COMMISSION STAFF WORKING DOCUMENT on the application of Directive 2002/98/EC on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC 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 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62EC setting standards of quality and safety for human blood and blood components
Date: 2016-04-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, blood transfusion, health control, health risk, national implementing measure, quality standard, safety standard, summarising

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 21.4.2016  SWD(2016) 129 final   COMMISSION STAFF WORKING DOCUMENT on the application of Directive 2002/98/EC on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC 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 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62EC setting standards of quality and safety for human blood and blood components {COM(2016) 224 final} {SWD(2016) 130 final}  
 
 
Table of contents  

1. 

2. 

Introduction ..................................................................................................................................... 6 

Implementation of the EU blood legislation ................................................................................... 6 

2.1.  General Provisions - Designation of competent authorities ................................................... 6 

2.1.1. 

Portfolio of competences of the national competent authorities .................................. 7 

2.1.2. 

Responsibilities of national competent authorities ........................................................ 7 

2.2.  Obligations on Member State Authorities ............................................................................ 11 

2.2.1. 

Designation/authorisation/accreditation or licensing of blood establishments .......... 11 

2.2.2. 

Inspections and control measures ................................................................................ 13 

2.2.3. 

Inspections of blood establishments ............................................................................. 17 

2.2.4. 

Other inspections .......................................................................................................... 20 

2.3. 

Provisions for Blood Establishments ..................................................................................... 23 

2.3.1. 

Responsible person ....................................................................................................... 23 

2.4.  Quality management ............................................................................................................. 23 

2.4.1. 

Quality System for blood establishments ..................................................................... 23 

2.4.2. 

Record keeping .............................................................................................................. 23 

2.5. 

Haemovigilance ..................................................................................................................... 24 

2.5.1. 

Traceability - Donor identification system .................................................................... 24 

2.5.2. 

Notification of serious adverse events and reactions ................................................... 25 

2.5.3. 

Import/export ................................................................................................................ 31 

2.5.4. 

Shortages and surplus of blood and blood components .............................................. 34 

2.5.5. 

Cross-border movement of Donors............................................................................... 35 

2.6.  Quality and safety of blood and blood components ............................................................. 35 

2.6.1. 

Provision of information to prospective donors ........................................................... 35 

2.6.2. 

Information required from blood donors and examination of blood donors ............... 36 

2.6.3. 

Eligibility criteria for donors of whole blood and blood components........................... 37 

2.6.4. 

Testing of Donations ...................................................................................................... 44 

2.6.5. 

Storage, transport and distribution conditions ............................................................. 49 

2.6.6.  More stringent measures .............................................................................................. 50 

2.7. 

Exchange of information, reports and penalties ................................................................... 50 

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2.7.1. 

Penalties ........................................................................................................................ 50 

2.7.2. 

Difficulties in transposition or implementation ............................................................ 51 

Annex 1: Individual country responses to the survey on the implementation of the EU Blood and 
Blood Components Directives conducted in 2013 and based on 2012 information ........................ 52 

A.1.1. 

Survey response Austria ................................................................................................ 52 

A.1.2. 

Survey response Belgium .............................................................................................. 60 

A.1.3. 

Survey response Bulgaria .............................................................................................. 68 

A.1.4. 

Survey response Croatia ................................................................................................ 82 

A.1.5. 

Survey response Cyprus ................................................................................................ 89 

A.1.6. 

Survey response Czech Republic ................................................................................... 98 

A.1.7. 

Survey response Denmark ........................................................................................... 107 

A.1.8. 

Survey response Estonia .............................................................................................. 115 

A.1.9. 

Survey response Finland .............................................................................................. 123 

A.1.10.  Survey response France ............................................................................................... 134 

A.1.11.  Survey response Germany ........................................................................................... 151 

A.1.12.  Survey response Greece .............................................................................................. 164 

A.1.13.  Survey response Hungary ............................................................................................ 175 

A.1.14.  Survey response Ireland .............................................................................................. 183 

A.1.15.  Survey response Italy .................................................................................................. 193 

A.1.16.  Survey response Latvia ................................................................................................ 203 

A.1.17.  Survey response Liechtenstein .................................................................................... 211 

A.1.18.  Survey response Lithuania........................................................................................... 219 

A.1.19.  Survey response Luxembourg ..................................................................................... 228 

A.1.20.  Survey response Malta ................................................................................................ 236 

A.1.21.  Survey response Netherlands ...................................................................................... 244 

A.1.22.  Survey response Norway ............................................................................................. 253 

A.1.23.  Survey response Poland .............................................................................................. 261 

A.1.24.  Survey response Portugal ............................................................................................ 273 

A.1.25.  Survey response Romania ........................................................................................... 282 

A.1.26.  Survey response Slovakia ............................................................................................ 292 

A.1.27.  Survey response Slovenia ............................................................................................ 301 

A.1.28.  Survey response Spain ................................................................................................. 310 

A.1.29.  Survey response Sweden ............................................................................................. 320 

A.1.30.  Survey response United Kingdom ............................................................................... 330 

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Annex 2: Fractionation Facilities ..................................................................................................... 338 

Annex 3: Number of positive test results in 2012 for HIV, hepatitis B and hepatitis C and the 
number of laboratories performing donor testing ......................................................................... 340 

4 

 
 
 
 
ABBREVIATIONS 

= European Commission 

EC  
ECDC  = European Centre for Disease Prevention and Control 
EEA   = European Economic Area 
= European Union 
EU 
GMP   = good manufacturing practices 
HBV   = hepatitis B virus 
HCV   = hepatitis C virus 
HIV   = human immunodeficiency virus 
HLA   = human leukocyte antigen 
HTLV  = human T-cell lymphotropic virus 
ISO 
NAT   = nucleic acid amplification test 
NCA  = national competent authority 
RAB  = Rapid Alerts for Blood 
SAE   = serious adverse event 
SAR   = serious adverse reaction 
SARE  = serious adverse reactions and events 
SOP   = standard operating procedures 

= International Standards Organisation 

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

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1. 

INTRODUCTION 

This  Staff  Working  Document  summarises  the  results  of a  questionnaire survey  of  Member 
States on the implementation of the EU blood legislation.  The survey was conducted in 2013 
and the data reported was from 2012. Replies were sent to the Commission by the 28 Member 
States,  Liechtenstein  and  Norway  (Annex  1)1.  The  quality  of  reporting  and  information 
provided by Member States  was satisfactory overall, but some answers called for  additional 
clarifications  and  verifications,  which  are  reflected  in  this  document.  Information  on  the 
application of the  principle  of “voluntary and unpaid donation”  is summarised in  a separate 
Staff Working Document. These two documents accompany 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 2002/98/EC, 2004/33/EC, 
2004/33/EC, 2005/61/EC and 2005/62/EC setting standards  of quality and safety  for  human 
blood and blood components. 

2. 

IMPLEMENTATION OF THE EU BLOOD LEGISLATION 

Overall,  the  implementation  of  the  EU  blood  legislation  by  Member  States  is  considered 
adequate.  

However, many Member States' experts reported difficulties in the interpretation of its scope. 
In  particular,  the  inclusion  of  the  donation,  procurement  and  testing  of  blood  and  blood 
components 'whatever their intended use' in  Article 2 on the scope of Directive 2002/98/EC 
has raised some questions for blood competent authorities, because it potentially extends the 
scope  beyond transfusion. While it is clear that if the blood or blood components are for the 
purposes of transfusion, then the processing, storage and distribution are within the scope of 
the  legislation,  a  number  of  questions  for  clarification  have  been  raised  at  the  competent 
authority meetings on scope issues.   

As the legislation in question does not provide a basis for full harmonisation, there are many 
differences  between  Member  States  in  the  approaches  they  have  taken  to  implementation.  
These differences facilitate successful integration of the requirements into national legislation 
but  in  some  cases  they  may  limit  the  possibilities  for  sharing  of  resources,  including  blood 
and blood components themselves. 

2.1. 

General Provisions - Designation of competent authorities 

Under  Article  4(1)  of  Directive  2002/98/EC,  Member  States  must  designate  the  competent 
authority or authorities responsible for implementing the requirements of the Directive. All 28 
Member  States  plus  Norway  and  Liechtenstein  have  designated  a  competent  authority  in 
accordance with this provision. 

In 16 Member States (AT, BE, BG, CY, DK, EE, ES, HR, HU, IE, LU, LV, MT, RO, SI and 
UK) plus Liechtenstein, there is one designated national competent authority. In nine Member 
States  (CZ,  DE,  FI,  FR,  IT,  LT,  NL,  PT  and  SK),  there  are  two  competent  authorities  at 
national  level.  In  three  Member  States  (Greece,  Sweden,  Poland)  plus  Norway,  there  are 
three.  More  than  one  competent  authority  exists  in  particular  where  oversight  is  divided 
between various activities or types of substances.  

1 In a number of cases clarification requests were sent to Member States to verify the information submitted. It is 
important to note that while the original replies of Member States are included at Annex 1, 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. 

6 

 
 
 
                                                            
2.1.1.  Portfolio of competences of the national competent authorities 

Four  Member  States  (EL,  ES,  LT  and  LU)  reported  that  their  competent  authorities  were 
empowered  solely  for  blood  and  blood  components.  Figure  1  shows  the  additional  areas  of 
competences of the competent authorities responsible for blood and blood components. 

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CZ, DE, FR, IE, LI, NO, PL, RO

8 

AT, BE, CY, CZ, DE, DK, FR, IE, IT, LI, LV, NL,
NO, PL, SE, SI, SK, UK

CY, CZ,  DK, EE, FI, FR, HR, IE, IT, LI, LV, MT,
NL, NO, PL, PT, SE, SK

AT, BE, CY, CZ,DE, DK, EE, FI, FR, HR, IE, IT,
LI, LV, MT, NL, NO, PL, SE, SI, SK

AT, BE, BG, CY,  CZ, DE, DK, EE, FI, FR, HU, IE,
LI, LV, MT, NL, PL, SE, SI, SK, UK

18 

18 

21 

21 

0

5

10

15

20

25

Fig. 1 - Additional competences of national competent authorities 

Some  Member  States  reported  that  their  competent  authorities  have  further  specific 
competences,  e.g.  for:  cosmetic  products,  veterinary  products  (France,  Ireland);  tattoo  inks, 
biocides, ancillary products, human breast milk (France); clinical trials approval, protection of 
animals (Ireland).  

Comments 

All Member States have appointed competent authorities for blood, which can be considered 
satisfactory.  It  is  for  the  Member  States  to  decide  on  the  organisational  set-up  of  their 
authorities and the designation of different oversight responsibilities.  

In  most  countries,  national  competent  authorities  for  blood  and  blood  components  are  also 
competent  for  other  sectors  (primarily  tissues  &  cells,  organs,  pharmaceuticals  and  medical 
devices).  

2.1.2.  Responsibilities of national competent authorities 

There  is  diversity  in  the  responsibilities  assigned  to  (each  of)  the  designated  competent 
authority(ies) as represented in Table 1. 

Table 1 – Roles/tasks of national competent authorities (NCAs) 

7 

 
 
 
 
 
 
 
 
 
 
 
 
Role/ tasks of national competent authorities* NCA1, NCA2, NCA3 

Authorisation/ 

Designation/ 

Accreditation/Licensing 

Inspection 

Haemovigilance 

Others 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2 

NCA1;NCA2 

NCA1; NCA2 

NCA1 

NCA1 

NCA1; NCA2 

NCA1 

NCA1 

NCA1; NCA2; NCA3 

NCA1 

NCA1; NCA2; 

NCA1 

NCA1; NCA2 

NCA1 

NCA1 

NCA2; NCA3 

NCA1 

NCA2; NCA3 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1, NCA2 

NCA1 

NCA1 

NCA1 

NCA2 

NCA2; NCA3 

NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2 

NCA2 

NCA1 

NCA1 

NCA1 

NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2, 

NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

NCA1 

AT 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

EL 

ES 

FI 

FR 

HR 

HU 

IE 

IT 

LI 

LT 

LU 

LV 

MT 

NL 

NO 

PL 

PT 

RO 

SE 

SI 

SK 

UK 

NCA1; NCA2 

NCA1; NCA2 

NCA1 

NCA1 

NCA1 

NCA1 

NCA2 

NCA1 

*NCA1 – National Competent Authority 1 

*NCA2 – National Competent Authority 2 

*NCA3 – National Competent Authority 3 

National competent authority 1 (NCA 1) 

In 22 Member States plus Norway, the NCA1s are responsible for designation, authorisation, 
accreditation  and/or  licensing  of  blood  establishments,  for  inspection  in  22  Member  States 

8 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
plus  Liechtenstein  and  for  haemovigilance  in  20  Member  States  plus  Norway  and 
Liechtenstein. 

Many  Member  States  and  Norway  mentioned  that  NCA1  has  additional  functions  and 
responsibilities: 

  Coordination of blood services/donation/transfusion (EL, IT, LT, RO, SK); 

  National  guidelines,  implementation  of  national  legislation,  policies,  legal  matters 

(BG, CZ, DK, EL, IE, ES, IT, RO); 

 

Import and export of blood components (ES, IT, RO, SK, CZ); 

  Personal data protection (EL, SK); 

  Recalls of blood components (EL, IE). 

National competent authority 2 (NCA2) 

The second competent authorities (NCA2) have one or more responsibilities that differ among 
countries. 

In  seven  Member  States,  the  NCA2  is  also  responsible  for  haemovigilance.  Six  Member 
States  plus  Norway  mentioned  inspection  as  a  main  task  of  NCA2.  Four  Member  States 
reported  designation,  authorisation,  accreditation  and  licensing  of  blood  establishments  as  a 
main task of NCA2s. Some Member States reported NCA2s being responsible for other tasks 
such as: 

  Epidemiological surveillance of transfusion transmitted infections (EL); 

  Coordination  and  control  of  national  and  European  provisions,  monitoring  actions, 
production  of  guidelines  for  quality,  safety  and  appropriate  use  of  blood  resources, 
education and qualification of blood inspectors (IT, SK); 

  Pharmaceuticals and medical devices (SE, SK); 

  Quality  of  practices  and  ethics,  health  policy,  elaboration  of  legislation  proposals, 

supervision of health agencies (FR); 

  Supervision of hospital blood banks (FI, SK, CZ). 

National competent authority 3 (NCA3) 

In three Member States (Greece, Sweden, Poland) plus Norway, there are three NCAs: 

  PL mentioned that NCA3 is responsible for legal issues, data collection, emergencies, 
budget  and  funding  issues  as  well  as  contract  management  with  different  blood 
establishments; 

  SE reported that NCA3 is responsible for legislative matters;  

 

In PL, the main task of NCA3 is organisation and financing;  

  NO specified inspection as a main task of the NCA3.  

Member States with federal or decentralised systems 

In  Member  States  with  federal  or  decentralised  systems  (IT,  DE,  HU,  ES),  the  regional 
competent authorities are responsible for designation, authorisation, accreditation, or licensing 
of blood establishments, inspection and haemovigilance. Germany explained that the regional 
competent  authorities  are  entrusted  with  supervision  and  continuous  monitoring  of 

9 

 
 
 
compliance with legal provisions. For these purposes, regional authorities grant authorisations 
of  blood  establishments  and  organise  inspections.  Finland  reported  that  the  national 
competent  authority  (Valvira)  and  the  six  regional  state  administrative  agencies  supervise 
hospital blood banks as a part of other healthcare service providers. 

Relations between National and Regional Competent Authorities 

Five  Member  States  described  existing  relations  between  national  and  regional  competent 
authorities (DE, FI, FR, ES and IT). 

Germany  reported  that  the  national  competent  authority,  the  Paul-Ehrlich-Institut  (PEI)  and 
the  regional  competent  authorities  of  the  Laender  work  together  on  some  activities  such  as 
inspections,  but  have  different  competences.  Regional  competent  authorities  are  responsible 
for activities related to Articles 5 and 8 of Directive 2002/98/EC: monitoring compliance with 
legal  provisions  and  imposing  penalties/sanctions.  The  national  authority  is  responsible  for 
the  marketing  authorisation  of  blood  products  and  pharmacovigilance.  The  German  Federal 
Government and PEI have different roles and responsibilities to the authorities in the regions 
(Laender). 

In  Finland,  the  Finnish  Medicines  Agency  (Fimea)  has  a  centralised  supervision  of  blood 
establishments,  while  the  supervision  of  hospital  blood  banks  by  the  National  Supervisory 
Authority for Welfare and Health (Valvira) and the six regional state administrative agencies 
is  decentralised.  Supervision  is  based  on  agreed  programmes  as  a  part  of  other  healthcare 
services, which provide guidance and manage related licensing activities. Valvira guides the 
six regional state administrative agencies and local authorities in the areas of health and social 
care, alcohol administration and environmental health. 

Spain  is  divided  in  17  autonomous  communities  or  regions.  Each  of  these  regions  has  a 
competent organisation for implementing health policies and for developing regulations at the 
community level. 

In  Italy,  regional  competent  authorities  are  by  law  entrusted  with  inspection-based 
authorisation and accreditation of blood establishments and blood collection units. Inspection 
programmes  and  teams  are  managed  by  the  regional  competent  authorities,  which  must 
include  at  least  one  nationally  qualified  blood  inspector.  Authorisation  and  accreditation 
requirements  are  defined  by  national  State-Region  agreements  in  compliance  with  the  EU 
Blood Directives and, where applicable, EU GMPs. The regional blood centres are entrusted, 
among  others  tasks,  with  regional  self-sufficiency  of  blood,  components  and  products, 
haemovigilance  data  collection  and  reporting  to  the  National  Blood  Centre,  regional 
coordination of blood establishments and blood collection units and interactions with plasma 
fractionation providers. 

Comments 

In  half  of  the  countries,  all  main  oversight  tasks  (inspection,  authorisation,  vigilance)  are 
handled by a single national competent authority. Where more than one competent authority 
is involved, and in particular where regional/local authorities perform some of these tasks, it 
is  essential  to  ensure  appropriate  coordination  and  communication  between  all  authorities 
concerned.  

To  facilitate  good  regulatory  communication  between  Member  States,  as  well  as  to  comply 
with  the  annual  reporting  requirements  to  the  Commission,  a  well-informed  national 
coordinating contact is  essential, even where  competent authority responsibilities  are shared 
among  multiple  organisations  or  regions.  Irrespective  of  the  organisational  set-up  in  each 
country, it is important that authorities have appropriate resources at their disposal in order to 

10 

 
 
 
ensure  their  independence  from  industry,  from  the  professional  sector  and  from  other 
influences. In this respect it could be problematic if an expert works for a national competent 
authority  and  –  at  the  same  time  –  for  a  blood  establishment.  Several  countries  suggested 
addressing  this  e.g.,  through  regional  collaborations  between  competent  authorities  of 
multiple countries. Some Member States called for a common reflection on the organisation 
of national competent authorities.  

Inadequate  staffing,  e.g.  in  the  inspection  department,  can  bring  other,  significant  risks  in 
terms of oversight. It is also important that staff are adequately trained, an issue that Member 
States  and  the  Commission  have  addressed  partially  in  the  past  and  continue  to  address 
through ongoing joint actions.  

2.2. 

Obligations on Member State Authorities 

2.2.1.  Designation/authorisation/accreditation or licensing of blood establishments 

Under  Article  5(1)  of  Directive  2002/98/EC,  Member  States  must  ensure  that  activities 
relating  to  the  collection  and  testing  of  human  blood  and  blood  components,  whatever  the 
intended  purpose,  and  to  their  preparation,  storage  and  distribution  when  intended  for 
transfusion,  are  undertaken  only  by  blood  establishments  which  have  been  designated, 
authorised, accredited or licensed by the competent authority for that purpose.  

Information provided by Member States 

Twenty-five Member States plus Norway and Liechtenstein reported that they have a system 
in place for accreditation/designation/authorisation/licensing of blood establishments and that 
the  responsible  NCAs  are  empowered  to  give  accreditation,  designation,  authorisation  or 
licences. 

In particular, Member States reported that blood establishments are provided with an: 

  Authorisation (BG, BE, CZ, ES, DE, DK, FR, HR, IE, NO, SK, SI, UK);  

  Accreditation (PL);  

  Designation (CY, NL);  

  Licence (EE, MT, FI, LT);  

  Authorisation/accreditation (IT);  

  Authorisation/designation (LV, RO); 

  Authorisation/licensing (AT, HU, LI, PT, SE); 

  Authorisation/designation/licence (EL);  

  Authorisation/accreditation/designation/licence (LU).  

11 

 
 
 
 
 
Authorisation/accreditation/designation/licence issued by national competent authorities 

Fig. 2 – 

All blood establishments have effectively received a designation, authorisation, accreditation 
or licence from the competent authorities in  25 Member States (AT, BE, BG,  CY,  CZ, DE, 
DK,  EE,  EL,  ES,  FI,  FR,  HR,  HU,  IE,  LT,  LU,  LV,  MT,  NL,  PL,  SE,  SI,  SK,  UK)  plus 
Liechtenstein and Norway.  

Three  Member  States  were  not  in  a  position  to  confirm  that  all  blood  establishments  were 
authorised,  licensed,  designated  or  accredited  in  line  with  the  Directive.  They  reported  the 
following: 

 

IT  reported  that  all  blood  establishments  were  authorised  according  to  pre-existing 
national requirements. The authorisation process of all blood establishments according 
to the new regulations complying with the EU Directives were expected to be finalised 
by the end of 2014.  By the end of September 2013, 6% of blood establishments had 
been authorised according to rules set out in EU legislation. The reasons for the delays 
were: a) lack of homogeneous performance among regions, b) significant demands of 
the  fulfilment  of  some  GMP  requirements  and  c)  an  excessive  number  of  blood 
establishments; 

  PT  reported  that  the  information  on  the  number  of  authorised  blood  establishments 
was not yet available as some blood establishments were still being evaluated by the 
new competent authority; 

  RO  reported  that  none  of  the  blood  establishments  were  authorised  because  the 
authorisation  process  had  not  yet  been  started,  but  blood  establishments  were 
designated  (authorisation  to  function  with  a  yearly  renewal)  by  Law  282/2005.  The 
reported reasons for the delay were: a) delay in setting up the Government Decision on 
organisation  and  functionality  of  BEs,  as  set  up  in  Law  282/2005  and  b)  a  need  to 
revise  the  Order  on  authorisation  of  BEs  and  revise  and  complete  the  national 
standards  to  ensure  the  legal  basis  for  verification  during  inspection.  In  2013,  an 
administrative reorganisation was foreseen including of the blood transfusion system. 

Inspections, accreditation, authorisation, designation and audit were measures reported by all 
Member  States  plus  Norway  and  Liechtenstein  to  ensure  the  compliance  with  the 
requirements of Article 5(1) of Directive 2002/98/EC. 

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BG, EE, IE, NL

4 

BE, BG, CZ, DE, DK, EE, FR, GR, HR, HU, IE, IT, LI, LT,
LU, MT, NL, NO, PL, PT, RO, SE, SI, SK, UK

25 

0

5

10

15

20

25

30

Fig. 3 – Control measures to ensure Article 5 requirements are met 

Under  Article  5(5),  the  competent  authority  or  authorities  may  suspend  or  revoke  the 
designation/authorisation/accreditation/licence  of  a  blood  establishment  if  it  is  found  to  no 
longer comply with the requirements of the Directives.  

Revoked authorisations were reported by Greece, Portugal and Liechtenstein: 

  EL reported that authorisations were revoked due to administrative reasons associated 
with a stepwise centralisation system, starting with the nationwide implementation of 
NAT  testing  for  HIV,  HCV  and  HBV  in  September  2008  and  followed  by  the 
economic crisis and the various structural changes in the national health system (early 
retirement or suspension of staff,  merging of blood services and in certain situations 
lack of resources delaying procedures); 

  PT  mentioned  as  reasons  for  revoking  authorisations:  problems  with  donor  testing, 

poor compliance with good practices and quality system issues. 

Comments 

All Member States fulfil their obligations to have a system of authorisation as laid down in 
the EU legislation, applied on almost all of the 1,363 reported blood establishments.  

2.2.2. 

Inspections and control measures 

Inspection Systems 

inspections  and  appropriate  control  measures 

Under  Article  8(1),  Member  States  must  ensure  that  the  competent  authority  or  authorities 
organise 
in  blood  establishments. 
Comprehensive  inspection  systems  were  reported  to  be  in  place  by  27  Member  States  plus 
Norway and Liechtenstein. Cyprus explained that the system is not in place due to a lack of 
trained professionals (four professionals were recently trained under an EU-funded project). 

In  26  Member  States  plus  Norway  these  inspections  of  blood  establishments  overlap  with 
other inspections schemes as shown in Figure 4. 

13 

 
 
 
 
Others:

Hospitals:

Medical devices:

Advanced therapies:

Pharmaceuticals:

Organs:

Tissues and cells:

0

2

4

6

8

10

12

14

16

18

20

Fig  4 – Overlapping inspection schemes 

Responsible authorities 

The  following  table  summarises  the  competent  authorities  and  departments  which  are  in 
charge of inspections for each Member State.  

14 

 
 
 
 
 
CA/ 
Department 

Country 

CA/ 
Department 

Country 

AT 

BE 

BG 

CY 

CZ 

CA/ 
Department 

for 
Federal  Office 
Safety 
in  Health 
Care  (BASG)  /  AGES 
Austrian  Agency  for 
Health  and  Food 
Safety 

Federal agency 
for medicines and 
health products  
FAMHP 

Country 

DE 

DK 

Executive Director of 
Bulgarian Drug Agency – 
inspections direct 
control 
CA/Department -“ 
Control of  blood 
transfusion system”- 
inspections . 
EE 

Regional Competent 
Authorities and the 
National Competent 
Authority – Paul-
Ehrlich-Institut (PEI) 

Sundhedsstyrelse
n (Danish Health 
and Medicines 
Authority) 

State Agency of 
Medicines (SAM), 
Department of 
Biologicals 

State Institute for 
Drug Control, 
Inspection Division, 
Clinical Practice and 
Surveillance over 
Biological Material 
Processing 

ES 

1. The Regional 
Health Authority 
Inspection 
Department 
2. Accreditation 
systems - scientific 
societies (CAT) 

Not reported 

EL 
For regular inspections 
National Blood Centre in 
cooperation with the 
Regional Health 
Authorities. Inspections 
in specific situations and 
in case of revocation  
SEYP (Body of Health 
Inspectors) 

FI 

FR 

HR 

HU 

IE 

The Finnish 
Medicines Agency 
(Fimea), Supervision 
and licences -
process, 
Inspectorate -unit. 

Biological 
Products 
Inspection 
Department and 
Control 
Department    

Country 

IT 

CA/ 
Department 

Regional health 
authorities 

Country 

MT 

LI 
Arzneimittelkontr
olle des Amtes für 
Gesundheit – 
coordination of 
inspections 
delegated to 
Swissmedic by 
agreement 
NL 

CA/ 
Department 

The Superintendent 
of Public Health 

Health Care 
Inspectorate 

Country 

RO 

SE 

National Institute for 
Quality- and 
Organizational 
Development in 
Healthcare and 
Medicines National 
Institute of Pharmacy 
Inspection department 
LU 

Health Directorate - 
Inspection Sanitaire 

Ministry of Health 
Service for blood, tissues 
and cells inspection 

LT 

Special department / 
unit in charge of 
inspections and control 
measures of BEs has not 
been established. 

The Compliance 
Department of the 
Irish Medicines 
Board (IMB)  

LV 

State Agency of 
Medicines. 
Pharmaceutical 
activities. 
Compliance 
evaluation 
department  

NO 

PL 

PT 

Norwegian Board of 
Health Supervision - 
Dept of planned 
inspections and 
Norwegian Medicines 
Agency- Dept for 
inspections and narcotic 
drugs control 
SI 

Institute of Hematology 
and Transfusion 
Medicine (IHTM) – 
Department of 
Transfusion Medicine  •  

Direccao Geral de 
Saude (DGS) -
Department of 
Quality in Health 

SK 

UK 

CA/ 
Department 

Public Health and 
Control in Public 
Health Directorate 
(PHCPHD)- 
inspection 
coordination  
Public Health 
County Authority- 
department of 
inspection.  

Health and Social 
Care Inspectorate: 
Medical Products 
Agency: 
Department of 
inspection 

Javna agencija Republike 
Slovenije za zdravila in 
medicinske pripomočke 
(Agency for Medicinal 
products and Medical 
Devices of the Republic 
of Slovenia) 

Inspection Section of 
The State Institute for 
Drug Control. 

Medicines 
Inspectorate, 
Inspection, 
Enforcement & 
Standards Division, 
MRHA 

Table 2- Competent authority (CA) and department in the authority in charge of inspections/Member State 

Empowerment 

The  number  of  full-time  inspectors  in  these  competent  authorities  ranges  from  1  to  113. 
Cyprus, Spain and Lithuania did not provide answers on the number of inspectors. Germany 
clarified that it was not appropriate to provide the numbers of inspectors since the inspectors 
typically  are  based  within  the  regional  competent  authorities,  whereas  the  Paul  Ehrlich 
Institute, as competent higher federal authority, typically participates with an expert function. 

15 

 
 
 
Under Article 8(3) of Directive 2002/98/EC, the competent authorities must be empowered to 
inspect blood establishments, as well as facilities of any third parties on  their own territory, 
take samples for examination and analysis, and examine any documents relating to the object 
of  the  inspection.  Twenty-five  Member  States  plus  Norway  reported  compliance  with  this 
Article.  

The answers from Greece and Liechtenstein did not clarify the powers of inspectors.  

Fig. 5 – Inspector empowerment 

Training and support 

Member  States  were  asked  their  views  on  projects  funded  by  the  Commission  for  training 
inspectors (Eustite, EUBIS, and CATIE), including participation and usefulness, rating them 
from  1  (not  important)  to  5  (essential).  Twenty-five  Member  States,  plus  Liechtenstein  and 
Norway had sent (or intended to send) their inspectors to the training courses funded by the 
European  Union.  The  training  courses  were  classified  as  very  good  and  essential  by  21 
Member  States  plus  Liechtenstein,  and  as  good  by  three  Member  States  plus  Norway.  No 
Member  State  considered  the  training  courses  as  not  important  and  only  Austria  classified 
them as sufficient.  

3(good): BE, EE, IE, 
NO; 
4 

2 (sufficient): AT 
 1 

5 (essential): CY, EL, 
ES, LT, MT, PL, RO, SI; 
8 

4(very good): BG, FI, 
HR, HU, IT, IT, LI, LU, 
LV, NL, PT, SE, SE, SK; 
14 

Fig. 5 – Training Course evaluation 

Denmark justified not sending inspectors for training courses due to lack of human resources, 
Czech Republic mentioned internal reasons (not specified), France explained difficulties due 
to ANSM reorganisation (in 2013, one inspector attended one training course) and the United 
Kingdom  cited  extensive  experience  in  inspecting  blood  establishments  and  third  countries 
since a change in national legislation in 1992. 

Ten  Member  States  (EE,  HR,  HU,  IE,  IT,  LV,  MT,  PL  RO  and  UK)  reported  international 
collaboration  on  inspections  with  other  Member  States,  such  as  an  inspection  of  a  blood 
establishment  in  another  Member  States,  an  inspection  of  a  blood  establishment  in  a  third 

16 

 
 
 
 
 
country, or responding to requests from other Member States regarding the results and control 
measures of their own inspections. 

Twenty-five Member States plus Liechtenstein and Norway use the Council of Europe Guide 
to  the  preparation,  use  and  quality  assurance  of  blood  components  at  national  level.  18 
Member States rated the guide as useful/helpful to excellent. Luxembourg reported that they 
had plans to use the guide in the future.  

No: DE, FR,UK 
 3 

Yes: AT, BE, BG, CY, 
CZ, DK, EE, EL, ES, 
FI, HR, HU, IE, IT, LI, 
LT, LU, LV, MT, NL, 
NO, PL, PT, RO, SE, 
SI, SK 
27 

 Fig. 6 – Use of the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components at 
national level/country 

Comments 

Whilst  overall  Member  States  appear  to  correctly  implement  the  provisions  concerning 
inspections, a number of Member States reported difficulties related to staffing, which makes 
it difficult to comply with the required 2-year inspection interval. Many considered that a risk-
based approach to inspection scheduling would be more effective and efficient instead of the 
required 2-year inspection interval. Also there is a need to clarify the basis of an inspection, 
i.e., desk-based assessments versus on-site inspections. 

Inspector  powers  and  inspector  training  were  regularly  commented  upon.  The  value  of 
international  projects,  at  EU  level  and  co-ordinated  by  the  Council  of  Europe,  are  clearly 
appreciated by most of the competent authorities in order to help maintain an adequate level 
of training and know-how within the groups of inspectors. 

2.2.3. 

Inspections of blood establishments 

Inspection Plan 

In 17 Member States plus Norway inspections are planned based on a risk-based approach.  

No: BE, CY, DK, EL, 
ES, HR, HU, IE, LI, 
MT, NL, SK; 
12 

Yes: AT, BG, CZ, DE, 
EE, FI, FR, IT, LT, 
LU, LV, NO, PL, PT, 
RO, SE, SI, UK; 
18 

Fig. 7 –  Risk-based approach to inspection 

17 

 
 
 
 
 
 
 
Number and type of inspections 

The  answers  provided  by  Member  States  were  not  detailed  enough  to  perform  a  complete 
analysis  concerning  the  number  and  type  of  inspections  (routine,  following  serious  adverse 
events  or  reactions  and  other)  in  2012.  However,  in  2012,  22  Member  States  plus  Norway 
reported 775 general system oriented on-site inspections. Cyprus, Hungary, Luxembourg and 
Liechtenstein reported that no inspections were performed in 2012. Data was not provided by 
Austria, Belgium and Denmark.  

Fig. 9 –  Number of system-oriented on-site inspections per country 

Fourteen  Member  States  reported  161  thematic/limited  on-site  inspections  in  2012.  Sweden 
reported  15  desk-based  inspections  and  79  on-site  inspections.  Slovenia  reported  that  15 
inspections were performed between 1 January 2008 and 1 December 2012. 

Fig. 10 - Number of thematic inspections per country 

As  set  out  in  the  Article  8(4)  of  Directive  2002/98/EC,  the  competent  authorities  must 
organise inspections  and carry  out control measures  as  appropriate  in  the event of  a  serious 
adverse reaction or event (SARE). Nine Member States (BG, DE, EE, FR, HR, IT, LT, PL, 
RO, SK) reported 21 inspections following a SARE or a suspected SARE. The UK reported 
that  SARE  information  was  considered  as  a  risk  indicator  when  planning  and  scheduling 
inspections, but was not necessarily a trigger for an immediate inspection. PL explained that 

18 

 
 
 
 
 
 
immediate  inspections  follow  every  SARE  and  are  analysed  by  a  special  team.  In  2012,  22 
cases were analysed in Poland.  

Additional information on inspections was provided as follows: 

  BG  reported  30  routine  and  five  non-routine  (following  SARE)  inspections  in 
hospitals  performing  transfusion  of  blood  and  blood  components  as  a  part  of  their 
medical activities; 

 

In ES, 24 blood establishments were inspected, of which five were on-site inspections 
for  accreditation  and  seven  for  monitoring, 16  ISO Norm 9001  inspections (nine  for 
accreditation and seven for monitoring) and eight “other” without specification; 

  FR  reported  seven  inspections  regarding  enhancement  of  the  processing  of  the 
amotosalen plasma (plasma pathogen reduced/pathogen inactivated),  four inspections 
of haemovigilance organisations and three at mobile collection sessions; 

  LT reported three inspections due to a whistle-blower. 

Difficulties  complying  with  the  required  two  year  intervals  when  inspecting  blood 
establishments 

In the last three years, 559 BEs were inspected at least twice as reported by 20 Member States 
plus Liechtenstein and Norway. However, CY, EL HR, IT, LU, MT, PT reported that none of 
their blood establishments were inspected at least twice in the last three years. 

84 

45 

40 

29 

24 

18 17 

6 

0 

3 

0  0  1  2  0  2  4  0  4  0  1 

94 

74 

41 

28 

23 

3 

16 

0 

T
A

E
B

G
B

Y
C

Z
C

E
D

K
D

E
E

S
E

I
F

R
F

L
E

R
H

U
H

E
I

T
I

I
L

T
L

U
L

V
L

T
M

L
N

O
N

L
P

T
P

O
R

E
S

I
S

K
S

K
U

Fig. 11 – Number of blood establishments inspected at least twice in the last 3 years/country 

Half of the reporting countries considered it difficult to comply with the two-year inspection 
interval required by Article 8(2) of Directive 2002/98/EC. 

No: BE, BG, CZ, DE, 
FI, IE, LI, LU, NL, 
NO, PL, RO, SI, SK, 
UK 15 

Yes: AT, CY, DK, EE, 
EL, ES, FR, HR, HU, 
IT, LT, LV, MT, PT, 
SE 
 15 

 Fig. 12 – Difficulties in complying with inspections every two years 

19 

 
 
 
 
 
The  reasons  mentioned  by  Member  States  experiencing  difficulties  were:  lack  of  human 
resources, current definitions in the EU Blood Directive 2002/98/EC not providing sufficient 
detail  in  the  description  of  site  activities  (e.g.  mobile  or  satellite  sites)  (Germany)  and  few 
results  compared  to  the  time  and  effort  invested.  Member  States  who  did  not  report  such 
difficulties quoted a sufficient number of inspectors, inspections performed by more than one 
competent  authority,  small  numbers  of  authorised  blood  establishments  and  blood  banks 
managed through an accreditation body, and existing adequate resources assigned to inspect 
the blood establishments. 

Inspection outcomes 

Some suspensions of authorisations or closure- of blood establishments were reported in the 
replies  to  the  survey.  No  data  is  available  on  the  number  of  blood  establishments  that 
voluntarily  ceased  operation  or  were  forced  to  cease  operation  for  other  reasons  (e.g. 
economic).  Poland  reported  the  dismissal  of  one  blood  establishment  director  in  2013. 
Romania  reported  that  four  inspections  were  organised  following  SARE  or  the  suspicion  of 
SARE.  For  three  of  them,  it  was  found  that  the  procedures  were  compliant  with  the 
regulations.  For  one,  administrative  measures  were  imposed  due  to  clerical  errors.  Four 
Member States reported having to impose penalties (BG, CZ, LT, SK). It was noted that there 
is a divergence in criteria for assessment, classification of deficiencies and eventual outcomes 
of inspections. 

Comments 

A move towards a system of risk-based assessment to prioritise establishments to be inspected 
has been cited as being effective by several Member States. Such systems would be preferred 
by  many  instead  of,  the  current  legislative  requirement  to  inspect  all  blood  establishments 
within at most a two-year interval.  

There  is  a  divergence  in  criteria  for  assessment,  classification  of  deficiencies  and  some 
Member States called for developing more common definitions of deficiencies and outcomes 
of inspections. 

2.2.4.  Other inspections 

Inspections and control measures of mobile and satellite collection sites 

Difficulties with inspecting mobile and satellite collection sites every two years, as required 
by Article 8 of Directive 2002/98/EC, were raised by many Member States, both in the 2013 
competent  authorities  meeting2  and  in  response  to  this  survey,  due  to  the  high  number  of 
existing sites and the definition of ‘mobile site’ not being adequately precise.  

Some  Member  States,  such  as  France,  the  United  Kingdom  and  Belgium,  have  proposed  a 
risk-based  approach  to  define  inspections  intervals  for  these  sites  and  a  clarification  of  the 
blood  establishment  definition.  France  also  proposed  changes  to  Article  8  to  include 
specifications regarding mobile site inspections. 

2  Meeting  of  the  Competent  Authorities  on  Blood  and  Blood  Components  17  and  18  April  2013, 
http://ec.europa.eu/health/blood_tissues_organs/docs/blood_mi_20130417_en.pdf 

20 

 
 
 
                                                            
o
N

e
t
i
l
l
e
t
a
s

y
r
e
v
E

o
N

e
l
i
b
o
m

/

d
n
o
c
e
s

i
t
c
e
p
s
n
i

s
e
t
i
s

r
a
e
y

s
n
o

CY, HR, LI, LU

4 

BE, BG, CZ, DK, ES,FI, IE, IT, LT, LV,
MT, NL, NO, PL, RO, SE, SI, UK

17 

EL

1 

0

5

10

15

20

Fig. 13 - Inspection scheme of mobile and satellite sites 

Inspection approaches for these sites are quite different between Member States. One Member 
State (Greece) reported having no inspections in place for these sites, while 21 Member States 
plus Norway reported following a variety of approaches for inspecting mobile/satellite sites: 

  DK,  HU,  IE,  LT,  LV,  RO,  SI,  plus  NO  reported  that  all  mobile  sites  are  inspected 
every two years although RO clarified that they only inspect fixed sites, not those sites 
where teams from a blood establishment go with their own equipment; 

 

 

 

In AT, at regional level, the sites are inspected based on a risk-based approach;  

In  BE,  satellite  collection  sites  are  inspected every  two  years.  The  mobile  collection 
sites  are  inspected  at  a  rate  of  two  per  province  (there  are  10  provinces  in  Belgium 
plus the region of Brussels); 

In BG, equipment and documentation are inspected on a regular basis during routine 
inspections  as  the  mobile  team’s  staff  are  considered  part  of  blood  establishment 
personnel. One blood establishment’s satellite site for blood collection was inspected 
twice in a period of four years, as part of the blood establishment; 

  CZ  reported  that  mobile  collection  sites  are  inspected  once  every  four  years  and 

satellite collection sites once every two years; 

  DE reported that for satellite collection sites and mobile sites inspection intervals are 
generally  equivalent  to  routine  inspections  of  the  related  blood  establishments,  since 
the satellite collection sites and the mobile sites are considered to be part of the blood 
establishment; 

  EE reported that satellite sites have separate authorisations and are inspected at least 
every two years as blood establishments. Mobile sites are inspected as part of a blood 
establishment; occasionally on-site inspections are carried out; 

  ES satellite sites are inspected every two years and a sample of the total number of the 

mobile collection sites is inspected; 

  FI has 18 satellite sites inspected every two years; 

 

In  FR,  the  operation  and  management  of  the  mobile  collection  site  teams  and 
equipment  are  inspected  every  two  years,  as  part  of  the  inspection  of  the  reference 
blood establishment. The premises are inspected as regularly as necessary (less than 
ten inspected every year); 

 

IT reported that the sites are inspected every two years, but a risk-based approach will 
be introduced; 

21 

 
 
 
 
  NL reported that mobile sites are inspected randomly without specifying the frequency 

and intervals;  

  PT  reported  that  the  intervals  for  inspecting  those  sites  are  yet  to  be  defined  by  the 

new competent authority; 

  SK  reported  that  blood  establishments  are  inspected  every  two  years.  Mobile  site[s] 

can be included in this inspection, without clarifying if they are inspected; 

 

In the UK, mobile sites are inspected based on a risk-based sampling exercise during 
the inspection of their associated blood establishment. 

Plasma establishment inspections 

In 2012, 253 plasma establishments (a site for the collection of plasma) were inspected in 11 
Member States plus Norway. CY, EE, HR, HU, IE, MT, PT, RO and SI reported not having 
sites for plasma collection. Bulgaria, Spain, Italy and Norway reported that they do not have 
establishments  exclusively  performing  plasma  collection.  The  United  Kingdom  reported  16 
inspections performed in third countries, as plasma is not collected nationally. Four Member 
States did not respond. 

Hospital Blood Bank Inspections 

Hospital  blood  banks  (HBB)  are  inspected  in  23  Member  States  plus  Liechtenstein  and 
Norway.  

No: CY, HU, LT, 
MT, NL 
 5 

Yes: AT, BE, BG, CZ, 
DE, DK, EE, EL, ES, 
FI, FR, HR, IE, IT, LI, 
LU, LV, NO, PL, PT, 
RO, SE, SI, SK, UK 
 25 

Fig. 14 – Hospital blood bank inspections  

In 17 Member States plus Liechtenstein and Norway, the blood national competent authority 
is  involved  in  the  inspections  of  the  HBBs.  Ireland  clarified  that  the  Irish  National 
Accreditation  Board  authorises  the  HBBs  with  the  supervision  of  the  blood  competent 
authority. 

No: BE, EE, ES, FI, 
IT, SI 
6 

Yes:AT, BG, CZ, 
DE, DK, EL, FR, HR, 
IE, LI, LU, LV, NO, 
PL, PT, RO, SE, SK, 
UK 19 

Fig. 15 – Hospital blood bank inspections with involvement of the blood competent authority/country 

22 

 
 
 
 
 
 
Comments 

A significant divergence between national practices emerges as regards the inspection of the 
731 mobile units and 534 satellite centres, where an important part of the blood (components) 
is collected.  

2.3. 

Provisions for Blood Establishments 

2.3.1.  Responsible person 

Under Article 9 of Directive 2002/98/EC, blood establishments shall designate a responsible 
person  whose  responsibilities  and  qualifications  are  defined  in  paragraphs  1  and  2  of  this 
Article. All Member States plus LI and NO reported having a designated responsible person 
fulfilling  the  Article  9  (2)  requirements  in  every  blood  establishment.  In  19  Member  States 
(BE, BG, CY,CZ, DK, EE, ES, FR, HR, IE, LI, LU, LV, NL, PL, RO, SE, SI, SK and UK) 
plus  Norway,  the  responsible  person’s  tasks  are  delegated  to  other  qualified  persons  where 
necessary. The competent authorities check the qualifications of the responsible person during 
inspections. 

Comments 

All  Member  States  reported  having  responsible  persons  in  each  blood  establishment.  The 
qualifications  of  the  responsible  person,  and  possibly  his/her  delegates,  are  verified  during 
inspections. Member States reported the value of Joint Actions and the work of the Council of 
Europe  (CoE)  in  clarifying  common  understanding  and  expectations  towards  responsible 
persons,  their  qualifications  and  possibilities  of  delegation,  as  these  can  vary  between 
Member States. 

2.4. 

Quality management 

2.4.1.  Quality System for blood establishments 

As  required  by  Article  11  (1)  of  Directive  2002/98/EC  and  Article  2  (1)  of  Directive 
2005/62/EC, Member  States shall take all measures to  ensure that each blood establishment 
and hospital blood bank (Article 6) maintains a quality system based on good practices. 

All Member States reported that blood establishments and hospital blood banks have a quality 
system which is verified and strengthened through the following measures: 

 

Inspections (AT, BE, BG, CZ, DK, EE, EL, ES, FI, FR, HR, HU, IE, IT, LT, MT, NL, 
PL, PT, RO, SE, SI, SK, UK plus LI and NO); 

  Audits (IE, LV, PL); 

  Training courses (FR, HR, LV, RO). 

2.4.2.  Record keeping 

Under Articles 13 and 14 (3) of Directive 2002/98/EC, Member States must ensure that blood 
establishments maintain records of the information required in Annexes II and IV. Moreover 
Articles  14  (3)  of  Directive  2002/98/EC  and  4  of  Directive  2005/61/EC  require  that  blood 
establishments,  hospital  blood  banks  or  facilities  keep  data  to  ensure  full  traceability  for  a 
minimum of 30 years in an appropriate and readable storage medium. 

As  reported,  compliance  with  this  requirement  is  verified  through  inspections  and  legal 
provisions to verify compliance:  

23 

 
 
 
 
 
  CY reported that requirements are fulfilled under the responsibility of the responsible 
person. Nonetheless it was not clear how this is checked by the competent authority;  

  EL  replied  that  for  BEs  and  HBBs  without  a  computerised  system,  this  requirement 
cannot be fully respected; it is therefore not certain if these requirements are fulfilled 
in all Greek BEs and HBBs;  

  ES mentioned specific computer systems; 

  UK reported that this is ensured by IT systems, data retention policies and a disposal 

schedule. 

The required mediums to store records are paper and electronic forms in 26 Member States, 
while  only  electronic  forms  are  required  in  2  Member  States  plus  Norway.  Liechtenstein 
requires only paper forms.  

Only paper records:  
LI; 
1 

Only electronic forms: 
DK, ES NO, 
 3 

Both:AT, BE, BG, CY, 
CZ, DE, EE, EL, FI, 
FR, HR, HU, IE, IT, 
LT, LU, LV, MT, NL, 
PL, PT, RO, SE, SI, 
SK, UK 
 26 

Figure 16 – Required data storage medium by Member State 

All  countries,  except  Romania  and Norway,  considered  30 years  an adequate timeframe  for 
data  storage.  Romania  considered  this  period  to  be  too  long  due  to  difficulties  foreseen  in 
ensuring archiving space and document management. 

Comments 

All  Member  States  report  to  have  quality  systems  in  blood  establishments,  as  well  as  in 
hospital  blood  banks.  These  are  verified  during  inspections  or  audits.  Member  States 
mentioned  the  work  of  the  Council  of  Europe  (CoE),  which  organises  regular  training  on 
quality management systems, to be helpful to keep these systems in line with legislation and 
state of the art practice in the sector.  

While  the  30  year  data  retention  period  is  questioned  by  some  Member  States,  this  time 
window  is  in  line  with  general  data  retention  periods  in  the  medical  sector.  Some  Member 
States do, however, call for a clarification and limitation of what data should be retained.  

2.5. 

Haemovigilance 

2.5.1.  Traceability - Donor identification system 

Under Article 14 (1) of Directive 2002/98/EC, Member States must ensure that all blood and 
blood  components,  collected,  tested,  processed,  stored,  released  and/or  distributed  on  their 
territory can be traced from the donor to the recipient and vice versa. In this regard, Member 

24 

 
 
 
 
 
States  are  required to  implement  a  donor  identification  system  for  each donation  and  single 
blood unit and component. 

Twenty-seven  Member  States  plus  Norway  reported  that  a  donor  identification  system  was 
implemented in their countries. There is one national coding system in 18 Member States plus 
Norway,  and  multiple  systems  in  nine  Member  States.  Liechtenstein  has  no  system 
implemented,  as  they  only  have  autologous  pre-deposit  donations.  All  Member  States 
reported that the same rules on traceability apply to blood establishments as well as to hospital 
blood banks. Member States reported the following policies and donor identification systems: 

  A national donor identification system is in place in CY, CZ, EE, EL, FI, FR, HR, HU, 

IE, IT, LU, MT, NL, NO, PL, RO, SE, SI, SK, UK; 

  AT, BE, BG, DE, DK, ES, LT, LV, PT have more than one system implemented. 

The donor identification systems used are: ISBT 128 (in 16 Member States plus Norway: AT, 
CY,  DE,  DK,  EE,  ES,  FI,  IE,  LT,  LV,  MT,  NL,  PL,  PT,  SE,  UK),  Codabar  (in  2  Member 
States:  Hungary,  Slovenia),  Codabar  plus  ISBT  128  (IE)  and  Eurocode  plus  ISBT  128 
(Germany). Spain reported that 76%, and Belgium that 96%, of blood establishments use the 
ISBT 128 system. 

The  use  of  international  coding  systems  by  Member  States  for  labelling  different  blood 
components is listed in the following figure: 

l
o
h
W
o
o
l
B

d
e
R

r
e
h
t
O
o
o
l
b
e

d

s
a
l
P

l
e
t
a
l
P

:
s

:
d

:
s
l
l
e
C

:
a
m

:
s
t
e

DE, DK,  EE, FI, HU, IE, NO, PL, PT, SE,SI, UK

12 

AT, DK, EE, ES, FI, HU, IE, LT, LV, MT, NL, NO, PL,
PT, SE, SI, UK
AT, CY, DE, DK, EE, ES, FI, HU, IE, LT, LV, MT, NL,
NO, PL, PT, SE, SI, UK
AT, CY, DE, DK, EE, ES, FI, HU, IE, LT, LV, MT, NL,
NO, PL, PT, SE, SI, UK
AT, CY, DE, DK, EE, ES, FI, HU, IE, LT, LV, MT, NL,
NO, PL, PT, SE, SI, UK

17 

19 

19 

19 

0

2

4

6

8

10

12

14

16

18

20

Fig. 17 - International coding systems used/component 

Some Member States specified which are the “other” labelled components: granulocytes (DE, 
HU, IE, PL, SE, SI), cryoprecipitate (Estonia, Poland, United Kingdom), buffy coat (Norway, 
United Kingdom), neonatal components (Ireland, Poland). Denmark, Portugal and the United 
Kingdom reported that all blood components are labelled using international codes. 

Comments 

The  great  majority  of  Member  States  have  implemented  international  standards  for  the 
identification and labelling of blood and blood components. 

2.5.2.  Notification of serious adverse events and reactions 

Under Article 15(1), Member States must ensure the notification to the competent authority of 
any  serious  adverse  events3  which  may  influence  the  quality  and  safety  of  blood  and  blood 

3 

According to Article 3(g) of Directive 2002/98/EC, ‘Serious adverse event’ shall mean any untoward 
occurrence  associated  with  the  collection,  testing,  processing,  storage  and  distribution  of  blood  and 

25 

 
 
 
 
                                                            
components  and  which  may  be  attributed  to  the  collection,  testing,  processing,  storage  and 
distribution  of  blood  and  blood  components,  as  well  as  serious  adverse  reactions4  observed 
during or after transfusion which may be linked to the quality and safety of blood and blood 
components. The procedures for notifying serious adverse events and reactions are laid down 
in Commission Directive 2005/61/EC. 

National vigilance system 

All Member States except for Hungary reported having a national vigilance system in place.  

In co-operation with Member States, templates, and practical guidance for their compilation, 
have been developed by the Commission for annual reporting  of serious adverse events and 
reactions  (Directive  2005/61/EC,  Articles  5  and  6).  This  guidance  is  also  used  at  national 
level in 24 Member States (AT, BE, CY, CZ, DK, EE, EL, ES, FI, HR, HU, IE, IT, LT, LU, 
LV, MT, NL, PL, PT, RO, SE, SI, SK, UK) plus Liechtenstein. Bulgaria and Norway reported 
using national regulations. In 24 Member States (AT, BE, CY, CZ, DK, EE, EL, ES, FI, HR, 
HU, IE, IT, LI, LT, LU, LV, MT, PL, PT, RO, SE, SI, SK) plus Liechtenstein, the European 
templates are also used at national level. BG, DE, FR, NL and NO use national templates. 

In 21 Member States plus Liechtenstein and Norway, there is a dedicated vigilance officer at 
national  level.  Member  States  without  an  appointed  officer  gave  different  reasons  for  this. 
Germany  explained  that  each  competent  authority  has  a  responsible  person  and  there  is 
cooperation between the federal competent authority and the regional competent authorities of 
the Laender. In Estonia, the same specialist is responsible for haemovigilance, licensing and 
inspecting  blood  establishments.  In  the  United  Kingdom,  there  is  a  team  of  two 
haemovigilance officers.  

No: CZ, DE, EE, HR, 
NL, RO, UK 
7 

Yes: AT, BE, BG, 
CY, DK, EL,ES, FI, 
FR, HU, IE,  IT, LI, 
LT, LU, LV, MT, … 

Fig. 18 – Vigilance officer in reporting countries 

Blood establishments reporting SARE in 2012 

In 2012, SARE reports were provided by 100% of blood establishments in 19 Member States 
plus Liechtenstein and Norway, 70-99% of blood establishments in eight Member States and 
50-60% of blood establishments in one Member State. 

blood  components  that  might  lead  death  or  life-threatening,  disabling  or  incapacitating  conditions  for 
patients or which results in, or prolong, hospitalisation or morbidity. 

4  

According to Article 3(h) of Directive 2002/98/EC, ‘Serious adverse reaction shall mean an unintended 
response  in  donor  or  in  recipient  associated  with  the  collection  or  transfusion  of  blood  or  blood 
components  that  is  fatal,  life-threatening,  disabling,  incapacitating  for  patients  or  which  results  in,  or 
prolong, hospitalisation or morbidity. 

26 

 
 
 
 
                                                                                                                                                                                          
 
50-69%  
SE 
1 

70-99%  
AT,CZ, DE, EL, HU, 
IT, PT, SK; 
8 

100%  
BE, BG, CY, DK, EE, 
ES, FI, FR, HR, IE, 
LI, LT, LU, LV, MT, 
NL, NO, PL, RO, SI, 
UK 
 21 

Fig. 18 – Percentage of reporting blood establishments/country 

All  countries,  except  United  Kingdom  and  Cyprus,  reported  having  a  mandatory  procedure 
for hospital blood banks when reporting SARE to the blood establishments which distributed 
the  blood  and  blood  components,  as  required  by  Article  5  (1)  of  Directive  2005/61/EC.  In 
Cyprus, the hospital blood banks report directly to the Ministry of Health. 

Root cause analysis of SARE 

A root cause analysis of SARE is performed in 23 Member States (AT, BE, BG, DE, DK, EE, 
EL,  ES,  FI,  FR,  HR,  HU,  IT,  LT,  LU,  LV,  MT,  NL,  PL,  PT,  RO,  SI,  SK)  plus  Norway. 
Cyprus and Liechtenstein explained that they had not performed root cause analyses because 
no  SARE cases  had been reported  so far. In  Czech Republic, Spain  and Sweden  mentioned 
that root cause analyses are performed by blood establishments and hospital blood banks. In 
Ireland,  root  cause  analyses  are  performed  by  the  National  Haemovigilance  Office  in 
association with the competent authority. 

Feedback to blood establishments of SARE reported at EU level 

Feedback  to  the  blood  establishments  regarding  SARE  reported  at  EU  level  is  given  by  23 
Member States (BE, BG, CY, CZ, DE, EE, EL, FI, FR, HR, HU, IE, IT, LT, LU, MT, NL, 
PL, PT, RO, SE, SK, UK) plus Norway. Spain and Norway waited for the publication of the 
European  Commission  summary  report  to  share  with  their  establishments.  Denmark  issue  a 
national yearly  

Recall procedures 

Article 15(1) of Directive 2002/98/EC requires blood establishments to have an efficient and 
verifiable procedure to withdraw distributed blood and blood components associated with the 
notification of SARE. All Member States plus Liechtenstein and Norway reported to have this 
in place. In 2012, 1,867 recalls were reported by a total of 14 Member States. Austria and the 
United  Kingdom  reported  that  data  was  unavailable,  Spain  reported  that  data  was  only 
available at regional level and Italy reported that recall reporting is not mandatory.  

7
0
5

4
9
3

4
3
1

2
2
1

500

400

300

200

100

0

6
  2
0

6
4
2

9
2
2

5
3
1

3
3

0

0

0

0

4

1

1
1

0

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0

0

3
  2
2

0

T
A

E
B

G
B

Y
C

Z
C

E
D

K
D

E
E

S
E

I
F

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F

L
E

R
H

U
H

E
I

T
I

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L

T
L

U
L

V
L

T
M

L
N

O
N

L
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T
P

O
R

E
S

I
S

K
S

K
U

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fig. 20 – Number of recalls in 2012/country 

Post donation information on donor health which could affect the quality and safety of blood 
and blood components was a common cause for recalls reported: 

Country 

Causes 

BE 

CZ 

EL 

FI 

FR 

HU 

IE 

NL 

PL 

PT 

In 26 cases, microbiological testing of platelets had been negative at the time of distribution but the samples 
subsequently became positive resulting in recall. 

135 (vast majority - look back procedure for plasma fractionation) 

1 unit in-date RBCs  was recalled, in the case of whole blood platelets transfusion severe WNV encephalitis 
transmission.  The  FFP  derived  from  the  same  blood  unit  was  already  transfused  in  to  another  patient  (who 
remained WNV asymptomatic). 

246 recalls in 2012 because of defective product (3), reclamation (complaints?) (164), look back/trace back (9) 
or deviation in transport temperature (70); over 90% of which were red cells. 

4 recalls of blood derived medical products were performed as a precautionary measure following the onset of 
a CJD (sporadic form) in a donor. 

11 events related with donor. Lyme risk 4 cases, tuberculosis 1 case of acute leukaemia, all cases detected after 
blood  collection.  2  minipools  HCV  contamination  detected  by  PCR  technique  by  plasma  fractionation 
company, but the infections were not evident in the patients. 

159 (69.4%) recalls due to post donation information (including abnormal full blood count); 29 (13%) recalls 
due to suspected bacterial contamination; 33 (14.4%) recalls due to suspected adverse reaction to product; 8 
(3.5%) repeated reactive virology test; 3 (1.3%) platelet aggregates; 2 (1%) air in line; 6 (2.6%) others. 

394  recalls  mostly  because  of  withdrawn  donations  and  positive  BactAlerts  (bacterial  contamination 
suspected) 

Storage – 66 Distribution – 13 Transport – 3  Other (no specify) – 52 

122  Total:  positive  bacterial  -  91  blood  components;  post  donation  information  -  21  blood  components; 
TRALI - 5 blood components; HIV positive - 1 blood component; other - 4 blood component 

Table 3- Reported causes for recalls 

Rapid alerts and blood establishment notification by competent authorities 

All Member States plus Norway and Liechtenstein reported having a system or procedure to 
notify blood establishments in case of a rapid alert either at national or at European level via 
the  rapid  alert  system  for blood. Member States were  asked to  provide information  on their 
systems or procedures (Table 4).  

28 

 
 
 
Country 

AT 

Information by mail 

BE 

Information note to 
the BEs by email 

Alert 
System 

Country 

Alert 
System 

DE 
PEI informs by e-mail the 
responsible regional CAs of 
the “Laender” and the 
graduated scheme officer/ 
qualified person. 
Graduated scheme officers 
are responsible to set up 
and manage a 
pharmacovigilance system 
and to collect and evaluate 
notifications on medicinal 
product risks and to co-
ordinate the measures 

Country 

FI 

The national rapid alert 
procedure secures the 
transmission of 
information e.g. between 
the Finnish Medicines 
Agency and blood 
establishments when 
urgent remedial or 
precautionary action is 
needed due to a serious 
public health threat. 

IT 

Rapid alert is part of the 
web-based HV system, 
performed by automated 
launch of emails to 
involved parties. 
MT 

The CA Haemovigilance 
Unit is responsible for 
alerting and forwarding 
both National alerts to the 
Blood Establishment and 
other stakeholders 
establishments on relevant 
alerts at an EU level 
received through the 
CIRCABC system 
RO 
Information sent by MoH 
or Centre for transmissible 
Diseases (depending on 
the case) to the NITH and 
from there to the BEs. If it 
is the case, BEs inform 
hospitals in their region. 

Alert 
System 

Country 

Alert 
System 

Country 

Alert 
System 

Country 

Alert 
System 

CY 

Information by 
fax, emails and via 
telephone to 
blood centre and 
blood banks  

CZ 
Information on web 
page of State 
Institute for Drug 
Control, and 
distributed via 
Medical Society 

BG 

In July 2011 has been 
created team (directors 
and responsible persons 
from all big blood 
establishments) for crisis 
management associated 
with transmissible 
infections (WNVD) 
which reacts in case of a 
national rapid alert. 

EE 

EL 

ES 

State Agency of 
Medicines(SAM) is 
responsible to notify all 
the BEs about the 
national rapid alert. All 
BEs have 24 hour phone 
number to be contacted 
by SAM .Information 
send by e mails as 
written confirmation.  

HR 

Blood establishments 
are notified through 
network of CA’s 
inspectors and 
responsible persons of 
blood establishments 
(by mail and fax). 

DK 
A blood establishment 
contact list is available 
if it is necessary. 

FR 
Rapid alert system of 
the EU (CIRCA) for 
communication with 
the Commission and 
Member States -
National emailing ,fax 
and phone calls - If 
necessary, a national 
crisis management 
team (CMT) is 
activated 

LI 
Information by fax and 
phone 

LT 
Information notified via 
emails and phone calls 

NL 

Only one blood 
establishment in the 
Netherlands, 
contacted by CA 
regularly. 

There is a standard 
operating procedure for 
notifying rapid alerts, 
and an updated mailing 
list of contact persons in 
all BEs. 

SE 

SI 

Ad hoc meeting on 
BTCS, the short 
description of alert and 
actions send to BE. In 
cases of SARE, CA is 
informed. 

Swedish National 
Board of Health and 
Welfare has a 24-
hours service, receives 
all alerts and informs 
all CA. CAs inform 
responsible CA as 
BE/hospital blood 
banks by e mail and 
public website. A 
blood establishment 
contact list is available 
to the coordinators at 
IVO.  

Coordinating 
Haemovigilance 
Centre (Skae) of 
the Hellenic 
Center for Disease 
Control and 
Prevention is 
sending classified 
mails to BEs. A 
system similar to 
RAB is now under 
construction 

HU 
The contact 
person - quality 
director- get the 
information from 
EU, countryside 
and it will be 
analysed with the 
clinical director of 
the service and 
coordinates the 
process. 

LU 
Direct information 
from NCA to BE 

NCA and the BEs’ 
responsible person 
are in touch by e-
mail and phone. A 
mail distribution list 
is continually 
updated. 
An alert system 
called e-Room, 
similar to the CIRCA 
BC platform under 
development 

IE 
Due to small 
number of BEs and 
BBs in Ireland, it is 
possible for the CA 
to communicate 
national rapid alerts 
via email to all 
relevant personnel 
and through use of 
CA website where 
required. 

LV 

Information not 
provided 

email 
communication 
send to the 
responsible persons 
of blood 
establishments 

UK 
MHRA would issue 
alerts by email 

Information on 
any new focus of 
infection is 
reported by the 
National IHR Focal 
Point or Main 
Sanitary 
Inspectorate to 
CA. CA informs 
BEs. 

SK 

Information is 
reported to State 
Institute for Drug 
Control and 
Ministry of 
Health. Inspectors 
of State Institute 
for Drug Control 
conduct  non- 
routine inspection 
and warn Head 
expert for 
Transfusion. 

29 

NO 

PL 

PT 

Table 4 – Summary of rapid alerts systems and procedures/country 

 
 
 
Alert notification to and from other national vigilance/alert systems 

Member States were asked if the national blood system notifies, or receives alerts from, other 
national vigilance or alert systems (e.g., pharmaceuticals or tissues & cells). Cyprus, Estonia, 
and Latvia reported no notification to or from other national vigilance/alert systems. Slovakia 
reported  not  receiving  alerts  from  other  national  vigilance/alert  systems.  In  Liechtenstein, 
there  is  only  one  national  vigilance/alert  system.  The  systems  with  which  information  is 
exchanged by Member States are shown in Figure 21. 

Fig. 21 – Alert notification to and from other national vigilance/alert systems 

Additional questions on traceability and SAR/E reporting 

Member  States  were  asked  for  additional  questions/  on  traceability  and  SARE  reporting. 
Poland suggested having a more precise and legally binding SAE definition: 'SAE – as only 
an event which is a real threat as result of improper component being issued for transfusion 
and  SAE  –  as  any  event  that  might  have  endangered  the  recipient’s  health,  even  though 
identified  and  eliminated  according  to  internal  control  procedures'.  Poland  considered  that 
the definition of “serious adverse events” should also include events that had taken place in a 
hospital laboratory, on a hospital ward or during the transfusion procedure.  

Simplification  of  the  imputability  table  related  to  serious  adverse  events  was  suggested  as 
follows: 

Transfusion-related imputability level: 

  0 - not assessable; 

  1  -  no  relation  –  there  is  evidence  for  attributing  the  adverse  reaction  to  alternative 

causes, and; 

  2 - relation assessed – evidence includes results of diagnostic tests. 

30 

 
 
 
 
Comments 

The  relatively  large  number  of  blood  establishments  that  do  not  report  SARE  requires 
particular  attention.  The  number  of  non-reporters  leads  to  the  conclusion  that  annual  SARE 
reporting  activities  are  an  underestimate  of  the  real  number  of  SARE,  and  national  efforts 
should be further scaled up.  

During  the  annual  presentations  of  SARE  data  during  the  competent  authority  meetings, 
national authorities have expressed their interest in further developing the root cause analyses 
of SARE, which can lead to valuable lessons learned for professionals and possible reductions 
in SARE numbers. There was a call for common definitions to further harmonise the SARE 
reporting  exercise.  Additional  questions  were  brought  up  on  how  to  involve  hospitals  in 
SARE reporting and how to involve local actors in root cause analyses. Competent authorities  
in this respect welcome the work by the CoE work on guidance and training. 

Competent authorities also highlight that the current legislation requires reporting of serious 
adverse  reactions  in  recipients  only;  even  a  donor  death  is  not  reportable  (Directive 
2002/98/EC,  Article  15).  This  is  despite  the  definition  of  a  serious  adverse  reaction  in  the 
same Directive (Article 3) that gives equal importance to adverse reactions in donors and in 
recipients.  Many  consider  that  donor  protection  is  to  be  strengthened  through  strong  legal 
protection  given  to  living  donors,  in  line  with  the  requirements  in  the  field  of  organs  laid 
down in Directive 2010/53/EC (Article 15). 

The national link to the EU rapid alert system for blood and blood components (RAB), set up 
in 2013, is now well established.   

2.5.3. 

Import/export  

Member State import rules and regulations  

Under  Article  21,  Member  States  shall  ensure  that  imported  blood  and  blood  components 
intended  for  use  or  distribution  in  the  Union  are  tested  in  conformity  with  the  Directive’s 
requirements. In addition, Member Sates shall ensure there is a quality system or equivalent in 
the stages preceding import (Article 2(3) of Directive 2005/62/EC), as well as a traceability 
system or equivalent as required under Directive 2005/61/EC. 

Twenty-two Member States (BE, BG, CZ, DE, EE, EL, FI, FR, HR, HU, IE, IT, LT, LU, LV, 
MT,  NL,  PL,  RO,  SE,  SI  and  SK)  plus  Liechtenstein  and  Norway  reported  having  rules  in 
place  for  authorisation  and  control  of  blood  and  blood  components  for  transfusion,  coming 
from  other  (EU  and  third)  countries.  These  rules  define  the  conditions  under  which  such 
import can take place, or in some cases prohibit such imports. Austria and Denmark reported 
they have no rules or conditions. Cyprus, Spain and Portugal replied that blood components 
are not imported for transfusion.  

The  existence  of  rules  to  authorise  and  control  import  of  blood  and  blood  components  for 
fractionation was reported by 17 Member States (AT, BE, BG, CZ, DE, EL, ES, FI, FR, HU, 
IT, LU, LV, PL, RO, SE and UK). 

Importation of blood components for transfusion 

Twenty Member States (BG, CY, CZ, DE, EE, EL, ES, FI, FR, HR, HU, IE, IT, LT, LU, NL, 
PT, RO, SI, SK) plus Norway reported having data regarding blood components imported for 
transfusion from third countries (outside the EU). However, only Greece and Ireland reported 
the  import  from  third  countries  in  2012:  25,200  red  cell  concentrates  from  the  Swiss  Red 
Cross Blood Centre to Greece and two red cell concentrates from the USA to Ireland. 

31 

 
 
 
Importation of plasma for fractionation 

Regarding plasma imported for fractionation, 15  Member States  (BG, CY, CZ,  DE,  EE, FI, 
FR, HR, LT, LU, NL, PT, RO, SE, SI,) plus Norway reported having data on plasma imported 
for  fractionation  from  third  countries.  See  Annex  2  for  information  reported  on  plasma 
fractionation facilities in Member States. Thirteen Member States (AT, CZ, DK, EE, IE, LT, 
LU, LV, MT, NL, PT, SI, SK) plus Liechtenstein and Norway do not report having data on 
imported plasma for fractionation or they do not import it. The national standards in place for 
verifying the equivalent quality and safety of blood components imported from third countries 
are listed Figure 22. 

:
s
r
e
h
t
O

:
s
d
r
a
d
n
a
t
s

:
s
d
r
a
d
n
a
t
s

o
i
t
a
n
r
e
t
n
I

l
a
n

t
n
e
l
a
v
i
u
q
E

 BE, CY, DE, ES, FR, IT, LI, LU,
LV, NL, PL, PT, SE, UK

14 

AT, FI, HU, IE, LT, SI

6 

BG, CZ, DK, EE, EL, ES, HR,
MT, NO, RO, SK

11 

0

5

10

15

Fig. 22 – Procedures to verify equivalent standards of quality and safety of imported blood components/country 

Regarding  “others”,  Belgium  and  the  United  Kingdom  mentioned  inspections  as  the 
verification  method  applied.  Germany,  France,  Italy  and  the  United  Kingdom  reported  that 
equivalent  standards  to  national  standards  are  required.  In  Sweden,  compliance  with  the 
Plasma  Master  File  is  a  requirement  in  addition  to  equivalent  standards  of  the  Directive 
2002/98/EC. Latvia reported that import is not allowed. 

Testing  requirements  for  import  of  blood  and  blood  components  from  third  countries  going 
beyond  the  minimum  requirements  provided  in  Annex  IV  to  Directive  2002/98/EC  are 
applied by 15 Member States (BE, CZ, DE, EL, ES, FR, HR, IE, IT, LI, NL, PL, PT, RO, SI, 
SK) plus Liechtenstein. These include the tests shown in Figure 23. 

Fig.  23 - Additional tests required for import/country 

32 

 
 
 
 
 
Ireland reported “possibly NAT and perhaps West Nile virus testing” and considered that the 
issue needs to be discussed with the European blood establishments and ECDC. 

Export 

In 2012, only Finland, France and Italy reported export of blood components for transfusion 
from their Member State to third countries (outside the EU):  

FI 

2  units red blood cells, leucocyte depleted in 
additive solution 

FR  200 units of therapeutic lyophilized plasma 

IT 

126 red blood cell units 

70 red blood cell units  

Table 5- Report on exported blood components/country  

Norway 

USA 
Congo, Paediatric Hospital of Kimbondo, for 
humanitarian aid 
Republic of San Marino according to bilateral 
agreement.   

A  majority  of  Member  States  reported  that  they  have  data  on  the  export  of  plasma  for 
fractionation  in  third  countries  or  in  other  EU  Member  States.    Just  six  Member  States 
reported data on the export of plasma for fractionation: 

DE  3,399,419 L 

Third countries (not specified) 

DK  214,576 (60,9 metric tons)  Switzerland 

EE 

34,196 ‘doses’ of plasma 

Countries not specified 

Table 6- Reported data on exported plasma for fractionation/country 

SK  3063 L  

Ukraine 

Member States reported the following rules for the authorisation and control of the export of 
blood and blood components for fractionation to EU Member States or third countries: 

  CY, EL, ES, FR, HR, HU, IE, MT, NL, PT and UK do not export blood components 

for fractionation; 

  BG limits export to humanitarian aid and production of drugs for their national needs;  

  NL  clarified  that  plasma  is  only  collected  for  fractionation  in  the  country  and  is  not 

exported; 

  AT referred to GMP Annex 145; 

  DE, DK, RO and SK referred to national laws;  

  CZ reported that requirements to export depend on the partner and export is  under a 

MoH export licence; 

 

 

In FI and NO, there are no special rules for the export of blood and blood components 
for fractionation; 

In IT, national plasma can only be sent to EU Member States for contract fractionation 
purposes.  This  is  authorised  and  controlled  by the  competent  authority  (the  National 

5  The  Rules  Governing  Medicinal  Products  in  the  European  Union,  Volume  4,  EU  Guidelines  for  Good 
Manufacturing  Practice  for  Medicinal  Products  for  Human  and  Veterinary  Use,  Annex  14.  Manufacture  of 
Medicinal  Products  Derived  from  Human  Blood  or  Plasma;  http://ec.europa.eu/health/files/eudralex/vol-
4/annex14_rev30-03_2011_en.pdf 

33 

 
 
 
                                                            
Medicines  Agency  (Agenzia  Italiana  del  Farmaco  -  AIFA).  Commercialisation  is 
strictly prohibited;  

  LI has authorised blood collection by the Austrian Red Cross, section Vorarlberg; 

  LT  reported  following  the  requirements  of  the  blood  Directives  and  European 

Pharmacopoeia (Ph. Eur.) monographs on human plasma-derived products; 

  LV  requires  a  manufacturing  licence  for  the  manufacture  of  medicinal  products  in 

another Member State; 

  SI reported that a contract and quality assurance agreement is required; 

  All  BEs  in  SE,  that  are  releasing  plasma  for  fractionation  abroad,  are  inspected  and 
authorised according the same national legislation as applies for use of the plasma in 
Sweden. 

Member States reported the following rules for the authorisation and control of the export of 
blood and blood components for transfusion to EU Member States or third countries: 

  Blood components are not exported for transfusion in AT, CY, EL, ES, HR, HU, LI, 

LU, MT, PT, SE, UK; 

  Export is limited to emergency situations in BG, IE, DK and SI which allows export to 

neighbouring countries for immunised patients or for humanitarian assistance;  

 

 

 

In FI, LT, NO, and PL there are no specific rules; 

In  FR,  there  is  a  legislative  rule  for  export  of  blood  components,  but  no  mandatory 
authorisation  procedure.  Export  is  carried  out  by  the  civil  National  Blood  Service 
(EFS), which notifies the competent authority (ANSM);  

IT reported a national legally binding specific procedure to export blood components 
for  transfusion,  which  must  fulfil  national  quality  and  safety  requirements  and  be 
authorised by the Ministry of Health; 

  NL  reported  that  only  authorised  blood  establishments  could  export  blood  or 
components  for  transfusion.  The  Military  Blood  Bank  supplies  the  Dutch  troops  in 
third countries; 

  RO and SK referred to national provisions which have to be followed. 

Comments 

While  it  is  clear  that  there  is  limited  movement  of  blood  and  blood  components  for 
transfusion  between  Member  States  and  to  and  from  third  countries,  it  is  difficult  to  draw 
conclusions  on the volumes  of plasma  for fractionation that  are imported  or exported  in the 
absence  of  a  harmonised  data  collection  system.  There  is  a  not  always  clear  distinction 
between  import/export  from/to  third  countries  and  distribution  from/to  other  EU  Member 
States. 

2.5.4. 

Shortages and surplus of blood and blood components 

In  this  survey,  regular  shortages  of  blood  components  for  transfusion  were  reported  by  six 
Member States: 

  BG reported red cell and platelet shortages once per year, most commonly seasonally, 
often  after  long  summer  holidays,  less  frequently  there  is  a  shortage  of  a  particular 
blood group; 

34 

 
 
 
  Shortages of red cells and platelets were reported by CY and SE;  

  EL  reported  red  cell  and  platelet  shortages  during  summer  holidays,  intensified  by 

WNV outbreaks; 

  HU reported shortages of platelets, plasma, red blood cells and whole blood; 

  PT  reported  having  a  shortage  of  red  cells  during  the  first  semester  of  2012,  which 

does not occur frequently.  

A  surplus  of  blood  and  blood  components  was  reported  by  five  Member  States:  platelets, 
plasma  and  red  blood  cells  reported  by  Germany,  red  blood  cells  by  Italy,  plasma  by 
Lithuania,  Romania  and  Sweden.  In  Romania  and  Italy,  surplus  plasma  is  discarded.  In 
Sweden it is sold to pharmaceutical companies.  

BG, CY, EL and HU expressed interest in concluding bilateral agreements with other Member 
States and in establishing short-term/ad-hoc mechanisms for addressing shortages, while Italy, 
Liechtenstein and Romania expressed interest in such agreements to address blood component 
surpluses.  Greece  has  taken  the  lead  on  an  initiative  to  draft  a  model  for  such  agreements 
within the group of national competent authorities. 

Comments 

The  existence  of  national  surpluses,  shortages  and  cross-border  donations  suggests  the 
potential benefits of closer collaboration between Member States.  

2.5.5.  Cross-border movement of Donors 

Thirteen Member States (EL, SK, EE, DE, IE,  FR, NL, HU, SI, LU, CZ, PL, UK) reported 
that  they  have  cross-border  movement  of  donors  to/from  their  countries.  Fifteen  other 
Member  States  (AT,  HR,  IT,  DK,  SE,  LV,  CY,  RO,  MT,  FI,  BE,  PT,  LT,  BG,  ES)  plus 
Liechtenstein and Norway reported that they do not observe this practice.  

Comments 

Close to half of the Member States report cross-border movements of donors, making donation 
outside  their  country  of  origin/residence.  Due  to  its  relationship  to  the  compensation  or 
incentives  offered  to  donors,  this  topic  is  covered  more  extensively  in  the  Staff  Working 
Document on the implementation of the principle of voluntary unpaid donation6. 

2.6. 

Quality and safety of blood and blood components 

2.6.1.  Provision of information to prospective donors 

Under  Article  16  of  Directive  2002/98/EC,  Member  States  must  ensure  that  blood 
establishments provide prospective donors of blood or blood components with the information 
set out  in  Part  A of Annex II  to Directive  2004/33/EC.  All  28 Member  States  plus Norway 
and  Liechtenstein  replied  that  they  have  measures  in  place  to  ensure  only  trained  personnel 
provide  the  required  information  to  donors.  Twenty-seven  Member  States  plus  Norway  and 
Liechtenstein  mentioned  that  the  information  for  donors  is  standardised  at  national/regional 
level  to  ensure  the  requirements  of  Article  2  of  Directive  2004/33/EC  are  fulfilled.  Eight 
Member  States  (CY,  FR,  IE,  IT,  RO,  SI,  SK,  UK)  plus  Liechtenstein  indicated  other 
measures. 

6 Note that in the survey for the VUD report also AT and CY reported cross-border movements, while CZ, DE, 

FR, EL, IE did not report these movements there. 

35 

 
 
 
 
                                                            
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s

t
a

:
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O

:
l
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l
a
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o

:
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T

CY, FR, IE, IT, LI, RO, SI,SK, UK

9 

BE, BG, CY, CZ, DE, DK, EL, ES,FI, FR, HR, HU, IE,
LI, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK,
UK

AT, BE, BG, CY, CZ, DE, DK,  EE, EL, ES, FI, FR,
HR,HU, IE,  IT, LI,  LT, LU, LV, MT, NL, NO, PL, PT,
RO, SE, SI, SK,UK

27 

30 

0

5

10 15 20 25 30 35

Fig. 24 – How Member States ensure that the required information is provided to blood donors 

The blood directives do not require the existence of a system for self-exclusion by a donor. 
Nevertheless,  19  Member  States  reported  to  have  such  a  system  in  place,  including  post-
donation cards with a bar code (Belgium); a section with questions for self-exclusion in the 
blood  establishment  website  (Ireland),  information  in  the  pre-donation  material  (Czech 
Republic, France, Italy); phone calls (Netherlands, Slovenia) and boxes available for posting 
self-exclusion forms (Slovakia).  

Given the widespread adoption of self-exclusion systems, which often lead to effective recalls 
of donated blood (components), competent authorities suggested that it might be valuable to 
reflect on measures to improve further adoption of these systems by EU Member States. 

:
o
N

DK, EE, FI, HR, LI, LU, LV, NO, PT, RO

10 

:
s
e
Y

AT, BE, BG, CY, CZ, DE, EL, ES, FR, HU, IE, IT, LT, MT, NL, PL, SE, SI,
SK, UK

20 

0

5

10

15

20

25

Fig. 25 – Donor self-exclusion system in place 

Comments 

All Member States reported having measures to inform prospective donors through interview 
by  trained  staff.  Many  Member  States  report  good  experiences  with  donor  self-exclusion 
systems which are one of the main triggers for recalls.  

2.6.2. 

Information required from blood donors and examination of blood donors 

Blood  donor  information  is  collected  through  a  personal  interview  by  a  healthcare 
professional, who may or may not be a medical doctor, through a standardised questionnaire, 
in  22  Member  States.  In  some  Member  States,  there  is  a  mixed  situation,  as  shown  in  the 
following figures.  

36 

 
 
 
 
 
 
 
Fig.  26 – Healthcare professional obtaining donor information/country  

There  have  been  numerous  discussions  in  the  competent  authority  meetings  related  to  the 
differences  in  the  questions  asked  on  the  national,  regional  or  local  forms.  An  exercise 
comparing  questions  and  streamlining  national  questionnaires  was  suggested 
for 
consideration. 

Fig.  27 – Use of standardised form to collect blood donor information/country 

Germany specified that a national standardised form to collect blood donor information does 
exist  but  blood  establishments  may  also  use  forms  not  standardised  at  the  national  level,  as 
long as requirements as set by national law (i.e. Transfusion law) and relevant guidelines (e.g. 
haemotherapy guidelines) are taken into account. 

Comments 

The personal donor interview by a healthcare professional is an essential step to help ensure 
that a planned donation is safe for the donor as well as for the future recipient(s). While the 
questionnaires are standardised within many Member States, they do however vary between 
Member States.  

2.6.3.  Eligibility criteria for donors of whole blood and blood components 

Article 18 of Directive 2002/98/EC requires that the evaluation of blood and blood component 
donors should be assured by blood establishments in compliance with criteria defined in the 
Annex III to Directive 2004/33/EC.  

Relevance of eligibility criteria 

In  response  to  the  question  on  the  most  relevant  acceptance/deferral  criteria  provided  in 
Annex  III,  nine  Member  States  (AT,  BE,  EE,  FR,  LV,  NL,  PL,  PT,  SK)  plus  Norway  and 
Liechtenstein consider all criteria equally relevant.  

37 

 
 
 
 
 
The United Kingdom considered that the criteria as a minimum standard are too broad, i.e. not 
specific enough. 

The  criteria  associated  with  higher  risk  of  disease  transmission,  and  pre-donation 
haemoglobin  levels  were  considered  the  criteria  most  relevant  to  protect  recipients  and 
donors, respectively. 

13 

All 

Drug use 

Disease outbreakes 

Transfusion transmitted infection 

Travel 

Pregnancy 

Medication 

Sexual behaviour 

Minor surgery 

Vaccination 

Donors diseases* 

Platelets 

Protein 

Haemoglobin  

Age and body weight 

3 

2 

2 

3 

4 

1 

1 

1 

1 

3 

2 

2 

8 

8 

0

5

10

15

Fig.  28 – The most relevant eligibility/deferral criteria 

Difficulties in implementing and verifying the eligibility criteria  

Sexual behaviour was considered by 19 Member States the most difficult or the least reliable 
criterion  to  implement  while  Germany,  Poland  and  Norway  expressed  no  difficulties  in 
verifying the eligibility criteria. 

38 

 
 
 
 
 
Fig.  29 – The most difficult criteria to implement/verify 

Changes in eligibility criteria  

Asked about the need to change the current age acceptance criteria considering an ageing EU 
population, seven Member States answered as follows:  

 

 

In BE, in 2012, the age of acceptance was raised from 65 to 71; 

In  CY,  donors  older  than  65  are  accepted  if  a  good  health  medical  certificate  is 
provided; 

  DE  proposed  that  upper  age  limits  should  be  decided  by  the  physician  in  charge  of 

donor selection when deciding on deferral or admission for donation; 

  FI has proposed that an annual permission for 66-70 year old donors could be given by 
a  qualified  healthcare  professional  (by  a  physician)  to  maintain  self-sufficiency  in 
Finland.  The  Finnish  Medicines  Agency  (Fimea)  proposed  a  revision  of  donor  age 
limits based on a risk assessment regarding donors and recipients, and a survey of the 
practice of annual permission for donors over 65 years old in EU countries;7 

 

In LU, since August 2012, the maximum age is 70 years; 

  NL replied that the size of the donor population could be increased if the age criteria 

were replaced with medical condition criteria; 

 

In  PL,  a  lower  age  limit  is  being  considered  if  it  does  not  conflict  with  other  Polish 
regulations. Persons over 65 can donate blood if there are no contraindications. 

7 Meeting of the Competent Authorities on Blood and Blood Components 6 and 7 November 2013.Summary 
Report; http://ec.europa.eu/health/blood_tissues_organs/docs/blood_mi_20131106_en.pdf 

39 

 
 
 
 
 
                                                            
Fourteen Member States considered that other eligibility criteria as laid down in Annex III to 
Directive 2004/33/EC need to be changed: 

No: AT, BG, 
CY, DK, EE, ES, 
HR, HU, IE, LI, 
LU, LV, NO, 
PT, SK, UK; 
16 

Yes: BE, CZ, 
DE, EL, FI, FR, 
IT, LT,  MT, 
NL, PL, RO,SE, 
SI, ; 
14 

Fig.  30 – Member State opinions regarding the need to change donor eligibility criteria 

Belgium proposed a change to the 28 day West Nile virus (WNV) deferral period8 (28 days 
after leaving an area with ongoing transmission of WNV to humans) by accepting donations 
when  a  molecular  genomic  test  is  negative  or  if  the  blood  component  is  treated  with  a 
pathogen  inactivation  method  (validated  for  inactivation  of  WNV).  This  has  been  partly 
addressed  in  a  recent  amendment  in  the  implementing  legislation9  and  development  of  a 
related  preparedness  plan  by  ECDC.  Moreover,  Belgium  proposed  that  for  particular 
epidemiological  situations  (e.g.  disease  outbreaks)10  notification  should  be  done  by  the 
competent  authority  of  the  Member  States  concerned  to  the  European  Commission,  with  a 
view to EU-level action. 

Finland proposed a survey of EU Member State practices and a risk assessment of the impacts 
of  raising  upper  age  limits  on  both  donors  and  recipients.  In  addition,  they  proposed 
discussion on the following changes: 

  Minor dental treatment11 - no deferral; 
  Malignancy  with  complete  recovery12  -  temporary  deferral;  permanent  only  for 

haematological malignancies; 

  Endoscopic examination performed in EU13- no deferral; 
  Acupuncture performed with sterile single-use needles14 - no deferral; 
  Malaria15 - criteria for deferral should be re-assessed. 

France also proposed revisions of: 

  The West Nile virus (and arbovirus) deferral period (analysis of the appropriateness of 
a  deferral  period  of  120  days),  genomic  testing  and  definition  of  West  Nile  Virus 
“affected area” as adopted by ECDC16; 

8 Point 2.2.1 of Annex III to Directive 2004/33/EC 
9  Directive  2014/110/EU  amending  Directive  2004/33/EC  as  regards  temporary  deferral  criteria  for  donors  of 
allogeneic blood donations 
10 Point 2.3 of Annex III to Directive 2004/33/EC 
11 Point 2.2.2 of Annex III to Directive 2004/33/EC 
12 Point 2.1 of Annex III to Directive 2004/33/EC 
13 Point 2.2.2 of Annex III to Directive 2004/33/EC 
14 Point 2.2.2 of Annex III to Directive 2004/33/EC 
15 Point 2.2.1 of Annex III to Directive 2004/33/EC 
16 West Nile virus risk assessment tool, ECDC TECHNICAL REPORT -, 2013 

40 

 
 
 
 
                                                            
  The  minimum  level  of  donor  haemoglobin:  Member  States  may  however  adopt 
requirements for minimum haemoglobin levels down to 120 g/l for females and 130 g/l 
for males on the basis of the results of studies carried out on their specific population; 

  Chikungunya and dengue: Analysis of the opportunity to introduce clinical criteria for 

donors at risk of exposure; 

  Analysis of risk and the measures to be taken regarding donors who have travelled. 

Croatia  proposed  an  extension  and  more  specific  point  2.3  of  2004/33/EC  for  particular 
epidemiological situations in affected areas (e.g. WNV, Malaria, Dengue, HEV). 
Italy  proposed  changes  on  hepatitis  B17:  except  for  HBsAg-negative  persons  who  are 
“demonstrated to be immune", it should be clarified what is intended by "demonstrated to be 
immune", considering that persons testing anti-HBs positive with (or even without) anti-HBc 
may test HBV DNA positive, thus resulting in OBI (Occult HBV Infection) carriers. 
Lithuania proposed that the behaviours at risk of acquiring infectious diseases18 that could be 
transmitted by blood should be listed. 

Malta proposed a change on haemoglobin levels in general. 

Changes proposed by the Netherlands included: 

  That if HBV-NAT screening is performed, HBsAg screening can be cancelled; 

  WNV-NAT instead of temporary deferral after visit to affected area; 

  An update on criteria for Malaria, Q-fever. 

Poland proposed the following changes: 

  Donors  under  17  years  of  age  may  donate  blood  in  exceptional  circumstances  (for 

instance: Donation of HLA–compatible blood components for family members); 

  Donor  weight  and  haemoglobin  concentration  definition  in  case  of  two  unit  red  cell 

apheresis; 

  Coagulopathy and bleeding tendency should be clarified; 

  “metabolic  disease”  and  endocrine  disorders  (e.g.  hypothyroidism)  should  be 

mentioned separately; 

  Diabetes  should be mentioned under donors on oral medication; 

  Body temperature criteria should be included; 

  Borreliosis  (Lyme  disease)  should  be  included  and  deferral  for  chronic  Q  disease 

should be more precise; 

  An update on criteria for Malaria and West Nile virus; 

  Point  2.2.2,  in  right  column  of  the  first  row  should  be  revised  to  include  HIV  and 
hepatitis  B,  and  in  the  left  column  to  include  hepatitis  B  carriers,  hepatitis  C  and 
HIV;19  

  Deferral period extension after hepatitis B vaccination;20 

17 Point 2.1 of Annex III to Directive 2004/33/EC 
18 Point 2.2.2 of Annex III to Directive 2004/33/EC 
19 Point 2.2.2 of Annex III to Directive 2004/33/EC 

41 

 
 
 
                                                            
  Precise  deferral  period  following  “exposure”  to  tick  born  encephalitis  and  after 

recovery from tick  born encephalitis;21 

  Guidelines for deferral during breastfeeding; 

  Coherence  and  precision  on  permanent  and  temporary  deferral  regarding  ”persons 
whose  behaviour  or  activity  places  them  at  risk  of  acquiring  infectious  diseases  that 
may be transmitted  by blood” ;22 

  Discussion  and  recommendations  on  accepting  donations  from  persons  detained  in 

juvenile correctional institutions (homes). 

The following changes were proposed by Romania: 

  Additional  temporary  deferral  criteria:  leucocytosis    (leucocytes  over  11000/mmc- 

12000); 

  Evaluation of iron status at least in particular situation in donors having borderline Hb 

value, based on physician decision. 

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

Assessment of sexual behaviours implying risk 

According to Annex III to Directive 2004/33/EC persons whose sexual behaviour puts them at 
high risk of acquiring severe infectious diseases that can be transmitted by blood  and blood 
components or derivatives should be permanently deferred for allogeneic blood donation. 18 
Member  States  plus  Norway  and  Liechtenstein  reported  existing  national  guidelines  for  the 
assessment of risk associated with sexual behaviour. 

No: AT, BG, EE, HR, 
IE, LT, LU, LV, RO, 
SE 
 10 

Yes: BE,  CY, CZ, 
DE, DK, EL, ES, FI, 
FR, HU, IT, LI, MT, 
NL, NO, PL, PT, SI, 
SK, UK 
 20 

Fig. 31 – Assessment of risk associated with sexual behaviour 

The  main  exclusion  criteria  for  sexual  risk  behaviour  listed  by  the  reporting  countries  were 
men having sex with men, being paid for sex with drugs or money, having sex with someone 
who injects drugs or  is  paid for sex,  having  sex  with  someone  who is  from an area  of high 
prevalence of HIV, having multiple sexual partners or a new partner. 

Assessment of variant Creutzfeldt Jacob disease (vCJD) 

Annex  III  to  Directive  2004/33/EC  foresees  precautionary  measures  regarding  vCJD. 
Seventeen  Member  States  plus  Norway  and  Liechtenstein  reported  existing  national 
guidelines to assess vCJD risk.  

20 Point 2.2.3 of Annex III to Directive 2004/33/EC 
21 Point 2.2.3 of Annex III to Directive 2004/33/EC 
22 Point 2.1 of Annex III to Directive 2004/33/EC and Point 2.2.2 of Annex III to Directive 2004/33/EC 

42 

 
 
 
 
                                                                                                                                                                                          
No: BG, DK, EE, 
EL, HR, HU,  IE, 
LT, LU, RO, SE 
11 

Yes: AT, BE, CY, 
CZ, DE, ES, FI, 
FR, IT, LI, LV, 
MT,  NL, NO, 
PL, PT, SI, SK,  
UK … 

Figure 32 – variant Creutzfeldt Jacob disease (vCJD) precautionary measures 

Main causes leading to deferrals 

Twenty-one  Member  States  reported  having  a  centralised  system  to  collect  data  on  blood 
donor deferral (either a national IT system or annual reports). 

Figure 33 – Centralised system regarding blood donor deferral data 

The  main  causes  leading  to  deferrals  reported  by  Member  States  that  collect  this  data 
nationally  were:  low  haemoglobin  levels,  risk  of  transmission  of  infectious  diseases,  risk 
behaviours,  travel,  medication  and  other  medical  reasons.  The  “other  medical  reasons” 
included abnormal blood pressure (CY, HR, LT, MT, SI and UK).  

Fig.  34 - Main causes leading to deferrals/country 

43 

 
 
 
 
 
 
 
 
Temporary derogations during a potential crisis 

In  2009,  in  view  of  a  potential  H1N1  pandemic,  Commission  Directive  2009/135/EC  was 
adopted to allow Member States to invoke temporary derogations to accept donors with lower 
haemoglobin levels, to ensure blood supply during times of potential crisis. Those temporary 
derogations were considered the most efficient measure to maintain blood supply in case of 
future crises by 22 Member States (BE, BG, CY, CZ, DK, EE, EL, FR, HR, HU, IE, IT, LT, 
LU,  LV,  MT,  NL,  PL,  PT,  SI,  SK,  UK)  plus  Norway  and  Liechtenstein.  Temporary 
derogations were applied by eight Member States (BE, BG, CY, EL, LU, LV, SK, UK). 

As additional measures, only Finland suggested that the donor upper age limit could be raised 
and that the competent authorities should be empowered to decide on temporary derogations. 
Germany explained that the situation may be very different for  some types of crises such as 
severe disasters.  

Overall, such temporary measures were considered useful. 

Comments 

The  main  causes  for  donor  deferral  are  the  risk  of  transmission  of  infectious  diseases,  low 
haemoglobin  levels,  risk  behaviours,  travel  history  and  other  medical  reasons,  such  as  high 
blood pressure. Other eligibility criteria relate to age limits, to temporary deferrals in case of 
crises and to the assessment of risk associated with sexual behaviour. Several Member States 
also emphasised the need for more donor protection measures. 

2.6.4.  Testing of Donations 

Under Directive 2002/98/EC, every blood and blood component donation should be tested by 
qualified laboratories, which have been accredited, designated, authorised or licensed (Article 
5, (1)) in conformity with the requirements of Annex IV (Article 21, (1)). 

Laboratory inspections 

In compliance with Article 5(1) of Directive 2002/98/EC, 27 Member States plus Norway and 
Liechtenstein inspect laboratories to ensure that  the tests required for donors are carried out 
only  by  qualified  laboratories  that  have  been  accredited,  designated,  authorised  or  licensed. 
The  methods  by  which  competent  authorities  ensure  compliance  with  this  requirement  are 
shown in the figure below:  

:
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DE, HR, IE, RO, SI

BG, EE, IE, NL, SE

5 

5 

AT, BE, BG, CZ, DE, DK, EE, EL, ES, FR, FI, HR, HU, IE, IT, LI, LT,
LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK, UK

29 

0

5

10

15

20

25

30

35

Fig.  35 - Competent authorities’ actions to comply with Article 5(1) 

Cyprus  reported  that  all  laboratories  performing  tests  for  donors  are  designated  by  the 
Ministry of Health. However, these laboratories are not inspected as an inspection system is 
not in place. In Finland, one blood establishment has activities relating to the testing of human 

44 

 
 
 
 
blood  and  blood  components.  However,  some  activities  relating  to  donor  testing  may  be 
performed  externally  (i.e.  rare  tests  for  donors)  under  a  written  contract  which  is  checked 
routinely  during  blood  establishment  inspections,  though  the  testing  activities  might  not  be 
inspected on-site every two years. Poland and Slovakia reported that laboratories are audited 
as well as blood establishments. 

Nucleic acid amplification testing (NAT)  

The competent authorities were also asked to provide data/information regarding use of NAT 
technology for routine testing of blood or blood components. NAT is not required by Annex 
IV  to  Directive  2002/98/EC,  but  it  is  used  in  some  Member  States  to  test  donor  blood 
samples.  

Twenty Member States (AT, BE, DE, DK, EE, EL, ES, FI, FR, HR, IE, IT, LT, LU, LV, NL, 
PL, PT, SI, UK) reported the use of NAT technology for routine testing of every donation. In 
most countries it is used for HIV, hepatitis B and C although in some of these Member States 
(Germany and France) it is not mandatory to use it for hepatitis B. It is also used much less 
frequently for West Nile virus (WNV), hepatitis A and Parvovirus B19 testing. 

NAT technology is not used in SE, SK, CY, RO, MT, HU, CZ, BG, plus Liechtenstein and 
Norway.  The  reasons  mentioned  for  this  were  financial  constraints  (BG,  CY,  CZ,  MT,  NO, 
RO,  SK),  minimal  benefits  (CZ,  MT,  NO,  SK)  and  lack  of  a  legal  obligation  (Sweden  and 
Liechtenstein).  In  Greece  and  Italy,  NAT  for  WNV  is  only  used  seasonally  (in  the  summer 
period), to ensure safety of the blood supply within the affected areas. 

In  Germany,  NAT  is  mandatory  as  routine  screening  for  HIV-1  (10.000mIU/ml)  and  HCV- 
(5.000 IU/ml), and for confirmatory testing for HIV-1, HCV, HBV. NAT for HBV, HAV and 
Parvovirus  B19  is  not  mandatory,  but  used  for  routine  screening  by  many  blood 
establishments, mainly those also delivering plasma for fractionation.  

n
o
i
t
a
n
o
D

h
t
i

w

e
v
i
t
a
g
e
n

g
n
i
n
e
e
r
c
s

:
s
t
l
u
s
e
r

n
i

T
N
W

d
e
t
c
e
f
f
a

h
c
a
E

:
s
a
e
r
a

:
n
o
i
t
a
n
o
d

LV

1 

EL, IT

2 

AT, BE, DE, DK, EE, EL, ES, FI, FR, HR, HR, IE, IT, LT, LU,
NL, PL, PT, SI, UK

20 

0

5

10

15

20

25

Fig. 36 – Circumstances of NAT use/country 

A  centralised  system  to  collect  positive/abnormal  test  results  was  reported  by  27  Member 
States (BE, BG, BI, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IE, IT, LT, LU, LV, MT,  
NL, PL, PT, RO, SI, SK, UK) and Norway. The number of positive test results in 2012 (on 
donations between 1/1/2012 and 31/12/2012)  for HIV, hepatitis  B, C and other  agents  were 
provided (see Annex 3).  

During  meetings  of  the  competent  authorities,  it  was  suggested  that  gathering  nationally 
centralised test results and comparing them at EU level would be beneficial. 

Additional tests performed on a routine basis 

All countries except Spain, Liechtenstein and Latvia reported having additional tests to those 
required  in  Annex  IV  to  Directive  2002/98/EC.  See  the  previous  point  for  NAT  tests  for 
Hepatitis B, C and HIV. 

45 

 
 
 
 
 
Country  AT 

BE 

BG 

CY 

CZ 

Additio
nal tests  

For whole blood donations: 
unspecific immune 
reaction marker 
(Neopterin, CRP) 

Syphilis testing and 
NAT for HIV1, HBV 
and HCV. 

Syphilis and irregular 
antibodies. They are 
mandatory under 
national legislation for 
each whole blood 
donation. 

Syphilis 
(Treponema 
pallidum) 

HIV p24 antigen, 
syphilis antibodies 

Country  DE 

DK 

EE 

EL 

ES 

Mandatory for whole blood 
donations and apheresis 
donations for transfusion 
are  " Blood grouping:  " 
Rh details (C,c,D,E,e), Kell 
criterion, serum blood 
group antibodies on the 
occasion of first and 
second whole blood 
donation. Infectious 
disease markers:  " Anti-
HBc antibodies " HCV 
Genom (NAT) " HIV-1 
Genom (NAT) " Anti-
Treponema pallidum 
antibodies 

Additio
nal tests 

Country  FI 

Additio
nal tests 

NAT for HIV-1–, HCV- 
and HBV are mandatory 
for whole blood donations. 
B19-DNA and HAV-RNA 
tests are done but not 
mandatory for whole blood 
donations  

Country 

Additio
nal tests 

IT 
NAT testing for HBV, HCV 
and HIV at each donation. 
HCV NAT mandatory since 
2002, HBV and HIV NAT 
since 2008 

Country  MT 

ID NAT for HIV; HBV 
and HCV 

Some of them are 
mandatory. HBV NAT 
test is not mandatory, 
but all the BE-s are using 
it in addition to HBsAg. 

No additional 
tests reported 

No additional tests 
reported 

HR 

HU 

IE 

HIV 1p24 antigen, HCV 
core, TP antibody 
(Syphilis) 

anti-HBc, TP 
antibody (Syphilis) 

NAT PCR  
performed on all 
allogeneic 
donations but not 
mandatory 

FR 
Screening tests for all 
donations: HIV NAT, 
HCV NAT, HBV NAT, 
Anti-HTLV I/II, Syphilis. 
NAT for HBV is not 
mandatory. Screening 
test for Malaria, 
Chagas disease: If 
necessary. Screening 
test for hepatitis E 
virus NAT since 
December 2012 for 
FFP-SD NAT (pool of 
96 samples), - by the 
CTSA in the earlier of 
2013 for plasma 
lyophilized pools.   

LI 

LT 

LU 

LV 

No additional tests 
reported 

HIV NAT, HBV NAT and 
HCV NAT 

Law only says that 
additional tests 
can be required 

No additional tests 
reported 

NL 

NO 

PL 

PT 

All donations are 
tested for HBV 
DNA, RNA HCV 
and RNA HIV 
(mandatory). 

NAT for HIV, HCV 
and HBV; EiA IgM 
and IgG testing for 
Syphilis - All blood 
donations EiA HTLV 
1 e HTLV 2 - First 
Time donations 
Malaria 

Additio
nal tests 

Anti HBc testing is 
performed 

Not mandatory. 

Ant- HBc when > 6 
months since last 
donation 

Country  RO 

Additio
nal tests 

Yes, MoH Order no. 
1226/2007 updated by 
Order 650/2012 

Table 7 – Additional tests/country 

SE 

SI 

SK 

UK 

anti-HTLV- I o II 
Treponema Pallidum 

Test for syphilis  is 
required: not required 
for autologous 
donations. 

anti- HB core 
(total) and ALT 
are mandatory 

Syphilis, HTLV, and 
HCV 

Member  States  were  asked  about  additional  tests  for  plasma  donations  but  reported  no 
additional  information.  Additional  tests  required  by  Member  States  are  usually  justified  for 
local reasons, e.g. the increased prevalence of certain infectious diseases. These criteria might 
however  also  limit  the  sharing  of  blood  and  blood  components  between  Member  States. 

46 

 
 
 
Members States authorities therefore expressed interest in having a transparent perspective on 
the additional tests implemented in each of the Member States. 

Additional  information on testing 

Some Member States provided additional information on testing: 

  BG reported that testing laboratories, as a part of blood establishments, participate in 
the  Proficiency  Testing  Scheme  organised  by  EDQM.    The  national  system  for 
external  control  of  transmissible  infections  for  testing  laboratories  in  blood 
establishments is organised by the National Centre of Infectious and Parasitic Diseases 
(NCIPD); 

  HR:  An  international  accreditation  system  for  testing  laboratories  is  foreseen  to  be 

implemented in renewed legislation; 

 

IT: European Proficiency Testing Studies, as already performed by EDQM, should be 
enhanced; 

  UK: All labs perform NEQAS (Scotland) (an external quality control program). 

Changes in basic testing requirements 

Eight Member States (CY, DE, EL, HR, IT, LT, NL, RO) considered changes are needed to 
the  mandatory  testing  requirements  for  donations  as  specified  in  Annex  IV  to  Directive 
2002/98/EC: 

  CY and RO proposed including testing for syphilis as a minimum requirement; 

  DE replied that a general answer cannot be given as it depends on national strategies, 
e.g. in relation to the specific epidemiology of a given country, the use of pathogen-
inactivated blood components etc; 

  EL, HR, IT and LT proposed mandatory NAT; 

 

IT proposed that WNV NAT should be regulated as an option to screen donors living 
in affected areas and to screen potentially exposed donors; 

  An  additional  sentence  was  proposed  by  NL:  "Additional  tests  or  alternative 
combinations  of  tests  may  be  required  for  ..."  This  will  allow  the  listed  tests  to  be 
omitted if another test or combination of tests makes the listed test redundant. 

Several of the testing requirements have been subject to discussion in the bi-annual competent 
authority meetings. 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.  

It was noted in the discussions at 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  and  their  introduction  can  have  a  major  impact  on  the  local 
availability  of  blood  and  blood  components.  Testing  can  therefore  not  be  considered  as  the 
single  pillar  for  safety  of  blood  and  blood  components  but  must  be  combined  with  deferral 
criteria and, where appropriate, inactivation techniques. It is through a combination of these 
strategies that safety risks are reduced to a minimum. 

Techniques for pathogen reduction/inactivation 

Techniques for pathogen reduction/inactivation are used in 16 Member States (AT, BE, CZ, 
DE, EL, ES, FR, IT, LT, LU, NL, NO, PL, PT, SE, SI, UK) plus Norway. Methylene blue, 

47 

 
 
 
and 
amotosalen 
reduction/inactivation techniques used, as summarised in Table 8. 

(riboflavin), 

detergent 

solvent 

are 

examples 

of 

pathogen 

Country 

AT 

BE 

CZ 

DE 

Pathogen 
inactivation 
techniques   

Plasma (Methylene 
blue / Intercept / 
Mirasol) Platelets, 
RBCs (Radiation) 

Plasma for transfusion: 
pathogen inactivation 
mandatory techniques 
used - methylene blue, 
solvent detergent, 
amotosalen.  
Platelets: pathogen 
inactivation techniques 
used- amotosalen, 
(riboflavin)   

Platelets: very few units 
(dozens), amotosoralen 

a) Therapeutic frozen MB plasma: 
methylene blue and light followed by 
absorption of methylene blue and its 
photo derivatives by blueflex filter.   
b) Therapeutic frozen SD plasma: plasma 
pooled and tested according to Ph.Eur. 
monograph Human Plasma for 
Fractionation; treatment with solvent and 
detergent and removal of these additives 
according to Ph.Eur. monograph Human 
Plasma (pooled and treated for virus 
inactivation c) Therapeutic frozen 
Intercept Plasma: plasma obtained from 
whole blood or apheresis donations 
treated with amotosalen-HCl and UVA b) 
Intercept-PC: platelet concentrates from 
pooled buffy coats or from apheresis 
donations suspended in plasma and 
additive solution, treated with 
amotosalen-HCl and UVA. 

Country 

EL 

ES 

FR 

IT 

Pathogen 
inactivation 
techniques   

Photo-inactivation of 
Plasma with 
Methylene blue 

Methylene-blue 
inactivation for plasma 
(transfusion) 

Amotosalen with UVA 
light exposure used for 
Platelets (platelets 
apheresis leucocyte-
depleted and platelets 
recovered pooled 
leucocyte-depleted) 
pathogen. For plasma 
fresh-frozen leucocyte-
depleted pathogen 
reduction/inactivation: 
Solvent-detergent, 
Amotosalen with light 
exposure. 

Country 

LT 

LU 

NL 

Pathogen 
inactivation 
techniques   

Mirasol technology is 
used for approx. 3 % 
of platelets. 

Only for FFP, solvent 
detergent plasma is 
used 

Irradiation: plasma 
Washing: all products 
Solvent Detergent: 
plasma 

Country 

PT 

SE 

SI 

Blood Component pathogen 
reduction/inactivation is not mandatory. 
Pathogen inactivation techniques are 
applied to a minor percentage of fresh 
frozen plasma for transfusion 
(riboflavin/UV, amotosalen/UVA, 
methylene blue, solvent detergent) and 
platelets (riboflavin/UV, 
amotosalen/UVA). Two specific full 
Health Technology Assessment studies, 
respectively on FFP and PLT pathogen 
inactivation, are in progress at the 
National Blood Centre, in order to make 
adequate data and information available 
for eventual national regulatory decision-
making. 

NO 
Solvent Detergent 
for all plasma 
units. Pathogen 
Reduction of 11 % 
of platelet 
concentrates 
(Intercept and 
Mirasol) 

UK 

PL 

Mirasol PRT for 
platelets and 
plasma for  clinical 
use and 
Macopharma 
Macotronic system 
for plasma for 
clinical use. 

Pathogen 
inactivation 
techniques   

Inactivation of 
pathogens by 
Amotosalen UVA 
(Intercept) in 1 BE 

Some of the blood 
establishments in 
Sweden are using 
pathogen inactivation 
techniques for 
platelets but it is not 
mandatory and the 
blood establishment 
itself has to consider if 
they want to use that 
technology. 

Amotosoralen + UV 
radiation (Intracept) for 
Platelets 

Methylene blue 
treatment of 
plasma (England, 
Northern Ireland) 

Table 8 - Reduction /inactivation techniques used/country 

Pathogen  inactivation  techniques  are  mainly  used  for  plasma  and  not  for  other  blood 
components. It was noted in the discussions  at the competent authority meetings that, while 
the  theoretical  value  of  pathogen  inactivation  techniques  can  be  high,  the  effective  value 
depends  largely  on  the  implementation  and  validation  of  these  techniques.  Pathogen 
inactivation techniques can therefore not be considered as the single pillar for safety of blood 

48 

 
 
 
 
 
and blood components but are to be combined with deferral criteria and testing. It is through a 
combination of these strategies that safety risks are reduced to a minimum. 

Comments 

In all Member States tests are performed by laboratories authorised by the blood  competent 
authority  or  other  competent  authorities.  Competent  authorities  also  recognise  the  role  of 
international accreditation programmes for these laboratories.  

While the EU legislation requires minimum testing for Hepatitis B, C and HIV (1/2), Member 
States  reported  additional  routine  tests  mainly  for  syphilis,  malaria,  hepatitis  A,  hepatitis  E 
and Parvovirus B19. 

Introduction  of  mandatory  NAT  testing  for  HIV  and  hepatitis,  and  where  appropriate 
pathogen  inactivation  techniques,  were  highlighted  as  important  issues  that  need  further 
reflection,  particularly  regarding  cost-benefit  assessments.  In  that  respect,  a  general  point 
mentioned  was  the  need  for  a  common  assessment  mechanism  to  understand  the  impact  of 
changes in deferral criteria, testing or other measures on safety, quality, cost and supply. The 
role  of  common  assessments  by  ECDC  and  the  Commission  was  recognised,  e.g.  the 
development of a preparedness plan to address the seasonal outbreaks of West Nile Virus in 
some Southern EU countries.  

Competent  authorities  reiterated  also  the  value  of  consolidating  nationally  centralised  test 
result data. 

2.6.5. 

Storage, transport and distribution conditions 

The  storage,  transport  and  distribution  conditions  of  blood  and  blood  components  in  blood 
establishments  and  in  hospital  blood  banks  must  comply  with  Article  22  of  Directive 
2002/98/EC,  and  Article  5  and  Annex  IV  to  Directive  2004/33/EC.  To  comply  with  these 
requirements, 23 Member States plus NO reported existing legislation and regulations:  

  CY reported existing national guidelines; 

  HR, LI and NL mentioned their blood establishments’ standard operating procedures 

(SOPs); 

  ES reported existing specific computer systems; 

  The  reply  from  HU  was  unclear  as  it  only  mentioned  refrigerator  validation  by  the 

quality assurance department;  

  13 Member States (BE, EL, FI, FR, IE, IT, MT, NL, NO, PL, PT, RO, SE and UK) 

plus NO ensure the compliance with these requirements by inspections; 

  LU reported that quality management is ensured by SOPs; 

  LV  reported  control  measures  as  visits  to  blood  establishments  and  hospital  blood 

banks and audits of documentation.  

Comments 

Many  Member  States  report  that  they  verify  compliance  with  these  EU  provisions  during 
inspection. Standard operating procedures, computer systems and audits were also mentioned 
as tools to verify or strengthen compliance. 

49 

 
 
 
 
2.6.6.  More stringent measures 

More stringent measures to ensure safety and quality, with respect to those foreseen under the 
Directive, were introduced or were maintained by 10 Member States. 

Fig. 37 - More stringent measures/country 

These measures included: 

  NAT testing for hepatitis B (HBV NAT), hepatitis C (HCV NAT), and HIV 1/2 (HIV 

1 NAT) for whole blood and apheresis donations; 

  NAT testing for WNV (EL); 

  Dengue fever testing (PT); 

  Pathogen inactivation techniques of plasma (EL); 

  Requiring  the  responsible  person  to  be  a licensed  physician,  specialist  in  transfusion 
medicine  or  equivalent  discipline,  with  at  least  5  years  of  post-graduate  full-time 
service in a blood establishment (IT); 

  Additional eligibility/deferral criteria (RO); 

  Mandatory inspection for hospital blood banks (RO); 

  Registration and reporting of all incidents and adverse reactions, including the activity 

performed at clinical service level (RO); 

  Penalties applicable to violations occurring at the clinical level - before, during or after 

transfusion, import or export of blood or blood components (BG). 

Comments 

Member  States  implement  additional  national  safety  and  quality  measures,  in  some  cases 
because of increased risk e.g. the increased local prevalence of a certain disease.  

2.7. 

Exchange of information, reports and penalties 

2.7.1.  Penalties 

Under Article 27 of Directive 2002/98/EC Member States must lay down rules on penalties 
applicable  to  infringements  of  the  national  provisions,  and  take  all  measures  necessary  to 
ensure that they are implemented and notified to the Commission. 

50 

 
 
 
  
 
Twenty-five Member States have adopted national provisions laying down rules on penalties 
for infringements. 

Fig. 38 – Member States adopting rules on penalties applicable to infringements of the national provisions 

Four  Member  States  reported  to  have  imposed  penalties:  BG,  CZ,  LT  and  SK.  The  main 
reasons  were  related  to  the  clinical  use  of  blood  and  blood  components  (Bulgaria  -  five 
financial  penalties),  the  change  of  legal  entity  of  blood  establishments  which  was  not 
announced in advance (Czech Republic - one financial penalty), non-compliance with testing 
documentation  requirements  (Lithaunia  -  one  licence  revoked),  and  major  shortcomings 
which were not eliminated after inspection (Slovakia – one authorisation suspension). 

The  penalties  foreseen  in  national  legislations,  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 where blood (components) are exchanged, 
it was suggested that further collaboration and coordination could be envisaged, potentially in 
a dedicated EU initiative related to inspections and authorisations. 

2.7.2.  Difficulties in transposition or implementation 

Asked  about  difficulties  they  may  have  encountered  when  transposing  or  implementing  the 
EU Blood Directives, Member States reported the following challenges: 

  Financial  constraints  for  implementing  quality  procedures,  resistance  to  change, 
insufficient  staff  at  the  competent  authority,  blood  centres  and  hospital  blood  banks 
(CY); 

  The time-frame of 30 years for data storage (EL); 

  Lack of resources (PT); 

  Progressive shortage  of medical  staff  in  blood  establishments  leading  to  overlapping 

of functions, non-compliant facilities and lack of a national IT system (RO); and 

  Challenges associated with verification of the requirements for donation and testing of 

blood components imported for uses other than transfusion. 

Comments 

Member  States  mentioned  that  general  reporting  requirements  were  considered  heavy  and 
called  for  a  reduction  in  the  frequency  of  these  requirements  (currently  foreseen  every  3 
years).  Also  restrictions  in  resources  and  financial  constraints,  both  at  blood  establishments 
and at competent authorities, were mentioned as complicating factors in the implementation 
of the legislation. 

51 

 
 
 
  
 
 
Annex  1:  Individual  country  responses  to  the  survey  on  the  implementation  of  the  EU 
Blood and Blood Components Directives conducted in 2013 and based on 2012 
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&nbsp;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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Federal Office for Safety in Health Care (BASG) / AGES Austrian 
Agency for Health and Food Safety 

Traisengasse 5 A-1200 Vienna Austria 

+435055536435 

inspektionen@ages.at 

www.basg.gv.at 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Medical devices 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

The Federal Office for the Safety in 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: Institut Marketing 
Authorisation on Medicinal Products & Lifecycle Management 
(Head: Dr. Christa Wirthumer-Hoche) Institute Assessment & 
Analysis (Head: Dr. Gerhard Beck) Institute Surveillance (Head: 
DDr. Alexander Hönel) Head of the Austrian Medicines and 
Medical Devices Agency: Dipl.-Ing. Dr. Christa Wirthumer-Hoche 

1.5. 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) 

Not applicable 

52 

 
 
 
 
 
1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

Not applicable 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

45 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

no information available 

no information available 

no information available 

no information available 

no information available 

No 

250303 

500 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

NA 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

Max. 700 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

13.471 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

NA 

NA 

24 

2 

Only trained personnel is allowed to provide such information 

Information is collected through a personal interview with a medical 
doctor 

included position in donor evaluation form 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

included position in donor evaluation form, contact by phone 
numbers, information provided during the interview 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

all criteria which are of relevance reagrding the product quality 

all criteria which are not of direct relevance reagrding the product 
quality 

No 

No 

53 

 
 
 
2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

2.2.11.1. If no, what other deferral criteria would you suggest for 
derogation? Would you have other suggestions on the usefulness and 
set-up of such temporary derogations? 

3.1. Testing 

see outcome of EDQM working group 

Yes 

No 

haemoglobin levels 

No 

No 

No 

No information available 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

By inspection 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

for blood donations every single donation 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

for whole blood donations: unspecific immune reaction marker 
(Neopterin, CRP) 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

mandatory 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

No 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

Plasma (Methylenblue / Intercept / Mirasol) Platelets, RBCs 
(Radiation) 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

No 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

By inspections 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

QM-System has to follow the principles defined in Guideline 
2002/98/EG, Article 29 h, laid down in national legislation (QS-VO-
Blut). 

54 

 
 
 
 
3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

By inspections 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

QM-System has to follow the principles defined in Guideline 
2002/98/EG, Article 29 h, laid down in national legislation (QS-VO-
Blut). 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

QM-System has to follow the principles defined in Guideline 
2002/98/EG, Article 29 h, laid down in national legislation (QS-VO-
Blut). 

national legislation (Blutspenderverordnung, BGBl. II Nr. 100/1999) 

Yes 

No 

Yes 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 
Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Inspections of the site/centre 

Yes 

45 

No 

BASG / AGES 

4.6. How many laboratories performing donor testing are active 
within your country? 

26 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

BASG / AGES 

4.8. How many hospital blood banks are active within your country? 

170 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

Baxter, Vienna / Octapharma, Vienna 

4.10.2. If yes, please state the responsible authority within your 
country. 

BASG / AGES 

5. Inspections (Art 8 Directive 2002/98/EC) 

55 

 
 
 
 
5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

BASG / AGES 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

4 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

Tissues and cells 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 

once in two years (45 BE - including plasma establishments)) 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

9 in 2012 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

none 

none 

none 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

based on PIC/S / EMA Compilation of Community Procedures 
template 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

all 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

on risk based approach on regional level 

satisfactory 

satisfactory 

satisfactory 

NA 

NA 

NA 

11 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

56 

 
 
 
5.9.1. If yes, please describe. 

No difference 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

No difference 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

depends, as it is not mandatory 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

2 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

by inspections 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, …)? 

ISBT 128 

6.1.4.2. If yes, for which blood components 
(more than 1 answer possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

By inspections 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

there is a haemovigilance officer who assesses the haemovigilance 
reports from the BE and clinical units 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

Yes 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

70-99% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

It is requested by law 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

it depends on the case. For example if it could have implications for 
other patients or donors or products 

57 

 
 
 
6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

No 

6.2.8.2. If no, why not. 

currently there is no summary report of the Commission available 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

none/ not available 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Information by email 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Information by email 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Tissues and cells 
Pharmacovilance 
Medical devices 

Yes 

6.2.14.1. If yes, please specify. 

tissue and cells, medical devices 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

no 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

None 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

see GMP Annex 14 

International standards 

No 

No 

No 

see GMP Annex 14 

NA. 

No 

No 

7.11. Is there a regular shortage of blood or blood components in 

No 

58 

 
 
 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

No 

No 

Yes 

8.2.1. If yes, please specify. 

financial penalties up to 7270 € or up to 36 340€ depending on type 
of violation 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

BMG 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Mosquito identification system (Allerberger / ECDC) 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

NA 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

Ärztegesetz (BGBl. I Nr. 169/1998) 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

NA  

NA 

59 

 
 
 
 
 
 
A.1.2. 

Survey response Belgium 

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

1.1.2. Address of&nbsp;NCA 1: 

Federal agency for medicines and health products  FAMHP 

Eurostation building, block 2 place Victor Horta, 40/40 1060 
Brussels  Belgium  

1.1.3. Telephone (central access point): 

1.1.4. E-mail (central access point): 

1.1.5. Website: 

00 32 2 524 80 00 

welcome@fagg-afmps.be 

www.fagg-afmps.be 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Medical devices 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 
2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

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 

/ 

6 

0 

0 

297.833 

246.062 

51.771 

No 

538.336 

Maximum 500ml (4time/year) 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

104.545 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

Maximum 650ml/ collect (2l/month, 15l /year) 

13.471 

350ml 

60 

 
 
 
2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

6.078 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

6 

6 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is not standardised at national/regional level 

By inspection of the Blood establishment 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

post-donations card with bar code 

2.2. Deferral (Directive 2004/33/EC) 
2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

The criteria are all relevant. Consider modification of the criteria 
according to the  development of scientific knowledge. 

In the case of temporary deferral criteria for donors of allogeneic 
donations, a date of confirmed cured is not always easy to know. So 
the medical doctor who is  at the collection, has the responsibility to 
accept or reject the donor. 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

Point 2.2.1.”West Nile Virus (WNV) (*):   28 days after leaving an 
area with ongoing transmission of WNV to humans”:   proposal to 
add: “may be accepted if a molecular genomic test is negative at 
each donation or if the blood component is treated with a pathogen 
inactivation method (validated for inactivation of WNV). Point 3.2.   
Deferral for particular epidemiological situations :” Particular 
epidemiological situations (e.g. disease outbreaks). Deferral 
consistent with the epidemiological situation (These deferrals should 
be notified by the competent authority to the European Commission 
with a view to Community action)”: Proposal of modification: :” 
Particular epidemiological situations (e.g. disease outbreaks). 
Deferral consistent with the epidemiological situation (disease 
outbreaks in a MS  should be notified by the competent authority of 
the MS concerned to the European Commission with a view to 
Community action)”:  

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

Sexual transmissible disease New partner Changing partners Paid 
sex MSM Sexual partner with sexual transmissible disease or using 
IV drugs now or in the past  

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

Yes 

Yes 

2.2.7.1. If yes, please explain and suggest your alternative. 

In Belgium, last year the current age of acceptance has been changed 
from 65 to  the age of 71 year. 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Too low hemoglobin:  30.746 deferred  donor s for a total of   
674.916 donations Donor risk (sexual multipartner, IV drug, tattoo, 
piercing,…):  21.711 defer red donors Other medical or not- medical 
reasons:  32.229 deferred donor s  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

61 

 
 
 
2.2.9.1. If yes, please specify. 

Activity report 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

3.1. Testing 
3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

84538 

Yes 

Yes 

By inspection 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

every donation 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

Yes 

Syphilis testing and NAT for HIV1, HBV and HCV. 

Syphilis testing and NAT for HIV1, HBV and HCV. 

No 

Yes 

10 

60 

18 

Syphilis : 46 

no 

Yes 

Plasma for transfusion: pathogen inactivation mandatory: techniques 
used : methylen blue, amotosalen Platelets: pathogen inactivation 
techniques used: amotosalen, (riboflavin)   

3.2. Processing 
3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

the delegation of tasks are under the responsability of the responsible 
person 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

By inspection 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

62 

 
 
 
3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

under the responsability of the BE 

By inspection  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

on a readable and appropriate support. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

By inspection 

By inspection 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Not mandatory 

Yes 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 
4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

6 : authorisation by 5 july 2004 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

The FAMHP, federal agency of medicines and health products. 

4.6. How many laboratories performing donor testing are active 
within your country? 

6 - Each blood establishment must to have his laboratory to 
performing donor testing. 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Regional competence 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

111 

No 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

4.10.2. If yes, please state the responsible authority within your 
country. 

C.A.F. – D.C.F. cvba sprl  De Tyraslaan 109 – BE 1120 NEDER-
OVER-HEEMBEEK Dhr. R. F. TIEBOUT, Directeur-Generaal 

Federal agency for medicines and health products  FAMHP 

5. Inspections (Art 8 Directive 2002/98/EC) 
5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 

DG Inspection of FAMHP 

63 

 
 
 
  
of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

Tissues and cells 

One general system-oriented inspection every two years 

All the satellite sites, every two years 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

44 

0 

0 

No 

No 

5.5.2.1. If no, why not? 

No problem 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

6 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

Satellite collection sites: every two years Mobile collection sites: 2 
per province. There are 10 provinces in Belgium + the region of 
Brussels  

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

0 

104 

10 

0 

0 

0 

10 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

A hospital blood bank is a hospital function. Hospitals are inspected 
by the regional authorities. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

No 

64 

 
 
 
5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

usefull information  

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

3 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 
Yes 
6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

FAMHP 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

By inspection 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 
6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

A web based template is used and an electronic word document is 
used as backup.  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Yes 

Yes 

Yes 

100% 

Yes 

A web based template is used and an electronic word document is 
used as backup 

6.2.7. Do you perform root cause analyses of the SARE? 

6.2.7.1. If yes, in which cases? 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

all 

Yes 

6.2.8.1. If yes, please specify. 

By distribution of information notes to the BEs.  

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

Platelet concentrates - not pathogen inactivated – are systematically 
tested for the presence of microbiological agents. They are 
distributed negative to date. In 26 cases the microbiological testing 
became positive after distribution of the platelets and a recall was 
started. 

6.2.11. Do you have in place a system/procedure to notify BEs in 

Yes 

65 

 
 
 
case of a national rapid alert? 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Information note to the BEs 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Information note to the BEs 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Via medical device vigilance system. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 
7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

For importation, the BEs need to verify that the foreign 
establishment has a quality system, a traceability system and a 
notification system answering the requirements of the Belgian 
legislation.(Art 3 quarter, art 4bis §5 and art 13 quarter RD 4 April 
1996 Preparation, conservation, delivery of blood) 

Art 2 Law 5 jul y1994 Blood :  Le sang ou les dérivés du sang ne 
peuvent être prélevés, préparés, importés, conservés, distribués, 
dispensés, délivrés et utilisés que conformément aux conditions 
imposées par la présente loi et par les arrêtés pris par le Roi en 
exécution de celle-ci. Le sang destine exclusivement à la préparation 
de dérivés stables du sang exclusivement réservés à l'exportation, 
peut être prélevé en dehors de la Belgique et importé en Belgique 
dans les conditions et avec les garanties fixées soit par la législation 
du pays auquel ils sont destinés soit par le Roi; les dérivés de sang 
destinés exclusivement à la préparation de dérivés stables ayant la 
même destination peuvent être préparés et importés dans les mêmes 
conditions et avec les mêmes garanties, à condition qu'ils soient 
préparés au départ d'un sang prélevé en dehors de la Belgique dans 
ces conditions et avec ces garanties. 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

by inspection 

Yes 

7.4.1. If yes, please specify. 

Syphilis testing an NAT HIV1, HBV and HCV 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

No 

No 

Art 2 Law 5 jul y1994 Blood :   Le sang destine exclusivement à la 
préparation de dérivés stables du sang exclusivement réservés à 
l'exportation, peut être prélevé en dehors de la Belgique et importé 
en Belgique dans les conditions et avec les garanties fixées soit par 
la législation du pays auquel ils sont destinés soit par le Roi; les 
dérivés de sang destinés exclusivement à la préparation de dérivés 
stables ayant la même destination peuvent être préparés et importés 
dans les mêmes conditions et avec les mêmes garanties, à condition 

66 

 
 
 
  
7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 
8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

qu'ils soient préparés au départ d'un sang prélevé en dehors de la 
Belgique dans ces conditions et avec ces garanties. 

Blood and blood components must comply with the requirements of 
the Belgian law. 

No 

No 

No 

No 

No 

No 

No 

0 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Information note to the BEs 

8.5. Which other communicable diseases are of relevance to you? 

Any other outbreack of communicable diseases in the world. 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Provided the collection, processing and application are carried out in 
the same (operating) room. Examples : hemodilution, blood salvage 
techniques, preparation of PRP.   

According to our views, the collection of blood or blood components 
from patients in hospitals and  intended for the preparation of 
ATMPs  or magistral preparations (serum eye drops)do not fall 
under the scope of directive 2002/98/EC. Also in our opinion, blood 
or blood components collected from patients in hospitals and used 
for the preparation of components intended for autologous 
application, other than transfusion purposes,  fall under the scope of 
Directive 2004/23/EC and not under the scope of Directive 
2002/98/EC.  

When stable derivatives are produced on an industrial scale using 
large pools (> 300 liter) of blood/blood components as starting 
materials. 

67 

 
 
 
 
 
 
A.1.3. 

Survey response Bulgaria 

1. Public information 

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

Bulgarian Drug Agency (BDA) 

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.4. E-mail (central access point): 

1.1.5. Website: 

8 Damyan Gruev,Str. 1303  Sofia Bulgaria  

tel: + 359 2 8903555 

bda@bda.bg 

www.bda.bg 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Inspection 
Haemovigilance 
Other 

1.1.7.1. If other, please specify. 

Note: The Ministry of Health is the legislative body responsible for 
changes in “Law for blood, blood donation and blood transfusion” 
according to variations in Bulgarian or European legislation in this 
area. Furthermore, it is responsible for blood establishments’s 
accreditation. Accreditation is carried out according to the "Health 
Establishments Law" Art. 86  by the Accreditation Council, which is 
a specialized accreditation body to the Minister of Health. 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

According to the “Law for blood, blood donation and blood 
transfusion” Art.38 : The Executive Director of the Bulgarian Drug 
Agency shall function as a competent authority. Executive Director 
of the Bulgarian Drug Agency shall execute direct control through 
officials determined by him. In 2007 the department of “Control of 
blood transfusion system” was established. The main tasks of this 
structure are: Annual inspections of each blood establishment. 
Routine inspections in hospitals which are performing transfusion of 
blood and blood products as a part of their medical activities. 
Inspections (event-related) shall be conducted in each case of a 
serious incident or adverse reactions or in doubt of a serious incident 
or serious adverse reaction. Laying down rules on the reporting of 
adverse reactions. Maintain register of adverse reactions and events.   
ŸHaemovigilance - supervision of the traceability of the unit of 
blood or blood component from the donor to the recipient and vice 
versa. ŸInforms the blood establishments about received by RAS 
/rapid alert system/ information connected to transmissible diseases 
and vice versa. Prepares a SARE report until 30 th of June to the 
European Commission every year. Publishes an annual reports on 
the agency website as a part of the BDA annual report and sends 
report to the Ministry of Health about activities as a competent 
authority. Prepares a report to the Ministry of Health every three 
years about all activities in the hemotransfusion area – transposition, 
inspections etc. Translated version of this report shall be sent to EC 
by Ministry of Health. Department “ Control of  blood transfusion 
system”- staff (personnel): A director (involved in the inspection 
activities too) 2 chief inspectors (one of them is a vigilance officer- 
maintains the  register of adverse reactions and events) 1 senior 
inspector 1 inspector (junior) 3 experts – their main tasks are the 
еvaluation of documentation for marketing authorization, the 
extension and renewal  or modification of the marketing 
authorizations for medicinal products derived from human blood or 
plasma but they are also involved in the  inspections as a part of  
inspection team if necessary. Department “Control of blood 
transfusion system” does not have its own budjet – it uses part of 
Bulgarian Drug Agency’s budjet. The Department as part of BDA is 
independent from the transfusion system, but it is part of the 
Ministry of Health. 

1.5. 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) 

Not applicable 

1.6. Could you please describe the competence/mandate of the 

No Regional Competent Authority(ies) in the country. 

68 

 
 
 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

Stand – alone :6 ;Hospital – based : 23  Total : 29  Note: 6 BEs  
carry out all the activities (e.g. testing for transmissible diseases and 
processing).  23 hospital based BEs carry out part of the activities 
(e.g. blood collection, storage and issue blood components to 
hospitals) 

0. No BEs that are satellite sites in itself. One BE has additional 
satellite site for blood collection as part of its structure. 

0. No BEs that are mobile sites in itself. Every BE has montly plan 
for blood collection using mobile team. The mobile team’s staff is 
part of BE personell. 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

122 779 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

43 245 

34 595 

No 

167 851 

450  +/- 10 % 

232 

500 

2 714 

200 

No other donations by apheresis in 2012. 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

6 laboratories in big stand – alone BEs. The laboratories are included 
in their structure.  

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

The same 6 laboratories in big stand – alone BEs. No special 
laboratories for testing plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Donor evaluation/selection form standardised at national level and 
donation form are uploaded. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

During thematic inspections documentation, connected to the blood 
donation is detailed checked.. Each blood donation has unique 
number (included in bar code) and all forms that must be filled in by 
the donor can be checked for donor's signature. We check whether 
donor screening questionaire is completed and signed by the donor 
and by physician - authorized interviewer  and whether informed 
consent form is signed by the donor.   The completeness of donation 
form about unique personal data that allow to identify the donor and 

69 

 
 
 
testing results, donor register (that every BE maintain as a electronic 
and paper records), SOPs for the donor selection process, personnel 
training records etc. are other documentations inspected by CA 
during  inspections.  When some of the test results for transmissible 
diseases are confirmed as  possitive we have special procedure in 
place. The representative of Blood establishment  (from  
transmissible  diseases testing laboratory ) contacts obligatory with 
family doctor (GP) of the donor using special form, called 
"Notifiction Letter". This document require GP to inform personally 
blood donor about testing results.  

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

We don’t have special self-exclusion form but the questionaire is 
designed to be understandable for the general public. Moreover all 
donors are obligatory informed by physician (that is authorised 
interviewer) for option to change their mind about donating prior to 
proceeding further, or the possibility of withdrawing or self-
deferring at any time during the donation process, without any undue 
embarrassment or discomfort. 

Having in regard that main task of all parts (including CA) and 
activities in the blood transfusion chain is the quality and safety of 
blood and blood components collected and transfused, the most 
relevant deferral criteria are these connected to transmissible 
infectious diseases. 

The deferral criteria in point 2.2.2  - in fact  a risky sexual 
behaviour, which puts persons at risk or at high risk of acquiring 
severe infectious diseases that can be transmitted by blood. 
Difficulties are connected to a balance between responsibilities for 
protection of health of donors and recipients in the area of blood 
transfusion and the respect the Charter of Fundamental Rights of the 
EU, including the prohibition of any discrimination based on sexual 
orientation. 

No 

No 

The risk behaviours having an impact on blood donor management 
are: - persons engaging in male-to-male sexual acts; - sex workers (  
persons who receive money or equivalent goods/services  in 
exchange for sexual services) because of high risk  for acquiring 
HIV and other sexually transmitted transfusion-relevant infections.  

No 

No 

1. Medication – about 50 % 2. Low haemoglobin levels in donor's 
blood – about 15 % 3. Low body weight – about 15% 4. Serious 
active, chronic, or relapsing diseases – about 10 % 5. Transmissible 
infectious diseases – about 10% Note: This information was 
provided by National Center of Transfusion Hematology that collect 
information about reasons for donors deferral from all BEs in the 
country.  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

According to the “Law for blood, blood donation and blood 
transfusion”  Art.36:  National Center of Transfusion Hematology 
shall establish and maintain a register of the first level in accordance 
with the requirements of Regulation № 29 of 19 July 2004 (on the 
conditions and order to draw up, processing, storage and provision 
of information from register under Art. 36  of “Law for blood, blood 
donation and blood transfusion” and the form of documents in 
hemotransfusion chain). The register included information about the 
donors:  personal data of the donor (name, surname, ID number, 

70 

 
 
 
home address, phone); data from clinical examination and laboratory 
tests; causes and duration of deferral  etc.         Each BE shall send at 
regular basis this information about donors to the National Center of  
Transfusion Hematology.  

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

16 718  deferrals 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

Yes 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

In Regulation № 9 / 25 April 2006 establishing medical standard of a 
transfusion haematology are listed basic characteristics of the 
locations where transfusion haematology can be practised (Section 
III). Laboratories for immuno-haematologic testing of donated blood 
and laboratories for screening of each unit of donated blood for 
markers of transmissible infections are part of BEs. No laboratories 
outside BEs that can test donated blood. Laboratories testing donated 
blood as a part of Blood Establishments are accredited by the 
Accreditation Council, which is a specialized accreditation body to 
the Minister of Health according to the "Health Establishments Law"  
Art. 86. All laboratories at BEs are inspected at regular basis each 
year by CA.  

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

In the end of 2012 was set up working group for evaluation the 
possibilities to implement NAT testing in BEs. The working group 
included representatives from Ministry of Health, Blood 
Establishments, National manufacture of medicines from plasma and 
Bulgarian Drug Agency as a competent authority. The final report 
was sent to Ministry of Health in February 2013 with proposal to 
implement NAT testing as a pilot project in one BE (National Center 
of Transfusion Hematology-Sofia) but because of shortage of money 
the project was stopped.  The main barrier to implement NAT testing 
is financial.         

Yes 

According to Regulation № 18 of 10 June 2004 on the conditions 
and procedure for the diagnosis,  processing and storage  of blood 
and  blood components and quality of blood from import. Issued by 
the Ministry of Health in force from 06.07.2004;  SG. 58 of 6 July 
2004,   each donated blood unit is to be tested for:  blood groups 
ABO, RhD, irregular antibodies and for markers of infections       
Anti-HIV-1        Anti-HIV-2       HIV-Ag       HBs-Ag      Anti-HCV      
HCV-Ag      Syphilis The additional tests performed on a routine 
basis are tests  for Syphilis and irregular antibodies. They are 
mandatory under national legislation for each whole blood donation.  

The donation of plasma is carried out in the same place where the 
donation of whole blood takes place - the blood estabishments. 
There are no special plasma collecting facilities. Each donated 
plasma unit is to be tested for the same markers of transmissible 
infections as whole blood donation.  

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

Yes 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

5 confirmed cases 

71 

 
 
 
3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

851 confirmed cases 

86 confirmed cases 

217 confirmed cases for Syphilis 

The testing laboratories, as a part of blood establishments, 
participate in Proficiency Testing Scheme organized by EDQM.  
The national system for external control of transmissible infections 
for testing laboratories in blood establishments is organized by 
National Center of Infectious and Parasitic Diseases (NCIPD).  

No 

Yes 

Yes 

Delegation of responsibilities is given only to individual who is 
trained for the task. The delegation  is obligatory in written form. 
According to “Rules of procedure of the Blood Establishments” 
Art.16a, competent authority  must be notified within 7 days for 
delegation of responsibilities. 

According to Regulation № 9 / 25 April 2006 establishing medical 
standard of a transfusion haematology all BEs should establish a 
procedure for selection of well-qualified personnel with appropriate 
education, training and experience. As a part of quality system, 
personnel qualification and training are checked by NCA at regular 
basis during  routine inspections. Subject to inspections are policy, 
SOPs, job descriptions, annual training program for staff, personal 
development plans, certificates from a training of personnel, training 
records and documented competency assessments.   Furthermore one 
of the basic rules of blood transfusion system written in   “Law of 
blood, blood donation and blood transfusion” Article 22.(1)” The 
persons engaged in collecting, diagnostic, processing and storage of 
blood and blood components shall pass a compulsory training course 
at least once in two years.”  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

BEs already established a quality system. It contain descriptions of 
at least the following processes: - quality management, quality 
assurance, continuous quality improvement, change control and 
validation processes;  - personnel and organization;  - premises and 
equipment;  - documentation;  - blood and blood components;  - 
testing and processing of blood and blood components;  - storage, 
issuing and distribution of blood and blood components;  - quality 
monitoring;  - quality control;  - deviations, complaints, adverse 
events or reactions, withdrawal of blood, corrective and preventive 
measures;  - self-inspections, audits and quality improvement;  - 
contract management.  

The quality system of BEs is documented. Part of the maintained 
documentation is listed in SMF (Site Master File - similar to SMF 
for producers of blood and blood components derived medicines 
adapted for Blood Establishments according EuBIS project.) which 
is sent every year by BEs  to competent authority. NCA checks 
quality system documents for updates and reviews during in site 
inspections and desk-based checks of the mandatory documentation. 
All official reporting forms are indicated in Regulation № 29 of 19 

72 

 
 
 
July 2004 on the conditions and order to draw up, processing, 
storage and provision of information from register under Art. 36 of 
“Law for blood, blood donation and blood transfusion” and the form 
of documents in hemotransfusion chain. Issued by the Ministry of 
Health.  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Records are kept using both paper records and computerized system. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

Storing conditions of blood components are described in Regulation 
№ 18 of 10 June 2004 on the conditions and procedure for the 
diagnosis,  processing and storage of blood and  blood components 
and quality of blood from import  and Regulation № 9 establishing 
medical standard of a transfusion haematology . All storage, 
distribution and transportation activities are validated and 
documented  (SOPs) , covering special requirements  as devices for 
temperature control with recording capabilities, additional alarm 
system to the freezers and refrigerators, reserve power source, 
enough storage space etc.  

Each blood donation has unique number (bar coded). A system of 
donation numbers is used to uniquely identify each donation. The 
unique personal data of the donor is kept in register of BE and only 
staff members have access to this information using required 
registration procedure. The staff involved in this process, sign 
declaration for data protection. The third parties have not 
information about donor (including hospitals for inpatient care, 
transfusing blood and blood components and manufacturers of 
drugs, derived from plasma). BEs issue blood and blood components 
units only as a unique number to hospitals for inpatient care. 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

A bar code based system is mandatory and is used during all 
processes – from donation to transfusion of blood and blood 
components. 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

European blood Directives and recommendations of Council of 
Europe Guide are basic documents implemented in National 
legislation connected to blood transfusion system- Regulation № 9 / 
25 April 2006  establishing medical standard of a transfusion 
haematology  and Regulation № 18 of 10 June 2004 on the 
conditions and procedure for the diagnosis,  processing and storage  
of blood and  blood components and quality of blood from import. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

All BEs are accredited and authorized. One of the big BEs was 
accredited and authorized in 2008. The others big BEs were 
accredited and authorized in 2009. Hospital – based, small BEs were 
accredited and authorized as part of hospitals where they are based. 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

73 

 
 
 
4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

4.6. How many laboratories performing donor testing are active 
within your country? 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Laboratories for immunohaematologic testing of donated blood and 
laboratories for screening of each unit of donated blood for markers 
of transmissible infections are part of BEs. No laboratories outside 
BEs that can test donated blood. Laboratories testing donated blood 
as a part of Blood Establishments are accredited by the Accreditation 
Council, which is a specialized accreditation body to the Minister of 
Health according to the "Health Establishments Law" Art. 86.  

6 laboratories in 6 big stand-alone BEs. 

Hospital blood banks pass accreditation as part of hospitals, where 
they are located by the Accreditation Council, which is a specialized 
accreditation body to the Minister of Health according to the "Health 
Establishments Law"  Art. 88. Authorisation and oversight of 
hospital blood banks is done by NCA for blood  – Bulgarian Drug 
Agency.  

4.8. How many hospital blood banks are active within your country? 

In 2012 they were  28  (five years ago number was 56). 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

4.10.2. If yes, please state the responsible authority within your 
country. 

We have one plasma fractionation facility in the country.  Bul Bio - 
National Center of Infectious and Parasitic Diseases Ltd. (BB-
NCIPD Ltd.) Address: Bulgaria, Sofia, 26 Yanko Sakazov Blvd. Zip 
1504 BB-NCIPD Ltd. is a public company and belongs to the 
Ministry of Health of Bulgaria. The production nomenclature of BB-
NCIPD Ltd. covers more than 600 medicines, divided in two main 
groups: human medicines and in-vitro diagnostic medicine products. 
The medicinal products derived from human blood or plasma which 
BB-NCIPD Ltd. is producing are albumins and immunoglobulins. 
They are intended only for national market and use in the country.  

Bul Bio- NCIPD Ltd. as every manufacturer of medicinal products 
in the country is controlled by Bulgarian Drug Agency - Control of 
medicinal products Department / Manufacturing Control Division. 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

According to the “Law for blood, blood donation and  blood 
transfusion” Art.38 : The Executive Director of the Bulgarian Drug 
Agency shall function as a competent authority. Executive Director 
of the Bulgarian Drug Agency shall execute direct control through 
officials  determined by him.  Department  “ Control of  blood 
transfusion system” of the CA is in charge of inspections .  

5 full time inspectors. Note: CAs inspectors perform inspections not 
only in BEs, but also in hospital blood banks and hospitals which are  
performing transfusion of blood and blood products as a part of their 
medical activities. 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Pharmaceuticals (including plasma derivatives) 
Others 

5.2.1.1. If others, please specify. 

The only overlap with the inspection scheme are pharmaceutical 
inspections (medicinal products derived from human blood or 
plasma). They are done by Qualified Person of   Bul Bio-NCIPD 
Ltd. (a national plasma fractionation facility) according  Directive 
2001/83/EC. The QP inspect only 6  big BEs that give plasma for 
fractionation. 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

53 inspections 

6 inspections 

74 

 
 
 
5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

29  inspections 

2 inspections (suspicion on SARE) but cases were not confirmed.      

30 routine inspections in hospitals which are performing transfusion 
of blood and blood products as a part of their medical activities. 5 
non routine (following SARE) inspections in hospitals which are 
performing transfusion of blood and blood products as a part of their 
medical activities.  Total number of inspections in 2012: 59 routine 
inspections 29 of them in BEs and 30 in hospitals 7 non routine 
inspections 2 of them in BEs and 5 in hospitals  

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

NCA uses risk based approach in the planning of inspections, having 
in regard the complexity of the site, its processes and products as 
well as the criticality of the products or services provided by the 
structure. The complexity and criticality usually remain fairly 
constant regardless of the compliance status of the site and this is the 
reason BEs to be inspected every year. 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

NCA perform every year inspections to all BEs in the country. This 
is obligatory according to the “Law for blood, blood donation and  
blood transfusion” Art.39 (2) (Amended, SG No. 65/2006) “The 
inspections shall take place at least once a year. Inspections shall be 
conducted in each case of a serious incident or unwanted event or in 
doubt of a serious incidents or serious unwanted events.” 

All 29 BEs in the country were inspected every year in this period. 

Every BE has montly plan for blood collection using mobile team. 
The mobile team’s staff is part of BE personell. The equipment and 
documentation (SOPs, job descriptions, work instructions, transport 
and cleaning records etc.) are inspected at regular basis during 
routine inspections. One BE has additional satellite site for blood 
collection as part of its structure and this structure was inspected 
twice in period of 4 years.  

In 2012 were performed thematic inspections of one of the most 
critical processes – labeling of blood components. The labeling of 
blood components is carried out only by big BEs. No shortcomings 
were observed. 

In 2012 were performed routine inspections in all BEs. The minor 
shortcomings were noted in some hospital based BEs. The 
shortcomings were connected with premises (facilities). They 
needed to be repaired. CAPA were done in time limit.   

In 2012 there were no major shortcomings were observed during 
inspections. 

In 2012 there were no inspection in BE followed by suspension of its 
authorization. 

In 2012 there were no inspection in BEs followed by closure of the 
blood establishment. 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

No other significant outcome of the inspections carried out in the 
BEs in 2012. 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

The donation of plasma is carried out in the same place where the 
donation of whole blood takes place - the blood estabishments. 
There are no special plasma collecting facilities. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 

Yes 

75 

 
 
 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

According to the “Law for blood, blood donation and  blood 
transfusion”, NCA perform inspections not only in BEs, but also in 
hospital blood banks and hospitals which are  performing transfusion 
of blood and blood products as a part of their medical activities. 
Usually blood banks are based in big hospitals that actively perform 
transfusion of blood components. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

Blood banks are responsible  for : Supply of blood and blood 
components for particular patient and storage until transfusion; 
Immunohematological tests of patients and selection or reselection  
of blood and blood components for patient; Distribution of blood 
and blood components to wards in hospital. Optimal use of blood 
components in wards of the hospital and haemovigilance. Blood 
banks do not have permission to collect blood from blood donors. 
They receive analyzed and tested blood and blood components from 
BEs. The blood banks are subject to inspection as all other structures 
operating pursuant to the “Law for blood, blood donation and blood 
transfusion”.  

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

NCA uses national legislation - Regulation № 9 / 25 April 2006  
"establishing medical standard of a transfusion haematology"  and 
Regulation № 18 of 10 June 2004" on the conditions and procedure 
for the diagnosis,  processing and storage  of blood and  blood 
components and quality of blood from import" and many other 
regulations but  recommendations of Council of Europe Guide is 
basic document implemented in national legislation, connected to 
blood transfusion system. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

NCA for blood  – Bulgarian Drug Agency. According to Regulation 
№ 9 / 25 April 2006  "establishing medical standard of a transfusion 
haematology" “Healthcare facilities providing services under “Law 
for blood, blood donation and blood transfusion”  ensure the 
traceability of blood and blood components through accurate 
identification procedures, record keeping and appropriate procedures 
for labelling and reporting of any serious adverse reactions and/or 
serious events to the competent authority.”  

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Both paper records and electronic forms 

During inspections of BEs, electronic register which keeps the 
unique personal data of the donors is checked for secure IT and 
long-term archiving areas for appropriate environmental control. 
Cross check between paper records and electronic ones is done. 

76 

 
 
 
6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

The system includes BEs, blood banks, hospitals which are 
performing transfusion of blood and blood products as a part of their 
medical activities and NCA. Procedures and requirements are 
described in Regulation № 9 / 25 April 2006  "establishing medical 
standard of a transfusion haematology" Section V. Haemovigilance. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

No 

6.2.2.1. If no, what template do you use (please specify)? If possible, 
please upload template. 

Healthcare professionals performing transfusion and observing 
adverse reactions in patients with imputability level 1, 2 and 3 
should immediately report such events by filling in the form 
contained in Annex No. 18 of Regulation 29 of 2004. (template 
uploaded) BEs send a rapid notification to BDA in the format 
presented, containing data about the reporting establishment, the 
date on which the serious adverse event occurred and the reasons 
that caused the accident. (template uploaded) BEs  submits to BDA 
on an annual basis a complete report on all serious adverse events by 
using the form presented. (template uploaded) The templates for 
SAE are indicated in the Regulation № 9 / 25 April 2006  
"establishing medical standard of a transfusion haematology".  

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

No 

6.2.3.1. If no, please specify what guidelines you use? If possible, 
please upload the template. 

NCA uses at national level Regulation № 9 / 25 April 2006  
"establishing medical standard of a transfusion haematology". We 
can not upload the template. 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Yes 

100% 

Yes 

Blood banks are responsible  for optimal use of blood components in 
wards of the hospital and haemovigilance. They receive analyzed 
and tested blood and blood components from BEs. In a case of SAR 
or SAE obligatory send report to the BEs which distributed the 
blood and blood components and to NCA for blood-BDA, according 
to the “Law for blood, blood donation and blood transfusion” Article 
42. (1) “Persons engaged in collecting, diagnostics, processing, 
transfusion and storage of blood or blood components, shall 
immediately inform the Bulgarian Drug Agency of all serious 
incidents or unwantedreactions or suspicion for serious incidents or 
unwanted reactions, taken place.”  and Regulation № 9 / 25 April 
2006  "establishing medical standard of a transfusion haematology".  

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

NCA maintains register of adverse reactions and events according to 
the “Law for blood, blood donation and blood transfusion” - Article 
40. (3) (New, SG No. 65/2006) “The Bulgarian Drug Agency creates 
and holds a register of the serious incidents and serious unwanted 
events, linked to the collection and use of blood and blood 
components.” All reported cases of SAR/E are included in the 
register of  SAR/E but adverse reactions in patients with imputability 
level 1- Possible, 2- Likely, Probable and 3- Certain are obligatory 
subject to root cause analyses.  Moreover according to the “Law for 
blood, blood donation and blood transfusion” – Article 42. (2) “The 

77 

 
 
 
executive director of the Bulgarian Drug Agency through authorised 
persons shall analyze and summarize the information about the 
serious incidents and the serious unwanted reactions and shall take 
measures for preventing them.”   

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

The whole official information, received from European 
Commission  DG SANCO or other authorized European institutions 
are sent to all big BEs. The big (regional)  BEs shall sent 
information to small, hospital based BEs in their region. 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

In 2012 there were no recalls related to safety and quality of 
blood/blood components were issued in the country. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

In July 2011 has been created team for crisis management associated 
with transmissible infections (in fact with WNVD). This team 
includes directors and responsible persons from all big blood 
establishments. The same structure will react in case of a national 
rapid alert. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Information received via the RAS is translated and sent to the big 
(regional) BEs. When alerts affect neighbouring countries (Rumania, 
Greece) information is sent directly to small, hospital based BEs 
which are located near to the border with affected country. 
Information usually include measures to be taken to prevent spread 
of disease mentioned in an alert. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

6.2.14.1. If yes, please specify. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

Pharmacovilance 
Medical devices 

Yes 

NCA receive alerts from national alert systems maintained by 
Medical devices and Pharmacovigilance structures as part of BDA. 

The rules and conditions for the authorisation and control of the 
import of blood and blood components for transfusion from EU 
Member States or third countries are clearly indicated in the “Law 
for blood, blood donation and blood transfusion” - Article 8. (1) 
Blood and blood components shall only be imported in the territory 
of this country with the permission of the Minister of Health or a 
Deputy Minister authorized by the Minister in case of emergencies 
where the available quantities of blood and blood components in the 
country are not sufficient for the protection of people's health.  (2) 
The import under Paragraph 1 above shall be allowed in case the 
blood and blood components have been diagnosticated, processed, 
labelled and provided by an institution legally recognised by the 
respective state and shall be accompanied by documentation making 
possible the identification of every unit of blood or blood 
components and by information about laboratory testing performed 
and about the methods of diagnostics and processing.  (3) The 
requirements, which the quality of blood and blood components 
under Paragraph 1 above should meet, shall be determined by the 
Regulation under Paragraph 2 of Article 20 of this Act.  Detailed 
description of the requirements for the importation of blood and 

78 

 
 
 
  
7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

blood components are listed in Regulation № 18 of 10 June 2004" 
on the conditions and procedure for the diagnosis,  processing and 
storage  of blood and  blood components and quality of blood from 
import" Chapter Six. Quality of imported blood.  

This rules and conditions are the same as those for import of blood 
and blood components for transfusion from EU Member States or 
third countries. 

Equivalent standards (bilateral agreements) 

No 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

In 2012 there were no blood components imported for transfusion 
from third countries (outside the EU). 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

Yes 

In 2012 there were no plasma imported for fractionation from third 
countries (outside the EU). 

The export rules are laid down in the “Law for blood, blood 
donation and blood transfusion” Article 7. (1) Blood and blood 
components shall only be exported beyond the territory of this 
country by a decision of the Council of Ministers, where they are 
meant for:  1. rendering humanitarian aid;  2. production of drugs for 
this country's needs.  (2) The Minister of Health shall organise the 
export of blood and blood components in the cases under item 2 of 
Paragraph 1 above.   

The export rules are laid down in the “Law for blood, blood 
donation and blood transfusion” Article 7. (1) Blood and blood 
components shall only be exported beyond the territory of this 
country by a decision of the Council of Ministers, where they are 
meant for:  1. rendering humanitarian aid;  2. production of drugs for 
this country's needs.  (2) The Minister of Health shall organise the 
export of blood and blood components in the cases under item 2 of 
Paragraph 1 above.   

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

In 2012 there were no blood components exported for fractionation 
from our country to third countries (outside the EU). 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

In 2012 there were no blood components exported for transfusion 
from our country to third countries (outside the EU). 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

Yes 

7.11.1. If yes, how often (per year) is there a shortage of blood or 
blood components in your MS? 

Once per year.  Although this is not a rule but the most common 
deficiency of blood is observed seasonally. Often after a big summer 
holydays. Less frequently and no each year there is a shortage of a 
particular blood group. 

7.11.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Red Blood Cells 

7.11.3. If yes, would you be interested in concluding bilateral 
agreements with other MS in order to address the shortage? 

7.11.4. If yes, would you be interested in establishing short-term/ad-
hoc mechanisms for addressing the shortage? 

Yes 

Yes 

79 

 
 
 
7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

No 

No 

Yes 

Yes 

The penalties are imposed for violations of the Regulation № 9 / 25 
April 2006  "establishing medical standard of a transfusion 
haematology"  in the part related to the clinical use of blood and 
blood components: Section  IV. Clinical use of blood and blood 
components (e.g. lack of required documentation - transfusion 
without informed consent in writing from the patient and lack of 
evidences for performed  bedside tests). 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

5 penalties were imposed in 2012 

Monetary penalties were imposed. 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

Yes 

8.2.1. If yes, please specify. 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

The Directive lays down the rules on penalties, applicable to 
infringements of the provisions directed to processes in BEs and 
hospital blood banks affecting quality and safety of blood and blood 
components. The national legislation includes additional penalties 
applicable to violations occurring at the clinical sphere - before, 
during or after transfusion, import or export of blood or blood 
components etc. 

No significant difficulties were encountered in the transposition and 
implementation of the Blood Directives. 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

In July 2011 has been created team for crisis management associated 
with WNVD,  included responsible persons from all blood 
establishments. Concerning confirmed cases of WNV for 2012 in 
neighbouring countries (Rumania, Greece) , Bulgarian Drug Agency 
as the Competent authority with regard to the activities of blood 
establishments and blood banks for collection,testing, processing, 
storage and distribution of human blood and blood components, 
consider the set- up of the following measures as indispensable: 
1.Strengthen surveillance of donor selection through extensive 
clinical examination and interviews, and especially for the residents 
and visitors of the affected areas and areas with high risk of 
mosquito bites- rivers, lakes, reservoirs. 2.Increasing awareness of 
the staff in blood establishments and blood banks and especially in 
the regions along Danube river and West border region along Struma 
river. 3.The donors will be required to inform Blood Establishmets 
and blood banks, if within a period of 15 days after donation he/she 
found the appearance of a febrile episodes or skin rush. 4.Temporary 
deferral of potential donors doubtful for disease for 28 days after 
leaving the areas with high risk of mosquito bites - rivers, lakes, 
reservoirs or flu-like symptoms pass away. ( for the period between 
June and October ). The measures will be in force between June and 
October 2013.  

8.5. Which other communicable diseases are of relevance to you? 

Malaria ; Dengue 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 

No 

80 

 
 
 
plasma) to fall under the EU blood legislation within your country? 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

NCA for blood is not responsible for bed-side techniques of 
collection, processing and application of blood or blood components. 
The final product of bed-side techniques is not collected and 
prepared in BEs, according to specific quality standards, Moreover 
“Law for blood, blood donation and blood transfusion” do not apply 
to stem cells. The bed-side techniques of collection, processing and 
application of blood or blood components are under legislation of 
medical standarts to the different medical specialties that use them. 
Some of them, when it comes to applying the blood cells that 
undergo changes could be attributed to Regulation № 1394/2007 on 
advanced therapy medicinal products in Member States as a hospital 
exemptions because they are prepared on a non-routine basis in a 
hospitals under the exclusive professional responsibility of a medical 
practitioner, in order to comply with an individual medical 
prescription for a custom-made product for an individual patient.  

No other techniques used in the country that we have doubts whether 
they fall under the scope of Directive 2002/98/EC. 

NCA do not consider that any process in preparation of blood 
components can change their natural origin. The techniques used can 
only make blood components more safely. Whole blood and blood 
components are not active substances in the meaning of 
pharmaceutical legislation. The comparisons are irrelevant. Whole 
blood and blood components shall remain under scope of Blood 
Directives. 

81 

 
 
 
 
 
 
A.1.4. 

Survey response Croatia 

1. Public information 

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

Ministry of Health 

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.5. Website: 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Ksaver 200a, 10000 Zagreb, Croatia 

+385 1 460 7671 

http://www.zdravlje.hr/ 

Blood and blood components 
Tissues and cells 
Human organs 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

Ministry of Health is a central state administration body. Activities 
are financed from the state budget. Additionally, for the costs of 
authorization BE are paying fee. Two units share responsibility for 
blood.  1. Health Protection Directorate  1.1. Service for Blood, 
Tissues and Cells Inspection (1 head of 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)      Uredba o unutarnjem 
ustrojstvu (trenutno važeća)       

Not applicable 

NA 

9 

0 

0 

67774 

58089 

11670 

No 

179305 

450 ml +/- 50 ml 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

0 

NA 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2646 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

280-300 ml 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

118 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

9 are performing serology testing, 1 is performing NAT 

82 

 
 
 
2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

0 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

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

Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Form in attachment 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

There is legal requirement for the documenting and reporting 
information to the donor.  Those issues are regularly checked during 
inspections.  

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Infectious diseases Intravenous or intramuscular drug use Sexual 
behaviour  Those criteria are the greatest threat to the public health.   

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Sexual behaviour 

No 

No 

MSM promiscuity paid sex sex with persons in risk groups  

No 

No 

Main causes leading to deferrals: low haemoglobin level, high/low 
blood pressure, endocrine diseases, respiratory diseases, other 
reasons.  Reduced hemoglobin 41.7 %,  Heart and blood vessels 
disease 2,8 %, Hyper and hypotonia 17.7 %, Neurological Diseases 
1.1 %, Respiratory Diseases 3,3 %, Digestive tract Diseases 3,4 %, 
Genitourinary Diseases 0.9 %, Skin and subcutaneous tissue 2.2 %, 
Endocrine pain., malnutrition and immunity 3.4  %, Mental illness 
0.9 %, Infectious and parasitic diseases 1.5 %, Injuries and 
poisoning 1.2 %, Vaccines 0.9 %, Menses, pregnancy, childbirth, 
lactation and abortion 1 %, Risk behavior 0.5 %, Collapse before 
giving blood 0.1 %, Cancellation before giving blood 0.2 %, Surgery 
3 %, Malignant diseases  0.3 %, Alcoholism 0.6 %, Other 13.1 % 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

National referral centre - Croatian Institute for Transfusion Medicine 
is collecting and processing data. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

29248 

No 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

There is legal requirement for laboratories to be authorized. 
Laboratories are regularly inspected.  

83 

 
 
 
3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

Individual donor testing for every donation  

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Yes 

HIV 1p24 antigen, HCV core, TP antibody (Syphilis) 

Yes (considering that plasma in total is recovered plasma) 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

Yes 

3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

Addition of obligatory NAT testing. 

Yes 

7 

14 

6 

Syphilis 8 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

International accreditation systems for testing laboratories is 
foreseen to be implemented in renewed legislation. 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

No 

Yes 

Yes 

In the most BEs responsibilities for collection, processing, testing 
and quality assurance are delegated to other qualified persons.  

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Authorisation requirement Inspections Regular evaluation of 
personnel Mandatory trainings  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

BEs’ QS includes: quality management, quality assurance, 
continuous quality improvement, personnel, premises and 
equipment, documentation, collection, testing and processing, 
storage, distribution, quality control, blood component recall, and 
external and internal auditing, contract management, non-
conformance, errors, complaints and self-inspection.  HBB: do not 
all have QS established (because of lack of personnel)  

Authorisation requirement Inspections Regular evaluation of 
personnel Mandatory trainings  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

both, paper records and electronic forms 

3.2.7. Is there a system in place to ensure that storage, transport and 

Yes 

84 

 
 
 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

There is implemented quality system (separated refrigerators or 
space in cooling chambers, SOPs for storage order) and IT system 
including labelling system insuring protection of mix-up, storage 
temperature is monitored in BE and HBB automatically, but during 
transportation is purely maintained (no cooling devices). 

National IT system is implemented allowing only authorised 
personnel to access the data. During the production and further there 
is no connection between donor and product. 

Yes 

Yes 

Yes 

Well accepted, foreseen to be mandatory in the next revision of the 
legislation. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

Yes 

9 

No 

Ministry of Health 

4.6. How many laboratories performing donor testing are active 
within your country? 

9 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

It is not obligatory for Hospital blood banks to be authorised. For 
oversight is responsible Ministry of Health. 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

33 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Service for blood, tissues and cells inspection 

1 head of Service and 2 inspectors 

Yes 

Tissues and cells 
Organs 
Advanced therapies 

85 

 
 
 
5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5 

2 

5 

2 

0 

No 

Yes 

0 

NA 

There were no inspections with such result.  

Corrective measures imposed  

Corrective measures imposed  

There were no inspections with such result 

There were no inspections with such result 

There were no inspections with such result 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

0 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

Requirements for HBBs are described in Ordinance on personnel, 
premises and technical equipment for health care providers. 
Requirements are in concordance with blood Directives. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

Ministry of Health’s Service for blood, tissues and cells inspection is 
responsible for inspection of HBBs. 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

Well accepted, foreseen to be mandatory in the next revision of the 
legislation. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

Yes 

5.11.1. If yes, how would you rate the usefulness and efficacy of 

4 

86 

 
 
 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Ministry of Health 

Yes 

all 

No 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

By inspection 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

BE and hospital blood banks must without delay, by phone, fax or e-
mail inform Croatian Institute for Transfusion Medicine and 
Ministry of Health about SARE. For that situation they have to use 
SARE template defined in Ordinance. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

No 

6.2.4.1. If no, why not? 

Lack of the personnel  

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

100% 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Hospital blood banks must without delay, by phone, fax or e-mail 
inform Croatian Institute for Transfusion Medicine and Ministry of 
Health about SARE. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

In all SARE 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

BEs are informed on SARE through the network consists of CA’s 
inspectors and responsible persons of BE. 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

Data are available only for CITM (in attachment) 

6.2.11. Do you have in place a system/procedure to notify BEs in 

Yes 

87 

 
 
 
case of a national rapid alert? 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

In case of RA BE are notified through network of CA’s inspectors 
and responsible persons of BE (by mail and fax). 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

In case of RA BE are notified through network of CA’s inspectors 
and responsible persons of BE (by mail and fax). 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Organs Tissues and cells  

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

Blood and blood components may not be exported or imported from 
or into the Republic of Croatia. Under exceptional circumstances, 
however, in the event of natural disasters and other extraordinary 
situations, or where justified by medical emergencies, the Minister 
may approve an export or import of blood and blood products. 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

NA 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.4.1. If yes, please specify. 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

Equivalent standards (bilateral agreements) 

Yes 

Syphilis  

Yes 

0 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

0 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Import and export is not allowed  

Import and export is not allowed  

Yes 

0 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

0 

88 

 
 
 
  
7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

No 

No 

No 

Yes 

No 

No penalties were imposed 

No penalties were imposed 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

No penalties were imposed 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

Expenses of the implementation of IT and requirements for 
equipment. Separation of BEs from HBBs. Reconstruction of the 
facilities to meet criteria of Directives (still in progress)   

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Croatian Institute for Transfusion Medicine is informed about all 
new data  of WNV outbreaks and they gave guidance to BE for 
donor eligibility. 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

A.1.5. 

Survey response Cyprus 

1. Public information 

Act on Health Care, CA is Ministry of Health 

Allogeneic apheresis of granulocytes. 

Processes which change original function of the blood component in 
the product (f.e. activating platelets for orthopaedic use). 

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

MINISTRY OF HEALTH CYPRUS 

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.5. Website: 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

"GEORGIO" 1 PRODROMOU Str.& 17 HILONOS Str. 1448 
NICOSIA CYPRUS  

0035722605736 

www.moh.gov.cy 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

89 

 
 
 
1.1.7.1. If other, please specify. 

1.2. National Competent Authority 2? 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

Other 

Public Health and Health Care  

No 

Deparments of the Ministry of Health:  1. Medical and Public Health 
Services 2. Nursing Services.3. Pharmaceutical Services 4. Dental 
Services 5. Mental Health Services 6. State General Laboratory At 
the central level there are various administrative units for the 
fulfilment of the obligations of the Ministry of Health as for 
example: Purchasing and Supply Section,  European Coordination 
Section, Health Monitoring Unit One, Computerisation, Health 
Promotion and Disease Prevention and Legislation. Another unit is 
being the Blood Center, the budget of which is part of the overall 
annual budget of the Ministry of Health dependence on goverment 
(wedges,staff, devices etc).     

Not applicable 

There is no Regional Competent Authority. All the district  blood 
banks are directly under the responsibility  of the Ministry of Health   

1 Blood Center and 4 blood banks  Blood Banks  Blood Banks  

none 

none 

48,121 

7148 Data collected oby the BC and 1 BB 

7106 

No 

57,847 

450ml 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

1507 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

360-480ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

272 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

200-250ml 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

261 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

4 

4 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.17.1. If other, please specify. 

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

Some of the Volunteers (doctors, chemists, nurses) of the Cyprus 
Coordinating body of Blood Donations and Awareness provide the 
national standarised information. Also information is provided by 

90 

 
 
 
2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

flyers  

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

questionnaire  

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

By written documentation on the blood donors questionnaire. Also 
after the testing when there is an upnormal result is 
documented.There is a responsible person from employees 
specificaly the person who is in charge for blood donations (doctor) 
who has the responsibility to settle via telephone an interview with 
the blood donor. When blood donor comes to the inerview is 
informe for the results.  

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

awareness campaign, lectures, leaflets  

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Low Haemoglobin level  is the most frequent reason for blood 
donation deferral.Most likely due to the high percentage of 
thalassaemia carriers in the country. Other frequent reason for 
deferral is the low blood pressure. Also medication reception 
especially b-blockers  

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

Communicable diseases and  sexual behavior as you depend on the 
honesty of the blood donor. Though because of the small size of the 
country such as cases are limited. 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.7.1. If yes, please explain and suggest your alternative. 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

No 

Yes 

Absence of steady partner  

Yes 

Yes 

Persons who are older than 65 years old in a good health condition 
and submit by their doctor a medical certificate   

Low Hb levels and Blood Pressure abnormalities 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

The Blood Center and the blood banks are keeping data (P/C, 
manual) and sending to the CA the data upon request 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

8062 

Yes 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

All the laboratories that carry out the tests for donors are public and 
hospital based They all designated by the Ministry of Health 
(Rebublic of Cyprus)  

91 

 
 
 
3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

High cost  

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

Syphilis (Treponema pallidum) is included in Blood Donation Law 
1997 (regulations article 31 No 322)  

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Yes as plasma donation is regulated and covered from the same 
National Blood Donation law.  

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

Yes 

3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

Syphilis (Treponema pallidum)  

Yes 

8 

19 

19 

Syphilis (Treponema pallidum): 42 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

no comment  

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

No 

Yes 

Yes 

Long time experience to blood banks prior to the adoption of article 
9(3) 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Appropriately  qualify personnel is selected and an ongoing in 
service training  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

There is an ongoing process of assuring  the maintenance of high 
quality based on the principles of good practice as described in 
Article 10 and 6  

These documentation is readily available upon request by CA 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

ICT and manually records are been kept  

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

CA prepared quidelines according to the Directive 2002/98,  Article 

92 

 
 
 
3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

22 and Article 29(e)  and to the Directive 2005/62 regarding 
starage,distributionand transport conditions. These quidelines were 
distributed to all of the Public Blood Banks and Blood Center and to 
all Hospitals/Clinics of the private sector on the 2 of May 2012  

We define two only persons from the stuff (to each blood bank and 
Blood Center) who are responsible for keeping blood donors data. 
Also on  the ICT data a password is in use which only these two 
persons have access   

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

No 

3.2.9.2. If no, why not? 

 Blood center and blood banks use manually the labelling. The cost 
is prohibiting factor for the acquisition of this system  

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

 Important and very useful element for the every day activities in 
Blood Center and Blood Banks  

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Designation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Other 

4.2.1. If other, please specify. 

Relevant documentation submited upon request 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

One BC 08/12/2006 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Ministry of Health 

4.6. How many laboratories performing donor testing are active 
within your country? 

4 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Ministry of Health 

4.8. How many hospital blood banks are active within your country? 

6 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

4.10. Are there plasma fractionation facilities in your country? 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

No 

No 

No 

5.1.3. If no, please explain why not. 

Only recently four professionals had been trained by EU funded 
project as inspectors   

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

No 

none 

none 

none 

93 

 
 
 
5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

5.9. Is a system in place for inspecting hospital blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

5.10.1. If yes, what is your experience with this Guide? 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

none 

none 

No 

Yes 

none 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

Yes 

No 

Yes 

useful  

Yes 

5 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 

Ministry of Health 

Yes 

for all  

Yes 

94 

 
 
 
components? 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT  

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

In each blood bank and Blood Center there is a store room for 
keeping these records. Only few people have the key   

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

At the level of Minstry of Health there is a person who is responsible 
to collect the data from all the blood banks, blood center and private 
hospitals 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.2. If no, how do you ensure that SAR/E are reported from 
Hospital Blood Banks to BEs? 

Yes 

Yes 

Yes 

100% 

No 

they do not reported to BEs but directly to the Ministry of Health  

6.2.7. Do you perform root cause analyses of the SARE? 

No 

6.2.7.2. If no, why not? 

because for the moment we do not observe serious SARE cases  

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Each blood bank and the Blood Center are informe immediatetly  by 
fax, letters and emails when a SAR recorded at EU level  

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

No recalls until now  

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

by sending fax, emails and via telephone we informe blood center 
and blood banks in a rapid alert case 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

the same as 6.2.11.1 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No 

No 

No  

95 

 
 
 
7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.3.1. If others, please specify. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

The recommedations of directive 2002/98 but we do not import 
blood and blood components from other EU MS or third countries  

As in 7.1 

Others 

N/A 

No 

Yes 

0 

Yes 

0 

N/A 

N/A 

Yes 

0 

Yes 

0 

Yes 

7.11.1. If yes, how often (per year) is there a shortage of blood or 
blood components in your MS? 

Three times yearly especially on  Christams, Easter and summer 
Holidays  

7.11.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Red Blood Cells 

7.11.3. If yes, would you be interested in concluding bilateral 
agreements with other MS in order to address the shortage? 

7.11.4. If yes, would you be interested in establishing short-term/ad-
hoc mechanisms for addressing the shortage? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

Yes 

Yes 

No 

No 

No 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 

Finance problems to implement quality procedures, resistance to 
change, not enough staff at the CA level and at the Blood Center and 

96 

 
 
 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

Blood Banks   

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

28 days deferrral of blood donors who traveled to the countries with 
the outbreaks of WNV 

8.5. Which other communicable diseases are of relevance to you? 

Malaria 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Yes 

No  

Factor VIII, Albumin, haemacell, fibrinogen 

97 

 
 
 
 
 
 
A.1.6. 

Survey response Czech Republic 

1. Public information 

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

Ministry of Health 

1.1.2. Address of&nbsp;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) 

Palackého nám 2, 128 20  Prague Czech Republic 

+420-224 971 111 

mzcr@mzcr.cz 

www.mzcr.cz 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 
Other 

1.1.6.1. If other, please specify. 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.1.7.1. If other, please specify. 

1.2. National Competent Authority 2? 

health care 

Other 

regulation, legislation 

Yes 

1.2.1. Name of National Competent Authority 2: 

State Institute for Drug Control 

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

Šrobárova 48,  100 41  Prague, Czech Republic 

+420 272185111 

posta@sukl.cz 

www.sukl.cz 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 
Other 

1.2.6.1. If other, please specify. 

1.3. National Competent Authority 3? 

price / cost regulation 

No 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

Ministry of Health: govermental institution. Blood components and 
plasma for fractionation are managed within Dpt. of Pharmacy. 
There is also special dpt. dealing with EU affairs.  State Institute for 
Drug Control: independent institution. Blood components and 
plasma for fractionation (together with cells and tissues) are 
managed within Clinical Practice and Surveillance over Biolog. 
Material Processing - Inspection Division. Haemovigilance is 
managed within Dpt. of Pharmacovigilance. There is also special 
dpt. dealing with price regulation.  

Not applicable 

no Regional Competent Authorities 

74 

12 

9 

272 152 

227 175 

49 252 

Yes 

2.1.7.1. If yes, please explain (from/to which other countries, 

Exact data are not available. There is small scale cross-border 

98 

 
 
 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

movement of plasma donors from CZ to Austria or Germany. 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

418 954 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

450 ml (standard) 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

617 617 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

800 ml (average) 

exact figures are not available, total No. of aphereses (excl. 
plasmapheresis, incl. platelets, red cells and/or multicomponent) is 
18 271 

"volume" is not available (and not regulated). Standard collection is 
2x 10^11 platelets 

exact figures are not available, total No. of aphereses (excl. 
plasmapheresis, incl. platelets, red cells and/or multicomponent) is 
18 271 

52, donor testing is performed only by some BEs 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

donor testing is performed by BEs if they perform plasmapheresis 
(see above) plus 2 laboratories for specialized plasma centers 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 

reqiurements are set in the CZ  Decree (MoH 143/2008 Coll.) and 
controlled during inspections 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

reqiurements are set in the CZ  Decree (MoH 143/2008 Coll.): the 
donor signs in the Questionnaire, that he/she has red "information", 
answered all questions to his / her best knowledge and reconsidered 
his/her responsibility (incl. possibility of self-exclusion) 

infection risk (harmonization within EU is important) 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

sexual behavior (there is a little reason for permanent exclusion for 
behavioral risk ! One should keep in mind that "behaviour can be 
changed") 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

sexual behavior (there is a little reason for permanent exclusion for 
behavioral risk ! One should keep in mind that "behaviour can be 
changed") 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

MSM, sexual intercourse with a person with AIDS/HIV pozit., sex. 
intercourse for money or drugs,  sex. intercourse with inj. drug adict, 
sex. intercourse with prostitute,  frequent changes of casual sex. 
partners 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 

Yes 

No 

99 

 
 
 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

- epidemiological: travelling to risk area (malaria, WNV...), 
exposition to "bloody" medical procedures / piercing / tatoo, thick 
bite - medical: low blood count, low ferritin, elevated leukocytes  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

there is a National Registry of donor found to be pozitive for HIV, 
HBV and/or HCV markers 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

150 

No 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

testing site in declared in the BEs licence,  requirements are checked 
during inspections  

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 

cost / benefit considerations 

Yes 

HIV p24 antigen, syphilis antibodies 

yes 

No 

Yes 

9 

30 

111 

syphilis: 30 

no 

Yes 

platelets: very few units (dozens), amotosoralen 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

100 

 
 
 
3.2.2.1. If yes, please specify. 

legislation allows to delegate tasks to other persons, but in practice it 
is not used 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

the requirement is stated in the decree (MoH 143/2008 Coll.) and 
checked during the inspections 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

the requirement is set in the decree (MoH 143/2008 Coll.)  and 
checked during the inspection 

the requirement is set in the decree (MoH 143/2008 Coll.)  and 
checked during the inspection 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

combination of printed documments and electonic copies. The 
requirements are set in the decree (MoH 143/2008 Coll.)  and 
checked during the inspection 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

the requirements are set in the decree (MoH 143/2008 Coll.) and 
checked during the inspection 

all manufactured products are labeled with unique numerical code 
(according to the "standard for labeling of blood components"). No 
data allowing identification of a donor are given to any BEs partner  

Yes 

Yes 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

in general - good 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

85 (1.8.2013) 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

4.6. How many laboratories performing donor testing are active 
within your country? 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

State Institute for Drug Control 

52 (within BEs) 

blood banks are not authorised but they are checked by State 
Institute 

4.8. How many hospital blood banks are active within your country? 

120 (68 run their services within authorised BE) 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 

No 

101 

 
 
 
14, 15, 22 and 24 of Directive 2002/98/EC? 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

State Institute for Drug Control, Inspection Division, Clinical 
Practice and Surveillance over Biolog.Material Processing 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

1,5 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Tissues and cells 
Others 

5.2.1.1. If others, please specify. 

Good Clinical Practice 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

45 inspections of BEs, 21 inspections of BBs in 2012 

5 inspections of BEs in 2012 

45 inspections of BEs in 2012 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

0 

2 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

basic inspection intervals have been established in compliance with 
the requirements set forth by Decree. The interval may be shortened 
based on the degree of risk based on the results of the previous 
inspection. Where the evaluation achieved is “satisfactory”, the 
interval may be shortened to 12 – 24 months. Where the evaluation 
achieved is “not satisfactory”, the interval for follow-up inspections 
shall always be 12 months or less.   

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

internal reasons 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

40 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

mobile collection sites inspected 1x/4Y satellite collection sites 
1x/2Y  

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

inspection report 

inspection report 

inspection report 

inspection report, number of cases: 0 

inspection report, number of cases: 0 

102 

 
 
 
5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

NA 

5 

No 

5.8.1. If no, please explain. 

only GMP inspectors for blood establishments (State Institute for 
Drug Control) has approx. 320 officials. 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

blood banks are not licence holders but there is a duty to annonce 
their activities. Blood banks are inspected once a 4 years. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

blood banks are not licence holders but there is a duty to annonce 
their activities. Blood banks are inspected once a 4 years. 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

in general - good 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

No 

5.11.2. If no, why not? 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

internal reasons 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

Ministry of Health (legal requirements), State Institute for Drug 
Control (in site inspections)  

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

whole blood, red blood cells, platelets, plasma, kryoprotein, 
kryoprotein-depleted plasma, granulocytes 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

the requirement is set in the law  (Act 378/2007 Coll.) and decree 
(MoH 143/2008 Coll.)  and checked during the inspections 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

blood establishments and blood banks are obliged to send immediate 
and annual hemovigilance reports. NCA statistically evaluates data, 
fills SARE template and sends it to EC 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

No 

6.2.2.1. If no, what template do you use (please specify)? If possible, 
please upload template. 

it is obligatory to use "template" published as an Annex of Decree 
No 143/2008 Coll. (this template is not, in our oppinion, very 
convenient and does not comply with practical requirements)  

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

Yes 

103 

 
 
 
6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

No 

6.2.4.1. If no, why not? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

internal reasons 

70-99% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

please see 6.2.1.1 

6.2.7. Do you perform root cause analyses of the SARE? 

No 

6.2.7.2. If no, why not? 

internal reasons (it is done by BE / BB) 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

results are presented to BTS medical community 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

135 (vast majority - lookback procedure for plasma fractionation) 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

web page State Institute for Drug Control, information is in paralell 
distributed via Medical Society 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

web page State Institute for Drug Control, information is in paralell 
distributed via Medical Society 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

all kinds of alerts are directed to the same institutions (MoH, State 
Institute for Drug Control). If relevant, they are send to partners / 
responsible bodies involved 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

no 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

reguirements are set in the law (Act 378/2007 Coll.), in addition an 
individual licence from MoH is necessary 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

reguirements are set in the law (Act 378/2007 Coll.), in addition an 
individual licence from MoH is necessary. As far as there is no 
fractionating capacity in the CZ, these  rules are not applicable 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Equivalent standards (bilateral agreements) 

Yes 

7.4.1. If yes, please specify. 

to fullfill CZ legal requirements (incl. HIV Ag, syphilis) 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

104 

 
 
 
7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

0 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

0 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

requirements depend on the partner, "export licence" from MoH is 
necessary 

requirements depend on the partner, "export licence" from MoH is 
necessary 

Yes 

0 

Yes 

0 

No 

No 

No 

Yes 

Yes 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

administrative failures - change of legal entity of blood 
establishments was not announced in advance. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

1 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

financial penalty 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

to define clearly the scope (as regards use of blood and it´s 
components for "non-transfusion" purposes, eg. topical use etc...) 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

donors travelling into "countries in risk" during summer season are 
deferred for 4 weeks 

8.5. Which other communicable diseases are of relevance to you? 

none of special concern 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 

currently in discussion 

Yes: eye drops with autologous plasma, autologous fibrin glue and 
sealants etc. 

pooling more then10 donations 

105 

 
 
 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

106 

 
 
 
 
 
 
A.1.7. 

Survey response Denmark 

1. Public information 

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

Sundhedsstyrelsen (Danish Health and Medicines Authority) 

1.1.2. Address of&nbsp;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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.1.7.1. If other, please specify. 

Axel Heides Gade 1 DK 2300 Copenhagen S, Denmark  

+45 72 22 74 00  

sst@sst.dk 

www.sst.dk 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 
Other 

Development and implementation of national legislation, 
formulation of national health policies, etc. 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

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 af healthcare services and inform 
Danish citizens on health issues. It is also our responsability to 
ensure the availability of effective and safe medicines, medical 
devices and new terapies 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 advise 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 responsability 
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 

Regional Competent Authorities are not present in Denmark 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

5 (in Denmark the blood establishment is an integrated part of the 
hospital system 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

58 

6 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

154,350 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

This data is not available for our office 

This data is not available for our office 

No 

293,765 

450 ml ± 45 ml 

2.1.10. For plasma donations by apheresis, could you please provide 

3,086 

107 

 
 
 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

600 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

1,232 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

irrelevant, no of plts is relevant 

0 

5 

5 

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

Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Not available in English. Appendix 1 (Bilag 1) in attached national 
regulation (BEK nr 366 af 23/04/2012) 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

By inspections (is there a system/spot checks) 

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

Criteria concerning HIV and hepatitis 

Criteria regarding diseases that are very rare in Denmark (it is not 
possible to ask about everything) 

No 

Yes 

male homosexual practice; prostitution (permanent deferral); women 
who have had sex with bisexual male, sexual contact with i.v. drug 
user, sex with person who shares or have shared injection needles 
with others, sex with person treated for hemophilia before 1988, sex 
with person from areas where HIV or HTLV infection is widespread 
in the general population (Africa South of Sahara, India, South East 
Asia, South America), sex with HIV positive,sex with prostitute (4 
months deferral), 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

No 

No 

Travelling Medication 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 

No 

No 

108 

 
 
 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

By inspections (systems and spot checks) 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

ID NAT 100 % 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Yes 

ID NAT for HIV; HBV and HCV 

It is mandatory 

No 

Yes 

0 

5 

4 

Not applicable 

No 

No 

Yes 

Yes 

Delegation only to qualified and trained personel 

Inspections (systems and spot checks) 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

The quality system follows requirements in the Directive 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Inspections (systems and spot checks) 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

IT systems 

3.2.7. Is there a system in place to ensure that storage, transport and 

Yes 

109 

 
 
 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

3.2.7.1. If yes, please specify. 

The system follows requirements in the Directive 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

All data is stored in state of the art blood bank IT systems (ProSang 
and Blodflödet) with protected and controlled access (user name and 
password). The function of these IT systems are inspected by the 
Danish Health and Medicines Authority in connection with the 
biannual inspection of blood establishments demanded in the Danish  
and European legislation . 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

No, but ISBT 128 is 100 % implemented 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

The guideline is followed in generel 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Inspections of the site/centre 

Yes 

5 

No 

Sundhedsstyrelsen (Danish Health and Medicines Authority) 

4.6. How many laboratories performing donor testing are active 
within your country? 

5 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Sundhedsstyrelsen (Danish Health and Medicines Authority) 

4.8. How many hospital blood banks are active within your country? 

See section 2.1 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Sundhedsstyrelsen (Danish Health and Medicines Authority) 

3 

Yes 

Tissues and cells 
Pharmaceuticals (including plasma derivatives) 
Medical devices 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

Every second year 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

0 

110 

 
 
 
5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

11 

0 

0 

No 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

80 % 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

Every second year 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

0 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

We do not classify shortcommings as minor nor major 

We do not classify shortcommings as minor nor major 

0 

0 

They are in generel in complience 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

10 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

The system is implemented in the NCAs quality system 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

We only have hospital blood banks in Denmark 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

The guide is very usable 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

No 

5.11.2. If no, why not? 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Do to lack of ressources 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 

Sundhedsstyrelsen (Danish Health and Medicines Authority) 

111 

 
 
 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 128 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

All components  

Only electronic forms 

Inspetions (systems for backup and storage, spot checks) 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

In accordance with Executive Orders forms are available from our 
website http://laegemiddelstyrelsen.dk/en/service-menu/product-
areas/blood-and-blood-products (in Danish only). The forms are in 
accordance with the Directives 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Yes 

Yes 

Yes 

100% 

Yes 

In accordance with Executive Orders forms are available from our 
website http://laegemiddelstyrelsen.dk/en/service-menu/product-
areas/blood-and-blood-products (in Danish only). The forms are in 
accordance with the Directives 

6.2.7. Do you perform root cause analyses of the SARE? 

6.2.7.1. If yes, in which cases? 

Yes 

All cases 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

No 

6.2.8.2. If no, why not. 

No we only issue a national yearly report on the blood product area 

6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Yes 

0 

Yes 

We have a contact list to the BE and contact them if it is necessary. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

112 

 
 
 
6.2.12.1. If yes, please give a short description of the 
system/procedure. 

See section 6.2.11.1 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

Same CA 

No 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

No rules. DK is self sufficient and has during the last 20 years 
imported less than 20 RBC units - all from EU/EEC member states 
and all for specific immunized patients. 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

No import 

Equivalent standards (bilateral agreements) 

No 

No 

No 

The rules are described in the Danish Blood Law 

Export allowed to neighbouring countries in case of emergencies or 
immunized patients 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

214.576 (60,9 metric tons); Switzerland 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

Yes 

0 

No 

No 

No 

Yes 

No 

8.1.2. If yes, what were the reasons for imposing the penalties? 

Not applicable 

113 

 
 
 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

Not applicable 

Not applicable 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

The danish comments to a potential revision of the directive was 
sent to Stefaan.VAN-DER-SPIEGEL@ec.europa.eu  on 02-01-2013. 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Travel deferral rules 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

None 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

Sundhedsloven (Danish National Health Act), Medical Devices Act  
Sundhedsstyrelsen (Danish Health and Medicines Authority) 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

No 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

We follow the EU-directive criteria for medicinal products 

114 

 
 
 
 
 
 
A.1.8. 

Survey response Estonia 

1. Public information 

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

State Agency of Medicines 

1.1.2. Address of&nbsp;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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Nooruse 1 50411 Tartu  Estonia 

+372 7374140 

info@ravimiamet.ee 

http://ravimiamet.ee/en 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

State Agency of Medicines (SAM) is a governmental body under the 
Ministry of Social Affairs. There is 6 departments in SAM. 
Department of Biologicals is responsible for the blood (and blood 
components), cells, tissues, organs and advance therapy medicinal 
products. There are 3 employees in the Department of Biologicals - 
head of department and 2 specialists. There have been major 
changes in staff during last two years. Therefore specialist nr 1 has 
1,8 years of experience, specialist nr 2 has 7 months of experience 
and head of the department has only 2 months of experience. In 
addition one GMP inspector from the Department of Inspection 
participates the inspections made to the cell, tissue and organ 
handlers or blood establishments. 

1.5. 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) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

There are no Regional Competent Authorities in Estonia.  

5 

1 

0 

35869 

28353 

7516 

Yes 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

Some donors has moved abroad. Therefore during the look-back 
procedures it can be sometimes hard to reach the donor (for exaple if 
additional testing is needed). 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

58120 

450 

1028 

650 

2.1.12. For platelet donations by apheresis, could you please provide 

105 

115 

 
 
 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

393 

804 

5 

5 

Only trained personnel is allowed to provide such information 

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is not standardised at national/regional level 

It is regulated by law. All information given to and received from 
the donors (including donor evaluation form) and all test results 
must be stored at least 15 years. All relevant abnormal findings must 
be reported back to the donor (including counseling) by the blood 
establishment.  

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

It is hard to highligh a single criteria, because all aspects that can 
affect either donor or a recipient are relevant. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

All criterias concerning donor behavior are hard to verify. 

No 

No 

Blood establishments have created donor selection questionnaires 
that include questions about the occasional sex partners (in return for 
money or drugs), having sex with men (for the male donors), having 
sex with a man who has had sex with man (for female donors) 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

No 

No 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Unfortunately we do not have an overview about all deferrals 
because blood establishments are not reporting every case. Blood 
establishments report cases that concern repeated donors' positive 
test results for the infectious diseases. 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

We are collectig deferrals of repeated donors that are associated with 
the look-back procedures. 

26 (for repeated donors) 

No 

Yes 

116 

 
 
 
3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Requirements for the laboratories that carry out testing of donors 
blood are established in legislation. During licensing and inspections 
of BE-s laboratories are regularly checked. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

Each donation is tested for the HIV, HBV and HCV markers using 
NAT testing. 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

Some of them are mandatory. HBV NAT test is not mandatory, but 
all the BE-s are using it in addition to HBsAg.  

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Some of them are mandatory. HBV NAT test is not mandatory, but 
all the BE-s are using it in addition to HBsAg.  

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

Yes 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

6 (confirmed positive cases for repeated and first time donors) 

13 (confirmed positive cases for repeated and first time donors) 

32 (confirmed positive cases for repeated and first time donors) 

Positive test results for syphilis - 15 (confirmed positive cases for 
repeated and first time donors) 

No 

Yes 

Yes 

Tasks can be delegated to the person who is nominated as a 
replacement person of responsible person. The requirements for the 
replacement person are set out in legislation. 

Qualification and training of personnel is controlled during licensing 
of BE (for some employees) and during inspections. All BE-s must 
establish training program for each employee. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

It is regulated by law. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

It is regulated by law and checked during the inspections. 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

It is regulated by law and checked during the inspections. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 

Yes 

117 

 
 
 
  
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

3.2.7.1. If yes, please specify. 

Requiremets are set out in law. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Donor codes are used to identify the donors. Donor name and the 
code can be related only by the BE-s.  

Yes 

Yes 

Yes 

- 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

5 (14.08.2013) 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Estonian Accreditation Centre. Laboratories that are part of the BE-s 
are controlled by SAM. 

4.6. How many laboratories performing donor testing are active 
within your country? 

5 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Health Board 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

24 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

State Agency of Medicines (SAM), Department of Biologicals is 
responsible for the ispections of BEs. 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

1 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Tissues and cells 
Organs 
Advanced therapies 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

24 

34 

0 

118 

 
 
 
5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

1 

0 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

All reports send by the BE-s about serious adverese reactions and 
serious adverse events are regularly analysed. Results are used to 
spot out errors that need intervention by CA. In case of major 
changes (new test systems, new machines) BEs notify CA. Based on 
that CA makes a decision about the need for inspection. 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

3 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

Satellite sites are inspected as BE-s. Mobile sites are inspected 
occasionally. 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Inspection focused on biovigilance system. BE improved the the 
way of reporting serious adverse events and reactions. 

BE improved the vigilance system.  

- 

- 

- 

Only one inspection was made during 2012 to the BEs because the 
inspector responsible for the BEs left and the training of the new 
inspector was needed before the inspections.     

No plasma establishments in Estonia 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

Health Board is responsible for inspecting hospital blood banks. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

No 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

It helps to prepare for the inspections. It is also very useful for the 
new inspectors just starting their jobs. It gives a good overview 
about general systems in BE. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 

Yes 

3 

Yes 

119 

 
 
 
the results and control measures of your inspections? 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

State Agency of Medicines 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

For all the blood components 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT system 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

Cryoprecipitate  

Both paper records and electronic forms 

It is regulated by law and controlled during inspections. 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

BEs are reporting SAR and SAE to the Sate Agency of Medicines 
(SAM).  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

No 

6.2.4.1. If no, why not? 

There is no separate vigilance officer in SAM. Biovigilance is a task 
for the specialist who is also responsible for the licencing and 
inspecting BEs. 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

100% 

Yes 

6.2.6.1. If yes, please provide a brief description. 

System is regulated by legislation. Hospital blood banks must inform 
concerned BEs of any serious adverse reactions. The template form 
for reporting is also set out in law. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

For all SARE reports BEs also send the investigation reports. If 
during the evaluation of these investigation reports (by CA) it seems 
that there may be also other aspects that need to be addressed, root 
cause analysis are done. Usually BEs are asked to send more 
information or asked to also study some other aspects. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

If there are SARE at EU level that can also affect Estonian BEs, 
SAM gives feedback to the BEs 

120 

 
 
 
6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Yes 

0 

Yes 

SAM is responsible to notify all the BEs about the national rapid 
alert. All BEs have provided SAM with the 24 hour phone number 
that can be used in urgent situations. Also e-mails are used to send a 
written confirmation about the situation.  

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Again SAM is responsible to notifay all the BEs about the national 
rapid alert. All BEs have provided SAM with the 24 hour phone 
number that can be used in urgent situations. Also e-mails are used 
to send a written confirmation about the situation.  

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

No 

Yes 

6.2.14.1. If yes, please specify. 

SAM also receives alerts via vigilande systems for tissues, cells and 
organs. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Blood and blood components are considered to be medicines, 
requiring special authorisation for transport and export/import 
to/from the European Economic Area (EEA) and third countries. 
Therefore State Agency of Medicines is notified about every 
import/export activities.      

There is no fractionation facilities in Estonia. 

Equivalent standards (bilateral agreements) 

No 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

No import of blood components for transfusion from third countries 
during 2012. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

No fractionation facilities in Estonia. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

Fractionation facilities are making their own inspections to the BEs 
before they sign a contract. 

All the export events must be notifyied to the SAM. Export and of 
blood and blood components used for medical purposes outside the 
European Economic Area requires an application for import/export 
special authorisation. 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

121 

 
 
 
  
7.9.1. If yes, please provide this data by country of destination. 

Octapharma - 26 997 doses of plasma Biotest AG - 7199 doses of 
plasma 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

No components were exported for transfusion from Estonia during 
2012. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

8.4.1. If yes, please provide us with detailed information. 

No 

No 

No 

Yes 

No 

- 

- 

- 

No 

- 

Yes 

BEs are using 28 days deferral for the donors that have visited 
countries affected by WNV. Testing of WNV in not routinely used. 

8.5. Which other communicable diseases are of relevance to you? 

Donors are routinely tested for syphilis. 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

National compentent authority is Health Board. 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

- 

-  

122 

 
 
 
 
 
 
A.1.9. 

Survey response Finland 

1. Public information 

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

The Finnish Medicines Agency (Fimea) 

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.5. Website: 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

P.O. Box 55, FI-00034 FIMEA, Finland 

+358 29 522 3341 

http://www.fimea.fi 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

Yes 

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

1.2.6.1. If other, please specify. 

The National Supervisory Authority for Welfare and Health 
(Valvira) 

P.O. Box 210, FI-00531 Helsinki, Finland 

+358 29 520 9111  

kirjaamo@valvira.fi 

http://www.valvira.fi/ 

Other 

The National Supervisory Authority for Welfare and Health 
(Valvira) and the six Regional State Administrative Agencies 
supervise hospital blood banks as a part of other healthcare service 
providers in Finland. 

1.3. National Competent Authority 3? 

No 

1.4. 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.). 

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. In 
addition, the organisation is supported by a process of internal 
services. The Supervision and licenses -process includes the 
Inspectorate unit and the Laboratory unit.  The Inspectorate is 
responsible for authorisation and inspection of blood establishments, 
and for haemovigilance functions. About 20 inspectors/experts are 
working in the Inspectorate. One senior inspector is responsible for 
the authorisation and inspection of blood establishments, and for 
haemovigilance actions. In addition, the Assessment of medicinal 
products -process provides medical expertise at need (mostly in 
haemovigilance). Legal expertise is provided by the process of 
internal services.  The National Supervisory Authority for Welfare 
and Health (Valvira) is a centralised body operating under the 
Ministry of Social Affairs and Health.  Valvira's purpose is to 
supervise and provide guidance i.e. to healthcare service providers, 
and to manage related licensing activities. Valvira guides the six 
Regional State Administrative Agencies and local authorities in the 
areas of health and social care, alcohol administration and 
environmental health. Valvira's aim is to foster similar guidance, 
licensing and supervision practices on every regional and local level. 
Valvira and the Regional State Administrative Agencies carry out 
their supervisory duties on the basis of jointly agreed supervision 
programmes.  Valvira and the Regional State Administrative 
Agencies are responsible for supervision of hospital blood banks as a 
part of other healthcare service providers. 

1.5. In case of MS with federal or decentralised systems, please 
indicate the roles/tasks of the Regional Competent Authority(ies). 

Other 

123 

 
 
 
(more than 1 answer possible) 

1.5.1. If other, please specify. 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

The National Supervisory Authority for Welfare and Health 
(Valvira) and the six Regional State Administrative Agencies 
supervise hospital blood banks as a part of other healthcare service 
providers in Finland. 

Supervision of BEs is centralised to the Finnish Medicines Agency. 
Supervision of hospital blood banks is decentralised: Valvira's 
purpose is to supervise and provide guidance i.e. to healthcare 
service providers, and to manage related licensing activities. Valvira 
guides the six Regional State Administrative Agencies and local 
authorities in the areas of health and social care, alcohol 
administration and environmental health. Valvira's aim is to foster 
similar guidance, licensing and supervision practices on every 
regional and local level. Valvira and the Regional State 
Administrative Agencies carry out their supervisory duties on the 
basis of jointly agreed supervision programmes. Valvira and the 
Regional State Administrative Agencies are responsible for 
supervision of hospital blood banks. 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

1 

2.1.2. How many of the BEs are satellite sites? 

There is only one blood establishment in Finland. The only blood 
establishment has 17 satellite sites (18 sites in total). 

2.1.3. How many of the BEs are mobile sites? 

The only BE has 6 sites that have mobile unit(s). 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

144226 

126914 

16649 

No 

246434 

460 

4127 

750 

438 

360 

0 

1 

1 

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

Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 

124 

 
 
 
2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

regional level 

Attached a copy of the donor evaluation form. 

The donor evaluation/selection forms (paper) and testing procedures 
are documented and standardized. The BE informs the donor about 
any abnormal findings. Before the donor evaluation/selection, the 
donor reads an appropriate information package given by the BE. 
The package informs that any relevant abnormal findings are 
reported to the donor. All the procedures need to be described in 
SOPs. 

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Body weight and hemoglobin. Permanent def. criteria: all criteria 
based on serious chronic medical conditions (except cured malignant 
diseases), criteria based on transfusion transmissible infections, and 
IV drug use. Temporary def. criteria: all criteria based on infections, 
criteria based on exposure to risk of acquiring a transfusion 
transmitted infection : mucosal splash etc., transfusion of blood, 
tissue or cell etc., tattoo or body piercing, persons whose behavior or 
activity... (E.g. new sex partner, sex with sex-worker, sex-tourism), 
all criteria based on vaccination, pregnancy, minor surgery, 
medication, deferral for particular epidemiological situations. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

Sexual risk behavior, IV drug use, xenotransplant recipients, risk of 
malaria (e.g. endemic area), and acupuncture (by qualified 
practitioner). 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

The Finnish Medicines Agency (Fimea) proposes the Commission to 
start discussions concerning the age limits of donors. Fimea’s view 
is that it would be useful to make a risk assessment of the age limits 
of donors (from the donors’ and recipients’ point of views) and to 
make a survey on practices with the annul permission for donors 
over 65 years old in the EU countries.  We also suggest to start 
discussions related to changes to the following deferral criteria: 
Minor dental treatment (no deferral), Malignancy with complete 
recovery (temporary deferral; permanent only for haematological 
malignancies), Endoscopic examination performed in EU (no 
defeferral), and Acupuncture performed with sterile single-use 
needles (no deferral). In addition, the EU criteria for malaria deferral 
should be re-assessed. 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

New sex partner, sex with sex-worker, sex-tourism, MSM sex, sex 
with IV drug user. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.7.1. If yes, please explain and suggest your alternative. 

Yes 

Yes 

The only Finnish BE has strongly expressed us their concern on the 
issue of self-sufficiency in blood and blood components in Finland. 
Referring to their collected data related to donor adverse events for 
donors age 65+, the BE has proposed that the annual permission for 
66-70 years old donors could be given by a qualified healthcare 
professional (by a physician only if necessary) to maintain the self-
sufficiency in Finland.  The Finnish Medicines Agency (Fimea) 
proposes the Commission to start a discussions concerning the age 
limits of donors. Fimea’s view is that it would be useful to make a 
risk assessment of the age limits of donors (from the donors’ and 
recipients’ point of views) and to make a survey on practices with 
the annul permission for donors over 65 years old in the EU 
countries. 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 

Main causes leading to deferrals, and the frequency of them:  Total 
number of deferrals: 28 794. Of them 24 700 temporary and 4 094 

125 

 
 
 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

permanent. Leading temporary def: Low Hb (6107), medical 
conditions (4 671), risk for transfusion transmissible infection (4 
626), infections (2 755), risk for malaria/other tropical or epidemic 
infection (2 200), surgery (1 978). Leading permanent def: Low Hb 
(1016), chronic medical conditions (2 199), risk for transfusion 
transmissible infection (263). 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

Deferrals codes are registered in electronic donor register. Statistic 
of deferral codes is made by an electronic rapport system. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

Number of deferrals recorded in 2012: Total number of deferrals: 28 
794. Of them 24 700 temporary and 4 094 permanent. 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

No 

No 

2.2.11.1. If no, what other deferral criteria would you suggest for 
derogation? Would you have other suggestions on the usefulness and 
set-up of such temporary derogations? 

A set-up of some other temporary derogations would also be useful, 
i.e. also upper age limit could be raised. In urgent crisis, it would be 
useful that the national CAs could make these decisions. 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

The donor testing is centralised in Finland. The required tests are 
carried only by a qualified laboratory. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

HBV NAT, HCV NAT and HIV-1 NAT tests are mandatory in 
Finland. 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

Yes 

HIV-1–RNA, HCV-RNA and HBV-DNA tests are mandatory for 
whole blood donations in Finland. B19-DNA and HAV-RNA tests 
are done but not mandatory for whole blood donations in Finland. 

NAT tests (HBV, HCV, and HIV-1) are mandatory in Finland. 

No 

Yes 

1 

2 

15 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

Syphilis (TrpAb): 51 (this antibody test was implemented in 2012, 
previous screening with cardiolipin). Parvo (B19): 46. Mal-Ab:  44 
(number of tested donors 424) 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

No 

Yes 

126 

 
 
 
  
3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

No 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

The BEs (all the satellite sites of the only BE) are inspected by the 
Finnish Medicines Agency on a regular basis. The National 
Supervisory Authority for Welfare and Health (Valvira) and the six 
Regional State Administrative Agencies are responsible for the 
supervision of hospital blood banks. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

A quality system requirement for BEs and hospital blood banks is 
set by the Blood Service Act (197/2005) and our national 
regulations. The Finnish Medicines Agency does not authorise a BE 
which does not have an appropriate qualitys system. 

The requirements for BEs and hospital blood banks are set by the 
Blood Service Act (197/2005) and our national regulations. The 
Finnish Medicines Agency does not authorise a BE which does not 
fullfil these requirements. The BEs (all the satellite sites of the only 
BE) are inspected by the Finnish Medicines Agency on a regular 
basis. 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

The requirement is set by the Blood Service Act (197/2005). The 
records are kept for a minimum of 15 years (i.e. donor information 
leaflets and donor testing results are kept in electronic format). 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

The requirements of the Directives have been transposed to the 
Blood Service Act (197/2005) and the Finnish Medicines Agency's 
regulations (1/2008 and 2/2008). The BEs (all the satellite sites of 
the only BE) are inspected by the Finnish Medicines Agency on a 
regular basis. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

These personal data requirements have been transposed to the Blood 
Service Act (197/2005) and the Finnish Medicines Agency's 
regulations (1/2008 and 2/2008). All the personal data of donors 
should be protected. The BEs (all the satellite sites of the only BE) 
are inspected by the Finnish Medicines Agency on a regular basis. 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

It is not mandatory. 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

The Guide is really useful. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

Yes 

1 

No 

The Regional State Administrative Agencies.  

127 

 
 
 
performing donor testing? 

4.6. How many laboratories performing donor testing are active 
within your country? 

1 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

The National Supervisory Authority for Welfare and Health 
(Valvira) and the Regional State Administrative Agencies. 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

41 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

The Finnish Medicines Agency (Fimea), Supervision and licences -
process, Inspectorate -unit. 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

One and a half 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Tissues and cells 
Organs 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

9 

0 

9 

0 

0 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

Inspections can be made after receiving a notification of serious 
adverse reaction or event. Inspectors spend more days in critical 
sites. The critical sites can be inspected more frequently than 
normally (2 years inverval). Sites undertaking substantial changes 
can be inspected before the approval. 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

There is only one blood establishment in Finland. The BE has 18 
sites. The BE has only one quality system and authorisation (a 
satellite organisation). 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

18 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

There is only one blood establishment in Finland. The BE has 18 
sites. All satellite collection sites and sites that has mobile blood 
service units are inspected in every two years. 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 

0 

9 

128 

 
 
 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

0 

0 

0 

No other outcomes. 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

2 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

The National Supervisory Authority for Welfare and Health and the 
six Regional State Administrative Agencies are responsible for 
supervision (including ispections) of hospital blood banks as a part 
of other healthcare service providers. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

No 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

The guide is very useful. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

Blood establishments: The Finnish Medicines Agency. Hospital 
blood banks: The National Supervisory Authority for Welfare and 
Health and the six Regional State Administrative Agencies. 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

For all of them. 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Both paper records and electronic forms 

The blood establishments are inspected on a regular basis. 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

Yes 

129 

 
 
 
6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Facilities (hospital blood banks / healthcare units) where transfusion 
occurs have procedures in place to retain the record of transfusions 
and to notify blood establishments without delay of any serious 
adverse reactions observed in recipients during or after transfusion 
which may be attributable to the quality or safety of blood and blood 
components.  Blood establishments notify to the Finnish Medicines 
Agency any serious adverse events related to the collection, testing, 
processing, storage and distribution of blood and blood components 
which may have an influence on their quality and safety, as well as 
any serious adverse reactions observed during or after transfusion 
which may be attributed to the quality and the safety of blood and 
blood components. 

Yes 

Yes 

Yes 

100% 

Yes 

Facilities (hospital blood banks / healthcare units) where transfusion 
occurs have procedures in place to retain the record of transfusions 
and to notify blood establishments without delay of any serious 
adverse reactions observed in recipients during or after transfusion 
which may be attributable to the quality or safety of blood and blood 
components. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

Blood establishments are required to perform a root cause analysis in 
every case (if possible). 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

The blood establishment is asked for further information of the 
SARE if needed. 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

246 recalls in 2012 because of defective product (3), reclamation 
(164), look back/traceback (9) or deviation in transport temperature 
(70); over 90% of which were red cells. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

The national rapid alert procedure for blood and blood components 
in place secures the transmission of information e.g. between the 
Finnish Medicines Agency and blood establishments when urgent 
remedial or precautionary action is needed due to a serious public 
health threat. Such threats include e.g. quality and/or safety defect 
notifications (recalls, preventive measures, advice, etc.) from other 
related healthcare sectors (e.g. medical devices, and tissues and 
cells) with potential consequences on the quality and safety of blood 
and blood components intended for human application, or 
development of rapid/significant epidemiological situations (e.g. 
disease outbreaks) which may have cross-border implications in the 
field of blood and blood components intended for human 

130 

 
 
 
6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

application. 

Yes 

The rapid alert system for blood and blood components in place 
secures the transmission of information e.g. between the Finnish 
Medicines Agency and blood establishments when urgent remedial 
or precautionary action is needed due to a serious public health 
threat (e.g. if a rapid alert from CIRCA-BC concerns Finland). Such 
threats include e.g. quality and/or safety defect notifications (recalls, 
preventive measures, advice, etc.) from other related healthcare 
sectors (e.g. medical devices, and tissues and cells) with potential 
consequences on the quality and safety of blood and blood 
components intended for human application, or development of 
rapid/significant epidemiological situations (e.g. disease outbreaks) 
which may have cross-border implications in the field of blood and 
blood components intended for human application. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

The Finnish Medicines Agency (Fimea) is a competent authority 
also for tissues and cells, and organs. The National Supervisory 
Authority for Welfare and Health (Valvira) informs Fimea when 
urgent remedial or precautionary action is needed due to medical 
device rapid alerts. 

A blood establishment can import blood and blood components for 
transfusion from EU Member States if it is authorised by the blood 
establishment licence, and the quality, safety and traceability 
requirements for blood and blood components set by the Blood 
Service Act (197/2005) are fulfilled.  Import of blood and blood 
components for transfusion from third countries requires Fimea's 
authorisation. Blood and blood components from third countries 
must fulfill the same quality, safety and traceability requirements set 
by the Blood Service Act (197/2005). 

Rules and conditions set by the Blood Service Act (197/2005) apply 
also for the import of blood and blood components for fractionation. 

International standards 

No 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

There were no blood or blood components for transfusion imported 
from third countries in 2012. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

Yes 

131 

 
 
 
  
7.6.1. If yes, please provide this data by country of origin. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

There were no blood or blood components imported for fractionation 
from third countries in 2012. 

There is no special rules for the export of blood and blood 
components for fractionation to EU Member States or third 
countries. Blood establishments must have standard operating 
procedures for the act of delivery (distribution) of blood and blood 
components to other blood establishments, hospital blood banks and 
manufacturers of blood and plasma derived products, and for the 
issuing of blood or blood components for transfusion. The 
requirements are set by the Blood Service Act (197/2005) and 
Fimea's regulations 1/2008 and 2/2008. 

There is no special rules for the export of blood and blood 
components for transfusion to EU Member States or third countries. 
Blood establishments must have standard operating procedures for 
the act of delivery (distribution) of blood and blood components to 
other blood establishments, hospital blood banks and manufacturers 
of blood and plasma derived products, and for the issuing of blood 
or blood components for transfusion. The requirements are set by the 
Blood Service Act (197/2005) and Fimea's regulations 1/2008 and 
2/2008. 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

There were no blood or blood components exported for fractionation 
to third countries in 2012. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

Only two units (Red Cells, Leucocyte Depleted in Additive 
Solution) were exported for transfusion from Finland to Norway in 
2012. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

No 

No 

No 

Yes 

8.2.1. If yes, please specify. 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

NAT testing is mandatory; The following nucleic acid amplification 
tests must be performed for whole blood and apheresis donations, 
including autologous predeposit donations: Hepatitis B (HBV NAT), 
Hepatitis C (HCV NAT), and HIV 1/2 (HIV 1 NAT). 

The blood Directives should be revised regarding autologous plasma 
and serum derived products. The Directives (2002/98/EC, 
2004/33/EC, 2005/61/EC, 2005/62/EC) are directed for the 
transfusion purposes of blood and blood components.  There are 
currently an emerging number of blood derived products which can 
be classified as blood products but which are not used for the 
transfusion purposes. When applying the Directives for these 
products in which the Directives have obviously not been meant for, 
different interpretations can be made and cause confusion and 
uncertainty.  It has been discussed in the previous meetings of the 
national competent authorities for blood and blood components that 
if such plasma/serum-derived products are used immediately after 
centrifuging and separating the blood components, they can be 
considered as part of a clinical act, and, thus, there is no need for a 
BE license. However, there are i.e. plasma/serum-derived products 

132 

 
 
 
that are stored in hospital laboratories for a few weeks before the 
autologous use. Such products currently used in the Finnish practices 
are e.g. Orthokine® and eye drops made of autologous serum. 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

28 day deferral after visiting risk areas (according  to the ECDC 
WNV-map for the previous years and observing the current year 
situation). 

8.5. Which other communicable diseases are of relevance to you? 

Q fever, Dengue, and Malaria. 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Like explained before (answer to question 8.3), if such products are 
used immediately after centrifuging and separating the blood 
components (bed-side techniques), they can be considered as part of 
a clinical act, and, thus, these products do not fall under the EU 
blood legislation. The National Supervisory Authority for Welfare 
and Health (Valvira) and the six Regional State Administrative 
Agencies are competent authorities for healthcare service providers 
(i.e. hospitals and private clinics). Their relevant primary legislation 
includes the Health Protection Act, the Act of Specialised Medical 
Care, the Act on the Status and Rights of Patients, and the Act on 
Healthcare Professionals. 

No other than PRP products, Orthokine, and serum eye drops 
derived from whole blood. 

It is difficult to define. 

133 

 
 
 
 
 
 
A.1.10. 

Survey response France 

1. Public information 

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

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.5. Website: 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.6.1. If other, please specify. 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.1.7.1. If other, please specify. 

Agence nationale de sécurité du médicament et des produits de santé 
(ANSM) : French National Agency for Medicines and Health 
Products Safety 

143-147 boulevard Anatole France - 93285 SAINT DENIS CEDEX 

+ 33 1 55 87 30 00  

www.ansm.sante.fr 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 
Other 

The other health products: contraceptive products, advanced therapy 
medicinal products, non-routine advanced therapy medicinal 
products, medical devices for in vitro diagnosis, biomaterials, 
products intended for the maintenance or application of contact 
lenses, non-corrective eye lenses, cosmetic products, micro-
organisms and toxins, tattooing products, biocide products 
(insecticides, miticides and pesticides), breastmilk. 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 
Other 

The ANSM is also in charge of the evaluation, the control (external 
quality control), the vigilance of all health products intended for 
human application (e.g. medicines, medical devices and medical 
devices for in vitro diagnosis, blood and blood components, tissues 
and cells, cosmetic products, tattooing products, biocide products, 
etc.) and the authorization and inspection of the establishments in 
charge of the processing, producing or manufacturing and marketing 
authorization of medicines. ANSM is the French OMCL for 
medicines, in charge of the official batch release for vaccines and 
blood derived-medicinal products. 

1.2. National Competent Authority 2? 

Yes 

1.2.1. Name of National Competent Authority 2: 

Direction Générale de la Santé (DGS), Ministère de la santé: 
Directorate General of Health, French Ministry of Health 

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

1.2.6.1. If other, please specify. 

14 avenue Duquesne, 75007 PARIS 

+ 33 1 40 56 60 00  

Raphael.capian@sante.gouv.fr 

www.sante.gouv.fr 

Other 

The DGS is responsible for all health products (Blood and blood 
components, Pharmaceuticals, including blood derivatives, Tissues 
and cells, Human organs, Medical devices, etc.) and quality of 
practices and ethics. The DGS is in charge of the definition of health 
policy. It is responsible for elaboration of legislation proposals, and 
supervises health agencies, ANSM in particular. 

1.3. National Competent Authority 3? 

No 

1.4. 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/ The ANSM was created by the Act of 29 December 2011 relating 
to the increased safety of medicines and health care products. It was 
implemented on the 1st of May 2012 following the publication of 
Decree n° 2012-597 on 27 April 2012. As a public body under the 
supervision of the Ministry of Health, the ANSM has taken over the 
tasks of the Afssaps and has been entrusted with new 
responsibilities. It is funded by a State subsidy (around 140 ME for 
2012). The ANSM conducts expert assessment of healthcare 
products and acts as a decision-making body in the field of sanitary 
regulation. Every year, its General Director takes tens of thousands 

134 

 
 
 
of decisions on behalf of the State. Their aim is to reconcile patient 
safety with access to therapeutic developments. The staff of ANSM 
consists of around 1,000 people, who are allocated mainly in 13 
divisions in ANSM (8 Products divisions and 5 Operating divisions). 
The total number of the agents assigned for blood components 
intended for transfusion is 20. This number is divided, by Division 
of the ANSM, as follows: 9 people for assessment and 
haemovigilance, 8 people for BEs inspection and authorization and 3 
people for laboratory control of blood components.  2/The Minister 
of Social Affairs and Health prepares and implements government 
policy in the fields of social affairs, solidarity and social cohesion, 
public health and the organization of the health care system.    

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

Not applicable 

Not applicable. 

17 

153 

17  

1,725,931   

1,369,527  

356,404  

Yes 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

Experience for the civil national blood service: From/to surrounding 
countries. Detailed information is Not available (N/A) (N/A). No 
experience for the military blood center   

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2,641,930  

400-500  

487,804  

200-750  

131,875  

200-650  

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

32,643  

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

14  

14 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.17.1. If other, please specify. 

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

Pre-donation information document given to prospective donors. 
Medical questionnaire filled by the prospective donors. 

135 

 
 
 
2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

Unfortunately, the French donor selection questionnaire does not 
currently exist in English. Please find here the French version of this 
questionnaire : http://www.dondusang.net/rewrite/article/4276/ou-
donner-son-sang/conseils-pratiques/infos-pre-don/infos-pre-
don.htm?idRubrique=1402 

The blood donor evaluation, the testing procedures and the blood 
components details are defined in the procedures of the blood 
establishment. There are, especially, procedures for donor 
information. All these details and measures taken are recorded and 
traced in the blood establishment secure IT system. In addition, for 
the CTSA, the results of blood testing are transmitted to the donor 
by a physician.  

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

For the EFS, there is no system for the self-exclusion. However, the 
French donor selection questionnaire is often used as a self-deferral 
tool. For the CTSA, the donor is informed in pre-donation, 
systematically for blood collection, using a standardised information 
format and, in Military School, using a standardised blood 
conference. In post-donation, the donor is informed, using a 
standardised information format, on the reasons why it is important 
that donors inform the blood establishment of any subsequent event 
that may render any prior donation unsuitable for transfusion   

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

All of them  

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

Those related to cancer, MSM, malaria, anaphylaxis/hypersensitivity 
reactions occurred in blood donors, exposure to risk of acquiring a 
transfusion-transmissible infection “transfusion of blood 
components”. 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

- Adapt the drafting of deferral criteria related risk behaviour (e.g 
sexual risk, MSM etc.) - Adapt the deferral measures relating to the 
history of cancer This is to take into account the evolution of 
medical knowledge. Thus, the draft of the 17th edition of the Guide 
of the Council of Europe takes into account this fact, now offering a 
temporary deferral to 5 years for most solid tumors. - Specify the 
minimum level of donor haemoglobin: “Member States may 
however adopt requirements for minimum haemoglobin levels down 
to 120 g/l for females and 130 g/l for males on the basis of the 
results of studies carried out on their specific populations. Where a 
Member State adopts these lower requirements, the possibility for 
individual derogations provided for in the first alinea of point 1 shall 
not be applicable as regards haemoglobin levels in donor's blood.” 
Member States shall inform the Commission on the justifications 
and conditions of application of these lower requirements at the time 
of their adoption.” - Identify the clinical selection to the risk of West 
Nile Virus and arboviruses a) Introduce into the Directive a deferral 
period based on the duration of viraemia in infected donors (more 
than a few days). It is proposed that the deferral period should not be 
taken as an example of the Guide of the Council of Europe which 
mentions a current deadline of 120 days may be excessive. The 
question of the beginning of the foreclosure action must be resolved. 
The concept of the duration of complete cure is difficult to define 
but essential especially in the software to set the duration of medical 
and technical deferral period. The applying would be a deferral 
measure based on the date of implementation of a screening test for 
positive viral genome for a period including a duration of complete 

136 

 
 
 
cure (to be defined) and a duration of deferral (to be defined). The 
principle is in epidemic situation as in Greece transfusion system 
that achieves the NAT can rely then on the date of the NAT positive 
in order to reaccept the donor without entering into considerations 
the cessation of treatment and absence of symptoms or complete 
cure, which can be unreliable in the donor personal interview. (b) In 
annex 1 Add the definition of the West Nile Virus “affected area” 
The drafting proposed is one that has been developed by the 
Commission in the preparedness plan: “WNV affected area: an area 
with 1 or more autochthonous (locally acquired) human WNV 
confirmed cases (neuro-invasive and non-neuro-invasive) meeting 
laboratory criteria as per EU case definition (Directive 
2008/426/EC). This definition equals the definition of area with 
ongoing transmission of WNV to humans used by Directive 
2004/33/EC,and at least the 1st case in an area should be confirmed 
according to laboratory tests for case confirmation (Directive 
2008/426/EC) and not  only tests for probable case.”  (c) Adapt the 
temporary deferral criteria for West Nile Virus prospective donors of 
blood or blood components for allogeneic donations, according to 
the model malaria (d) Complete the temporary deferral measure 28-
day traveler risk area by the possibility of a screening test for viral 
RNA (NAT).  (e) Referral to ECDC by the European Commission 
on the following topics:  - For the West Nile virus: analysis of the 
appropriateness of a deferral period of 120 days - For Chikungunya 
and dengue: 1. Analysis of the opportunity to introduce clinical 
criteria for donors at risk of exposure to the dengue and 
Chikungunya; 2. Analysis of risk and the measures to be taken 
against traveler donors because the problem of endemic areas is very 
different.  

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

There is in France a Ministerial order for the selection of donors 
(Arrêté du 12 janvier 2009 fixant les critères de sélection des 
donneurs de sang) in particular for risky sexual behaviours and 
vCJD etc.  For risky sexual behaviours:  - Unprotected sex with a 
casual partner - Multiple sex partners: more than one partner in the 
last 4 months - Unprotected sex with a new partner in the last 2 
months - For men: sex with another man - The donor partner has had 
more than one sex partner in the last 4 months - The donor partner 
who have any history of non-prescribed IV or IM drug use, 
including bodybuilding steroids or hormones and his/her HIV or 
HBV serology status is unknown - The donor partner has a positive 
serology for HIV, HTLV, HCV, HBV (AgHBs+) For HCV positive 
donor partner: no deferral of donor when NAT of partner is negative 
for more than a year. For HBV positive donor partner (AgHBs+): no 
deferral when donor is vaccinated and immunized (sufficient level of 
anti-HBs antibodies). The donor partner has had a recent STD 
(sexually transmitted disease) or is currently under treatment   

Yes 

No 

Most leading to deferrals: criteria related to infectious diseases Least 
leading to deferrals: criteria related to CJD risk, vaccines  Detailed 
data are Not available (N/A) (N/A). Overall, 15% of prospective 
donors. 8,5% of prospective donors are deferred. For the CTSA: 
visitors to malaria endemic areas, vaccines  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

There is no system of centralized collection of data on deferrals in 
the EFS.  However, there is an only one database in the CTSA.  

For the CTSA, 2212 deferrals (9% of the total number of prospective 
donors) were recorded in 2012 For the EFS: Overall, 281 646 
prospective donors (15% of the total number of blood donation 

137 

 
 
 
candidates) were deferred in 2012, representing 8,5% of the 
candidacies. 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

No 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Authorization, inspection of qualified laboratories of BEs by ANSM  

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

All donations are tested NAT HIV, HBV and HCV. However, NAT 
testing for HBV is not mandatory. For the EFS, ID-NAT in 9 
regional BEs and minipools (of 8 samples) in 5 regional BEs in 
2012. For the CTSA, ID-NAT Ultrio.  

Yes 

Screening tests for all donations: Anti-HIV 1+2, HIV NAT, Anti-
HCV, HCV NAT, HBsAg, Anti-HBc, HBV NAT, Anti-HTLV I/II, 
Syphilis, ABO/RH grouping. However, NAT testing for HBV is not 
mandatory. Screening test for Malaria disease: If necessary 
(individuals who have lived in a Malaria disease area or with history 
of Malaria disease, visitors to endemic area …). Screening test for 
Chagas disease: If necessary (individuals who have lived in a 
Chagas disease area or with history of Chagas disease, visitors to 
endemic area …).  The tests listed above are the minimum 
laboratory tests required by the French regulation for the blood and 
blood components donations. Screening tests HEV (hepatitis E 
virus) NAT was implemented: - by the EFS in December 2012 for 
FFP-SD NAT (pool of 96 samples), - by the CTSA in the earlier of 
2013 for plasma lyophilized pools.  Other tests can be added 
according to the: specific therapeutic indications, particular 
epidemiologic situations.  

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

In the French legislation, there are no differences for the mandatory 
list of screening tests between whole blood and plasma donations 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

Yes 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

Not available  

Not available  

Not available  

Not available  

No additional comments 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

- Amotosalen with UVA light exposure is a technique used in France 
for the Platelets (platelets apheresis leucocyte-depleted and platelets 

138 

 
 
 
recovered pooled leucocyte-depleted) pathogen 
reduction/inactivation in 3 regional BE in French overseas 
Departments and 1 regional metropolitan BE. - Several techniques 
are used in France for the plasma (plasma fresh-frozen leucocyte-
depleted) pathogen reduction/inactivation: Solvent-detergent, 
Amotosalen with light exposure - The other blood and blood 
components (whole blood, red blood cells, granulocytes etc.) are not 
pathogen reduced/inactivated.   

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

The Director of the CTSA is also its Responsible person. She 
complied with the requirements of the article 9 of the directive 
2002/98/EC. She delegates permanently to other persons, qualified 
by training and experience, such tasks as the Quality Management 
System (ISO 9001 since 2002), the definition and monitoring of the 
quality indicators, the internal and external audits, the vigilance. EFS 
Deputy Director - Medicine, Safety, Quality Management and 
Research is the Responsible person for the safety and quality 
insurance of blood and blood components throughout the blood 
transfusion chain. His tasks are delegated to 2 other Medical 
Doctors, qualified by training and experience.  

The inspection of the ANSM verifies regularly the written policies 
and procedures to describe the approach to training, including a 
record of training that has taken place, including its contents, and its 
effectiveness. The inspection of the Regional Health Agency verifies 
the existence and applying in hospital blood banks of the equivalent 
procedures  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

There is in France national principles of good practices in BE and 
HBB since 1993. These principles are in compliance with the 
requirements and the rules of the blood directives.  The EFS is 
certified ISO 9001.  

The inspection of the ANSM verifies regularly that BEs maintain 
documentation on operational procedures, guidelines, training and 
reference manuals, and reporting forms. The inspection of the 
Regional Health Agency verifies the existence and applying in 
hospital blood banks of the equivalent procedures  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

BEs maintain records of the traceability information, and these 
records are kept for a minimum of 15 years, by using of both paper 
and electronic (secure IT) archiving systems 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

There is in France national principles of good practices in BE and 
HBB since 1993. These principles are in compliance with the 
requirements and the rules of the blood directives on storage, 
transport, distribution. In addition, the quality system of the EFS is 
certified ISO 9001. The inspectors of the ANSM verify in regular 
intervals that these requirements/rules are applied by the BEs. The 
inspectors of the Regional Health Agency verify in regular intervals 
that these requirements/rules are also applied by the HBBs.   

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 

There is in France national mandatory requirements for coding 
(alpha numeric bar code based system) for the identification of 

139 

 
 
 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

donors, the blood and blood components donations, the blood and 
blood components units, the ABO groups and the other biological 
tests used in BEs and HBBs, the patients. There is also, in the French 
law, legislative requirement prohibiting any link between the 
medical files of the donor and the recipient. The inspectors of the 
ANSM verify in regular intervals that these requirements/rules are 
applied by the BEs. The inspectors of the Regional Health Agency 
verify in regular intervals that these requirements/rules are also 
applied by the HBBs.   

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

There is in France national mandatory requirements for coding 
(alpha numeric bar code based system) for the identification of 
donors, the blood and blood components donations, the blood and 
blood components units, the ABO groups and the other biological 
tests used in BEs and HBB. Management and updating of the system 
is ensured at national level by the ANSM. 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

For the EFS, the guide is a very useful tool. Beyond the Council of 
Europe guide, the CTSA uses the European Agreement on the 
exchange of therapeutic substances of human origin in Paris 
December 15, 1958, for the preparation of lyophilized plasma.  

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

222 (12/2007) Process in progress in 2013 

No 

ANSM 

4.6. How many laboratories performing donor testing are active 
within your country? 

14 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

4.9.1. If yes, please specify the scope of these extra rules. 

There is no national authority who is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks. However, there are 26 Regional Health Agencies (22 
Metropolitan and 4 overseas Regional Health agencies) responsible 
for authorization and oversight of hospital blood banks. 

650 

Yes 

Specify the following definitions to ensure consistency between 
them.  Ensure consistency the definition of f) “hospital blood bank” 
and the definition of k) “distribution” in the article 3 of Directive 
2002/98/EC. The definition of “hospital blood bank” doesn’t include 
“issuing”. To ensure a better understanding, it is also suggested to 
introduce the definition of “issuing” in the article 3 of the directive 
2002/98/CE. The definition of « hospital blood bank " must be 
revised in the light of the evolution of the definitions of 
"Distribution" and "Issuing". - « Hospital blood bank » shall mean a 
hospital unit which stores and delivers blood and blood components 
exclusively for use within hospital facilities, including hospital 
based transfusion activities, and may perform compatibility tests on 

140 

 
 
 
blood and blood components. It may deliver blood and blood 
components, within the framework of the vital urgency, some blood 
and blood components to patients of the other hospitals- "Issuing” 
(definition in d) Art. 1 of the directive 2005/61/CE): “issue” means 
the provision of blood or blood components by a blood 
establishment or a hospital blood bank for transfusion to a recipient. 
Introduce the definition of “issuing in the article 3 of the directive 
2002/98/CE.  

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

- LFB Biomédicaments – 2 premises (Les Ulis and Lille)- public- 
manufacturing- albumin, coagulation factors, immunoglobulins - 
Octapharma – (Lingolsheim) – private- manufacturing and import 
albumin, coagulation factors, immunoglobulins  

4.10.2. If yes, please state the responsible authority within your 
country. 

ANSM 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Biological Products Inspection Department and Control Department  
- The inspections system was implemented since 1993. An 
inspections program is defined annually. - The external quality 
control for blood and blood components was implemented since 
1996. An external quality control program is defined annually.  

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

3 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.2.1.1. If others, please specify. 

Tissues and cells 
Pharmaceuticals (including plasma derivatives) 
Others 

No overlap since teams are dedicated, but interaction if necessary 
(e.g. tissues and cells or blood and pharmaceuticals or tissues and 
cells and GCP in the frame of clinical trials), since the same 
Division is in charge of the inspection for the whole range of health 
products and activities during the life-cycle of the products.  

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

39 

5 

33 

1 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

- Enhancement of the processing of the amotosalen plasma (plasma 
pathogen reduced/pathogen inactivated): 7 - Haemovigilance 
organization: 4 - Mobile collect sessions: 3  

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

Inspections based on SARE and following major shortcoming 
notification   

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

17 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

No frequency due to the great number of mobile collect sessions. 
Satellite collection sites are inspected each 6 years at least. Less than 
10 mobile collection sessions are inspected every year. 

141 

 
 
 
5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

0 

0 

3 

0 

0 

Not applicable 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

20 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

The organising inspections system for Hospital blood banks was 
updated by the decree published in French Official Journal on 9 
September 2007. The inspections were performed, on a regional 
level, by health inspectors. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

There is no national authority who is responsible for inspection of 
hospital blood banks. However, there are 26 Regional Health 
Agencies (22 Metropolitan and 4 overseas Regional Health 
agencies). 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

No 

5.10.2. If no, which guidelines/regulations are used for inspections at 
national level? 

National guidelines and regulations 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

No 

5.11.2. If no, why not? 

ANSM reorganization (1 in 2013) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

There is in France national mandatory requirements for coding 
(alpha numeric bar code based system) for the identification number 
of blood donors, blood and blood components donations, blood and 
blood components units, ABO groups and other biological tests used 
in BEs and HBB. Management and updating of the system is 
ensured at national level by the ANSM. 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

There is, in France, a national mandatory requirement for coding 
(alpha numeric bar code based system) for the identification number 
of all blood and blood components units (about 1400 different 
codes). Management and updating of the system is ensured at 
national level by the ANSM. 

142 

 
 
 
6.1.4. Do you apply an international coding system for blood 
components? 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Both paper records and electronic forms 

There is, in France, a national mandatory requirement for data 
storage. These requirements are in compliance with those of the 
blood directives.  The inspectors of the ANSM verify in regular 
intervals that these requirements/rules are applied by the BEs.  

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Key elements on the French haemovigilance system: The French 
system of haemovigilance was set up since:   - January 24, 1994 to 
collect, supervise and evaluate all the adverse reactions (AR) 
occurring in patients/recipients  - November 2, 2002 to collect, 
supervise and evaluate Serious adverse events (SAE) related to the 
incorrect blood transfusion (without adverse reactions) - May 7, 
2007 to collect, supervise and evaluate all Serious adverse events 
(SAE) related to the blood collection, testing, processing, storage, 
distribution/issuing and transfusion of blood and blood components  
- May 7, 2007 to collect, supervise and evaluate Serious adverse 
reactions occurring in donors of blood and blood components 
(dSAR)  - October, 2002 to collect, supervise and evaluate post 
donation information (PDI) who have a potential impact in blood 
recipients   The reporting establishments are 1508 hospitals/clinics 
and 17 blood establishments (151 satellite sites who have blood 
collection and distribution/issuing activities).     - Each reporting 
establishment (hospital and/or blood establishment) notifies the 
ANSM its adverse reactions, occurring in patients, and its SAE, 
directly on a secure online reporting system (e-FIT) and directly 
integrated into a database. - For the events occurring at the blood 
donors, each blood establishment notifies the ANSM its dSAR and 
its PDI, directly on a secure online reporting system (e-FIT) and 
directly integrated into a database.  Currently, French 
haemovigilance system employs:     - at the national level in the 
ANSM: 8 people (3 doctors, 2 pharmacist, 1 epidemiologist, 1 
secretary and 1 IT engineer), - at the national level in the EFS 
(French national blood service): 4 people (2 doctors, 1 pharmacist 
and 1 secretary), - at the regional level coordination : 30 regional 
coordinators (doctors),  - at the local level in the different 
geographical locations in blood establishments and regional level in 
blood establishments: 151 + 17 doctors, - at the local level in 
hospitals and clinics: 1508 local haemovigilance correspondents 
(doctors). All haemovigilance adverse events (recipient AR, donor 
SAR, SAE, PDI) are reported online in on a secure electronic 
reporting system, e-FIT, and are available in real time.  A reform of 
all vigilances is currently ongoing in France  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

No 

6.2.2.1. If no, what template do you use (please specify)? If possible, 
please upload template. 

We use the EC template only for the annual reporting to the EC. At 
the national level, there are more details in the French template 
comparing to the EC template. However, the French template 
includes the minimum required in the EC template 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

No 

6.2.3.1. If no, please specify what guidelines you use? If possible, 
please upload the template. 

We use the Common Approach Document developed for the Annual 
reporting only for the annual reporting to the EC. At the national 
level, there are more details in the French template comparing to this 

143 

 
 
 
document. However, the national Common Approach Document 
includes the minimum required in the EC template 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

100% 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Same procedure (see above 6.2.1.1) 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

SAE occurred in blood donors Incorrect blood components 
transfusion (wrong blood component to wrong patient) associated or 
not to adverse reaction. Transfusion delayed in particular in 
emergency situations Near misses: patients identification Blood 
components storage failed  Etc.  

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

The feedback to BEs and is mandatory in France. This is one of 
missions of the  haemovigilance of the ANSM.  

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

For the NCA, 4 recalls of blood derived medical products were 
performed as a precautionary measure following the onset of a CJD 
(sporadic form) in a donor. None for the EFS and CTSA.  

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

- Rapid alert system of the European commission (CIRCA) for 
communication with the Commission and between Member States. - 
National emailing system, together with fax and phone calls - If 
necessary, a national crisis management team (CMT) is activated  

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

We have a mailing list of all the Contact Persons (CP). We must 
verify they received the alert message. The CP must acknowledge 
the message. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

6.2.13.1.1. If other, please specify. 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 
Other 

Medical devices for in vitro diagnosis, identification of patients 
vigilance, hospital management reports of nosocomial infections, 
software vigilance, quality systems in BEs and Hospitals/clinics etc. 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Rapid alert system for tissues and cells (RATC) for the European 
commission 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No at this point as a reform of all vigilances is currently ongoing in 
France. 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

There are mandatory rule and conditions for import of blood and 
blood components authorization in France (decree n° 2006-215 of 22 
February 2006). The form for import authorization include: a) The 
name and address of the importer; b) The nature and quantity of the 
imported blood component; c) If applicable, the name and address of 

144 

 
 
 
the supplier if it is not the BE responsible of the blood collection and 
its authorization issued by the local health authorities as appropriate; 
d) The name and address of the BE responsible of the blood 
collection; e) The name and address of the receiving institution if it 
is not the importer of the blood components; f) The intended use of 
the blood components and the justification of the need to import the 
blood components, especially when it intended for transfusion for an 
identified patient or a blood component rare group; g) The nature 
and results of tests that meet the French requirements. The nature 
and results of tests are attested by the legal person authorized to 
perform these operations in the country of origin; h) The 
identification number of the blood component to ensure traceability; 
i)) The requirements for the suitability of donors of blood and 
plasma and the screening of donated blood, including permanent 
deferral and possible exemptions criteria and the criteria for 
suspension.  

Same decree (see above 7.1) An authorisation is given to the civil 
and military national blood services (EFS, CTSA) or to a 
manufacturing authorised site for each import operation or for a 
succession of import operations.  

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

There are mandatory rule and conditions for import of blood and 
blood components authorization in France (decree n° 2006-215 of 22 
February 2006). To date, the importations, of blood and blood 
components intended for transfusion, were realised from certain 
European countries. Mainly autologous blood components were 
imported. The convention, signed by the blood establishments 
(exporter and importer), specifies the French provisions related to 
the quality and safety, necessary for the import of blood and blood 
components. An operation of import of blood of rare phenotype was 
authorized in 2012 by the ANSM.  

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Yes 

7.4.1. If yes, please specify. 

The form for import authorization include: The nature and results of 
tests that meet the French requirements. The nature and results of 
tests are attested by the legal person authorized to perform these 
operations in the country of origin. Screening tests for all donations: 
Anti-HIV 1+2, HIV NAT, Anti-HCV, HCV NAT, HBsAg, Anti-
HBc, HBV NAT, Anti-HTLV I/II, Syphilis, ABO/RH grouping. 
Screening tests for Malaria and Chagas diseases: If necessary 
(individuals who have lived a Chagas disease area or with history of 
Chagas disease, visitors to endemic area …)  The tests listed above 
are the minimum laboratory tests required by the French regulation 
for the blood and blood components donations. Other tests can be 
added according to the: specific therapeutic indications, particular 
epidemiologic situations  

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

None.France has never imported blood components for transfusion 
from third countries  

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

Yes 

- Import authorisations were delivered by the ANSM in 2012 for :  * 
287 800 litres of plasma for fractionation, * 524 000 litres, to the 
fractionator “Octapharma”, of blood of the Octapharma suppliers 
located in Stockholm and Vienna. Blood units have transited through 
these two suppliers but were collected in collection centres 
registered in the PMF certified by the EMA on 15 March 2012. 

145 

 
 
 
These centres registered in the PMF collection include collection 
centres in third countries, * 72 000 litres, from Florida's Blood 
Centre and New York Blood Centre, of human plasma for 
fractionation intended to clinical trials in France, USA and EU,  * 
157 800 litres, from Brazil, of human plasma for fractionation 
intended to the export to Brazil of medicinal products derived from 
human plasma, * 18 000 litres, from Morocco, of human plasma for 
fractionation intended to the export to Morocco of medicinal 
products derived from human plasma, * 40 000 litres, from 
Octapharma Mexico, of human plasma for fractionation intended to 
the export to Mexico of medicinal products derived from human 
plasma, - Other authorisations were also delivered for human plasma 
intended for the manufacturing of medical devices and medical 
devices for in vitro diagnosis (data Not available (N/A) (N/A)).  

There are mandatory rule and conditions for export of blood and 
blood components authorization in France (Art. L1222-3 of French 
public health legislation). There is currently no export of blood 
collected in France.  

There is a mandatory legislative rule for export of blood 
components. There is no mandatory authorization procedure. 
However, the export of blood and blood components, intended for 
transfusion, to EU Member States and to third countries, is carried 
out by the EFS, the civil National blood service which into formless 
the ANSM in the form of notification. There is no specific rules for 
the export of plasma for fractionation and of the plasma therapeutic 
lyophilized prepared by the army blood centre.  

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

There is currently no blood component exported for fractionation.  

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

200 units of therapeutic lyophilized plasma were exported in 2012 to 
the USA. N/A for the EFS.  

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

No 

No 

No 

Yes 

No 

Not applicable  

Not applicable  

Not applicable  

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

Yes 

8.2.1. If yes, please specify. 

- In the organization of the French competent authority, inspection 
and control are clearly separated and are taken in charge in two 
different departments. Does an external quality control of blood and 
blood components (or an equivalent system) exist in other Member 
States? A feedback from the EC concerning this point seems to us 
necessary - The implementation of the strict values of the minimum 
level of donor haemoglobin - The absence of Common approach to 

146 

 
 
 
8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

apply several deferral measures concerning epidemiological 
situations  

See  above 2.2.3.1, 4.9.1, 6.2.15 Inspection of blood establishments: 
clarify the frequency, control measures and the definition of mobile 
collection Adapt the provision of the frequency of inspections of the 
blood establishment sites (fixed and mobiles sites) and specify what 
we do understanding of the wording “control measures". The 
implementation of the article 8 point 2 of the directive 2002/98/EC 
concerning the interval between two inspections causes difficulties 
because of the numbers of blood establishments and activities to be 
inspected. A feedback from the EC concerning this point seems to us 
necessary as well as the synthesis of these questionnaires filled the 
competent authorities of the Members States. Many Member States 
have raised with the European Commission the difficulties of 
implementation of provisions relating to the periodicity of the Blood 
establishments inspection (inspection every 2 years) and inspection 
of mobile sites (EMA issue with response interpretation of the 
European Commission on 2006). The implementation of the article 8 
point 2 of the directive 2002/98/EC concerning the interval between 
two inspections causes difficulties because of the numbers of blood 
establishments and activities to be inspected. A feedback from the 
EC concerning this point seems to us necessary as well as the 
synthesis of these questionnaires filled the competent authorities of 
the Members States. Thus, it is proposed to adapt the frequency of 
BE sites inspection by using "an appropriate frequency based on risk 
analysis." The French authorities suggest the drafting proposal for 
article 8.2 (mirrored the wording of article 1111.b of the directive 
2001/83/EC on medicinal products for human use): « Inspection and 
controls measures shall be organized by the competent authority at 
an appropriate frequency based on risk”. In addition, it would be 
necessary to introduce in article 3 the definition of the “mobile site”. 
Moreover, the French authorities believe that "control measures" 
mentioned in article 8 of directive 2002/98/EC should be specified. 
Clarify the definition of mobile sites and inspection measures for 
this type of collection The French authorities are currently working 
to develop a more precise definition of the mobile collection, which 
will soon be submitted to the Commission.  Provisions relating to 
mobile collection should be included in this Article 8: “Full 
information regarding mobile collection teams' operation and 
management, as well as their equipments, are reviewed during the 
inspection of the blood establishment. The inspections of mobile 
collection sites' premises are done as necessary". Proposals related to 
the blood collection activity Introduce some precautions related to 
the collection In the Directives, it would be necessary to specify the 
minimal precautions as for example, measures of safety of the 
aphaeresis procedures (maximum extracorporeal volume of 20%.for 
example). Proposals to clarify the legal rules  Status of the blood 
components: A necessary clarification  Define their status only 
according to their destination (intended transfusion purpose or 
whatever their intended purpose)  Difficulties of interpretation 
appeared on the status of the plasma intended for transfusion (FFP-
SD, FFP quarantine, FFP-Intercept, etc.) according to their 
preparation method (industrial or not industrial method). This 
difficulty will also arise for the other blood components, considered 
in France as Labile blood products (LBP) intended for transfusion, 
as also the dried plasma, or still the platelets concentrates pathogen 
inactivated (Intercept). Other situations had been raised by the other 
MS with the European Commission for the status of products such 
as the PRP (Platelet rich plasma) autologous (see minutes of the 
meeting of April 19-20th, 2012) and which is classified in the 
EDQM " as Blood component for topical uses  ", Extracorporeal 
photopheresis.  So by suggesting defining the status of the blood 
components only according to their intended purpose, this adaptation 
proposed by the French authorities can clarify and secure the status 
of LBP of certain blood products.  The autologous PRP and the 

147 

 
 
 
autologous serum used in ophthalmology are concerned (see 
discussion proposed in the agenda of the meeting of the blood 
European competent authorities). Quality of the blood components: 
Clarify the expression of the standard in factor VIII in the FFP 
intended for transfusion and introduce a monograph for the FFP 
pathogen inactivated Fix a minimum value of factor VIII in the FFP 
intended for transfusion, as a replacement of the current formulation 
The French authorities consider that the provision drafted in the 
Annex V of the directive 2004/33/CE is not applicable « Factor 
VIIIc: Average (after freezing and thawing): 70% or more of the 
value of the freshly collected plasma unit ». The proposed writing is 
for quarantine FFP: Factor VIII content: " Not less than (after 
freezing and thawing), 0.7 UI / mL of factor VIII in individual 
plasma (non-pooled)" Introduce a monograph for the individual FFP 
(non-pooled) pathogen inactivated  The proposed writing is: Factor 
VIII content: "Not less than (after freezing and thawing), 0.5 UI / 
mL of factor VIII in individual plasma (non-pooled) pathogen 
inactivated” AND  Fibrinogen content: "Not less than (after freezing 
and thawing), 2 g/ of fibrinogen content in individual plasma (non-
pooled) pathogen inactivated " Voluntary and unpaid blood 
donation: Clarify the definition of the non-remuneration Clarify the 
definition of the "Voluntary and unpaid donation" with regard to the 
notion of compensation for the donors. It would be necessary to 
clear up the consensus applied with regard to the compensation of 
certain donations intended for fractionation (manufacturing of 
medicines products derived from plasma) with regard to the recital 
23 of the directive 2002/98/CE. For medicines products derived 
from plasma, the Manufacturers have to supply information on the 
compensations possibly proposed to the donor (Chapter 2.1 (Plasma 
origin) of Guideline on the scientific data requirements for a plasma 
master file (EMEA/CHMP/BWP/3794/03), published by the EMA 
within the framework of the directive 2003/63/ CE which defines the 
documentation to supply in the file of authorization request of 
launch on the market of medicines products derived from plasma or 
in the plasma master file subject with the aim of certification to the 
EMA The difficulties result from the heterogeneity of the terms used 
by the different Manufacturers on their files subjected to the EMA 
(expense allowance, remuneration, small re-imbursement, 
compensation). However, Most of the Manufacturers consider that 
the allocation of a sum of money constitutes a remuneration, 
whatever is its amount. Within the framework of the certification of 
the PMF, the allocation of a lump sum is recognized as a 
remuneration, acceptable in certain limits (rising of the order of 25-
30 euro by donation) and certain conditions (regular donors). In case 
of blood donation during the working time, the question of the loss 
of remuneration for the donor could give rise to debate. In this case, 
the French authorities underline that it is important that the 
employers can continue to be authorized to maintain the 
remuneration in conformance with the exercise of the professional 
activity of the employees during the necessary duration of the 
donation without it constitutes a payment in the sense of the French 
regulations (article L1211-4 of the French public health code). 
Definitions: Ensure consistency between definitions and specify six 
definitions  Specify the following definitions  - “Mobile site” 
(definition in i) Art. 1 of the directive 2005/62/CE): introduce the 
definition of “mobile site” in the article 3 of the directive 
2002/98/CE. As evoked in 1.1.2, the French are currently working to 
develop a more precise definition of the mobile collection, which 
will soon be submitted to the Commission. -  Blood establishment 
(BE)  The French authorities suggest thinking about the adaptation 
of this definition within the framework of the evolution of the 
organization of the transfusion chain, in particular the development 
of the cooperation between BE and the pooling of means between 
establishments, within the framework of an unique national blood 
service. -  Collection  It is suggested replacing in the directives the 

148 

 
 
 
term "collection" by that more precise of "donation" -  
Haemovigilance It is suggested adapting the definition of 
haemovigilance Translation: verify the translations to avoid the 
difficulties of interpretation of MS and Manufacturers Revise the 
translation of the version in English of every language version of 
directives of the European Union and correct in particular: a) In the 
directive 2004/33/CE, the mistranslation in French of an item of the 
questionnaire donor: « il a reçu des réponses satisfaisantes aux 
questions qu’il a posées ». b) In the directive 2004/33/CE, the 
mistranslation in French of permanent and temporary deferral 
criteria for risky sexual behaviour. In the French version, there are 
the same wording for both temporary and permanent deferral c) In 
the Directive 2005/62/CE: correct the recurring problem of 
translation on the term "processing". It was translated into French 
language sometimes by the word "transformation" wrong 
translation), and sometimes by the word "préparation" (correct 
translation). It is suggested to use in the French version the word 
“préparation”.  

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

8.5. Which other communicable diseases are of relevance to you? 

In 2012, temporary deferral measures of prospective donors, 
returning from countries where WNV cases were reported in 2011, 
were implemented for the seasonal period of the 1st of June to the 
end of November. The deferral period for prospective donors is 28 
days after return of the affected area Therefore, the systematic 
deferral measures (i.e. without waiting for any report of 
epidemiological ECDC) was implemented for travellers returning 
from the following countries: Albania, Canada, Greece, Hungary, 
Israel, Italy (Venetia, Friuli Julian Venetia and Sardinia regions) 
Macedonia, Romania, Russia, Tunisia, Turkey, Ukraine, USA. 
Later, additional countries have been added to the list: Algeria, 
Bosnia, Croatia, Italy (Basilicate region), Kosovo, Montenegro, 
Palestinian territories and Serbia.  

The surveillance and detection plans against chikungunya, dengue 
and west Nile virus dissemination in metropolitan France include a 
specific structure recommending measures to be taken in order to 
reduce risk of transmission from human blood, organs/tissues and 
cells. This structure is called « crisis management team » (CMT), 
cellule d’aide à la décision éléments et produits du corps humain”.  
This structure is held under the aegis of the French National Agency 
for Medicines and Health Products Safety (ANSM) when cases are 
reported by the French Institute for Public Health Surveillance 
(Institut de veille sanitaire) in metropolitan France, in overseas 
departments and in foreign countries. It comprises virologists 
(reference centre) and experts from various institutions (French 
Agency for the safety of health products, French civil and Army 
blood establishments, French Institute for Public Health 
Surveillance, French biomedecine agency, Ministry oh health, 
Haemovigilance actors). The objectives are to discuss the relevance 
of measures regarding blood, tissues, and cells collected in the 
concerned geographical areas, taking into account the specific alert 
and also, when available, technologies already in place (e.g. 
Pathogen reduction, blood screening, existing exclusion criteria).  
This structure can also be used for other emerging situations 
(coronavirus, Q fever, malaria in Greece…). In this case, it involves 
others reference centres.  In addition, we take into account of the 
vigilance notifications including haemovigilance reports. The recent 
increase of reports on transfusion-transmitted hepatitis E infection 
has been identified as a new concern.  

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

149 

 
 
 
8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

PRP intended for an autologous use: collection, processing and 
hospital therapeutic use. The process is performed in is the 
autologous PRP is not stored. It is administered during the same 
medical procedure. The French regulation considers that it is an 
hospital activity of care which is outside of the blood directive and 
outside of the other directives like tissue-cells directives. 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

None 

None 

150 

 
 
 
 
 
A.1.11. 

Survey response Germany 

1. Public information 

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

Paul-Ehrlich-Institut 

1.1.2. Address of&nbsp;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) 

1.1.6.1. If other, please specify. 

Paul-Ehrlich-Straße 51-59 D-63225 Langen  

06103 77-0 

leitung@pei.de 

www.pei.de 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Medical devices 
Other 

" vaccines " allergens " sera " antibodies " recombinant analogues of 
blood derivatives " ATMP " Medicinal products for veterinary use: 
sera, vaccines, distinct immunological veterinary medicinal 
products, e.g. immune modulators " high risk IVD for human use  
see also answer to question 1.4 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Inspection 
Haemovigilance 
Other 

1.1.7.1. If other, please specify. 

" Providing national marketing authorization (licensing) and 
assessment of marketing authorization applications to the EMA" 
batch release (if legally required) " authorization of clinical studies  " 
GCP inspections, pharmaco-/haemo-/tissue vigilance inspections and 
dossier-related inspections prior to licensing, expert participation in 
inspections of regional authorities " inspections related to the Plasma 
Master File procedure " batch release of high risk IVD for notified 
body " vigilance of high risk IVD 

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: 

Yes 

list will be uploaded 

list will be uploaded 

list will be uploaded 

list will be uploaded 

list will be uploaded 

1.2.6.&nbsp;What are the role/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.3. National Competent Authority 3? 

No 

1.4. 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.). 

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 Blood and Blood 
Components. 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 pharmacovigilance, hemovigilance and 
tissue vigilance. The sections “EU-Cooperation/Biological 
Medicinal Products”, “Legal Affairs”, “Clinical Trials”, “Microbial 

151 

 
 
 
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 
see the Annual Report of the Paul-Ehrlich-Institut 
(http://www.pei.de/DE/institut/jahresberichte/jahresberichte-
node.html).  

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 
Other 

The Regional Competent Authorities in the German Laender are 
basically entrusted with the task of supervising and continuously 
monitoring the compliance with legal provisions. For this purpose, 
they grant authorisations of blood establishments and laboratories 
and organise inspections. 

There is a splitted competence between the National Competent 
Authority (PEI) and the Regional Competent Authorities of the 
Laender. Generally spoken, the Regional Competent Authorities are 
responsbible for activities in matters of Article 5 and 8 of the 
Directive 2002/98/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 blood products as well as for the fulfillment 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 directed to the 
Laender.   For further information abregarding the Regional 
Competent Authorities of the Laender see answer 1.7 of the 
questionnaire concerning tissues and cells.  

280 

142 

184 

2,867,230 

2,458,347 

408,883 

Yes 

From Poland to Brandenburg for plasma donation   Brandenburg is 
by extension the 5th largest of the German Laender and has ca. 2.5 
million inhabitants (80.5 million inhabitants in Germany), 12 blood 
establishments acc. to RL 2002/98/EG Article 3 e) and 6 mobile 
sites acc. to RL 2005/62/EG Article 1 i).  No further information 
available to the competent authorities  

1.5. 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) 

1.5.1. If other, please specify. 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

2.1.8. For whole blood donations, could you please provide the 

4,785,048 

152 

 
 
 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

450-500 ml 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2,445,918 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

Donation volumes (incl. anticoagulans) allowed as listed below 
depend on the donors body weight:  d60kg -  maximal 650 ml  
d80kg -  maximal 750 ml  >80kg -  maximal 850 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

196,106 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

Maximal donation volume (incl. anticoagulans) allowed is 750 ml 
per donation which yields an average of 2 platelet concentrates 
obtained from one apheresis procedure. 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

35,245 (Erythrocytes: 14,699 Granulocytes: 629 Multicomponents: 
19,917) 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

141 laboratories perform donation testing 

92 laboratories perform donation testing 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 
Information is collected through a donor evaluation/selection form 
that is not standardised at national/regional level 
Other 

http://www.pei.de/DE/infos/pu/zulassung-
humanarzneimittel/verfahren/blut-
blutkomponenten/spenderfragebogen/spenderfragebogen-
blutspende-inhalt.html 

2.1.18.2. Please provide a copy of the donor evaluation/selection 
form standardised at regional level (in English if possible). 

not available 

2.1.18.3. If other, please specify. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

sec. 31 para 4 sentence 1 number 1  nd number 3 of the 
Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV) 
define the eligibility criteria according to the relevant EU-Directives.  
Furthermore, according to sec. 5 para 1 of the German Transfusion 
Act and chapter 2.1.3 of the national Hemotherapy Guidelines the 
information required by Art. 3 and Annex II, Part B of Directive 
2004/33 has to be collected through a personal interview with a 
medical doctor or a health care professional and through a donor 
evaluation/selection form.   The donor eligibility criteria as required 
according to Annex III 2004/33/EC for the donor history 
questionnaire are additionally layed down in the national 
Hemotherapy guidelines.   There exists a standardised questionnaire 
(see 2.1.18.1) which is not implemented to be used mandatory.   
Both, German Transfusion Act and national Hemotherapy 
Guidelines require the donor release performed by the responsible 
medical doctor.  

Information of the donor and documentation requirments pursuant 
sec. 6 and 11 of the German Transfusion Act (Transfusionsgesetz / 
TFG) and sec. 31 para. 4 number 1 and 3 Arzneimittel- und 
Wirkstoffherstellungsverordnung (AMWHV) Information of the 
donor: sec. 19 para. 1 sentence 4 and 5 TFG;  information and 
education of patients pursuant sec. 630c, sec. and 630e, 
documentation pursuant sec. 630f BGB Patientenrechtegesetz  

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

153 

 
 
 
2.1.20.1. If yes, please describe (bar code, etc.). 

sec. 6 para 1 of the German Transfusion Act  Individual organisation 
by blood establishment   

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Most important deferral criteria are those assuring good health of the 
donors (limits for Hb, IgG, platelets, deferral of donors with critical 
diseases which do not allow blood donation like cardiovascular 
disease) and those protecting recipients from any harm by 
transfusions (e.g. deferral of donors with severe infectious diseases 
transmittable by blood or the risk of acquiring such). 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

The eligibility criteria most difficult to implement are deferral 
criteria which refer to a donor´s behaviour, especially when a yes 
answer may suggest unwanted social comportment. 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

1. Annex III of 2004/33/EC no.2.1 permanent criteria, sexual 
behaviour,  versus 2.2.2 temporary deferral, exposure to risk 
deferral. because of the following reasons: a) There are no data to 
distinguish between different risk categories which justify a 
permanent deferral (sexual behaviour at high risk) on the one hand 
and a temporary deferral (exposure to risk) on the other hand. b) 
Behaviour may be changed and hence the persons risk to aquire and 
bear undetected transfusion transmittable diseases.  A permanent 
deferral based on behaviour at risk therefore lacks any scientific 
basis.  2. Fixed upper age limits should be deleted and decisions on 
upper age limits should be made by the physician in charge of donor 
selection when deciding on deferral or admission for donation.  3. In 
addition to the  total serum protein level also serum IgG levels 
should be determined in plasmapheresis donors and should not be 
below 6g/l. (Schulzki T et al. A prospective multicentre study on the 
safety of long-term intensive plasmapheresis in donors (SIPLA). 
Vox Sang 2006;91:162-73).  4. Deferral for 4 weeks after flu-like 
illness to avoid blood component contamination with Yersinia 
enterocolitica.  

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

Sex among men, sex workers, risky heterosexual behaviour like sex 
among heterosexuals with frequently changing partners  

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

Yes 

Yes 

2.2.7.1. If yes, please explain and suggest your alternative. 

see number 2 to in the answer to question 2.2.3.1  

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

2.2.11.1. If no, what other deferral criteria would you suggest for 
derogation? Would you have other suggestions on the usefulness and 
set-up of such temporary derogations? 

No information available as data on donor deferral reasons are not 
collected centrally. 

No 

No 

No 

In case of an influenza pandemic or pandemics with similar 
characteristics derogation of the deferral criteria Hb levels and 
deferral window after flu-like symptoms will be useful to sustain 
blood supply.  In Germany, calculation had only been made for 
influenza pandemic (see presentation at the CA meeting in autumn 
2009).The situation may be very different for other types of crises 
like severe disasters. Therefore, no additional predictions can be 

154 

 
 
 
3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

made for other crisis situations.  

" authorisation of laboratories pursuant sec. 13 of the German 
Medicinal Products Act (Arzneimittelgesetz / AMG) " surveillance 
and regular inspection of laboratories pursuant sec. 64 of the 
German Medicinal Products Act  

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

" Mandatory for routine screening: HIV-1 NAT (10.000mIU/ml) and 
HCV-NAT (5.000 IU/ml)  " Not mandatory, but used for routine 
screening by many blood establishments, mainly those who also 
deliver plasma for fractionation: HBV-NAT, HAV-NAT, Parvovirus 
B19 NAT " Mandatory for confirmatory testing: HIV-1 NAT, HCV-
NAT, HBV NAT with highest sensitivity available  

Yes 

Mandatory for whole blood donations and apheresis donations for 
transfusion are  " Blood grouping:  " Rh details (C,c,D,E,e), Kell 
criterion, serum blood group antibodies on the occasion of first and 
second whole blood donation. Infectious disease markers:  " Anti-
HBc antibodies " HCV Genom (NAT) " HIV-1 Genom (NAT) " 
Anti-Treponema pallidum antibodies  

Mandatory for plasma for transfusion (see 3.1.3.1), not mandatory 
for plasmapheresis donations intended to be used as plasma for 
fractionation  

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

Yes 

3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

Answer to 3.1.4 is no, but this comment is to be added: No general 
answer can be given as it depends on national strategies, e.g. use of 
other tests like highly sensitive combined antigen-antibody tests 
instead of NAT tests, the specific epidemiology of a given country, 
the use of pathogen-inactivated blood components etc.  

3.1.5. Do you have a system of centralised collection of data with 
test results? 

Yes 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

114 positive samples, see comment in 3.1.5.4 

510 positive samples, see comment in 3.1.5.4 

358 positive samples, see comment in 3.1.5.4 

for Syphilis: 345 positive samples  Note: the numbers in the answers 
for 3.1.5 and following are NOT the numbers for positive test 
results, as you have to perform multiple tests including confirmation 
tests on an initially positive  sample.  This means: the numbers do 
NOT include false positive test results and do NOT include 
confirmationary testing.  The numbers are positive samples of 
people willing to donate blood (as some BEs perform pre-donation 
tests with first time donors)  

In case of defined European requirements for testing laboratories 
and e.g. regular external quality control offered at a European level 
no further international accreditation systems for testing laboratories 
seems to be required. 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

a) Therapeutic frozen MB plasma: plasma treated with methylene 
blue and light followed by absorption of methylene blue and its 
photo derivatives by blueflex filter.  b) Therapeutic frozen SD 
plasma: plasma pooled and tested according to Ph.Eur. monograph 
Human Plasma for Fractionation; treatment with solvent and 

155 

 
 
 
3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

detergent and removal of these additives according to Ph.Eur. 
monograph Human Plasma (pooled and treated for virus inactivation 
c) Therapeutic frozen Intercept Plasma: plasma obtained from whole 
blood or apheresis donations treated with amotosalen-HCl and UVA 
b) Intercept-PC: platelet concentrates from pooled buffy coats or 
from apheresis donations suspended in plasma and additive solution, 
treated with amotosalen-HCl and UVA  

Yes 

No 

This is part of authorisation and surveillance of blood 
establishments,  see sec. 14 para 1 number 5c and 6a, sec. 64 of the 
German Medicinal Products Act,  see also sec. 4 and sec. 12 
AMWHV and  sec. 4 sentence 1 number 1 and 2 of the German 
Transfusion Act  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

Required pursuant sec. 31 para. 1 AMWHV 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

sec. 20 para 2 AMWHV 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Documentation requirements pursuant sec. 10 and 20 para. 2 
AMWHV 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

Requirements pursuant sec. 31 para. 4 number 7  and sec. 7 
AMWHV  

sec. 11 of the German Transfusion Act 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

no there is no legal basis 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

No 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.2.1. If other, please specify. 

Inspections of the site/centre 
Other 

authorisation pursuant sec. 13 of the German Medicinal Products 
Act 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

233 (December 31st, 2012) 

156 

 
 
 
4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

(The answer to question 4.4 covers the year 2012, NOT 2008.)  see 
answer to question 1.2.1 

4.6. How many laboratories performing donor testing are active 
within your country? 

141 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

see answer to question 1.2.1 

4.8. How many hospital blood banks are active within your country? 

reported by Laender Authorities: 144;  no complete data available 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

4.10.2. If yes, please state the responsible authority within your 
country. 

5. Inspections (Art 8 Directive 2002/98/EC) 

a) Biotest AG, Landsteinerstr. 3-5, 63303 Dreieich,  
www.biotest.com b) CSL Behring GmbH, Philipp-Reis-Straße 2, 
65795 Hattersheim am Main, www.cslbehring.com  Comment: all 
public available information can be obtained from the homepages of 
the companies. A national CA is not allowed to publish confidential 
data. 

Regierungspräsidium Darmstadt  Luisenplatz 2 64283 Darmstadt 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

see answers to question 1.2.1 See answers to questions 1.2, 1.5 and 
1.6 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.2.1.1. If others, please specify. 

No further data available. 

Yes 

Tissues and cells 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 
Medical devices 
Hospitals 
Others 

Pharmacies, Clinical Trials, (Testing) Laboratories, Active 
pharmaceutical ingredient (API), SoHO,  Comment: Due to the 
federal organisation of inspections, interaction of inspections differs 
from inspectorate to inspectorate 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

93 in 2012 

19 in 2012 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

53 

1 

0 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

a) Regarding the participation of the agencys assessors in 
inspections (national and in third countries) of regional authorities as 
experts, a risk-based approach for inspection planning is applied by 

157 

 
 
 
the regional authorities according to a written procedure. The 
inspection intervals follow the Compilation of Community 
Procedures as well as the national legislation. Inspections are 
conducted at least every two years. Exception: There exist very few 
establishments in Germany for the preparation of autologous 
donations where inspections are carried out within an interval of no 
more than 3 years.  b) Concerning inspections in third countries 
under the centralized procedure (i.e. inspections related to the 
Plasma Master File) a risk based approach is applied. Inspections are 
currently conducted every two to three years based on the centres 
compliance during the previous inspections. 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

Correct answer to question 5.5.1 is "YES" Correct question to 
5.5.2.1 is: "IF YES, WHY?"  This is the answer to "If yes, why?"  a) 
short personal resources  b) Current definitions in the EU Blood 
Directive 2002/98/EC do not provide sufficient detail in the 
description of site activities (e.g. mobile or satellite sites). This 
hinders the desired risk-based approach to inspection including those 
regarding inspections related to the Plasma Master File and control 
measures.  

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

84 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

Satellite collection sites are inspected on a given cause and on 
random basis. Satellite sites are inspected from one site in 5 years to 
14 sites in one year depending on the resources of the Competent 
Authority and the causes for inspection.  Mobile sites are inspected 
on a random basis. 

Granting of new authorizations  Granting of GMP-Certificates all 
authorisations were automatically renewed 

Corrective Action Plan: ( tracking of shortcomings, determine 
measures, supervision of actions);  granting of GMP-Certificates, 
authorization for new premises, all authorizations were 
automatically renewed, expansion of authorizations, granting of new 
authorizations  

Corrective Action Plan (tracking of shortcomings, determine 
measures, putting a deadline for corrective measures, supervision of 
actions);  Granting of a GMP-Certificate (after correction of major 
shortcomings), Expansion of a license; after correction of major 
shortcomings all authorizations were finally renewed 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

Not applicable 

Not applicable 

Not applicable 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

79 

No 

5.8.1. If no, please explain. 

Not all the NCA officials work in the field of inspections, but may 
perform other taks, e.g. batch release testing for medicinal products, 
prepare pharmacovigilance reports, or administrative duties of the 
CA.  For the rights of inspectors during an inspection see in 
particular  sec. 64 para. 4  of the German Medicinal Products Act 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

158 

 
 
 
5.9.1. If yes, please describe. 

See answers to question 5.1 et seqq sec. 64 AMG  

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

See answers to question 5.1 et seqq sec. § 64 AMG 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

No 

5.10.2. If no, which guidelines/regulations are used for inspections at 
national level? 

National laws (German Medicinal Products Act (Arzneimittelgesetz 
/ AMG), German Transfusion Act (Transfusionsgesetz / TFG), 
Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV))  
National guidelines (Guideline on procurement of blood and blood 
components and use of blood products- Hemotherapy 
(Hämotherapierichtlinien)) National aide memoire “Blood” 
(Inspectors Manuals of Experts of the Laender Authorities)  

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

No 

5.11.2. If no, why not? 

The correct answer to question 5.11 is "yes", to question 5.11.1 is 
"3".  But additionally: Some Laender Authorities nominated 
inspectors but they were not admitted by EMA. They will consider 
sending inspectors depending on the content of the future training 
programs. 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

see answer to question 1.2.1 

No 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT, Eurocode 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.4.2.1. If other, please specify. 

Platelets 
Plasma 
Red Blood Cells 
Others 

Granulocytes 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

the cited Directive 2006/86/EC concerns tissues and cells!! for 
blood: sec. 20 para. 2 AMWHV  

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

According to para 63c and 63i of the German Medicinal Products 
Act, every marketing authorisation holder for blood preparations is 
obligated to document and report every suspected serious adverse 
event and every suspected serious adverse reaction to the Federal 
Competent Authority immediately, or at the latest within 15 days of 
acquiring this knowledge. The Paul-Ehrlich-Institut is responsible 
for the evaluation of any reported event and reaction and the 
introduction of risk minimization measures.  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

No 

159 

 
 
 
6.2.2.1. If no, what template do you use (please specify)? If possible, 
please upload template. 

The blood establishments are requested to use the notification form, 
which is available on the PEI homepage, or to use the online 
reporting tool. 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

No 

6.2.3.1. If no, please specify what guidelines you use? If possible, 
please upload the template. 

PEI uses the Common Approach Document in combination with 
specific national requirements (e. g. donor look back procedure). 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

No 

6.2.4.1. If no, why not? 

There is cooperation between the federal competent authority and 
the regional competent authorities of the “Laender”. Each 
Competent Authority has a responsible person.  

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

70-99% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

The appointed transfusion specialist is requested to use the 
notification form, which is available on the PEI homepage, or to use 
the online reporting tool. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

Transmission of infections, haemolytic transfusion reactions, 
TRALI. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

An annual blood vigilance report is published by the PEI. 

6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Yes 

33 

Yes 

In case of a national rapid alert the PEI informs the responsible 
regional competent authorities of the “Laender” and the graduated 
scheme officer/ qualified person by e-mail. Graduated scheme 
officers are responsible to set up and manage a pharmacovigilance 
system and to collect and evaluate notifications on medicinal 
product risks and to co-ordinate the necessary measures.   

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

See answer to question 6.2.11.1 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Tissues and cells   Organs  Medical devices   

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

no 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 

Import authorisation and certification pursuant sec 72, 72a of the 
German Medicinal Products Act for import from third countries, 

160 

 
 
 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

granted by the Regional Competent Authorities, see also sec. 17 
AMWHV 

Import authorisation and certification pursuant sec 72, 72a of the 
German Medicinal Products Act for import from third countries, 
granted by the Regional Competent Authorities, see also sec. 17 
AMWHV 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

According to sec. 72 German Medicinal Products Act, the importing 
organisation needs a license by regional authorities which implies 
that the blood component has to fulfil all requirements regarding 
collection, processing, testing, vigilance, quality assurance etc.  as 
laid down in the German Transfusion Act., i.e. equivalent standards 
to national standards are required. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Yes 

7.4.1. If yes, please specify. 

See answers to questions 7.3.1. and 3.1.3. 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

No imports of blood components from third countries outside the 
European Economic Area (EU, Norway, Iceland, Liechtenstein) 
were reported. 

Yes 

3,952,549 litres from third countries outside the European Economic 
Area (EU, Norway, Iceland, Liechtenstein). More detailed data are 
not available.  Not all of this is used for fractionation. Overall only 
2,158,406 litres were fractionated in Germany.  

sec. 73 AMG sec. 20 para. 1 AMWHV (Documentation)  

sec. 73 AMG sec. 20 para. 1 AMWHV (Documentation)  

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

3,399,419 litres to third countries outside the European Economic 
Area (EU, Norway, Iceland, Liechtenstein). More detailed data are 
not available. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

No exports of blood components to third countries outside the 
European Economic Area (EU, Norway, Iceland, Liechtenstein) 
were reported. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

No 

Yes 

7.12.1. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 

7.12.2. If yes to Q. 7.12., what do you do with the surplus of blood 
or blood components? 

The extent of blood component surplus is  (a) too low to look for 
another special destination.  (b) The surplus at the end of the shelf 
life cannot be used for other therapeutic purposes.  All non-directed 
prepared blood components reveal a very low percentage of expired 

161 

 
 
 
7.12.3. If yes to Q. 7.12., would you be interested in concluding 
bilateral agreements with other MS in order to address the surplus? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

products. This is due to the short shelf life of especially cellular 
blood components and the necessity of compatible transfusion which 
requires the selection of compatible components from a larger 
storage pool. Moreover, there is a loss of plasma components which 
cannot be released after quarantine hold and in many of these cases 
it is not possible to dedicate it as plasma for fractionation. In 
contrast, there is nearly no loss of granulocyte concentrates as they 
are prepared for certain patients.  

This is not a national issue as the blood donation system is not a 
national system. In principle, the BEs can close contracts with other 
BEs on their own responsibility and risk.  

No 

Yes 

No 

The answer to question 8.1.1 cannot be given as "yes" or "no", for 
the following reason: There are no specific statistical data available 
relating to infringements against blood regulations. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

see answer to question 8.1.2 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

see answer to question 8.1.2 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

EU-KOM already started an inquiry among stakeholders on this 
topic, so these results should be taken into account  

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

2003: Visitors returning from USA, Canada, and from   2004 on also 
from Mexico are deferred for at least 4 weeks from donating blood.  
2012: information exchange on impact of deferral of visitors 
returning from European countries. 

8.5. Which other communicable diseases are of relevance to you? 

Any kind of severe infectious diseases transmittable by blood. 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

Two possible cases:  1) Preparation (collection, processing, testing, 
release) and administration is performed by two different persons 
under different immediate responsibilities:  Blood directives apply.  
2) The physician in charge is the person who himself prepares (or 
preparation is done under his direct responsibility) and administers 
the blood component: Blood directives do not apply, the activity is 
regarded as part of patient treatment.   

Donor lymphocytes, see our letter from June 3rd, 2013 und last CA-
Meeting Tissues and Cells  There are more and more medical 
devices legally on the market which enable the bed-side preparation 
of autologous blood components like PRP, fibrin glue, so called 
“growth factor rich plasma”, so called “plasma rich fibrin” etc. To 
our knowledge there exists no proof of efficacy from clinical studies, 
however, because of situation No. 2 (see answer to question 8.6.1) 
blood directives do not apply.  

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 

Pooling according to Ph. Eur. like for SD plasma fall under 
pharmaceutical legislation, i.e. 2001/83/EC. Pooling performed in 
order to achieve an amount necessary for 1 therapeutic unit (e.g. 

162 

 
 
 
inactivation techniques, &hellip;) 

pool-platelet concentrates made from buffy coats of 4-5 whole blood 
donations) is not regarded as industrial process and falls under the 
blood directive regulations (2002/98/EC).  Analogous all processing 
steps, performed on single therapeutic units like pathogen 
inactivation procedures or lyophilisation of single donor plasma are 
also regulated under the blood directives and its corresponding 
national laws.  

163 

 
 
 
 
 
 
A.1.12. 

Survey response Greece 

s 

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

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.4. E-mail (central access point): 

1.1.5. Website: 

NATIONAL BLOOD CENTRE, MINISTRY OF HEALTH 
HELLENIC DEMOCRACY 

Olympic Champion Ch. Mantika 7 position Basins 13678 Acharnes - 
Athens 

00302132146700 

info@ekea.gr 

www.ekea.gr 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Blood and blood components 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Inspection 
Other 

1.1.7.1. If other, please specify. 

--Coordinates the blood services for an effective function of all 
blood transfusion activities --Manages the national blood supply --
Recalls blood components if necessary --Implements a quality 
system --Follows -up maintenance of internal and external quality 
control --Promotes mechanisms for the protection of personal data -- 
Makes national guidelines for the collection, storage and 
transportation of plasma as well as for blood testing and processing 

1.2. National Competent Authority 2? 

Yes 

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

1.2.6.1. If other, please specify. 

COORDINATING HAEMOVIGILANCE CENTRE (SKAE) OF 
THE HELLENIC CENTER FOR DISEASE CONTROL AND 
PREVENTION 

AVEROF STREET 10 ATHENS 10433 GREECE 

00302108233673 

skae@keelpno.gr 

www.keelpno.gr 

Haemovigilance 
Other 

EPIDEMIOLOGICAL SURVEILLANCE OF TRANSFUSION 
TRANSMITTED INFECTIONS 

1.3. National Competent Authority 3? 

Yes 

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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.3.6.1. If other, please specify. 

1.4. 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.). 

SECTION OF BLOOD TRANSFUSION DIRECTORATE OF 
HOSPITAL UNITS DEVELOPMENT (S BT-DHUD) MINISTRY 
OF HEALTH 

ARISTOTELOUS STREET 17-19 ATHENS GREECE 

00302132161420 

intrel@yyka.gov.gr 

www.moh.gov.gr/  

Other 

--Promotes regulations and examine legal issues in relation to blood 
donation and transfusion --Collects data on blood logistics --Deals 
with emergencies --Recommends  budgets and funding for the blood 
services --Manages  legal contracts  for networking  of BEs, HBBs  
and private clinics -- Manages  legal contracts with plasma 
fractionation  Centres abroad and with Swiss Red Cross for 
importation of RBCs 

According to 17 October 2005 Law3402 implementing Directive 
2002/98/EC The Ministry of Health has the exclusive competence 
and responsibility for the organization of blood transfusion and  of 
all blood transfusion  activities including the collection testing 
processing storage distribution and management of blood and blood 
components. These duties are performed through the National Blood 
Centre  (EKEA) and the blood services  (blood centers (BCs), Blood  
Establishments (BEs) and Hospital Blood Banks (HBBs) as well as 
the Plasma Fractionation (PFC) EKEA is the national coordinator of 
all BCs, BEs, HBBs AND PFC and  advocates the Minister of 
Health  for the designation, authorization, accreditation and licensing 

164 

 
 
 
of all blood services EKEA performs inspection regularly every two 
years as well as in emergencies in case of severe adverse  event. 
EKEA is responsible for blood  components recall and notification 
of the PFC in cooperation with the Hellenic CDC. EKEA enacts and 
follows -up a quality and safety for all donation and transfusion 
activities.National  Guidelines for blood transfusion  scientific 
activities and specifications relating to quality for BEs and HBBs 
and regulated by EKEA. EKEA's staff (35-40 people) is specialised 
in transfusion medicine, virology, immunohaematology,  biology 
and administration. The  Coordinating Haemovigilance Centre 
(SKAE) of the Hellenic CDC (Foundation in Nov. 1995, 
Govermental Journal No 831/29 June 2001 and Govermental Journal 
-Ministerial Resolution 261/17-02- 2011 is the competent authority  
for the development and function of haemovigilance system. It 
collects, records, and analyse information about adverse reactions 
and adverse events associated with the transfusion and the  donation 
of blood and blood  components. Serious adverse reactions and 
events are notified to SKAE that reports to EKEA and to the 
Ministry of Health. Traceability of blood components and tracing 
and recall of  potentially infections donations  reported to BEs and 
HBBs are coordinated by SKAE as well as epidemiological 
surveillance of transfusion transmitted infections (TTIs). SKAE has 
specialized staff in transfusion medicine,  epidemiology, 
statistics,communication  and informatics.SKAE operates through a 
national network with six bases. The section of Blood Transfusion 
(SBT-DAMY) Directorate of Hospital Units Development has 
regulatory responsibilities  advocating the Minister of  Health on 
issues related to implementing EU Directives and other relevent 
regulations of Council of Europe and the WHO Legislative issues 
concerning blood donation and blood transfusion as  well as funding 
and budgeting of  BEs, HBBs and the PFC are within the 
competence of SBT-DAMY. Other responsibilities are : measures 
for the increase of Voluntary Blood Donation and the development 
of a registry for  voluntary blood donors, a database  for blood 
logistics (blood collection and blood distribution), regulation of 
blood sessions in cooperation with the Ministry of Defence , close 
cooperation with EKEA as well as BEs and HBBs and  SKAE 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

Not applicable 

not applicable 

9 

101 

0 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

333.335 whole blood donors and another 18.123 plateletapheresis 
donors 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

276.668 

56.667 

Yes 

The majority (4.2%) of your donor travel to EU countries, USA,  
Canada and to Australia. A small (0.5%) proportion travel to 
Australia Another 0.3% travel to non EU European Countries as 
well as  in other destinations. People of  Albanian origin who live for 
more than  10 years in Greece (1%) visit their mother country and 
are accepted for donation in accordance with the suitability criteria 

2.1.8. For whole blood donations, could you please provide the 

400.002  Comment : These are data from 81% of total blood 

165 

 
 
 
number of whole blood donations in 2012 (01/01-31/12/2012). 

collection 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

450 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.146 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

350-470 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

18.123 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

Depending on the equipment usedin aphaeresis and the prescribed 
quantity of the products the average volume varies from 280 ml 
(2.8x10'') to 400ml (4x10'') 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

0 

92 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

comment: plasma donations are collected only during 
plateletaphaeresis 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

attached 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

The donor signs the blood donor form (questionnaire on donor 
medical history) assuring that he/she has not experienced at risk 
sexoual behaviors and/or in drug abuse. However a multicenter  
study published in Transfusion  Medicine in 2007 on ''Factors that 
motivate and hinder blood donation in Greece'' showed that a small 
percentage of donors confessed to having concealed part of the truth 
to background  information 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

This measure is applied in some blood establishments only 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

--Haemoglobin levels in donor's blood (women)  --Medication  --
Disease outbreakes (seasonally e.g. WNV) --Travel  

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

History of HIV-1/2 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

Section 2.3 of 2004/33/EC may be more extended and specific for 
particular epidemiological situations in affected aress (eg WNV, 
Malaria, Dengue,HEV) 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

-Persons who have had even one homosexual contact since 1977 -
Persons who have injected drugs intravenously -Persons 
systematically involved in unsafe sexual activity during the last 10 
years -Sexual partners of multi-transfused patients -Persons who 
during the last 12 months had sexoual contact with someone who 

166 

 
 
 
 
 
received payment for sex in money or drugs -Generally anyone who 
thinks that he/she may be exposed to HIV 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

No 

No 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

-Hb levels in women and first time donors (3.5% of deferrals) -
Medication (3%) -WNV and Malaria outbreaks in Attiki (seasonally 
10%) -Travel in various endemic areas for HBV, Malaria , Chagas 
and because of vCJD 4% AND 2.5% respectively 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

- The total number of deferrals per blood establishment is recorded 
in the database of the SBT-DAMY/MoH -The Coordinating 
Haemovigilance Centre collects data on deferrals due to TTIs -
Detailed data for each deferral are kept by most BEs 

4% of total blood collection (about 16,000 units) 

Yes 

Yes 

- By inspections every two years -Through the data on anality issues 
collected by SKAE -Through ISO Certificates and Proficiency 
testing from the EDQM and external independed bodies -Use of the 
Council of Europe ''Guide to the Preparation, Use And Quality 
Assurance of Blood (Greek Edition) 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

In every donation for HIV,HCV,HBV and seasonally in affected 
areas for WNV 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

Donor eligibility criteria testing for TTIs and labelling criteria are 
mandatory 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Plasma donations by aphaeresis procedures are rare and performed 
together  

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

Yes 

3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

Addition of NAT testing 

Yes 

21 

432 

86 

HTLV I/II : 22 SYPHILIS : 73 WNV  :   4 

This is to be considered and planned 

167 

 
 
 
3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Photoinactivation of Plasma with Methylen Blue 

Yes 

No 

The National Blood Centre is conducting investigation for existing 
GMPs, promotes processing and packaging instructions and 
manages various manufacturing operations.SKAE is making 
enquiries  about documentation, pre- established proceduresand 
other quality parameters. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Most BEs and many of the HBBs have a system for maintaining 
quality control, keep records on materials, test results, equipment 
presentation and maintenance. Self inspections are performed  by the 
responsible persons  and  in the large blood Centres performing 
Molecular Biology testing for TTIs  anditing is applied. 

Through Inspections by the National Blood Centre and by means  of 
an inquiry operated by the Coordinating Haemovigilance Centre. 
The regional Blood Centres are also entitled to perform  visits and to 
examine documentation  of records in the network of HBBs of their 
region  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

- Through manual as well as computerized systems all procedures 
are labelled with unique numerical codes - All blood service are 
following national guidelines for the examination of medical history 
of donors, store the blood donor forms (signed by the examing 
physician and the donor) for at least 15  years and store samples of  
donor blood for at least 1 year. Deferral criteria and blood testing 
results as well as haemovigilance data are recorded and stored 
carefully. Documentation and record keeping are favored  because of 
the existing   decentralized system 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

The National Blood Centre and the regional as well as the local 
Health and Hospital Authorities follow national specifications and 
perform tenders that are under central control from the  Goverment  

The Coordinating Haemovigilance Centre has focused on the issue a 
data confidentiality of both donors and recipients 

Yes 

no 

Yes 

It is the golden standard of transfusion internationally . The guide 
translated in Greek is on the bench of everyone working in the blood 
services inspiring and guiding all activities, in donations  and 
transfusion Its standards and  principles that fully compatible with 

168 

 
 
 
the EU legislation provide the base for every regulatory and 
scientific act, guaranteeing that consistency with ethics and scientific 
progress  

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Designation 
Authorisation 
Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

102 ( information of records are available by the Directorate of 
Hospital Units 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.4.1. If yes, what were the reasons for the revocation(s) or 
suspension(s) (more than 1 answer possible) ? 

Yes 

Others 

4.4.1.1. If other, please specify. 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

4.6. How many laboratories performing donor testing are active 
within your country? 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Administrative reasons associated with a stepwise centralization 
system starting with the nationwide implementation of NAT testing 
for HIV, HCV and HBV in September 2008 followed by the 
economic crisis and the various structural changes in the national 
health system (early retirement or suspension of staff, conflation of 
blood services and in certain situations lack of resources delaying 
procedures). 

The Minister of Health after the relative recommendations from the 
National Blood Centre 

92 

AS 4.5 

4.8. How many hospital blood banks are active within your country? 

83 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

Yes 

4.9.1. If yes, please specify the scope of these extra rules. 

-Blood collection follwing the guidelines of the National Blood 
Centre - Recruitment of blood donors - Notification and counseling 
of donors positive for TTIs  - Take part in the investigation and 
management of disturbances of haemostasis and transfusion 
depended diseases 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

The National Plasma Fractionation Centre ''Elias Politis'' is located 
in the area of Thracomacedones in Attiki and is one of the National 
Blood Centre Units.  

4.10.2. If yes, please state the responsible authority within your 
country. 

It collects whole blood derived plasma provided by BEs and HBBs 
and cooperates with SANQUIN for fractionation and the production 
of Albumin under mutual contract It is public and its capacity  is less 
than 100,000 liters of plasma per year 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

For regular inspections, the activity is performed by the National 
Blood Centre in cooperation with the Regional Health Authorities 
for inspections in specific situations and in case of revocation  SEYP 
(Body of Health Inspectors) is the competent authority 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

Three (1 director of a regional BE, 1 administror ,1 specialized in 
engineering) 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 

Yes 

169 

 
 
 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

Tissues and cells 
Organs 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 
Medical devices 
Hospitals 

-52 inspections accomplished before 2009 for the purposes of the 
plasma Master File --41 regular inspections in the blood services of 
Western Greece, Macedonia and Thrace -- 3 inspections in the 
Plasma Fractionation Centre performed by SEYP 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

as 5.3.1 

as 5.3.1 

as 5.3.1 

0 

No 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

None 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

5.8.1. If no, please explain. 

They have not been inspected 

No inspections performed in 2012 except for the purpose of centrally 
planned consolidation  of eight blood services 

as 5.6.1 

as 5.6.1 

as 5.6.1 

as 5.6.1 

as 5.6.1 

None 

No 

Only qualified NCA officials are entitlited to perform inspections, 
examine documents and if required to take samples for analysis 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

It is the same system applying for BEs. The inspection Criteria and 
guidelines have been formulated by the Scientific Committee of the 
National Blood Centre on the basis of the ''Guide'' and EU- EUBIS 

170 

 
 
 
5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

5.9.2.1. If yes, please specify. 

and CATIE 

Yes 

HBBs are inspected by the National Blood Centre in cooperation 
with the Regional Health Authorities (abbreviated in greek EPY) 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

Extremely useful for the general functionality of the blood services 
as well as for inspections, audits, proficiency testing and 
accreditation 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

5 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

Coordinating Haemovigilance Centre 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

Whole blood, RBCs, FFP, whole blood derived platelets, apheresis 
platelets and whole blood derived plasma intended for fractionation 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

For BEs and HBBs without a computerised system, this requirement 
cannot be fully respected 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

The Coordinating Haemovigilance Centre (Known as SKAE) was 
founded by the Hellenic Center for Infectious Diseases Control 
(KEEL, now KEELPNO) in November 1995. It was established for 
reasons in line with European efforts to promote the strictest 
possible standards for quality in blood donation and transfusion 
medicine and particularly to limit the risks that arise in this area of 
public health, thus to improve the safety of the blood transfusion 
chain from donor to patient  Basic functions of SKAE -Surveillance 
of transfusion transmitted infections in blood donors and in blood 
donations - Traceability of blood components -Tracing and retrieval 
of potentially infectious donations--Look back programme -
Surveillance of adverse reactions and adverse events in blood donors 
during or after donation -Surveillance of adverse reactions and 
adverse events associated with the transfusion of blood and blood 
components -Reporting to the competent authorities for blood 
transfusion (EKEA)   and public health (KEELPNO) - 
Recommending preventine and corrective measures -Informing the 
medical community about adverse events and reactions associated 
with blood donation and transfusion - Warning blood services and 
clinical departments about adverse events and reactions that could 
involve more than a single recipient -Crisis management -Education-

171 

 
 
 
Publications 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

Yes 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

70-99% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Ministerial Resolution 261/Febr. 2011 article 2, paragragh 3,4 
mandates notification of SAR/SAE of imputability level 2 or 3 
attributable to the quality and safety of blood and blood componets 
to  SKAE using a rapid notification format that is followed by a 
confirmatory procedure. SKAE reports to the National Blood Centre 
and in some cases to the Ministry of Health. Annual notification data 
of SARs/SAEs to SKAE are also collected and analysed by SKAE 
by type, degree of severity, level of imputability, degree of 
morbitidy and clinical outcome 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

-ABO incompatibility causing immunological haemolysis - TRALI - 
Transfusion-transmitted infections 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

This information is disseminated in the context of national and 
regional meetings for haemovigilance as well as in haematology and 
transfusion medicine congresses 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

Recall of one unit in-date RBCs in the case of transfusion 
transmitted WNV  in a patient who received whole blood platelets 
and developed severe encephalitis. The FFP that derived from the  
same blood unit was already transfused in to another patient who 
remain WNV asymptomatic 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

So far, SKAE is sending classified mails to BEs. A system similar to 
RAB is now under construction 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

see 6.2.11.1  

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

In very rare cases, the National Organization for Drugs (EOF) is 
communicating a rapid alert for medicine devices defects 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

SKAE is working for tracing of recipients of potentially infections 
blood donations and for post donation information 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

In the case of importing annualy about 20,000 units of RBCs from 
the Swiss Red Cross Blood Centre the provisions required from EU 
legislation are met in the mutual contract with the Ministry of  

172 

 
 
 
7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

Details of this information can be provided by the Section of Blood 
Transfusion -Directorate of Hospital Units Development of the 
Ministry of Health 

Health 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Equivalent standards (bilateral agreements) 

Yes 

7.4.1. If yes, please specify. 

NAT testing for : HIV-RNA, HCV-RNA, HBV-DNA 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

25,200 units of RBCs 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

No 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

not applicable 

not applicable 

No 

No 

Yes 

7.11.1. If yes, how often (per year) is there a shortage of blood or 
blood components in your MS? 

During summer holiday Blood shortage have been intensified 
because of WNV outbreak 

7.11.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Red Blood Cells 

7.11.3. If yes, would you be interested in concluding bilateral 
agreements with other MS in order to address the shortage? 

7.11.4. If yes, would you be interested in establishing short-term/ad-
hoc mechanisms for addressing the shortage? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

Yes 

Yes 

No 

No 

No 

Yes 

8.2.1. If yes, please specify. 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

Testing seasonaly for WNV-RNA in the affected areas Testing 
seasonaly for malaria in the area of Evrotas - Lakonia (affected area 
in the period 2009-2012) Pathogen inactivation of FFPwith 
Methylen Blue 

Time - frame of 30 years for data storage  Addition of NAT testing 
for HIV,HCV and HBV 

173 

 
 
 
8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

WNV and blood safety measures (in comformity with the final EU 
preparedness Plan 2012) For affected areas  -Deferral of potential 
donors residing or working in these areas  -Quarantine of blood 
components collected since beginning of July until NAT testing of 
plasma samples stock has been performed  -Retrospective NAT 
testing and look back procedures of blood collected since 1st July -
Donor deferral is withdrawn when NAT testing is implemented  For 
unaffected areas  -Deferral of travellers/visitors for a period of 28 
days after their return from an affected area  General measures -
Reinforcement of the donor clinical evaluation, particularly for 
visitors to the affected areas and continuous information fron the 
Hellenic CDC web www.keelpno.gr conserning the  epidemiological 
data on the seasonal cycle of the WNV -Deferral of potential donors 
who reside in USA and Canada  Other measures Haemovigilance  
Persons with diagnosis of WNV may be accepted for blood donation 
120 days after diagnosis Post donation information : Request all 
donors to inform blood collecting services in case of fever, flu-like 
and other symptoms within 15 days after donation in order to 
examine for  WNV(positive donors reported as a case) Post 
transfusion information : In case of history of recent blood 
transfusion in confirmed or suspected WNV cases, apply look back 
and traceability procedures including call up and testing of  
implicated blood donors  Surveillance of WNV in thalassaemic 
patients  Ensuring blood sufficiency  Special attention to the optimal 
use of blood components and appropriate management of the 
national blood supply should ensure sufficiency of blood in affected 
areas  Viral inactivation of about 12% of FFP by Methylen Blue   

8.5. Which other communicable diseases are of relevance to you? 

Malaria 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Yes 

No 

We think that pathogen inactivation techniquesapplied in  individual 
blood units or should not fall under the pharmaceutical legislation  

174 

 
 
 
 
 
 
A.1.13. 

Survey response Hungary 

1. Public information 

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

National Institute for Quality- and Organizational Development in 
Healthcare and Medicines National Institute of Pharmacy 

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.5. Website: 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

 H-1051 Budapest, Zrínyi u. 3. 

+36 1 88 69 -300 

http://www.ogyi.hu/ 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

Goverment based, 2 inspectors 

1.5. 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) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

Centralised system 

1 

5 

23 

239133 

183380 

55753 

Yes 

Some people give plasma in private plasma collection centres in 
Austria. No more information about it. 

425637 

450 

- 

- 

3573 

250 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

825 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2 

2 

175 

 
 
 
2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

Véradók nyilvántartása, véradás előtti kivizsgálása és a teljes vér 
vétele/ Donor selection, register, examination before blood donation 
and blood collection 2nd Edition, OVSZ, Budapest, 2009. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

eProgesa software is used by the Hungarian National Blood 
Transfsuion Service, this is covered the whole country, we have only 
one donor register. 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

The donors prepare a declaration about it and sign the document  

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.9.1. If yes, please specify. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

3.1. Testing 

hemoglobin concentration 

sexual risk 

No 

Yes 

MSM, frequent chnage of sexual partners 

No 

No 

low hemoglobin concentration 

Yes 

eProgesa 

68309 

No 

Yes 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

The Analysis Certificate are controlled by the CA in the BEs, and to 
inspect the work of the laboratories. The laboratories are involved in 
the proficiency tests. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

BE can afford to use this test in the confirmatory process. 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 

Yes 

176 

 
 
 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

anti-HBc, anti TP 

no information 

No 

Yes 

4 

12 

111 

68 anti-HBc 

No 

Yes 

No 

Each of work place have an annual training plan and at the end of 
the year the QA officer have to close it after controlling of the 
details of it, and send about a report to the QA director in the 
Headquaters of HNBTS. During an audit these are controlled by the 
auditor of the BEs and the inspectors of the CA.   

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

The Hungarian National Blood Transfusion Service (HNBTS) has a 
quality system according to the principle of GMP directive and 
62/2005/EC directive (it was implemented into the 3/(II.10) 2005. 
EüM decree). Since 2002 the CA has inspected it in every second 
year to give the licence. 

During the inspection the documentation is controlled, read the 
reports, etc. 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

On paper form and on the server.  

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

The refrigerators are validated by the QA department in partly. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

ISBT 128 code identifies each of donation of the donors and only the 
authorisied staff can see the person in the IT system. 

177 

 
 
 
  
3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Yes 

ISBT128 

Yes 

QA departmen follows up the modification of the Guide and 
implements it in the rules. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 
Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

4.6. How many laboratories performing donor testing are active 
within your country? 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

Yes 

1 

No 

GYEMSZI-OGYI 

2/1 Blood Service 

National Public Health and Medical Officer Service 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

23 

No 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

HumanBioplasma Ltd bilongs to Kedrion. This is a private 
company. 

4.10.2. If yes, please state the responsible authority within your 
country. 

GYEMSZI-OGYI 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Inspection department 

2 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Tissues and cells 
Pharmaceuticals (including plasma derivatives) 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 

ni 

ni 

5 

0 

178 

 
 
 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

ni 

No 

Yes 

1 

5 

licence 

corrective action 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

no 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

5.9. Is a system in place for inspecting hospital blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

licence 

OK 

- 

- 

Yes 

No 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

BE impelemts the Guide into the regulation. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

4 

Yes 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

Yes 

Yes 

all of type 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

Barcode 

179 

 
 
 
6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

Granulocyt 

Both paper records and electronic forms 

To archivate on electronical version 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

No 

Yes 

Yes 

Yes 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

70-99% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Blood Transfusion Regulation 2 edition OVSZ, Budapest, 2010, this 
rule is mandatory on decree level (3/(II.10) 2005. EüM law, but this 
data collection have been coordinated since 1976, but the request 
data was different in the past. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

The Blood Transfusion Service is involved and analyse, and 
cooperate wit the hospital and the plasma fractionation factory.  

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

The contact person (who has been delegated by the ministry) works 
in the Headquaters of the BE service. 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

In the last year 11 events were ensured by the responsible persons 
according to our Hemovigilance rule. The donor made a signal of 
risk Lyme 4 cases after the blood collection, 1 the donor was 
infected by tuberculosis (after the donation getting the information), 
1 ALL deasis in the donor after the collection, risk the HCV 
contamination in 2  minipool that was detected PCR technique in the 
plasma fractionation company, but the infections were not showed in 
the patients.   

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

According to the rule the contact person (quality director) will get 
the information from EU, countryside and it will be analised with the 
clinical director of the service and coordinate the process. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

look at the 6.2.11.1. 

6.2.13. Do you notify alerts communicated via the blood national 

Yes 

180 

 
 
 
vigilance system also to other national vigilance/alert systems? 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Collaboration with the national institution 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

no 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.11.1. If yes, how often (per year) is there a shortage of blood or 
blood components in your MS? 

7.11.2. If yes, for which blood components (more than 1 answer 
possible)? 

decree 

decree 

International standards 

No 

Yes 

0 

No 

no 

no 

No 

Yes 

0 

Yes 

according to the EU directive, Guide and 3/(II.10.) 2005 EüM decree 

Platelets 
Plasma 
Red Blood Cells 
Whole blood 
Others 

7.11.2.1. If others, please specify. 

granulocyte concentrate 

7.11.3. If yes, would you be interested in concluding bilateral 
agreements with other MS in order to address the shortage? 

7.11.4. If yes, would you be interested in establishing short-term/ad-
hoc mechanisms for addressing the shortage? 

Yes 

Yes 

7.12. Is there a regular surplus of blood or blood components in your  No 

181 

 
 
 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

No 

No 

No 

No additional problem. 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

In 2010 the WN infection was sporadic localization. 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

no 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

Only the blood establishment responsible to collect blood and 
prepare blood products.  

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

no 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

plasma fractionation 

182 

 
 
 
 
 
 
A.1.14. 

Survey response Ireland 

1. Public information 

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

Irish Medicines Board 

1.1.2. Address of&nbsp;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) 

Kevin O' Malley House  Earlsfort Centre Earlsfort Terrace Dublin 2 
Ireland 

00353-1-6764971 

compliance@imb.ie 

www.imb.ie 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 
Other 

1.1.6.1. If other, please specify. 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.1.7.1. If other, please specify. 

Cosmetic products, advanced therapy medicinal products, clinical 
trials, veterinary medicinal products 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 
Other 

Overseeing recalls, advice to government, international 
representation, enforcement powers. 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

There are four (4) departments directly involved in carrying out 
IMB's regulatory functions:1: Compliance (inspections and audits, 
market compliance and enforcement), 2: Humjan 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 blodd components, tissues and cells and medical devices, 4: 
Veterinary Sciences (licensing and safety of medicines for animal 
use, scientific animal protection). There are three (3) departments 
which provide cross organisational support: 1: Finance and 
Corporate Affairs, 2: Human Resources, 3: IT Mangement 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 21 inspectors working accross 
different specialities including GMP, GDP, GCP, Blood, Tissues 
Cells and Organs (BTO). There is a dedicated team for Blood 
inspection comprised of the BTO mangaer, two BTO inspectors and 
one 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 Blood. The human product monitoring 
department is made up of pharmacovigilance, medical device 
vigilance and human products vigilance assessment, comprising of 
approximately 40 staff, there is 1 dedicated BTO vigilance officer, 
we also have access to senior management staff as required. The 
Irish Medicines Board is 85% self funded through licensing, 
inspection fess, the remainder is funded by the Irish Department of 
Health.    

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

Not applicable 

Not applicable 

2.1.1. Please provide the number of BEs in your country recorded at 

3 

183 

 
 
 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

 1 BE has a satellite site 

1 BE has 8 mobile sites 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

117,511 

102,101 

15,410 

Yes 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

Minimal due to vCJD restrictions. Generally this would be donors 
from Ireland who have moved to live in Northern Ireland. No data 
on actual numbers involved. 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

138,099 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

450ml +/- 10% 

N/A we do not use Irish plasma 

N/A we do not use Irish plasma 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

12,023 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

Not available - volume collected depends on donation 
(single/double/treble) - always meets CoE Specification >40ml per 
60x10^9 of platelets 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

0 

3  

N/A 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.17.1. If other, please specify. 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

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

 One BE is responsible for obtaining allogeneic donations across the 
country and the donor/evaluation and selection is standardised by 
this organisation. The  other two BEs are involved in the collection 
of autologous donations and therefore the donor/evaluation and 
selection is specific to those organisations and is carried out by 
appropriately trained staff. 

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 
Information is collected through a donor evaluation/selection form 
that is not standardised at national/regional level 

We have only one BE who obtains allogeneic donations so the 
evaluation/selction form is standardised across their organisation. 
Attached are 2 forms, one for repeat donors and the second for new 
or lapsed donors. 

2.1.18.2. Please provide a copy of the donor evaluation/selection 
form standardised at regional level (in English if possible). 

Not applicable 

2.1.19. How do you ensure that the donor evaluation and testing 

We have only one BE who obtains allogeneic donations, they 

184 

 
 
 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

manage this through a computerised system called Progesa. These 
processes can be reviewed on inspection. 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

The BE has a website www.IBTS.ie with a section of questions for 
self exclusion. There is also an FAQ section. 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Specific for BE, unable to provide a response as not appropriate for 
CA to comment 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Specific for BE, unable to provide a response as not appropriate for 
CA to comment 

No 

No 

Can be seen on HLQ: If you have ever been given money or drugs 
for sex; if you are male have you ever had oral or anal sex with 
another male with or wothout a condom or other form of protection; 
Do you or your partner have HIV; In the past 12 months have you 
had: - sex with anyone who has HIV or hepatitis; sex with anyone 
who has ever been given money or drugs for sex; sex with anyone 
who may have had sex in parts of the world where HIV is very 
common? this includes Africa and South East Asia; sex with anyone 
who may has ever injected or who has been injected with non-
prescribed drugs even once a long time ago thisi includes body 
building drugs; sex with anyone with Haemophilia or other blood 
clotting disorder who has ever been treated with clotting factor 
concentrates; if you are female sex with a male who has ever has 
ever had oral or anal sex with another male with or without a 
condom or other form of protection    

No 

No 

Low Hb has been the main cause leading to deferral. Total deferral 
rate is 18.49% of which 8.7% relates to Hb referrals. 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

Progesa, a computer based system 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

18.49% 

No 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

If the testing laboratory is within the BE (as for BE responsible for 
Allogeneic Donations), the laboratory is assessed during routine 
inspections of the BE by the CA. If the testing laboratory is outside 
the BE (as for the two BEs who perform autologous donations) the 
testing laboratories used are required to have ISO 15189 
accreditation, this is a requirement of the BE's authorisation. This 
can be reviewed on inspection. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 

For all allogenic donations. 

185 

 
 
 
used? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

NAT PCR  performed on all allogeneic donations but not 
mandatory. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Not applicable 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

No 

Yes 

1 

1 

2 

3 confirmed positive for syphilis and 9 confirmed positive for 
bacterial screening, 0 postive for HTLV 

No 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

Job description, training records. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

On inspection in the BE the personnel training records are reviewed.  
The BB's are accredited to ISO 15189 and a part of audit process is 
to review training records of BB staff. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

BE quality systems incorporate blood legislation, COE guide and 
PICS inspection guidance for BE.  BB quality systems incorporate 
ISO 15189 requirements and additional IMB/INAB documents on 
traceability and SAE/R reporting 

This is ensured through routine inspection for BEs and audits for 
BBs. 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Currently kept forever electronically. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

This is reviewed as part of the inspection process. In 2013 a new BE 
was authorised specifically for the transport and distribution of 
blood and blood components in Ireland. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 

A unique identification number is applied at donation and used 
throughout the process. Any correspondance with third parties uses 

186 

 
 
 
  
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

the donor identification number, therefore the third party never 
knows the donor identity.   

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

All BEs use a codebar system, some use ISBT 128, the rest will 
eventually use ISBT 128. 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

This guide is useful but we would recommend it includes principles 
of GMP. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4 (31/07/13) 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

As we mandate that laboratories performing testing are ISO 15189 
accredited the national authority responsible is INAB (Irish National 
Accreditaion Body).  However if a BE perfoms testing themselves 
we authorise it. 

4.6. How many laboratories performing donor testing are active 
within your country? 

3 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

INAB is the national authority with IMB supervision. IMB can also 
perform inspections as required. 

4.8. How many hospital blood banks are active within your country? 

46 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

Yes 

4.9.1. If yes, please specify the scope of these extra rules. 

As part of ISO 15189 accreditation hospital blood banks are required 
to meet the requirements of document AML-BB which sets out 
specific detailed minimum requirements in relation to traceability 
and SAE/Rs. Hospital blood banks are also required to submit 
annual reports to the IMB on activities. 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

The Compliance Department of the IMB are in charge of inspections 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

1. Blood, Tissues and Organs Manager, 2. Blood, Tissues and 
Organs Inspectors, 1. Blood, Tissues and Organs Scientific Officer 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Tissues and cells 
Organs 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 
Hospitals 

5.3.1. Number of inspections by type:&nbsp;Please specify the 

In 2012, 6 routine inspections were performed of the main BE in 

187 

 
 
 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

Ireland collecting allogeneic donations. (2 in the main processing 
sites and 4 in donation clinics) 

0 in 2012. However it is possible to perform inspections when we 
receive an application to vary the BE authorisation, based on the 
report of a SAE/SAR or serious incident. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

0 

0 

0 

No 

No 

5.5.2.1. If no, why not? 

We have a small number of authorised BEs and BBs are managed 
through an accreditation body. 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

2 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

They are inspected every 2 years. 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

N/A 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

Corrective actions were propsed by the BEs and assessed by the 
IMB, if acceptable they will be followed up on the next inspection. 

Corrective actions were propsed by the BEs and assessed by the 
IMB, if acceptable they will be followed up on the next inspection. 

none 

did not occur 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

N/A 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

we have none 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

The CA may perform an inspection on foot of an SAE /R or upon 
suspension of ISO15189 accreditation. All HBBs routinely inspected 
for ISO 15189 compliance by the national accrediting body, INAB. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

Only upon suspension of ISO15189 accrediation or upon reporting 
(or lack thereof) of SAEs/SARs of concern. All BBs also required to 
submit annual report to CA based on activities and compliance with 
requirements of legislation. 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

Contains relevant guidance for BEs - However more GMP guidance 

188 

 
 
 
is needed. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

3 

Yes 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

IMB is the CA that oversees traceability by the BE. Our BE have to 
demonstrate traceability on inspection. 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

All blood components. 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 128 is currently applied to all donations in conjunction with 
the codabar system. This is to facilitate BBs who have not yet 
moved to ISBT 128. It is envisaged that all BBs will move to ISBT 
128 in due course. 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Neonatal products, granulocytes etc. 

Both paper records and electronic forms 

By verification on inspection. 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

A National Haemovigilance Office was established prior to 
implementation of the Directive. Hospitals report SAEs/SARs 
associated with blood components to this office. The IMB as CA has 
an agreement in place with this office and quarterly meetings are 
arranged to review SAEs/ SARs reported in the intervening periods. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

Yes 

Yes 

100% 

No 

6.2.6.2. If no, how do you ensure that SAR/E are reported from 
Hospital Blood Banks to BEs? 

There is no mandatory procedure in place for this. However, the 
National Haemovigilance Office is based at the main BE in Ireland 

189 

 
 
 
(for allogeneic donation) and thus all BBs report SAEs and SARs to 
the BE via this office. Concerns regarding quality and safety are 
communicated to the relevant personnel at the BE and the process is 
reviewed on inspection. 

6.2.7. Do you perform root cause analyses of the SARE? 

No 

6.2.7.2. If no, why not? 

The reporter (BB) performs RCA  and the National Haemovigilance 
Office in association with the CA assess adeqacy. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

When published by the EU, the IMB will circulate the reports to all 
BEs. 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

In 2012, 229 recalls in total: 159 (69.4%) recalls due to post 
donation information (including abnormal FBC); 29 (13%) recalls 
due to suspected bacterial contamination; 33 (14.4%) recalls due to 
suspected adverse reaction to product; 8 (3.5%) repeat reactive 
virology test; 3 (1.3%) platelet aggregates; 2 (1%) air in line; 6 
(2.6%) Others. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Due to small number of BEs and BBs in Ireland, it is possible for the 
CA to communicate national rapid alerts via email to all relevant 
personnel and through use of CA website where required.  

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Due to small number of BEs and BBs in Ireland, it is possible for the 
CA to communicate  rapid alerts received from CIRCA-BC via 
email to all relevant personnel and through use of CA website where 
required.  

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Same team at CA responsible for Tissues & Cells and Organs and so 
therefore possible to communicate vigilance alerts through these 
systems if required. There are also close links within the CA to 
Medical Devices and Pharmacovigilance sections so communication 
with these sections is also possible if required. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Importers must be authorised BEs. 

Not applicable 

International standards 

Yes 

7.4.1. If yes, please specify. 

Possiblly NAT Testing and perhaps West Nile Virus Testing. 

190 

 
 
 
  
However, there is a need to discuss this with the Blood 
Establishments throughout Europe and the ECDC. 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

2 red cell units both from USA 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

No 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

Not applicable 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

Export is to third countries.  It has only occurred once on response to 
humanitarian disaster in Haiti. All exported products must meet the 
requirements of the EU Directives. 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

No 

No 

No 

No 

No 

Yes 

No 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

not applicable  

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

0 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

not applicable 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

Regulation of BB, SAE.R definitions, the control of 
distribution/transport of blood components and the standard to be 
met for same.  

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

8.5. Which other communicable diseases are of relevance to you? 

Deferral and more recently the introduction of testing those donors 
attending clinics who have been to endemic areas in the previous 28 
days. 

Hepatitis E prevalence is currently under study at the Irish Blood 
Transfusion Service. There are concerns regarding the use of Hep E 
positive donations in neonates and immunosupressed patients.  

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

These are regulated outside the scope of the Blood Legislation at the 
moment in Ireland. There is a potential for these techniques to fall 
within medicines law if there is a medicinal claim associated with 

191 

 
 
 
the product. 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

Any products collected, processed and applied at the bedside need 
careful consideration and do not necessarily fit within the 
requirements of the Blood Legislation. 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Where under the control of the BE, these activities should remain 
under the remit of the Blood Legislation.  

192 

 
 
 
 
 
 
A.1.15. 

Survey response Italy 

1. Public information 

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

Ministry of Health 

1.1.2. Address of&nbsp;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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 
1.1.7.1. If other, please specify. 

1.2. National Competent Authority 2? 

Viale Giorgio Ribotta, 5 00144 Rome, Italy 

+39 06 59941 

segr.dgprev@sanita.it 

http://www.salute.gov.it 

Blood and blood components 
Tissues and cells 
Human organs 
Medical devices 
Other 

Blood and blood components legislation, planning of blood activities 
at national level (upon technical indications from the National Blood 
Centre), labile blood components import-export authorization, 
promotion of research in blood activities and transfusion medicine. 
Yes 

1.2.1. Name of National Competent Authority 2: 

National Blood Centre (on behalf of the Ministry of Health) 

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.&nbsp;What are the role/tasks of the NCA? (more than 1 
answer possible) 
1.2.6.1. If other, please specify. 

1.3. National Competent Authority 3? 

1.4. 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.). 

1.5. 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) 

c/o Istituto Superiore di Sanità Via Giano della Bella, 27 00162 
Rome, Italy 
+39 4990 4953 

cns@iss.it 

http://www.centronazionalesangue.it 

Haemovigilance 
Other 
Coordination and technical-scientific control on all issues 
concerning blood and blood components as regulated by national 
and European provisions (including cord blood and peripheral 
haematopoietic stem cells collection, processing, banking and 
distribution); definition of plans for B and BC regional and national 
self-sufficiency and relevant monitoring actions; production of 
guidelines for B and BC quality and safety; definition and promotion 
of national plans and guidelines for appropriate use of blood 
resources; education and qualification of blood inspectors. 
No 

a) Ministry of Health: the Blood and Transplant Office is a branch of 
the Directorate General of Prevention; it is managed by an Office 
Director with longstanding experience in blood, cells, tissues and 
organ legislation, legal affairs and vigilance. The Office has a 
dedicated staff composed of 10 persons, both healthcare 
professionals and administrative. The Ministry of Health is entrusted 
with the definition of the "national basic healthcare services", 
including blood and transfusion medicine services, that must be 
homogenously guaranteed nationwide.  b) National Blood Centre 
(NBC): the NBC is a technical/scientific centre operating at the 
Istituto Superiore di Sanità (National Health Institute); it acts as 
blood competent authority on behalf of the Ministry of Health, 
reporting to the latter on all issues pertaining to its tasks. It 
coordinates the 21 Regional Blood Centres (which are by law 
instituted in each Region) as concerns blood and blood product self-
sufficiency, quality and safety, haemovigilance, information flows, 
etc. The NBC provides blood inspectors' education and qualification, 
as well as the management of a national list of qualified blood 
inspectors and the periodic assessment of their skills. The NBC also 
cooperates with the National Medicines Agency (AIFA) as concerns 
quality and safety of plasma for fractionation produced at national 
level. It is managed by a Centre Director who must be a physician 
experienced in blood, blood products, transfusion medicine and 
healthcare management. It has a staff of 25 operators, including a 
medical affairs and inspection systems manager, a national 
haemovigilance officer, a plasma and plasma products manager, a 
research and education manager, an information system manager, as 
well as administrative staff.       
Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

193 

 
 
 
1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 
2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 
2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 
2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 
2.1.7. Do you experience cross-border movement of donors 
into/from your country? 
2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 
2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 
2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 
2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 
2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 
2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 
2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 
2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 
2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 
2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 
2.1.17.1. If other, please specify. 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.2. Please provide a copy of the donor evaluation/selection 
form standardised at regional level (in English if possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

The Regional Competent Authorities (RCAs) are by law entrusted 
with authorisation and accreditation of Blood Establishments (BEs) 
and Blood Collection Units (BCUs). Authorisation/accreditation of 
BEs and BCUs is issued by the RCAs based on inspections which 
must be performed every two years. Inspection programs and teams 
are managed by the RCAs; the latter must guarantee that in each 
inspection team at least one nationally qualified blood inspector is 
included. Authorisation and accreditation requirements are defined 
by national State-Regions agreements in compliance with EU blood 
directives and, as applicable, EU GMPs. The Regional Blood 
Centres are entrusted with regional blood and blood products self-
sufficiency, haemovigilance data collection and reporting to the 
NBC, regional coordination of BEs and BCUs, relations with plasma 
fractionation industries and other tasks related to the regional blood 
activities. 

313 

None 

None 

1,739,712 

1,443,770 

295,942 

No 

2,683,127 

450 

403,554 

Std < 650  Avg. 560 

80,051 

300-400 

26,417 

174 

same as 2.1.15 

Only trained personnel is allowed to provide such information 
Other 

Information to donors will be standardized at national/regional level 
by the issuing of a new decree of the Minister of Health which is in a 
final phase of definition and will presumably be issued by the end of 
2013 (current form and draft standardized form enclosed at 
2.1.18.2).  
Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is not standardised at national/regional level 
The donor/evaluation form will be standardized at national/regional 
level by the issuing of a new decree of the Minister of Health which 
is in a final phase of definition and will presumably be issued by the 
end of 2013 (current form and draft standardized form enclosed - in 
Italian).  
Donor evaluation and testing procedures must be recorded in the 
automated BEs' information systems. Reporting of abnormal 
findings to the donor is envisaged as mandatory by law.  

194 

 
 
 
2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 
2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 
2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 
2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 
2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 
2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 
2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 
3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 
3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 
3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 
3.1.3.2. If yes, please specify whether these are mandatory under 

In the pre-donation information material each donor is informed that 
he/she may exert self-exclusion at any moment of the donation 
procedure, as well as after donation. 

a) Haemoglobin levels in donor's blood, especially concerning 
women in child-bearing age who are most prone to iron depletion 
following whole blood / red blood cell donation b) Transfusion 
transmissible infections, especially concerning donors having been 
in/coming from national areas/countries where: i) 
prevalence/incidence of transfusion transmissible infections are 
higher than at national level; ii) emerging pathogens are 
endemic/epidemic c) At risk/high risk sexual behaviours     
Least reliable to verify: at risk sexual behaviours 

Yes 

Concerning 2.1 "Infectious Diseases: Hepatitis B, except for 
HBsAg-negative persons who are demonstrated to be immune", it 
should be clarified what is to be intended by "demonstrated to be 
immune", considering that persons testing anti-HBs positive with (or 
even without) anti-HBc may test HBV DNA positive, thus resulting 
OBI (Occult HBV Infection) carriers.  
Yes 

Any risky sexual behaviours are considered for donor deferral with 
no distinction of gender and sexual orientation; differentiation 
between risk and high risk behaviours is adopted, applying 
temporary and permanent deferral respectively. In 2001, the criteria 
for blood donor eligibility were modified by a ministerial decree 
from a permanent deferral for "men who have sex with men" to an 
individual risk assessment of sexual behaviours. 
Yes 

No 

Criteria most leading to donor deferral: a) Exposure/potential 
exposure to transfusion transmissible pathogens b) Haemoglobin 
concentration measured at pre-donation screening (supported by 
mandatory full blood count at each donation and ferritin testing once 
a year) 
No 

No 

Yes 

Through the application of national legislation transposing 
Directives 2002/98/EC, 2005/61/EC and 2005/62/EC and the 
inspection system established by the transposition of Directive 
2002/98/EC.  
Yes 

NAT testing for HBV, HCV and HIV is performed at each donation 
by CE marked diagnostic systems, either ID (Novartis diagnostic 
system) or 6-minipool (Roche diagnostic system). WNV NAT 
testing is performed at each donation of blood donors living in 
affected areas, during defined Summer periods. 
Yes 

NAT testing for HBV, HCV and HIV at each donation. HCV NAT 
has been mandatory since 2002, HBV and HIV NAT since 2008. 
YES 

195 

 
 
 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 
3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

3.1.5. Do you have a system of centralised collection of data with 
test results? 
3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 
3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 
3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 
3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 
3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 
3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 
3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 
3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 
3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 
3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 
3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 
3.2.6.1. If yes, please specify how. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 
3.2.7.1. If yes, please specify. 

Yes 

Introduction of HBV, HCV and HIV NAT testing should be 
evaluated for adoption according to specific epidemiological 
assessments. WNV NAT testing should be regulated as an option to 
screen donors living in affected areas and to screen potentially 
exposed donors. 
Yes 

143 

868 

351 

Positive WNV NAT tests: 14 (fourteen) 

European Proficiency Testing Studies, as already performed by 
EDQM,  should be enhanced. 
Yes 

BC pathogen reduction/inactivation is not mandatory so far. 
Pathogen inactivation techniques are applied to a minor percentage 
of fresh frozen plasma for transfusion (riboflavin/UV, 
amotosalen/UVA, methylene blue, S/D) and platelets 
(riboflavin/UV, amotosalen/UVA). Two specific full Health 
Technology Assessment studies, respectively on FFP and PLT 
pathogen inactivation, are in progress at the National Blood Centre, 
in order to make adequate data and information available for 
eventual national regulatory decision-making. 

Yes 

No 

By law, physicians must hold an academic specialty in or equivalent 
to transfusion medicine. By law, biologists must hold an academic 
specialty in or equivalent to clinical pathology. Newly employed 
physicians, biologists, nurses and medical technologists are 
specifically trained when assigned to a BE/HBB. All staff's skills 
must be periodically verified and, as necessary, additional training 
must be provided. 
Yes 

The BE/HBB quality system is defined by specific national 
regulation compliant with Directives 2002/98/EC, 2005/62/EC and 
the applicable EU-GMPs (State-Regions Agreement of 16 December 
2010). 
By the relevant regulation (see 3.2.4.1) and the inspection system. 

Yes 

By BE information technology systems. 

Yes 

By the relevant regulation (see 3.2.4.1) and the inspection system. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 

Acces to all data is restricted to authorised operators (e.g. access to 
IT systems). Labels on blood components are anonymized and any 
information concerning blood donors is basically encrypted in 

196 

 
 
 
rendered anonymous so that the donor cannot be identified (Article 
23)? 
3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 
3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 
3.2.10.1. If yes, what is your experience with this Guide? 

codes/barcodes. 

Yes 

YES 

Yes 

The Guide is used as a complementary reference. The experience is 
quite positive. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 
4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 
4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 
4.3.2.&nbsp;If no, how many BEs have not received authorisation 
by [please provide date of record]? 

4.3.3. If no, when will this approval process be completed? 

4.3.4. If no, what is (are) the difficulties / reason(s) for the delay in 
the approval process? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 
4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 
4.6. How many laboratories performing donor testing are active 
within your country? 
4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 
4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 
4.9.1. If yes, please specify the scope of these extra rules. 

4.10. Are there plasma fractionation facilities in your country? 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

4.10.2. If yes, please state the responsible authority within your 
country. 
5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 
5.1.1. If yes, please specify the CA/Department of the CA in charge 

Authorisation 
Accreditation 
Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

No 

All BEs are authorised according to preceding regulation. By 30th 
September 2013, about 6% BEs have been authorised according to 
the new regulation complying with EU Directives; as to the 
remaining BEs the new authorisation process is in progress and 
expected to be completed by 31st Dec 2014.   
By 31st December 2014 (established by State-Regions Agreement of 
16 December 2010 and Law of 26 February 2010, n.10). 
a) Lack of homogeneous performance among Regions; b) the 
fulfilment of some GMP requirements results significantly 
demanding; c) excessive number of BEs. 
No 

Regional health authorities are responsible for the authorisation and 
accreditation of laboratories performing donor testing. 

174 (75 of which perform NAT testing beyond serology testing) 

Regional health authorities. 

313. NOTE: All BEs function also as hospital blood banks, being 
BEs hospital-based by law. 
Yes 

Extra rules are in place setting requirements concerning the activities 
of the vein-to-vein process not covered by the provisions indicate at 
4.9, including the clinical activities performed by BEs.    
Yes 

1) Kedrion Biopharma SpA:  - locations: a) Italy, Bolognana 
(Lucca); b) Italy, Sant'Antimo (Naples) - products: human albumin, 
IVIg, FVIII, FIX, Prothrombin complex, Antithrombin, Iper-
immune Igs (including anti-Rho(D) and anti-HBV), Plasminogen 
concentrate, S/D plasma, FV forthcoming. - capacity: 1,100,000 Kgs 
- owners: national company - import/export: a) import plasma and 
intermediates from US and European countries; b) export plasma-
derived medicinal products to 60 countries worldwide. 2) Baxter - 
locations: a) Italy, Rieti (plant performing only plasma fractionation 
and production of intermediate fractions); b) Italy, Pisa (plant 
performing only human albumin filling) - products: in Italy Baxter 
produces only intermediate fractions which are sent for further 
manufacturing to plants located in other European countries (e.g. 
Austria) - capacity: 700,000 Kgs - owners: international company - 
import/export: a) import plasma and intermediates from US and 
European countries; b) export only intermediate fractions.  
National Medicines Agency (Agenzia Italiana del Farmaco - AIFA) 

Yes 

Regional health authorities. 

197 

 
 
 
of inspections. 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 
5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 
5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 
5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 
5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 
5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 
5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 
5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 
5.5.1.1. If yes, please explain. 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 
5.5.3. How many BE have been inspected at least twice in the last 3 
years? 
5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 
5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 
5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 
5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 
5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 
5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 
5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 
5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 
5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 
5.9. Is a system in place for inspecting hospital blood banks? 

Regional health authorities inspectors: n.a. Nationally qualified 
inspectors: 113 (part-time); at least one nationally qualified inspector 
must be included in each regional inspection team. 
Yes 

Tissues and cells 
Hospitals 
Inspections performed according to the new 
authorisation/accreditation system: 18 at BEs, 30 at Collection sites.  
None. 

Routine inspections performed according to the new 
authorisation/accreditation system: none. 

3 

None. 

Yes 

Not envisaged at the moment but it will be defined within 2014 in 
order to make the overall inspection system less demanding while 
ensuring the requested levels of quality and safety.  
Yes 

None. 

Every two years, but a risk based approach will be introduced (See 
5.5.1.1) 
positive 

positive 

positive 

No BE authorisation was suspended. 

No BE was closed following inspections. 

None. 

No establishments performing only plasma collection exist in Italy. 

Yes 

Yes 

5.9.1. If yes, please describe. 

HBBs coincide with BEs (see 4.8)  

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 
5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 
5.10.1. If yes, what is your experience with this Guide? 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

No 

Yes 

The Guide is used as a complementary reference. Experience is quite 
positive. 
Yes 

198 

 
 
 
5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 
5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 
6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

Yes 

4 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 
6.1.2. Which is the CA for ensuring traceability in your Member 
State? 
6.1.3. Do you have a single national coding system for blood 
components? 
6.1.3.1. If yes, for which blood components? 

Yes 

Ministry of Health and National Blood Centre: setting regulation. 
Regional health authorities: application of rules.  
Yes 

ALL 

No 

6.1.4. Do you apply an international coding system for blood 
components? 
6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 
6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 
6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 
6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 
6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

Both paper records and electronic forms 

Yes 

Yes 

National mandatory requirements, verified during inspections. 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 
6.2.1.1. If yes, please give a short description of the system. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 
6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 
6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 
6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 
6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 
6.2.6.1. If yes, please provide a brief description. 

Yes 

The national HV system is thoroughly web-based and managed by 
the National Blood Centre. The BEs collect data on SAR/E in 
hospitals and report to the Regional Blood Centres which, in turn, 
report to the National Blood Centre. The National Blood Centre 
elaborates data and publishes results. First national report (2008-
2011) just issued. 
Yes 

Yes 

Yes 

70-99% 

Yes 

BEs and HBBs coincide (see 4.8) 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

Cases with high severity (grade 3-4). 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 
6.2.8.1. If yes, please specify. 

Yes 

Diffusion of data.  

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 
6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 
6.2.11.1. If yes, please give a short description of the 
system/procedure. 
6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 
6.2.12.1. If yes, please give a short description of the 
system/procedure. 
6.2.13. Do you notify alerts communicated via the blood national 

Recalls related to safety and quality of blood/blood components are 
mandatory but reporting to CA is not mandatory. 

Yes 

Rapid alert is part of the web-based HV system, performed by 
automated launch of emails to involved parties.  
Yes 

The National Blood Centre notifies the Regional Blood Centres 
which, in turn, notify the respective BEs. 
Yes 

199 

 
 
 
vigilance system also to other national vigilance/alert systems? 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 
6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 
6.2.14.1. If yes, please specify. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 
7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 
7.3.1. If others, please specify. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 
7.4.1. If yes, please specify. 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 
7.5.1. If yes, please provide this data per component and by country 
of origin. 
7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 
7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 
7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 
7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 
7.12. Is there a regular surplus of blood or blood components in your 
MS? 
7.12.1. If yes, for which blood components (more than 1 answer 
possible)? 

Tissues and cells 
Medical devices 
Yes 

Tissues and cells 

None 

Import of blood and blood components from other EU MS or third 
countries is a very rare event (very few cases concerning red blood 
cells bearing rare phenotypes). Import must be authorised by the 
Ministry of Health according to a specific procedure defined in the 
blood legislation. Imported blood and blood components must 
comply with national quality and safety requirements.  
Import of plasma for fractionation is regulated according to EU 
provisions on medicinal products. The National Medicines Agency 
(Agenzia Italiana del Farmaco - AIFA) is the CA entrusted with 
authorisation to import and the relevant control measures. 
Others 

Concerning blood components for transfusion their import is a very 
rare event, basically related to the exceptional need for blood 
components bearing rare/specific phenotypes; they must be certified 
as compliant with the Italian quality and safety requirements which 
are preliminarily notified to the issuing organization(s); derogations 
are allowed upon specific risk assessment in case of vital need of the 
involved patient(s). Concerning plasma for fractionation see 7.2. 
Yes 

See 7.3.1. 

Yes 

ZERO.  

No 

Concerning plasma for fractionation, national plasma can be 
exported only to EU MS and only for contract fractionation purposes 
(being its commercialisation strictly prohibited). The National 
Medicines Agency (Agenzia Italiana del Farmaco - AIFA) is the CA 
entrusted with authorisation to export and the relevant control 
measures. 
Export of blood components for transfusion must be authorised by 
the Ministry of Health according to a specific procedure defined in 
the blood legislation. Exported blood components must comply with 
national quality and safety requirements.  
Yes 

ZERO, so far.  

Yes 

126 red blood cell units exported to Congo, Paediatric Hospital of 
Kimbondo, for humanitarian aid. 70 red blood cell units exported to 
the Republic of San Marino according to bilateral agreement.   
No 

Yes 

Red Blood Cells 

200 

 
 
 
7.12.2. If yes to Q. 7.12., what do you do with the surplus of blood 
or blood components? 

7.12.3. If yes to Q. 7.12., would you be interested in concluding 
bilateral agreements with other MS in order to address the surplus? 
7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 
8. Sanctions and general comments 

The surplus is seasonal (mainly April-June / October-December); 
basically, it causes prolonged RBC turn-over, less frequently higher 
RBC discard.   
Yes. Also planned surplus RBC production could be organized. 

No 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 
8.1.1. If yes, have penalties already been imposed? 

Yes 

No 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 
8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 
8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 
8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 
8.2.1. If yes, please specify. 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 
8.4.1. If yes, please provide us with detailed information. 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 

No penalties imposed so far. 

No penalties imposed so far. 

No penalties imposed so far. 

Yes 

a) Annex IV. Basic testing requirements for blood and plasma 
donations: introduction of mandatory HCV NAT testing in 2002 and 
mandatory HBV and HIV NAT testing in 2008. b) Article 9 (2): 
Responsible person: must be a licensed physician, specialist in 
transfusion medicine or equivalent discipline, with at least 5 years of 
post-graduate full-time service in a BE.   
The main difficulty was represented by the fact that the organisation 
of BEs assumed by the Directives is significantly different from the 
Italian organisation (see 4.8). Issues for a potential revision of 
Directive 2002/98/EC: a) Article 3(e): BEs’ responsibility for 
processing, storage and distribution of blood and blood components 
when they are NOT intended for transfusion should be clarified, 
considering that most BEs produce and release – by the same 
processing, storage and distribution - plasma which can be intended 
both for transfusion and for fractionation; b) Articles 5(1) and 9(1): 
same comment as for article 3(e); in particular: concerning article 
9(1), who should be responsible for processing, storage and 
distribution of blood and blood components when they are NOT 
intended for transfusion, as in the case of plasma for fractionation?   
c) Article 8(1): a reflection on the hypothesis/opportunity of defining 
basic common requirements for blood Competent Authorities’ 
functions should be done, particularly as concerns requirements for 
inspectors, third-party independence of inspections, common 
definitions of and common schemes for BEs licensing, authorization, 
accreditation procedures; d) Whereas (29) and Article 21:  given the 
important scientific and technical advances in blood testing, 
particularly as concerns HCV, HIV and HBV NAT, and the 
evidence on window period shortening associated to these tests, a 
reflection on the introduction of NAT testing for HCV, HIV and 
HBV (excluding autologous donations) should be done, supported 
by specific epidemiological assessments.  
Yes 

As already reported at the Blood CAs meetings, in Italy the 
following measures for the prevention of WNV transmission by 
blood mainly consist of: a) introduction of NAT testing for all 
donors resident in the areas recognised as affected by the national 
WNV surveillance plan issued by the Ministry of Health, during 
seasonal periods in which vector mosquitoes are active (July-
November); b) 28 day deferral of donors having been for at least one 
night in the affected areas during the above seasonal periods; 
alternatively, these donors can be admitted to donate provided their 
donations are tested by WNV NAT. Inter-institutional and 
multidisciplinary cooperation as well as adoption of the EC WNV 
preparedness plan are of paramount importance at national and 
international level to make preventive plans successful. 
Other vector-borne diseases from Arboviruses transmissible by 
blood require adequate epidemiological surveillance. 
Yes 

201 

 
 
 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 
8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 
8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

None 

NA 

202 

 
 
 
 
 
 
A.1.16. 

Survey response Latvia 

1. Public information 

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

State Agency of Medicines of the Republic of Latvia 

1.1.2. Address of&nbsp;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) 

15 Jersikas Street, Riga, LV-1003  

+371 67078424  

www.zva.gov.lv 

www.zva.gov.lv 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

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 

10 

1 

3 

36113 

24108 

12005 

No 

55590 

450 ml 

During  the  year 2012 there was no plasma collected by apheresis 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

800 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

3461 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

180 ml 

203 

 
 
 
2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

0 

1 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

During  the  year 2012 there was no plasma collected by apheresis 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Donor evaluation/selection form  accessible in  Blood  
establishments. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

Visits at the Blood establishments and Blood center. Analysis of the 
mandatory documentation   

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

We  accept all the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC .  

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

Identification of  persons whose sexual behaviour puts them at high 
risk of  acquiring severe infectious diseases that can be transmitted 
by  blood 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

No 

No 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

persons whose sexual behaviour puts them at high risk of  acquiring 
severe infectious diseases that can be transmitted by  blood 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Yes 

No 

Low Haemoglobin levels in donor's blood 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

It is maintained  by  the National Blood Servise- PROSANG 
network. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

Data not available 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

Yes 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

All donor samples  are tested in the laboratory of  the National  Blod 
Service. 

3.1.2. Do you use NAT technology for routine testing blood or blood  Yes 

204 

 
 
 
components in your Member State? 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

All donations with the negative screening results  are tested by NAT 
technology. 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

No 

No 

Yes 

12 

52 

205 

No  

No   

No 

Yes 

Yes 

Blood establishments  can delegate  some of the responsible person's 
tasks  to other persons qualified by training and experience to 
perform  these tasks. 

• Visits of the blood establishments,  Blood center and hospital 
blood banks • Audits of the  documentation  - diploma, certificate or 
other evidence of formal qualifications in the field of medical or 
biological sciences  and evidence of  practical post-graduate 
experience in relevant areas for at least two years, in one or more 
establishments which are authorised to undertake activities related to 
collection and/or testing of human blood and blood components, or 
to their preparation, storage, and distribution Regular training of the  
staff (certificate or other evidence).  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Each BE and  hospital blood  bank  establishes and maintains a  
quality system based on the principles of good practice. 

• Visits of the BEs and hospital blood banks. • Audits of 
documentation on operational procedures, guidelines, training and 
reference manuals, and reporting forms.   

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

PROSANG  network Records 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

• Visits of Blood establishments  and hospital blood banks • Audits 
of documentation – SOP and records 

205 

 
 
 
3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

• Visits of Blood establishments  and hospital blood banks • Audits 
of documentation •               Each operator processing personal data 
must register with the Data State Inspectorate. 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

ISBT 128 

Yes 

These recommendations   provids  eksperts  with  a set of standarts  
and principles  relating  to the preparation, use and quality assurance  
of blood components 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Designation 
Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

10      www.zva.gov.lv 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Latvian National Accreditation Bureau  

4.6. How many laboratories performing donor testing are active 
within your country? 

1 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

State Agency of Medicines  of Latvia 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

54 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

State Agency of Medicines. Pharmaceutical activities compliance 
evaluation department is responsible for inspections 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

2 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Tissues and cells 
Organs 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 

4 

0 

3 

206 

 
 
 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

0 

0 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

Type  of Inspections is selected depending on the particular situation 
and information available to CA.    Type  of Inspections is selected 
depending on the particular situation and information available to 
CA.     

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

4 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

Once in 2 year period  

0 

4 

0 

0 

0 

No any other outcome 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

0 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

SOP in place for inspecting hospital blood banks.  

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

SOP in place for inspecting hospital blood banks. They are inspected  
once in 2-3 year. 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

These recommendations  provids  experts  with  a set of standarts  
and principles  relating  to the preparation, use and quality assurance  
of blood components. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

Yes 

4 

5.12. Has there been any international collaboration on inspections 

Yes 

207 

 
 
 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

Traceability  is ensured by the National Blood Service.  

No 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 128 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

• Inspections of the blood establishments and center. • Inspection  of 
the documentation  and computerized system  

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Senior expert of Pharmaceutical Activities Compliance Evaluation 
Department is responsible of data collection, documentation, 
analysis, corrective and preventive actions. Also for issue of Rapid 
Alert System (if necessary) at a national level or communication to 
EU CIRCA platform. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Yes 

Yes 

Yes 

100% 

Yes 

All  hospital blood banks using  application  forms have to report 
any SAR/SAE - relevant information to CA and Blood 
establishment/ Blood center engaged in the donation, preparing, 
testing, processing, storage and distribution  of  blood components in 
order to facilitate traceability and ensure quality and safety.  

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

Evaluate suspected serious adverse reactions according to the  
imputability levels ( likely, probable, certain)  and specify clinical 
outcome. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

No 

6.2.8.2. If no, why not. 

No SAR/SAE was reported  

6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 

Yes 

No cases  

208 

 
 
 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

All  blood establishments using  application  forms have to report 
any SAR/SAE  cases  to CA 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

CA using SOP to notify BEs when a rapid alert is issued via the 
Rapid Alert System for blood at European level   

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

No 

Yes 

6.2.14.1. If yes, please specify. 

 CA receive alerts via other national vigilance/alert systems, such as 
for tissues and cells, organs  and medical devices 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

National  regulations require that blood components are not 
imported  

National  regulations require that blood components are not 
imported  

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

National  regulations require that blood components are not 
imported  

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

No 

No 

No 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

Manufacturing license for the manufacture of medicinal products is 
required. export  to another MS  for fractionation is regarded as 
Outsourced activities  and are evaluated during  GMP   inspections. 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

We  do not export  blood and blood components for transfusion to 
EU Member States or third countries. 

No 

No 

No 

No 

No 

209 

 
 
 
8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

No 

No 

None 

No 

None 

Yes 

None 

None 

210 

 
 
 
 
 
 
A.1.17. 

Survey response Liechtenstein 

1. Public information 

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

Amt für Gesundheit 

1.1.2. Address of&nbsp;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) 

1.1.6.1. If other, please specify. 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.2. National Competent Authority 2? 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

Aeulestrasse 51 9490 Vaduz  Liechtenstein 

00423 236 73 25 

pharminfo@llv.li 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 
Other 

reimbursement of pharmaceuticals and medical devices, public 
medical office, health prevention and promotion 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

No 

n/a 

Not applicable 

n/a 

1 

0 

0 

5 

no 

no 

No 

5 

450ml +/- 50ml 

na 

na 

na 

na 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

none 

211 

 
 
 
  
2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

1 

none 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

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

2.1.17.1. If other, please specify. 

verification during regular inspections 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

The BE has to have relevant procedures in place, describing the 
handling of abnormal findings. Procedures and records are verified 
during the regular inspections. 

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Every criterium is an important part of the whole. There is not a 
criterium more important than another. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

3.1. Testing 

Persons whose behaviour /activity places them at risk of acquiring 
infectious diseases that may be trasnmitted by blood 

No 

Yes 

- previous, current sexual partners with HIV - new sexual partners 
different sexual partners within the last 12 months MSM sex-
workers sexual partners who is sex worker or had MSM 

Yes 

No 

na, only autologous pre-deposit donations 

No 

No 

Yes 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

by inspections 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

is not compulsory for autologous donations 

No 

No 

212 

 
 
 
3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

No 

Yes 

Yes 

persons must be trained and qualified for this support of validated IT 
systems handling of deviations must clearly be defined 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

training must be recorded training records are subject of regular 
inspections 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

it is required SMF or Quality Manual written guidelines and SOPs 
qualification/calibration-ystem for equipment (incl. maintenance) 
documentation system (procedures and records) training and 
qualification of personnel system to handle deviations, recalls, 
changes, look-backs, post-donation information, hemovigilance  

maintenance, storing and archiving of documents and records must 
be defined in SOPs verification during inspection 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

paper-based storage 

Yes 

temperature monitoring of storage equipment temperature alert 
system regular checks of temperature sensors qualification of storage 
equipment transport in insulated boxes (only short time transports 
within Li) 

na (autologous pre-deposit donations only) 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

No 

3.2.9.2. If no, why not? 

na:  homologous blood and blood components are imported from 
Austria which use their own code 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

the separation of principles from standards is confusing and of no 
value (inspectors' opinion) 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 
Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 

213 

 
 
 
  
4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

1, since 2013 revoked 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Amt für Gesundheit (authorisation for lab) and Swissmedic (donor 
testing) 

4.6. How many laboratories performing donor testing are active 
within your country? 

1 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Amt für Gesundheit 

4.8. How many hospital blood banks are active within your country? 

1 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Arzneimittelkontrolle des Amtes für Gesundheit in charge of 
coordination, inspections delegated to Swissmedic by agreement 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

6 Swiss inspectors available 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

No 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

2012:0 

2012:0 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

0 

0 

0 

No 

No 

5.5.2.1. If no, why not? 

We get the inspectors of Swissmedic according to schedule 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

2 

na 

na (no inspections in 2012) 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 

na 

na  

214 

 
 
 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

na 

na 

na, no blood inspection carried out in 2012 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

0 

No 

5.8.1. If no, please explain. 

The NCA mandate includes many different activities (p.e. 
reimbursement, health promotion etc). For the issues of blood etc. 
only 2 persons are qualified. 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

according to directive 2002/98/EG 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

We coordinate the inspections and perform enforcement measures if 
necessary. The inspection is carried out by Swissmedic inspectors 
(agreement) 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

since the structuring between principles and standards it is not so 
simple anymore; bad experience 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

No 

6.1.1.1. If no, why not? 

we have only autologous pre-deposit donations in Liechtenstein 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

na 

No 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Only paper records 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

by inspections 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

215 

 
 
 
6.2.1.1. If yes, please give a short description of the system. 

SARE reported for Austrian blood/components are reported to the 
Austrian manufacturer ... (and only for information to the AG) 
SARE of the autologous donations, and SARE at the hospital are to 
be reported also to the Amt für Gesundheit and Swissmedic 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Yes 

Yes 

Yes 

100% 

Yes 

The (only 1) Li-hospital gets the blood/components from the 
Austrian hospital LKH Feldkirch by agreement. This agreement 
requires the reporting. During inspections reporting is checked. 

6.2.7. Do you perform root cause analyses of the SARE? 

No 

6.2.7.2. If no, why not? 

was not necessary till now 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

No 

6.2.8.2. If no, why not. 

Should we? 

6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Yes 

0 

Yes 

by fax and phone 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

only if necessary, by fax and phone 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

No 

No 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

we have only one national vigilance/alert system contact point 
located in the Amt für Gesundheit 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.3.1. If others, please specify. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

only import form the Austrian hospital LKH Feldkirch, Austria, is 
accepted, the import has to be authorised 

na 

Others 

na 

Yes 

216 

 
 
 
7.4.1. If yes, please specify. 

if necessary 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

No 

No 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

The Austrian Red Cross, section Vorarlberg, is allowed to collect 
blood in Liechtenstein. An authorisation of Liechtenstein is needed. 

na 

No 

No 

No 

No 

No 

Yes 

No 

na 

na 

na 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

Being in the Customs Union with Switzerland we already had good 
legal requirements for blood in place. We had to take over the EU 
regulations which means now that we have to do  good explaining 
(in the inspections...) 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

No 

8.5. Which other communicable diseases are of relevance to you? 

Dengue Fever, Chagas, Malaria 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

partly in the Li-Ärztegesetz (consent)  

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

- 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

we have no experience with industrial processes in Li when applied 
on blood components 

217 

 
 
 
 
218 

 
 
 
 
 
A.1.18. 

Survey response Lithuania 

1. Public information 

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

Ministry of Health 

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.4. E-mail (central access point): 

1.1.5. Website: 

Vilniaus str. 33, LT-01506 Vilnius, Lithuania 

(+370) 5 266 1400 

ministerija@sam.lt 

www.sam.lt 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Blood and blood components 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Inspection 
Haemovigilance 
Other 

1.1.7.1. If other, please specify. 

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: 

Coordination of blood donation/transfusion activities 

Yes 

State Health Care Accreditation Agency under the Ministry of 
Health 

Zalgirio str. 92, LT-09303 Vilnius, Lithuania 

(+370) 5 261 51 77 

vaspvt@vaspvt.gov.lt  

www.vaspvt.gov.lt/en 

1.2.6.&nbsp;What are the role/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 

1.3. National Competent Authority 3? 

No 

1.4. 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 is responsible for coordination and control of 
blood donation / blood transfusion activities. State Health Care 
Accreditation Agency under the Ministry of Health is responsible 
for:   Licensing of the health care organizations (blood 
establishments including)  Market surveillance of  medical devices   
Supervision and control of quality of health services (blood 
establishments’ services including) Special department / unit in 
charge of inspections and control measures of BEs has not been 
established yet. Staff working on implementation of blood 
directives,  haemovigilance is responsible for other domains as well.  

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

Not applicable 

not applicable 

4 

2 

0 

56332 

32962 

22922 

No 

79367 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

450 ml ± 50 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

11 

219 

 
 
 
2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

650 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

1049 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

> 40 ml per 60x109  of platelets 

Multicomponent  2221 

6 

1 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

Donor questionnaire is approved by the Ministry of Health 

By organization of BEs inspections, desk-based analysis of the 
mandatory documents. 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

According to the order of the Ministry of Health, self-exclusion by a 
donor procedures are defined in the documents of the BEs 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Hemoglobin levels in donor’s blood Infectious diseases (hepatitis B, 
hepatitis C, HIV)  

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

Item 2.2.2 First section - tattoo and acupuncture performance time 
and sterility Second section  

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

In item 2.2.2 behaviour at risk of acquiring infectious diseases that 
may be transmitted by blood should be listed 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

No 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

According to international recommendations (CoE, WHO, etc.) 

No 

No 

The main causes of temporary deferral: Low haemoglobin or 
platelets level  High blood pressure Tattoo Usage of medications 
The main causes of permanent deferral: Hepatitis B and C positive 
test results Syphilis positive test results Serious diseases 
(cardiovascular, CNS, gastrointestinal, immunological, metabolic )  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

The data on deferrals are collected in the Blood Donors’ Registry. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

561 from June 1 to December 31, 2012 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to  No 

220 

 
 
 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

By organization of BEs inspections, desk-based analysis of the 
mandatory documents. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

HIV NAT, HBV NAT and HCV NAT are mandatory for every 
blood and blood components donation 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Yes 

Yes, HIV NAT, HBV NAT and HCV NAT. 

Yes, HIV NAT, HBV NAT and HCV NAT. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

Yes 

3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

Additions to basic testing requirements:  HIV NAT, HBV NAT and 
HCV NAT testing  

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

Yes 

29 

167 

482 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

None 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 

Mirasol technology is used for approx. 3 % of platelets. 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

No 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

By organization of BEs inspections, desk-based analysis of the 
mandatory documents. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 

A quality system for BEs based on the principles of good practice is 
mandatory by law. 

By organization of BEs inspections, desk-based analysis of the 
mandatory documents 

221 

 
 
 
  
Article 6)? 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

Mandatory by law. 

Yes 

Storage, transport  and distribution requirements of blood and blood 
components are defined in the order of the MoH. 

By organization of BEs inspections, desk-based analysis of the 
mandatory documents 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Not mandatory 

Yes 

This Guide is partly transposed into the order on requirements to the 
preparation and quality assurance of blood components. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4 BEs have been authorized / licensed: 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

State Health Care Accreditation Agency under the Ministry of 
Health 

4.6. How many laboratories performing donor testing are active 
within your country? 

5 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

State Health Care Accreditation Agency under the Ministry of 
Health is responsible for licensing of hospitals. 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

47 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Ministry of Health is responsible for coordination and control of 
blood donation / blood transfusion activities.  State Health Care 
Accreditation Agency under the Ministry of Health is responsible 
for:   Licensing of the health care organizations (blood 
establishments including)  Market surveillance of  medical devices   
Supervision and control of quality of health services (blood 
establishments’ services including) Special department / unit in 
charge of inspections and control measures of BEs has not been 

222 

 
 
 
5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

established.  

It is difficult to define staffing responsible for inspecting BEs 
because the same employees are responsible for supervision and 
control of various health care services (BEs services including). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Medical devices 
Hospitals 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

12 

16 

0 

5 

3 inspections due to a whistle-blower 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

The planning of inspections is based on following: Number and 
severity of non-compliances observed during the previous 
inspections; SARs and SAEs notified since the previous inspection 
Recalls of blood components notified since the previous inspection 
Complaints of consumers of blood components received by CA 
since the previous inspection  

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

4 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

BE’s affiliates are inspected at least every two years 

Licenses issued 

- 

- 

- 

- 

- 

0 

Yes 

223 

 
 
 
5.9. Is a system in place for inspecting hospital blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

5.10.1. If yes, what is your experience with this Guide? 

No 

Yes 

This Guide is partly transposed into the order of the MoH on 
requirements to the preparation and quality assurance of blood 
components. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

5 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

Ministry of Health 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

By organization of BEs inspections, desk-based analysis of the 
mandatory documents. 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

According to the order of the Ministry of Health, blood 
establishments, hospital blood banks or hospitals where transfusion 
takes place shall notify to the Ministry of Health all relevant 
information about serious adverse reactions and/or serious adverse 
events. Reporting establishments evaluate SAR/SAEs to identify 
preventable causes within the process. Blood establishments have in 
place a procedure to withdraw from distribution blood or blood 
components associated with notification mentioned above.  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

Yes 

Yes 

Yes 

100% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 

Yes 

224 

 
 
 
 
 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

According to the order of the Ministry of Health, hospital blood 
banks shall report about SAR/SAEs to the  blood establishments 
which distributed the blood and blood components as well as to the 
MoH. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

Root cause analysis is performed for SARE imputability level 2 or 3. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Written information about SAR/SAEs recorded at EU level is 
forwarded to the BEs 

6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

0 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

In case of a national rapid alert BEs are notified via emails and 
phone calls 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

In case of rapid alert at European level BEs are notified via emails 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Medical devices 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

no 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

According to the order of the Ministry of Health, imported blood 
components intended for transfusion shall meet equivalent standards 
of quality and safety as laid down in the blood directives transposed 
into Lithuanian law 

Blood components for fractionation have never been imported to 
Lithuania 

International standards 

No 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

Blood components for transfusion have not been imported to 
Lithuania from third countries in 2012. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

Yes 

Blood components for fractionation have not been imported to 
Lithuania from third countries in 2012 

7.7. Which rules exist for the authorisation and control of the export 

According to the order of the Ministry of Health, blood components 

225 

 
 
 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

for fractionation intended for export to the European Economic Area 
member states shall meet equivalent standards of quality and safety 
as laid down in the blood directives transposed into Lithuanian law 
and requirements which are given in the general monograph Human 
plasma for fractionation (0853) of the European Pharmacopoeia (Ph. 
Eur.). 

According to the order of the Ministry of Health, blood components 
for transfusion intended for export to EU Member States or third 
countries shall meet equivalent standards of quality and safety as 
laid down in the blood directives transposed into Lithuanian law. 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

Blood components have not been exported for fractionation from 
Lithuania to third countries in 2012 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

Blood components have not been exported for transfusion from 
Lithuania to third countries in 2012. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.12.1. If yes, for which blood components (more than 1 answer 
possible)? 

7.12.2. If yes to Q. 7.12., what do you do with the surplus of blood 
or blood components? 

7.12.3. If yes to Q. 7.12., would you be interested in concluding 
bilateral agreements with other MS in order to address the surplus? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

No 

Yes 

Plasma 

Search for realization of surplus plasma 

Yes 

No 

Yes 

Yes 

Due to non - compliance with testing documentation requirements 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

None 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

Revoke of licence 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

Issues to be addressed: deletion in Annex III Labeling requirements 
,,composition of anticoagulant and/or additive solution“ 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Temporary deferral 28 days after leaving an area with ongoing 
transmission of WNW to humans 

8.5. Which other communicable diseases are of relevance to you? 

HBV, HCV, HIV, tuberculosis 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 

Bed-side techniques of collection and processing of blood and blood 

226 

 
 
 
competent national authority? 

components are not applicable in Lithuania 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

No 

No 

227 

 
 
 
 
 
 
A.1.19. 

Survey response Luxembourg 

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

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.5. Website: 

Health Directorate - Inspection Sanitaire 

5a, rue de Prague L-2348 Luxembourg 

+352 247-85650 

http://www.ms.etat.lu 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Blood and blood components 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

The Inspection Sanitaire is a department of the Health Directorate of 
the Ministry of Health. 1 senior inspector and 1 trainee inspector are 
part of the NCA. The Inspection Sanitaire is depending of the 
Government. The budget is undefined and is depending on the 
incoming costs. 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 
2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

Not applicable 

n/a 

1 

0 

0 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

13704 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

9364 

1106 

Yes 

Ca.20-30% of the donors are coming from other countries. Most of 
them from France, some others from Belgium and Germany. 
Unfortunately numbers are unavailable. Donors from Luxembourg 
who are donating in other countries is quite rare. 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

20631 

500 

3132 

200 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

679 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

254-380 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

0 

1 

1 

228 

 
 
 
2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

5 documents upoloaded, all exists in german, french and english 
language 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

With a personal interview for the medical problems and with letters 
for all biological problems 

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 
2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

infectious diseases including temporary exclusion for any infection 

sexual behaviour of the donors as they provide the information 
which can not be verified. 

No 

No 

Sex with an HIV positive person. Sex with a person who injects or 
has injected drugs People are asked if they practise prostitution. Sex 
with a person who practise prostitution Sex with a person who 
regularly receives blood transfusion Sex with a person who 
originates from Africa For men: Sex with another man before 1977 
Fro women: Sex with a man who had sex with another man before 
1977 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

No 

Yes 

2.2.7.1. If yes, please explain and suggest your alternative. 

Raising the maximum age up to 70 years (in Luxembourg since 
August 2012) 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

No response after convocation (581 persons in 2012) personnel 
reason (295 persons in 2012) age criteria (64 persons in 2012)  
medical criteria: neoplasia (33 persons in 2012) heart problems (13 
persons in 2012) bad veins (10 persons in 2012) 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

IT data: MAGIC (system of the BE of Luxembourg) 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

3.1. Testing 
3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

1219 persons (567 men, 652 women) 

Yes 

Yes 

Control of the SOP's during the inspection 

229 

 
 
 
3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

for all donations: PCR HIV, HVA, HVB, HVC and Parvovirus B19 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

not mandatory under national legislation for whole blood donations, 
law only sais that additional tests can be required 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

not mandatory under national legislation for whole blood donations, 
law only sais that additional tests can be requires 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 
3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

No 

Yes 

0 

3 

0 

Syphilis: 1 

No 

Yes 

only for FFP, plasma SD is used 

Yes 

Yes 

Dr.Paul Courrier Médecin biologiste détenteur du DUTS 3 years of 
exercise EFS 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

internal and external training practical training in each department 
supervised by quality managment 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

internal managment supervised by a quality committee 

accessible on Intranet QUALIOS (R) and a copy is ranged in a 
secured manner by the documentalist of the BE 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

- electronical form - paper form - on CD, in MAGIC (system of BE 
of Luxembourg), on optical disc UDO 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

quality managment ensured by SOP's 

3.2.8. How do you ensure that all data, including genetic 

personnel logins and passwords for informatical access where all 

230 

 
 
 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

information is available anonymisation with barcodes from the 
beginning of the donation All people working in BE have a 
professional secret The data collection has been authorised by the 
national comittee of data protection (ref. T007125) 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

Yes 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

very good, it is used as a GMP 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 
4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Designation 
Authorisation 
Accreditation 
Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

Yes 

1 

No 

Health Directorate - Inspection Sanitaire 

4.6. How many laboratories performing donor testing are active 
within your country? 

1 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

legal agreement by minister of health 

4.8. How many hospital blood banks are active within your country? 

9 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 
5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

Health Directorate - Inspection Sanitaire 

2 

No 

0 

0 

0 

0 

5.4.3. Number of inspections by cause: Please specify other type of 

0 

231 

 
 
 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

For any problem, The NCA is informed and will plan, if necessary 
an onsite inspection 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

Not concerned on inspections of BE's working with medicaments on 
humans 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

0 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

No mobile and satellite collection site in Luxembourg 

No inspections in 2012 

No inspections in 2012 

No inspections in 2012 

No inspections in 2012 

No inspections in 2012 

No inspections in 2012 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

0 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

HBB will be inspected starting end of 2013 in the same way than the 
BE 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

As NCA we have to inspect either BE and HBB 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

inspections will only start end of 2013, but the Guide will be used 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 
Yes 
6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

6.1.2. Which is the CA for ensuring traceability in your Member 

Directorate of Health - Inspection Sanitaire 

232 

 
 
 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

for homologous, autologous and paediatric RBC concentrate, plasma 
apherisis concentrate, mix of platelets concentrate, homologous and 
autologous fresh frozen plasma 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

IT data 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 
6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Notification is given by the hospital to the BE and/or NCA, further 
investigation will be done by BE or/and NCA 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

Yes 

Yes 

100% 

Yes 

6.2.6.1. If yes, please provide a brief description. 

notification form is part of the legislation 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

infectious diseases death 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

transmission of all information 

6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Yes 

0 

Yes 

direct information from NCA to BE 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

direct information from NCA to BE 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Yes 

Other 

6.2.13.1.1. If other, please specify. 

All departments are part of the Health Directorate, so everybody 
who needs the information will get it. 

6.2.14. Do you also receive alerts via other national vigilance/alert 

Yes 

233 

 
 
 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

6.2.14.1. If yes, please specify. 

See 6.2.13.1.1 = idem 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No 

7. Import - export (Art 21 Directive 2002/98/EC) 
7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.3.1. If others, please specify. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

Convention of approvisioning is done between the BE of 
Luxembourg and the EFS Lorraine/Champagne in France 

Importation only done from EFS Lorraine/Champagne in France 
(less than 10 units per year), only from voluntary donors 

Others 

None 

No 

Yes 

0 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

0 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

Plasma Masterfile Octopharma on the way of realisation: Plasma 
Masterfile CAF-DCF Belgium 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

None 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 
8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

Yes 

0 

Yes 

0 

No 

No 

No 

No 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

None 

8.4. During the last years there have been outbreaks of West Nile 

Yes 

234 

 
 
 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

8.4.1. If yes, please provide us with detailed information. 

Temporary deferral for people who have been travelling to countries, 
where outbreaks have been. Control of vectors of West-Nile-Virus in 
Luxembourg (mosquitoes) 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

None 

Yes 

No 

None 

235 

 
 
 
 
 
 
A.1.20. 

Survey response Malta 

1. Public information 

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

Superintendence of Public Health 

1.1.2. Address of&nbsp;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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Superintendence of Public Health SLH - OPD - Level 1 St. Lukes 
Road G' Mangia 

+00356 25953302/25953328 

healthstandards.sph@gov.mt 

https://ehealth.gov.mt/HealthPortal/public_health/publichealthregula
tion/introduction.aspx; 
https://ehealth.gov.mt/HealthPortal/public_health/healthcare_serv_st
andards/blood_bloodcomponents.aspx 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.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 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. Inspections of the  blood establishment in Malta have till now 
been carried out by a foreign inspector as a lead inspector assisted by 
two GMP inspectors from the Malta Medicines Authority.   

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

Not applicable 

Not applicable 

1 (One)  

 2 (Two ) 

One  

11394 

2905 

771 

No 

16995 

475mls 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

Nil 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

Not applicable 

236 

 
 
 
2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

469 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

300mls 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

nil 

One 

One 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

Copy is found in the uploaded document below. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

The mandatory testing is done. Any positive results are traced so that 
the donor can be contacted and the results explained by a medical 
doctor and any necessary relevant referrals made and actions taken. 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

If the person self excludes himself, he is not registered into the 
system 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

It is not possible to answer this question since in specific 
circumstances all factors are important. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

The assessment of risky sexual behaviour. 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Changing the haemoglobin levels  

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

High risk sexual behavior including MSM, multiple sexual partners, 
new sexual contact within the last 6 monthss. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Yes 

No 

Low Hb, Weight < 50kg, Medical Reasons ( History, Blood 
Pressure). 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

Since in Malta there is only one blood establishment, this 
establishment would have all the national data. 

The deferral rate is that of 25.5%. 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

No 

237 

 
 
 
2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

The laboratories and tests are also assessed during the inspection of 
the blood establishment. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

NAT testing is expensive and the benefit to cost ratio is minimal. 

Yes 

Anti HBc testing is performed. 

Not applicable as there is no plasmapheresis in Malta. 

No 

Yes 

0 

0 

Two (2) 

Two (2) positive tests for syphilis 

Nil 

No 

Yes 

No 

The Licensing Authority checks the availability of formal 
qualifications and requests documentation of regular training and 
proficiency testing of the personnel. Qualification and training of the 
personnel is part of the quality system and it is inspected during the 
inspections. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

The qulaity system is based on GMP and GLP 

These are inspected at the inspection by asking for the 
documentation and for written SOPs 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

The information is kept for 15 years both in the form of paper 

238 

 
 
 
3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

records and of electronic records. Blood establishments have to have 
a documentation retention policy in place. 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Yes this system is inspected during the inspection for the purpose of 
licensing. There has to be a fully validated and auditable sytem of 
storage, transport and distribution in place. 

The donor is given a unique identifier number. All donations are 
anonymised. 

Yes 

No 

Yes 

The guide gives a lot of valuable information based on best practices 
and is continously updated. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

One licenced establishment 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

The same Licensing Authority that licences blood establishments 
(Superintendence of Public Health) 

4.6. How many laboratories performing donor testing are active 
within your country? 

One 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

The same Licensing Authority that licences blood establishments 
(Superintendence of Public Health) 

4.8. How many hospital blood banks are active within your country? 

Two public hospital blood banks 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

The Superintendent of Public Health 

Three 

Yes 

Pharmaceuticals (including plasma derivatives) 

239 

 
 
 
5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

One 

One 

Nil 

0 

0 

No 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

0 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

The aim is to have a general inspection every two years and follow-
up themed inspections in between to ensure that corrective and 
preventive actions were taken on any identified deficiencies. 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

5.9. Is a system in place for inspecting hospital blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

5.10.1. If yes, what is your experience with this Guide? 

0 

0 

0 

0 

0 

0 

Nil 

Yes 

No 

Yes 

It gives valuable information on good practice and provides a basis 
for inspection against these best practice guides. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

5 

Yes 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

240 

 
 
 
6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

The Superintendent of Public Health 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

For all blood components 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

By randomly asking for tracebility records of a randomly selected 
donor 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Serious adverse events and reactions collected by wards and 
hospitals are first reported to the hospital blood bank which 
investigates and decide whether the reactions/events are reportable 
to the blood establishment that distributed the blood and to the 
Competent Authority. The blood establishments too report any 
reportable events and reactions to the Competent Auithority. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Yes 

Yes 

Yes 

100% 

Yes 

End users (transfusion nurses, etc) report any SAE's and SAR's to 
the blood bank that issued the blood which in turn investigates the 
cause and reports to the blood establishment that distributed the 
blood and to the Competent Authority. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

Root cause analysis is carried out even in the case of near misses. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Annual National Haemovigilance reports for Malta are published 
online . Such reports contain a section about the Maltese reports on 
SARs and SAEs that are reportable at EU level according to the 
Directives and the Common Approach Document 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

There were no recalls. 

241 

 
 
 
6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

The Competent Authority has a Haemovigilance Unit that is also 
responsible for forwarding both National alerts to the Blood 
Establishment and other stakeholders and is also responsible for 
alerting such establishments on relevant alerts at an EU level 
received through the CIRCABC system. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

The rapid alert received through the CIRCABC is forwarded through 
the National Rapid Alert system to all stakeholders for which it is 
relevant including blood establishments, blood banks, clinical end 
users, epidemiologists, microbiologists, infectious disease control 
unit, Medicines Authority, Tissue and Cell establishments and organ 
transplant centres (if relevant) and to the Comptent Authority 
responsible for medical devices (MCCAA) (if relevant) 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 
Other 

6.2.13.1.1. If other, please specify. 

End users (hospitals/wards, etc). 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

The Competent Authority responsible for haemovigilance systems is 
also responsible for national vigilance/alert systems for Tissues and 
Cells and Organs. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

Nil 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

No person shall import into Malta any blood or blood components, 
including blood or blood components intended for use as a starting 
material or raw material in the manufacture of medicinal products, 
from a country or territory outside the European Community which 
does not meet standards of quality and safety equivalent to those laid 
down in Annex V of Directive 2004/33/EC and any amendments 
thereto.  

Not applicable- there is no blood fractionation in Malta. 

Equivalent standards (bilateral agreements) 

No 

No 

No 

Not applicable. Blood is not exported for fractionation. 

7.8. Which rules exist for the authorisation and control of the export 

Export can only occur through a blood establishment authorised to 

242 

 
 
 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

do so after ensuring equivalence of standards. 

No 

No 

No 

No 

No 

Yes 

No 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

Not applicable 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

Nil 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

Not applicable 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

8.5. Which other communicable diseases are of relevance to you? 

No 

Nil 

No 

Any communicable disease that can potentially be contracted by 
potential donors while travelling and subsequently inroducing any 
such diseases in Malta. 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

The National Competent Authority has to be informed about this 
procedure and it in turn will check that adequate safeguards are in 
place. 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Nil 

Nil 

243 

 
 
 
 
 
A.1.21. 

Survey response Netherlands 

1. Public information 

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

1.1.2. Address of&nbsp;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) 

Ministry of Health, Welfare and Sport (Ministerie van 
Volksgezondheid, Welzijn en Sport, VWS) 

P.O. Box 20350  2500 EJ Den Haag  The Netherlands 

+ 31 70 340 7911 

- 

www.minvws.nl 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 

1.2. National Competent Authority 2? 

Yes 

1.2.1. Name of National Competent Authority 2: 

Health Care Inspectorate (Inspectie voor Gezondheidszorg, IGZ) 

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

1.3. National Competent Authority 3? 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

P.O. Box 2680  3500 GR Utrecht  The Netherlands 

+ 31 (0)88-120 5000 

meldpunt@igz.nl 

www.igz.nl 

Inspection 
Haemovigilance 

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 
blood; staff for international/European inspection and vigilance: 2 
senior, 1 junior, 1 support, 1 legal.  

Not applicable 

N/a 

1 

- 

- 

379.846 

295.891 

37.468 

Yes 

Only very small numbers from and to neighbouring countries. 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

498.117 

244 

 
 
 
2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

500 ml. 

321.184 

650 ml. 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

4723 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

Depending on trombocytes-count.  

Not under Blood Directive. 

1 

1 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Files too large. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

Data is recorded in digital database. Reporting of abnormal findings 
to the donor is regulated in BE's standard operating procedures and 
documented in the donors' dossier. 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

Donor can inform BE after donation by telephone about 
circumstances that might disqualify him/her as donor. 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

all 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

Criteria concerning behaviour. 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

delete: in case HBV-NAT screening is performed, HBsAG screening 
can be cancelled; delete: WNV-NAT in stead of temporary deferral 
after vist to affected area; replacement: update criteria for Malaria, 
Q-fever; 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

-having sex for which donor received drugs or money;  -during last 
12 month having sex for which donor paid with drugs or money; -
during last 12 month having sex with IV-druguser;  -during last 12 
month having sex with person originating from region with high 
AIDS prevalence;  -during last 12 month having sex with HIV or 
HTLV I/II infected person; -during last 12 month having sex with 
person with venereal disease or hepatitis;  -during last 12 month 
having sex with person suffering from haemophilia -MSM: Man 

245 

 
 
 
2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.7.1. If yes, please explain and suggest your alternative. 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

who has had sex with other men -Female having had sex during last 
12 month with man who has had sex with other men. 

Yes 

Yes 

With more people ageing healthy, donor population could be 
increased when we replace age criteria with medical condition 
criteria. 

Donor deferral in 2012: Cardio Vascular Diseases 2158, malignity 
1467, blood transfused in the past 1634, difficulties during 
venapunction 877, Hb value 736, Anti-HBc/Anto-HBs 707. 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

One BE, so one database 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

12.160 

No 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Tests are performed by BE's laboratories, wich are accredited and 
inspected regularly 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

Highly automated NAT testing of all donations on HIV, HBC, HCV. 
Testing on pools of donations, in case of positive results the pool 
will be further tested untill the individual positive donation is found.  

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Yes 

Not mandatory. 

Not mandatory. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

Yes 

3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

Addition to last sentence: "Additional tests OR ALTERNATIVE 
COMBINATIONS OF TESTS may be required for ..." ; This will 
allow the listed tests to be omitted if another test or combination of 
tests  makes the listed test redundant. 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

Yes 

2 

19 

4 

Lues: 15 HTLV I/II: 2 

3.1.6. Do you have any additional comments on testing (e.g. 

No addition to remarks above. 

246 

 
 
 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 

Irradiation: plasma Washing: all products Solvent Detergent: plasma 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Supervision of the processing of blood and blood products is 
delegated to other qualified persons. 

Checked during on-site inspections. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Quality system in place. 

Checked during on-site inspections. 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Records are kept in hard copy and in digital database, and process is 
regulated in BE's Standard Operating Procedures. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

Process is regulated in BE's and hospitals' Standard Operating 
Procedures. 

Coding system. 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

No, but system is broadly implemented. 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

The BE in the Netherlands consider the Guide of the Council of 
Europe as a field guide. National guidance documents regarding 
quality and safety of blood and blood products are based on the 
CoE-Guide. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Designation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

1, by 31/12/1997 

4.4. Have authorisations been revoked or suspended by the 

No 

247 

 
 
 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

NCA1: Ministry of Health, Welfare and Sport 

4.6. How many laboratories performing donor testing are active 
within your country? 

1 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Hospital blood banks are NOT authorised. Hospital bloodbanks in 
The Netherlands are regulated by a general Law on Quality of 
Health Care Institution. 

4.8. How many hospital blood banks are active within your country? 

circa 100 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

Yes 

4.9.1. If yes, please specify the scope of these extra rules. 

Hospital bloodbanks in The Netherlands are regulated by a general 
Law on Quality of Health Care Institution. 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

Sanquin; 

4.10.2. If yes, please state the responsible authority within your 
country. 

5. Inspections (Art 8 Directive 2002/98/EC) 

NCA1: Ministry of Health, Welfare and Sport 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

NCA2: Health Care Inspectorate 

3 

Yes 

Tissues and cells 
Organs 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 
Medical devices 
Hospitals 

27 collection sites as part of BE and 2 BC in 2012 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

0 in 2012 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

5.5.2.1. If no, why not? 

27 collection sites as part of BE and 2 BC in 2012 

0 

0 

No 

No 

At the moment we manage the 2-year frequency, but we experience 
little result compared to the time and effort.The frequency could be 
extended to 3 or 4 years combined with a risk-based approach. 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

all (=1) 

248 

 
 
 
5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

5.9. Is a system in place for inspecting hospital blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

mobile randomly, fixed collection sites every 2-year.  

Outcome of inspections in 2012: 29 authorisations renewed 

See 5.6.1 

See 5.6.1 

0 

0 

N/a 

25 

Yes 

No 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

We use it as useful background information 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

NCA2: Health Care Inspectorate 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

All components. 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

This is regulated in BE's standard operating procedures and quality 
system. 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

Yes 

6.1.8. Do the same rules on traceability that apply to BE also apply 

Yes 

249 

 
 
 
to hospital blood banks? 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

A delegated institute (TRIP) collects and analyses all SAR/E. 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

No 

6.2.2.1. If no, what template do you use (please specify)? If possible, 
please upload template. 

http://www.tripnet.nl/pages/nl/documents/MELDINGVANEENBLO
EDTRANSFUSIEREACTIE.pdf 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

No 

6.2.4.1. If no, why not? 

Delegated to institution (TRIP). 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

100% 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Implemented in national regulation 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

In all SAR/E root cause analysis is performed. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Feedback to the BE is regulated in written standard operating 
procedures of NCA2 (IGZ). 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

In the Netherlands 394 recalls were issued in 2012, mostly because 
of withdrawn donations and positive BactAlerts. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Only one BE in the Netherlands, we contact them regularly.  

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

We contact the BE by email and telephone. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 

see 6.2.13.1. 

no 

No import in the Netherlands for transfusion, we are self-sufficient. 
Import is restricted to Dutch BE (Sanquin). 

No import for fractionation. 

250 

 
 
 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.4.1. If yes, please specify. 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

No import. 

Yes 

No import. But any imported product has to comply to national 
standards. 

Yes 

0 

Yes 

No plasma imported in The Nertherlands for fractionation from third 
countries. Plasma from Viropharma/US is processed in NL, but the 
whole batch is exported back to US. 

No specific rules; plasma is only collected for fractionation in The 
Netherlands. 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

Only authorised Blood Establishment is allowed to export for 
transfusion. Exception for export is made for Military Blood Bank 
that supplies the Dutch troops in third countries. 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

0 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

This regards export for UN-missions; no data available. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

No 

No 

No 

Yes 

No 

- 

- 

- 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

To be discussed 

8.4. During the last years there have been outbreaks of West Nile 

Yes 

251 

 
 
 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

8.4.1. If yes, please provide us with detailed information. 

Exclusion criteria for donors who have visited WNV affected areas  

8.5. Which other communicable diseases are of relevance to you? 

Q-fever; Hep E;  

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

National Law on quality of health care  institutions NCA2: Health 
Care Inspectorate 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

- blood samples used for educational purposes/research - "blood" 
tears - therapeutic blood cells 

inactivation steps, pooling for further processing.  

252 

 
 
 
 
 
 
A.1.22. 

Survey response Norway 

1. Public information 

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

Norwegian Directorate of Health 

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.5. Website: 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

1.1.6.1. If other, please specify. 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.1.7.1. If other, please specify. 

PO Box 7000 St Olavs plass, N-0130 Oslo, Norway 

+47 24 16 3000  

www.helsedir.no 

Blood and blood components 
Tissues and cells 
Human organs 
Medical devices 
Other 

The Norwegian Directorate of Health is an executive agency and 
competent authority subordinate to the Norwegian Ministry of 
Health and Care Services.The Directorate of Health shall improve 
the health of the entire nation through integrated and targeted 
activities across services, sectors and administrative levels. The 
Directorate shall do so by virtue of its role as a sub-ministerial 
agency, as a regulatory authority and as an implementing authority 
in areas of health policy. 

Designation, authorisation, accreditation, licensing of BEs 
Haemovigilance 
Other 

EU affairs and legal matters. Issuing national Guidelines to Blood 
Establishments. 

1.2. National Competent Authority 2? 

Yes 

1.2.1. Name of National Competent Authority 2: 

Norwegian Board of Health Supervision 

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

PO Box 8128 Dep. NO-0032 Oslo Norway 

(+47) 21 52 99 00 

postmottak@helsetilsynet.no 

www.helsetilsynet.no 

Inspection 

1.3. National Competent Authority 3? 

Yes 

1.3.1. Name of National Competent Authority 3: 

Norwegian Medicines Agency 

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: 

Postboks 63 Kalbakken NO-0901 Oslo Norway 

+47 2289 7700 

post@noma.no 

http://www.legemiddelverket.no/ 

1.3.6.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Inspection 

1.4. 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.). 

NCA 1: The Norwegian Directorate of Health is an executive agency 
and competent authority subordinate to the Norwegian Ministry of 
Health and Care Services. Responsible for the implementation of the 
provisions of the Blood Directives on delegation from the Ministry 
of Health and Care services: 1,25 senior offiicers. Vigilance: 3 
officers, each 20% position. NCA 2: Norwegian Board of Health 
Supervision performs inspections according to the Blood Directives 
and national guidelines. Senior inspectors;1,5. NCA 3: Norwegian 
Medicines Agency performs inspections according to the Blood 
Directives with special focus on blood components intended for 
medicinal products. Senior inspectors: 1,25 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

Not applicable 

Not applicable 

2.1.1. Please provide the number of BEs in your country recorded at 

74 

253 

 
 
 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

31 

3 

100052 

83463 

16589 

No 

198584 

450 ml 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

4693 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

600 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

5100 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

600 ml 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

4654 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

19 

19 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

Not avaliable in English 

Electronic donor and transfusion management systems 

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

All are relevant 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

None 

No 

Yes 

254 

 
 
 
2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

New partner in the last 6 months, MSM, prostitutes, sex with 
prostitutes.  

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Yes 

No 

Travel activities.  Donors' health; use of medicinal products. 

No 

No 

Yes 

Testing laboratories are included in the routine inspections 
performed by the NCA 2  and NCA 3 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Cost/benefit analysis 

Yes 

Ant- HBc when > 6 months since last donation 

Ant- HBc when > 6 months since last donation 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

Yes 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

0 

4 

2 

0 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

Solvent Detergent for all plasma units. Patogen Reduction of 11 % 
of platelet concentrates (Intercept and Mirasol) 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

255 

 
 
 
  
3.2.2.1. If yes, please specify. 

Delegation is documented 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

 Covered by inspections performed by NCA 2 and NCA 3 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

Principles of good practise is implemented i SOPs 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

 Covered by inspections performed by NCA 2 and NCA 3 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

All data stored in the Blood Donor registers 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

 Covered by inspections performed by NCA 2 and NCA 3 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

All data collected  are linked to a unique donation number which can 
not identify the donor by third parties 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

ISBT 128 mandatory 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

Very useful 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

4.6. How many laboratories performing donor testing are active 
within your country? 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

Yes 

74 

No 

NCA 1 

19 

NCA 1 

4.8. How many hospital blood banks are active within your country? 

3 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 

Yes 

256 

 
 
 
measures of BEs? 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

NCA 2, Dept of planned inspections NCA 3, Dept for inspections 
and narcotic drugs control 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

2,5 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

Pharmaceuticals (including plasma derivatives) 

36 

0 

36 

0 

0 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

The usual frequency is every second year, but if the risk factors 
identified are larger than expected, the sites frequency may be 
increased 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

BEs are inspected by two NCAs, 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

74 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

Every second year 

No cases 

Corrective actions carried out 

Corrective actions carried out 

No cases 

No cases 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

N/A   

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

All plasma establishments are blood esablishments. All blood 
establishments produce plasma, so the same number of inspections, 
i.e. 36 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

257 

 
 
 
5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

The Hospital Blood Banks are implemented in the inspection plan 
for BEs conducted by NCA 2 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

ref 5.9.1 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

very useful 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

3 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

NCA 1, The Norwegian Directorate of Health 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

All components 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 128 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

Buffy Coat 

Only electronic forms 

Implemented in the inspection program for NCA 1 and NCA 2 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

No 

6.1.7.1. Please explain why not. 

30 years data storage is OK as long as the time-frame is a minimum.  
National law in Norway requires that for some data there is no upper 
limit for data storage, meaning endless storage. 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

The system is established under the responsibilityof NCA 1, run by 
the Norwegian Knowledge Centre for the Health Services. It is a 
national system to which it is manadtory for all BEs to notify 
electronically  all SAR/E. The system is based on  previous 
voluntary Haemovigilance system in place from 2004.  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

No 

6.2.2.1. If no, what template do you use (please specify)? If possible, 
please upload template. 

The forms used are based om the previous voluntary system, 
amended according to the provisions of the Blood Directives. There 
are sevearl forms, one example attached 

258 

 
 
 
6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

No 

6.2.3.1. If no, please specify what guidelines you use? If possible, 
please upload the template. 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

National guidelines. File with guideline is too large 

Yes 

100% 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Is included in the The national "Blood Regulation"  

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

In complicated cases 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Annual report Annual seminar 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

507 recalls, 1139 components. No list avaliable  

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

We have a standard operating procedure for notifying rapid alerts, 
and an updated mailing list of contact persons in all BEs 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Same as 6.2.11.1. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

For all systems mentioned above the Competent Authorirty is the 
same as NCA 1 for blood. We have internal procedures for alerting 
the other systems 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

Requirements to traceability, notification of SAR/E, and 
requirements to standards and spesifications relating to quality 
systems are the same for blood/blood components from EU Member 
States and third countries 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

N/A.  

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Equivalent standards (bilateral agreements) 

No 

259 

 
 
 
  
7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

Yes 

0 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

0 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

Same requirements as for blood / blood components used for 
transfusion  in Norway 

Same requirements as for blood / blood components used for 
transfusion  in Norway 

Yes 

0 

Yes 

0 

No 

No 

No 

No 

No 

none in particular 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

8.5. Which other communicable diseases are of relevance to you? 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

28 days deferral for donors who have spent at least 24 hours in 
affected areas 

All communicable diseases with outbreaks in southern Europe where 
many Norwegians go on summer holidays 

Yes 

No 

has not been considered 

260 

 
 
 
 
 
 
A.1.23. 

Survey response Poland 

1. Public information 

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

Ministry of Health (MH) 

1.1.2. Address of&nbsp;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) 

00-952 Warsaw, Miodowa Street 15  

48 (22) 634-96-00 

kancelaria-mz@mz.gov.pl 

www. mz.gov.pl 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 
Other 

1.1.6.1. If other, please specify. 

• organization of public health in Poland  •  treatment procedures   

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 

1.2. National Competent Authority 2? 

Yes 

1.2.1. Name of National Competent Authority 2: 

Institute of Hematology and Transfusion Medicine (IHTM) 

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

02-776 Warsaw, Indiry Gandhi Street 14 

48 (22)  3496 100 

sekihit@ihit.waw.pl 

www.ihit.waw.pl 

Inspection 
Haemovigilance 
Other 

1.2.6.1. If other, please specify. 

.regular training for : physicians, diagnosticians, nurses from blood 
establishments (BE) and hospitals  

1.3. National Competent Authority 3? 

Yes 

1.3.1. Name of National Competent Authority 3: 

National Blood Center (NBC) 

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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

00-080 Warsaw, Miodowa Street 1 

48 (22) 55 64 900  

nck@nck.gov.pl 

www.nck.gov.pl 

Other 

1.3.6.1. If other, please specify. 

• organization • finacing  

1.4. 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.). 

• IHTM was delegated as CA by the Polish Blood Transfusion Act 
of 22nd August 1997.   • NBC was designated by Ordination of the 
Minister of Health of 12 October 2006.  Within the scope related to 
blood collection, the IHTM and the NBC are financed from the 
central budget.    

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

Not applicable 

Not applicable 

167 BEs;  21 regional blood transfusion Centers (subordinate to 
MH) , one (1) Military Blood Transfusion Center (subordinate to the 
Ministry of Defence) and one (1) Blood Transfusion Center of the 
Ministry of Internal Affairs (subordinate to the Ministry of Internal 
Affairs).   

2.1.2. How many of the BEs are satellite sites? 

144 

2.1.3. How many of the BEs are mobile sites? 

11 103 mobile collections organized in 2012 by 21 BEs  

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

627 847  

2.1.5. Could you please provide the number of repeat donors active 

456 526 

261 

 
 
 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

171 321  

Yes 

Data unavailable   

1 173 050  

450 ml +/- 10% 

21 042  

600 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

34 133 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

200-300 ml 

• Red Blood Concentrate  –  488 • Granulocyte Concentrate – 102  

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

 donor testing in BE (23); reference laboratory in IHTM; syphilis 
confirmation tests in designated diagnostic laboratories.  

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

donor testing in BE (23); reference laboratory in IHTM and syphilis 
confirmation test in designated diagnostic laboratories.   

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 
Other 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Blood Donor Questionnaire & Information on infectious diseases for 
Blood Donors 

2.1.18.3. If other, please specify. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

One exemplary donor questionnaire has been prepared by IHTM 
according to Medical standards for collection,  preparation and 
distribution of blood and blood components. BEs can adapt this 
document to address their specific  regional and local needs.   

Double documentation system in place (paper form, IT system)    
Donor notification procedure in place – prior to donation the donor 
signs the following statement: Upon receipt  of the notification to 
collect my test results I pledge to report in the BE in due time. I fully 
acknowledge  If  - despite triple notification - I do not report to 
collect my test results,  the BE  is released from responsibility  for 
the consequences that may ensue.    

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

Special „boxes” for self-exclusion are provided at the BE site and 
local procedures implemented to inform donors of  the possibility of 
self exclusion at any stage of blood donation.  Additional 
information provided  at the bottom of the Blood Donor 
Questionnaire.  

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

All criteria are relevant to safety of blood  

262 

 
 
 
2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

No problems are encountered 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

Suggestions of our CAs regarding changes in Directives (related 
among others to Annex III of the 2004/33/EC ) was sent  to the 
European Commission  at the beginning of September 2012. 
Nevertheless, please find below:  1. The  Directive should state that 
donor under 17 years of age may donate blood in exceptional 
circumstances (for  instance: donation of HLA – compatible blood 
components for family members). 2. The Directive should state  the 
donor weight  in case of  2 unit red cell apheresis. 3. The Directive 
should  state the value of  donor hemoglobin concentration in case of  
2 unit red cell apheresis. 4. There should be no inconsistency 
between coagulopathy and bleeding tendency (the term 
coagulopathy includes  also thrombotic events)  5. “metabolic 
disease” and endocrine disorders ( eg. hypothyroidism) should be 
mentioned separately.  6. In case of diabetes  only disease when 
treated with insulin is mentioned. It should also include donors on 
oral  medication.  7. The Directive raises doubts as to the category of 
donors to be deferred;donors with hepatitis or donors with  present 
HBV or HCV markers. In case of HIV and HTLV the detection of 
disease markers is sufficient for donor deferral. 8. Borreliosis (Lyme 
disease) should be included as cause of deferral. In terms of 
epidemiology the Lyme disease is an  important entity because the 
number of cases is steadily growing. Although there is no direct 
evidence of Borrelia  transmission with blood in humans (the 
available studies on borreliosis transmission are however old and 
date back to  the 1990 ies) transmission with blood was proved on 
animal models and Borrelia survives in the temperature of blood  
storage.  9. The Directive should be more  precise in case of deferral 
for chronic Q disease. 10. The Directive should state the value of 
body temperature in case of deferral due to fever. 11. We suggest to 
actualize the Directive referring to malaria in accordance with 
current medical knowledge as there  is some discrepancies between 
the Directive and the last EDQM edition of Guide to the Preparation, 
Use and Quality  Assurance of Blood Components. 12. For West 
Nile Virus we suggest to make precise the length of stay in an 
affected area as ground for donor  deferral as well as to introduce 
guidelines for donors who recovered from West Nile Fever. 13. 
There should be reference to Hepatitis B and HIV in the right 
column  of point 2.2.2.  14. We suggest one common deferral period  
(e.g. 6 months) for persons with exposure to risk of acquiring a 
transfusion-transmissible infection :  hepatitis  B, C and HIV”   (in a 
sentence of Directive  “ close  household contact” there is  reference 
only to hepatitis B ( but not to  hepatitis C and HIV).    In this point 
there are mentioned persons with hepatitis B (eg. diseased people), 
but there is lack of category: “disease carriers”.  A “carrier “ is not 
the same category as person with hepatitis (sick person). 15. It 
would seem reasonable to extend the deferral period Hepatitis B 
(possibility of  false positive results of HBV  test after vaccination). 
16. We suggest precise donor deferral following “exposure” to tick 
born encephalitis and after  recovery from tick  born encephalitis. 
17. There should be guidelines for deferral during breast feeding 
period. 18. ”Persons whose behaviour or activity places them at risk 
of acquiring infectious diseases that may be transmitted  by blood “ 
in one case refers to permanent deferral,  while -in the other one  
”Persons whose behavior or activity  places them at risk of acquiring 
infectious diseases that may be transmitted by blood →defer after 
cessation of risk  behavior for a period determined by the disease in 
question, and by the availability of appropriate tests “ –refers to  of  
temporary deferral. The difference between those two donor 
categories and reason for discerning between  permanent and 
temporary deferral should be made precise.  19. We suggest precise 

263 

 
 
 
recommendations for handling persons detained in the  juvenile 
correctional institutions  (homes). These are persons aged 18-21 
years who are not  in the strict sense and under legal regulations the 
prisoners.  Can they give blood or should be deferred as regular 
prisoners?   

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.7.1. If yes, please explain and suggest your alternative. 

Medical standards for collection, preparation and distribution of 
blood and blood components.  Quote from the Blood  Donor 
Questionnaire:  Do not donate blood if you have had any of the 
following hazardous contacts that have put your blood at risk: -  
present or past intravenous drug abuse  - sexual contacts with 
partners who use intravenous drugs - sexual contacts with many  - 
sexual contacts with partners (men or women) whom you know for a 
short time  -  sexual contacts for money, - sexual contacts with 
partners with positive test results for syphilis, AIDS (HIV), HCV 
and HBV, We are fully aware that by referring to these issues we 
intrude on very private spheres of life. However, the already  small 
risk of transmitting infectious diseases by blood  transfusion can be 
reduced even further only if you  carefully  analize the above 
situations  before donating blood  and provide acurate information. 
The answers remain confidential.  If test results are positive ( 
infection) you will be informed  by  the doctor.   

Yes 

Yes 

Lower age limit for young blood donors is being considered 
providing there is no  conflict with other Polish regulations.  Persons 
over 65 can donate blood if there are no contraindications.   

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Permanent deferrals : Internal disorders including metabolic 
disorders, diseases of     the endocrine system, respiratory  and 
circulatory disorders  Temporary deferrals :  low hemoglobin and 
other abnormal test results   

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

• The National Registry of Blood Donors (NRBD) is a uniform IT 
system set up in 2011. The system is regularly  updated.   • annual 
reports from BEs   

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

number of permanent deferrals - 10 582;  number of temporary 
deferrals – 222 121  

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

No 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

BE laboratories are subject to Quality Control internal audits and 
external inspections according to:    • Polish Blood Transfusion Act 
of 22nd August 1997  • Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy  (updated)       

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

All donations are tested for HBV DNA, RNA HCV and RNA HIV.  

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

Yes 

264 

 
 
 
3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

All donations are tested for HBV DNA, RNA HCV and RNA HIV 
(mandatory). 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

All donations are mandatory tested for HBV DNA, RNA HCV and 
RNA HIV. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

Yes 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

52 in 1 272 572 donations tested 

731 in 1 272 572 donations tested 

557 in 1 272 572 donations tested 

Syphilis: 149 in 1 272 572 donations tested; Parvovirus B19: 4 in 63 
819 donations tested. 

No 

Yes 

The following pathogen inactivation systems are used in Poland: 
Mirasol PRT for platelets and plasma for  clinical use and 
Macopharma Macotronic system for plasma for clinical use. 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

The tasks specified under Article 9 (1) can be delegated to other 
qualified persons 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

• Verification through exams and tests performed at regular intervals 
• Regular updated training provided  • Specialization encouraged  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

• Polish Blood Transfusion Act of 22nd August 1997.   • Decree of 
the Minister of Health of 11 December 2012 regarding blood and 
blood components therapy in health care entities which conducts 
medical activities with readings to blood and blood components 
therapy  • Medical standards for collection, preparation and 
distribution of blood and blood components  prepared,  published 
and regularily updated by IHTM based the regulations of the Polish 
Blood Transfusion Act   

BE and hospital blood bank documentation on operational 
procedures is subject to internal audits and external  inspections 
according to:  • Polish Blood Transfusion Act of 22nd August 1997 • 
Decree of the Minister of Health  of 16 April 2004 regarding 
procedures for inspections of blood establishments of the public 
blood transfusion service  • Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy • Act on Medical Activity of 
15 April 2011  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Archivizations of records • on paper  • IT system   

3.2.7. Is there a system in place to ensure that storage, transport and 

Yes 

265 

 
 
 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

Specific recommendations referring to the conditions for storage, 
transport and distribution of blood and blood components are set 
down in : •  Polish Blood Transfusion Act of 22nd August 1997. 
IHTM organizes regular inspections to ensure that these 
recommendations are met.   • Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy  Medical standards for 
collection, preparation and distribution of blood and blood 
components  prepared, published and regularily updated by IHTM 
based the regulations of the Polish Blood Transfusion Act   decree of 
the Ministry of Health of 2 February 2011 regarding facility 
requirements      

 system ISBT 128  

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Mandatory 

Yes 

Recommendations of the Guide to Preparation, Use, and Quality 
Assurance of Blood Components were gradually  implemented in 
BE activity since 1995. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Accreditation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.2.1. If other, please specify. 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 
Other 

training 

Yes 

By 2012 all  blood transfusion centers were authorized: 21 regional 
BEs + 1 Blood Transfusion Center of the Ministry of Internal Affairs 
(subordinate to the Ministry of Internal Affairs + 1 Military Blood 
Transfusion Center (subordinate to the Ministry of Defence)  

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

MH based on IHTM recommendations 

4.6. How many laboratories performing donor testing are active 
within your country? 

23 in BEs  + reference laboratory in IHTM  and designated 
diagnostic laboratories.  

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

4.9.1. If yes, please specify the scope of these extra rules. 

23 blood transfusion centers  

546 

Yes 

Decree of the Minister of Health of 11 December 2012 regarding 
blood and blood components therapy in health care entities which 
conduct medical activities with readings to blood and blood 
components therapy  

266 

 
 
 
4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

4.10.2. If yes, please state the responsible authority within your 
country. 

5. Inspections (Art 8 Directive 2002/98/EC) 

BIOMED Lublin SA  - Lublin Factory of Sera and Vaccines. 
Production of anti D immunoglobulin and anti HBs only. (private) 

Main Pharmaceutical Inspector 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

IHTM – Department of Transfusion Medicine  • Polish Blood 
Transfusion Act of 22nd August 1997;  • Decree of the Minister of 
Health of 16 April 2004 regarding procedures for inspections of 
blood  establishments of the public blood transfusion service    

17 inspectors: each inspection team includes: Inspector of Quality 
Assurance (1 person), Immunology for Transfusion Medicine ( 1 
person), Virology ( 1 person),  registration, collection, donor 
examination, preparation  and issue ( 1 person).  Inspections are 
conducted within working hours.  

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

No 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

24 inspections: 10 inspections in blood transfusion centers + 14 in 
satellite sites  

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

24 inspections  

2 inspections 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

0  

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

According to Medical Standards for collection, preparation and 
distribution of blood and blood components each SAR is  reported to 
one of the 23 blood transfusion centers within 24 hours of 
transfusion ( on a standard form). Immediate  Inspections follow. 
Post-control recommendations are sent back to the hospital and the 
whole documentation to IHTM.  The SAR is analized by a special 
team appointed by the IHTM Director. Recommendations, if any, 
are sent to the blood  transfusion centers.    In 2012 the IHTM team 
analized 22 SAR cases.   

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

additional inspections are called in case of organization changes in 
BEs  

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

It is routine procedure according to our national guidelines 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

16 BEs  

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

IHTM Inspections in blood transfusion centers are performed every 
2 years. An inspection of a blood center also includes  1 satellite site 
or 1 mobile site.  

Following 24 BE  inspections/2012  there were no BE with no 
shortcomings   

Following 24 BE inspections in 2012  minor shortcomings were 
found in 23 BEs.  

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 

Following 24 BE inspections in 2012  major shortcomings were 
found in 24 BEs  

267 

 
 
 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

no BE inspection of 2012 was followed by suspension of 
authorization.  

There was no BE closure  

2012 inspections resulted in dismissal of one BE director in 2013.  

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

0 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

IHTM inspects blood transfusion centers and their respective 
hospital blood banks – every 2 years (rotation) according  to: Polish 
Blood Transfusion  Act of 22nd August 1997.   BEs inspect hospital 
blood banks regularly.   

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

IHTM inspections in blood transfusion centers and their respective 
hospital blood banks – every 2 years  (rotation) According to Polish 
Blood Transfusion Act of 22nd August 1997    BE inspections - 
regularily performed  in  hospital blood banks.     

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

Medical standards for collection, preparation and distribution of 
blood and blood components  prepared, published and  regularily 
updated by IHTM according to the Polish Blood Transfusion  Act of 
22nd August 1997 and Decree of 16 April 2004 are based on the 
recommendations of the Guide and the EU  Directives  

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

5 

Yes 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

The Ministry of  Health / the Institute of Hematology and 
Transfusion Medicine  

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

Concerns all blood components (ISBT 128) 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 128 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

6.1.4.2.1. If other, please specify. 

Granulocyte Concentrates/ Cryoprecipitate/cellular blood 
components – irradiated,    inactivated, leukodepleted, pediatric, for 

268 

 
 
 
6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

neonatal use  

Both paper records and electronic forms 

Audits and inspections of documentation  

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Hospitals are under obligation to report SARE to respective BE ; 
BEs report SARE from  their own territory/region to the CA  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

Yes 

Yes 

Yes 

100% 

Yes 

According to Medical Standards for collection, preparation and 
distribution of blood and blood components each SAR is  reported to 
one of the 23 blood transfusion centers within 24 hours of 
transfusion ( on a standard form). Immediate  Inspections follow. 
Post-control recommendations are sent back to the hospital and the 
whole documentation to IHTM.  The SAR is analized by a special 
team appointed by the IHTM Director. Recommendations, if any, 
are sent to the blood  transfusion centers.      

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

All "severe" cases reported to CAs  by BEs   

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Outcome of CA analysis and appropriate recommendations are 
referred back to the BEs 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

Storage – 66 Distribution – 13 Transport – 3  Other (no specify) – 52  

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Information on any new focus of infection are reported by National 
IHR Focal Point or Main Sanitary Inspectorate to CA.   CA inform 
BEs.   

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Information from CIRCA-BC are immediately sent to CA. CA 
inform BEs   

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

269 

 
 
 
6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

Main Pharmaceutical Inspector; The Office for Registration of 
Medicinal Products, Medical Devices and Biocidal  Products, 
National Center for Cell and Tissue Banking; Poltransplant  

Additional comments of our CA on traceability and SAR/E reporting 
were sent to the European Commission at the  beginning of 
September 2012. Nevertheless, please find below. 1.We suggest that 
the legally binding SAE definition is  more precise. In particular it 
should  distinguish between: • SAE –as only an event which is a real 
threat as result of improper component being issued for transfusion • 
SAE –as any event that might have endangered the recipient’s 
health, even though identified and eliminated  according to internal 
control procedures. It is unclear whether the definition of “serious 
adverse events” also includes  events that had taken place in a 
hospital  laboratory, on a hospital ward or  during the  transfusion 
procedure.   2. We suggest to simplify the table related to Serious 
adverse events – imputibility level  to run as follows:   Transfusion-
related  imputibility level:      0     - not assessable     1 - no relation – 
there is evidence for attributing the adverse reaction to alternative 
causes     2  - relation assessed – evidence includes results of 
diagnostics tests      

According to article 16.2.1 Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy [Dz. U. 2013 poz. 5], one of 
the main duties of the blood banks is placing orders for blood and 
blood components in the appropriate blood establishment, according 
to the orders of the hospital departments. So the only source of blood 
and blood components for therapy  in health care entities, that is for 
transfusion, are blood establishments, which implemented the 
quality system and all quality requirements (parameters, the minimal 
scope of laboratory tests, the manner of storage, including system of 
identifying blood and blood components), in accordance with 
appointed directives. These requirements were also determined in 
“Medical Standards for collection, preparation and distribution of 
blood and blood components”,  and were implemented for applying 
in all blood establishment. 

 According to article 16.2.1 Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy [Dz. U. 2013 poz. 5], one of 
the main duties of the blood banks is placing orders for blood and 
blood components in the appropriate blood establishment, according 
to the orders of the hospital departments. So the only source of blood 
and blood components for therapy  in health care entities, that is for 
transfusion, are blood establishments, which implemented the 
quality system and all quality requirements (parameters, the minimal 
scope of laboratory tests, the manner of storage, including system of 
identifying blood and blood components), in accordance with 
appointed directives. These requirements were also determined in 
“Medical Standards for collection, preparation and distribution of 
blood and blood components”,  and were implemented for applying 
in all blood establishment. 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

According to article 16.2.1 Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy [Dz. U. 2013 poz. 5], one of 
the main duties of the blood banks is placing orders for blood and 

270 

 
 
 
blood components in the appropriate blood establishment, according 
to the orders of the hospital departments. So the only source of blood 
and blood components for therapy  in health care entities, that is for 
transfusion, are blood establishments, which implemented the 
quality system and all quality requirements (parameters, the minimal 
scope of laboratory tests, the manner of storage, including system of 
identifying blood and blood components), in accordance with 
appointed directives. These requirements were also determined in 
“Medical Standards for collection, preparation and distribution of 
blood and blood components”,  and were implemented for applying 
in all blood establishment. 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Yes 

7.4.1. If yes, please specify. 

In emergency: requirements provided in Annex IV + NAT testing  

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

No 

No 

According to article 16.2.1 Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy [Dz. U. 2013 poz. 5], one of 
the main duties of the blood banks is placing orders for blood and 
blood components in the appropriate blood establishment, according 
to the orders of the hospital departments. So the only source of blood 
and blood components for therapy  in health care entities, that is for 
transfusion, are blood establishments, which implemented the 
quality system and all quality requirements (parameters, the minimal 
scope of laboratory tests, the manner of storage, including system of 
identifying blood and blood components), in accordance with 
appointed directives. These requirements were also determined in 
“Medical Standards for collection, preparation and distribution of 
blood and blood components”,  and were implemented for applying 
in all blood establishment 

According to article 16.2.1 Decree of the Minister of Health of 11 
December 2012 regarding blood and blood components therapy in 
health care entities which conducts medical activities with readings 
to blood and blood components therapy [Dz. U. 2013 poz. 5], one of 
the main duties of the blood banks is placing orders for blood and 
blood components in the appropriate blood establishment, according 
to the orders of the hospital departments. So the only source of blood 
and blood components for therapy  in health care entities, that is for 
transfusion, are blood establishments, which implemented the 
quality system and all quality requirements (parameters, the minimal 
scope of laboratory tests, the manner of storage, including system of 
identifying blood and blood components), in accordance with 
appointed directives. These requirements were also determined in 
“Medical Standards for collection, preparation and distribution of 
blood and blood components”,  and were implemented for applying 
in all blood establishment 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

No 

No 

No 

7.12. Is there a regular surplus of blood or blood components in your  No 

271 

 
 
 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

No 

Yes 

No 

no penalties imposed   

no penalties imposed  

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

 no penalties imposed  

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

8.4.1. If yes, please provide us with detailed information. 

8.5. Which other communicable diseases are of relevance to you? 

No 

No  

Yes 

The National Consultant for Transfusion Medicine is responsible for 
the monitoring the spread of West Nile Virus on the  territory of 
Poland and  informing BEs for appropriate measurest to be  
immediately implemented.   

Other communicable diseases relevant for Poland: malaria, Dengua 
fever, Chikungunya.  

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

National guidelines:  • Act on Medical Activity of 5 April 2011;  • 
Decree of the Ministry of Health of 11 December 2012 regarding 
blood transfusion  

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

No    

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

None. Blood and blood components should not fall under the 
pharmaceutical legislation.   

272 

 
 
 
 
 
 
A.1.24. 

Survey response Portugal 

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

1.1.2. Address of&nbsp;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) 

Direção-Geral da Saúde (DGS) 

 Alameda D. Afonso Henriques, 45 - 1049-005 Lisboa  

 +351 21 843 05 00 

sanguetransplantacao@dgs.pt  

www.dgs.pt 

Blood and blood components 
Tissues and cells 
Human organs 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 

1.2. National Competent Authority 2? 

Yes 

1.2.1. Name of National Competent Authority 2: 

Instituto Português do Sangue e da Transplantação (IPST) 

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

Avenida Miguel Bombarda n. 6, 1000-208 Lisboa 

 +351 210 063 063 

dirips@ipst.min-saude.pt 

 ipsangue.org 

Haemovigilance 

1.3. National Competent Authority 3? 

No 

1.4. 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.). 

DGS: This new CA is only responsible for this área since the end of 
2012. It is an área included in the DGS Quality Departement, which 
is depending of the Ministry of Health; the staff is composed by a 
medical doctor, an hospital manager, a pharmacist (also veterinary 
doctor) and an architect; we may  consider that 2 of them are seniors 
and 2 juniors, but none is a formal inspector. 1 members (the MD) 
participates in EU affairs.   IPST: Haemovigilance Group - 
responsible for collecting information from blood establishments, 
hospital blood bank and facilities where the transfusion takes place 
(activity monitoring and notification of serious adverse reactions and 
events) Composed by five medical professionals.   

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 
2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

Not applicable 

Not Applicable 

(IPST: 34) 

(IPST: 10) 

(IPST: 0) 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

(IPST: 249168) 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

(IPST: 204291) 

(IPST: 44877) 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

No 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

(IPST: 387222) 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

(IPST: 450 (+/- 10%)) 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 

(IPST: 0) 

(IPST: 0) 

273 

 
 
 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

(IPST: 4568) 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

NA 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

(IPST: 346) 

(IPST: 22) 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

0 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

Donor questionnaire (Portuguese version only) 

DGS performs regular inspections, accordingly with the law. (IPST: 
performs internal audits) 

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 
2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

DGS: All of them are relevant, but those related with blood levels in 
donors (1.2 - 1.4), donors diseases and exposure to transmissible 
diseases are considered the most relevant ones.  

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

DGS: Asymptomatic diseases that are dificult to identify and that the 
donor is not aware of and sexual behaviors (IPST: Risk Sexual 
behaviors) 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

No 

Yes 

More than one sexual partner in the previous 6 months; 
new/different sexual partner in the previous 6 months; sex for drugs 
or money; MSM: men who have sex with men 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

Yes 

No 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

(IPST:    Low Hemoglobin levels - 22408; Flu or flu like symptoms: 
4714; Travel: 2475; Risk behavior: 2078) 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

(IPST: Annual report of blood establishments) 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

(IPST: 97915) 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

No 

2.2.11. In case of future crisis, would temporary derogation of the 

Yes 

274 

 
 
 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

3.1. Testing 
3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Inspections and documental analysis 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

In all blood donations (NAT for HIV, HCV and HBV) 

Yes 

NAT for HIV, HCV and HBV; EiA IgM and IgG testing for Syphilis 
- All blood donations EiA HTLV 1 e HTLV 2 - First Time donations 
Malaria Testing according the Directive 2002/98/EC 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Not Applicable  

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

No 

Yes 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

(IPST:  33) 

(IPST: 55) 

(IPST: 32) 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

(IPST:     Syphilis: IgM positive IgG negative - 13; IgM positive IgG 
positive - 23; IgM negative IgG positive - 599; IgM/IgG  positive 
(not discriminated) - 695) 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

(IPST: inactivation of pathogens by Amotosalen UVA (Intercept) in 
1 BE) 

3.2. Processing 
3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Yes 

No 

Inspections and documental analysis 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Confirmed by inspections and documental analysis Mandatory by 
law 

Confirmed by inspections and documental analysis Mandatory by 
law 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Data bases and sometimes also in paper; confirmed by inspections 

275 

 
 
 
  
3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

and documental analysis (IPST: Annual Survey/report) 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Confirmed by inspections and documental analysis Mandatory by 
law 

Validated in inspections. 

Yes 

No 

Yes 

DGS: Not much yet, as this new CA is only in charge of this field 
since the end of 2012. (IPST: the Co-E Guide is used by IPST BE as 
a reference tool/guidelines) 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 
4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 
Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

This information is not yet available as some BE are still being 
evaluated by this new CA 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

Yes 

4.4.1. If yes, what were the reasons for the revocation(s) or 
suspension(s) (more than 1 answer possible) ? 

Problems with donor testing 
Poor compliance with the good practices and quality system issues 
in the establishment  

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

4.6. How many laboratories performing donor testing are active 
within your country? 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

NCA1 - DGS 

(IPST: 22) 

NCA1 - DGS 

4.8. How many hospital blood banks are active within your country? 

(IPST: 107) 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 
5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

NC1 - DGS (Department of Quality in Health) 

There is no full time inspectors. The 4 members of the staff are 
responsibles for inspections, but none is formal inspector. 2 of thme 
as just done the CATIES's course.  

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 

Yes 

276 

 
 
 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

Tissues and cells 

15 (11-T&C and 4 BE) 

15 (11-T&C and 4 BE) since the end of 2012 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

0 (By the new CA) 

0 (By the new CA) 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

0 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

The planning of the inspections is based on the potencail risk for the 
Public Health. 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

0 (By the new CA) 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

Not yet defined by the new CA. 

0 (By the new CA) 

0 (By the new CA) 

0 (By the new CA) 

0 (By the new CA) 

0 (By the new CA) 

0 (By the new CA) 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

0 (By the new CA) 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

Accordingly with national law (coming out of the Directives) 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

Accordingly with national law and together with the General 
Inspectorate of Health Activities 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

For the time being it is yet limited for the new CA 

5.11. Did you (do you intend to) send your inspectors to the trainings  Yes 

277 

 
 
 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 
Yes 
6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

Direção-Geral da Saúde (NCA) and Instituto Português do Sangue e 
da Transplantação 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

All other blood components 

Both paper records and electronic forms 

Inspections and documental analysis 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 
6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

(IPST: A web based system for notification of all adverse reactions 
and eventes (SAR and SAE) in all transfusion chain) 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

Yes 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

70-99% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Mandatory by the National Law (Decreto-Lei n.º 267/2007; Article 
15º): all blood establishments, hospital banks and transfusion points, 
are obliged to report to the NCA all SARE  

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

(IPST: In all cases of imputability levels 1, 2 and 3) 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

(IPST: Annual Haemovigilance System meeting (for all notifiers) 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 

(IPST: 122 Total (positive bacterial - 91 blood components; pos 
donation information - 21 blood components; TRALI - 5 blood 

278 

 
 
 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

components; HIV positive - 1 blood component; other - 4 blood 
component)) 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

(IPST: email communication send to the responsible persons of 
blood establishment) 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

(IPST: email communication send to the responsible persons of 
blood establishment) 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

(IPST: Tissues and Cells; Organs; communicable diseases and other 
threats to health) 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No 

7. Import - export (Art 21 Directive 2002/98/EC) 
7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

 (IPST: Portugal doesn't send blood components to other Member 
States, as well as doesn't import/export blood components from third 
countries) 

 (IPST: Portugal doesn't send blood components to other Member 
States, as well as doesn't import/export blood components from third 
countries) 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

 (IPST: NA (Portugal doesn't send blood components to other 
Member States, as well as doesn't import/export blood components 
from third countries)) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Yes 

7.4.1. If yes, please specify. 

 (IPST: Portugal doesn't send blood components to other Member 
States, as well as doesn't import/export blood components from third 
countries; Please, see answer 3.1.3.1)  

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

Yes 

NA 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

NA 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

(IPST: Portugal doesn't fractionates plasma) 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

 (IPST: Portugal doesn't send blood components to other Member 
States, as well as doesn't import/export blood components from third 
countries) 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 

Yes 

279 

 
 
 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.9.1. If yes, please provide this data by country of destination. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

NA 0 

Yes 

0 

Yes 

7.11.1. If yes, how often (per year) is there a shortage of blood or 
blood components in your MS? 

(IPST: There was a blood shortage in the 1st semester 2012; does 
not occur frequently) 

7.11.2. If yes, for which blood components (more than 1 answer 
possible)? 

7.11.3. If yes, would you be interested in concluding bilateral 
agreements with other MS in order to address the shortage? 

7.11.4. If yes, would you be interested in establishing short-term/ad-
hoc mechanisms for addressing the shortage? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 
8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

Red Blood Cells 

No 

Yes 

No 

No 

Yes 

No 

No penalties 

No penalties 

No penalties 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

Yes 

8.2.1. If yes, please specify. 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

(IPST: NAT screening test for HIV, HBV, HCV; EiA  screening test 
for syphilis; EiA screening test for HTLV (first time donors); RT-
PCR Dengue screening test at epidemiological context (Dengue 
outbreak in Madeira Island)) 

The new CA is still in process of internal organization, so it is to 
soon to identify issues of this kind. For the time being the main 
difficulty to implement BD is lack of resources.  

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

(IPST: Donor deferral criteria) 

8.5. Which other communicable diseases are of relevance to you? 

(IPST: Dengue outbreak in Madeira Island (October 2012 - March 
2013); Malaria) 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

(IPST: we don't have yet a position in this matter) 

(IPST: Data not known) 

(IPST: level of pooling) 

280 

 
 
 
281 

 
 
 
 
 
 
A.1.25. 

Survey response Romania 

1. Public information 

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

Ministry of Health 

1.1.2. Address of&nbsp;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) 

1.1.6.1. If other, please specify. 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

1.1.7.1. If other, please specify. 

no. 1-3, Cristian Popişteanu alley , district 1, 010024, Bucharest  

+4 021 3072 500 +4 021 3072 600 

dcspms@ms.ro 

www.ms.ro 

Blood and blood components 
Other 

Food, cosmetic products, biocides, water, health care, etc. 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 
Other 

- elaboration of national policy and strategy for sustained 
development of the national blood transfusion system - organization 
of national transfusion system and elaboration of annual national 
program  -ensure human, financial and technical resources to the 
national transfusion system -take necessary measures, through its 
specific structures, to ensure self-sufficiency on blood and blood 
components - monitoring of optimal and rational use of blood and 
blood components - setting up the responsibilities for all categories 
of institutions involved in any stage of the transfusion activity - 
elaboration of primary and secondary legislation to regulate the 
transfusion field - take all the necessary measures to ensure 
implementation of a quality management system based on good 
practice principles by any institution involved in the transfusion 
activity - coordinates the collaboration of all institutions involved in 
the promotion and support of blood donation - elaborates and 
implements a unique national system for the identification of each 
blood donation, each unit of blood and blood component collected 
and processed - ensure elaboration and implementation of a unique 
codification system for the donors’ identification data , to be used in 
case of reporting to third parties, in charge with collection and 
monitoring of epidemiologic data  

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

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 is one directorate with responsibilities in the field of 
blood and blood components: the Public Health and Control in 
Public Health Directorate (PHCPHD).   The main responsibilities in 
the field of blood and blood components are: - developing of legal 
acts (PHCPHD); - carrying out inspections  and control measures in 
BE and HBB regarding the quality and sanitary safety of blood and 
blood components    - organizing and coordinating the vigilance 
system and taking the necessary measures in the field 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 Order  no 824/2006 regarding the Norms for functioning 
and organizing of the sanitary state inspection.  We have inspectors 
(86 inspectors) who are dedicated to inspect establishments with 
transfusion activities – BEs and HBBs- 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 and blood 
establishments. According to the Governmental Decision no. 

282 

 
 
 
1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

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 State Sanitary Inspectorate.  

Not applicable 

RO does not have a federal or decentralized system 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

50 (42 BE legal entities + 5 buses + 3 satellites sites) 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

3 

5 buses 

521132 

245568 

91902 

No 

399848 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

450ml/donation 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

1 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

Maximum 750 ml/procedure 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

6830 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.17.1. If other, please specify. 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

Maximum 650ml/procedure 

1037 (128 eritrocytapheresis+ 909 combined apheresis procedures 

42 

42 

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

Requirements regarding the scope of information to be provided to 
the prospective donors have been set up through a specific regulation 
(Order no. 1193/2007) 

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Romanian version has been uploaded 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 

 These requirements are regulated by: - Order no. 1193/2007 
updated by 293/2010,  - 1226/2007 updated by 650/2012,  - 1132/ 

283 

 
 
 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

2007.   - Additionally, SOPs are in place in each BE .    - 
Additionally, SOPs are in place in each BE .  

2.1.20. Do you have a system for the self-exclusion by a donor? 

No 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

- eligibility criteria: age, body weight (minimal limit to estimate the 
volume allowed for collection), haemoglobin, protein, platelets (for 
apheresis), blood pressure, puls.  - deferral criteria: cardiovascular 
diseases, abnormal bleeding tendency, history of syncope, 
convulsions, infectious diseases, malignant diseases, drug use, 
sexual behaviour, psychiatric diseases ,  gastrointestinal diseases, 
etc.  They allow basic objective selection and protection of both 
donor and recipient.  

vCJD, malaria, drug use, history of different infectious diseases 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

* addition as eligibility criteria:  -Complete cell blood count- for 
leucocytes, platelets, indirect signs of iron deficiency- at least for 
apheresis, first time donors, repeat/regular donors with borderline 
Hb value - evaluation of iron status at least in particular situation, 
based on physician decision * addition as temporary deferral criteria 
: leucoytosis (leucocytes over 11000/mmc- 12000)  * replacement:  - 
point 2.2.2, 1st raw:  introduce “…provided a NAT test for HCV, 
HBV, HIV is negative’ to replace “NAT test for hepatitis C is 
negative” - point 2.2.2, 1st raw, last line: introduce “….close 
household contact with persons with hepatitis B, C, HIV, 
tuberculosis” to replace “close household contact with hepatitis B”  

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

No 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

-According to Annex III, POINT 2.1(table-last row) transposed in 
Order 1193/2007, permanent deferral for “persons whose sexual 
behavior puts them at high risk of acquiring severe infectious  
diseases that can be transmitted by blood ” . -Temporary deferral 
according to Annex III, point 2.2.2 , 2nd  row : “persons whose 
behaviour…place them at risk of acquiring infectious diseases that 
may be transmitted by blood”. -The national standardized 
questionnaire contains questions focused on identifying these risks:  
- sexual contact with partners infected with HBV/HCV/HIV/TP  - 
sexual partner using i.v. drugs - paid sexual partner - has he/she ever 
been paid for sex - multiple partners - recent change of sexual 
partner (last 6 months) - number of sexual partners during the last 6 
months  

No 

No 

most frequent: - anemia and Hb lower than minimal standard - 
higher blood pressure - cardiovascular diseases - sexual risky 
behaviour - history of or acute infectious diseases - high ALT values 
(mandatoty testing)  • least frequent: - psychiatric diseases - 
neurologic diseases - malignant diseases - vaccination - malaria - 
vCJD  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

No 

No 

No 

284 

 
 
 
2.2.11.1. If no, what other deferral criteria would you suggest for 
derogation? Would you have other suggestions on the usefulness and 
set-up of such temporary derogations? 

3.1. Testing 

Derogation of Hgb level only for first time donors 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Regulation on authorization of BEs- Order 1225/2006; verification 
during inspections; national protocol for testing, endorsed by 
National Institute of Transfusion Hematology 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

- limited financial resources  - reorganization of BEs is under 
discussion, concentration of testing in several laboratories is 
foreseen; after the accomplishment of this objective, progressive 
implementation of NAT in routine,  based on the results of a pilot 
study, will be introduced, if financial resources available  

Yes 

Yes, MoH Order no. 1226/2007 updated by Order 650/2012. 

Yes, MoH Order no. 1226/2007 updated by Order 650/2012 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

Yes 

3.1.4.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

- addition: testing for syphilis 

Yes 

66 

2612 

422 

-Ab anti HTLV: 28;   -Ab anti TP (EIA): 1237  

No 

No 

Yes 

Yes 

Tasks are delegated to one or more persons in most of the BEs, if the 
responsible person is absent and the delegated person replace her. 
Still, because of shortage of specialized personnel, in  some BEs 
only one person with universitary degree is hired, the director 
(physician or scientist). Given this situation, no other person is 
qualified to be delegated as replacement for the responsible  person 
in those BEs.  

Mandatory requirements set up in Order 1214/2007 on qualification 
and training requirements; verification during inspections, self-
inspections and accreditation process (the last one for HBBs only) 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

285 

 
 
 
3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Mandatory requirements set up in Law no. 282/2005 and Order no. 
1132/2007 

By organizing: -  a self-inspection program by BEs and hospitals - 
regular inspection in BEs and hospitals;  - data on documentation, 
training, testing and other aspects of mandatory activities are 
collected at county level on annual basis from hospitals/HBBs, 
transmitted and  collated at MoH level - BEs report on regular basis 
on the status of internal management control system, that includes 
the documentation on quality.(Government Decision 946/2005 for 
public institution)  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

- mandatory provisions covered by the existing regulations - 
organization of archive is under responsibility of each institution  

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

Mandatory requirements covered by regulations. SOPs in place, 
Documentation of temperature monitoring; verification during 
inspection Self-inspection program  

Mandatory requirements regarding confidentiality responsibilities 
and measures foreseen in Law 506/2004 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

No 

3.2.9.2. If no, why not? 

Only few BEs have introduced lately an internal IT system, no 
extension so far to the related HBBs. Even though these BEs use 
barcodes, they must use numeric codes in parallel, to ensure  
traceability. Each donation has a nationally unique  numeric code.   

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

We consider it very useful. It is used as a guidance for technical 
issues. 16th edition was translated by MoH. It is foreseen to translate 
the 17th edition , too. Having a representative in the GTS group, 
ensures direct contact, information exchange for the technical 
aspects.  

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Designation 
Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

No 

4.3.2.&nbsp;If no, how many BEs have not received authorisation 
by [please provide date of record]? 

BEs have been designated by Law 282/2005 and by County Public 
Health Authority,(authorization to function, yearly renewed), NITH 
to perform activities in the field, according to the scope of the BE 
definition.The authorization process hasn't yet started. So, none of 
the BEs has been authorized yet. 

4.3.3. If no, when will this approval process be completed? 

2014 

4.3.4. If no, what is (are) the difficulties / reason(s) for the delay in 
the approval process? 

Delay in setting up the Government Decision on organization and 
functionality of BEs, as set-up in the Law 282/2005. Need to revise 
the Order on authorization of BEs and revise and complete the  
national standards to ensure the legal basis for verification during 
inspection. For 2013, the Government has launched a project for the 
administrative reorganization of the country, to create regions. In the 

286 

 
 
 
frame of this project, reorganization of the transfusion system is  
foreseen.  

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

MoH through the DPHCPH. During the authorization procedure, 
each activity is authorized, including testing.  

4.6. How many laboratories performing donor testing are active 
within your country? 

42 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

4.8. How many hospital blood banks are active within your country? 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

4.9.1. If yes, please specify the scope of these extra rules. 

MoH through the County Public Health Authority 

340 

Yes 

Requirements related to art. 8 - inspection, 12(2) are mandatory for 
HBBs also. A national guide on rational clinical use of blood and 
blood components has been adopted through  Order 1343/2007.  

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

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 (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

PHCPHD in the MoH coordinates inspection activities performed by 
inspectors working at county level (Public Health County Authority- 
department of inspection) HG 524/ 2013 foresees a Sanitary State 
inspection department in the MoH  

86 : 2 in MoH + 84 at county level 

Yes 

Tissues and cells 
Organs 
Hospitals 
Others 

5.2.1.1. If others, please specify. 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

Clinical laboratories, health care cabinets, dental cabinets 

BEs:  41 /year, organized each 2 years (  2011 and 2013) 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

0 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

BE: 0; HBB:  220 in 2012  

4 

None 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

We decide the type of inspection to be conducted based on the: • 
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  

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

287 

 
 
 
5.5.2.1. If no, why not? 

They have been planned so as to comply with Directive requirement 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

41 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Each 2 years 

- 

- 

- 

- 

- 

For the 4 inspections organised for SARE or suspicion of: - 3 of 
them: procedures compliant with the regulations applied - 1: 
administrative measures (clerical errors)  

0. This type of establishment does not exist in Romania. 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

According with Law no. 282/2005; same requirements as for BEs: at 
least 1 inspection each 2 years 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

- Coordination of county inspection units,  - collection of data on 
inspection outcome,  - organization of training for inspectors,  - 
elaboration of inspection guidelines and procedures  

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

It is used as a guidance for technical issues.16th edition was 
translated by MoH. It is foreseen to translate the 17th edition , too. 
Having a representative in the GTS group, ensure direct contact, 
information exchange for the technical aspects.   The EuBis Guide is 
very useful. It was translated into Romanian by MoH and provided 
to all CPHCPHA, inspectors and BEs. It is used for training, 
elaboration of technical documents/SOPs, inspection  and self-
inspection plans and activities.  

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

5 

Yes 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

Yes 

MoH 

288 

 
 
 
6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

Platelets, Plasma, Red Blood Cells, Whole blood 

6.1.4. Do you apply an international coding system for blood 
components? 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Mandatory requirements by regulation SOP Verification during 
inspection  

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

No 

6.1.7.1. Please explain why not. 

Too long. Difficulties are foreseen to ensure archiving space and 
document management. 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Order 1228/2006 Some changes have been discussed and revision is 
foreseen for 2014. The general scheme includes: - National 
haemovigilance coordinator is the MoH, through Sanitary State 
Inspection department. - county coordinator: county public health 
authority- inspection service - local coordinator of BE - local 
coordinator of hospital If SAR/E, the local coordinator of hospital 
reports to the county public health authority and to the BE providing 
the blood components. From county level, information is sent to 
MoH. If SAR/E in BE, information is sent to the county public 
health authority and to the National Institute of Transfusion 
Hematology. From here, to the MoH. Other adverse reactions and 
events are centralized locally and regularly reported: BE to the 
national institute and HBBs to the county inspectors. Both the 
national instituite and the county inspection services send the data to 
the MoH on annual basis.  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

No 

6.2.4.1. If no, why not? 

The sanitary inspectors who are responsible for the formal control in 
the transfusion field are in charge of collecting SAR/E at county 
level.  

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

100% 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Order 1228/2006 

6.2.7. Do you perform root cause analyses of the SARE? 

6.2.7.1. If yes, in which cases? 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

SAR/E 

Yes 

6.2.8.1. If yes, please specify. 

Information provided during meetings of CAs representatives are 
disseminated to BEs representatives during half-yearly meetings 
with directors or other occasions. There is no standard formal 
procedure or mandatory requirement for that  

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 

Data not available 

289 

 
 
 
 
 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Informative message is send by MoH or Center for transmissible 
Diseases (depending on the case) to the NITH and from there to the 
BEs. If it is the case, BEs inform hospitals in their territory. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Informative message is send by the CA contact person to the NITH 
and from there to the BEs. If it is the case, BEs inform hospitals in 
their territory 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

X Tissues and cells X Organs X Communicable diseases and other 
threats to health  

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

Order 608/2013 

Order 608/2013 

Equivalent standards (bilateral agreements) 

Yes 

7.4.1. If yes, please specify. 

Same mandatory testing as at national level (RO) 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

No imports done in 2012 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

Yes 

No imports done 

Order 608/2013  

Order 608/2013  

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

290 

 
 
 
7.9.1. If yes, please provide this data by country of destination. 

No exports done 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

No exports done 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.12.1. If yes, for which blood components (more than 1 answer 
possible)? 

7.12.2. If yes to Q. 7.12., what do you do with the surplus of blood 
or blood components? 

7.12.3. If yes to Q. 7.12., would you be interested in concluding 
bilateral agreements with other MS in order to address the surplus? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.2.1. If yes, please specify. 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

No 

Yes 

Plasma 

Discarded 

Yes 

No 

No 

Yes 

- Additional eligibility/deferral criteria - mandatory requirement for 
authorization of HBBs - mandatory inspection for HBBs - 
mandatory registration and reporting of all incidents and adverse 
reactions, including the activity performed at clinical service level  

- during implementation: progressive shortage of medical staff in 
BEs, leading to overlapping of functions, non-compliant facilities, 
lack of national IT system 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Romania was member of the working group that drafted the EU 
preparedness plan for WNV outbreaks adopted by MS. Based on this 
one, a national plan was enacted by MoH Order in 2011: Order  no. 
1483/2011.Since 2011, this plan has been activated by the task force 
each season. Measures are implemented according to the evolution 
of outbreaks, in direct collaboration with RO Centre for  disease 
control, information provided by ECDC site and other MS. 

8.5. Which other communicable diseases are of relevance to you? 

HBV, HCV, HIV, sifilis,  TBC, new emerging agents 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

No 

- 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Ozonetherapy Local application of autologous blood components in 
dermatology/ cosmetics  

Any intervention on the blood unit for further processing, 
treatments, pooling, etc  

291 

 
 
 
 
 
 
A.1.26. 

Survey response Slovakia 

1. Public information 

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

Ministry of Health of the Slovak Republic  

1.1.2. Address of&nbsp;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) 

Limbová 2 P.O. BOX 52 837 52 Bratislava 37  

++421 2 593 73 111   

office@health.gov.sk  

www.health.gov.sk  

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Human organs 
Medical devices 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 

1.2. National Competent Authority 2? 

Yes 

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

1.3. National Competent Authority 3? 

1.4. 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.). 

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

State Institute for Drug Control  

Kvetná 11 825 08 Bratislava 

+421-2-50701 111 

 sukl@sukl.sk 

www.sukl.sk 

Inspection 
Haemovigilance 

No 

The state institute that is a state administration body for the field of 
human pharmacy and drug precursors. The State Institute is a budget 
organization. It is headed by a director that is appointed and 
withdrawn by the Minister of Health. The State Institute for Drug 
Control is the institution of the Ministry of Health of the Slovak 
Republic responsible for ensuring surveillance of the quality, 
efficacy and safety of medicinal products for human use and 
medicinal products used in health care.  Three inspectors of 
Inspection Section are responsible for conducting of inspections of 
blood establishments.  Section of drug safety and clinical trials of 
The State Institute for Drug Control is responsible for 
haemovigilance.  

Not applicable 

N/A 

47 

0 

0 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

121 542 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

91 557 

29 985 

Yes 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

Slovak donors traveling to Austria to donate plasma by apheresis (in 
private plasmapheretic establishment close to the Slovak-Austrian 
border - Hainburg an der Donau). 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

203 825 

292 

 
 
 
2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

450 ml +/- 45 ml 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

152 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

600 ml 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

6 257 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

200 - 400 ml 

108 

47 

14 

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

2.1.17.1. If other, please specify. 

These data are part of the selection form (questionnaire). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

N/A 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

It is mandatory based on Decree of the Ministry of Health of the 
Slovak Republic No. 333/2005 Coll.  

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

box for questionnaires from self-excluded donors in every blood 
establishment 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

All eligibility/deferral criteria are equally relevant. 

Defferal criteria concerning malaria - we do not perform malaria 
testing in our labs.  Donors, who have suffered from malaria or have 
spent first five years of life in malaria endemic region,  are 
definitively excluded from blood donation. 

No 

Yes 

Persons whose behaviour or activity places them at risk of acquiring 
infectious diseases that may be transmitted by blood. Persons whose 
sexual partners have tested positive for HIV.  

Yes 

No 

There were no data available. 

2.2.9. Do you have a system of centralised collection of data on 

Yes 

293 

 
 
 
deferrals? 

2.2.9.1. If yes, please specify. 

Datas on the total number of the defferals, total number of the 
defferals in first time donors and total number of the defferals in 
repeat/regular donors  are collected on central bases. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

27 874 

Yes 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Labs are audited on regular basis. These controls are part of 
inspections of blood establishments. Labs must participate in 
external quality control. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

economical; acceptable epidemiological situation / data 

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

 anti- HBcore (total) and ALT are mandatory under national 
legislation 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

yes, anti- HBcore (total) and ALT are mandatory under national 
legislation 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

No 

Yes 

2 

24 

25 

31 - syphilis 

No 

No 

Yes 

Yes 

in the absence of responsible persons, their responsibilities are 
delegated to other persons qualified by training and experience to 
perform such tasks 

All personnel in blood establishments shall receive initial and 
continued training appropriate to their specific tasks. Training 
records shall be maintained. Training programmes shall be in place 
and shall include good practice. The contents of training 

294 

 
 
 
programmes shall be periodically assessed and the competence of 
personnel evaluated regularly.This requirements are mandatory 
based on Decree of the Ministry of Health of the Slovak Republic 
No. 487/2006 Coll. Criteria and responsibilities of The Quality 
Assurance Manager and Processing or Operations Manager are 
defined in Act No. 362/2011 Coll. on Drugs and Medical Devices 
and on Amendment and Supplementing of Certain Acts as amended 
later. Quality Assurance Managers participate in  regular courses at 
Slovak Medical University. 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

The principles of good practice are mentioned in Decree of the 
Ministry of Health of the Slovak Republic No. 333/2005 Coll. on 
Requirements for the Good Preparation Practices for Blood 
Products. 

It is mandatory to maintain documents setting out specifications, 
procedures and records covering each activity performed by the 
blood establishment based on Decree of the Ministry of Health of 
the Slovak Republic No. 487/2006 Coll. This documentation is 
controlled during regular inspections.  

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

It is mandatory based on Decree of the Ministry of Health of the 
Slovak Republic No. 487/2006 Coll. and controlled during 
inspections. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

The specifications of storage, transport and distribution conditions 
are implemented in Decree of the Ministry of Health of the Slovak 
Republic No. 333/2005 Coll.  

Privacy is mandatory based on Decree of the Ministry of Health of 
the Slovak Republic No. 333/2005 Coll. and Act no. 122/2013 Coll. 
on Protection of Personal Data and about amendment of other acts. 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

This system is mandatory. 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

This guide is helpfull for all processes conducted in BE. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

Yes 

47 

No 

Ministry of Health of the Slovak Republic 

295 

 
 
 
4.6. How many laboratories performing donor testing are active 
within your country? 

47 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

4.8. How many hospital blood banks are active within your country? 

Ministry of Health of the Slovak Republic 

46  blood banks not depended on blood establishments and 34 as a 
part of blood establishment 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Inspection Section of The State Institute for Drug Control. 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

3 inspectors 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

Pharmaceuticals (including plasma derivatives) 

Every BE is inspected in 2-years intervals. 

When it is necessary. 

15 

1 

1 follow-up inspection 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

No 

5.5.2.1. If no, why not? 

we have sufficient number of inspectors 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

23 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

Blood establishments are inspected every two years. Mobile site can 
be included in this inspection. 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

State Institute for Drug Control issued Certificate of good 
preparation practice for blood products. This certificate is valid for 2 
years. 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

After eliminated minor shortcomings was issued Certificate of good 
preparation practice for blood products. This certificate is valid for 2 
years. 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

After eliminated major shortcomings was issued issued Certificate of 
good preparation practice for blood products. This certificate is valid 
for 2 years. 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 

No suspension of authorisation  

No closure of blood establishment 

296 

 
 
 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

State Institut for Drug Control - proposal for sanction. Ministry of 
Health is responsible for sanctioning. 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

1 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

Decree  333/2005 Coll. on good practice of the blood preparation, 
Annex VI. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

Act 362/2011 Coll. on Medicinal Products and Medical Devices § 
129(2)o). Decree 333/2005 Coll. on good practice of the blood 
preparation, § 14 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

It is helpfull. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

Ministry of Health in collaboration with State institute for Drug 
Control  

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

for all 

No 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

Both paper records and electronic forms 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

It is mandatory based on Decree of the Ministry of Health of the 
Slovak Republic No. 333/2005 Coll.  

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Vigilance system is ensured by State Institute for Drug Control 
(Inspection section, Section of drug safety and clinical trials), Head 
expert for Transfusion and Regional experts for Transfusion. 
Haemovigilance system is described in Decree of the Ministry of 
Health of the Slovak Republic No. 487/2006 Coll.  

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

Yes 

Yes 

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6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

Yes 

70-99% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Hospital blood banks have to notify blood establishments which 
distributed the blood and blood components. Investigation of serious 
adverse reactions are usualy performed by regional BE in its 
specialized lab. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

We perform root cause analyses of serious adverse reactions 
(Immunological Haemolysis, Transfusion-transmitted bacterial 
infection, Transfusion-transmitted viral Infection...) for all patients 
except some patients (depend on the adverse reaction) with known 
multiple  anti- HLA antibodies or repeat allergies already  
investigated. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Serious adverse reactions (which are reported on EU level by State 
Institute for Drug Control)  are investigated  by regional BEs under 
the supervision of  Regional experts for Transfusion and  final 
repport is sent to blood establishments. Very serious adverse events 
are immediately repported to Head Expert of MofH in Transfusion 
and to Ministery of Health if investigations on place are needed. 
Investigations are conducted by State Institute for Drug Control and 
(depend on type of SAR or SAE) with collaboration of Ministry of 
Health.  

6.2.9. Do you require your BEs to have recall procedure? 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

Yes 

No recalls. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

In case of national rapid alert, this serious information is reported to 
State Institute for Drug Control and Ministry of Health. Inspectors of 
State Institute for Drug Control condact  non- routine inspection and 
warn Head expert for Transfusion. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

In this case Ministry of Health and Head expert for Transfusion 
notify Regional experts for Transfusion. Regional experts warn 
single blood establishments in their regions. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

6.2.13.1.1. If other, please specify. 

Pharmacovilance 
Communicable diseases and other threats to health 
Other 

in case of endemia, we report endemic areas and warn Public Health 
Authority of the Slovak Republic. 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No 

No 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 

They have to meet equivalent standards for quality assurance. Blood 
and blood components imported from third countries, including 

298 

 
 
 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

those used as starting material/raw material for the manufacture of 
medicinal products derived from human blood and human plasma, 
should meet the quality and safety requirements set out in this 
Decree of the Ministry of Health of the Slovak Republic No. 
333/2005 Coll.  

There are not any plasma fractionation facilities in our country 

Equivalent standards (bilateral agreements) 

Yes 

7.4.1. If yes, please specify. 

Certificate of CA. No import.  

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

0 (No import of blood components from third countries)  

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

0 (No import of plasma from third countries)  

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

The rules are designated in national legislation: Act No. 362/2011 
Coll. on Drugs and Medical Devices and on Amendment and 
Supplementing of Certain Acts as amended later, § 70. Ministry of 
Health of the Slovak Rebublic issues authorisations for export of 
human plasma. 

Ministry of Health of the Slovak Rebublic issues authorisations for 
export of human plasma. Act 362/2011 Z.Coll. § 70. 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

3063 L of plasma - country of destination Ukraine  

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

0 (No export of blood components  to to third countries)  

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

No 

No 

No 

Yes 

Yes 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

One of imposed major shortcomings was not eliminated after 
inspection.  

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

1 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

1  - suspension of authorisation, 1 - fine 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

299 

 
 
 
8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

No difficulties. 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Donors, who visited endemic areas can not donate blood and blood 
components during 1 month after return. Donor with the symptomes 
of WNV desease cannot donate the blood  during 3 month after his 
recovery. 

8.5. Which other communicable diseases are of relevance to you? 

Dengue, Chicungunya, Malaria  

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

Pharmaceutical legislation, but separated from blood and blood 
component  legislation - Act No. 362/2011 Coll. on Drugs and 
Medical Devices Competent authority is  Ministry of Health 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

no 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

In our country, legal framework for blood and blood components, 
which implement EU blood legislation, is a part of pharmaceutical 
legislation, Act No. 362/2011 Coll. on Drugs and Medical Devices 
and on Amendment and Supplementing of Certain Acts as amended 
later in our country. 

300 

 
 
 
 
 
 
A.1.27. 

Survey response Slovenia 

1. Public information 

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

1.1.2. Address of&nbsp;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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Javna agencija Republike Slovenije za zdravila in medicinske 
pripomočke (Agency for Medicinal products and Medical Devices of 
the Republic of Slovenia)  

Ptujska ulica 21, 1000 Ljubljana 

+386 (0)8 2000 500 

info@jazmp.si 

www.jazmp.si 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Tissues and cells 
Medical devices 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

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), “Public Agencies Act” (2002, 2004, 2011) and 
“Decision on the establishment of the Public Agency for Medical 
Products and Medical Devices of the Republic of Slovenia” (2006). 
JAZMP is organised in 12 sectors. EU issues are as a rule treated 
with very high priority by JAZMP.  

1.5. 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) 

Not applicable 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

NA 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

3 BE (with dislocated blood departments, total number of sites: 15) 

2.1.2. How many of the BEs are satellite sites? 

9 

2.1.3. How many of the BEs are mobile sites? 

3, Each BE is authorised to perform blood collection with mobile 
site. 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

59.634 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

NA 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

10.706 

Yes 

Some sporadic blood donors  (less then 0,5 %) do come for whole 
blood collection, mostly because of longer staying in Slovenia due to 
work, imigration, study..).  They came from EU countries, Bosnia, 
Croatia... 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

93.099 

450 mL 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

623 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 

500 mL 

301 

 
 
 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.343 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.17.1. If other, please specify. 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

single dose unit with additive solution = 300 mL, double dose unit 
with additive solution = 600 mL 

granulocytes, apheresis: 125 

3 

2 

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

- Other paper material - web sides of Red Crossand Transfusion 
Service - educational program for prospective young donors (Club 
25)  

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 

Please see uploaded document. 

Legal requirement (Rules on mandatory testing of blood and blood 
components, Official Gazzette 9/2007, Art.6) 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

Pre-donation exclusion is based on questionnaire and interview with 
medical doctor, post-donation self exclusion is possible by telephone 
call 

Medical condition of donor (which are relevant to not harm donor). 

Deferral for particular epidemiological situation, sexual behaviour. 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

Specialy for the first time donors (whole blood and apheresis blood 
components)  the criteria not just body weight, but it would be 
appropriate to calculate extracorporal volume (on the basis of body 
weight and body high). 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

Yes 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

During the last 12 months have you had sexual contact with: - a 
partner who is HIV positive or has viral jaundice (hepatitis)? - a 
partner who has injected drugs? - a partner who receives payment 
for sex, in money or drugs? - a man who had sex with another man? 
Have you ever - injected drugs? - accepted payment for sex, in 
money or drugs? - had sex with another man (male donors)?  

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

Yes 

No 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 

Low level of Hb = 28,5% High/low blood pressure = 8,2% Deferral 
for particular epidemiological reasons = 4,9% Not feel well = 5,3% 

302 

 
 
 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

Flu-like illness and fever > °C = 5% Medication = 3.8% Too short 
time between two donation = 2,1% (Data from BTCS)  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

Annual report to Competent Authority 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

12.979 

No 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

Checking during Authorisation procedure and during Inspection 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

According to Slovene legislation NAT testing for viruses (HIV, 
HBV, HCV) is mandatory for all allogenic donations.  

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

Yes 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

Additional test for syphillis  is required: anti-Treponema pallidum, 
not required for autologous donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

Additional test for syphillis  is required: anti-Treponema pallidum, 
not required for autologous donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

No 

Yes 

2 

8 HbsAg pos and 4 HBV DNA -only pos 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

4 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 

Anti-TP(syphillis): 10  

No 

Yes 

Amotopsoralen + UV radiation (Intracept) for Plateles 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

Tasks are delegated Only In cases of absence of QP, however the QP 
or Deputy should be available 24/7. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

The requirements are certified during authorisation procedure and 
during inspections. 

303 

 
 
 
3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

ISO 9001:2008 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Legal requirement, verified during authorisation procedure and 
during inspections. 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Documentation should be maintained for 30 years, in paper records. 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

Provision in legislation. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Provision in legislation, Genetic data are not specified in our 
legislation. 

Yes 

Yes. 

Yes 

Very useful. There are some differences in eligibility criteria for 
donors. 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

1.7.2013: 3 (WITH ALL SITES) 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

Ministry of Health 

4.6. How many laboratories performing donor testing are active 
within your country? 

3 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

Ministry of Health 

4.8. How many hospital blood banks are active within your country? 

3 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

No 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Inspection 

304 

 
 
 
5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

4 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

Tissues and cells 

1.1.2008-31.12.2012: 28 

1.1.2008-31.12.2012: 15 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

7 

1 

1 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

Based on findings in previous inspections, legal requirements (at 
least 2-years inteval) and after authorisations of new activity (ctitical 
steps could be assesed/ inspected earlier than legal requirement)  
annual plan of inspections for current year is prepared.   

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

Small country, we do not have a lot of BE. 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

3 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

The 2-years inspection intervals are equal for all sites.  

Complient, 2-years inspection period is forseen. 

CAPA, CAPA assess, 2-year period 

CAPA, CAPA assess, after 1 year follow-up or routine inspection in 
2-year period 

NA 

NA 

NA 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

We do not have plasma establishments (sites just for plasma 
collections) 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

No 

5.8.1. If no, please explain. 

Only inspectors can inspect blood establisments and any third 
parties. 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

305 

 
 
 
5.9.1. If yes, please describe. 

Quality manegement service on the BTCS is involved in inspecting 
hospital blood banks by contract. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

No 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

Very good tool 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

5 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

JAZMP 

Yes 

6.1.3.1. If yes, for which blood components? 

For all blood components (Ertc, Pt, Plasma, Lkc, Whole blood) 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

CODABAR 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

6.1.4.2.1. If other, please specify. 

granulocyte apheresis 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Both paper records and electronic forms 

Provision in legislation 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Any serious adverse event related to the collection, testing, 
processing, storage and distribution of blood and blood components 
which may have an influence on their quality and safety, as well as 
any serious adverse reactions observed during or after transfusion 
which may be attributed to the quality and the safety of blood and 
blood components are notified to the competent authority. All 
SAR/E reports are reported on prescribed forms-templates. These 
templates have two parts, in the first part there are basic 
informations about SAR/E and in the second part there is a 
conformation question regarding the SAR/E. As basic information 
there is a needs to indicate the institution that reports, identification 
of report, day of report and day of the SAR/E. For SAR they need to 
then specify the blood component/s, type od the reaction and rate of 
connection between transfusion and reaction. At the second part they 
confirm SAR, rate of connection between transfusion and reaction 
and clinical outcome. For SAE they need to specify irregularity and 
type of specification. At the second part they confirm the event, root 

306 

 
 
 
6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

cause analysis and corrective action taken. We keep records of all 
the received reports and, if necessary, inform inspectors. Reports 
that we receive through CIRCABC, Rapid Alert System for Human 
Blood and Blood Components we sent to the appropriate recipients 
for further consideration. Then they take all the necessary measures 
and inform us about them.  

Yes 

Yes 

Yes 

100% 

Yes 

All SAR/E reports are reported on prescribed forms-templates. 
These templates have two parts, in the first part there are basic 
informations about SAR/E and in the second part there is a 
conformation question regarding the SAR/E. As basic information 
they need to indicate the institution that reports, identification of 
report, day of report and day of the SAR/E. For SAR they need to 
then specify the blood component/s, type od the reaction and rate of 
connection between transfusion and reaction. At the second part they 
confirm SAR, rate of connection between transfusion and reaction 
and clinical outcome. For SAE they need to specify irregularity and 
type of specification. At the second part they confirm the event, root 
cause analysis and corrective action taken. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

In cases when SARE may be connected with quality and safety. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

No 

6.2.8.2. If no, why not. 

No legal requirement 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

23 units of blood components    

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

Ad hoc meeting on BTCS, the short describtion of alert and actions 
send to BE. In cases of SARE CA is informed. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

CA informs Hemovigilance service at BTCS. Ad hoc meeting on 
BTCS, the short describtion of alert and actions send to BE. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Via Rapid alert system for human tissues and cells, Medical Devices 
Vigilance System, Pharmacovigilance system, National system for 
communicable diseases 

307 

 
 
 
6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

No 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.4.1. If yes, please specify. 

The imported blood must fulfill the national requirements. (Blood 
Supply Act, Official Gazette No.104/2006, Art. 26) 

NA (Slovenia does not import blood and blood components for 
fractionation; Slovenia does not have fractionation facilities) 

International standards 

Yes 

Our demand goes more beyond the minimum requirements, as NAT 
testing f.exp. in Slovenia is done on single donations, as in others 
countries is done on pooled donations. 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

0 blood component was imported in 2012. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.6.1. If yes, please provide this data by country of origin. 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

Yes 

0 units of plasma was imported in 2012, we do not have plasma 
fractination facilities in Slovenia. 

Contract and quality assurance agreement. 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

Only in emergency cases as humanitarian help, with special 
authorisation of Minister of Health. (Blood Supply Act, Official 
Gazette No.104/2006, Art. 28) 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.9.1. If yes, please provide this data by country of destination. 

No units of blood components were exported for fractination to third 
countries in 2012. 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.10.1. If yes, please provide this data by country of destination. 

No units of blood components were exported for transfusion to third 
countries in 2012. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

No 

No 

No 

Yes 

No 

NA 

0 

308 

 
 
 
8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

NA 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

In our legislations  the formal  uniform transfusion service as one 
organisation is not supported enough, so we are experiencing 
different organisation and approaches  

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

28-days deferral for donors coming from impacted aereas. 

8.5. Which other communicable diseases are of relevance to you? 

Flue, Tick borne disease 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

We regulate PRP under Tissue and Cells legislation. The National 
Competent Authority is JAZMP. The decision for regulating other 
»borderline« products and techniques under Tissue and Cells, Blood 
or Medicinal Product legislation, should be taken case-by-case. 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

No 

No 

309 

 
 
 
 
 
 
A.1.28. 

Survey response Spain 

1. Public information 

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

1.1.2. Address of&nbsp;NCA 1: 

1.1.3. Telephone (central access point): 

1.1.4. E-mail (central access point): 

1.1.5. Website: 

1.  General Directorate for Public Health. Ministry of Health, Social 
Services and Equality 
2.  Autonomous Communities: Health Departments (17) 

Paseo Del Prado 18-20. 28014. Madrid. 

34 91 5962062 

dgspci@msssi.es 

http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransf
usional/home.htm 

1.1.6. The NCA is responsible for? (more than 1 answer possible) 

Blood and blood components 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Haemovigilance  
Other 

1.1.7.1. If other, please specify. 

1. Basic legislative  
2 It dictates guidelines for action in transfusion security national 
policy 
3. Authorization of importation/exportation of blood and blood 
components 

1.2. National Competent Authority 2? 

1.3. National Competent Authority 3? 

No 

No 

1.4. 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.). 

The Ministry of Health exercises the activities linked to the National 
System for the Transfusional Security (SNST), and is competition to 
establish common basic standards that set the conditions and 
minimum requirements, chasing an equalizing basic conditions in 
the functioning of public services 
The Ministry has set as objectives the self-sufficiency of blood and 
derivatives based on altruistic donations, to guarantee safety for the 
donor and recipient and an optimal use of blood and blood 
components in accordance with guidelines from the European 
Union. For advice on this matter, it has a Scientific Committee 
(CCST) 
1. The Scientific Committee for Transfusion Safety (CCST) is a 
technical advisory body under the Ministry of Health through the 
General Directorate of Public Health  
The technical advisory is responsible for proposing the guidelines on 
transfusion safety at national level. The committee operates under 
the principles of objectivity, impartiality and confidentiality in the 
performance of their duties. 
2. The National Commission for Hemotherapy (CNH): coordinating 
body 

1.5. 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) 

Designation, authorisation, accreditation, licensing of Bes 
Inspection 
Haemovigilance 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

Spain is divided in 17 autonomous communities (also called 
regions). Each of these regions has a competent organization for 
implementing health policies and for developing further regulations 
than national ones. 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

24 (Will be 20 in 2014) 

2.1.2. How many of the BEs are satellite sites? 

If it refers to establishments-dependent units it is 4 

2.1.3. How many of the BEs are mobile sites? 

The number of units estimated is 150 (national total) 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

1.214.281 donors (first time + repeat + known donors) 

828.955 

233.062 

2.1.7. Do you experience cross-border movement of donors 

No 

310 

 
 
 
 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

1.702.768 

450 cc 

22.564 

550 cc 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

7.880 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

75% Units should be > 3 x 10 (11) of platelets. 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

Multicomponent aphaeresis = 24.235 
Erithroaphereis: 493 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

24 

24 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form standardised at national level (in English if possible).* 

2.1.18.2. Please provide a copy of the donor evaluation/selection 
form standardised at regional level (in English if possible).* 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

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

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at regional level 

http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransf
usional/publicaciones/docs/criteriosBasicosTomoII_2006_030907.p
df 

See Annex I (see Attached files) (Selection form of two regional) 

1. Through regular inspections carried out by the regional authorities 
(regional) 
2. Assessments carried out by The Scientific Committee for 
Transfusion Safety 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

In the information provided to the donor, there is a specific 
questionnaire opt-out, but it is not usual to have the Blood 
Establishments unit of opt-out 

All of them are relevant 

Aspects related to sexual risk behaviours 

No 

Yes 

http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransf
usional/publicaciones/docs/criteriosBasicosTomoII_2006_030907.p
df (page 39) 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 

Yes 

No 

311 

 
 
 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

There is a computerized registry of donors in the 24 BEs. The 
specific causes and their frequencies are recorded in each BE (24). Is 
not collected at national level 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

24 Centers of Blood Transfusion (BEs) report to the Ministry 
annually total number of excluded donors, and of these the number 
of temporary and permanent exclusions 

Total number of excluded donors: 194.346 (total registered donors: 
1.214.281) 
Excluded temporarily: 176.013 (90, 7%) 
Excluded permanently: 18.333 (9, 3%) 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

No 

No 

2.2.11.1. If no, what other deferral criteria would you suggest for 
derogation? Would you have other suggestions on the usefulness and 
set-up of such temporary derogations? 

- 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

The corresponding authorizations are applied to the autonomous 
communities, as well as proof of registration 
Annually the 24 BE are asked for the type of tests used, (including 
the trademark), for each infectious marker 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

HIV: Tested Units: 100% 
HBV: Tested Units: 100% 
HCV: Tested Units: 100% 
Total Tested Units NAT: 1.762.042 (100%) 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

3.1.5.2. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

3.2. Processing 

No 

No 

Yes 

142 

474 

252 

Selective test: 
HTLV-I-II: 35 positives (Tested units: 534.886) 
Paludismo: 124 positives (Tested units: 17. 6739 
Tripanosoma Cruzi: 125 positives (Tested units: 87.609) 

- 

Yes 

Methylen-Blue inactivation for plasma (transfusion) 

312 

 
 
 
3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

1 Inspections carried out by regional authorities (CCAA)  
2 Inspections carried out by the CAT Foundation (Committee on 
accreditation in Transfusion), this Agency has been recognized in 
2010 by the national accreditation entity (ENAC), as certification for 
BEs and transfusion services (HBB).  
About the CAT Foundation: It is an organization made up of the 
Spanish society of Hematology and Hemotherapy (AEHH) and the 
Spanish society of Blood Transfusion and Cellular therapy (SETS) 
of December 11, 2008. Its origins lie in 1973, with the creation of 
the accreditation program of blood banks 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

1. Annually information on quality systems implemented in both 
BEs and HBB is collected. The 100% of HBB have "standard 
operating procedures of work". 

A) Through the implementation of quality systems certification 
bodies, such as: 
1. CAT Foundation inspects and certifies the quality systems of BEs 
and HBB 
2. Organisms dependent on regional authorities such as the 
accreditation agency of health centers of Andalusia (ACSA) 
3. Private independent agencies: Bureau-Veritas, AENOR etc. 
(B) By the publication and distribution of manuals and guides of 
quality: 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Specific computer systems 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

Specific computer systems 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

1. There is legislation specifies: law on data protection, and bioethics 
Research Act 
2. Specific computer systems 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

Yes 

3.2.9.1. If yes, is this system mandatory? 

It is mandatory to have a code system but is not mandatory to be the 
same system for all the country. Currently the following systems are 
used: 
ISBT- 128: 76% 
CODABAR: 18% 
Others (CODE 39):6% 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

Yes 

3.2.10.1. If yes, what is your experience with this Guide? 

The experience has been excellent. Spain since 1988 is part of the 
Group of experts on the elaboration of the Guide to the preparation, 
use and quality control of the Council of Europe. It has been 
translated several times, and is systematically disseminated to alls 
BEs 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

313 

 
 
 
 
4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

The authorization of establishments is granted by 
the regional authority 
Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

All BEs (n=24). See table in annex II. 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

The laboratories are approved by the regional authorities (17) 

4.6. How many laboratories performing donor testing are active 
within your country? 

24 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

By the regional authorities 

4.8. How many hospital blood banks are active within your country? 

There is 368 Hospital Transfusion Services (HBB) 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

Yes 

4.9.1. If yes, please specify the scope of these extra rules. 

The implementation of quality Systems (art. 32 RD 1088/2005) 
The implementation of Hospital Transfusion Committees (art. 40 
RD 1088/2005) 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

Laboratories Grifols (private) were founded in 1940. (Barcelona. 
Catalonia). In 2006, the company changed its name to Grifols 
S.A.The plasma sent by the BEs to Grifols is processed into 
therapeutic plasma products, and returned to them for distribution to 
the hospitals 
In Barcelona, Grifols fractionation plant has a fractionation capacity 
of 2.1 million litres annually 
In 2012 it fractionated 365.000 litres of Spanish plasma 

4.10.2. If yes, please state the responsible authority within your 
country. 

Jurisdiction of the Spanish Agency for Drugs and Medical Devices 
(Agency) 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

1. The Regional Health Authority Inspection Department 
2. Accreditation systems carried out by scientific societies (CAT) 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

1. Inspector of the Regional Health Authority Inspection 
Department, together with one or two experts in transfusion 
medicine (2-3) 
2. CAT: Experts in transfusion medicine (2) 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

No 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

See annex II table inspection 

See annex II table inspection 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

- 

- 

314 

 
 
 
5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

See annex II table inspection 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

100% (24) 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

Satellite: every 2 years. 
Mobile collection sites: a sample of the total number 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

0% 

100% 

0% 

0% 

0% 

- 

0%. There are no plasma establishments in Spain 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

CAT Foundation and some regional authorities. 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

No 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

The experience has been excellent. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

5 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.4. Do you apply an international coding system for blood 
components? 

Specific computer systems 

No 

Yes 

315 

 
 
 
6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT-128 (76%) 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 

Only electronic forms 

Specific computer systems 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

Local level (level 1): this level is composed by the HBBs 

Spain is divided in 17 autonomous communities (also called 
regions). Each of these regions has a competent organization for 
implementing health policies and for developing regulations. In 
accordance with this organization, the national network is made up 
of the HV network of the 17 regions, together with the 
Haemovigilance Unit. 
The current system is organized in three levels (see figure):  
• 
and the Blood Establishments BEs. The detection and first analysis 
of potential adverse events and reactions is responsibility of the 
HBB and the BE staff.   
• 
Regional Haemovigilance Networks. Within this level, tasks that 
involve collecting information from BE and HBB depending on each 
regional authority and the coordination with the Ministry of Health 
are developed. The responsible person is the Regional 
Haemovigilance Coordinator.  
• 
find the Haemovigilance Unit that is responsible for the coordination 
of the 17 regions and for the relationship with the European 
Commission. This Unit gathers the information related to the events 
registered by the regional networks and it prepares an annual report. 

National level (level 3): this is the place where we can 

Regional level (level 2): this level is made up by the 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

Yes 

6.2.2.1. If no, what template do you use (please specify)? If possible, 
please upload template. 

A similar template to the one developed for the annual reporting is 
use for gathering the SAEs.  A more complete template than the EC 
one is used for reporting SARs. 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.1. If yes, please provide a brief description. 

6.2.6.1. If yes, please provide a brief description. 

Yes 

Yes 

100% 

Yes 

A procedure was made in 2004. It includes common definitions, 
templates for reporting SAREs and a general reporting framework. 

A procedure was made in 2004. It includes common definitions, 
templates for reporting SAREs and a general reporting framework. 

6.2.7. Do you perform root cause analyses of the SARE? 

Yes 

6.2.7.1. If yes, in which cases? 

In all cases. Templates use for reporting SARs at HBBs include 
questions intended to evaluate their possible cause. The root cause 
analyses for SAEs is made by BEs 

316 

 
 
 
6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

No 

6.2.8.2. If no, why not. 

Because we were waiting for data of SAR/E recorded at EU level to 
be more consolidated and for an official and public report from the 
EU. 

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

Information only available at regional level. 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

The NCA and the responsible person in every BEs are in touch by e-
mail and phone. A mail distribution list is made and it is continually 
updated. 
We also are working in a system called e-Room which is expected to 
be an alert system. This system is quite similar to the CIRCA BC 
platform. 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

The NCA and the responsible person in every BEs are in touch by e-
mail and phone. A mail distribution list is made and it is continually 
updated. 
We also are working in a system called e-Room which is expected to 
be an alert system. This system is quite similar to the CIRCA BC 
platform. 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

Communicable diseases and other threats to health 
Medical devices 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

Blood components are not imported for transfusion 

Jurisdiction of the Spanish Agency for Drugs and Medical Devices 
(Agency) 
The importing pharmaceutical laboratory must be authorized by the 
Agency to import, store, and analyze Plasma as raw material of 
biological origin (Biomat) 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Equivalent standards (bilateral agreements)  
If it was necessary, equivalent standards verification would be 
applied. 

7.3.1. If others, please specify. 

IVO: If a BE is in a situation that they have to import blood or blood 
components they have a responibility to ensure that the place where 
they import from has the same quality standard as the national. (e.g 
EU legislation)  MPA: För plasma for fractionation, the compliance 
with the EU-standards is documented in Plasma Master Files, which 
is scrutinized before approval of the PMF and of the corresponding 
plasma derived medicinal products. A reassessment of the PMF, as 
updated, is thereafter made annually. PMFs are certified by EMA in 
a EU-centralised procedure 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 

Yes 

317 

 
 
 
 
Directive 2002/98/EC? 

7.4.1. If yes, please specify. 

In the event that it was necessary, application of NAT technology in 
minimum markers would be required, detection of Chagas` disease, 
as well as the application of procedures of leukodepletion and/or 
viral inactivation 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

Yes 

7.5.1. If yes, please provide this data per component and by country 
of origin. 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10.1. If yes, please provide this data by country of destination. 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

No components for transfusion were imported. 

No. 
Jurisdiction of the Spanish Agency for Drugs and Medical Devices 
(Agency) 

Jurisdiction of the Spanish Agency for Drugs and Medical Devices 
(Agency) 

Not applicable 

Yes 

Yes 

= 0 

No 

No 

Yes  No  
We do not understand this question. 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

Yes 

No 

Yes 

8.2.1. If yes, please specify. 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

There is a protocol of actions from the National Epidemiological 
Surveillance Network that establishes the bases of surveillance and 
the public health measures to control communicable diseases that 
must be reported in Spain, and those diseases that must be monitored 
in the framework of the European Union, including WNV. 
1st. As described in the Protocol, (updated in April 2013) active 
epidemiological surveillance in humans begins when viral 
circulation in animals (birds or horses) and/or vectors is detected. 
These criteria are adjusted depending on the epidemiological 
situation. The epidemic territory is defined according to the 
circulation and dynamics of the infection of the virus and in it the 
recommended public health measures will be applied. In areas where 
have already been detected human cases, active surveillance is 

318 

 
 
 
 
 
reactivated at the beginning of each season of activity of the vector. 
If, at any time, a doctor or laboratory detects a case of infection by 
this virus, it notifies by urgent and compulsory way this fact to the 
epidemiological surveillance of the corresponding autonomous 
community service, and from here to the central level. 
Public health measures 
Preventive measures 
Broadly, the prevention of human infection is based on preventing 
mosquito bites and to increase transfusion and transplantation safety. 
In human outbreaks that have occurred in our environment, 
surveillance of WNV outbreaks in horses has been a fundamental 
element to delimit the epidemic territory, so it is essential to have 
up-to-date and GEO-referenced information from these foci. 
Notifiable diseases protocols: 
http://www.isciii.es/ISCIII/es/contenidos/fd-servicios-cientifico-
tecnicos/fd-vigilancias-alertas/fd-procedimientos/protocolos.shtml 

Preventive measures of transmission by blood: 
Recommendations of the Scientific Committee on Transfusion 
Safety (November 2010) after the Spanish outbreak is available in: 
http://www.msssi.gob.es/profesionales/saludPublica/medicinaTransf
usional/acuerdos/docs/Virus_Nilo.pdf. 

8.5. Which other communicable diseases are of relevance to you? 

No 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

No X 
(But currently it is not clear (platelets rich plasma)) 

It depends on the type of product, as well as the form of obtaining 

RPP, autologous eyes drops 

Any plasma with industrial treatment (Example: SD inactivated 
plasma). 

319 

 
 
 
 
 
 
 
A.1.29. 

Survey response Sweden 

1. Public information 

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

Health and Social Care Inspectorate (IVO) 

1.1.2. Address of&nbsp;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) 

Inspektionen för vård och omsorg (IVO) Box 45184 104 30 
Stockholm Sweden 

+46 10 788 50 00 

registrator@ivo.se 

www.ivo.se 

Blood and blood components 
Tissues and cells 
Human organs 

1.1.7.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

Yes 

1.2.1. Name of National Competent Authority 2: 

Medical Product Agency 

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

1.2.6.1. If other, please specify. 

1.3. National Competent Authority 3? 

Läkemedelsverket Box 26 SE-751 03 Uppsala Sweden 

+46 18 17 46 00 

registrator@mpa.se 

www.lakemedelsvarket.se 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Other 

Pharmaceuticals (including blood deriatives) and Medical devices 

Yes 

1.3.1. Name of National Competent Authority 3: 

National Board of Health and Welfare 

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: 

Socialstyrelsen 106 30 Stockholm  Sweden  

+46 75 247 30 00 

socialstyrelsen@socialstyrelsen.se 

www.socialstyrelsen.se 

1.3.6.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

Other 

1.3.6.1. If other, please specify. 

Legislation, knowledge  

1.4. 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 an Social Care Inspectorate: Independent CA with 
assignment from the govenment to supervise and authorize health 
and social care in Sweden. Total numbers of staff approx 500 
localized as six regional offices and one central office. Tha staff 
consists of various expertise depending on the area for supervision, 
accordingly the staff consists of health care personell, social workers 
and legal advisers. 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, 
tissue and cells and organs. Medical Product Agency: Independent 
CA responsible for regulation and surveillance of the development, 
manufacturing and sale of medicinal products and for the 
surveillance of medical devices. Approximately 750 people work att 
the agency; most are pharmacist and doctors.  The agency is divided 
into four departments; Development, Licensing, Supervision and 
Usage. The agency is actively involved in EU matters in the field of 
pharmaceuticals and medical devices. The National Board of Health 
and Welfare: Independent CA with assigment from government to 
perform follow up, national guidelines, issue bylaws and keep 
national registries in the areas of Health and Social care. Total 
numbers of staff is approximaltely 400 divided into three 
departments; Regualtions and Licences, Statistics, Monitoring and 
Evaluation and Knowledge-based Policy and Guidance.    

1.5. 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) 

Not applicable 

320 

 
 
 
1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

NA 

2.1. Collection 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

MPA: 91 IVO:28 See 4.7 for explanation 

94. incl certain satellites, used with low frequency, included in the 
authorisation of a regular BE 

13 

247549 

247549 

NA 

No 

484755 

450 

9929 

700 

NA 

NA 

NA 

23 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

se answer 2.1.15 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

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

Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is not standardised at national/regional level 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

By inspections 

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

If a donor for some reason after donation no longer want the BE to 
use his/her blood they have a possibility to give notice to BE and 
they cannot ask why. If this is happening the blood and blood 
components will be registrered with a code in the IT system and no 
components will be used. When this donors occures in a BE he/she 
will be checked up before donate again. 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

All criteria are relevant but some of them have to be evaluated on a 
national level because of the actual situation in the country. 

2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 

Section 2.1, Sexual behaviour: We have encountered interpretation 
difficulties concerning “permanent deferral” and “high risk”.  

321 

 
 
 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

Yes 

2.2.3.1. If yes, please specify (additions/deletions/replacements, 
&hellip;). 

In Annex III section 2.1 of the Commission Directive 2004/33/EC of 
22 March 2004 implementing Directive 2002/98/EC of the European 
Parliament and of the Council as regards certain technical 
requirements for blood and blood components there are the 
following permanent deferral criteria for donors of allogeneic 
donations: Sexual behavior Persons whose sexual behavior puts 
them at high risk of acquiring severe infectious diseases that can be 
transmitted by blood A deferral period would be more reasonable 
and enable these persons to donate blood or blood components, if a 
reasonable time frame could be set to rule out the risk of transferable 
diseases. To clarify such an interpretation, the directive should be 
amended as follows: The above mentioned lines in section 2.1 on 
sexual behavior are omitted. Instead, an amendment of section 2.2.2 
Exposure to risk of acquiring a transfusion-transmissible infection 
under 2.2 Temporary deferral criteria for donors of allogeneic 
donations is done by inserting a new line as a third paragraph: 
Sexual risk behavior Defer for 12* months after cessation of risk 
behaviour  (*appropriate time period may be a subject of discussion)  

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

No 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

There is several risky behaviours that should  be taken into account 
when You have to consider donor deferral. Most important is to 
identify high risk sexual behaviours in the the interwiew with the 
potential donor. 

No 

No 

The population in Sweden travelling a lot and therefor it is very 
common with temporary deferral for that reason. Even tattooes are 
very common and gives a period of deferral. 

No 

No 

No 

2.2.11.1. If no, what other deferral criteria would you suggest for 
derogation? Would you have other suggestions on the usefulness and 
set-up of such temporary derogations? 

NA 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

It is mandatory by legislation only to use accredited laboratories. 
Analyses of the mandatory documentation is requested from all BEs 
and they have to show which laboratory they use for donor testing 
(and have a written agreement applicable). The accreditation by 
SWEDAC is publicly available and the laboratory holds an 
accreditation licence. MPA:  the laboratories must be inspected and 
comply with the Codes of statutes LVFS 2006:16. 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

No 

3.1.2.2. If no, please specify the main barriers to implement NAT 
testing? 

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 

322 

 
 
 
3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

testing will be mandatory. As a voluntary measure applied by BEs, 
blood components are collected only from repeat tested donors in 
Sweden which means that a first time donor will not be allowed to 
give blood. 

Yes 

HIV 1 o 2 Ag, Anti HBc,  anti-HTLV- I o II Treponema Pallidum 

Anti HBc, anti-HTLV- I o II Treponema Pallidum 

No 

No 

No 

Yes 

Some of the BE in Sweden is using pathogen inactivation techniques 
for platelets but it is not mandatory and the BE itself has consider if 
they want to use that technology. 

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

Most of the BEs have other have a limited numbers of persons that 
may perform parts of the activities under Article 9 (1) by delegations 
but the overall responsability is a task for the responible person. 
MPA: limited number of trained persons may perform parts of 
quality assurance but the overall responsibility of the release of 
plasma for fractionation is within the remit of the responsible 
person. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Inspections of the site/centre - Analysis of the mandatory 
documentation 

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

It is mandatory in national legislation to have a quality system in 
place and it is for BE most common to have that also complying 
with the GMP regulations. 

Inspections of the site/centre - Analysis of the mandatory 
documentation 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Electonic archives or on paper 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

Every BE has to comply with the requirerments in Directive 
2002/98, annex IV and 2005/62/EC and that is mandatory to 
document in the BE's quality system. Due inspections there a follow 
up to ensure that. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 

Due inspections. 

323 

 
 
 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Yes 

No 

Yes 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 
give (more than 1 answer possible)? 

Authorisation 
Licensing 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

MPA: 91 IVO: 28 See 4.7 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

All BEs has to use a accreditated laboratory and The Swedish Board 
for Accreditation and Conformity Assessment (SWEDAC) is 
responsible for that in Sweden. www.swedac.se Medical Products 
Agency: For BEs authorised for the collection of plasma for fraction, 
laboratories must be authorised by MPA.  

4.6. How many laboratories performing donor testing are active 
within your country? 

23 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

In Sweden BE and hospital blood banks are within the same 
organization. The "main BE" in a region or organization, are 
responsible for a couple of units linked to them. In Sweden there are 
28 "main BE" and all of them are situated at a hospital. Most main 
BE has responsibility for a couple of other hospital blood banks and 
have also satellite and mobile centers in the same organization. IVO 
gives authorization for the main BE and the hospital blood banks 
linked to every BE. If they also collect plasma for fractionation they 
have to be authorized by Medical Products Agency. According to 
the MPA regulations, in turn complying with the guidelines issued 
for PMF by EMA/CHMP, all collection centers (albeit not including 
satellites used at a low frequency) are classified as BEs. Therefore 
the different figures reported by the two CAs is a matter of 
classification. See also point 2.1.1. 

4.8. How many hospital blood banks are active within your country? 

... 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

4.10.2. If yes, please state the responsible authority within your 
country. 

5. Inspections (Art 8 Directive 2002/98/EC) 

Octapharma Stockholm 

Medical Products Agency 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Health and Social Care Inspectorate: Responsible for inspections 
(both regular and in the event of SAR/E) according to Directive 
2002/98/EC Article 8 (1-4) in the field of blood and blood 
components for transfusion. Medical Products Agency: Department 
of inspection 

324 

 
 
 
  
5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

MPA: 2 IVO: 2 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

Tissues and cells 
Pharmaceuticals (including plasma derivatives) 
Advanced therapies 
Hospitals 

MPA and IVO: See 5.4.1  

IVO: 15 desk-board revision and 21 at site inspection 

MPA: 45 IVO: 34 the routine inspections is a combination of 
general system-oriented and thematic 

MPA: 0, IVO: 0 

MPA: 0, IVO: 0 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

IVO:  A risk based approach is in use both for the regular and other 
inspecions. The common approach is to use all reported SAR/E for 
the actual BE/hospital blood bank as a compliment to the ordinairy 
template for regular inspection. The ordinairy template is also 
revised annually on a national level after analyses of findings in 
former inspecions nationwide. MPA: No 

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

Yes 

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

MPA: 40 IVO: all 28 main BE has been inspected twice 

IVO: The main BE/hospital blood bank is inspected every second 
year but not all including units (other hospital blood banks/BE in the 
same organization). They will be inspected at least every fourth year 
and the responsible person for main BE has to responsible for all 
units all time. If there is a possibility both CAs are trying to 
coordinate inspections so both CAs inspect at the same time. 
MPA:Every second year 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

MPA: 0, IVO: 3 

MPA: 45, IVO: 31 

MPA: 0, IVO:0 

MPA: 0, IVO: 0 

MPA: 0, IVO: 0 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

NA 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

1 

325 

 
 
 
5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

Se answer 5.5.4 

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

IVO: This CA has responibilty for supervision of health care in 
order to patient safety on national level and the organisation in 
Sweden of BE/hospital blood banks gives opportunity to inspect the 
whole chain "from vein to vein". MPA: no 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

Yes 

5.10.1. If yes, what is your experience with this Guide? 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

5.11.1. If yes, how would you rate the usefulness and efficacy of 
these trainings on a scale from 1 (not important) &ndash; 2 
(sufficient) &ndash; 3 (good) &ndash; 4 (very good) to 5(essential) 

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Helpful 

Yes 

4 

No 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

MPA and IVO 

6.1.3. Do you have a single national coding system for blood 
components? 

Yes 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

All components 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

Granulocytes 

Both paper records and electronic forms 

By inspections on sites 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

SAR snd 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 BE. The 
coordinators collect the reports, evaluate the suggested/performed 
actions and the reports according to classification that should be 
reported later to EC. If needed the coordinators may ask for 
additional actions that has to be completed before the report is 
closed. 

326 

 
 
 
6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

Yes 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

50-69% 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

Yes 

6.2.6.1. If yes, please provide a brief description. 

Not applicable because of the national organisation of BE/hospital 
blood banks in Sweden. The hospital blood banks and BE are in the 
same organisation and of course they have mandatory procedure for 
reporting SAR/SAE in place. Se answer to 6.2.1.1 

6.2.7. Do you perform root cause analyses of the SARE? 

No 

6.2.7.2. If no, why not? 

The response for SAR/E is the BE and they have to do the root cause 
analysis and send report to CA who has to approve or not. 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Every second year, Health and Social Care Inspectorate (former 
Swedigh National Board of Health and Welfare) invites all BE to a 
meeting where one point in the agenda is to give feed-back 
regarding SAR/E recorded at EU level.  

6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

MPA: 1. IVO: 1 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

The Swedish National Board of Health and Welfare have a function 
with a 24-hours service that provide all other CA with information if 
there is a rapid alert in the field of blood and blood components, 
Tissue and cells ,organs. ( all kinds of rapid alerts under the Swedish 
Ministry of Health and Social affairs responsibility is reported to this 
function).  The person in duty has to inform responsible CA as soon 
as the alert is actual so they have to consider what to do and if there 
is a need to contact BE/hospital blood banks. The coordinators at 
IVO have contact list covering all BE's and an e-mail is sent out 
together with an alert on our public website. MPA: no 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Se answer 6.2.11.1 

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

6.2.11.1 MPA: OMCL,  EMA (both rarely) 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

NO 

7. Import - export (Art 21 Directive 2002/98/EC) 

327 

 
 
 
7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

National law on blood safety 2006:496 and the CAs Codes of 
statutes 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

National law on blood safety 2006:496,  National law on 
pharmaceuticals 1992:859 and the MPAs Codes of statutes LVFS 
2006:16, LVFS 2004:7 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

IVO: If a BE is in a situation that they have to import blood or blood 
components they have a responibility to ensure that the place where 
they import from has the same quality standard as the national. (e.g 
EU legislation)  MPA: För plasma for fractionation, the compliance 
with the EU-standards is documented in Plasma Master Files, which 
is scrutinized before approval of the PMF and of the corresponding 
plasma derived medicinal products. A reassessment of the PMF, as 
updated, is thereafter made annually. PMFs are certified by EMA in 
a EU-centralised procedure 

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

No 

No 

Yes 

7.6.1. If yes, please provide this data by country of origin. 

Proprietary info in PMF dossiers 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

All BEs in Sweden, that are releasing plasma for fractionation, are 
inspected and authorised according the same national legislation as 
applies for use of the plasma in Sweden 

7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

.. 

No 

No 

No 

Yes 

7.12.1. If yes, for which blood components (more than 1 answer 
possible)? 

Plasma 

7.12.2. If yes to Q. 7.12., what do you do with the surplus of blood 
or blood components? 

BEs sell the plasma to  fractionation( pharmaceutical) companies 

7.12.3. If yes to Q. 7.12., would you be interested in concluding 
bilateral agreements with other MS in order to address the surplus? 

MPA: No 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

No 

No 

No 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 

MPA: We have encountered problems related to the import to the 
EU of blood components collected in third country (e.g. red blood 

328 

 
 
 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

cells) used as a reagent (not starting material) in the manufacture of 
a medicinal product, which has a marketing authorisation in Sweden 
(granted previous to the implementation of the Blood directives). 
The company is not willing to ensure that the RBCs comply with the 
criteria of 2004/33/EC, neither that the BE is inspected and approved 
according to the Blood directives. It is not in the remit of the 
Inspectorate of Sweden to inspect, becasue the MS of import, 
likewise the MS responsible of survey of the manufacturer of the 
medicinal product, does not require that the BE is inspected 
according to the Blood directives.   

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

8.5. Which other communicable diseases are of relevance to you? 

When we receive alerts from ECDC abouts outbreaks of WNV in 
some of the Member States all CAs in Sweden in the field of blood 
and blood components will consider if we have to forward this alert 
to BE immidiately or not. The BEs has to introduce 28 days of 
quarantine for donors who has visited the actual area. 

All blood transfusion transmitted communicable diseases will have 
relevance. 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

Yes 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Overlap / classification problems concerning the survey of 
establishments collecting blood cells to be used as a basis for cell 
derived products. Would cells be derived from a sample taken at a 
medical care centre and then be further processed, for example in the 
preparation of an autologous cell therapy product, the traceability  
might be at risk of becoming non-sufficient.  

 Preparation of a product for an individual patient is out of scope of 
the pharmaceutical legislation (2001/83/EC Art 3.2 and 3.6) but any 
product starting with a pooling of plasma for further processing 
would be considered to fall under the scope of the pharmaceutical 
legislation. 

329 

 
 
 
 
 
 
A.1.30. 

Survey response United Kingdom 

1. Public information 

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

Medicines and Healthcare Products Regulatory Agency 

1.1.2. Address of&nbsp;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.&nbsp;What are the roles/tasks of the NCA? (more than 1 
answer possible) 

151 Buckingham Palace Road London SW1W 9SZ 

020 3080 6000 

info@mhra.gsi.gov.uk 

www.mhra.gov.uk   (moving to www.gov.uk during 2014) 

Blood and blood components 
Pharmaceuticals (including blood derivatives) 
Medical devices 

Designation, authorisation, accreditation, licensing of BEs 
Inspection 
Haemovigilance 

1.2. National Competent Authority 2? 

No 

1.4. 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.). 

The Competent Authority (MHRA) is a government department 
affiliated to the UK Department of Health.  MHRA also fulfils the 
duties of Competent Authority for medicines and medical devices. 
With respect to the number of staff responsible for performing the 
duties relating to the blood competent authority, this is as follows: 
Inspectors – 6 senior inspectors, 3 accredited inspectors (multi-
skilled, performing blood and pharmaceutical inspections) 
Haemovigilence – 3 Regulatory / EU affairs – 1 Administrative staff 
(processing of authorisation applications etc) – 4 (multi-skilled, 
processing blood and pharmaceutical applications)  
http://www.mhra.gov.uk/Aboutus/index.htm  

1.5. 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) 

1.6. Could you please describe the competence/mandate of the 
Regional Competent Authority(ies) and their relation with the 
National Competent Authority(ies): 

2.1. Collection 

Not applicable 

N/A 

2.1.1. Please provide the number of BEs in your country recorded at 
31/12/2012. 

13 

2.1.2. How many of the BEs are satellite sites? 

2.1.3. How many of the BEs are mobile sites? 

There are approximately 10 satellite collection sites operated under 
the responsibility of a nearby main blood establishment 

4 blood establishment authorisation holders (the main UK Blood 
Services) operate mobile collection activities. This accounts for the 
majority of blood establishment collections in the UK 

2.1.4. Could you please provide the number of donors active in 2012 
(01/01-31/12/2012). 

1,376,013 

2.1.5. Could you please provide the number of repeat donors active 
in 2012 (01/01-31/12/2012). 

2.1.6. Could you please provide the number of first time donors 
active in 2012 (01/01-31/12/2012). 

2.1.7. Do you experience cross-border movement of donors 
into/from your country? 

2.1.7.1. If yes, please explain (from/to which other countries, 
plasma/blood donations, estimated magnitude, explaining factors, 
&hellip;). 

2.1.8. For whole blood donations, could you please provide the 
number of whole blood donations in 2012 (01/01-31/12/2012). 

2.1.9. For whole blood donations, could you please provide what is 
the standard or average volume of a whole blood donation in your 
country (in ml per donor). 

670,716 (England, Scotland & Northern Ireland) 

198,526 

Yes 

From Republic of Ireland, blood donations less than 1% of 63,000 
donors FFP for transfusion in UK children is sourced from Austria  

2,256,736 

450-495ml 

2.1.10. For plasma donations by apheresis, could you please provide 
the number of plasma donations in 2012 (01/01-31/12/2012). 

2.1.11. For plasma donations by apheresis, could you please provide 
what is the standard or average volume of a plasma donation in your 
country (in ml per donor). 

Nil 

N/A 

330 

 
 
 
2.1.12. For platelet donations by apheresis, could you please provide 
the number of platelet donations in 2012 (01/01-31/12/2012). 

148,012 

2.1.13. For platelet donations by apheresis, could you please provide 
what is the standard or average volume of a platelet donation in your 
country (in ml per donor). 

2.1.14. Could you please provide the number of other donations by 
apheresis in 2012 (01/01-31/12/2012). 

2.1.15. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for whole blood donations. 

2.1.16. Could you please provide the number of laboratories 
performing donor testing at 31/12/2012 for plasma donations. 

2.1.17. What measures are in place to ensure that donors are 
provided with the appropriate information, as required under Art. 16 
and Annex II, Part A of Directive 2004/33? (more than 1 answer 
possible). 

2.1.17.1. If other, please specify. 

2.1.18. What methods are in place to ensure that donors provide the 
appropriate information, as required by Art. 17 and Annex II, Part B 
of Directive 2004/33? (more than 1 answer possible). 

197-231 mls single platelet donation 

Nil 

7 

N/A 

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

This information is on the Donor Welcome Pamphlet which every 
donor receives on arrival and is required to read prior to signing their 
informed consent statement. This is/can be reinforced verbally by 
BSQR trained staff when required (Wales).  Donor information 
leaflet is provided at each session. Consent statement requires donor 
to say that they have read and understood it. All publications 
available on website. Audio versions available for visually impaired 
donors (Scotland).  Information provided in written format (leaflet) 
and may be followed up verbally by trained staff as appropriate 
(Northern Ireland).  

Information is collected through a personal interview with a medical 
doctor 
Information is collected through a personal interview with a health 
care professional that is not a medical doctor 
Information is collected through a donor evaluation/selection form 
that is standardised at national level. Information is collected 
through a donor evaluation/selection form that is standardised at 
regional level 
Other 

2.1.18.1. Please provide a copy of the donor evaluation/selection 
form&nbsp;standardised at national level (in English if possible). 

Sample attached 

2.1.18.3. If other, please specify. 

2.1.19. How do you ensure that the donor evaluation and testing 
procedures are documented and any relevant abnormal findings are 
reported to the donor (Art. 18(2) of Directive 2002/98)? 

All new donors are interviewed with greater depth by a registered 
nurse in a personal donor interview. Repeat donors who have not 
donated in the previous two years are also interviewed by registered 
nurses (Scotland)  Information is collected through a personal 
interview with a healthcare professional who may or may not be a 
medical doctor and is collected through a donor healthcheck 
questionnaire which is standardised at national level (Northern 
Ireland)  

All donor deferrals and relevant comments are recorded in eProgesa. 
If required additional information can be sought from the donor’s 
own doctor using a medical referral form on session. This would be 
managed by Donor Carer Doctors and the donor would be notified in 
writing or by telephone call of the outcome. Any relevant comments 
or derferral codes would be recorded in e Progresa. The donor would 
be notified of any abnormal test results by a doctor in line with 
Scotland’s national policies and SOPs (Scotland)  Procedures 
contained in Quality Management Systems and SOPs are in place in 
Northern Ireland  

2.1.20. Do you have a system for the self-exclusion by a donor? 

Yes 

2.1.20.1. If yes, please describe (bar code, etc.). 

2.2. Deferral (Directive 2004/33/EC) 

2.2.1. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most relevant? Please explain. 

Wales: No, except non-attendance Northern Ireland: Yes, 
Healthcheck, Website information  Scotland: Not a formal system, 
but the literature offers the donors the opportunity to leave the 
session without explanation. England: No  

In general the guidance is too broad and not specific enough and 
does not give any real rationale. The guidance is very much a 
minimum standard and could be better evidence-based than 

331 

 
 
 
2.2.2. Which of the eligibility/deferral criteria provided in Annex III 
of Directive 2004/33/EC do you find most difficult to implement or 
least reliable to verify? 

2.2.3. Would you suggest changes in eligibility/deferral criteria in 
Annex III of 2004/33/EC? 

2.2.4. Are there national guidelines for the assessment of risky 
sexual behaviours as required under Annex III of Directive 
2004/33/EC? 

2.2.5. Please specify which risky sexual behaviours are considered 
during donor deferral. 

2.2.6. Are there national guidelines for the assessment of vCJD? 

2.2.7. With ageing population, is there a need to change the current 
age acceptance criteria (point 1.12 of Annex III of 2004/33/EC)? 

2.2.8. What have been the main causes leading to deferrals in your 
country? Can you provide information on the frequency of donor 
deferral along the different deferral/eligibility criteria. Which criteria 
are most/least leading to donor deferral? 

currently. It is also largely silent on some key areas. 

Travel associated risk 

No 

Yes 

IV Drug use Sex with partners from high prevalence countries MSM 
Female sex with a man who has had sex with a man Sex with sex 
workers Sex workers Persons who believe their partner has or may 
be HIV positive, HTLV positive or be a carrier or Hep B or C 
Persons who have sex with injectable drug users  

Yes 

No 

Travel or medication (Northern Ireland & Wales) Low blood 
pressure 3%, medical 2.3%, infections 1.4% and travel 0.5% 
(England) Hb failure 2.48%, awaiting medical test results 1.04%, 
WNV risk 1%, age assessment 0.55%, tattoo and body piercing 
0.52%, malaria 0.47%, unhealed wounds 0.37%, endoscopy 0.36%, 
dental 0.29& and D&V 0.29% (Scotland)  

2.2.9. Do you have a system of centralised collection of data on 
deferrals? 

Yes 

2.2.9.1. If yes, please specify. 

Wales: Local database based on donation outcomes, numbers only 
recorded Northern Ireland: Local database based on donation 
outcomes, numbers only recorded Scotland: Deferrals recorded in e-
Progesa England: PULSE (main donor database)  

2.2.9.2. If yes, how many deferrals have been recorded in 2012 
(01/01-31/12/2012)? 

Wales: 2,176 

2.2.10. In 2009, Commission Directive 2009/135/EC was adopted to 
allow Member States temporary derogations to ensure blood supply 
during time of potential crisis. Was this derogation effectively 
applied by BEs in your country? 

2.2.11. In case of future crisis, would temporary derogation of the 
deferral criteria in Commission Directive 2009/135/EC (Hgb levels 
and deferral window after flu-like symptoms) be the most efficient 
to maintain supply? 

Yes 

Yes 

3.1. Testing 

3.1.1. How do you ensure, as CA, that tests required for donors are 
carried out only by qualified laboratories accredited, designated, 
authorised or licensed Art 5(2)? 

MHRA inspections and CPA 

3.1.2. Do you use NAT technology for routine testing blood or blood 
components in your Member State? 

Yes 

3.1.2.1. If yes, please specify how and how often NAT technology is 
used? 

Every donation, pools of 24 donations 

3.1.3. The basic testing requirements for donations are specified 
under Annex IV of Directive 2002/98/EC. In your country, are 
additional tests performed on a routine basis? 

3.1.3.1. If yes, please specify whether these are mandatory under 
national legislation for whole blood donations. 

3.1.3.2. If yes, please specify whether these are mandatory under 
national legislation for plasma donations. 

3.1.4. Would you suggest changes in basic testing requirements for 
donations as specified under Annex IV of Directive 2002/98/EC? 

3.1.5. Do you have a system of centralised collection of data with 
test results? 

3.1.5.1. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for HIV: 

Yes 

Syphilis, HTLV & HCV are mandatory 

N/A 

No 

Yes 

15 confirmed positive results 

3.1.5.2. If yes, could you provide the number of positive test results 

70 confirmed positive and 1 non determinate results 

332 

 
 
 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis B: 

3.1.5.3. If yes, could you provide the number of positive test results 
in 2012 (on donations between 1/1/2012 and 31/12/2012) for 
Hepatitis C: 

3.1.5.4. If yes, could you provide the number of 'other' positive test 
results in 2012 (on donations between 1/1/2012 and 31/12/2012) as 
well as specify which ones: 

3.1.6. Do you have any additional comments on testing (e.g. 
international accreditation systems for testing laboratories)? 

69 confirmed positive results 

Syphilis 76 confirmed positive results HTLV 10 confirmed results 
Bacteria 3  

All labs perform NEQAS (Scotland) 

3.1.7. Are pathogen reduction/inactivation techniques used in your 
Member State? 

Yes 

3.1.7.1. If yes, please describe the processes used and the blood 
components concerned. 

Bacterial Monitoring of Platelets (Wales, Northern Ireland) 
Methylene blue treatment of plasma (England, Northern Ireland)  

3.2. Processing 

3.2.1. Has every BE designated a responsible person, which fulfils 
the minimum conditions of formal qualification and practical 
experience (Article 9 (2))? 

3.2.2. Are tasks under Article 9 (1) delegated to other persons 
qualified by training and experience to perform such tasks? 

Yes 

Yes 

3.2.2.1. If yes, please specify. 

3.2.3. How do you ensure that personnel in BEs and hospital blood 
banks is qualified and trained (Article 10 and Article 6)? 

Responsibilities defined in job descriptions During periods of leave 
to suitably qualified or experienced personnel During periods of 
leave and via a BECS IT platform  

Relevant qualifications, by maintaining CPD and formal training to 
SOPs with regular competency assessments Annual assessment of 
registration, training matrix, training budget and policy and through 
top management commitment to budget allocation  

3.2.4. Have BE and hospital blood banks a quality system for blood 
establishments based on the principles of good practice (Article 11 
and Article 6)? 

Yes 

3.2.4.1. If yes, please specify. 

As inspected by MHRA BE based on principles of ICHQ10  

3.2.5. How do you ensure that BEs and hospital blood banks 
maintain documentation on operational procedures, guidelines, 
training and reference manuals, and reporting forms (Article 12 and 
Article 6)? 

Through MHRA inspection 

3.2.6. Do BE maintain records of the information required in 
Annexes II and IV and under Article 29(b), (c) and (d) and are these 
records kept for a minimum of 15 years (Article 13)? 

Yes 

3.2.6.1. If yes, please specify how. 

Paper and computer archives 

3.2.7. Is there a system in place to ensure that storage, transport and 
distribution conditions of blood and blood components in BEs and in 
hospital blood banks comply with the requirements referred to in 
Directive 2002/98, Annex IV, and Directive 2005/62/EC? 

Yes 

3.2.7.1. If yes, please specify. 

3.2.8. How do you ensure that all data, including genetic 
information, collected within the scope of this Directive by BEs and 
hospital blood banks and to which third parties have access is 
rendered anonymous so that the donor cannot be identified (Article 
23)? 

3.2.9. Do BEs and hospital blood banks in your country use a bar 
code based system for the distribution of blood and blood 
components? 

3.2.9.1. If yes, is this system mandatory? 

3.2.10. Do your BE's use the Council of Europe Guide to the 
Preparation, Use and Quality Assurance of Blood Components? 

3.2.10.1. If yes, what is your experience with this Guide? 

Inspections Annual Blood Compliance Reports from HBBs Quality 
management systems  

Data security systems 

Yes 

Yes 

Yes 

Helpful Being integrated in Quality management systems  Note: 
Yes, but there is also the UK Red Book (Guide for blood transfusion 
services in the UK) 

4. Designation, authorisation, accreditation and licensing (Art 5 Directive 2002/98/EC) 

4.1. For the collection of blood or blood components, does your CA 

Authorisation 

333 

 
 
 
give (more than 1 answer possible)? 

4.2. How do you ensure that BE comply with the requirements laid 
down in Art. 5 Directive 2002/98/EC&nbsp;(e.g. trained personnel, 
conditions accredited, designated, authorised, licensed) (more than 1 
answer possible)? 

Inspections of the site/centre 
Desk-based analysis of the mandatory documentation 

4.3. Have all BEs been designated, authorised, accredited or licensed 
by the competent authority/ies? 

Yes 

4.3.1. If yes,&nbsp;how many BEs have been authorised by [please 
provide date of record]? 

14 by 31 March 2014 

4.4. Have authorisations been revoked or suspended by the 
competent authorities in 2008? (Art. 5(5) Directive 2002/98/EC)? 

No 

4.5. Which national authority is responsible for the accreditation, 
designation, and authorisation or licensing of laboratories 
performing donor testing? 

MHRA; although standalone labs are not holders of a BEA. 

4.6. How many laboratories performing donor testing are active 
within your country? 

There are no standalone labs in the UK. All donor testing labs are 
associated with BEs performing collection and processing. 

4.7. Which national authority is responsible for authorisation 
(accreditation, designation, licensing) and oversight of hospital 
blood banks? 

The MHRA has oversight of hospital blood banks 

4.8. How many hospital blood banks are active within your country? 

433 

4.9. Are there additional rules governing hospital blood banks than 
those laid down in provisions covering articles 7, 10, 11(1), 12(1), 
14, 15, 22 and 24 of Directive 2002/98/EC? 

No 

4.10. Are there plasma fractionation facilities in your country? 

Yes 

4.10.1. If yes, please provide a list with details of the sites (location, 
products, capacity, owners' name (public/private), import/export, 
&hellip;). 

Bio Products Laboratory (BPL), Elstree. http://www.bpl.co.uk/  
They manufacture a full range of plasma derived medicinal products.   

4.10.2. If yes, please state the responsible authority within your 
country. 

MHRA 

5. Inspections (Art 8 Directive 2002/98/EC) 

5.1. Is there a system in place for organising inspections and control 
measures of BEs? 

Yes 

5.1.1. If yes, please specify the CA/Department of the CA in charge 
of inspections. 

Medicines Inspectorate, Inspection, Enforcement & Standards 
Division, MHRA 

5.1.2. If yes, please specify staffing (how many inspectors (full time 
equivalents) are responsible for inspecting BEs?). 

6 inspectors, part time with other duties, equivalent to approximately 
2 full time equivalents to inspect both hospital blood banks and 
blood establishments. 

5.2. Does the inspection scheme interact or overlap with the 
inspection scheme for other activities, e.g. pharmaceuticals, tissues 
and cells etc. (e.g. same inspector team, common training, common 
documentation, etc.)? 

Yes 

5.2.1. If yes, please specify which one(s) (more than 1 answer 
possible). 

Pharmaceuticals (including plasma derivatives) 
Advanced therapies 
Medical devices 

5.3.1. Number of inspections by type:&nbsp;Please specify the 
number of&nbsp;general system-oriented inspections on-site . 

43 Blood Establishment inspections and 51 hospital blood bank 
inspections. 

5.3.2. Number of inspections by type: Please specify number of 
thematic/limited inspections on-site. 

Three inspections of limited scope; these were performed ‘for cause’ 
based on a range on intelligence sources. 

5.4.1. Number of&nbsp;inspections by cause: Please specify number 
of routine inspections of BEs conducted in 2012 (01/01/2012 to 
31/12/2012). 

5.4.2. Number of inspections by cause: Please specify number of 
inspections of BE following SARE or a suspicion thereof in 2012 
(01/01/2012 to 31/12/2012). 

5.4.3. Number of inspections by cause: Please specify other type of 
inspections that were conducted and how many&nbsp;(e.g. due to a 
whistle-blower). 

Please see response to 5.3.2 

None as a sole trigger for inspection. SARE information considered 
as risk indicators when planning and scheduling inspections 

Please see response to 5.3.2. None due to a whistle-blower 

5.5.1. Frequency of inspections: Is there a risk based approach in the 
planning of inspections? 

Yes 

5.5.1.1. If yes, please explain. 

Risk indicators such as previous inspection compliance, SARE 
reports, other intelligence (e.g. relating to the healthcare organisation 

334 

 
 
 
operating the site) is considered in the risk based scheduling of 
inspections.  Risk is also used to determine those functions to be 
reviewed (and the depth of such review) during the inspection. For 
example, donor viral screening is considered a higher risk activity.  

5.5.2. Do you find it difficult to comply with the 2-year requirement 
for intervals for inspecting BEs required by Article 8(2) Directive 
2001/83/EC? 

No 

5.5.2.1. If no, why not? 

Adequate resources are assigned to inspect the number of UK Blood 
Establishments. The fixed minimum 2-year requirement does place a 
challenge upon the full implementation of a risk based scheduling 
system.  However, a fixed interval legislative requirement makes it 
difficult to fully implement a risk based approach for highly 
compliant sites where, in the pharmaceutical sector, interval between 
inspections may be extended.  

5.5.3. How many BE have been inspected at least twice in the last 3 
years? 

All Blood Establishment sites performing authorised functions as 
defined in the Directive are inspected every 2 years. 

5.5.4. How regularly are mobile and satellite collection sites 
inspected in your country? 

Satellite (fixed location) sites are inspected every 2 years, at the 
same time as their ‘parent’ main site. Mobile collection sessions are 
inspected on a risk based sampling basis during the inspection of 
their ‘parent’ main site. 

5.6.1. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where no shortcomings 
were observed? 

Where no shortcomings are identified, compliance is confirmed as 
being generally acceptable, and the competent authority continues to 
support site activities. 

5.6.2. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where minor shortcomings 
were noted? 

5.6.3. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) where major shortcomings 
were noted? 

5.6.4. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
suspension of authorisation? 

5.6.5. What was the outcome of the inspections carried out in the 
BEs in 2012 (01/01/2012 to 31/12/2012) which were followed by 
closure of the blood establishment? 

5.6.6. Please specify any other outcome of the inspections carried 
out in the BEs in 2012 (01/01/2012 to 31/12/2012). 

5.7. Please specify the number of plasma establishments inspected in 
2012 [a site for collection of plasma]. 

5.8. Are all NCA officials empowered to inspect blood 
establishments as well as facilities of any third parties on its own 
territory, take samples for examination and analysis, and examine 
any documents relating to the object of the inspection? (Art. 8(3) 
Directive 2002/98/EC) 

Deficiencies classified as ‘other’ (minor in nature, as per EMA 
Compilation of Community Procedures for Pharmaceuticals) were 
identified at most inspections. In all cases, compliance was 
considered to be generally acceptable for continued support of site 
activities. 

Deficiencies classified as ‘major’ are usually able to be addressed to 
a satisfactory level following inspection, such that a final decision of 
general compliance (and continued support for site activities) can be 
achieved. 

There were no suspensions of Blood Establishment Authorisations in 
this period. 

N/A 

N/A 

16 plasmapheresis inspections, performed in third countries 

Yes 

5.9. Is a system in place for inspecting hospital blood banks? 

Yes 

5.9.1. If yes, please describe. 

UK law requires each hospital blood bank to submit a compliance 
report annually. These submissions are assessed to identify risk 
factors to trigger inspections ‘for cause’.  

5.9.2. If yes, are you as blood NCA involved in inspecting hospital 
blood banks? 

Yes 

5.9.2.1. If yes, please specify. 

See response to 5.9.1 

5.10. Do you use at national level the Council of Europe Guide to 
the Preparation, Use and Quality Assurance of Blood Components? 

No 

5.10.2. If no, which guidelines/regulations are used for inspections at 
national level? 

In 2012, EUGMP and annex to Directive 2005/62/EC. The UK 
transposition of the Blood Directives is also used as an inspection 
standard. 

5.11. Did you (do you intend to) send your inspectors to the trainings 
organised by EU-funded projects (e.g. EUBIS, CATIE)? 

No 

5.11.2. If no, why not? 

The UK has experience of inspecting blood establishments in the 

335 

 
 
 
UK and third countries since a change in UK law in 1992.  

5.12. Has there been any international collaboration on inspections 
with other MS, such as an inspection of a BE in another MS, an 
inspection of a BE in your country, or a request by another MS on 
the results and control measures of your inspections? 

Yes 

6.1. Traceability (Article 14 Directive 2002/98/EC, Directive 2005/61/EC) 

6.1.1. Was a donor identification system (Art. 14(1)) implemented in 
your country? 

Yes 

6.1.2. Which is the CA for ensuring traceability in your Member 
State? 

MHRA 

6.1.3. Do you have a single national coding system for blood 
components? 

6.1.3.1. If yes, for which blood components? 

6.1.4. Do you apply an international coding system for blood 
components? 

Yes 

All 

Yes 

6.1.4.1. If yes, which coding system (ISBT, Eurocode, &hellip;)? 

ISBT 128, Codabar for product codes 

6.1.4.2. If yes, for which blood components (more than 1 answer 
possible)? 

6.1.4.2.1. If other, please specify. 

6.1.5. How is the data storage for traceability purposes organised in 
your BEs (Art 8(4) Directive 2002/98)? 

6.1.6. How do you ensure that the 30 years data storage requirement 
is respected (Directive 2006/86/EC, Art 9)? 

Platelets 
Plasma 
Red Blood Cells 
Wholeblood 
Others 

Pooled Cryo, pooled Buffy coas 

Both paper records and electronic forms 

IT systems, data retention policy, retention and disposal schedule 

6.1.7. Do you consider 30 years an adequate time-frame for data 
storage? 

6.1.8. Do the same rules on traceability that apply to BE also apply 
to hospital blood banks? 

Yes 

Yes 

6.2. Notification of serious adverse events and reactions (Article 15 Directive 2002/98/EC, Directive 2005/61/EC) 

6.2.1. Do you have a national vigilance system in place (for the 
reporting of SAR/E (Article 15(1))? 

Yes 

6.2.1.1. If yes, please give a short description of the system. 

SABRE is an online reporting system designed to allow BEs, HBBs 
and other reporting establishments to report SAEs and SARs to meet 
their statutory obligations.  It is based on the requirements of the 
Annexes to Directive 2005/61/EC 

6.2.2. Do you use the SAR/E templates developed for the Annual 
reporting to the EC (Dir. 2005/61, Article 5 and 6) also at national 
level? 

6.2.3. Do you use the Common Approach Document developed for 
the Annual reporting to the EC also at national level? 

6.2.4. Do you have a dedicated vigilance officer in charge of 
collecting SAR/E from all BEs? 

Yes 

Yes 

No 

6.2.4.1. If no, why not? 

There is a team of two 

6.2.5. How many BE provided in 2012 the SAR/E data as requested 
(please provide the % from the total number of BEs authorised in 
your country) (only 1 answer possible) 

6.2.6. Do you have a mandatory procedure for hospital blood banks 
when reporting SAR/SAE to the BEs which distributed the blood 
and blood components (Art 5.1)? 

6.2.6.2. If no, how do you ensure that SAR/E are reported from 
Hospital Blood Banks to BEs? 

100% 

No 

HBB are not required to report SAR/E to BEs, but to the Competent 
Authority.  HBB report SARs to BEs if they are related to the quality 
and safety of the blood. The UK Blood Safety and Quality 
Regulations require the reporting of SAR/E. 

6.2.7. Do you perform root cause analyses of the SARE? 

No 

6.2.7.2. If no, why not? 

Not required 

6.2.8. Do you give feedback to the BEs regarding SAR/E recorded at 
EU level? 

Yes 

6.2.8.1. If yes, please specify. 

Mentioned in presentations of National data 

336 

 
 
 
6.2.9. Do you require your BEs to have recall procedure? 

Yes 

6.2.10. How many recalls related to safety &amp; quality of 
blood/blood components were issued in your country in 2012? 
Please provide a list (you may upload one), specifying the causes 
and which blood components were recalled. 

This information is not held by MHRA 

6.2.11. Do you have in place a system/procedure to notify BEs in 
case of a national rapid alert? 

Yes 

6.2.11.1. If yes, please give a short description of the 
system/procedure. 

MHRA would issue alerts by email 

6.2.12. Do you have in place a system/procedure to notify BEs when 
a rapid alert is issued via the Rapid Alert System for blood at 
European level (CIRCA-BC)? 

Yes 

6.2.12.1. If yes, please give a short description of the 
system/procedure. 

Relevant information is sent to the Joint United Kingdom Blood 
Transfusion and Tissue Transplantation Services Professional 
Advisory Committee (JPAC)  

6.2.13. Do you notify alerts communicated via the blood national 
vigilance system also to other national vigilance/alert systems? 

Yes 

6.2.13.1. If yes, which of the following systems are usually 
contacted (more than 1 answer possible)? 

Tissues and cells 
Organs 
Pharmacovilance 
Medical devices 
Communicable diseases and other threats to health 
Other 

6.2.13.1.1. If other, please specify. 

All options available but usually Pharmacovigilance and Devices via 
internal MHRA communications 

6.2.14. Do you also receive alerts via other national vigilance/alert 
systems, such as for tissues and cells,&nbsp;organs, or medical 
devices? 

Yes 

6.2.14.1. If yes, please specify. 

All options apply 

6.2.15. Do you have any additional comments on traceability and 
SAR/E reporting? 

7. Import - export (Art 21 Directive 2002/98/EC) 

7.1. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for transfusion 
from EU Member States or third countries? 

7.2. Which rules and conditions exist for the authorisation and 
control of the import of blood and blood components for 
fractionation from EU Member States or third countries? 

The MHRA’s Haemovigilance team has incorporated its own 
categorisation to existing Directive categories to assist analysis of 
data received.  We further break down the Event categories “Other”, 
and “Storage” and the Specification category “Human error”.  Since 
introducing these categories and providing specific and targeted data 
analysis, SAE reports have reduced by nearly 18 %  

The Blood Safety and Quality Regulations 2005 as amended 

The Blood Safety and Quality Regulations 2005 as amended 

7.3. Which procedures do you have in place for verifying the 
equivalent standards of quality and safety for importation of blood 
components from third countries? (only 1 answer possible) 

Others 

7.3.1. If others, please specify. 

The responsibility is placed upon importing BEs to demonstrate 
equivalence with EU/UK requirements. The systems in place to 
make this assessment are periodically assessed for their suitability 
during inspection of the BE.  

7.4. Do you foresee requirements for the testing requirements for 
import of blood and blood components from third countries that go 
beyond the minimum requirements provided in Annex IV of 
Directive 2002/98/EC? 

7.5. Do you have data on the numbers of blood components 
imported for transfusion from third countries (outside the EU) in 
2012 (01/01/2012 to 31/12/2012)? 

7.6. Do you have data on the numbers of plasma imported for 
fractionation from third countries (outside the EU) in 2012 
(01/01/2012 to 31/12/2012)? 

7.7. Which rules exist for the authorisation and control of the export 
of blood and blood components for fractionation to EU Member 
States or third countries? 

No 

No 

No 

In the UK, no blood / blood components for fractionation are 
exported / used for fractionation, due to vCJD risks in the population 

337 

 
 
 
7.8. Which rules exist for the authorisation and control of the export 
of blood and blood components for transfusion to EU Member States 
or third countries? 

7.9. Do you have data on the number of blood components exported 
for fractionation from your Member State to third countries (outside 
EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.10. Do you have data on the number of blood components 
exported for transfusion from your Member State to third countries 
(outside EU) in 2012 (01/01/2012 to 31/12/2012)? 

7.11. Is there a regular shortage of blood or blood components in 
your MS? 

7.12. Is there a regular surplus of blood or blood components in your 
MS? 

7.13. Are you aware of any significant changes in 2013 which may 
invalidate the 2012 data on imports/exports between your country 
and other third countries? 

8. Sanctions and general comments 

8.1. Have penalties for infringements of the national provisions 
adopted pursuant to the Directive been laid down? (Art. 27 Directive 
2002/98/EC) 

8.1.1. If yes, have penalties already been imposed? 

8.1.2. If yes, what were the reasons for imposing the penalties? 
Please describe. 

8.1.3. If yes, how many penalties have been imposed in 2012 
(01/01/2012 to 31/12/2012)? 

8.1.4. If yes, what kinds of penalties were imposed? Please describe 
(e.g. suspension of authorisation, criminal penalty, etc.) 

8.2. Have you introduced or maintained more stringent measures 
than those foreseen under the Directive? 

8.3. What difficulties were encountered by the Member State in the 
transposition or implementation of the Blood Directives? What 
specific issues would need to be addressed by the Commission in the 
course of a potential revision of Directive 2002/98/EC? 

In the UK, no blood / blood components for fractionation are 
exported for transfusion, due to vCJD risks in the population 

No 

No 

No 

No 

No 

Yes 

No 

N/A 

N/A 

N/A 

No 

None specific to the Blood Directives 

8.4. During the last years there have been outbreaks of West Nile 
Virus in different EU Member States. Are there any preventive 
measures of West Nile Virus transmission by blood in place in your 
country? 

Yes 

8.4.1. If yes, please provide us with detailed information. 

Donor eligibility criteria, targeted donor screening 

8.5. Which other communicable diseases are of relevance to you? 

vCJD, and those addressed by the EU Donor eligibility / mandatory 
screening requirements 

8.6. Do you consider bed-side techniques of collection, processing 
and application of blood or blood components (e.g., platelet rich 
plasma) to fall under the EU blood legislation within your country? 

No 

8.6.1. If no, which is the applicable legal framework and the 
competent national authority? 

8.7. Are there other techniques/components used within your 
country on which you have doubts whether they fall under the scope 
of Directive 2002/98/EC? 

8.8. Can you specify which industrial processes, when applied on 
blood components, make you consider that these components would 
fall under the pharmaceutical legislation? (e.g., level of pooling, 
inactivation techniques, &hellip;) 

Medical practice legislation if the procedure is conducted within the 
immediate environment of the patient and there is no off-site 
processing. 

Possibly monocytes/dendritic cells 

Scale of activity but MHRA would need to consider each case on its 
own merits. Some guiding principles which would apply across all 
EU National Competent Authorities would be welcome 

Annex 2: Fractionation Facilities 

Thirteen countries reported having fractionation facilities within their borders. 

338 

 
 
 
 
No: CY, 
CZ,DK, EE, FI, 
HR, IE, LI,  
LT, LU, LV, 
MT, NO, PT, 
RO, SI, SK;  
17 

Yes: AT,BE, 
BG, DE, 
EL,ES, FR, 
HU,  IT, NL, 
PL, SE, UK;  
13 

Country 

AT 

BE 

BG 

DE 

Fractionator 

Baxter, Vienna  
Octapharma, Vienna 

C.A.F. – D.C.F.  
Baxter, Nivelles 

Country 
ES 
Fractionator  Laboratories Grifols 

(private) 

Country 

IT 

EL 

The National Plasma 
Fractionation Centre 
''Elias Politis'' 23 

NL 

Fractionator 

Kedrion Biopharma 
SpA, 
Baxter (private) 

Sanquin 

Bul Bio - National 
Center of Infectious and 
Parasitic Diseases Ltd. 
(BB-NCIPD Ltd.) 
(public) 

FR 

- LFB Biomédicaments 
(public)  
Octapharma – (private) 
PL 

BIOMED Lublin SA - 
Lublin Factory of Sera 
and Vaccines. 
Production of anti D 
immunoglobulin and 
anti HBs only. (private) 

Biotest AG, Landsteinerstr. CSL Behring 
GmbH 

HU 

Human Bioplasma Ltd belongs to Kedrion. 
(private) 

SE 

UK 

Octapharma 
Stockholm 
(private) 

Bio Products 
Laboratory (BPL), 
Elstree 

23 Note that this fractionation facility was not mentioned in the  survey on the application of the principle of 
voluntary unpaid donation 

339 

 
 
 
 
 
 
 
                                                            
Annex  3:  Number  of  positive  test  results  in  2012  for  HIV,  hepatitis  B  and  hepatitis  C 

and the number of laboratories performing donor testing 

HIV  Hepatitis B  Hepatitis C 

Ratio positive tests 
(HIV, HBV, HCV) over 
donations WB and 
plasma 

Number of laboratories 
performing donor 
testing for WB 
donations 

Number of laboratories 
performing donor testing 
for plasma donations 

AT 

- 

NA 

NA 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

ES 

FI 

10 
5 

8 

9 

114 

0 

6 

142 

1 

FR  NA 

GR 

HR 

HU 

IE 

IT 

21 

7 

4 

1 
143 

LI 

0 

LT 

LU 

LV 

MT 

NL 

NO 

PL 

PT 

RO 

29 

0 

12 

0 

2 

0 
52 

33 

66 

60 

851 

19 

30 

510 

5 

13 

474 

2 

NA 

432 

14 

12 

1 

868 

NA 

167 

3 

52 

0 

19 

4 

731 

55 

2.612 

SE 

NA 

NA 

SI 

SK 

UK 

2 

2 

15 

12 

24 

70 

18 

86 

19 

111 

358 

4 

32 

252 

15 

NA 

86 

6 

111 

2 

351 

NA 

482 

0 

205 

2 

4 

2 

557 

32 

422 

NA 

4 

25 

69 

0,01% 

0,56% 

0,08% 

0,01% 

0,01% 

0,00% 

0,09% 

0,22% 

0,00% 

0,00% 

0,02% 

0,02% 
0,03% 

0,00% 

0,04% 

0,00% 

0,85% 

0,01% 

0,48% 

0,01% 

0,00% 

0,00% 

0,11% 

0,03% 

0,78% 

0,00% 

0,02% 

0,03% 

0,01% 

24 

6 

6 

4 

52 

141 

5 

5 

24 

1 

14 

92 

10 

2 

3 

2 

6 

6 

4 

92 

5 

5 

24 

1 

14 

0 

2 

174 

174 

1 

6 

1 

1 

1 

1 

19 

23 

22 

42 

23 

3 

47 

7 

1 

1 

1 

1 

19 

23 

0 

42 

23 

2 

14 

Not applicable 

340