scored as serious inspection is 
mandatory. NCTCB is involved in investigation and corrective 
actions.  SAREs related to procurement and clinical use of tissues 
and cells are magaged together by NCTCB and Poltransplant 
Yes 

Yes 

No 

All tissue and cells establishments inspectors are responsible for 
managing of SAREs. They are all trained during EUSTITE or 
SOHOV7S projects and during internal trainings. 
100% 

Yes 

Tissue establishments are responsible to send SARE notification 
form to each transplant centers where they distribute tissues and 
cells. Poland started implementation of electronic notification of 
SAREs from transplant centers via "Registry" platform administered 
by Poltransplant. SARE cases are immidiately reported to the 
Ministry of Health. Minister of Health designates adequate CA for 
inspection according to writen procedure describing CA's 
competency.  

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded  Yes 

346 

 
 
  
 
 
 
 
at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Annonimous data are analysed for educational reasons during 
training courses organised by National Centre for Tissue and Cell 
Banking.  
Yes 

Annonimous data are analysed for educational reasons during 
training courses organised by National Centre for Tissue and Cell 
Banking  
Yes 
0 

Yes 

Notification is dane via e-mail and/or fax communication. 

Yes 

Notification is dane via e-mail and/or fax communication.  

No 

Data are provided directly to the European Comission. 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Yes 

5 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 

Explicit consent (opt-in) 

- potental donor was informed about the riscs related to donation (in 
written form); - potential donor agreed to became a donor (written 
agreement for procedurę of donation); - potential donor has full 
competency for legal actions; - in case when potential donor has no 
full competency for legal actions the decission of legal 
representative or a court is required.   
Presumed consent (opt-out) 

No further authorisation is needed 

Yes 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 

11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 

347 

 
 
  
 
 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 

11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 

11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

- Act of 6 November 2008 on the rights of the patient and the 
patient's Ombudsman (art.13) - Implementation of coding system for 
tissues and cells (ISBT 128);  - Only codes appear on tissue grafts 
labels;  - Legal requirement of anonimity between donor and 
recipient.  
- Act of 6 November 2008 on the rights of the patient and the 
patient's Ombudsman (art.13) - Implementation of coding system for 
tissues and cells (ISBT 128);  - Only codes appear on tissue grafts 
labels;  - Legal requirement of anonimity between donor and 
recipient.  
No 

Act of 6 November 2008 on the rights of the patient and the patient's 
Ombudsman (art.13) 

Inspections of TEs and procurement sites 
Audit of documentation 
Regular evaluation of medical personnel 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Other 

There is no regulation regarding ART in Poland. 
No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 

Authorisation requirement 
Inspections 
Internal audits 
External audits 

348 

 
 
  
 
 
  
 
 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 

13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 

13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Yes 

There are traininng programmes for responsible persons and 
personel of tissue establishments, procurement and transplantation 
medical personel created and developed during realisation of 
Transition Facility 2004 project dedicated to National Centre for 
Tissue and Cell Banking. Trainings (6-7 courses) are organised 
every year since 2006. Trainigs are free of charge for participants 
and financed from National Programme for Development of 
Transplantation Medicine for years: 2010-2020.   
Except of responisible person, each tissue establishment designates 
quality manager. 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 

14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 
External audits are not obligatory, but some of tissue establishments 
applied for and received ISO accreditaion. JACIE accreditaion 
programme of procurement and transplantation centers as well as 
tissue establishments in the field of HSC starts this (2013) year.   

Yes 

Yes 

- the list of third party agreements is a mandatory part of a 
documentation provided by tissue establishment during application 
for designation, - third party agreements and related documents (see 
below) are reviewed during on site inspections, - the responsibility 
lies on tissue establishment and if such activity of third party is 
accredited in Poland (eg. laboratory testig, radiation-sterilisation) the 
certifficate of such accreditaion document is required.   

349 

 
 
 
 
 
 
15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

- obligatory part of application for designation for tissue 
establishment activities, - third party agreements and related 
documents are reviewed during on-site inspections.  

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

No 

ART provisions 

There is no consesus in the Parliament to transpose and then 
implement regulatiuons regarding ART.  
No shortcomings 

350 

 
 
  
 
 
 
 
 
A.1.24. 

Survey response Portugal 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer 
possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 
Please specify 'other': 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer 
possible) 

1.2.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 

1.3. National Competent Authority 3? 
1.3.1. Name of National Competent Authority 3: 

1.3.2. Address of NCA 3: 

1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 answer 
possible) 
1.3.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 

1.4. National Competent Authority 4? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior 
inspectors, staff working on EU affairs and legal matters, 
vigilance officers, budget, independence from government 
etc.). 

Instituto Português do Sangue e da Transplantação, IP 
(IPST) 
Avenida Miguel Bombarda, n.º 6; 1000-208 Lisboa 
+351 210 063 063 
transplantacao@ipst.min-saude.pt 
http://ipsangue.org/ipsangue2011/index.php 
Non-reproductive tissues and cells 
Blood and blood components 
Human organs 
Accreditation, authorisation, licensing of TEs 
Other 
IPST is responsible for the biovigilance system and the 
authorization of  import/export and circulation activities 
Yes 
Direção-Geral de Saúde 
Alameda Dom Afonso Henriques,  45 - 1049-005 Lisboa  
-+351 21 843 05 00 
sanguetransplantacao@dgs.pt 
www.dgs.pt 
Non-reproductive tissues and cells 
Blood and blood components 
Human organs 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Yes 
Conselho Nacional de Procriação Medicamente Assistida 
(CNPMA) 
Assembleia da República Palácio de São Bento 1249-068 
LISBOA  
+351 21 391 93 03 
cnpma.correio@ar.parlamento.pt  
http://www.cnpma.org.pt 
Reproductive tissues and cells 

Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
IPST is a public institute directly dependent of Ministry of 
Health, responsible for: -           Coordination of procurement 
and transplant of organs, tissues, cells and blood (and blood 
components); -          National System of Biovigilance and 
haemovigilance; -          Monitoring the national activity with 
organs, tissues, cells and blood (and blood components); -          
Authorization of tissue and cells import/export activities; -          
Proposal of new regulations to the CA (DGS), based on the 
analysis of national activity. Staff of IPST Transplant 
department (central services): 1 – IPST Director (PhD, MD) 

351 

 
 
 
1 – Transplant National Coordinator (MD.) 2 – Biologists 
(with 4 years experience in the field of inspections and 
national coordination) 1 –Jurist/legal advisor   IPST, IP is 
also responsible for: -  Public Tissue Bank (amniotic 
membrane; bone; cardiac valves; blood vessels; skin) - 
Public Cord Blood Bank; - Histocompatibiity centers -  
Regional Blood Establishments.  Diretorate-General of 
Health is a central organism directly dependent of Ministry 
of Health, responsible for: -          Quality and safety of 
organs, tissues, cells and blood; -          Monitoring the 
quality and safety of national activity with organs, tissues, 
cells and blood; -          Authorization of  services and 
activities with organs, tissues, cells and blood and 
inspections; -          Proposal of new regulations to the CA, 
based on the analysis of national activity Staff of DGS 
(Central service) Quality and Safety Department (QSD) for 
cells, tissues and organs: 1 – QSD Director (MD) 1 – 
Medical Doctor 1 – Manager Hospital/Jurist 1 – Pharmacist 
and veterinary doctor 1 - Architect DGS is also responsible 
for the authorization and monitoring of quality and safety of: 
-  Public Tissue Banks (amniotic membrane; bone; cardiac 
valves; blood vessels; skin) -  Public Cord Blood Bank; -  
Private Cord Blood Banks -  Regional Public Blood 
Establishments  CNPMA (National Council for Assisted 
Reproduction Technologies) was created in 2006, under the 
Law 32/2006, of 26 July. CNPMA is an independent 
authority that functions under the aegis of the  Portuguese 
Assembly of the Republic, with powers, in general, to 
pronounce on ethical, social and legal questions of assisted 
reproduction technologies. Among others, the Council is 
responsible for: a) establishing the terms for authorization of 
centres where assisted reproduction techniques are 
administered, and of centres where gametes or  embryos are 
preserved and monitoring the activities of those centres; b) 
updating scientific information on assisted reproduction 
technologies; c) issuing opinions on the implementation of 
assisted  reproduction techniques within the National Health 
Service; d) centralizing all relevant information on the 
application of assisted reproduction techniques, namely 
registers of donors, beneficiaries  and children born, as well 
as providing information related to donors, within the limited 
framework permitted by law.  National Council for Assisted 
Reproduction Technologies comprises nine distinguished 
persons of recognized merit who are especially qualified in 
the field of the ethical, scientific, social and legal  issues 
raised by assisted reproduction technologies: a) Five 
members are elected by the Assembly of the Republic; and 
b) Four members are appointed by the members of 
Government responsible  for health and science. Staff: two 
policy officers. Regarding inspections and auditing, it is the 
Ministry of Health administrative body for Health 
Inspections that is responsible for monitoring public and 
private ART TE, under the guidance of the  CNPMA, which 
assures initial and permanent training for clinical and 
laboratory inspectors. 

352 

 
 
Not applicable 

Not applicable 

1.6. In case of MS with federal or decentralised systems, 
please indicate the roles/tasks of the Regional Competent 
Authority(ies). (more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of 
the Regional Competent Authority(ies) and their relation 
with the National Competent Authority(ies) for tissues and 
cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of 
procurement"? (more than 1 answer possible) 

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with 
procurement that is available in the tissue establishment 
working with procurement centres 
None (By this new CA, in charge of these field since the end 
of 2012) 
None (By this new CA, in charge of these field since the end 
of 2012) 

None (By this new CA, in charge of these field since the end 
of 2012) 

None (By this new CA, in charge of these field since the end 
of 2012) 

28 

2.1.2. How many such authorisations were granted in 2011 
(01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement centres in 
which procurement of "traditional tissues and cells" (skeletal 
tissues, cardiovascular tissues, skin, ocular tissues, amniotic 
membrane, pancreatic islet, hepatocytes, adipose tissue etc.) 
were carried out in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in 
which procurement of haematopoietic stem cells (bone 
marrow, PBSC, cord blood etc.) were carried out in 2011 
(01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in 
which procurement of gametes, embryos and other 
reproductive tissues were carried out in 2011 (01/01-
31/12/2011). 
2.2.4. Please provide the number of procurement centers in 
which procurement of tissues/cells for ATMP manufacturing 
were carried out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply 
with the requirements laid down in Art. 5 of Directive 
2004/23/EC and its implementing Directive 2006/17/EC 
(e.g. trained personnel, conditions accredited, designated, 
authorised, licensed) ? (more than 1 answer possible) 
2.4. Are you also responsible for the accreditation, 
designation, authorisation or licensing of laboratories 
performing donor testing? 
2.4.2. Which National Authority is in charge of this activity?  CA2 - DGS 
2.5. How do you ensure, as CA for T&amp;C, that tests 
required for donors are carried out only by qualified 
laboratories accredited, designated, authorised or licensed 
Art. 5(2))? (more than 1 answer possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are 
performed etc.). 
2.7. Do you have any additional comments on procurement?  No addicional comments on procurement 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of 
non-reproductive tissues and cells in your Member State. 
(more than 1 answer possible) 

Anti-HIV 1 
Anti-HIV 2 
NAT HIV 1 
HBs AG 

353 

Inspections of the laboratories 
Analysis of the mandatory documentation requested from the 
tissue establishment 

Since this NCA is dealing with this field (end of 2012): 2 . 
However there are many other being validated by this CA. 

 
 
 
 
 
 
3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more 
than 1 answer possible) 

3.3. If NAT testing is not mandatory in your country, could 
you please indicate whether you intend to make it mandatory 
or to encourage its use? Please specify why or why not (e.g. 
number of additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests 
and test procedures for deceased donors? 
3.4.1. Please specify why: 

3.5. Are any other laboratory tests required for donors of 
non-reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems 
for testing laboratories? 
3.7.1. Please specify. 
3.8. Do you have any additional comments on testing? 

Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
HTLV-2 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
HTLV-2 
NAT Chlamydia 
Treponema Pallidum 
NAT mandatory in Portugal (CNPMA - NCA3): Regarding 
reproductive cells, NAT is not mandatory for HIV, HBV and 
HCV (but it requires a second tests on samples collected 
after quarentine period).  
Yes 

Still under analysis by the new CAs (in charge since the end 
of 2012) 
No 

No 

Yes 

International Guidelines  
No addicional comments on testing. 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue 
establishments under your responsability? 
4.2. Is inspection a prerequisite for the designation, 
authorisation, accreditation or licensing of tissue 
establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer 
possible) 

Yes 

None (By this new CA, in charge of these field since the end 
of 2012) 
Yes 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting 
documentation 
None (By this new CA, in charge of these field since the end 
of 2012) 

4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity 
to a quality system standard (e.g. ISO, JACIE, FACT)? 

4bis. Overview of tissue/cells establishments authorised by the NCA 

354 

None (By this new CA, in charge of these field since the end 
of 2012) 

No 

 
 
 
 
 
 
4.7. Tissue establishments with authorisation pending 
approval at 01/01/2011 (more than 1 answer possible): 

4.7.3. How many ocular tissue establishments? 
4.7.6. How many cord blood tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.8. Tissue establishments with authorisations pending 
approval by 31/12/2011 (more than 1 answer possible): 

4.8.3. How many ocular tissue establishments? 
4.8.6. How many cord blood tissue establishments? 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 
01/01/2011 and 31/12/2011 (more than 1 answer possible): 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 
(more than 1 answer possible): 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the 
direct agreement of the Competent Authority according to 
Art. 6(5) during 2011? Please provide number(s) per type 
tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national 
provisions pursuant to the Directive been defined (Article 
27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and 
control measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in 
charge of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common 
training, common documentation, etc.)? (more than 1 answer 
possible) 
5.3. How many routine inspections of tissue establishments 
for non-reproductive tissues/cells were conducted in 2011 
(from 1/1/2011 to 31/12/2011)? 

Ocular tissue establishments 
Cord blood tissue establishments 
Multi-tissue establishments 
Information not yet available by this new CA   
Information not yet available by this new CA 
Information not yet available by this new CA 
Ocular tissue establishments 
Cord blood tissue establishments 
Multi-tissue establishments 
Information not availble yet by this new CA 
Information not yet available by this new CA 
Information not yet available  by this new CA 
Other tissue establishments 

Information not yet available by this new CA 
ART tissue establishments 

10 
18 
Tissues and cells distributed in 2011: Bone Marrow: 36 
Peripheral Blood: 555 Cord blood: 11 Heart Valves: 75 
Musculoskeletal: NA Amniotic Membrane: 233 units (43385 
cm2) ocular tissues: 752 

Yes 

No 
No addicional comments. 

Yes 

DGS - Departamento da Qualidade na Saúde (DGS-NCA2). 
(CNPMA - NCA3): For ART it is the Ministry of Health 
administrative body for Health Inspections (IGAS) in 
collaboration with CNPMA. 
 (DGS-NCA2): CA team is constituted by 4 elements and 2 
of them (one medical doctor and one pharmacist) have done 
the CATIE's course and 6 designated experts, for the time 
being; the inspections are also performed by inspectors from 
the Ministry of Health Inspection Central Department, 
included in the CA team; (CNPMA - NCA3): Team is 
constituted by two inspectors and four designated experts 
(two clinical and two laboratorial). 
No 

None (By this new CA, in charge of these field since the end 
of 2012) 

355 

 
 
 
 
 
 
5.3.1. How many inspections of tissues establishments for 
non-reproductive tissues/cells were conducted  in 2011 (from 
1/1/2011 to 31/12/2011) following serious adverse events or 
reactions, or suspicion thereof ? 
5.3.2. How many other type of inspections of tissues 
establishments for non-reproductive tissues/cells were 
conducted in 2011 (from 1/1/2011 to 31/12/2011) (e.g. due 
to a whistle-blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where no 
shortcomings were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of other inspections carried out? 
Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, 
or suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted 
on ART establishments (from 1/1/2011 to 31/12/2011) (e.g. 
due to a whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments 
carried out in 2011 (01/01/2011 to 31/12/2011): What was 
the number of inspections carried out where no shortcomings 
were observed? 
5.4.4. What was the number of inspections carried out in 
ART establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in 
ART establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in 
ART establishments followed by suspension of 
authorisation? 
5.4.7. What was the number of inspections carried out in 
ART establishments followed by closure of respective 
establishements? 

 None (By this new CA, in charge of these field since the end 
of 2012) 

None (By this new CA, in charge of these field since the end 
of 2012) 

 None (By this new CA, in charge of these field since the end 
of 2012) 

 None (By this new CA, in charge of these field since the end 
of 2012) 

None (By this new CA, in charge of these field since the end 
of 2012) 

 None (By this new CA, in charge of these field since the end 
of 2012) 

None (By this new CA, in charge of these field since the end 
of 2012) 

None (By this new CA, in charge of these field since the end 
of 2012) 

10 

1 

1 

0 

8 

2 

0 

0 

356 

 
 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? 
(more than 1 answer possible) 

5.6. How do you decide which type of routine inspection to 
conduct? 

5.7. Until 2011, did you implement the requirement 
concerning the time interval between two inspections (Art. 
7.3.)? 
5.7.1. Why not? 

5.7.2. How do you prioritise tissue establishments to be 
inspected? 
5.8. How many TEs were inspected at least twice between 
2008-2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement 
sites outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual 
for Competent Authorities on inspection of tissue and cell 
procurement and tissue establishments - Guidelines for 
inspections (Commission Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training 
courses organised by EU-funded projects (e.g. EUSTITE, 
SOHO V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and 
efficacy of these training courses on a scale from 1 to 5 (1 = 
not important, 2 = sufficient, 3 = good, 4 = very good, 5 = 
essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA 
in that MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement 
centres or tissue establishments in third countries from which 
tissues and/or cells were imported in your country (as 
recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been 
requested by any other MS, on the results and control 
measures of your inspections, as part of an 
enquiry/investigation? 
5.17. Would you be interested in developing joint 

0 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 
(DGS - NCA2): The routine inspections are decided among 
those urgent pending from the previous CA; the CA also 
pretend to cover proporcionally public and private 
establishements and blood/T&C E  (CNPMA - NCA3): The 
first routine inspections is always a general system-oriented 
inspection; afterwards it may be followed by a thematic 
inspection (just to check the overcome of the diagnosed  
shortcomings) or a desk based reviews if the aim is to 
monitor the implementation of corrective measures.  
No 

Because this new CA only is in charge of these field since 
the end of 2012 
First of all those who are urgent, pending from the previous 
CA. 
Information not yet available by this new CA 

Yes 

Information not yet available for this new CA 
No 
Not yet analised and organised by this new CA 
Yes 

Yes 

5 

No 

No 

No 

No 

Yes 

357 

 
 
inspections? Joint inspections should be understood as 
inspections of tissue establishments conducted jointly by two 
or more Member States' Competent Authorities on their 
territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue 
establishments that are explicitly authorised to perform 
import/export of tissues and celles from/to third countries? 
6.2. Please specify the number of tissue establishments 
authorised to import tissues and cells from third countries 
(recorded by 31/12/2011). 
6.3. Please specify the number of tissue establishments 
authorised to export tissues and cells from third countries 
(recorded by 31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 
6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) 
tissues from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from 
third countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than 
cord blood) from third countries. 

6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 

6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from 
third countries. 
6.11. Did you import tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of 
origin. 
6.12. Did you export tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 

No addicional comments  

Yes 

2 cells HSC banks 

2 cells HSC banks 

Portugal only receives tissues from other Member States 
(there are no authorizations for importation tissues from third 
countries) 
Portugal only receives tissues from other Member States 
(there are no authorizations for importation tissues from third 
countries) 

Portugal only receives tissues from other Member States 
(there are no authorizations for importation tissues from third 
countries) 

Portugal only receives tissues from other Member States 
(there are no authorizations for importation tissues from third 
countries) 
There are 2 HSC banks authorized to import/export units. 
This authorization was given after inspection where the 
procedures were evaluated. The other HSC banks have to ask 
authorization every time they need to export/import (through 
the submission of a documented process) 
There are 2 HSC banks authorized to import/export units. 
This authorization was given after inspection where the 
procedures were evaluated. The other HSC banks have to ask 
authorization every time they need to export/import (through 
the submission of a documented process) 
Portugal only receives reproductive cells from other Member 
States (there are no authorizations for importation 
tissues/cells from third countries) 

Yes 

Non Reproductive cell (HSC) imported during 2011: USA: 6 
Canada: 1 Swiss: 1 

Yes 

Non Reproductive cell (HSC) exported during 2011: Swiss: 
1; USA: 11; New Zeland: 1; Canada: 4; Brazil: 1; Uruguai: 
2; Russia: 1; None reproductive tissues/cells were exported 
No 

358 

 
 
 
 
which may invalidate the 2011 data on imports/exports of 
tissues/cells between your country and other third countries? 
6.14. What is the relation between import/export of tissues 
and cells and self-sufficiency? (more than 1 answer possible) 

6.14.1. If A or D were selected, please explain how you 
quantify local/national needs. 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on 
import/export? 

A. Export of tissues/cells is authorised only after checking 
that local/national needs are fulfilled. 
E. Import of tissues/cells is authorised based on estimations 
showing that there is chronic deficiency of those tissues/cells 
Every year Portugal has to import tissues from other MS, in 
this way is considered that the nationals TE aren't able to 
respond to the need (of public and private) heath institutions 
in Portugal 
No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and 
cells? 
7.1.1. If yes, how do you address the possible more stringent 
quality and safety measures established by other Member 
States? Please specify. 

Yes 

The TE must comply with the requirements imposed by the 
MS where the products will be distributed. CA should 
collaborate in order to evaluate the quality and safety of the 
products distributed in  different MS. 
Yes 

NAT  

TE must submit a documented authorization request, also 
IPST ask for the collaboration of the CA from the MS of 
origin, in order to determine the compliance of the criteria 
imposed by the Directives  and National Legislation. 
No 

No 

Yes 

HSC distributed in other MS:  German: 8 Italy: 15 Spain: 14 
Austria: 1 United Kingdom: 2 France: 6 Greece: 1 Belgium: 
1 Sweden: 1 Finland: 1 Slovenia: 1 Netherlands: 2 

HSC: German - 41; United Kingdom - 2; Italy - 1; Spain - 1; 
Netherlands - 1 Ocular Tissues: Italy - 162 Musculoskeletal: 
Spain - 118 Other tissues: Spain - 21 
No 

No 

7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
7.1.2.1. How do you address this difference for tissues and 
cells coming from a MS with minimum quality 
requirements? Please specify. 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding 
quality of tissues and cells during distribution? Please 
specify. 
7.3. Do you allow direct distribution to hospitals/clinics in 
your MS from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient 
of specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange 
of tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, 
type of tissue/cell and number of units distributed) 
concerning distribution to other MS in 2011 (01/01/2011-
31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on cross-border exchanges of 
tissues/cells between your country and other EU MS? 
7.7. Do you allow brokerage companies for either 
distribution in EU and/or import/export of tissues/cells? In 
this context, a brokerage company means a body that 
arranges transactions between a supplier (tissue 
establishment/company selling tissues or cells) and a buyer 
(a tissue establishment/a hospital or clinic/an individual) 
without undertaking activities of processing, preservation or 
storage. 

359 

 
 
  
 
 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the 
activities of tissue establishments in your Member State? 
(Article 10(1)). If yes, please upload the template. 
8.2. How many tissue establishments submitted annual 
reports of their activities during 2011. Please provide an 
estimation. (1 answer possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the 
consolidated activities of all tissue establishments in your 
country? 
8.4.1. Please insert the link to the published national annual 
report. 

No 
Yes 

60-99% 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's 
web site. 

8.6. Do you provide data regarding tissues and cells activities 
to the EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please 
specify. 
8.7. Do you have any additional comments on reporting? 

http://ipsangue.org/ipsangue2011/index.php?option=com_co
ntent&view=category&layout=blog&id=75&Itemid=118; 
http://www.cnpma.org.pt/Docs/RELATORIO_ATIVIDADE
_PMA2011.pdf 
Yes 

http://www.dgs.pt/ms/8/default.aspx?pl=&id=5521&acess=0   
(DGS); CNPMA: 
http://www.cnpma.org.pt/centros_lista.aspx 
Yes 

Tissues and cells and HSC forms ART forms 

The annual report form is available on line at: 
http://ipsangue.org/ipsangue2011/index.php?option=com_co
ntent&view=category&layout=blog&id=81&Itemid=124  

Yes 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) 
implemented in your country? 
9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
9.3. How is the data storage for traceability purposes 
organised in your tissue establishements (Art 8(4))? (only 1 
answer possible) 
9.4. How do you ensure that the 30 years data storage 
requirement is respected (Directive 2006/89/EC, Art. 9)? 
Please specify. 
9.5. Do you have any additional comments on traceability? 

Tissue establishment 

Both paper records and electronic forms 

The CA validates it in the inspections, analising the available 
documentation. 

(CNPMA - NCA3): Until 31.12.2012 assignment of unique 
code for each donations was assured by ART TE. Since 
01.01.2013, it is a centralized registry - National Competent 
Authority assigns the unique code  for each donation.   

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for 
the reporting of serious adverse events and reactions (Article 
11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of its 
organisation. 

Instituto Português do Sangue e da Transplantação (IPST) 
(NCA1); CNPMA (NCA3) 
On-line form for notification of SAR and SAE; each 
organization (TE, procurement unit, transplant units) have a 

360 

 
 
  
 
 
 
 
 
 
login and password and can submit notification at anytime; 
in the begging of every  year TE must full fill the annual 
reports through the form available also on-line at: 
http://ipsangue.org/ipsangue2011/index.php?option=com_co
ntent&view=category&layout=blog&id=81&Itemid=124  
Everytime that there are an alert, information is sent to every 
organizations that have requested authorization.  CNPMA 
(NCA3): there is a form and standardized procedures to 
report SAE and reactions (urgent notification: within 48 
hours or until 15th of every month for non-urgent SAE/SAR) 
- Everytime that there is an  alert, information is sent to the 
responsible person of each ART TE (notification by email). 
No 

(IPST NCA1) available at: 
http://ipsangue.org/ipsangue2011/index.php?option=com_co
ntent&view=category&layout=blog&id=81&Itemid=124 
(CNPMA NCA3) available at: 
http://www.cnpma.org.pt/profissionais_notificacao.aspx 
Yes 

Yes 

70-99% 

Yes 

TE are responsible for collecting the follow up notifications 
of all the recipients of the distributed products 
Yes 

Divulgation of EC Annual reporting  
Yes 

the data is presented only through communications on 
courses and seminars  
Yes 
0 

Yes 

e-mail communication with the responsible persons of every 
organization that have requested authorization 
Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do 
you use the SAR/E (to the CA (2006/76 art 6.4)) templates 
developed to the Annual reporting ot the EC also at national 
level? 
10.2.1. If no, what template do you use? You are welcome to 
upload the template if you wish. 

10.3. Do you use the Common Approach Document 
developed for the Annual reporting to the EC also at national 
level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the 
total number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the 
transplantation centres when reporting SAR/SAE to the TEs 
which distributed the tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please 
specify the number and which tissues were recalled and why 
(e.g. missing consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify 
Tissue Establishments and procurement sites in case of a 
national rapid alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify 
Tissue Establishments and procurement sites when a rapid 
alert is issued via the EU RATC platform? 

361 

 
 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues 
and cells national vigilance system also to other national 
vigilance/alert systems? 
10.14.1. If yes, please specify which of the following 
systems are usually contacted. (more than 1 answer possible) 
10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO 
V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and 
efficacy of these trainings on a scale from 1 (insufficient) - 2 
(sufficient)  3 (good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE 
reporting? 

e-mail communication with the responsible persons of every 
organization that have requested authorization 
No 

not requested 
Yes 

Haemovigilance 

Yes 

4 

Accordingly with the portuguese law 

Presumed consent (opt-out) 

No further authorisation is needed 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
Explicit consent (opt-in) 
11.1. What consent system for living tissue/cell donation do 
you have in place within your Member State? 
11.1.1. Please specify your choice of consent system for 
living tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation 
do you have in place within your Member State? 
11.3. According to your national legislation, in case of 
deceased donations, please specify who is giving the 
authorisation for the tissue donation? (more than 1 answer 
possible) 
11.4. Is the consent system for deceased tissue donation the 
same as for organs? 
11.5. How is this consent verified during inspections? (more 
than 1 answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by 
Art. 13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors 
and recipients remain unidentifiable when access is given to 
third parties (Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure 
that the identity of the receipient is not disclosed to the donor 
and vice versa. 
11.9. Does your national legislation allows disclosure of 
donor data in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures 
in place. 

Yes 

No 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such 
information 

The CA verifies the acess levels to the information by the 
HCP and the procedures in place to ensure the 
confidenciality. 
The CA validates the procedures in place to ensure the 
confidenciality levels (inspection/documental analysis) 

(CNPMA- NCA3): Donor's identity is kept confidential 
except if the donor express consent on contrary and only 
when the children born turns 18. Any other case, disclosure 
of donor data is only  allowed for weighty reasons 
recognized by a judicial decision. Since 2013 there is a 
centralized registry with restricted access. 

11.10. Do you have any additional comments on consent and 
data protection? 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 

362 

 
 
  
 
 
  
 
 
Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 
Audit of documentation 

Inspections of ART centres 

No 

Interview with the donor's family or a person who knew the 
donor well 
Medical records of the donor 
Yes 

Age criteria: 35 for oocyte donors and 45 for sperm donor 
For oocyte donation there is only allowence for 3 oocyte 
pick-ups cycles per donor. For sperm donation, a donor can 
only originate 8 deliveries. 
No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Audit of the centre of human application 

12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of 
reproductive cells) are respected in your country (Art. 15(1), 
Annex I Directive 2006/17/EC)? (more than 1 answer 
possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection 
than those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the 
evaluation of a deceased donor of tissues/cells? (more than 1 
answer possible) 
12.5. Do you have more stringent criteria for selection of 
donors of reproductive cells than those listed in Annex III of 
the Directive 2006/17/EC? 
12.5.1. Please specify. 

12.6. Do you have more stringent criteria for autologous 
donation than those listed in Annex I of the Directive 
2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the 
Annex of Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding 
tissues and cells' procurement, packaging and transport are 
complied with by tissue establishments in your country (Art 
15(1), Annex IV of Directive 2006/17/EC? (more than 1 
answer possible)(For this question "audit" means a 
documented review of procedures, records, personnel 
functions, equipment, materials, facilities, and/or vendors in 
order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe 
Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

Authorisation requirement 
Inspections 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your 
country have in place a quality system respecting the 
provisions of the Directive 2004/23/EC Art 16.1? (more than 
1 answer possible). (For this question "audit" means a 
documented review of procedures, records, personnel 
functions, equipment, materials, facilities, and/or vendors in 
order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe 
Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? 
(more than 1 answer possible) 

Authorisation requirement 
Inspections 
Other 

363 

 
 
  
 
 
Please specify 'other'. 
13.3. How do you ensure an appropriate training for the 
personnel directly involved in the activities of tissue 
establishments? (more than 1 answer possible) 
13.4. Do you have national/regional/local training 
programmes for the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, 
responsible person, personnel? 

HCP titulation (Portuguese Professional Associations)  
Authorisation requirement 
Inspections 

Yes 

The TE do some trainnig programmes for the personnel of 
TE, in their Activities Plans, accordingly with the law. 

Inspections of tissue establishments 

Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your 
country fulfill the requirments of the Art. 19 (Tissue and cell 
reception) of Directive 2004/23/EC and Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your 
country fulfill the requirements of the Art. 20 (Tissue and 
cell processing) of Directive 2004/23/EC? (more than 1 
answer possible) 
14.3. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 21 (tissue and cell 
storage conditions) of Directive 2004/23/EC? (more than 1 
answer possible) 
14.4. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 22 (labelling, 
documentation and packaging) of Directive 2004/23/EC and 
Annex IV of Directive 2006/17/EC? (more than 1 answer 
possible) 
14.5. Any additional comments on reception, processing, 
storage, labelling and packaging? 

Inspections of tissue establishments 

Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your 
national legislation? 
15.1.1. If yes, have tissue establishments in your Member 
State notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) 
by the Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality 
and safety requirements than those requested by the EU 
legislation in this field (e.g. restrictions concerning the 
donation/use of certain tissues/cells, mandatory unpaid 
donation etc.)? 
16.1.1. Please specify. 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 

Yes 

Yes 

Each time an external activity takes place which influences 
the quality and safety of T and C processed in cooperation 
with a third party, namely the topics under article 24 of the 
directive, that were included in  the portuguese law.     
In the inspections and documental analysis 

No additional comments 

Yes 

NAT 
ART provisions 
Import-export 
Vigilance 
Authorisation-accreditation-licensing of TEs 
Other 

364 

 
 
  
 
 
  
 
 
 
 
16.2.1. For all selected options in question 16.2., please 
provide a short description. 

16.3. In your opinion, in which of the following Directives 
are there shortcomings (if any)? (more than 1 answer 
possible) 

(CNPMA - NCA3): The specificity of ART are such that 
would require more adjusted measures and requirements. We 
welcome the planned introduction of specific chapters 
regarding this field. (DGS - NCA2): This CA is still in 
organization process and has not enough resources for the 
time being. 
No shortcomings 

365 

 
 
 
 
 
A.1.25. 

Survey response Romania 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 

1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 
1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.3. National Competent Authority 3? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

National Transplant Agency 
2-8 Constantin Caracas street, 4-th floor, sector 1, 011155 Bucharest 
+40317101473, +40317101474,  fax +40213130434, 
ant@transplant.ro 
www.transplant.ro 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Human organs 
Accreditation, authorisation, licensing of TEs 

Yes 
Ministry of Health - Public Health and Control in Public Health 
Directorate 
1-3, Cristian Popisteanu street, sector 1 Bucharest 
+40213072557 
sparvu@ms.ro 
www.ms.ro 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Pharmaceuticals 
Medical devices 
Other 
health care etc 
Inspection 
Vigilance 
No 
National Transplant Agency (NTA) is an independent body 
subordinated to the Ministry of Health. The staff consists in 6,5 
positions occupied from 18  approved. NTA does not have 
inspectors. NTA has 2 experts representing Romania to the 
European institutions and 1 judicial expert. The budget of NTA is  
established by the Ministry of Health. Ministry of Health Romania - 
Public Health and Control in Public Health Directorate The Ministry 
of Health is a governmental institution, financed from the public 
budget. According to the Governmental Decision no 144/2010 
regarding the  organizing and functioning of the Ministry of Health, 
there are two directorates with responsibilities in the field of 
transplant: the Public Health and  Control in Public Health 
Directorate (PHCPHD) and the Health Care and Public Polices 
Department (HCPPD) The main responsibilities in the field of 
transplant are: - developing of legal acts (HCPPD); - carrying out 
inspections  and control regarding the quality and sanitary safety of 
human grafts for therapeutic use and for application of art. 7 form 
the  Directive 2004/23/EC of the  European Parliament and of the 
Council of 31 March 2004 on setting standards of quality and safety 
for the donation, procurement, testing, processing,  preservation, 
storage and  distribution of human tissues and cellular (PHCPHD) - 
organizing and coordinating the vigilance system and taking the 
necessary measures for food categories in the fields of competence; - 
carrying out official control according to the annual plans of 
PHCPHD as well as control thematic actions initiated at the central 
level and in case of  complaints from the population; - coordinating 
the activity of inspectors from the County Public Health Control  
The responsibilities of the County Public Health Directorates 
(CPHCD), are established by the Ministerial Order no. 1078/ 2010 
for organizing and functioning  of the CPHDs and the Ministerial 

366 

 
 
Order no 824/2006 regarding the Norms for functioning and 
organizing of the sanitary state inspection.  We have inspectors how 
are dedicated to inspect establishments with transplant activities (44 
inspectors), but they do inspections in other fields to. They  are 
certificated in the field of medical sciences which was awarded of a 
university course of study and experience of working within a CA 
that inspects  hospitals, blood establishments, hospital blood banks 
and tissues and cells establishments. According to the Governmental 
Decision no. 524/2013 beginning with de the 2nd of September the 
Ministry of Health is reorganizing. Regarding this  decision there 
will be two other departments: Strategies and Health Policies 
Department and the Stat Sanitary Inspectorate. 
Not applicable 

No 

Yes 
Other 

NTA is not allowed by law to realize inspections but only 
evaluations. NTA realizes evaluation of the documentation and 
evaluation of all procurement centers according to the requirements 
of the EU Directives. 
35 

5 (2 skeleletal; 1skin; 2 cornea) 

3 

30 

0 

Analysis of the mandatory documentation 
Other 

Evaluation on the site of the centre 
Yes 

6 National Transplant Agency being in charge for this activity 

Analysis of the mandatory documentation requested from the tissue 
establishment 

 6  accredited laboratories since 2005. Donor tests performed are 
those in complying with the requirements of the EU Directives. 

No 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 
Please specify 'other': 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
Please specify 'other': 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

367 

 
 
 
 
3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.7.1. Please specify. 

3.8. Do you have any additional comments on testing? 

Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
Treponema Pallidum 
HTLV-2 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
NAT HIV 1 
HBs AG 
Anti HBc 
NAT HBV 
Anti HCV-Ab 
NAT HCV 
HTLV-2 
NAT HTLV-2 
Treponema Pallidum 
We intend to encourage  its use because the superior quality of this 
test and the shorter period for the validation.  

No 

No 

No 

Yes 

Not requested but used. Some of the accredited laboratories have 
EFI accreditation.  
No 

Yes 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 
2 

No 

0 

yes – evaluation performed by NTA, not inspection, 35 evaluations 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 

368 

 
 
 
 
 
 
 
 
4.7.1. How many skin tissue establishments? 
4.7.2. How many musculo-skeletal tissue establishments? 
4.7.3. How many ocular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.6. How many cord blood tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 

4.8.1. How many skin tissue establishments? 
4.8.2. How many musculo-skeletal tissue establishments? 
4.8.5. How many HSC tissue establishments? 
4.8.6. How many cord blood tissue establishments? 
4.8.7. How many ART tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
0 
0 
0 
0 
0 
0 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
1 
2 
3 
7 
28 
ART tissue establishments 

4 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
1 
0 
2 
0 
3 
0 
0 
7 
2 
26 
x 

Yes 

No 
No 

Yes 

Ministry of Health  - Public Health and Control in Public Health 
Directorate (Stat Sanitary Inspectorate after de 2nd of September.) 
2 inspectors at the Ministry of health and 42 inspectors at county 
level. 
Yes 

Blood 
Organs 
Hospitals 

369 

 
 
 
 
 
 
Please specify other. 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

Others 
laboratories, dental offices 
0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

In 2011 there were 32 ART establishments 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  We decide the type of the routine inspection to conduct based on the: 

370 

 
 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 

• type of the establishment (complexity of site operations), • number 
of deficiencies in a previous inspection and compliance with existing 
regulations, • number of adverse events/reactions reported or recalls 
conducted, • volume of activity including significant changes. 
Yes 

There were 49 TEs inspected at least twice between 2008-2011 

Yes 

We inspected 43 hospitals in 2012, 60 hospitals in 2013.  
Yes 
8 
Yes 

Yes 

5 

No 

No 

No 

No 

Yes 

No 

Yes 

0 

0 

Asking for documentation  to prove that the TE complies with the 
requiements of the EU Directives and checking this documentation 

Asking for documentation  to prove that the TE complies with the 
requiements of the EU Directives and checking this documentation 

Asking for documentation  to prove that the TE complies with the 
requiements of the EU Directives and checking this documentation 

371 

 
 
 
 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

Asking for documentation  to prove that the TE complies with the 
requiements of the EU Directives and checking this documentation 

Asking for documentation  to prove that the TE complies with the 
requiements of the EU Directives and checking this documentation 

Asking for documentation  to prove that the TE complies with the 
requiements of the EU Directives and checking this documentation 

Asking for documentation  to prove that the TE complies with the 
requiements of the EU Directives and checking this documentation 

No 

No 

No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
Checking the stock of tissues and cells in accreditted TE 

Yes 

40 corneas in 2011 

No 

No 
 Asking for documentation 

Yes, no restrictions apply 

No 

Yes 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 

No 

No 

No 

0 

0 

372 

 
 
 
 
7.9. Do you have any additional comments on distribution? 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 

100% (all) 

Yes 

8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site.  www.transplant.ro   
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

www.transplant.ro 
Yes 

Yes 

all data requested by Eurocet 
No 

Yes 
Yes - public by request. They will be soon published on the official 
site www.transplant.ro   
Yes 

Yes 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
Please specify 'other'. 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Other 

No 

the unique national code system under construction 
Both paper records and electronic forms 

requirement by law 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of its organisation. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 

10.5. How many tissue establishments provided in 2011 the 

The Ministry of Health – Public Health and Control in Public Health 
Directorate (Stat Sanitary Inspectorate after de 2nd of September.) 
Ministry of Health Romania The Ministry of Health is a 
governmental institution, financed from the public and budget. 
According to the Governmental Decision no 144/2010 regarding  the 
organizing and functioning of the Ministry of Health, there is one 
directorate responsible in this field: the Public Health and Control in 
Public Health  Directorate (PHCPHD).  The main responsibility is to 
organize and coordinate the vigilance system at national level.  The 
necessary measures are taken by the sanitary inspectors  from the 
County Public Health Control.   The responsibilities of the County 
Public Health Directorates (CPHCD), are established by the 
Ministerial Order no 824/2006 regarding the Norms for  functioning 
and organizing of the sanitary state inspection and the Ministerial 
Order no. 1078/ 2010 for organizing and functioning of the CPHDs.  
Yes 

Yes 

No 

The sanitary inspectors who are responsible for the official control in 
the transplant field are in charge of collecting SAR/E. 
<50% 

373 

 
 
 
 
 
 
 
 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.2. If no, please specify why not. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.2. If no, please specify why not. 

10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Yes 

We have a V&S system in place covered by the Ministry of Public 
Health no. 1763/2007, published in the Official Journal no. 698 from 
16 october 2007.  
Yes 

If the TEs is involved in the recorded SAR/SAE 
Yes 

If the TEs is involved in the recorded SAR/SAE 
Yes 
0 

No 

 The system is not yet operational because the national procedure is 
drafted and has to be approved as a Ministry Order. 
No 

There is no procedure but we inform the National Agency of 
Transplant and the sanitary inspectors form CPHDs 
No 

not until now 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Yes 

5 

No 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 

Yes 

Explicit consent (opt-in) 

Explicit informed consent of the donor  

Explicit consent (opt-in) 

First degree relatives (including spouse) 

Analysis of documentation 

Only trained personnel is allowed to provide such information 

374 

 
 
 
 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

Legal requirement 

Legal requirement 

No 

Only at the specific requirement of the authorities (police, coroner 
office). 
No 

Inspections of TEs and procurement sites 
Audit of documentation 
Regular evaluation of medical personnel 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 
Audit documentation 
Regular evaluation of medical personnel 

No 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Audit of the centre of human application 

No 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 

Authorisation requirement 
Inspections 
Internal audits 

Authorisation requirement 

375 

 
 
 
 
 
 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 

13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.2. If no, in which country(ies) is your personnel trained? 

13.4.2.1. Please specify EU-countries. 
13.4.2.2. Please specify non EU-countries. 
13.5. Any additional comments on quality management, responsible 
person, personnel? 

Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Regular evaluation of personnel 
Mandatory trainings 
No 

EU countries 
Non-EU countries 
Spain, Italy, Germany, UK, Austria 
USA 
No 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 

16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
No 

Yes 

No 

No 

No 

ART provisions 
Authorisation-accreditation-licensing of TEs 
Inspections 
For ART - complains of the ART centers that ther equiremnts of the 
EU Directives are excessive for this field For accreditation of TEs 
and inspections - The accreditation issued by National Transplant 
Agency needs to be approved by the Ministry of Health.  For 
inspections - since 2012, NTA is not allowed anymore to provide 
inspections but only evaluations of the TEs.  
No shortcomings 

376 

 
 
 
 
 
 
 
 
 
 
 
A.1.26. 

Survey response Slovakia 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 

1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 
1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 
Please specify 'other': 
2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 

Ministry of Health of the Slovak Republic 
Ministry of Health of  the Slovak Republic Limbová 2 837 52  
Bratislava Slovak Republic 
+4212 59373111 
office@health.gov.sk  
www.health.gov.sk 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Accreditation, authorisation, licensing of TEs 

No 
Section of Health together with Section of Legislation  Department 
of Health Care Ministry of Health of the Slovak Republic  

Not applicable 

Regional Competent Authorities can only approve so called 
Common Examination and Therapeutic Establishments (SVaLZ) 
which might serve as helper in procurement of tissues and cells 

Yes 
Other 

by administration approval 
3 

1 

1 

1 

0 

Analysis of the mandatory documentation 

No 

SNAS - Slovak National Acreditation Service 
Analysis of the mandatory documentation requested from the tissue 
establishment 

32 

377 

 
 
 
 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

NO 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Proposals were given 

No 

No 

No 

No 

NO 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.3. Are preparation processes authorised? 
4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 
0 

No 

No 

0 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 

4.7.5. How many HSC tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 

4.8.5. How many HSC tissue establishments? 
4.8.7. How many ART tissue establishments? 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

HSC tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
2 
1 
1 
HSC tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
1 
1 
1 
ART tissue establishments 

378 

 
 
 
 
 
 
 
 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.3. If no, please specify why not. 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 

1 
HSC tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
1 
1 
0 
1 
1 
0 
0 

No 

No 

No 

In preparation 
No 

1 

0 

0 

1 

0 

0 

0 

0 

0 

379 

 
 
 
 
 
 
0 

0 

0 

0 

0 

0 

0 

0 

0 

Yes 

5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  According to needs 
5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

Yes 

Yes 

No 

No 

No 

No 

No 

No 

5 

0 

General system-oriented inspections 

Because of absence of inspectors  
No 
There was no need 
Yes 

380 

 
 
 
 
6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

No 

0 

1 

no import from third countries 

no import from third countries 

no import from third countries 

no import from third countries 

no import from third countries 

no import from third countries 

no import from third countries 

No 

No 

No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
checking of hospital requests 

No 

no 

No 
checking of TE records 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.4.1. If yes, how many authorisations were given in 2011 
(01/01/2011 to 31/12/2011)? 
7.4.2. If yes, for which tissues/cells? 

Yes 

0 

Yes, but only via an authorised TE in my MS 

according to requests 

381 

 
 
 
 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Yes 

valid since 12/12 

N/A 

No 

No 

No 

no 

Yes 

60-99% 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.2. If no, why not? 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 
8.7. Do you have any additional comments on reporting? 

according to their data forms 
no 

they are kept in paper form 
No 

in preparation 
Yes 

No 
No 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Yes 

no 

National Competent Authority 

Both paper records and electronic forms 

TEs are working no longer than 17 years 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.3. If no, why not? 

No 

every TE has to have vigilance system (national system is not 
finalized yet) 
Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 

Yes 

No 

382 

 
 
 
 
 
 
 
 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.2. If no, how do you ensure that SAR/SAE are reported to the 
TEs? 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 
10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.2. If no, please specify why not. 

10.16. Do you have any additional comments on SARE reporting? 

System is not finalized yet 
70-99% 

No 

It is mandaty according to the Government Regulation nr.622/2007 
sec4 
Yes 

via letter of CA 
Yes 

via letter of CA 
Yes 
0 

Yes 

via phone and e-mail to RP and TE 

Yes 

via phone and e-mail to RP and TE 

Yes 

as required by EUROCET 
No 

No 

There were change of people (person who was already applied 
changed job) 
no 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
Please specify 'other'. 

Other 

Explicit consent (opt-in) 

signed informed consent 

Presumed consent (opt-out) 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 

Slovak National Transplantation  Organization - Registry of non-
donors 
Yes 

Analysis of documentation 

Information for donors are standardised at national/regional level 

383 

 
 
 
 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

Only unique code of the tissue is given to the third party 

Only unique code of the tissue is given 

No 

Only unique code of gametes is given 

no 

Stadardised questionnaires at national levels 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

No 

Standardised questionnaires at national level 

Please specify 'other'. 
12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Medical records of the donor 
Autopsy report 
Other 
other examination if needed 
No 

No 

No 

Inspection of tissue establishment 

no 

Inspections 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 

Inspections 

384 

 
 
 
 
 
 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 
13.5. Any additional comments on quality management, responsible 
person, personnel? 

Inspections 

Yes 

Certified training course at the Slovak Medical University 
no 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

no 

Inspections of tissue establishments 

Inspections of tissue establishments 

Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 

Yes 

No 

no 

No 

Import-export 
Authorisation-accreditation-licensing of TEs 
Inspections 
System of authorisation-acreditation-licensing of TEs and 
inspections system are not finalized yet 
Directive 2004/23/EC 

Preambule 18: As a matter of principle, tissue and cell application 
programmes should be founded on the philosophy of voluntary and 
unpaid donation. Article 12 paragraph 2 .... Member states shall 
endeavour to ensure that the procurement of tissues and cells as such 
is carried out on a non-profit basis. These provisions and paragraphs 
were transponed into Slovak legislation. But still does exist chaos 
what can be paid and what can not be paid, how to handle with 
potential brokers etc. We have to put these problems on agenda of 
our regular meetings with advice of lawyers. 

385 

 
 
 
 
 
 
 
 
 
 
 
A.1.27. 

Survey response Slovenia 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 
2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 
2.5. How do you ensure, as CA for T&amp;C, that tests required for 

Javna agencija Republike Slovenije za zdravila in medicinske 
pripomočke / Agency for Medicinal Products and Medical Devices 
of the Republic of Slovenia 
Ptujska ulica 21 SI-1000 Ljubljana Slovenia 
+386 (0)8 2000 500 
info@jazmp.si 
www.jazmp.si 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Pharmaceuticals 
Medical devices 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
No 
JAZMP is an Independent agency founded 1.1.2007. The Agency 
was established and operates according to the legislation which 
explicitly states its  competences and tasks (“Medicinal Products 
Act” (2006, 2008), “Medical Devices Act” (2009), “Blood Supply 
Act” (2000, 2004, 2006), “Act on Quality, Safety of Human Tissues 
and Cells” (2007)).  JAZMP is organised in 12 sectors.  EU issues 
are as a rule treated with very high priority by JAZMP.   
Not applicable 

NA 

Yes 
By inspecting all procurement centres 

16 

10 

14 

3 

1 

Inspections of the site/centre 
Analysis of the mandatory documentation 

No 

Ministry of Health (3 laboratories perform donor testing)  
Analysis of the mandatory documentation requested from the tissue 

386 

 
 
 
 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 
3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.4.1. Please specify why: 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

establishment 

NA 

Please see 3.8 

Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
This issue was not discused yet. 

Yes 

Cases of false-positive HIV test results in deceased donors. 
No 

No 

No 

- Licences for testing laboratories are in Ministry of Health 
competences - Laboratories performing tissues and cells donor 
testings perform also testing for blood donations - The testing 
laboratories are included in national and international testing 
scheemes - Testing laboratories must have quality system in place 
(Legal requirement) 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

5 

Yes 
During routine inspections 
During inspections organised for this purpose 
By review of a submitted application with supporting documentation 
0 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 

0 

387 

 
 
 
 
 
 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.6. How many cord blood tissue establishments? 
4.9.8.  How many multi-tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

4.10.2.1. How many public musculo-skeletal tissue establishments? 
4.10.2.2. How many private musculo-skeletal tissue establishments? 
4.10.6.1. How many public cord blood tissue establishments? 
4.10.6.2. How many private cord blood tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 

Other tissue establishments 

No pendinng approvals at 01/01/2011. 
Multi-tissue establishments 

5  
Cord blood tissue establishments 
Multi-tissue establishments 
1 
5 
Musculo-skeletal tissue establishments 
Cord blood tissue establishments 
Multi-tissue establishments 
1 
2 
0 
2 
16 
2 
0 

Yes 

No 
No 

Yes 

Inspection 

4 inspectors 
Yes 

Blood 
26 inspections in 5 Tissue Establishments 

0 

0 

0 

0 

388 

 
 
 
 
 
 
 
 
0 

0 

5 

0 

shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 
5.6. How do you decide which type of routine inspection to conduct?  We consider that during the routine inspection general system- 

General system-oriented inspections 

3 

0 

0 

0 

0 

0 

0 

0 

3 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 

oriented inspection should be performed. 
Yes 

23 

Yes 

10 
Yes 
2 
Yes 

Yes 

5 

389 

 
 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.16.1. If yes, please specify. 

5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 

6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 

No 

No 

No 

Yes 

We asked for outcomes of inspections: UK: outcome of inspection in 
one TE NL: outcome of inspection in one TE BE: outcome of 
inspection in one TE DE: outcome of inspection in one TE   
Yes 

No. 

Yes 

6 

6 

Authorisation procedure, Inspections 

Authorisation procedure, Inspections 

Authorisation procedure, Inspections 

Authorisation procedure, Inspections 

Authorisation procedure, Inspections 

Authorisation procedure, Inspections 

Authorisation procedure, Inspections 

Yes 

From USA: 3x Achiles Tendom, 1x Bone Tendom with Qurad Hemi 
Small Bone, 1x Anterior Tibialis Tendom From Bosnia and 
Herzegovina: 1x cord blood for autologous storage 
No 

390 

 
 
 
 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

No 

C. Export of tissues/cells is authorised irrespective of national needs 

Yes 

1 case, inport from USA, infertility treatment, sperm cells (man's 
authologous sperm) for a couple. 
No. 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 
7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
Please specify 'other'. 

No 

7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.4.1. If yes, how many authorisations were given in 2011 
(01/01/2011 to 31/12/2011)? 
7.4.2. If yes, for which tissues/cells? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

Yes 
It's member state's right to ensure Q&S, if it is needed.  

Before cross-border exchange is authorised by Slovene CA, copy of 
valid authorisation of TE  issued by relevant national CA is needed. 
According to our law, foreigin TE are considered as third parties. 
Other 

We allow direct distribution to hospitals/ clinics, but with special 
authorisation issued for each case. Tissues and cells are used on 
physician's responsability.  
Yes 

0 

NA 
Yes 

To Germany: 77 cord blood units for autologous use (storage) To 
Belgium: 446 cord blood units for autologous use (storage) 

From Slovenia: 523 units of cord blood for authologous use 
(storage) 

No 

No 

No 

Companies described in 7.7. can only be the third parties of Slovene 
Tissue Establishment, authorised for import, export and cross-border 
distribution. 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 

100% (all) 

Yes 

No 

391 

 
 
 
 
 
 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify. 

8.7. Do you have any additional comments on reporting? 

Yes 

http://www.slovenija-transplant.si/index.php?id=porocila  
Yes 

http://www.slovenija-transplant.si/index.php?id=presajanje-tkiv  
Yes 

Tissue establishments, tissue banks, their activities and type of 
tissues and cells 
No. 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
Please specify 'other'. 

Other 

Yes 

9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 
9.5. Do you have any additional comments on traceability? 

Procurement centre or tissue establishments, depends on type of 
tissue or cells 
Only paper records 

There's a legal provision in national legislation. 

We have data stored in paper records up to 2013, from 2013 data are 
stored in electronic database. Electronic database includes national 
coding system ( natioanl code is given automaticaly) and is EU 
compatible.  

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of its organisation. 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/76 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are welcome to upload 
the template if you wish. 

10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 
10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 

Agency of Medicinal products and medical Devices of the Republic 
of Slovenia; some tasks, mostly on national level, are assigned to 
Slovenija-transplant. 
Please see 1.5 
No 

We use tamplates prepared nationaly , they are templates from 
Directive 2006/86/EC, Ann III, Part A, B; Annex IV, Part A, B, in 
slovene language. 
Yes 

Yes 

100% 

Yes 

All SARE should be reported to TE. 
Yes 

At annual meeting of responseble persons the feedback is given to 
the TEs. 
Yes 

At annual meeting of responseble persons the feedback is given to 
the TEs. 
Yes 
0 

392 

 
 
 
 
 
 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

Please specify 'other'. 
10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Yes 

All relevant TEs are informed/ contacted  immidiatly by phone, e-
mails, personal contacts. 
Yes 

All relevant TEs are informed/ contacted  immidiatly by phone, e-
mails, personal contacts. 
No 

Not required by national legislation. 
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Other 
National Institute of Health, in cases of epidemiological alerts. 
Yes 

5 

No. 

Explicit consent (opt-in) 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 

We will have data stored in paper records up to 2013, from 2013 in 
electronic database. 
Presumed (opt-out) and explicit (opt-in) consent 

National legislation presumes that every citizen agree on donation if 
he/she disagree. Legislation includes opt-in registry. 
First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Friends 
Yes 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 
11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 

Every donor (donation) and recipient must get a local unique code in 
order to prevent personal data abuse. 

Provisions in legislation, every donor and recipient must get a local 
unique code in order to prevent personal data abuse. 
Yes 

Comment to 11.9: Yes, but for medical purposes to the medical staff 
only!  

393 

 
 
 
 
 
 
Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 
Audit of documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Standardised questionnaires at national level 
Inspections of ART centres 
Audit documentation 

No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Autopsy report 
No 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 

No. 

Authorisation requirement 
Inspections 
Internal audits 
External audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 
13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

Authorisation requirement 
Inspections 

Authorisation requirement 
Inspections 

Yes 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 

Inspections of tissue establishments 

394 

Events with lecturers, strongly recommendeted for responsible 
person, recomendated for other. 
No. 

 
 
 
 
 
 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 
14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 
14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 

16.2.1. For all selected options in question 16.2., please provide a 
short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 

16.3.1. How would you suggest to solve these issues in Directive 
2004/23/EC? 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 
16.3.3. How would you suggest to solve these issues in Directive 
2006/86/EC? 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

No. 

Yes 

Yes 

Third part agreements for: Transport, Procurement, Testing, 
Processing in cases when TE is not able to perform all tasks.  Third 
part agreement for Back-up procedures is legal requirement for all 
TEs. 
Agreemennts should be submitted to CA before authorisation is 
granted. CA assesses if the agreements are in line with the 
legislation. All variations in agreements should be submitted to CA. 
No. 

No 

ART provisions 
Procurement provisions 
Testing provisions 
Traceability 
ART, procurement and Testing: special law and/or rules in national 
legislation. Tracebility: no unique EU- code is available.  
Directive 2004/23/EC 
Directive 2006/17/EC 
Directive 2006/86/EC 
We support suggestions for changes presented at CA meeting in 
Dec2012. 
We support suggestions for changes presented at CA meeting in 
Dec2012. 
We support suggestions for changes presented at CA meeting in 
Dec2012. 

395 

 
 
 
 
 
 
 
 
 
A.1.28. 

Survey response Spain 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer 
possible) 

1.1.7.What are the role/tasks of the NCA? (more than 1 answer 
possible) 
Please specify 'other': 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 

1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The  NCA is responsible for? (more than 1 answer 
possible) 
1.2.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 
Please specify 'other': 

1.3. National Competent Authority 3? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, 
staff working on EU affairs and legal matters, vigilance officers, 
budget, independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 

Organización Nacional de Trasplantes 
Sinesio Delgado 4-8, Pabellón 3, 28029-Madrid, Spain 
+34-902300224 
ont@msssi.es 
www.ont.es  
Non-reproductive tissues and cells  
Human organs  

Other 

The ONT is a coordinating and technical body for the development of 
functions related to the procurement and clinical use of organs, tissues 
and cells.  
Other areas of work: training programs;  international cooperation; 
relation with the media; research projects; transplant registries; quality 
and safety; regulation and ethics; promotion and education. 
Yes 
National Commission on ARTs. 
Ministry of Health, Social Services & Equity.  
National Commission on ARTs. 
Paseo del Prado 18-20 
28071- Madrid  
+34915964106 
jrey@msssi.es 
http://www.cnrha.msssi.gob.es/  
Reproductive tissues and cells 

Other 

The Commission is an advisory board to the Ministry of Health on 
ARTs and also has a role in providing public information on activities 
related to  ARTs developed by Autonomous Communities, which are in 
charge of authorization and control of these activities by the centers in 
their respective territories. 
No 
The National Organisation for Transplantation (ONT) is the technical 
and coordinating institution that deals with donation and transplantation 
matters. It belongs to the Ministry of Health, Social Services and Equity 
(hereinafter MoH).  
In addition to those areas of work described in question 1.1.7, it should 
be remarked again the coordinating role of the ONT. In this line, the 
ONT acts as the interface between the MoH and the regional authorities 
and also between them and the EC and other MS. 
Some of the areas of work directly related to tissues and cells are: 
scientific aid, regulatory provision, inspection support, coordination of 
the surveillance network and support for professionals training courses, 
registries of activity, information to public, provision of national 
policies, etc.  
Personnel at the ONT: Director; General Secretary; Medical staff; 
Nursing staff; Technical staff; IT staff and General staff. Total: 43 
people. Their duties are carried out by interdisciplinary working teams. 
The National Commission on ART is an advisory board under the head 
of the Spanish General Secretary for Health and Consumer Affairs, 
made up by eighteen members representing different social, professional 
and administrative organizations. Four of them, representing 
Autonomous Communities, are appointed by the Spanish Interterritorial 
Council of the National Health System. The Interterritorial Council is 
the coordination body of the Regional Health Authorities and the 
Ministry of Health. 
The Commission is not endowed with executive competences, except its 
role to inform the requirements made to the Regional Authorities  on  
some special practices of PGD.   
Authorization  

396 

 
 
 
indicate the roles/tasks of the Regional Competent 
Authority(ies). (more than 1 answer possible) 

Please specify 'other': 

1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? 
(more than 1 answer possible) 
Please specify 'other': 

2.1.2. How many such authorisations were granted in 2011 
(01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out 
in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 

2.2.4. Please provide the number of procurement centers in 
which procurement of tissues/cells for ATMP manufacturing 
were carried out in 2011 (01/01-31/12/2011). 

2.3. How do you ensure that procurement centres comply with 
the requirements laid down in Art. 5 of Directive 2004/23/EC 

Inspection 
Vigilance 
Other 
The former selected answers are specific of the Regional CAs, however, 
they are responsible at a regional level for many other elements of the 
activity.  

The healthcare provision in Spain and its organization is transferred to 
the Regional Authorities (hereinafter, RAs). Each regional authority has 
its independent healthcare system.  
The Interterritorial Council for the National Health System is the 
common forum to coordinate the health-care in Spain. Consisting of 
several committees, there is a specific one dealing with donation and 
transplantation matters, for the discussion as well as political and 
technical agreements on the area. 
As regards the human tissues and cells, all the policies are discussed at 
the so-called Permanent Commission for Transplantation, the one 
mentioned above. The RAs are represented in this Committee. It is 
chaired by the Director of the ONT. As already mentioned, all these 
representatives discuss and make joint decisions on the affairs included 
in the agenda of each session.  
Regarding the coordination role of the ONT, see answers 1.1.7 and 1.5. 
The  healthcare  provision  in  Spain  and  its  organization  is  transferred  to 
the Regional Authorities (hereinafter, CCAA). Each Regional Authority 
has its independent healthcare system.  
The  Interterritorial  Council  for  the  National  Health  System  is  the 
common  forum  to  coordinate  the  health-care  in  Spain.  Made  up  by 
several  committees,  some  of  them  (the  one  related  to  public  health; 
another  one  coping  with  benefits  of  the  Spanish  Health  Care  System) 
have to do with ARTs and its deployment in reproductive general, public 
or private centers. 

Yes 
By inspecting all procurement centres 
Other 
A system for the authorization exists at a national level and is regulated 
in  the  Royal  Decree. Nevertheless,  the  RAs  provide  the  authorizations, 
as already mentioned.  
86 

211 

272 

There  is  no  disposable  information  for  2011.  As  an  answer  to  the 
requests  of  Eurocet  made  through  the  Italian  National  Institute  of 
Health, in January 2013 it was sent to Eurocet a list of Spanish centers 
practicing  different  activities  included  in  or  related  to  ARTs.  The  total 
number  of  centers  included  in  the  list  at  that  time  was  390.  In  march 
20th, 2013 it was received a new request from that Institute, on behalf of 
Eurocet, asking to adapt the list previously sent, which was a copy of the 
register of centers appearing at the web page of the Spanish Commision 
on ARTs, to a new format proposed by Eurocet. This new format means 
the  exclusion  of  a  certain  number  of  centers  developing  some  kind  of 
activities  related  to  ARTs,  like  the  ones  only  being  banks  of  sperm, 
oocytes or embryos. After some consultations with Eurocet, the last one 
being  answered  in  September  2th,  a  new  list  will  be  sent  along 
September.     
There is not a specific authorization for procurement centres for ATMP, 
nevertheless  those  centres  which  are  authorized  for the  procurement  of 
"traditional  tissues  and  cells"  hold  the  authorization  as  the  source  of 
cells to produce Advance Therapies. 
Inspections of the site/centre 
Analysis of the mandatory documentation 

397 

 
 
 
 
 
and its implementing Directive 2006/17/EC (e.g. trained 
personnel, conditions accredited, designated, authorised, 
licensed) ? (more than 1 answer possible) 
2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor 
testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 
2.4.2. Which National Authority is in charge of this activity? 

2.5. How do you ensure, as CA for T&amp;C, that tests required 
for donors are carried out only by qualified laboratories 
accredited, designated, authorised or licensed Art. 5(2))? (more 
than 1 answer possible) 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are 
performed etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art 4; Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 
1 answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 
1 answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number 
of additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and 
test procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.5.1. Please specify. 

3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.6.1. Please specify. 

3.7. Do you request/use international accreditation systems for 
testing laboratories? 

No 

There are not available data. 

The authorization of control of this activity relies on the RAs.  
The National authority lays down national requisites and regulation and 
coordinates the transmission of results and the dissemination of other 
information when it is necessary.  
Inspections of the laboratories 
Analysis of the mandatory documentation requested from the tissue 
establishment 

The ONT does not have that kind of information at that level of detail, 
nevertheless it is estimated that the number of qualified labs is similar to 
the one for Tissue Establishments. 

No 

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
NAT is broadly used.  
For ART it has not foreseen as for now. Activities are widely developed 
at private centers and controls have not produced any problems with less 
expensive and more traditional methods.  

No 

Yes 

Anti-HTLV II 
For HSC it is also required PCR in addition to Anti HCV Ab.  

No 

Clinical studies are applied to exclude clinical phases of toxoplamosis, 
rubella, herpes, cytomegalovirus, neisseria or Chlamydia, but laboratory 
test for these diseases are not mandatory in the absence of clinical 
symptoms.   
Yes  
(No for ART) 

3.8. Do you have any additional comments on testing? 

Some testing laboratories in Spain usually search for international 
accreditation (ISO, etc) besides the CA authorisation.  

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments 
under your responsability? 
4.1.1. Please specify. 

No 

A system for the authorization exists at national level and is regulated in 
the Royal Decree. Nevertheless, the RAs provide the authorizations, as 
already mentioned.  
Yes  

4.2. Is inspection a prerequisite for the designation, 

398 

 
 
 
 
 
 
 
 
 
 
 
 
 
authorisation, accreditation or licensing of tissue establishments? 

(No for ART) 

4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 

4.3. Are preparation processes authorised? 

4.3.1. How are they authorised? (more than 1 answer possible) 

4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were suspended in 2011? 

4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many authorisations/accreditation/licenses 
were revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 
4.6.1. What is the relation between the independent 
certification(s) (e.g. ISO, JACIE, FACT) and the CA 
authorisation of the tissue establishments? (more than 1 answer 
possible) 
4.6.2. Please specify 

Data not available at national level.  
The inspections are responsibility of the RAs. In general, the procedure 
for authorization and register of health establishments by the Regional 
Authorities requires the submission of documentation as well as to carry 
out inspections and audits. 
Yes  
(No for ART) 
During routine inspections 
During inspections organized for this purpose 
Data not available at national level. Inspections are responsibility of the 
RAs. In general, the procedure for authorization and register of health 
establishments by the Regional Authorities requires the submission of 
documentation as well as to carry out inspections and audits. 
None 
(For ART data are not available at national level) 

No 

Other 

The certification/accreditation is optional.  
TEs may obtain the accreditation by JACIE, ISO, etc. if they apply for 
it.  
4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval 
at 01/01/2011 (more than 1 answer possible): 

4.7.1. How many ocular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.8. Tissue establishments with authorisations pending approval 
by 31/12/2011 (more than 1 answer possible): 
4.8.8. How many multi-tissue establishments? 
4.9. Tissue establishments first time authorised between 
01/01/2011 and 31/12/2011 (more than 1 answer possible): 
4.10. All tissue establishments authorised by 31/12/2011 (more 
than 1 answer possible): 
4.10.2.1. How many authorised centres (2012 data) 
4.10.2.2. How many Skin tissue establishments? 
4.10.3.1. How many Musculo-skeletal tissue establishments? 
4.10.3.2. How many Ocular tissue establishments 
4.10.5.1. How many Cardiovascular tissue establishments? 
4.10.5.2. How many HSC tissue establishments? 
4.10.6.1. How many Cord blood tissue establishments? 
4.10.6.2. How many Multi-tissue establishments? 
4.10.7.1. Other tissue establishments 
4.11. How many tissues and cells were distributed under the 
direct agreement of the Competent Authority according to Art. 
6(5) during 2011? Please provide number(s) per type 
tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 

ART tissue establishments 
(The RAs provide the authorizations, as already mentioned.  Following 
the Spanish regulation, the ONT receives the final information including 
the authorized centers, nevertheless the data pertaining to the 
‘authorizations pending for approval’ remains at the regional level.) 
Please see 4.7 
Please see 4.7 
Data not available at national level 
Please see 4.7 
ART tissue establishments 

Please see 4.7 
ART tissue establishments 

ART tissue establishments 

502 
42 
149 
245 
62 valves centres, 83 segments centres 
90 
272 
321 
194 
Data not available  

Yes 

No 
For ART data not available, as penalties would have been imposed at 

399 

 
 
 
 
 
 
 
 
 
4.16.1.1. How many penalties have been imposed  in 2011 (from 
01/01/2011-31/12/2011)? 
4.16.1.2. What were the reasons for imposing the penalties? 
Please describe. 
4.16.1.3. What kind of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty etc.) 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in 
charge of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 
5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common 
training, common documentation, etc.)? (more than 1 answer 
possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments for 
non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) following serious adverse events or 
reactions, or suspicion thereof ? 
5.3.2. How many other type of  inspections of tissues 
establishments for non-reproductive tissues/cells were conducted 
in 2011 (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where no 
shortcomings were observed? 
5.3.4. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of other inspections carried out? Please 

regional level 
None 
For ART data not available 

NA 

NA 

Currently, there are several disciplinary proceedings ongoing.  

Yes 

Regional competent authorities (RAs). 

Data not available at national level. 
Yes 

Blood 
Organs 
Pharmaceuticals 
Advanced therapies 
Medical devices 
Hospitals 
Accreditation organisations (e.g. JACIE) 
Data not available at national level since the competencies for the 
inspections rely on the RAs. 

Please see 5.3 

Please see 5.3 

Please see 5.3 

Please see 5.3 

Please see 5.3 

0 

0 

Please see 5.3 

400 

 
 
 
 
 
specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted Fin ART 
establishments following serious adverse events or reactions, or 
suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on 
ART establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a 
whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments 
carried out in 2011 (01/01/2011 to 31/12/2011): What was the 
number of inspections carried out where no shortcomings were 
observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective 
establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more 
than 1 answer possible) 
5.6. How do you decide which type of routine inspection to 
conduct? 
5.7. Until 2011, did you implement the requirement concerning 
the time interval between two inspections (Art. 7.3.)? 
5.7.1. Why not? 
5.7.2. How do you prioritize tissue establishments to be 
inspected? 

5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.1. If yes, how many? 
5.10. Did you carry out inspections of third parties? 
5.10.1. If yes, how many? 
5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell 
procurement and tissue establishments - Guidelines for 
inspections (Commission Decision 2010/453/EU)? 
5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO V&S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 
2 = sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in 
that MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.14.1. Could you please explain why? 

Data not available 

NA 

Data not available 

Data not available at national level 

Data not available at national level 

Data not available at national level 

Data not available at national level 

Data not available at national level 

Data not available at national level 

General system-oriented inspections 
Desk based reviews 
The regional authority plans ahead the type of inspection.  

Yes 
(For ART data not available at national level) 
Regional Authorities are in charge of inspections. 
The regional authority prioritizes the Tissue Establishement to be 
inspected.   

Data not available at national level. 

Yes 

Data not available at national level. 
No 
Data not available 
Yes  
For ART No since the Ministry of Health has no capacity to carry direct 
inspections of centres in the Authonomous Regions  

Yes  
For ART No 
4 

No 

Yes 
For ART No 

The inspectors of the HTA (UK) inspected the Transplant Services 
Foundation (TSF), Spain, to allow the export of skin. 
For ART Inspections of centres at the request of another country have to 
be deployed by Regional Authorities. In some cases concerned regional 

401 

 
 
 
 
5.15. Did you organise any inspections of procurement centres 
or tissue establishments in third countries from which tissues 
and/or cells were imported in your country (as recorded by 
31/12/2011)? 
5.16. Have you asked another MS, or have you been requested 
by any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? 
Joint inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments 
that are explicitly authorised to perform import/export of tissues 
and celles from/to third countries? 
6.2. Please specify the number of tissue establishments 
authorised to import tissues and cells from third countries 
(recorded by 31/12/2011). 

6.3. Please specify the number of tissue establishments 
authorised to export tissues and cells from third countries 
(recorded by 31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 

6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) 
tissues from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from third 
countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than cord 
blood) from third countries. 
6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 

authorities have been asked to inspect some centers at the request of 
NCAs of other countries.    
No 

No 

Yes  
For ART No 

No 

No 

The authorizations in Spain are given for all the activities at a time, i.e. 
procurement, processing, storing, distribution, import and export, so that 
all the TEs are authorized to import and export. 
For ART, exchanges of sperm, oocytes or embryos with other countries 
belonging to the EU, which are the more frequent in ARTs  cannot be 
considered import nor export, and cannot be subject of any kind of 
special controls. 
Please see 6.2 

The requests to import tissues and cells are received at the ONT from 
the concerned TE. 
The ONT prepares the favorable report which is sent to the Ministry of 
Health (Public Health General Directorate). Imports are specifically 
authorized by this DG. 
The TE presents the requested documents at the ONT. Since several 
requirements have to be met, the responsible at the ONT verifies that the 
standards of quality and safety are equivalents to the Spanish ones.  

Please see 6.4 

Please see 6.4 

Please see 6.4 

Please see 6.4 

Please see 6.4 

Importation of sperm, oocytes or embryos from third countries not 
belonging to the UE is very uncommon, reduced to a little number of 
individual requests. When these cases take place, they are directed to 
some fixed customs, following the procedure described in 6.4. 
Yes     
For ART not applicable 

402 

 
 
 
 
 
 
 
 
 
 
 
 
 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of 
origin. 
6.12. Did you export tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination.* 
6.13. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on imports/exports of tissues/cells 
between your country and other third countries? 
6.14. What is the relation between import/export of tissues and 
cells and self-sufficiency? (more than 1 answer possible) 

6.14.1. If A or D were selected, please explain how you quantify 
local/national needs. 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

CBU 60, PBSC 49, BM 18, musculoskeletal 700 

Yes  
For ART not applicable 
CBU 96, PBSC 3, blood vessel 2, musculoskeletal 25 

No 

A. Export of tissues/cells is authorised only after checking that 
local/national needs are fulfilled. 
D. Import of tissues/cells is authorised only after checking that 
local/national needs are not fulfilled 
Each regional authority checks the local needs and the availability of 
tissues. Then, the ONT does the same at the national level before 
preparing the report which is sent to the Ministry of Health (Public 
Health General Directorate). Please see also 6.4.  
The HSC are regulated by a different system, based on the Bone Marrow 
Donors Worldwide (BMDW) Standards. 
No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and 
cells? 
7.1.1 Please specify 

Yes 

7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding 
quality of tissues and cells during distribution? Please specify. 
7.3. Do you allow direct distribution to hospitals/clinics in your 
MS from TEs in another MS? (only 1 answer possible). 
7.3.1 Please specify  

7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 

7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011). 

The free circulation of tissues and cells among the EU Member States is 
assumed in Spain.  
For ART is the same. 
No 

By the inspections  

Other  

All the tissues and cells are distributed through a Spanish TE except for 
the distribution of products derived of human tissues such as DBM and 
lyophilized products which may have a direct distribution to 
hospital/clinics. 
For ART it is only via an authorised TE in my MS 
No 

Yes  
For ART No 

Germany:  CBU 7, PBSC 4, cardiac tissue 49, blood vessel 7, 
musculoskeletal 54; 
Austria: CBU 6, PBSC 1, cardiac tissue 6, blood vessel 3; 
Belgium: CBU 5, PBSC 1; 
Czech Republic: CBU 1; 
Croatia: CBU 1; 
Denmark: CBU 4; 
France: CBU 48, PBSC 6, BM 2, blood vessel 2, musculoskeletal 30; 
Greece: CBU 5, cardiac tissue 1, musculoskeletal 202; 
Netherlands: CBU 20, cardiac tissue 8, blood vessel 7, musculoskeletal 
42; 
Hungary: CBU 6; 
UK: CBU 23, PBSC 2, skin 72, cardiac tissue 2,  
Italy: CBU 10, cornea ; 
Poland: PBSC 1; 

403 

 
 
 
 
 
 
 
 
 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011) 

7.6. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on cross-border exchanges of 
tissues/cells between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in 
EU and/or import/export of tissues/cells? In this context, a 
brokerage company means a body that arranges transactions 
between a supplier (tissue establishment/company selling tissues 
or cells) and a buyer (a tissue establishment/a hospital or 
clinic/an individual) without undertaking activities of 
processing, preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if 
any) as a Competent Authority, in their authorization 
/monitoring or inspection 

Portugal: CBU 1, skin 4, musculoskeletal 115 
Germany: CBU 8, PBSC 134, BM 58; 
UK: CBU 3, PBSC 12, BM 8; 
Portugal: PBSC 13, BM 1; 
France: CBU 6, PBSC 7, BM 6; 
Italy: CBU 2, PBSC 2, BM 2, cornea 1; 
Poland: PBSC 2; 
Belgium: CBU 1; 
Netherlands: musculoskeletal 1243 
No 

Yes  
For ART No 

A system for the authorization exists and is regulated in the Royal 
Decree.  
Nevertheless, the RAs provide the authorizations, as already mentioned.  

7.8. Are brokers actively supplying health 
professionals/establishments in your country? 

Yes    
For ART No 

7.8.1. Where are the brokers located? 

7.8.2. If the broker is located in another country, how 
easy/difficult is it to ensure that safety and quality requirements 
are met? 
7.9. Do you have any additional comments on distribution? 

Your country 
Another country 
If the tissues are coming into Spain from a non- EU country, there is a 
thorough document revision. 

No. 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the 
activities of tissue establishments in your Member State? 
(Article 10(1)). If yes, please upload the template. 

8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 
answer possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 

8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 

8.4.1. Please insert the link to the published national annual 
report 
8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web 
site. 
8.6. Do you provide data regarding tissues and cells activities to 
the EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please 
specify. 

Yes 
For ART the report, based on a noncompulsory register on activities in 
ARTs, is made by the Spanish Society of Fertility (SEF), according to an 
annual contract signed by the Society and the Ministry of Health. The 
results are used to send data required to different European registers 
(Eurocet; ESHRE) 
100% (all)  
For ART 50-69%  

by 

interested 

Yes 
The data are included in the national annual report. 
http://www.ont.es/infesp/Paginas/DatosdeDonacionyTrasplante.aspx 
For ART Data informing on activity and outcomes of each center, to be 
known 
at:  
http://www.cnrha.msssi.gob.es/registros/actividades.htm    
Yes 
For ART Ministry of Health receives this annual report according to the 
terms of the contract signed with SEF. The report is not published by the 
Ministry of Health, but SEF makes public the data in its own bulletin. 
http://www.ont.es/infesp/Paginas/DatosdeDonacionyTrasplante.aspx 

users,  may 

accessed 

be 

Yes 

https://reports.ont.es/Autorizaciones.aspx 
For ART http://www.cnrha.msssi.gob.es/registros/centros/home.htm  

Yes 

All data requested by EUROCET for tissues and cells.  
For ART, data requested by EUROCET in the format provided for 

404 

 
 
 
 
 
 
 
 
 
 
8.7. Do you have any additional comments on reporting? 

ARTs. 
No. 

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented 
in your country? 
9.1.1. If no, why not? 

No 

9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
Please specify  

9.3. How is the data storage for traceability purposes organised 
in your tissue establishements (Art 8(4))? (only 1 answer 
possible) 
9.4. How do you ensure that the 30 years data storage 
requirement is respected (Directive 2006/89/EC, Art. 9)? Please 
specify. 
9.5. Do you have any additional comments on traceability? 

It has been partially implemented, awaiting the final guidance from the 
Commission.   
For ART, a compulsory general register of donors is not yet 
implemented. Data of donors are conserved at the centers. 
Other 

It has been partially implemented, awaiting the final guidance from the 
Commission.   
Both paper records and electronic forms 

There is an obligation as stated in the regulation. 
For ART not yet regulated. 

No. 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/86) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 

Yes  
For ART No 

10.1.1. If yes, which CA/institution is responsible? 

10.1.2. If yes, please provide a short description of its 
organisation. 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you 
use the SAR/E (to the CA (2006/86 art 6.4)) templates 
developed to the Annual reporting ot the EC also at national 
level? 
10.3. Do you use the Common Approach Document developed 
for the Annual reporting to the EC also at national level? 

10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed 
the tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

The ONT as the National Competent Authority, the regional competent 
authorities and the National Group of Biovigilance. 
For ART, Regional Authorities are responsible of control of ARTs 
centers in its own territories 
The Vigilance Network is constituted by three levels:  
1) 

hospital/centres- all authorized centres (for procurement, processing 
and transplantation). 
 regional level- regional competent authorities 
national level- the ONT 

2) 
3) 

The National Group of Biovigilance is responsible for the coordination 
of vigilance tasks and also gives the approval to the annual national 
report.  

Yes 

Yes  
For ART No 

Yes  
For ART No 

Not applicable to ART 
100% 

Yes  
For ART No 

There is a procedure approved* in 2009 by the Interterritorial Council 
for the reporting and management of SAR/SAE occurred in procurement 
centres, tissue establishments and transplantation centres. Please note 
that the procedure takes into account possible SAR/SAES in living 
donors at procurement centres. 
The system establishes principles and rules for notification and 
management and respects the internal organisation of the National 
Health System and the Spanish administration. 
* National Vigilance Protocol, accessible at 
http://www.ont.es/infesp/TejidosPHCelulas/Sistema_de_Biovigilancia.p

405 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
10.7.1. Please specify  

10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.1. Please specify  
10.9. Do you require your TEs to have a recall procedure? 

10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please specify 
the number and which tissues were recalled and why (e.g. 
missing consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure.  

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is 
issued via the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure 
10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not 
10.14. Do you notify alerts communicated via these tissues and 
cells national vigilance system also to other national 
vigilance/alert systems? 
10.14.1. If yes, please specify which of the following systems 
are usually contacted. (more than 1 answer possible) 

10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO V&amp;S? 

10.15.1. If yes, how would you rate the usefulness and efficacy 
of these trainings on a scale from 1(insufficient) - 2 (sufficient) 3 
(good) - 4 (very good) to 5 (essential)? 

df 

Yes 
For ART No 

An annual report is provided in a specific meeting to the network, then 
presented to the Transplantation Committee of the Interterritorial 
council, and finally sent, in written format, to the network. 
Yes  
For ART No 

Alerts are transmitted to the TE through the Vigilance Network 
Yes  
For ART No 

None in 2011  

Yes  
For ART No 

An alert can be quickly transmitted to the vigilance network by an 
established dissemination procedure, using mail and the 24 hours 
coordination office at the ONT.  

Yes  
For ART No 

The same system is used for EU alerts transmitted via RATC platform. 

No 

Because those data are sent to the European Commission. 
Yes  
For ART No 

Haemovigilance 
Pharmacovilance 
Medical devices 
Yes  
For ART No 

4 very good  

10.16. Do you have any additional comments on SARE 
reporting? 

No. 

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 
11.2. What consent system for deceased tissue/cell donation do 
you have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell donation, please specify 

Explicit consent (opt-in) 

11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 

Please specify 'other'. 

Written consent is a mandatory requisite for living donation. It cannot be 
carried out without it, likewise i.e. being of age, or good health status.   

Presumed (opt-out) and explicit (opt-in) consent 

Although in Spain there is presumed consent by law (i.e. Ley 30/1979 
art.5), in practice the families are always approached and they have the 
last decision, which is respected (a form is always signed).  
First degree relatives (including spouse) 
Other relatives 
Other 

‘Other relatives’ are asked (i.e. siblings) for the donation whenever there 
are no first degree relatives (spouse, parent, or sons/daughters). 

406 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11.4. Is the consent system for deceased tissue donation the same 
as for organs? 
11.4.1. If  no, please describe the difference. 

11.5. How is this consent verified during inspections? (more 
than 1 answer possible) 
Please specify 'other'. 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third 
parties (Art. 14(1)). Please specify. 

11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice 
versa. 

11.9. Does your national legislation allows disclosure of donor 
data in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 

For ART no further authorization is needed  
No 

Sometimes the consent is given for organs and tissues together, and 
sometimes it is specific for tissues. 
Analysis of documentation 
Other  
The consent form remains in the corresponding record for each donor. 
Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 
For ART information for donors are controlled at regional level 

Restricted Access to personal information.  
Confidentiality regulated by Law, and sanctionable in cases it is 
not fulfilled.  
Dissociation mechanisms in place.  
Contracts with third parties establishing such obligation.  
Data protection supervision at hospital, regional and national level 
etc.  

All those mentioned above plus a specific ban to disclose any 
information which may allow identification between donor and 
recipient or to their relatives.  

- 
- 

- 
- 
- 

- 

No 

Disclosure of donor data can only be done in case of congenital diseases 
appeared. 

11.10. Do you have any additional comments on consent and 
data protection? 

No 

Inspections of TEs and procurement sites 
Audit of documentation 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of 
reproductive cells) are respected in your country (Art. 15(1), 
Annex I Directive 2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection 
than those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of 
a deceased donor of tissues/cells? (more than 1 answer possible) 

Inspections of ART centres 

No 

12.5. Do you have more stringent criteria for selection of donors 
of reproductive cells than those listed in Annex III of the 
Directive 2006/17/EC? 
12.6. Do you have more stringent criteria for autologous 
donation than those listed in Annex I of the Directive 
2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex 
of Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues 
and cells' procurement, packaging and transport are complied 
with by tissue establishments in your country (Art 15(1), Annex 
IV of Directive 2006/17/EC? (more than 1 answer possible)(For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, 
and/or vendors in order to evaluate adherence to the written 

Interview with the donor's family or a person who knew the donor well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
No 

No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Audit of the centre of human application 

407 

 
 
 
 
 
 
 
 
 
 
 
SOP, standards or governments laws and regulations (from 
Council of Europe Guide to the Safety and Quality Assurance 
for the Transplantation of Organs, Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

No. 

Authorisation requirement 
Inspections 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your 
country have in place a quality system respecting the provisions 
of the Directive 2004/23/EC Art 16.1? (more than 1 answer 
possible). (For this question "audit" means a documented review 
of procedures, records, personnel functions, equipment, 
materials, facilities, and/or vendors in order to evaluate 
adherence to the written SOP, standards or governments laws 
and regulations (from Council of Europe Guide to the Safety and 
Quality Assurance for the Transplantation of Organs, Tissues 
and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? 
(more than 1 answer possible) 
13.3. How do you ensure an appropriate training for the 
personnel directly involved in the activities of tissue 
establishments? (more than 1 answer possible) 

Authorisation requirement 
Inspections 

13.4. Do you have national/regional/local training programmes 
for the personnel of tissue establishments? 
13.4.1. If yes, please specify.  

13.5. Any additional comments on quality management, 
responsible person, personnel? 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Yes. 
For ART No 
There are training programmes dedicated to T&C donation and 
transplantation and all aspects related, as well as specific programmes 
dedicated to particular areas (i.e. inspections).   

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your 
country fulfill the requirments of the Art. 19 (Tissue and cell 
reception) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your 
country fulfill the requirements of the Art. 20 (Tissue and cell 
processing) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.3. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 21 (tissue and cell storage 
conditions) of Directive 2004/23/EC? (more than 1 answer 
possible) 
14.4. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 22 (labelling, 
documentation and packaging) of Directive 2004/23/EC and 
Annex IV of Directive 2006/17/EC? (more than 1 answer 
possible) 
14.5. Any additional comments on reception, processing, 
storage, labelling and packaging? 

No 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 

SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 

SOPs for procedures associated with labelling and packaging are 
mandatory for authorisation 
Inspections of tissue establishments 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your 
national legislation? 

15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 
15.1.1.2. How are third party agreements controlled (Art 6.2) by 
the Competent Auhtority(ies) in your MS? Please specify. 

Yes  
For ART No 

Yes 

Those allowed in the regulation, i.e, supply of materials, storage, etc. 

Regulation establishes the conditions under which contracts with third 
parties can be signed: ie. Those contracts have to be communicated to 
the corresponding CA, or can be subject to inspection, etc.  

408 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and 
safety requirements than those requested by the EU legislation in 
this field (e.g. restrictions concerning the donation/use of certain 
tissues/cells, mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 

16.2.1. For all selected options in question 16.2., please provide 
a short description. 

16.3. In your opinion, in which of the following Directives are 
there shortcomings (if any)? (more than 1 answer possible) 

No 

No 

ART provisions 
Import-export 
Traceability 

Import-export: it is necessary the publication of the Directive with 
homogeneous criteria of import/export. 
Traceability: clarifications on the coding are needed in order to have 
more functional and traceable systems.  
For ART: a high percent of ART centers are private. ART policies are 
not a priority for many regional authorities, being on the contrary a high 
priority for a short number of them. National policies are more difficult 
in this context. 
No shortcomings 

409 

 
 
 
 
 
 
 
 
A.1.29. 

Survey response Sweden 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 

1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer 
possible) 

1.1.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 

1.2. National Competent Authority 2? 
1.2.1. Name of National Competent Authority 2: 
1.2.2. Address of NCA 2: 
1.2.3. Telephone (central access point): 
1.2.4. E-mail (central access point): 
1.2.5. Website: 
1.2.6. The NCA is responsible for? (more than 1 answer 
possible) 

Please specify 'other': 

1.2.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 

1.3. National Competent Authority 3? 
1.3.1. Name of National Competent Authority 3: 
1.3.2. Address of NCA 3: 
1.3.3. Telephone (central access point): 
1.3.4. E-mail (central access point): 
1.3.5. Website: 
1.3.6. The NCA is responsible for? (more than 1 answer 
possible) 

1.3.7. What are the role/tasks of the NCA? (more than 1 
answer possible) 
Please specify 'other': 
1.4. National Competent Authority 4? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior 
inspectors, staff working on EU affairs and legal matters, 
vigilance officers, budget, independence from government 
etc.). 

  Health and Social Care Inspectorate  / Inspektionen för vård och Omsorg 
(IVO) 
IVO Box 45184 104 30 Stockholm  Sweden 
+46 10 788 50 00 
registrator@ivo.se 
www.ivo.se 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Yes 
Medical Products Agency 
Läkemedelsverket Box 26 751 03 Uppsala Sweden 
+46 18 1746 00 
registrator@mpa.se 
www.lakemedelsverket.se 
Pharmaceuticals 
Medical devices 
Other 
Tissues and cells for manufacturing of Advanced therpuetic medicinal 
products (ATMP)  
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Yes 
The National Board of Health and Welfare  
Socialstyrelsen  106 30 Stockholm Sweden 
+46 75 247 30 00 
socialstyrelsen@socialstyrelsen.se 
www.socialstyrelsen.se 
Non-reproductive tissues and cells 
Reproductive tissues and cells 
Blood and blood components 
Human organs 
Other 

Regulatory, Disease precautions, National registries and statistics  
No 
Health and Social Care Inspectorate:  Independent CA with assignment from 
the governement to supervise and authorize health care and social care in 
Sweden. Total no of staff approx 500 localized as six regional offices and 
one central office. The staff consists of expertise in the areas for supervision, 
accordingly most personnel holds a degree in medicine- or social sciences 
alternativly are legal advisors.  Supervision according to EU directives is 
centralized to one regional department in Stockholm and those inspectors (3) 
are contact points for EU affairs dealing with Blood, tissues and cells and 
organs.   Medical Products Agency:  Independent CA responsible for 
regulation and surveillance of the development, manufacturing and sale of 
drugs and other medicinal products. Its operations are largely financed 
through fees. Approximately 750 people work at the agency; most are 
pharmacists and doctors. The agency is divided into four departements; 
Development, Licencing, Supervision and Usage. The agency are actively 
involved in EU matters in the field of  pharmaceuticals and medicinal 
poducts.   The National Board of health and Welfare:  Independent CA with 

410 

 
 
1.6. In case of MS with federal or decentralised systems, 
please indicate the roles/tasks of the Regional Competent 
Authority(ies). (more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of 
the Regional Competent Authority(ies) and their relation 
with the National Competent Authority(ies) for tissues and 
cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of 
procurement"? (more than 1 answer possible) 

2.1.2. How many such authorisations were granted in 2011 
(01/01-31/12/2011)? 
2.2.1 Please provide the number of procurement centres in 
which procurement of "traditional tissues and cells" (skeletal 
tissues, cardiovascular tissues, skin, ocular tissues, amniotic 
membrane, pancreatic islet, hepatocytes, adipose tissue etc.) 
were carried out in 2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in 
which procurement of haematopoietic stem cells (bone 
marrow, PBSC, cord blood etc.) were carried out in 2011 
(01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in 
which procurement of gametes, embryos and other 
reproductive tissues were carried out in 2011 (01/01-
31/12/2011). 
2.2.4. Please provide the number of procurement centers in 
which procurement of tissues/cells for ATMP manufacturing 
were carried out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply 
with the requirements laid down in Art. 5 of Directive 
2004/23/EC and its implementing Directive 2006/17/EC 
(e.g. trained personnel, conditions accredited, designated, 
authorised, licensed) ? (more than 1 answer possible) 
Please specify 'other': 

2.4. Are you also responsible for the accreditation, 
designation, authorisation or licensing of laboratories 
performing donor testing? 
2.4.2. Which National Authority is in charge of this activity? 

2.5. How do you ensure, as CA for T&amp;C, that tests 
required for donors are carried out only by qualified 
laboratories accredited, designated, authorised or licensed 
Art. 5(2))? (more than 1 answer possible) 
Please specify 'other': 

2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are 

assignment from the governement to perform follow up, national guidelines, 
issue bylaws and keep national registries in the areas of Health care and 
Social care.  Total no of staff is approx 400 divided into three departments ; 
Regulation, Statistics and Knowledge based Policy and Guidance. EU 
matters in these areas are coordinated from the staff of the Director Gerneral 
.  
Not applicable 

Not applicable; 

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement centres 
The TE holds the authorization , only procurement is not authorized.  

34 

7 

17 

3 

Inspections of the site/centre 
Analysis of the mandatory documentation 
Other 

Most of the TE ´s (i.e 45 out of 52) also procure the tissues & cells and for 
the other TE´s it is the responsibility of the TE to perform audits at the 
procurement center, and the result of these audits are examined during the 
inspection of the TE  
No 

The Swedish Board for Accreditation and Conformity Assessment 
(SWEDAC)  www.swedac.se 
Analysis of the mandatory documentation requested from the tissue 
establishment 
Other 

The TE are requested to show which laboratory they use for donor testing 
(and have a written agreement if applicable ) The accrediatation by 
SWEDAC is publicly available and the laboratory holds an accrediatation 
licence.  
32 laboratories (Clinical microbiology are accredited by SWEDAC )  
http://search.swedac.se/sv/ackrediteringar?ackomrade=1%3AKlinisk%20mi
krobiologi.  

411 

 
 
 
 
performed etc.). 
2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of 
non-reproductive tissues and cells in your Member State. 
(more than 1 answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more 
than 1 answer possible) 

3.3. If NAT testing is not mandatory in your country, could 
you please indicate whether you intend to make it mandatory 
or to encourage its use? Please specify why or why not (e.g. 
number of additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests 
and test procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of 
non-reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems 
for testing laboratories? 
3.7.1. Please specify. 

3.8. Do you have any additional comments on testing? 

Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
Anti-HIV 1 
Anti-HIV 2 
Ag HIV 
HBs AG 
Anti HBc 
Anti HCV-Ab 
HTLV-2 
Treponema Pallidum 
Epidemiological data in Sweden does not motivate a legal obligation to 
perform NAT testing. The National Board of Helath and Welfare and the 
Swedish Institute for Communicable Disease Control have the 
responisibility to follow and perform risk assessments of these diseases and 
for the moment we have no indications that NAT testing will be mandatory. 
No 

No 

No 

Yes 

The Accreditation by SWEDAC is based on SS-EN ISO 15189:2007  
alternatively  SS-EN  ISO 17025: 2005  
 All tissue establishments are legally obliged to use an Accredited laboratory 
for donor testing, and some may also have additional tests performed 
depending on their own wishes i.e EBV, CMV for HPC donors or 
Chlamydia for oozyte donors.     

No 

Yes 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue 
establishments under your responsability? 
4.2. Is inspection a prerequisite for the designation, 
authorisation, accreditation or licensing of tissue 
establishments? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer 
possible) 
4.4. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 
2004/23/EC), how many 
authorisations/accreditation/licenses were revoked in 2011? 
4.6. Do you require TEs to be certified by an external entity 
to a quality system standard (e.g. ISO, JACIE, FACT)? 

No 

0 

0 

Yes 
By review of a submitted application with supporting documentation 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending 
approval at 01/01/2011 (more than 1 answer possible): 

Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 

412 

 
 
  
 
 
 
 
 
 
4.7.1. How many skin tissue establishments? 
4.7.2. How many musculo-skeletal tissue establishments? 
4.7.3. How many ocular tissue establishments? 
4.7.4. How many cardiovascular tissue establishments? 
4.7.5. How many HSC tissue establishments? 
4.7.6. How many cord blood tissue establishments? 
4.7.7. How many ART tissue establishments? 
4.7.8. How many multi-tissue establishments? 
4.7.9. Please specify the type of tissues/cells and how many. 
4.8. Tissue establishments with authorisations pending 
approval by 31/12/2011 (more than 1 answer possible): 

4.8.1. How many skin tissue establishments? 
4.8.2. How many musculo-skeletal tissue establishments? 
4.8.3. How many ocular tissue establishments? 
4.8.4. How many cardiovascular tissue establishments? 
4.8.5. How many HSC tissue establishments? 
4.8.6. How many cord blood tissue establishments? 
4.8.7. How many ART tissue establishments? 
4.8.8. How many multi-tissue establishments? 
4.8.9. Please specify the type of tissues/cells and how many. 
4.9. Tissue establishments first time authorised between 
01/01/2011 and 31/12/2011 (more than 1 answer possible): 

4.9.1. How many skin tissue establishments? 
4.9.2. How many musculo-skeletal tissue establishments? 
4.9.3. How many ocular tissue establishments? 
4.9.4. How many cardiovascular tissue establishments? 
4.9.5. How many HSC tissue establishments? 
4.9.6. How many cord blood tissue establishments? 
4.9.7. How many ART tissue establishments? 
4.9.8.  How many multi-tissue establishments? 
4.9.9. Please specify the type of tissues/cells and how many. 
4.10. All tissue establishments authorised by 31/12/2011 
(more than 1 answer possible): 

Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
0 
0 
0 
0 
0 
0 
0 
0 
TE´s processing Cells for ATMP  = 0 pending  
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
0 
0 
0 
0 
0 
0 
1 
0 
 TE´s processing cells for ATMP = 0 pending 
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
0 
0 
0 
0 
0 
0 
0 
0 
TE´s processing cells for ATMP = 0  
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
ART tissue establishments 
Multi-tissue establishments 
Other tissue establishments 

413 

 
 
4.10.1.1. How many public skin tissue establishments? 
4.10.1.2. How many private skin tissue establishments? 
4.10.2.1. How many public musculo-skeletal tissue 
establishments? 
4.10.2.2. How many private musculo-skeletal tissue 
establishments? 
4.10.3.1. How many public ocular tissue establishments? 
4.10.3.2. How many private ocular tissue establishments? 
4.10.4.1. How many public cardiovascular tissue 
establishments? 
4.10.4.2. How many private cardiovascular tissue 
establishments? 
4.10.5.1. How many public HSC tissue establishments? 
4.10.5.2. How many private HSC tissue establishments? 
4.10.6.1. How many public cord blood tissue 
establishments? 
4.10.6.2. How many private cord blood tissue 
establishments? 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.10.8.1. How many public multi-tissue establishments? 
4.10.8.2. How many private multi-tissue establishments? 
4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 
4.10.9.2. Please specify the type of 'other' private 
tissues/cells establishements and how many. 
4.11. How many tissues and cells were distributed under the 
direct agreement of the Competent Authority according to 
Art. 6(5) during 2011? Please provide number(s) per type 
tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national 
provisions pursuant to the Directive been defined (Article 
27)? 
4.16.1. Have penalties already been imposed? 
4.17. Do you have any additional comments on 
accreditation, authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and 
control measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in 
charge of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common 
training, common documentation, etc.)? (more than 1 answer 
possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

5.3. How many routine inspections of tissue establishments 
for non-reproductive tissues/cells were conducted in 2011 
(from 1/1/2011 to 31/12/2011)? 
5.3.1. How many inspections of tissues establishments for 
non-reproductive tissues/cells were conducted  in 2011 

3 
0 
15 

0 

2 
0 
1 

0 

5 
0 
1 

0 

6 
10 
5 
0 
Public TE processing cells for ATMP = 1 

Private TE processing cells for ATMP = 1 

0 

Yes 

No 

Yes 

The Health and Social Care Inspectorate (previously the dept of Supervision 
at  National Board of Health and Welfare ) have centralized coordination of 
the inspections and supervision to one department located in Stockholm. The 
coordinators plan the inspections which are then performed together with a 
regional inspector .   
The coordinators are 3 and regional inspectors are 1-2 in each of the six 
regions.   
Yes 

Blood 
Advanced therapies 
Hospitals 
32 

0 

414 

 
 
 
 
  
 
 
(from 1/1/2011 to 31/12/2011) following serious adverse 
events or reactions, or suspicion thereof ? 
5.3.2. How many other type of inspections of tissues 
establishments for non-reproductive tissues/cells were 
conducted in 2011 (from 1/1/2011 to 31/12/2011) (e.g. due 
to a whistle-blower)? Please specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where no 
shortcomings were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out where major 
shortcomings were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of inspections carried out that were 
followed by closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): 
What was the number of other inspections carried out? 
Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART 
establishments following serious adverse events or reactions, 
or suspicion thereof (from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted 
on ART establishments (from 1/1/2011 to 31/12/2011) (e.g. 
due to a whistle-blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments 
carried out in 2011 (01/01/2011 to 31/12/2011): What was 
the number of inspections carried out where no 
shortcomings were observed? 
5.4.4. What was the number of inspections carried out in 
ART establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in 
ART establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in 
ART establishments followed by suspension of 
authorisation? 
5.4.7. What was the number of inspections carried out in 
ART establishments followed by closure of respective 
establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? 
(more than 1 answer possible) 

5.6. How do you decide which type of routine inspection to 
conduct? 

0 

4 

18 

2 

0 

0 

0 

16 

0 

0 

3 

13 

0 

0 

0 

0 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 
The general system oriented inspection is always one part, then a 
theme/focus  for the routine inspection is decided by the coordinators, 
depending on occurances during the year (reported SAR/SARE, risk 
assessment or any paricular questions / unclear matters that have been 

415 

 
 
5.7. Until 2011, did you implement the requirement 
concerning the time interval between two inspections (Art. 
7.3.)? 
5.7.1. Why not? 

5.7.2. How do you prioritise tissue establishments to be 
inspected? 

5.8. How many TEs were inspected at least twice between 
2008-2011 (01/01/2008-31/12/2011)? 

5.9. Did you perform/conduct inspections of procurement 
sites outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual 
for Competent Authorities on inspection of tissue and cell 
procurement and tissue establishments - Guidelines for 
inspections (Commission Decision 2010/453/EU)? 
5.11.1. If no, which guidelines/regulations are used for 
inspections at national level? 

5.11.2. If no, please provide a hyperlink to these 
guidelines/inspections. 

5.12. Did you send any of your inspectors to the training 
courses organised by EU-funded projects (e.g. EUSTITE, 
SOHO V&amp;S)? 
5.12.2. Why not? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA 
in that MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS 
in collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement 
centres or tissue establishments in third countries from 
which tissues and/or cells were imported in your country (as 
recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been 
requested by any other MS, on the results and control 
measures of your inspections, as part of an 
enquiry/investigation? 

discussed since last inspection round) .  Each inspection is preceeded by a 
demand to send certain documentation to the inspector (Respond to a 
Questionaire and attach relevand documents) and these are reviewed prior to 
the inspection.  
No 

All TE´s were authorized 2010, and accordingly inspected for the first time 
2010 and 2011.  Thereafter the time interval between inspections has not 
exceeded 2 years.   
Our first two inspections (2010) were chosen in order to test and evaluate 
our inspection protocol;  we chose one TE that we suspected had everything 
"in place"  and one TE that we suspected to have some problems.  Thereafter 
we evaluated our inspection protocol, and inspected a multi-TE in order to 
get an overview of the various procedures for different tissues and cells.  
After this, inspctions have been carried out according to their location and 
the most suited coordinator and according to the time scheme.  
1 (one of the first pilot TE´s  that did not have all mandatory routines / 
documents in place was inspected 2010 and 2011 based on the result of the 
pilot-inspection)   
No 

Most TE´s also procure the tissues and cells and if not, we require (and 
review) a written agreement between the procurement center and the TE.   
No 
Written agreements are required (and reviewed)  if any third part is involved 
in the chain between procurement and clinical use of the T&C . The most 
pertinent "third part" , the laboratory performing donor testing, is Accredited 
by another CA and we do not intervene or overlap with other CA´s 
inspections. In addition it is the responisbility of the TE to perform audits/ 
review any third part that they have agreement with.   
No 

In principle we follow the Guidelines for inspections,  but adapted to the 
organisation of TE´s in Sweden. The regulations "Socialstyrelsens 
föreskrifter" SOSFS 2009:30, SOSFS 2009:31 and 2009:32  covers 
Donation - Tissue establishments - and Usage of Tissues and Cells 
respectively and our inspections are based on these regulations.     
http://www.socialstyrelsen.se/sosfs/2009-30;  
http://www.socialstyrelsen.se/sosfs/2009-31; 
http://www.socialstyrelsen.se/sosfs/2009-32 
No 

Lack of time  
No 

No 

No 

No 

416 

 
 
5.17. Would you be interested in developing joint 
inspections? Joint inspections should be understood as 
inspections of tissue establishments conducted jointly by two 
or more Member States' Competent Authorities on their 
territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

Yes 

1.Joint inspections would be valuable in particular in the situation where a 
TE  has procurement activities in an other MS .  2. The number of 
inspections (non-reproductive tissues and cells) exceeds the total number of 
"minor"- "major"- and "no shortcomings" due to that some TE´s have more 
than one site and inspections were carried out on more than one site, wheras 
only one inspection report to the TE was written.  

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue 
establishments that are explicitly authorised to perform 
import/export of tissues and celles from/to third countries? 
6.2. Please specify the number of tissue establishments 
authorised to import tissues and cells from third countries 
(recorded by 31/12/2011). 
6.3. Please specify the number of tissue establishments 
authorised to export tissues and cells from third countries 
(recorded by 31/12/2011). 
6.4. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of skin from third countries. 
6.5. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of musculo-skeletal (bone, tendons, fascia etc.) 
tissues from third countries. 
6.6. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of ophtalmic (cornea, sclera, etc) tissues from 
third countries. 
6.7. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cardio vascular tissues from third countries. 

6.8. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of haematopoietic stem cells (HSC) (other than 
cord blood) from third countries. 

6.9. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of cord blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from 
third countries. 
6.11. Did you import tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of 
origin. 

6.12. Did you export tissues/cells from 3rd countries during 
2011 (01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 

Yes 

6 

6 

it is the responibility of the importing TE to ensure that quality and safety of 
the tissues and cells to be imported corresponds to the same standard as the 
T&C Directive (no import licences for skin is currently authorized)     
it is the responibility of the importing TE to ensure that quality and safety of 
the tissues and cells to be imported corresponds to the same standard as the 
T&C Directive (one import licence for tendons is currently authorized and 
the exporting TE is authorized by FDA)     
it is the responibility of the importing TE to ensure that quality and safety of 
the tissues and cells to be imported corresponds to the same standard as the 
T&C Directive ( one import licence for ophtalmic tissue is currently 
authorized and the exporting TE is authorized by FDA)     
it is the responibility of the importing TE to ensure that quality and safety of 
the tissues and cells to be imported corresponds to the same standard as the 
T&C Directive (no import licences for cardio vascular tissue is currently 
authorized)     
it is the responibility of the importing TE to ensure that quality and safety of 
the tissues and cells to be imported corresponds to the same standard as the 
T&C Directive  and they  use the following criteria  1.  Does the exporting 
TE hold an other accreditation , FACTS, JACIE, WMDA ? 2. if not, a 
Questionaire with focus on quality and safety and traceability will be sent 
out and depending on the answers the importing TE will accept the HPC . 
Since import of HPC is intended for a given patient in need of a 
transplantation, a risk assessment will be performed by the medically 
responisble person wherafter the dicision will be documented.  
see answer to 6.8  

It is not legally possible to import frozen reproductive cells from third 
countries (Swedish law: Lag  2006:351 om genetisk  integritet mm )  
http://www.notisum.se/rnp/sls/lag/20060351.htm 

Yes 

The import was HPC but number of HPC-units as well as the country of 
origin is not collected by the CA (only the tot number of tissues / cells 
recieved from another TE is collected and that "other TE " may be National, 
within another MS or from third country)   
Yes 

12 HPC units were exported  TO 3rd countries during 2011 . The country of 

417 

 
 
 
 
number/volume of exported tissues and cells by country of 
destination. 
6.13. Are you aware of any significant changes in 2012 
which may invalidate the 2011 data on imports/exports of 
tissues/cells between your country and other third countries? 
6.14. What is the relation between import/export of tissues 
and cells and self-sufficiency? (more than 1 answer possible) 

Please specify 'other': 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on 
import/export? 

destination is not reported to the CA .  

No 

C. Export of tissues/cells is authorised irrespective of national needs 
E. Import of tissues/cells is authorised based on estimations showing that 
there is chronic deficiency of those tissues/cells 
F. Other 
Import and Export of HPC are performed on a patient based need , and the 
TE´s authorized for import/export of HPC decide without additional permit 
from the CA .  
No 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and 
cells? 
7.1.1. If yes, how do you address the possible more stringent 
quality and safety measures established by other Member 
States? Please specify. 

Yes 

7.1.2. If yes, do you have more stringent quality and safety 
measures than in other Member States? 
7.1.2.1. How do you address this difference for tissues and 
cells coming from a MS with minimum quality 
requirements? Please specify. 

7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding 
quality of tissues and cells during distribution? Please 
specify. 
7.3. Do you allow direct distribution to hospitals/clinics in 
your MS from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient 
of specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange 
of tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, 
type of tissue/cell and number of units distributed) 
concerning distribution to other MS in 2011 (01/01/2011-
31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning 
distribution to other MS in 2011 (01/01/2011-31/12/2011) 
7.6. Are you aware of any significant changes in 2012 which 
may invalidate the 2011 data on cross-border exchanges of 
tissues/cells between your country and other EU MS? 
7.7. Do you allow brokerage companies for either 
distribution in EU and/or import/export of tissues/cells? In 
this context, a brokerage company means a body that 
arranges transactions between a supplier (tissue 
establishment/company selling tissues or cells) and a buyer 

We use the interpretation that it is the responisbility of the recieving MS to 
make sure that the delivering MS fulfill the national quality and safety 
measures. If necessary, the recieving MS may ask the Swedish TE to add 
some assay in the donor testing (i.e NAT assays) or any other additional 
requirement that can be fulfilled.     
Yes 

For reproductive cells (sperms) the Swedish law  require that the donor 
identity must be avalable to the child at adult age, which prohibits the use of 
frozen sperms from other MS where anonomous donations are allowed. 
Since it is the responisbility of the recieving MS (i.e the Swedish TE) to 
make sure that Swedish regulations on quality and Safety are fulfilled the 
Swedish TE  can not use such tissues and cells without violating the national 
laws and regulations. For other tissues and cells (including ATMP) Sweden 
do not have more stringent quality and safety measures than other MS and 
we rely on the authorization given in each MS to be in accordance with the 
Directive and thecnical directives.  
It is included in our inspections, to ensure that TE´s have validated their 
methods for distribution.    

Yes, but only via an authorised TE in my MS 

No 

Yes 

Only the number of (unis) tissues and cells distributed to other EU MS are 
reported, not the country of destination.  During 2011; 33 HPC units  and 20 
blood vessels were distributed to other EU MS / EES. 

= 7.5.1 ??  

No 

No 

418 

 
 
  
 
 
(a tissue establishment/a hospital or clinic/an individual) 
without undertaking activities of processing, preservation or 
storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

No 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the 
activities of tissue establishments in your Member State? 
(Article 10(1)). If yes, please upload the template. 
8.2. How many tissue establishments submitted annual 
reports of their activities during 2011. Please provide an 
estimation. (1 answer possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 

100% (all) 

Yes 

8.4. Do you publish a national annual report of the 
consolidated activities of all tissue establishments in your 
country? 
8.4.1. Please insert the link to the published national annual 
report. 
8.5. Is there a publicly accessible register of authorised 
tissue establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's 
web site. 
8.6. Do you provide data regarding tissues and cells 
activities to the EUROCET registry (non-mandatory 
reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please 
specify. 

8.7. Do you have any additional comments on reporting? 

Yes 
They are as all material within a governemental authority in Sweden 
publicly available upon request.   
Yes 

http://www.ivo.se/publiceratmaterial/rapporter/Documents/lagesrapport-for-
vavnadsinrattningar-2011-2012.pdf 
Yes 

http://www.ivo.se/Tillstand-och-
register/register/vavnadsinrattningar/Sidor/default.aspx 
Yes 

All available data, but Eurocet do ask for much more data than specified in 
the Directive and all of these data are not collected by the CA.  In particular 
concerning ART (different IVF methods, no.of births ect) and HPC 
(diagnoses , number of searches in different registries etc )  

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) 
implemented in your country? 
9.1.1. If no, why not? 

No 

9.2. Who assigns the unique code for each donation? (only 1 
answer possible) 
9.3. How is the data storage for traceability purposes 
organised in your tissue establishements (Art 8(4))? (only 1 
answer possible) 
9.4. How do you ensure that the 30 years data storage 
requirement is respected (Directive 2006/89/EC, Art. 9)? 
Please specify. 

9.5. Do you have any additional comments on traceability? 

All TE´s have a donor identification system, but it is not (yet) a common 
coding system for all TE´s .  Most tissues and cells are procured, storaged 
and used within the same TE or hospital and therefore we have accepted 
local coding systems .  For HPC that are distributed between TE´s - hospitals 
and cross- borders the ISBT128 coding system is used.  
Tissue establishment 

Both paper records and electronic forms 

This is included in our inspections, and for those that have only paper the 
storage is in fire-resistant cupboards, for the electronic form we make sure 
that the TE have required from their information system support that 
electronic storage is accessible also after new versions of software etc.  

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/76) 
10.1. Do you have a national vigilance system in place (for 
the reporting of serious adverse events and reactions (Article 
11(1))? 
10.1.1. If yes, which CA/institution is responsible? 

Yes 

10.1.2. If yes, please provide a short description of its 
organisation. 

The Health and Social Care Inspectorate (tissues and cells) and the Medical 
Products Agency (ATMP)  
SAR and SAE are reported directly to the coordinators at the CA close to the 
event/reaction and in addition an annual report of all SAR and SAE should 
follow the annual report for the activity of the TE. The coordinators collect 

419 

 
 
  
 
 
  
 
 
  
 
 
10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do 
you use the SAR/E (to the CA (2006/76 art 6.4)) templates 
developed to the Annual reporting ot the EC also at national 
level? 
10.3. Do you use the Common Approach Document 
developed for the Annual reporting to the EC also at national 
level? 
10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the 
total number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the 
transplantation centres when reporting SAR/SAE to the TEs 
which distributed the tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE 
recorded at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE 
recorded at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of 
tissues/cells were issued in your country in 2011? Please 
specify the number and which tissues were recalled and why 
(e.g. missing consent, quality defects etc). 
10.11. Do you have in place a system/procedure to notify 
Tissue Establishments and procurement sites in case of a 
national rapid alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify 
Tissue Establishments and procurement sites when a rapid 
alert is issued via the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the 
EUROCET registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 

10.14. Do you notify alerts communicated via these tissues 
and cells national vigilance system also to other national 
vigilance/alert systems? 
10.14.1. If yes, please specify which of the following 
systems are usually contacted. (more than 1 answer possible) 
Please specify 'other'. 

the reports, evaluate the suggested/ performed actions and classify the 
reports according to clasification that should be reported later to the EC. If 
needed the coordinators may ask for additional actions, that have to be 
completed before the report is closed.    
Yes 

Yes 

No 

This is the same staff that perform inspections (i.e the coordinators)  
<50% 

Yes 

The user of tissues and cells should report back to the TE both the actual 
usage (i.e recipient identification-that may be coded or if discarded) and if 
any serious adverese events or reactions occured according to the national 
regulation SOSFS 2009:32 on "Usage of Tissues and Cells within health 
care and clinical reseach"        
Yes 

Every second year we invite 2 staff members from each TE to a meeting 
where feedback from the recorded SAR/E  as well as from inspections is 
provided. In addition we also discuss interpretation questions and other 
relevant issues.  A summary of the recorded SAR/E is also provided in the 
written report which is publically available (see Q .8.4.1)  
Yes 

At the meeting mentioned above, with the TE but also at other meetings 
where coordinators are invited to speak about issues relevant to the TE´s .   
Yes 
0 

Yes 

The coordinators have a contact list covering all TE ´s and an e-mail is sent 
out togther with an alert on our public webpage.    
Yes 

see 10.11.1  and the contact list is divided according to the specific tissues 
and cells handled by the TE so only the relevant TE´s are notified.   
No 

We provide data to the EC, and upon request we could provide 
corresponding data also to Eurocet.  
Yes 

Medical devices 
Other 
If applicable we will notify the MPA (i.e tissues and cells for production of 

420 

 
 
10.15. Did you send a vigilance officer/contact point to the 
trainings organised by the EU-funded project SOHO 
V&amp;S? 
10.15.2. If no, please specify why not. 
10.16. Do you have any additional comments on SARE 
reporting? 

ATMP)  If a medical devise is involved in an event regarding T&C the TE is 
obliged to report this event also to the MPA according to SOSFS 2009:31 
kap 11 4§.  
No 

Lack of time  

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
Explicit consent (opt-in) 
11.1. What consent system for living tissue/cell donation do 
you have in place within your Member State? 
11.1.1. Please specify your choice of consent system for 
living tissue/cell donation. 

11.2. What consent system for deceased tissue/cell donation 
do you have in place within your Member State? 
11.2.1. If you have chosen both consent systems for 
deceased tissue/cell dontation, please specify. 

11.3. According to your national legislation, in case of 
deceased donations, please specify who is giving the 
authorisation for the tissue donation? (more than 1 answer 
possible) 
11.4. Is the consent system for deceased tissue donation the 
same as for organs? 
11.5. How is this consent verified during inspections? (more 
than 1 answer possible) 
11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by 
Art. 13(2)? (more than 1 answer possible) 
11.7. What measures are in place to ensure that both donors 
and recipients remain unidentifiable when access is given to 
third parties (Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure 
that the identity of the receipient is not disclosed to the 
donor and vice versa. 
11.9. Does your national legislation allows disclosure of 
donor data in case of gametes donation? 
11.10. Do you have any additional comments on consent and 
data protection? 

Written and signed consent is required and in case of minors written consent 
from parents and an additional permit after application to the National Board 
of Health and Welfare is needed. 
Presumed (opt-out) and explicit (opt-in) consent 

If the deseased possible donor has not registered his/her will in the national 
donor registry a person who knew the diseased well need to give their 
consent.  
First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Friends 
Yes 

Analysis of documentation 
Interviews with personnel 
Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 

Donor code and recipient code is used  

The Donor code is used in the recipient documentation and the recipient 
code is used in the donor documentation.  

Yes 

Disclosure of donor ID is only possible for the born child at adult age and 
not for the parents.    

Stadardised questionnaires at national levels 
Inspections of TEs and procurement sites 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of 
reproductive cells) are respected in your country (Art. 15(1), 
Annex I Directive 2006/17/EC)? (more than 1 answer 
possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
12.3. Do you have more stringent criteria for donor selection 
than those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the 
evaluation of a deceased donor of tissues/cells? (more than 1 
answer possible) 
12.5. Do you have more stringent criteria for selection of 
donors of reproductive cells than those listed in Annex III of 
the Directive 2006/17/EC? 

Standardised questionnaires at national level 
Inspections of ART centres 

No 

Interview with the donor's family or a person who knew the donor well 
Medical records of the donor 
Interview with the treating physician 
No 

421 

 
 
  
 
 
 
 
12.6. Do you have more stringent criteria for autologous 
donation than those listed in Annex I of the Directive 
2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the 
Annex of Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding 
tissues and cells' procurement, packaging and transport are 
complied with by tissue establishments in your country (Art 
15(1), Annex IV of Directive 2006/17/EC? (more than 1 
answer possible)(For this question "audit" means a 
documented review of procedures, records, personnel 
functions, equipment, materials, facilities, and/or vendors in 
order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe 
Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)) 
12.9. Do you have any additional comments on selection, 
evaluation and procurement? 

No 

No 

Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation centre, 
ART centre) 

In combination with inspections document reviews are performed and all TE 
for reproductive tissue are also ART centers,  so also the centers for "human 
application" have been inspected.  

Authorisation requirement 
Inspections 
Internal audits 
External audits 

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your 
country have in place a quality system respecting the 
provisions of the Directive 2004/23/EC Art 16.1? (more than 
1 answer possible). (For this question "audit" means a 
documented review of procedures, records, personnel 
functions, equipment, materials, facilities, and/or vendors in 
order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe 
Guide to the Safety and Quality Assurance for the 
Transplantation of Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? 
(more than 1 answer possible) 
Please specify 'other'. 

13.3. How do you ensure an appropriate training for the 
personnel directly involved in the activities of tissue 
establishments? (more than 1 answer possible) 

Please specify 'other'. 

13.4. Do you have national/regional/local training 
programmes for the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

Authorisation requirement 
Inspections 
Other 
In case of a change of responsible person, an application together with CV of 
the new responsible person must be approved by the CA.  
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Other 
During inspection we also interview the personell and their possibity to get 
extended training is one of the questions.      
Yes 

Personnel working in the laboratory of a TE must be licenced as Biomedical 
Analysts, other personnel are are licenced nurses, MD´s or have a degree in 
biomedicine depending on their assignement in the TE. Additional training 
specific for the TE is provided locally as well as by regional and national 
courses arranged by the National Tissue Council.  (Vävnadsrådet; 
www.vavnad.se)    

13.5. Any additional comments on quality management, 
responsible person, personnel? 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your 
country fulfill the requirments of the Art. 19 (Tissue and cell 
reception) of Directive 2004/23/EC and Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your 
country fulfill the requirements of the Art. 20 (Tissue and 
cell processing) of Directive 2004/23/EC? (more than 1 
answer possible) 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 

422 

 
 
 
 
  
 
 
14.3. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 21 (tissue and cell 
storage conditions) of Directive 2004/23/EC? (more than 1 
answer possible) 

14.4. How do you ensure that tissue establishments in your 
country fulfill the requirements of Art. 22 (labelling, 
documentation and packaging) of Directive 2004/23/EC and 
Annex IV of Directive 2006/17/EC? (more than 1 answer 
possible) 
14.5. Any additional comments on reception, processing, 
storage, labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your 
national legislation? 
15.1.1. If yes, have tissue establishments in your Member 
State notified third party agreements? 
15.1.1.1. Under which circumstances and for which 
responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) 
by the Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality 
and safety requirements than those requested by the EU 
legislation in this field (e.g. restrictions concerning the 
donation/use of certain tissues/cells, mandatory unpaid 
donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please 
provide a short description. 

16.3. In your opinion, in which of the following Directives 
are there shortcomings (if any)? (more than 1 answer 
possible) 
16.3.2. How would you suggest to solve these issues in 
Directive 2006/17/EC? 

External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with labelling and packaging  are mandatory 
for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 

Yes 

Yes 

Donor testing: only laboratories that are accredited by SWEDAC are 
accepted and the agreement covers reponsibility issues relating to testing, 
electronic transfer of test results (if applicable), obligation to notify the TE if 
testresults are unreliable/ failures in the compulsary assay comparisons etc.   
Procurement from diseased donors (ocular tissue, skin, heart valves) where 
the agreement covers responibility to perform procurement according to the 
SOP´s from the TE and the permission to allow the TE to perform audits .  
Data storage: the TE´s processing and distributing allogeneic HPC have 
agreements with the National Registry of Bone Marrow donors (Tobias 
registret) covering the responisbility of the registry to keep and maintain 
records of the donor-identity when the TE only get a donor code as identity.     
Before the authorization and during routine inspections.   

In case of new third party agreements; it is considered as a major change in 
the TE , that has to be approved by the CA ( by document review)  

No 

Testing provisions 

The 24 hr time limit to perform donor testing in case of diseased donor have 
a negative effect on donor availability for procurement as it may take longer 
for the concent to be given.  
Directive 2006/17/EC 

Annex II 2.4 Change the time limit from 24 hr to 48 hrs since no scientific 
evidence was the basis for the 24 hrs time limit. Annex II 2.5 (b) add for 
clarification: "under these circumstances tissues and cells are in quarantine 
until results from the second test are available and evaluated "  

423 

 
 
  
 
 
 
 
 
 
A.1.30. 

Survey response United Kingdom 

UK - HFEA 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 2: 

1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 
1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

Please specify 'other': 

Human Fertilisation and Embryology Authority 
Finsbury Tower 103-105 Bunhill Row London EC1Y 8HF United 
Kingdom 
0207 291 8200 
admin@hfea.gov.uk 
www.hfea.gov.uk 
Reproductive tissues and cells 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
The HFEA is the UK's national regulator for ensuring ART clinics 
adhere to the requirements of the Human Fertilisation and 
Embryology Act 1990 (as amended) [the HF&E Act 1990 (as 
amended)]. The HFEA also licenses and monitors establishments 
undertaking human or human admixed embryo research.  We also 
maintain a Register of Information.  The HFEA Register is a data set 
on regulated fertility treatments, including the handling and storage 
of embryos, eggs and sperm.  
No 
The HFEA is an independent regulator, operating as a UK arms-
length body, sponsored by the Department of Health. It employs 
approximately 69 staff, divided into three directorates: Compliance 
and Information; Strategy; Finance, Facilities and Information 
Technogy.  Each of these directorates are led by a Director, 
reporting to the CEO. The Compliance team has 2 senior inspectors 
and 10 inspectors (who comprise the inspection and vigilance team), 
reporting to either the Head of Inspection or the Head of Research 
Regulation and Clinical Governance.  The HFEA also has a board. 
There are also 12 members of the Authority (the board) who 
determine HFEA policies and review treatment and research licence 
applications. Members have a broad range of expertise, from 
medicine to law and religion to philosophy. To ensure that the 
HFEA has an objective and independent view, the HFE Act requires 
the Chair, Deputy Chair and at least half of the HFEA Members are 
not doctors or scientists involved in human embryo research or 
fertility treatment.   
Not applicable 

Not applicable 

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
Other 
We license and inspect establishments that carry out procurement 
activities where they also process and use gametes and / or embryos. 
We also issue a Code of Practice in which we provide advice on the 
requirements related to conditions of procurement. We may not 
inspect all procurement centres as some procurement centres operate 

424 

 
 
 
 
 
2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 
2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
Please specify 'other': 

2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 

2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
Please specify 'other': 

2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 
2.7. Do you have any additional comments on procurement? 

through a third party agreement with a licensed establishment. The 
Person Responsible (i.e 'responsible persons') at these licensed 
establishments must ensure that the practices, staff and premises are 
suitable at any third party establishment. They will do this in a 
variety of ways, including conducting audits of the third party. The 
HFEA reviews third party arrangements during a routine inspection 
of the licensed establishment.  
35 HFEA licences were renewed in in 2011. In addition one new 
licences was granted in 2011.  
Procurement of traditional tissue and cells is authorised by the 
Human Tissue Authority (HTA) 

Procurement of haematopoietic stem cells is authoroised by the 
HTA. 

115 of which 111 are licensed by the HFEA. Four centres procure 
gametes under third party agreements with a licensed HFEA centre.  

Procurement of tissue / cells for ATMP manufactoring falls is 
authorised by the HTA. 

Inspections of the site/centre 
Analysis of the mandatory documentation 
Other 

The HFEA, by law, produces a Code of Practice. The HFEA Code 
of Practice is intended to help and encourage licensed centres to 
understand and comply with their legal requirements. It also gives 
guidance on how centres are expected to go about meeting those 
requirements. In addition which provide guidance through a regular 
news letter.  
Yes 

The HFEA does not licence laboratories performing donor testing. 
The HFEA has made it a condition of all treatment and storage 
licences issued to tissue establishment that donor testing must be 
carried out by a qualified laboratory, which has suitably accreditated 
(for example by the Clinical Pathology Accreditation [CPA (UK) 
Ltd] or another body accrediting to an equivalent standard). The 
CPA (UK) Ltd , a private organisation, provides a voluntary national 
accreditation service. Over 95% of UK labs are CPA accredited.  
Analysis of the mandatory documentation requested from the tissue 
establishment 
Other 

During inspections visits to tissue establishments HFEA inspectors 
will audit the medical records for a number of patients. As part of 
this audit we look for evidence that the donor testing has been 
carried out by a qualified laboratory.  
The HFEA does not accredit, authorise or license laboratories which 
carry out donor testing. Over 95% of laboratories carrying donor 
testing are accrediated by the Clinical Pathology Accrediatation 
[CPA (UK) Ltd). 
The following requirementss are conditions of all licences issued by 
the HFEA:  - Where the sperm is procured at home, the centre must 
record this in the gamete provider’s records. - No money or other 
benefit must be given or received in respect to any supply of 
gametes, embryos or human admixed embryos unless authorised by 

425 

 
 
3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

Directions. - There must be a documented system in place that 
ensures the identification of all gametes and embryos from 
procurement to use or disposal.  

Anti-HIV 1 
Anti-HIV 2 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
HTLV-2 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
NAT Chlamydia 
Treponema Pallidum 
NAT testing is not currently mandatory in the UK, with the 
exception of the testing for Chlamydia. The Advisory Committee on 
the Safety of Blood, Tissues and Organs (SaBTO) advises UK 
ministers and health departments on the most appropriate ways to 
ensure the safety of blood, cells, tissues and organs for 
transfusion/transplantation. SaBTO has recommended NAT, in 
particular product testing rather than donor serum testing.     
No 

No 

No 

No 

The testing of donors of non-reproductives cells comes under the 
authority of the Human Tissue Authority in the UK. Additional 
testing for donors of reproductive tissue and cells is carried in 
accordance with the rquirements set out in Annex 111 of Directive 
2006/17/EC. 

4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.2.1. How many inspections were performed in 2011 for 
authorising/accrediting/licensing/designating TEs? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

Yes 

37 inspections were performed in 2011 for the purpose of renewing 
or granting a HFEA licence to tissue establishments.  
Yes 
During routine inspections 
By review of a submitted application with supporting documentation 
None 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 
4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

3 licences were revoked 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.7. How many ART tissue establishments? 

4 

ART tissue establishments 

426 

 
 
 
 
 
 
 
 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.7. How many ART tissue establishments? 
4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 
4.9.7. How many ART tissue establishments? 
4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 
4.10.7.1. How many public ART tissue establishments? 
4.10.7.2. How many private ART tissue establishments? 
4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.16.1.1. How many penalties have been imposed in 2011 (from 
01/01/2011-31/12/2011)? 
4.16.1.2. What were the reasons for imposing the penalties? Please 
describe. 

4.16.1.3. What kind of penalties were imposed? Please describe (e.g. 
suspension of authorisation, criminal penalty etc.) 
4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 
Please specify other. 

ART tissue establishments 

13 
ART tissue establishments 

One 
ART tissue establishments 

66 (42 of these also treat private patients) 
45 (27 of these also treat publicly funded patients) 
0 - None 

Yes 

Yes 
One licence had a condition placed on it to restrict the number of 
ART treatment cycles which could be carried per month.  
The Person Responsible had failed to ensure that suitable practices 
(required under section 17(1)(d) of the HF&E Act) were being used 
in the course of the activities being caried out at the ART centre. 
One licence had a condition placed on it to restrict the number of 
ART treatment cycles which could be carried per month. 
In relation to 4.5 three licences were revoked but these were at the 
request of the Person responsible (i.e. the reponsible person), so we 
class these as voluntary revocations.   In relation to 4.7.7: four tissue 
establishment were inspected in 2010 but the decision on whether or 
not the HFEA licence should be renewed was not taken until early 
2011.   In relation to 4.8.7: 12 tissue eatablishments were inspected 
in 2011 but the decision on whether or not the HFEA licnece should 
be renewed was not taken until early 2012. In adition one of the new 
tissue eatablishments inspected in 2011 was not granted a licnece 
until 2012.   In relation to 4.10.7.1: In the UK there are 66 ART 
centres located in NHS [National Health Service(public)] hospitals; 
of these 42 also treat privately funded patients.  In relation to 
4.10.7.2: In the UK there are 45 private ART centres; of these 27 
also treat NHS funded patients.  

Yes 

Directorate of Compliance and Information 

The HFEA has two senior inspectors and 10 inspectors. There are 
also two Heads of Department and a Director. The HFEA also has a 
panel of external advisors who occassionaly form part of the HFEA's 
inspection teams. These external advisors are clinicians, nurses, 
embryologists or counsellor who work in licensed ART centres. A 
list of the HFEA's external advisors mcan be found in our annual 
report (http://www.hfea.gov.uk/annual-report.html)  
Yes 

Others 
As well as being the Competent Authority for tissues and cells for 
human application, the HFEA is also responsible for ensuring tissue 
establishments are compliant with the Human Fertilisation and 
Embryology Act 1990 (as amended) and we are also responsibe for 
licensing and inspecting laboratories which use human or human 

427 

 
 
 
 
 
 
5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 
5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 
5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

admixed embryos in research.  
N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

60 

2 

One 

3 

54 

50 

0 - None 

0 - None  

3: two to investigate an SARE and one following a complaint/ 
whistleblower 
General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  The HFEA’s continuous monitoring cycle of licensed UK fertility 

centres involves a four year inspection cycle during which the 

428 

 
 
majority of centres will receive a four year licence and be inspected 
once every two years. More frequent inspections may be made when 
we have concerns about a centre’s compliance - particularly if we 
consider the safety of patients, embryos and gametes are at risk. The 
purpose of an inspection is to:  - assess the extent to which centres 
comply with the Human Fertilisation and Embryology Act; licence 
conditions; directions and the provisions of the Code of Practice  - 
provide an independent and professional perspective on the running 
of the centre  - promote good practice so that centres can improve 
the quality of service they provide to patients and donors   
Compliance with all of the requirements of the HF&E Act 1990 (as 
amended), which incorprates the requirements of the EUTCD, are 
inspected prior to a licence being granted or renewed.   An interim 
inspection takes place mid way through the four year inspection 
cycle. During the interim inspection the inspection team evaluates: - 
the action(s) taken by the centre in relation to areas of non-
compliance identified either at the last inspection visit or through the 
continuous monitoring cycle  - compliance against the inspection 
themes (the Authority has decided that a number of areas of practice 
should be looked at all inspections. These are referred to as 'themes'. 
The themes are changed every two years.)   The HFEA also 
conducts thematic reviews where we look at compliance against a 
particular requirement e.g. consent to donation and these may 
involve additional inspection visits to tissue establishments.   The 
variation of licences is sometimes carried out by desk based reviews. 
For example if a tissue establishment applied to have an additional 
licensed activity added to thier licence we would ask them to submit 
documentation and this would be reviewed without an inspection 
visit being carried out.  
Yes 

All TEs licensed by the HFEA between 01/01/2008 -31/12/2011 
were inspected at least twice between 2008 -2011. The HFEA 
continues to carry out a site based inspection of all licensed tissue 
establishments every two years. 
No 

The Person Responsible (the Responsible Person) at HFEA licensed 
tissue establishments are required to have a third party agreement 
with procurement sites. These third party agreements are reviewed 
as part of the inspection process. There are only 4 procurements sites 
that are not licensed by the HFEA. 
No 
No issues were raised during inspections of the licensed tissue 
establishments and no series adverse events or reactions were 
reported in relation to third parties.  
No 

We do not use the Operational Manual for Competent Authorities on 
inspection of tissue and cell procurement and tissue establishments - 
Guidelines for inspections, however our inspection guidelines are 
based on this document. We provide licensed tissue establishments 
with numerous guidance on our website, to assist them with 
inspection preparation and guidance on what licensed tissue 
establishments need to do to comply with the HFEA's Code of 
Practice. We use internal standard operating procedures to provide 
guidance for inspectors on how to conduct an inspection. We also 
hold at least on training day for HFEA inspectors and the HFEA's 
external advisors per year. These days are used to ensure consistency 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 

5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.11.1. If no, which guidelines/regulations are used for inspections at 
national level? 

429 

 
 
5.11.2. If no, please provide a hyperlink to these 
guidelines/inspections. 

5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

between inspectors. 
The information on how the HFEA monitors licensed tisues 
establishment can be found at http://www.hfea.gov.uk/6670.html. 
The information on the inspection process can be found at 
http://www.hfea.gov.uk/6672.html and the information on what 
licensed tissue establishments need to do to ensure they comply with 
the HF&E Act 1990 (as amended) and the Code of Practice can be 
found at http://www.hfea.gov.uk/6676.html.   
Yes 

5 

No 

No 

No 

No 

Yes 

The HFEA continually monitor licensed centres to ensure their 
compliance with the HF&E Act (as amended), standard licence 
conditions, additional licence conditions, directions and the Code of 
Practice. To aid this process the HFEA has developed a tool, known 
as the Risk Based Assessment Tool, which helps us assess the 
information provided to us by centres.  The Risk Tool analyses 
information provided to the HFEA through Register submissions and 
to the HFEA finance directorate to assess quality of service in terms 
of: - outcomes (in the form of  real time analysis of clinical 
pregnancy rates)  - multiple clinical pregnancy rates  - submission of 
critical donor information  - incident reporting.  Where the analysis 
shows that a centre’s outputs are outside the sector norms we will 
share this information with the centre and support them in 
identifying whether there is an opportunity for improvement. The 
same will apply where clinical multiple birth rates indicate that a 
centre is not likely to meet HFEA targets; where critical Register 
submissions are not submitted. A more detailed explanation of the 
HFEA Risk Tool can be found at http://www.hfea.gov.uk/6674.html.      

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 

Yes 

85 

85 

N/A 

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6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 
6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 

6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 
destination. 

6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 
6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.16. Do you have any additional comments on import/export? 

N/A 

N/A 

N/A 

N/A 

N/A 

The HFEA requires the tissue establishment in the third country to 
be accredited, designated, authorised or licensed under the laws or 
other measures of the country in which it is situated in relation to 
quality and safety. 
Yes 

In 2011, the UK imported 1104 vials/ampoules/straws of sperm from 
the following third countries: Australia, USA and Uruguay. The UK 
also imported 297 eggs from the following third countries: Australia, 
Russia and the USA. Embryos were also imported from another 
third country. The HF&E Act 1990 (as amended) prohibits the 
HFEA from disclosing information which could potentially lead to a 
patient being identified, for this reason we are unable to provide the 
quantities imported from third countries and in the case of the 
imported embryos we are also unable to disclose the name of the 
country of origin.  
Yes 

In 2011, the UK exported 47 vials/ampoules/straws of sperm to the 
following third countries: Australia, USA and Uzbekistan. The UK 
also exported 96 embryos to the following third countries: American 
Samoa, Australia, Canada, India, Israel, Japan, New Zealand, 
Singapore, South Africa and the USA. The HF&E Act 1990 (as 
amended) prohibits the HFEA from disclosing information which 
could potentially lead to a patient being identified, for this reason we 
are unable to provide the quantities exported to individual third 
countries. 
No 

F. Other 

THe HFEA does not hold information about local/ national needs. 
No 

The HFEA has issued General Directions to all tissue 
establishments, licensed to carry out treatment and storage; theses 
Directions set out the requirements which must be met in order to 
permit gametes and / or embryos to be imported or exported. A copy 
of these Directions can be found at: 
http://www.hfea.gov.uk/docs/2009-09-
09_General_directions_0006_-
_Import_and_export_of_gametes_and_embryos_-_version_2.pdf. 
Where a centre wants to export or import gametes or embryos to or 

431 

 
 
from a country outside the EEA or Gibraltar, the person responsible 
must obtain and retain (for three years) written evidence that:   i) the 
receiving or sending centre is accredited, designated, authorised or 
licensed under the laws or other measures of the country in which it 
is situated in relation to quality and safety   ii) the centre has 
appropriate quality management and traceability systems, and   iii) 
the gametes or embryos have been procured and processed in 
appropriate facilities, and following procedures that minimise 
bacterial or other contamination.   In each case, a copy of the 
information retained must be provided to the Authority on request.   
In all cases, all the requirements in the relevant HFEA Directions on 
import and export of gametes and embryos relating to identification, 
consent, parenthood, payment of the donor, use of the gametes and 
embryos, and screening must be met.   

Yes 
It is the responsibility of the Person Responsible to ensure the 
requirements of other Member States have been met prior to 
distributing gametes or embryos to tussue establishments in the 
relevant MS. 
No 

Tissue establishments are required to put into place service level 
agreements with couier compancies which define the obligations for 
complying with requirements in relation to ensure the quality and 
saferty of the gametes and embryos are maintained.    
No 

No 

Yes 

In 2011, the UK distributed 42 vials/ampoules/straws of sperm to the 
following member states: Cyprus, Denmark, Germany, Greece, 
Ireland and Spain. The UK also sent 32 embryos to the flowing 
Member states: Germany, Ireland and Spain.   The HF&E Act 1990 
(as amended) prohibits the HFEA from disclosing information which 
could potentially lead to a patient being identified, for this reason we 
are unable to provide the quantities sent to individual MS. 
In 2011, the UK received 1003 vials/ampoules/straws of sperm from 
the following member states: Cyprus, Denmark, Germany, Norway 
and Spain. The UK also received embryos from a country within the 
EEA.  The HF&E Act 1990 (as amended) prohibits the HFEA from 
disclosing information which could potentially lead to a patient 
being identified, for this reason we are unable to provide the 
quantities received from individual MS and in the case of embryos 
received we can not disclose the MS from which the embryos were 
received from.  
No 

No 

No 

The wording of questions 7.5.1 and 7.5.2 are virtual identical. 
Therefore, in relation to question 7.5.1 we have provided data in 

432 

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 

7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 

7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 

7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 

7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.9. Do you have any additional comments on distribution? 

 
 
 
 
relation to the quanitity of gametes and embryos which were 
distributed from the UK to other MS and in relation to question 7.5.2 
we have provided data in relation to the receipt of gametes and 
embryos from other MS into the UK. 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.3.1. If yes, please insert the link(s) to the report(s). 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.1. Please insert the link to the published national annual report. 

Yes 
http://www.hfea.gov.uk/1270.html 
Yes 

60-99% 

http://www.hfea.gov.uk/docs/HFEA_Fertility_Trends_and_Figures_
2011_-_Annual_Register_Report.pdf and 
http://www.hfea.gov.uk/1270.html. The HFEA also publishes data in 
relation to each licensed fertility centre (tissue establishment) this 
can be found on our website in the 'Choose a Fertility Clinic' section: 
http://guide.hfea.gov.uk/guide/  
Yes 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 
8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify.  We supply annual activity data to the EC and we assume this 

http://guide.hfea.gov.uk/guide/AllClinics.aspx?x=A 
Yes 

8.7. Do you have any additional comments on reporting? 

information then goes to the EUROCET registry. We complete all 
mandatory reporting.   
The HFEA collects data and statistics about over 60,000 fertility 
treatments performed each year in the UK. We are committed to 
making as much of this information available as possible to aid and 
inform patients, researchers and clinicians. Our ‘Fertility treatment 
in 2011 – facts and figures’ report presents information about 
patients, treatments and results from 2010 and 2011. It also 
highlights some short term and longer term changes over time. An 
new annual report is published each Autumn. The annual return 
upload only relates to information about treatment cycles involving 
the insemination using partner sperm. Data on all other ART 
treatments e.g. IVF using either partner donation or non-partner 
donation; insemination using non-partner sperm or ICSI using either 
partner or non-partner donation are submitted to the HFEA register 
on a regular basis in accordance with HFEA General Directions 
(http://www.hfea.gov.uk/docs/0005_Collecting_and_recording_infor
mation_for_the_HFEA_-_approved.pdf). This information is 
published in the annual report as well as being available on our 
website in the 'Choose a fertility' section.    

9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
Please specify 'other'. 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 

Other 

Yes 

9.5. Do you have any additional comments on traceability? 

Tissue establishments or procurement centres 
Both paper records and electronic forms 

We require a records retention policy to be in place. We check this is 
in place both at the initial licence application stage and during 
inspections.   
All tissue establisments licensed by the HFEA must adhere to a 
number of licence conditions, the following licnece conditions 

433 

 
 
 
 
 
 
relating to traceability apply to all licensed ART centres: 
Traceability and coding  T99. The centre must establish, implement 
and comply with documented procedures to ensure that: a. all 
gametes and embryos, and b. all relevant data relating to anything 
coming into contact with those gametes or embryos  are traceable 
from procurement of gametes to patient treatment or disposal and 
vice versa.  T100. The documented procedures referred to in licence 
condition T99 include the following information: a. the unique and 
accurate identification of each patient/donor b. the unique and 
accurate identification of each set of gametes and embryos c. date of 
procurement d. place of procurement e. type of treatment f. 
description and origin of any and all products associated with the 
procurement, processing, use and storage of gametes and embryos, 
and g. description of all processing steps applied to the procurement, 
use and storage of gametes and embryos.  T101. The centre must 
ensure that all containers (dishes, vials, ampoules, tubes etc) used in 
the course of procurement, possessing, use and storage of gametes 
and embryos are labelled with the patient’s/donor’s full name and a 
further identifier. If at some stages (eg, labelling patient/donor 
sperm) it is not possible to label the dishes or tubes with the 
patient/donor name then it must be ensured that the patient/donor 
code used is uniquely identifying.  T102. The centre must record 
such information as is necessary to facilitate the traceability of 
gametes and embryos and any information relating to the quality or 
safety of gametes and embryos. This information must be provided 
to the Authority upon request.  T103. The centre must keep data 
necessary to ensure traceability for a minimum of thirty years (and 
for such longer period as may be specified in Directions) in an 
appropriate readable storage medium.   T104. Records not covered 
by licence condition T103 and test results that impact on the safety 
and quality of the embryos and gametes, must be kept so as to ensure 
access to the data for at least 10 years after the expiry date, clinical 
use or disposal.  

HFEA 
The HFEA is a non-department goverment body responsible for 
implemeting the HF&E Act 1990 (as amended) and is one of the two 
UK Competent Authorties for implemeting the EUTCD.  
No 

We use the HFEA incident reporting form. The HF&E Act 1990 (as 
amended) set out the requirments which must be meet by ART 
centres these rquirments include those set out in the EUTCD but also 
includes additional requirments in relatio to consent, welfare of the 
child, legal parnethood. The HFEA also licenses the use of gametes 
and embryos in treatment. Therefore the incident reporting form 
reflects our extended powers.  
No 

The HFEA issues guidance on SAERs in the HFEA Code of 
Practice, see http://www.hfea.gov.uk/3476.html Licensed 
establishments are required to report SAREs to the HFEA within 24 
hours of them being discovered. 
Yes 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/86) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/86 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are welcome to upload 
the template if you wish. 

10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.3.1. If no, please specify what guidelines you use. 

10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 

100% 

434 

 
 
 
 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 
tissues/cells (Art 11.2)? 
10.6.1. If yes, please provide a brief description. 

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 
10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 
10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 
10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 
10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.1. If yes, please specify what data. 

10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 
Please specify 'other'. 

10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

Yes 

The use of gametes and / or embryos in treatment must take place in 
a licensed centre. These centres must report all SAERs to the HFEA 
in accordance with General Directions 
http://www.hfea.gov.uk/docs/2011-10-
01_General_directions_0011_-_Version_2.pdf 
Yes 

Report / inspection process / HFEA newsletter / workshops 
Yes 

The HFEA notifies establishments about any SARE implications in 
a regular e-newsletter.  
Yes 
No recalls were issued in 2011. 

Yes 

Alerts are uploaded on to the HFEA clinic portal and TEs are 
notified via email. 
Yes 

Alerts are uploaded on to the HFEA clinic portal and TEs are 
notified via email. 
Yes 

The HFEA provides all the requested information to the EUROCET 
registry.  
Yes 

Medical devices 
Other 
We communicate alerts to the Medicines and Healthcare products 
Regulatory Agency and the Human Tissue Authority. We also share 
details of SAREs reported to us if we believe they could have an 
impact on medicines and healthcare products and/or non-
reproductive tissues and cells. 
Yes 

5 

10.5 above is actually not applicable for the HFEA: Establishments 
report SAREs within 24 hours of their discovery, and not via an 
annual report. As a result, we may not receive data from every 
establishment every year, as serious reactions or events may not take 
place at every establishment. We received a total of 611 incident 
reports in 2011.  We found the training excellent.   We follow the 
EC RATC Platform standard operating procedures when reporting 
an incident on the RATC platform.   

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 

Explicit consent (opt-in) 

435 

 
 
 
 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 

11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 
Please specify 'other'. 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.4.1. If no, please describe the difference. 

11.5. How is this consent verified during inspections? (more than 1 
answer possible) 

Please specify 'other'. 

11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
Please specify 'other'. 

11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 

11.8. Please specify what measures are in place to ensure that the 

The use of gametes in treatment may only take place if consent has 
been provided by the gamete provider. In the case of the use of 
embryos in treatment consent must have been by both gamete 
providers. The storage of gametes may only take place in consent 
has been obtained from the gamete provider. The exception to this is 
that a parent or guardian may consent to the storage of gametes of a 
child but these gametes may not be used in treatment without 
consent of the gamete provider i.e. the child when they become 
capable of providing the necessary consent. The storage of embryos 
may only take place provided consent has been obtained from both 
of the partners (or donors) whose gametes were used to create the 
embryos.  
Explicit consent (opt-in) 

Other 

Only the gamete providers may give consent to the use of their 
gametes or embryos, created using thier gametes, after their death.  
No 

The legislation regarding the consent system for organs is under the 
regulation of the HTA.  
Analysis of documentation 
Interviews with personnel 
Interviews with living donors 
Other 
We also conduct traceability audits to verify the consent 
documentation in randomly selected cases (including matching 
stored tissue samples to consent files).   
Only trained personnel is allowed to provide such information 
Other 

Ensure correct procedures are in place at the initial application 
assessment stage. Follow up during inspections.  
The HF&E Act 1990 (as amended)sets out the legal requirements in 
realtion to the disclosure of information. In summary: A centre may 
hold information that could lead to the identification of:  a) an 
individual donor or recipient of gametes or embryos   b) an 
individual or couple seeking or receiving treatment services (other 
than basic partner services), or  c) an individual who may have been 
born as a result of such services or as a result of donated sperm.   
The centre may disclose this information only in the specific 
circumstances set out in the HF&E Act 1990 (as amended).  The 
information may, for example, be disclosed:  a) to anyone, provided 
that it is disclosed in such a way that no individual can be identified 
from it   b) to the Authority  c) to another licensed centre to enable 
that centre to carry out its functions under its licence  d) to the 
person to whom the information relates, and to their partner (if they 
are being treated together, or their partner has served notice of 
consent to be treated as the legal parent of any resulting child)   e) 
with the consent of each person who could be identified from the 
information (although disclosure in this case is limited to 
information other than that from which a donor of gametes could be 
identified)  f) in connection with specific proceedings, including, for 
example, in relation to the formal complaints procedure, or   g) in an 
emergency, if disclosure is necessary to avert imminent danger to 
the health of the person to whom the information relates, and it is not 
reasonably practicable to obtain their consent to disclosure.    
Donor details are not stored in recipient notes and vice versa. This 

436 

 
 
identity of the receipient is not disclosed to the donor and vice versa.  may not be the case if the donation is directed and the donor is 

11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.10. Do you have any additional comments on consent and data 
protection? 

known to the recipient (e.g. sibling to sibling, parent to child etc.).  
Yes 

Other 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 
Please specify 'other'. 

Not applicable - this is regulated by the HTA 
Inspections of ART centres 
Audit documentation 
Other 

Audit of medical files during inspections.  
No 

Other 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.5.1. Please specify. 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 
12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.8.1. Please specify. 

12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

The posthumous use of gametes or embryos created using gametes 
from a patient / donor who has since deceased may only be used in 
the gamete provider has been screened in accordance with the 
requirements set out in the EUTCD.  
Yes 

Age of donors 
No 

No 

Inspection of tissue establishment 
Audit of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Audit of the centre of human application 
Other 

Ensure correct procedures are in place at the initial application 
assessment stage. Follow up during inspections.   

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 

Authorisation requirement 
Inspections 
Internal audits 
External audits 

Authorisation requirement 
Inspections 

437 

 
 
  
 
 
  
 
 
than 1 answer possible) 

Please specify 'other'. 

13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 
13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

Regular evaluation of personnel 
Other 
An individual can be appointed as the Person Responsible 
(reponsible person) only with the approval of the HFEA. That 
person must complete this Persons Responsible Entry Programme 
(PREP) assessment before the HFEA can consider whether or not to 
approve them.  
Inspections 
Regular evaluation of personnel 

Yes 

All Persons Responsible are required to complete a PR entry 
programme. Other personnel working within the tissue establishment 
may also complete this training.  

14.  Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

National regulation/policy for reception of tissues/cells 
Inspections of tissue establishments 
Internal audits of tissue establishments 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 

Yes 

Yes 

The HF&E Act 1990 (as amended) requires licensed centres to 
establish written agreements with third parties every time an external 
activity will be carried out that influences the quality and safety of 
gametes procured, tested or processed.  
Third party agrement are reviewed during the inspection process.  

Yes 

The HF&E Act 1990 (as amended) provides that only permitted 
gametes or embryos may be used in treatment.  
No difficulties 

No specific difficulties to report.   

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 
2006/17/EC? (more than 1 answer possible) 
14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 

15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 
15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.1.1. Please specify. 

16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 
short description. 

438 

 
 
  
 
 
  
 
 
  
 
 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

Directive 2006/17/EC 

We would like to see a revision of this Directive and in particular 
Annex III. We consider that the technical nature of this Directive 
requires that is reviewed on a regular basis to ensure that it continues 
to reflect scientific development.  In particular, we would welcome 
of a review of the requirment to screen and test non-partner donors 
each time gametes are procured and a review of the requirement for 
HTLV testing for all gamete donors 

UK - HTA 

1. Public information 
1.1. Name of National Competent Authority (NCA) 1: 
1.1.2. Address of NCA 1: 
1.1.3. Telephone (central access point): 
1.1.4. E-mail (central access point): 
1.1.5. Website: 
1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Please specify 'other': 

1.1.7. What are the role/tasks of the NCA? (more than 1 answer 
possible) 

Please specify 'other': 

1.2. National Competent Authority 2? 
1.5. Please give a short description of the legal status and 
organisation of the National Competent Authority(ies) (e.g. 
departments, staffing, number of senior and junior inspectors, staff 
working on EU affairs and legal matters, vigilance officers, budget, 
independence from government etc.). 

1.6. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 
(more than 1 answer possible) 
1.7. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies) for tissues and cells: 

2. Procurement (Article 5 Directive 2004/23/EC) 

Human Tissue Authority (HTA) 
151 Buckingham Palace Road London SW1W 9SZ United Kingdom 
+4420 7269 1900  
enquiries@hta.gov.uk 
www.hta.gov.uk 
Non-reproductive tissues and cells 
Blood and blood components 
Human organs 
Other 
The HTA licenses organisations in England, Wales and Northern 
Ireland that remove, store and use human tissue for purposes outside 
of direct patient treatment, under the authority of the Human Tissue 
Act 2004.   These other purposes include anatomy, research, post-
mortem examination, teaching, and public display. In Scotland, the 
Human Tissue (Scotland) Act 2006 applies. 
Accreditation, authorisation, licensing of TEs 
Inspection 
Vigilance 
Other 
The HTA also gives approval for organ and bone marrow donations 
from living people and is involved in policy development and 
implementation.  
No 
The HTA is an independent government watchdog, operating as a 
UK arms-length body, sponsored by the Department of Health. It 
employs approximately 40 staff, divided into four directorates: 
Regulation, Communications and Public Affairs, Resources and 
Strategy and Quality. Each of these directorates are led by a 
Director, reporting to the CEO. The Regulation team has 
approximately 17 Regulation Managers (RMs) (who comprise the 
inspection and vigilance team), reporting to three Heads of 
Regulation. The Regulation directorate also comprises the licensing 
and scheduling team and Regulation Officers to support RMs and 
Heads. RMs and members of the Strategy and Quality Directorate 
are involved in policy work, including EU affairs.   The Resources 
team include legal, finance and governance and business technology 
Heads.  Decisions about the general strategic direction of the HTA 
and complex living organ donation matters are made by a board (12 
members and a Chair). The board delegates responsibility for some 
strategic decision making to the senior management team.  
Not applicable 

Not applicable  

439 

 
 
 
 
 
 
 
2.1. Do you authorise the "conditions of procurement"? 
2.1.1. How do you authorise the "conditions of procurement"? (more 
than 1 answer possible) 

Please specify 'other': 

2.1.2. How many such authorisations were granted in 2011 (01/01-
31/12/2011)? 

2.2.1 Please provide the number of procurement centres in which 
procurement of "traditional tissues and cells" (skeletal tissues, 
cardiovascular tissues, skin, ocular tissues, amniotic membrane, 
pancreatic islet, hepatocytes, adipose tissue etc.) were carried out in 
2011 (01/01-31/12/2011). 
2.2.2 Please provide the number of procurement centers in which 
procurement of haematopoietic stem cells (bone marrow, PBSC, 
cord blood etc.) were carried out in 2011 (01/01-31/12/2011). 
2.2.3 Please provide the number of procurement centers in which 
procurement of gametes, embryos and other reproductive tissues 
were carried out in 2011 (01/01-31/12/2011). 
2.2.4. Please provide the number of procurement centers in which 
procurement of tissues/cells for ATMP manufacturing were carried 
out in 2011 (01/01-31/12/2011). 
2.3. How do you ensure that procurement centres comply with the 
requirements laid down in Art. 5 of Directive 2004/23/EC and its 
implementing Directive 2006/17/EC (e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) ? (more than 
1 answer possible) 
Please specify 'other': 

2.4. Are you also responsible for the accreditation, designation, 
authorisation or licensing of laboratories performing donor testing? 
2.4.1. Please provide the number of the laboratories performing 
donor testing. 

2.5. How do you ensure, as CA for T&amp;C, that tests required for 
donors are carried out only by qualified laboratories accredited, 
designated, authorised or licensed Art. 5(2))? (more than 1 answer 
possible) 
Please specify 'other': 

Yes 
By inspecting some procurement centres 
By inspecting the documentation associated with procurement that is 
available in the tissue establishment working with procurement 
centres 
Other 
We license and inspect establishments that carry out procurement 
activities and provide advice on standards related to conditions of 
procurement. We may not inspect all procurement centres as some 
procurement centres operate through a third party agreement with a 
licensed establishment. Designated Individuals (i.e 'responsible 
persons') must ensure that suitable practices, staff and premises take 
place at third party establishments, they will do this in a variety of 
ways, including conducting audits of the third party. The HTA 
reviews third party arrangements during a routine inspection of the 
licensed establishment.  
Nine new licences were granted in 2011 for procurement activity.  
We conducted 68 inspections of establishments that were licensed 
for Procurement in that period. 
58 

21 

Two. This is only applicable for ovarian or testicular tissue. 
Procurement of gametes, embryos and other reproductive cells are 
within the remit of the HFEA. 
13 

Inspections of the site/centre 
Analysis of the mandatory documentation 
Other 

We also require submission of annual activity data by licensed 
establishments. We investigate allegations made about non-
compliance with procurement standards. To ensure continued 
compliance, we send out correspondence to the sector, for example 
through the regular HTA newsletter. We run regular workshops for 
the sector to ensure that they stay up to date with regulatory 
requirements. Designated Individuals are also required to undergo an 
online training programme. 
Yes 

There are 98 establishments that are licensed to oversee donor 
testing. Laboratories are not directly licensed by the HTA. Clinical 
Pathology Accreditation (CPA), a private organisation, provides a 
voluntary national accreditation service. over 95% of UK labs are 
CPA accredited. 
Inspections of the laboratories 
Analysis of the mandatory documentation requested from the tissue 
establishment 
Other 
Any laboratory undertaking testing under the EUTCDs must either 
be a licensed entity or it must be working under a third party 
agreement (TPA) with a licensed establishment. We verify that 
establishments are only using laboratories where there is a TPA in 

440 

 
 
2.6. Please provide data on qualified laboratories accredited, 
authorised or licensed in your country (e.g. number, year of 
accreditation/authorisation/license, which donor tests are performed 
etc.). 

2.7. Do you have any additional comments on procurement? 

3. Testing (Art. 4, Annexes I, II and III of Directive 2006/17/EC) 
3.1. Please specify laboratory tests required for donors of non-
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.2. Please specify laboratory tests required for donors of 
reproductive tissues and cells in your Member State. (more than 1 
answer possible) 

3.3. If NAT testing is not mandatory in your country, could you 
please indicate whether you intend to make it mandatory or to 
encourage its use? Please specify why or why not (e.g. number of 
additional cases detected, cost-benefit etc.). 

3.4. Do you have concerns on accuracy of the available tests and test 
procedures for deceased donors? 
3.5. Are any other laboratory tests required for donors of non-
reproductive tissues and cells in your Member State? 
3.6. Are any other laboratory tests required for donors of 
reproductive tissues and cells in your Member State? 
3.7. Do you request/use international accreditation systems for 
testing laboratories? 
3.8. Do you have any additional comments on testing? 

place; TPA's must include requirements for reporting serious adverse 
events and reactions and traceability.  Even though we do not always 
inspect laboratories, we do sometimes include laboratories as part of 
the inspection, including ascertaining that lab testing is done with 
CE marked kits. 
There are 98 establishments that are licensed to oversee donor 
testing. These establishments may include laboratory premises, 
however laboratories are not directly licensed by the HTA. Clinical 
Pathology Accreditation (CPA), a private organisation, provides a 
voluntary national accreditation service. We can directly license 
laboratories for testing, however there are no active licences held by 
TEs that are laboratories only. There was one licence held by a 
laboratory involved in testing in 2011, however this is now inactive.  
The minimum testing requirements can be found in paragraphs 90 – 
94 of our Guide to Quality and Safety Assurance for Human Tissues 
and Cells for Patient Treatment . These tests apply to all relevant 
material for the purposes of the Human Tissue (Quality and Safety 
for Human Application) Regulations 2007.   The following 
biological tests must be performed for all donors as a minimum 
requirement:  HIV 1 and 2  - Anti-HIV-1,2 Hepatitis B - HBsAg, 
Anti HBc Hepatitis C  - Anti-HCV-Ab Syphilis - Treponema 
pallidum  HTLV-I antibody testing must be performed for donors 
living in, or originating from, high-prevalence areas or with sexual 
partners originating from those areas or where the donor’s parents 
originate from those areas.  

Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
Treponema Pallidum 
HTLV-2 
Anti-HIV 1 
Anti-HIV 2 
HBs AG 
Anti HBc 
Anti HCV-Ab 
HTLV-2 
Treponema Pallidum 
NAT testing is not currently mandatory in the UK. The Advisory 
Committee on the Safety of Blood, Tissues and Organs (SaBTO) 
advises UK ministers and health departments on the most 
appropriate ways to ensure the safety of blood, cells, tissues and 
organs for transfusion/transplantation. SaBTO has recommended 
NAT, in particular product testing rather than donor serum testing.   
The HTA considers that there is a very strong case for requiring 
mandatory NAT testing, particularly in instances where you might 
have a treatment involving donation from multiple donors and where 
the donations are not stored and therefore cannot be retested at 180 
days. 
No 

No 

No 

No 

Please note for 3.2 this is only applicable for ovarian or testicular 
tissue which may come under the HTA's remit.  Gametes and 

441 

 
 
 
 
4. Accreditation, designation, authorisation or licensing of tissue establishments (Article 6, Directive 2004/23/EC) 
4.1. Do you have a system of designation, authorisation, 
accreditation or licensing for all types of tissue establishments under 
your responsability? 
4.2. Is inspection a prerequisite for the designation, authorisation, 
accreditation or licensing of tissue establishments? 
4.3. Are preparation processes authorised? 
4.3.1. How are they authorised? (more than 1 answer possible) 

Yes 

No 

embryos come under the authority of the Human Fertilisation and 
Embryology Authority (HFEA) in the UK.   Extra tests must be 
undertaken, for example HTLV-1, when the conditions in Annex 
111, 2.4 apply.  We do not specifically request or use international 
accreditation systems for testing laboratories, however, some UK 
laboratories have European Federation for Immunogenetics 
Accreditation (EFI). For organ donation audits we do suggest 
Clinical Pathology Accreditation (a private UK provider), but do not 
accredit laboratories ourselves. For tissues and cells we ensure that 
all testing is done using CE marked kits and the correct tests are 
completed.  

Yes 
During routine inspections 
By review of a submitted application with supporting documentation 
Four suspensions took place. These were not suspensions of the 
whole licence, but rather specific licensable activities. For example, 
one processing activity was suspended on a licence following an 
inspection and a regulatory action panel where critical shortfalls 
were found. 
1 revocation took place.  

Musculo-skeletal tissue establishments 

one establishment storing bone. 
Multi-tissue establishments 
Other tissue establishments 
one multi-tissue establishment and one "other" establishment. 
There were two TEs with pending authorisations at the end of 2011. 
Both licences were granted in 2012. The first "other" tissue type 
procures, stores, tests, processes and distributes fetal tissue. The 
other multi-tissue establishment stores, exports and imports bone, 
demineralised bone matrix, acellular bone chips, other skeletal tissue 
and heart valves.  
Skin tissue establishments 
Musculo-skeletal tissue establishments 
HSC tissue establishments 
Cord blood tissue establishments 
Multi-tissue establishments 
One. This is also a multi-tissue establishment. 
Five with skeletal tissue only, plus one other multi-tissue 
establishment.  
Four with HSC type tissue only. There were an additional two multi-
tissue establishments storing HSC type tissue.  
One. This is also a multi-tissue establishment.  
Three multi-tissue establishments. One of these was storing amniotic 
membrane.  
Skin tissue establishments 
Musculo-skeletal tissue establishments 
Ocular tissue establishments 
Cardiovascular tissue establishments 

4.4. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were suspended in 
2011? 

4.5. Following inspections/controls (Art. 6.4, Directive 2004/23/EC), 
how many authorisations/accreditation/licenses were revoked in 
2011? 
4.6. Do you require TEs to be certified by an external entity to a 
quality system standard (e.g. ISO, JACIE, FACT)? 

No 

4bis. Overview of tissue/cells establishments authorised by the NCA 
4.7. Tissue establishments with authorisation pending approval at 
01/01/2011 (more than 1 answer possible): 
4.7.2. How many musculo-skeletal tissue establishments? 
4.8. Tissue establishments with authorisations pending approval by 
31/12/2011 (more than 1 answer possible): 
4.8.8. How many multi-tissue establishments? 
4.8.9. Please specify the type of tissues/cells and how many. 

4.9. Tissue establishments first time authorised between 01/01/2011 
and 31/12/2011 (more than 1 answer possible): 

4.9.1. How many skin tissue establishments? 
4.9.2. How many musculo-skeletal tissue establishments? 

4.9.5. How many HSC tissue establishments? 

4.9.6. How many cord blood tissue establishments? 
4.9.8.  How many multi-tissue establishments? 

4.10. All tissue establishments authorised by 31/12/2011 (more than 
1 answer possible): 

442 

 
 
 
 
 
 
4.10.1.1. How many public skin tissue establishments? 

4.10.1.2. How many private skin tissue establishments? 

4.10.2.1. How many public musculo-skeletal tissue establishments? 

4.10.2.2. How many private musculo-skeletal tissue establishments? 

4.10.3.1. How many public ocular tissue establishments? 

4.10.3.2. How many private ocular tissue establishments? 

4.10.4.1. How many public cardiovascular tissue establishments? 

4.10.4.2. How many private cardiovascular tissue establishments? 

4.10.5.1. How many public HSC tissue establishments? 

4.10.5.2. How many private HSC tissue establishments? 

4.10.6.1. How many public cord blood tissue establishments? 

HSC tissue establishments 
Cord blood tissue establishments 
Multi-tissue establishments 
Other tissue establishments 
Three public TEs with only skin - some multi-tissue establishments 
did work with skin tissue and cells among other tissue types. Skin 
establishments were classified as those working with whole skin, 
fibroblast and / or keratinocyte cells.  
No private TEs with only skin - some multi-tissue establishments did 
work with skin tissue and cells among other tissue types. Skin 
establishments were classified as those working with whole skin 
and/or fibroblast and / or keratinocyte cells.  
41 public TEs with only musculo-skeletal - some multi-tissue 
establishments did work with musculo-skeletal tissues and cells 
among other tissue types. Musculo-skeletal establishments were 
classifed as those working with any combination of the following 
bone, tendons/ligaments, cartilage and chondral tissue, 
demineralised bone, acellular bone chips and other skeletal tissue. 
19 private TEs, with only musculo-skeletal. In addition some multi-
tissue establishments did work with musculo-skeletal tissues and 
cells among other tissue types. Musculo-skeletal establishments 
were classifed as those working with any combination of the 
following bone, tendons/ligaments, cartilage and chondral tissue, 
demineralised bone, acellular bone chips and other skeletal tissue. 
Two public TEs with only ocular tissue - some multi-tissue 
establishments did work with ocular tissue among other tissue types. 
Establishments were classified as ocular if they worked with cornea, 
sclear, limbal stem cells and / or other ocular tissue. There were 
other ocular establishments classified as multi-establishments if 
working with ocular tissue and amniotic membrane (other).  
One private TE with only ocular tissue. In addition some multi-
tissue establishments did work with ocular tissue among other tissue 
types. Establishments were classified as ocular if they worked with 
cornea, sclear, limbal stem cells and / or other ocular tissue. There 
were other ocular establishments classified as multi-establishments 
if working with ocular tissue and amniotic membrane (other).  
Three public TEs with only cardiovascular tissue - some multi-tissue 
establishments did work with cardiovascular tissue among other 
tissue types. Establishments were classified as cardiovascular if 
reporting work with heart valves, iliac vessels and other vessels.  
One private TEs with only cardiovascular tissue - some multi-tissue 
establishments did work with cardiovascular tissue (particularly 
cardiac and iliac vessels) among other tissue types. Establishments 
were classified as cardiovascular if reporting work with heart valves, 
iliac vessels and other vessels.  
28 public TEs with only HSC type cells - some multi-tissue 
establishments did work with HSC type cells among other tissue 
types. The HTA does not have a specific reporting category for 
HSC. For the purpose of the survey establishments were categorised 
as HSC establishments if working with any combination of the 
following tissue types: PBSCs, bone marrow, cells for donor 
lymphocyte infusions, other blood cells and embryonic stem cells.  
Three private TEs with only HSC. In addition, some multi-tissue 
establishments did work with HSCs among other tissue types. The 
HTA does not have a specific reporting category for HSC. For the 
purpose of the survey establishments were categorised as HSC 
establishments if working with any combination of the following 
tissue types: PBSCs, bone marrow, cells for donor lymphocyte 
infusions, other blood cells and embryonic stem cells.  
Three public TEs with only cord blood - some multi-tissue 
establishments did work with cord blood among other tissue types. 

443 

 
 
4.10.6.2. How many private cord blood tissue establishments? 

4.10.8.1. How many public multi-tissue establishments? 

4.10.8.2. How many private multi-tissue establishments? 

4.10.9.1. Please specify the type of 'other' public tissues/cells 
establishements and how many. 

4.10.9.2. Please specify the type of 'other' private tissues/cells 
establishements and how many. 

4.11. How many tissues and cells were distributed under the direct 
agreement of the Competent Authority according to Art. 6(5) during 
2011? Please provide number(s) per type tissues/cells. 

4ter. Sanctions 
4.16. Have penalties for infringements of the national provisions 
pursuant to the Directive been defined (Article 27)? 
4.16.1. Have penalties already been imposed? 
4.16.1.1. How many penalties have been imposed in 2011 (from 
01/01/2011-31/12/2011)? 

4.16.1.2. What were the reasons for imposing the penalties? Please 
describe. 

4.16.1.3. What kind of penalties were imposed? Please describe (e.g. 
suspension of authorisation, criminal penalty etc.) 

4.17. Do you have any additional comments on accreditation, 
authorisation, designation and licensing? 

Please note, If an establishment reported cord blood and cord tissue, 
they were categorised as a multi-tissue establishment. 
Two private TEs with only cord blood - some multi-tissue 
establishments did work with cord blood among other tissue types. 
Please note, If an establishment reported cord blood and cord tissue, 
they were categorised as a multi-tissue establishment. 
There were 46 public multi-tissue establishments. The combination 
of tissue types held  varies. There was one establishment, King's Cell 
Isolation Unit that reported two types of "other" cells: pancreatic 
islets and hepatocytes. This was therefore included in the multi-
tissue establishment category.  
There were 16 private multi-tissue establishments. The combination 
of tissue types held  varies.  
There were three public tissue establishments in the other category. 
There were two that did not report any activity in 2011 and the other 
was the DRWF Human Islet Isolation Facility - reporting work with 
pancreatic islet cells.  There was one establishment, King's Cell 
Isolation Unit that reported two types of "other" cells: pancreatic 
islets and hepatocytes. This was therefore included in the count for 
the multi-tissue establishment category.  Other tissue type categories 
reported to the HTA are: "other tissues and / or cells", umbilical cord 
tissue, pancreatic islets, hepatocytes, amniotic membrane, adipose 
tissue (e.g. adipocytes). 
There were four private tissue establishments in the other category. 
These were: one that did not report any activity in 2011.  The other 
three reporting "other" types of tissues and cells were MTS 
Cryostores, BioEden and the London Centre of Aesthetic Surgery. 
Other tissue type categories reported to the HTA are: "other tissues 
and / or cells", umbilical cord tissue, pancreatic islets, hepatocytes, 
amniotic membrane, adipose tissue (e.g. adipocytes). 
0 

Yes 

Yes 
There were 11 sanctions on establishments imposed in 2011, of 
varying degrees of severity. There are a range of sanction options 
open to the HTA ranging from directions and conditions to criminal 
penalties.  For 2011, there were no criminal sanctions imposed.  
There were a number of reasons for imposing the various penalties 
managed through the regulatory decision making process.  The 
majority of penalties were imposed following an inspection where 
shortfalls against regulatory requirements had been identified. 
Penalties imposed included conditions or directions on seven 
licences, suspensions of specific licensable activities on three 
licences and one revocation. There were no criminal penalties 
imposed.  
The HTA licenses procurement establishments and establishments 
that store viable cellular tissue for end use for more than 48 hours.   
From 4.2, while inspection is not a prerequisite for authorisation, we 
performed 89 routine HA site-based inspections (96 including non-
routine inspections). Inspections are a not a prerequisite for 
licensing, however inspections form part of the ongoing licensing 
and authorisation process. Initial licence application assessments are 
desk-based.   From 4.10.8.1 and 4.10.8.2: There is no specific HTA 
reporting category for a multi-tissue establishment. Establishments 
report on the full range of cell types, rather than identifying 
specifically as “a multi-tissue establishment”, so this was assessed 
by manually analysing the annual activity data. An establishment 

444 

 
 
 
 
was categorised as multi-tissue if it had more than one tissue in any 
of the EC categories, this included umbilical cord blood + umbilical 
cord tissue = multi-tissue, and also cord blood + HSCs = multi-
tissue. Some of the eye banks also keep amniotic membrane (other) 
as well as ocular tissue, so these have been classified as multi-tissue 
establishments. Where an establishment had multiple “other” types 
of tissues and cells, this was also categorised as a multi-tissue 
establishment.  

Yes 

The Regulation directorate at the HTA is in charge of inspections.  

There are 17 (full time equivalent) Regulation Managers carrying 
out inspections. Inspections typically require one to two inspectors.  
Yes 

Blood 
Organs 
Advanced therapies 
Hospitals 
Accreditation organisations (e.g. JACIE) 
Others 
As well as being the European competent authority for tissues and 
cells for human application and organs, the HTA inspects a range of 
establishments across several sectors in the UK, being: post mortem; 
anatomy, research and public display.  
89 

There were no non-routine inspections conducted as a result of an 
SAE or SAR. There were seven non-routine inspections conducted 
of TEs in 2011, but  these were for other reasons such as new  
premises, changes to licensable activities, follow-up from a previous 
inspection and follow-up for progress made against conditions on 
the licence. 
There were seven non routine inspections in 2011 for the following 
reasons:  1. A move to new premises. 2. A move to new premises. 3. 
Checking  the suitability of proposed in-house testing facilities for 
donor serology and NAT testing, and also to verify other recent 
changes to the licence. 4. A more focussed inspection required.  5. 
To follow up issues found on previous inspection and designated 
individual suitability.  6. Checking that shortfalls found during 
previous inspection had been rectified. 7. To assess progress against 
conditions. 
16 

50 

24 

One critical shortfall led to regulatory action panel leading to 
suspension of processing activity (not entire licence) 

5. Inspections (Article 7, Directive 2004/23/EC) 
5.1. Is a system in place for organising inspections and control 
measures of tissue establishments? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 
5.1.2. If yes, please specify staffing (how many inspectors). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme of other activities, for example blood, 
pharmaceuticals, etc. (e.g. same inspector team, common training, 
common documentation, etc.)? (more than 1 answer possible) 
5.2.1. If yes, please specify. (more than 1 answer possible) 

Please specify other. 

5.3. How many routine inspections of tissue establishments for non-
reproductive tissues/cells were conducted in 2011 (from 1/1/2011 to 
31/12/2011)? 
5.3.1. How many inspections of tissues establishments for non-
reproductive tissues/cells were conducted  in 2011 (from 1/1/2011 to 
31/12/2011) following serious adverse events or reactions, or 
suspicion thereof ? 

5.3.2. How many other type of inspections of tissues establishments 
for non-reproductive tissues/cells were conducted in 2011 (from 
1/1/2011 to 31/12/2011) (e.g. due to a whistle-blower)? Please 
specify. 

5.3.3. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where no shortcomings 
were observed? 
5.3.4.  Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where minor 
shortcomings were noted? 
5.3.5. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out where major shortcomings 
were noted? 
5.3.6. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 

445 

 
 
 
 
was the number of inspections carried out that were followed by 
suspension of authorisation? 
5.3.7. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of inspections carried out that were followed by 
closure? 
5.3.8. Outcome of inspections of TEs for non-reproductive 
tissues/cells conducted in 2011 (01/01/2011 to 31/12/2011): What 
was the number of other inspections carried out? Please specify. 
5.4. How many routine inspections were conducted in ART 
establishments (from 1/1/2011 to 31/12/2011)? 
5.4.1. How many inspections were conducted in ART establishments 
following serious adverse events or reactions, or suspicion thereof 
(from 1/1/2011 to 31/12/2011)? 
5.4.2. How many other type of inspections were conducted on ART 
establishments (from 1/1/2011 to 31/12/2011) (e.g. due to a whistle-
blower)? Please specify. 
5.4.3. Outcome of inspections of ART tissue establishments carried 
out in 2011 (01/01/2011 to 31/12/2011): What was the number of 
inspections carried out where no shortcomings were observed? 
5.4.4. What was the number of inspections carried out in ART 
establishments where minor shortcomings were noted? 
5.4.5. What was the number of inspections carried out in ART 
establishments where major shortcomings were noted? 
5.4.6. What was the number of inspections carried out in ART 
establishments followed by suspension of authorisation? 
5.4.7. What was the number of inspections carried out in ART 
establishments followed by closure of respective establishements? 
5.4.8. What was the number of other inspections of ART 
establishments? Please specify. 
5.5. Which type of routine inspections do you conduct? (more than 1 
answer possible) 

0 

0 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

General system-oriented inspections 
Thematic inspections 
Desk based reviews 

5.6. How do you decide which type of routine inspection to conduct?  Desk-based reviews generally take place for the initial application 

5.7. Until 2011, did you implement the requirement concerning the 
time interval between two inspections (Art. 7.3.)? 
5.8. How many TEs were inspected at least twice between 2008-
2011 (01/01/2008-31/12/2011)? 
5.9. Did you perform/conduct inspections of procurement sites 
outside tissue establishments? 
5.9.2. If no, why not? 

assessment.  Inspections are scheduled within the two year time 
frame using a risk tool to prioritise inspections. The HTA is 
currently modifying its risk assessment tool. Typical factors include 
size of establishment and range of activity, experience of designated 
individual responsible for oversight of the licence and compliance 
history. The risk tool is also being developed to determine whether 
inspections should be general or themed. A recent themed inspection 
pilot used a number of the factors mentioned above,  including input 
from Regulation Managers to identify suitable establishments.  
Yes 

112 HA licences were inspected at least twice during this period. 

No 

The Designated Individual is responsible for oversight of any third 
parties. Third party agreements (TPAs) are to be reported to the 
HTA, although this is not authorised by the HTA at the time of 
submission. TPAs are reviewed during inspection.   Annex C - 
Statutory conditions on licences authorising activities that may 
involve third parties states:   "The Licence Holder, and, where 
different, the Designated Individual, any person to whom a licence 
applies, any third party with whom the establishment has a third 
party agreement, and any personnel of either the licensed 
establishment or third party, must secure that all necessary 
arrangements are made to ensure that all information which is 
collected in pursuance of the licence or a third party agreement in 

446 

 
 
5.10. Did you carry out inspections of third parties? 
5.10.2. If no, why not? 

5.11. Do you use at national level the Operational Manual for 
Competent Authorities on inspection of tissue and cell procurement 
and tissue establishments - Guidelines for inspections (Commission 
Decision 2010/453/EU)? 
5.11.1. If no, which guidelines/regulations are used for inspections at 
national level? 

5.11.2. If no, please provide a hyperlink to these 
guidelines/inspections. 

5.12. Did you send any of your inspectors to the training courses 
organised by EU-funded projects (e.g. EUSTITE, SOHO 
V&amp;S)? 
5.12.1. If yes, how would you rate the usefulness and efficacy of 
these training courses on a scale from 1 to 5 (1 = not important, 2 = 
sufficient, 3 = good, 4 = very good, 5 = essential)? 
5.13. Did you request/organise an inspection of a tissue 
establishment in another MS in collaboration with the NCA in that 
MS (Art 7(6))? 
5.13.1. Could you please explain why? 

5.14. Did you receive/organise an inspection of a tissue 
establishment in your country at the request of another MS in 
collaboration with the NCA in that MS (Art 7(6))? 
5.15. Did you organise any inspections of procurement centres or 
tissue establishments in third countries from which tissues and/or 
cells were imported in your country (as recorded by 31/12/2011)? 
5.16. Have you asked another MS, or have you been requested by 
any other MS, on the results and control measures of your 
inspections, as part of an enquiry/investigation? 
5.16.1. If yes, please specify. 

5.17. Would you be interested in developing joint inspections? Joint 
inspections should be understood as inspections of tissue 
establishments conducted jointly by two or more Member States' 

relation to the licence:  (a) is available for the purpose of tracing 
donations;  (b) is kept up-to-date and corrected without delay where 
any discrepancy relating to such information is identified; and  (c) is 
held securely and subject to safeguards against unauthorised 
additions, deletions, modifications and transfer of information." 
No 
The Designated Individual is responsible for oversight of any third 
parties. Third party agreements (TPAs) are to be reported to the 
HTA, although this is not authorised by the HTA at the time of 
submission. TPAs are reviewed during inspection.  
No 

We do not use the Operational Manual for Competent Authorities on 
inspection of tissue and cell procurement and tissue establishments - 
Guidelines for inspections, however our inspection guidelines are 
based on this document. For example, we have adopted the 
preparation process dossier template. We provide establishments 
with the 'Guide to the quality and safety assurance of human tissues 
and cells for patient treatment' on our website, to assist them with 
inspection preparation.   We use internal standard operating 
procedures to provide guidance for Regulation managers on how to 
conduct an inspection including:  - REG-SOP-103 Preparing for a 
routine HTA site visit inspection; - REG-SOP-105 Scheduling and 
preparing for a joint inspection with the MHRA; and  - REG-SOP-
106 Conducting a joint inspection with the MHRA. 
http://www.hta.gov.uk/_db/_documents/Annex_-
_Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_
for_Patient_Treatment.pdf 
Yes 

5 

Yes 

A Regulation Manager observed an inspection in Germany in 2012 
following allegations made against a German tissue establishment 
about procurement without consent. The HTA participated in this 
because of potential effects on UK establishments importing tissue 
from Germany.  
No 

No 

Yes 

We do not keep records on the number of requests from or to other 
member states. We frequently liaise with other competent authorities 
over issues of mutual interest, such as the results and control 
measures of inspections, as part of general enquiries or 
investigations. 
Yes 

447 

 
 
Competent Authorities on their territory or in third countries. 
5.18. Do you have any additional comments on inspections? 

6. Import/export (Article 9 Directive 2004/23/EC) 
6.1. Do you have a register of authorised tissue establishments that 
are explicitly authorised to perform import/export of tissues and 
celles from/to third countries? 
6.2. Please specify the number of tissue establishments authorised to 
import tissues and cells from third countries (recorded by 
31/12/2011). 
6.3. Please specify the number of tissue establishments authorised to 
export tissues and cells from third countries (recorded by 
31/12/2011). 
6.4. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of skin 
from third countries. 
6.5. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
musculo-skeletal (bone, tendons, fascia etc.) tissues from third 
countries. 
6.6. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
ophtalmic (cornea, sclera, etc) tissues from third countries. 
6.7. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
cardio vascular tissues from third countries. 
6.8. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of 
haematopoietic stem cells (HSC) (other than cord blood) from third 
countries. 
6.9. Please specify which procedures you have in place for verifying 
the equivalent standards of quality and safety for importation of cord 
blood from third countries. 
6.10. Please specify which procedures you have in place for 
verifying the equivalent standards of quality and safety for 
importation of reproductive cells (sperm, egg cells) from third 
countries. 

6.11. Did you import tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.11.1. If yes, please provide the data concerning the 
number/volume of imported tissues and cells by country of origin. 
6.12. Did you export tissues/cells from 3rd countries during 2011 
(01/01/2011-31/12/2011)? 
6.12.1. If yes, please provide the data concerning the 
number/volume of exported tissues and cells by country of 

From 5.2.1: There are a number of other UK healthcare regulatory 
agencies with work adjoining that of the HTA. In particular, we 
carry out joint inspections with the Medicines and Healthcare 
products Regulatory Agency (responsible for blood, devices and 
medicines) at establishments who are developing Advanced Therapy 
Medicinal Products. We are also developing similar arrangements 
with the Human Fertilisation and Embryology Authority which 
regulates embryos and gametes. For example, establishments where 
hESCs are derived from embryos and establishments that 
procure,test, process, store ovarian / testicular tissue.  We also 
inspect sites such as laboratories and hospitals that are also inspected 
by other accreditation organisations, such as JACIE, NetCord-FACT 
and the Clinical Pathology Accreditation organisation.   Other 
interactions include work with NHS Blood and Transplant, where 
work intersects with the MHRA's regulation of the Blood Directives. 
There has been some engagement with the US Food and Drug 
Administration to exchange information about establishments.  

Yes 

63 

54 

We verify equivalent standards of quality and safety for importation 
of all tissues and cells from third countries is in place through the 
initial licence application assessment and inspections.  
We verify equivalent standards of quality and safety for importation 
of all tissues and cells from third countries is in place through the 
initial licence application assessment and inspections. 

We verify equivalent standards of quality and safety for importation 
of all tissues and cells from third countries is in place through the 
initial licence application assessment and inspections.  
We verify equivalent standards of quality and safety for importation 
of all tissues and cells from third countries is in place through the 
initial licence application assessment and inspections.  
We verify equivalent standards of quality and safety for importation 
of all tissues and cells from third countries is in place through the 
initial licence application assessment and inspections.  

We verify equivalent standards of quality and safety for importation 
of all tissues and cells from third countries is in place through the 
initial licence application assessment and inspections. 
This is only relevant in the case of ovarian or testicular tissue. 
Sperm, egg cells and embryos fall within the remit of the HFEA. We 
verify equivalent standards of quality and safety for importation of 
all tissues and cells from third countries is in place through the initial 
licence application assessment and inspections.  
Yes 

We do not collect data on specific country of origin. The total 
number of tissues and cells imported during 2011 was 22539. 
Yes 

We do not collect data on specific country of destination The total 
number of tissues and cells exported during 2011 was 216. 

448 

 
 
 
 
destination. 
6.13. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on imports/exports of tissues/cells between 
your country and other third countries? 
6.14. What is the relation between import/export of tissues and cells 
and self-sufficiency? (more than 1 answer possible) 
Please specify 'other': 

6.15. Did you authorise direct imports of tissues/cells to 
hospitals/clinics in your country? 
6.15.1. If yes, please specify the number of cases and for which type 
of tissues/cells. 
6.16. Do you have any additional comments on import/export? 

No 

C. Export of tissues/cells is authorised irrespective of national needs 
F. Other 
We are not responsible for determining national needs, when 
authorising tissue establishments to import and export tissues and 
cells. Certain licensed establishments do however take national need 
into account, for example, NHS Blood and Transplant and the 
Anthony Nolan Trust, a charity involved in collection and allocation 
of cord blood cells to address national needs.   
Yes 

We have directly authorised one import of a cranial flap autograft 
from the USA.  
We provide guidance for TEs in the form of the 'Guide to the quality 
and safety assurance of human tissues and cells for patient treatment' 
at:  http://www.hta.gov.uk/_db/_documents/Annex_-
_Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_
for_Patient_Treatment.pdf Specific guidance on import and export is 
available from paragraphs 203 - 210. We also provide FAQs on 
distribution, import and export on our website at:  
http://www.hta.gov.uk/licensingandinspections/sectorspecificinform
ation/tissueandcellsforpatienttreatment/distributionandimportexportf
aqs.cfm  Further guidance which we provide to all our sectors 
regulated under the Human Tissue Act 2004 is available in the form 
of the code of practice 8: import and export of human bodies, body 
parts and tissue:  
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codeso
fpractice/code8importandexport.cfm   For 6.9 specifically:  
Guidance on import and export related to cord blood is also provided 
through our guidance document on cord blood:  
http://www.hta.gov.uk/_db/_documents/Cord_Blood_Guidance_Doc
ument_final_draft.pdf  We have also directly authorised two exports 
to date: one heart valve to Egypt and one PBSC autologous sample 
to the USA.   We have seen an increase in the level of oversight 
required to ensure that products imported from the US meet 
equivalent standards. HTA is organising meetings with the 
American Association of Tissue Banks and FDA in October with the 
aim of starting to address some of the issues. HTA is involved in the 
Import / Export Working Group and considers that many of the 
current difficulties of ensuring equivalence will be addressed by the 
introduction of the proposed Implementing Directive. We also 
consider that there is scope to explore the value of establishing an 
EU inspectorate for third countries.    

7. Distribution/intra community exchanges (Article 23 Directive 2004/23/EC) 
7.1. Do you have intra-community exchanges of tissues and cells? 
7.1.1. If yes, how do you address the possible more stringent quality 
and safety measures established by other Member States? Please 
specify. 

7.1.2. If yes, do you have more stringent quality and safety measures 
than in other Member States? 
7.2. How do you ensure that tissues establishments fulfil the 
requirements of Art. 23 of Directive 2004/23/EC regarding quality 
of tissues and cells during distribution? Please specify. 

7.3. Do you allow direct distribution to hospitals/clinics in your MS 
from TEs in another MS? (only 1 answer possible). 
Please specify 'other'. 

Yes 
Tissue establishments are required to put into place service level 
agreements with licensed establishments in other member states to 
define the obligations for complying with relevant requirements 
across jurisdictions.  
No 

Tissue establishments are required to put into place service level 
agreements with licensed establishments in other member states to 
define the obligations for complying with relevant requirements 
across jurisdictions.  
Other 

We do allow direct distribution to end users, without requiring a 

449 

 
 
 
 
7.4. Have you authorised direct distribution to the recipient of 
specific tissues and cells (Art. 6, Directive 2006/17/EC)? 
7.5. Do you collect data regarding the cross-border exchange of 
tissue/cells between your country and other EU MS? 
7.5.1. Please provide us with data (country of destination, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011). 
7.5.2. Please provide us with data (country of origin, type of 
tissue/cell and number of units distributed) concerning distribution 
to other MS in 2011 (01/01/2011-31/12/2011) 

7.6. Are you aware of any significant changes in 2012 which may 
invalidate the 2011 data on cross-border exchanges of tissues/cells 
between your country and other EU MS? 
7.7. Do you allow brokerage companies for either distribution in EU 
and/or import/export of tissues/cells? In this context, a brokerage 
company means a body that arranges transactions between a supplier 
(tissue establishment/company selling tissues or cells) and a buyer (a 
tissue establishment/a hospital or clinic/an individual) without 
undertaking activities of processing, preservation or storage. 
7.7.1. Please describe the legal requirements and your role (if any) as 
a Competent Authority, in their authorisation/monitoring or 
inspection. 

7.8. Are brokers actively supplying health 
professionals/establishments in your country? 
7.8.1. Where are the brokers located? 
7.9. Do you have any additional comments on distribution? 

licence, provided tissues and cells will not be stored for longer than 
48 hours.  
No 

Yes 

We do not collect information on country of destination. The total 
number distributed to other MS in that period was 41271.  

We do not collect information on country of origin. The total 
number distributed from other MS in that period was 238244.   
Please note - the question wording above says "to other MS" this 
would be the same response as 7.5.1. We have assumed that the 
question should have read "from other MS". 
No 

Yes 

There are organisations that operate in the UK as intermediaries 
obtaining tissue for end users, however most of these are licensed as 
they are engaged in an intermediate storage step. Our role is 
therefore to authorise these and monitor them through inspection. 
We currently license one broker, Cryolife. It is only licensed for 
distribution, import and export, without storage. We have licensed 
another broker in the past engaged in the activities of distribution, 
import and export, however storage was also listed on that licence. 
The licence is now inactive.  
Yes 

Your country 

Yes 

8. Register of tissue establishments and reporting obligations (Article 10, Directive 2004/23/EC) 
8.1. Do you have an annual report model/template on the activities 
of tissue establishments in your Member State? (Article 10(1)). If 
yes, please upload the template. 
8.2. How many tissue establishments submitted annual reports of 
their activities during 2011. Please provide an estimation. (1 answer 
possible) 
8.3. Are these reports publicly available? (Article 10(1)) 
8.4. Do you publish a national annual report of the consolidated 
activities of all tissue establishments in your country? 
8.4.2. If no, why not? 

100% (all) 

No 
No 

Currently the data are not publicly available, but we direct enquiries 
about these data to the Eurocet site. UK licensed establishments do 
not want potentially sensitive commercial information to be made 
publicly available. 
Yes 

http://www.hta.gov.uk/_db/_documents/Licensing_Reports_-
_HA_201307021659.pdf 
Yes 

8.5. Is there a publicly accessible register of authorised tissue 
establishements in place? (Article 10(2)) 
8.5.1. If yes, please provide us with the link to the register's web site. 

8.6. Do you provide data regarding tissues and cells activities to the 
EUROCET registry (non-mandatory reporting)? 
8.6.1. If yes, what data are provided to EUROCET? Please specify.  We supply annual activity data to the EC and we assume this 

8.7. Do you have any additional comments on reporting? 

information then goes to the EUROCET registry. We complete all 
mandatory reporting.  

450 

 
 
  
 
 
  
 
 
9. Traceability (Article 8, Directive 2004/23/EC; and Directive 2006/86/EC) 
9.1. Was the donor identification system (Art. 8(2)) implemented in 
your country? 
9.2. Who assigns the unique code for each donation? (only 1 answer 
possible) 
Please specify 'other'. 
9.3. How is the data storage for traceability purposes organised in 
your tissue establishements (Art 8(4))? (only 1 answer possible) 
9.4. How do you ensure that the 30 years data storage requirement is 
respected (Directive 2006/89/EC, Art. 9)? Please specify. 

Other 

Yes 

Tissue establishment or procurement centre. 
Both paper records and electronic forms 

We require a records retention policy to be in place. We check this is 
in place both at the initial licence application stage and during 
inspections.  

9.5. Do you have any additional comments on traceability? 

10. Notification of serious adverse events and reactions (Article 11 Directive 2004/23, Article 6 Directive 2006/86) 
10.1. Do you have a national vigilance system in place (for the 
reporting of serious adverse events and reactions (Article 11(1))? 
10.1.1. If yes, which CA/institution is responsible? 
10.1.2. If yes, please provide a short description of its organisation. 

Yes 

HTA  
The HTA is a government sponsored regulator and the UK 
Competent Authority for Tissues and Cells and the Competent 
Authority under the EU Organ Donation Directive.  We are an 
independent watchdog which ensures human tissues and organs are 
used safely and ethically and with proper consent. We regulate 
organisations that remove, store and use tissue for research, 
anatomy, medical treatment, post-mortem examination, teaching and 
display in public. We also give approval for organ and bone marrow 
donations from living people. 
No 

Licensed establishments in the tissues and cells for patient treatment 
sector are required to report SAREs to the HTA within 24 hours of 
them being discovered. Establishments report via our web Portal and 
reports are assigned to an HTA Regulation Manager (RM) who 
reviews the establishment’s investigation of the matter. 
Establishments are asked to provide a copy of their internal 
investigation report within 90 days of submitting the notification. All 
communication and RM notes about the SAREs are stored against 
the licence record on our licence management system, CRM. 
No 

We signpost establishments to the EUTITE V&S Tools for reference 
when they report SAREs. Information and guidance about SAREs 
reporting is also provided by RMs on inspection and in our Guide to 
Quality and Safety Assurance for Human Tissues and Cells for 
Patient Treatment  on our website, on pages 40-41 and in Annexes C 
and D.  http://www.hta.gov.uk/_db/_documents/Annex_-
_Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_
for_Patient_Treatment.pdf 
No 

The HTA has a dedicated team of Regulation Managers in place 
who assess SAREs from establishments. The team have monthly 
meetings and promote SAREs reporting and learning across the 
HTA and when on inspection. A Regulation Officer acts as the 
administrator and data manager for the team and the reporting 
system is monitored by the team on a 24 hour basis, and any reports 
received are responded to within 24 hours.  
100% 

10.2. Annual reporting (Article 6.4, Dir. 2006/86/EC). Do you use 
the SAR/E (to the CA (2006/86 art 6.4)) templates developed to the 
Annual reporting ot the EC also at national level? 
10.2.1. If no, what template do you use? You are welcome to upload 
the template if you wish. 

10.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
10.3.1. If no, please specify what guidelines you use. 

10.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all TEs? 
10.4.1. Why not? 

10.5. How many tissue establishments provided in 2011 the 
SAR/SAE data as requested (please provide the % from the total 
number of TEs authorised in your country). 
10.6. Do you have a mandatory procedure for the transplantation 
centres when reporting SAR/SAE to the TEs which distributed the 

No 

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tissues/cells (Art 11.2)? 
10.6.2. If no, how do you ensure that SAR/SAE are reported to the 
TEs? 

10.7. Do you give feedback to the TEs regarding SAR/SAE recorded 
at national level? 
10.7.1. Please specify. 

10.8. Do you give feedback to the TEs regarding SAR/SAE recorded 
at EU level? 
10.8.1. Please specify. 

10.9. Do you require your TEs to have a recall procedure? 
10.10. How many recalls related to safety and quality of tissues/cells 
were issued in your country in 2011? Please specify the number and 
which tissues were recalled and why (e.g. missing consent, quality 
defects etc). 

10.11. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites in case of a national rapid 
alert? 
10.11.1. If yes, please give a short description of the 
system/procedure. 

10.12. Do you have in place a system/procedure to notify Tissue 
Establishments and procurement sites when a rapid alert is issued via 
the EU RATC platform? 
10.12.1. If yes, please give a short description of the 
system/procedure. 

The SAREs reporting requirement is outlined in HTA standards and 
when establishments initially apply for a licence in the tissues and 
cells for patient treatment sector. Establishments licensed by the 
HTA are required to have end-user agreements in place with 
transplantation centres, which include the requirement to report 
SAREs. Incident reporting is promoted and monitored on inspection. 
Yes 

The HTA provides feedback during inspections, to suggest better 
practice through lessons learned from SAR/Es. We notify 
establishments about any SAR/E implications in a regular e-
newsletter. We are currently organising a SAREs workshop for 
October 2013 which will share learning and best practice. It will 
include interactive sessions to allow staff from licensed 
establishments to discuss SAREs reporting.   We are also 
considering how we can provide further guidance on our website, 
e.g. by publishing case studies. 
Yes 

The HTA provides feedback during inspections, to suggest better 
practice through lessons learned from SAREs. We notify 
establishments about any SARE implications in a regular e-
newsletter. We are currently organising a SAREs workshop for 
October 2013 which will share learning and best practice. It will 
include interactive sessions to allow staff from licensed 
establishments to discuss SAREs reporting.  
Yes 
The HTA did not issue any recalls related to the quality and safety of 
tissues and cells in 2011. We are aware that three establishments 
issued recalls as follows in 2011: -Recall of heart valves due to 
faulty packaging. -Recall of corneas due to microbiological 
contamination. -Recall of corneas which had been released 
prematurely from quarantine. 
Yes 

Our process is formalised in REG-SOP-033-Preparing and Issuing a 
Regulatory Alert.   A decision to issue a regulatory alert can be made 
for a number of reasons, including: information from the EU, 
another CA/regulator, a serious adverse event or reaction or other 
regulatory action.   Once a decision is made to issue an alert, the 
alert is added to the regulatory alert register. The Head of 
Media/Communication and Communications Officers are informed 
and a distribution list and lines to take are prepared. The distribution 
list is based on data we hold about the activities of potentially 
affected UK establishments and the tissues/cell types they work 
with.   The alert wording is approved by a Head of Regulation or 
Director of Regulation and reviewed by the Head of 
Media/Communication. Once the alert is approved, we issue a 
statement on our website and email all establishments on the 
distribution list. The Head of Regulation or Director of Regulation 
reviews all responses to the alert.   
Yes 

A RATC is one of the reasons we may make a decision to issue a 
regulatory alert. If we believe UK establishments are affected by the 
RATC, we will issue a rapid alert following our formal process in 
REG-SOP-033-Preparing and Issuing a Regulatory Alert.   Once a 
decision is made to issue an alert, the alert is added to the regulatory 

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10.13. Do you provide data regarding SAR/SAE to the EUROCET 
registry (non-mandatory reporting)? 
10.13.2. If no, please specify why not. 
10.14. Do you notify alerts communicated via these tissues and cells 
national vigilance system also to other national vigilance/alert 
systems? 
10.14.1. If yes, please specify which of the following systems are 
usually contacted. (more than 1 answer possible) 

Please specify 'other'. 

10.15. Did you send a vigilance officer/contact point to the trainings 
organised by the EU-funded project SOHO V&amp;S? 
10.15.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (insufficient) - 2 (sufficient)  3 
(good) - 4 (very good) to 5 (essential)? 
10.16. Do you have any additional comments on SARE reporting? 

alert register. The Head of Media/Communication and 
Communications Officers are informed and a distribution list and 
lines to take are prepared. The distribution list is based on data we 
hold about the activities of potentially affected UK establishments 
and the tissues/cell types they work with.   The alert wording is 
approved by a Head of Regulation or Director of Regulation and 
reviewed by the Head of Media/Communication. Once the alert is 
approved, we issue a statement on our website and email all 
establishments on the distribution list. The Head of Regulation or 
Director of Regulation reviews all responses to the alert.  
No 

Reporting not mandatory. We report all mandatory information.  
Yes 

Haemovigilance 
Pharmacovilance 
Medical devices 
Other 
We communicate alerts to the Medicines and Healthcare products 
Regulatory Agency and Human Fertilisation and Embryology 
Authority. We also share details of SAREs reported to us if we 
believe they could have an impact on medicines and healthcare 
products and/or reproductive tissues and cells. 
Yes 

5 

10.5 above is actually not applicable for the HTA: Establishments 
report SAREs within 24 hours of their discovery, and not via an 
annual report. As a result, we may not receive data from every 
establishment every year, as serious reactions or events may not take 
place at every establishment. We received a total of 130 SARE 
reports in 2011.  We found the training excellent.   We follow the 
EC RATC Platform standard operating procedures when reporting 
an incident on the RATC platform.  

11. Consent and personal data protection (Article 13 and 14, Directive 2004/23/EC) 
11.1. What consent system for living tissue/cell donation do you 
have in place within your Member State? 
11.1.1. Please specify your choice of consent system for living 
tissue/cell donation. 

Explicit consent (opt-in) 

11.2. What consent system for deceased tissue/cell donation do you 
have in place within your Member State? 
11.2.1. If you have chosen both consent systems for deceased 
tissue/cell dontation, please specify. 

11.3. According to your national legislation, in case of deceased 
donations, please specify who is giving the authorisation for the 
tissue donation? (more than 1 answer possible) 

Consent or authorisation is given by the donor . If a donor is a child, 
the child or a person with parental responsibility can give consent. If 
an adult has mental incapacity, an appropriate person can give 
consent on their behalf, in line with the Mental Capacity Act. 
Peripheral Blood Stem Cell donations from children are subject to an 
approval process by HTA volunteer accredited assessors. This 
involves interviews with the donor and recipient to ensure there are 
no potential issues around coercion etc. Any difficult cases can be 
referred to the HTA Board for a final decision.  
Presumed (opt-out) and explicit (opt-in) consent 

The Welsh national assembly has recently passed a Bill to change 
the Welsh position to one of presumed (opt-out)consent. This system 
is not yet in place, but will be different from the rest of the UK, 
which currently has an explicit (opt-in) system of consent.  
First degree relatives (including spouse) 
Other relatives 
Non-marital partners 
Friends 
Other 

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Please specify 'other'. 

11.4. Is the consent system for deceased tissue donation the same as 
for organs? 
11.5. How is this consent verified during inspections? (more than 1 
answer possible) 

Please specify 'other'. 

11.6. What measures are in place to ensure that 
donors/relatives/authorising persons on behalf of donors are 
provided with the appropriate information, as requested by Art. 
13(2)? (more than 1 answer possible) 
Please specify 'other'. 

11.7. What measures are in place to ensure that both donors and 
recipients remain unidentifiable when access is given to third parties 
(Art. 14(1)). Please specify. 
11.8. Please specify what measures are in place to ensure that the 
identity of the receipient is not disclosed to the donor and vice versa. 

11.9. Does your national legislation allows disclosure of donor data 
in case of gametes donation? 
11.9.1. If no, please specify the circumstances and measures in 
place. 
11.10. Do you have any additional comments on consent and data 
protection? 

In England, Wales and Northern Ireland a person in life or a person's 
"nominated representative" can give consent. There is no mention of 
"nominated representatives" under the Human Tissue (Scotland) 
Act.  
Yes 

Analysis of documentation 
Interviews with personnel 
Other 
We also conduct traceability audits to verify the consent 
documentation in some randomly selected cases (including matching 
stored tissue samples to consent files).  
Only trained personnel is allowed to provide such information 
Information for donors are standardised at national/regional level 
Other 

Ensure correct procedures are in place at the initial application 
assessment stage. Follow up during two yearly inspections.  
Donor and recipient numbers are used to ensure donors and 
recipients are unidentifiable.  

Donor details are not stored in recipient notes and vice versa. This 
may not be the case if the donation is directed and the donor is 
known to the recipient (e.g. sibling to sibling, parent to child etc.). 
No 

This is not applicable - gamete donation is regulated by the HFEA. 
The HTA does not hold information to confirm this.  

Inspections of TEs and procurement sites 

12. Selection, evaluation and procurement (Article 15 Directive 2004/23; Annexes I-IV Directive 2006/17) 
12.1. How do you ensure that all requirements related to the 
evaluation and selection of donors (except donors of reproductive 
cells) are respected in your country (Art. 15(1), Annex I Directive 
2006/17/EC)? (more than 1 answer possible) 
12.2. How do you ensure that all requirements related to the 
evaluation and selection of donors of reproductive cells are 
respected in your country (Art 15 (1), Annex III of Directive 
2006/17/EC)? (more than 1 answer possible) 
Please specify 'other'. 
12.3. Do you have more stringent criteria for donor selection than 
those listed in Annex I of the Directive 2006/17/EC? 
12.4. What sources are required in your MS for the evaluation of a 
deceased donor of tissues/cells? (more than 1 answer possible) 

Other 

Not applicable - this is regulated by the HFEA.  
No 

Interview with the donor's family or a person who knew the donor 
well 
Medical records of the donor 
Interview with the treating physician 
Interview with the general practitioner 
Autopsy report 
Other 
Tissue establishments may use a number of sources to evaluate a 
donor, including those described in 12.4. We do not specify how to 
evaluate a deceased donor.  
No 

Please specify 'other'. 

12.5. Do you have more stringent criteria for selection of donors of 
reproductive cells than those listed in Annex III of the Directive 
2006/17/EC? 
12.6. Do you have more stringent criteria for autologous donation 
than those listed in Annex I of the Directive 2006/17/EC? 
12.7. Do you require more information on the donation of 
tissues/cells than the mandatory one as laid down in the Annex of 
Directive 2004/23/EC (Art 15(3)? 

No 

No 

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12.8. How do you ensure that all requirements regarding tissues and 
cells' procurement, packaging and transport are complied with by 
tissue establishments in your country (Art 15(1), Annex IV of 
Directive 2006/17/EC? (more than 1 answer possible)(For this 
question "audit" means a documented review of procedures, records, 
personnel functions, equipment, materials, facilities, and/or vendors 
in order to evaluate adherence to the written SOP, standards or 
governments laws and regulations (from Council of Europe Guide to 
the Safety and Quality Assurance for the Transplantation of Organs, 
Tissues and Cells, 2011)) 
12.8.1. Please specify. 

12.9. Do you have any additional comments on selection, evaluation 
and procurement? 

Inspection of tissue establishment 
Inspection of the centre of human application (e.g. transplantation 
centre, ART centre) 
Other 

Ensure correct procedures are in place at the initial application 
assessment stage. Follow up during two yearly inspections.  

13. Quality management, responsible person, personnel (Article 16, 17, 18 Directive 2004/23/EC) 
13.1. How do you ensure that tissue establishments in your country 
have in place a quality system respecting the provisions of the 
Directive 2004/23/EC Art 16.1? (more than 1 answer possible). (For 
this question "audit" means a documented review of procedures, 
records, personnel functions, equipment, materials, facilities, and/or 
vendors in order to evaluate adherence to the written SOP, standards 
or governments laws and regulations (from Council of Europe Guide 
to the Safety and Quality Assurance for the Transplantation of 
Organs, Tissues and Cells, 2011)). 
13.2. How do you ensure that tissue establishments have a 
responsible person fulfilling the requirements of Art. 17(1)? (more 
than 1 answer possible) 

Authorisation requirement 
Inspections 
Internal audits 
External audits 

Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Authorisation requirement 
Inspections 
Regular evaluation of personnel 
Mandatory trainings 
Yes 

13.3. How do you ensure an appropriate training for the personnel 
directly involved in the activities of tissue establishments? (more 
than 1 answer possible) 

13.4. Do you have national/regional/local training programmes for 
the personnel of tissue establishments? 
13.4.1. If yes, please specify. 

13.5. Any additional comments on quality management, responsible 
person, personnel? 

We provide e-learning training for designated individuals. All 
designated individuals are required to undertake this training as a 
licence condition. It is open for other registrants.   This is available 
here:  http://www.hta.gov.uk/trainingandconferences/e-
learningcourses.cfm  We also run workshops for TE's e.g we 
recently ran one on authorisation of preparation processes and we 
are planning another in September on SAREs. 

14. Reception, processing, storage, labelling and packaging (Art 19-22 Directive 2004/23/EC) 
14.1. How do you ensure that tissue establishments in your country 
fulfill the requirments of the Art. 19 (Tissue and cell reception) of 
Directive 2004/23/EC and Annex IV of Directive 2006/17/EC? 
(more than 1 answer possible) 
14.2. How do you ensure that tissue establishments in your country 
fulfill the requirements of the Art. 20 (Tissue and cell processing) of 
Directive 2004/23/EC? (more than 1 answer possible) 

Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 

SOPs for all processes affecting quality and safety are mandatory for 
authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with storage of tissues and cells are 
mandatory for authorisation 
Inspections of tissue establishments 
Internal audits of tissue establishments 
External audits of tissue establishments (e.g. ISO) 
SOPs for procedures associated with labelling and packaging  are 
mandatory for authorisation 
Inspections of tissue establishments 

14.3. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 21 (tissue and cell storage conditions) 
of Directive 2004/23/EC? (more than 1 answer possible) 

14.4. How do you ensure that tissue establishments in your country 
fulfill the requirements of Art. 22 (labelling, documentation and 
packaging) of Directive 2004/23/EC and Annex IV of Directive 

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2006/17/EC? (more than 1 answer possible) 

Internal audits of tissue establishments 
External audits of tissue establishments(e.g. ISO) 

14.5. Any additional comments on reception, processing, storage, 
labelling and packaging? 

15. Third party agreements (Art. 24 Directive 2004/23/EC) 
15.1. Are third party agreements foreseen/allowed in your national 
legislation? 
15.1.1. If yes, have tissue establishments in your Member State 
notified third party agreements? 
15.1.1.1. Under which circumstances and for which responsibilities? 
15.1.1.2. How are third party agreements controlled (Art 6.2) by the 
Competent Auhtority(ies) in your MS? Please specify. 

Yes 

Yes 

To conduct licensable activities other than storage.  
The Human Tissue (Quality and Safety for Human Application) 
Regulations 2007 (the Regulations) define a third party agreement 
(TPA) as:  “An agreement in writing between a licence holder (or 
the designated individual on behalf of the licence holder) and 
another person, which is made in accordance with any directions 
given by the Authority under section 23(1) of the 2004 Act for the 
purpose of securing compliance with the requirements of Article 24 
of the first Directive (relations between tissue establishments and 
third parties), and under which the other person:   (a) carries out 
licensed activity (other than storage) on behalf of the licence holder; 
or (b) supplies to the licence holder any goods or services which 
may affect the quality or safety of tissue or cells.”   A TPA may be 
used to provide a third party with the authority to undertake 
licensable activities on behalf of a licensed establishment. For this 
reason, there are stringent criteria that a TPA must meet, set down in 
paragraph 118 of HTA’s Directions 002/2007.   For TPAs where a 
person or establishment is supplying to the licence holder any goods 
or services which may affect the quality or safety of the tissues or 
cells, the requirements for the TPA are contained in paragraph 119 
of HTA’s Directions 002/2007.  The HTA has powers to enter and 
inspect third party premises.The HTA has powers to direct a 
licensed establishment to put in place a TPA with a supplier of 
goods or services where it considers this necessary. The HTA 
equally has powers to direct an individual licensed establishment not 
to use a named supplier of either goods or services. Under extreme 
circumstances the HTA may give details of suppliers from whom no 
licensed establishment may receive goods or services.   The term 
TPA is used for non-licensed establishments contracting with 
licensed establishments in the UK. The term 'service level 
agreement' is used for agreements between HTA licensed 
establishments and for agreements with parities from the EU or third 
countries.   We provide FAQs and a 'third party agreement 
submission form' on our website:  
http://www.hta.gov.uk/licensingandinspections/sectorspecificinform
ation/tissueandcellsforpatienttreatment/thirdpartyagreementfaqs.cfm
#SLA .  We have further information available about TPA content 
and HTA powers in our 'Guide to the quality and safety assurance of 
human tissues and cells for patient treatment' at:  
http://www.hta.gov.uk/_db/_documents/Annex_-
_Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_
for_Patient_Treatment.pdf 

15.2. Any additional comments on third party agreements? 

16. General comments - implementation 
16.1. Do you have at national level more stringent quality and safety 
requirements than those requested by the EU legislation in this field 
(e.g. restrictions concerning the donation/use of certain tissues/cells, 
mandatory unpaid donation etc.)? 
16.2. Has your Member State encountered any difficulties in 
implementing the requirements in the EU Tissues and Cells 
Directives? Please choose from the options below. 
16.2.1. For all selected options in question 16.2., please provide a 

No 

No difficulties 

No specific difficulties to report.  

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short description. 
16.3. In your opinion, in which of the following Directives are there 
shortcomings (if any)? (more than 1 answer possible) 
16.3.2. How would you suggest to solve these issues in Directive 
2006/17/EC? 

Directive 2006/17/EC 

We would like to see a revision of this Directive and in particular 
Annex 11. We consider that the technical nature of this Directive 
requires that is reviewed on a regular basis to ensure that it continues 
to reflect scientific development.  In particular, we consider that 
there is a reasonable basis to consider making NAT testing 
mandatory in certain situations (i.e multiple donors, one recipient 
and no storage), product testing instead of serum testing in certain 
proscribed situations and a review of the requirement for HTLV 
testing for all tissue types e.g should terminally sterilised products 
be excluded from the requirement? 

457