Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Date: 2022-07-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: artificial reproduction, blood transfusion, cytology, health control, quality standard, safety standard, stem cell, substance of human origin, therapeutics

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 14.7.2022  COM(2022) 338 final 2022/0216 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance) {SEC(2022) 304 final} - {SWD(2022) 189 final} - {SWD(2022) 190 final} - {SWD(2022) 191 final}  
 
1. 

• 

EXPLANATORY MEMORANDUM 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 
The  Blood  Directive  -  2002/98/EC1  and  the  Tissues  and  Cells  Directive  - 
2004/23/EC2  (the  BTC  legislation)  have  helped  ensure  the  safety  of  millions  of 
patients  undergoing  blood  transfusion,  transplantation  and  medically  assisted 
reproduction. The legislation sets out quality and safety requirements for all activities 
from  donation  to  human  application  (unless  the  donations  are  used  to  manufacture 
medicinal products or medical devices, in which case the legislation only applies to 
donation, collection and testing).  

Every  year,  EU  patients  are  treated  with  25  million  blood  transfusions  (during 
surgery  emergency,  cancer  or  other  care),  a  million  cycles  of  medically  assisted 
reproduction,  over  35,000  transplants  of  stem  cells  (mainly  for  blood  cancers)  and 
hundred thousands of replacement tissues (e.g., for orthopaedic, skin, cardiac or eye 
problems).  These  therapies  are  only  available  thanks  to  the  willingness  of  fellow 
citizens to make altruistic donations.  

In the European Union, the collection, processing and supply of each individual unit 
is typically organised on a local small-scale by public services, (academic) hospitals 
and non-profit actors.   

After almost 20 years in place, the legislation no longer addresses the scientific and 
technical state of the art and needs to be updated to take into account developments 
that  have  taken  place  in  the  sector.  While  an  evaluation  of  the  BTC  legislation3 
confirmed that it has brought very good levels of overall safety and quality in these 
sectors  (less  than  one  serious  patient  reaction  for  every  12,000  applications), 
shortcomings of the legislation were identified as follows: 

• 

• 

Patients  are  not  fully  protected  from  avoidable  risks  due  to  out-of-date 
technical rules; 

Blood,  tissues  and  cells  (BTC)  donors  and  children  born  from  donated  eggs, 
sperm or embryos (offspring) are exposed to avoidable risks; 

•  Member  States  have  divergent  approaches  to  oversight  that  hampers  cross-

border exchanges of BTC; 

• 

• 

Full  potential  of  BTC  processed  or  used  in  new  ways  is  not  reached  for 
patients; 

Patients are vulnerable to interruptions in EU supply of BTC. 

The  COVID-19  pandemic  highlighted  some  of  these  shortcomings,  in  particular, 
those impacting on rules for preventing the risk of disease transmission by BTC and 

1 

2 

3 

Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27  January  2003  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 (OJ L 33, 8.2.2003, p. 30). 
Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  on  setting 
standards of quality and safety for the donation, procurement, testing, processing, preservation, storage 
and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48). 
Evaluation  of  the  Union  legislation  on  blood,  tissues  and  cells  {SWD  (2019)  376  final} 
https://ec.europa.eu/health/system/files/2019-10/swd_2019_376_en_0.pdf  

EN 

1 

  EN 

                                                 
the lack of measures  to  ensure sufficiency  of supply. The proposal  aims to  address 
these  shortcomings,  by  revising  the  current  legislation.  The  overall  objective  is  to 
ensure a high level of health protection for EU citizens and ensure they have access 
to safe and effective BTC. As new technologies or risks will continue to emerge, it is 
desirable that the future framework is more effectively implemented, future proof, 
crisis  resistant  and  agile  enough  to  accommodate  new  risks  and  trends  while 
continuing  to  provide  appropriate  safety  and  quality  requirements.  Being  a  REFIT 
initiative,  areas  for  improving  the  efficiency  of  the  legislation  and  simplifying  its 
implementation by all stakeholders were also explored.  

• 

Consistency with existing provisions in the policy area 

The EU framework for safety and quality of substances of human origin (SoHOs) has 
currently  three  main  Directives,  respectively  for  Blood,  Tissues  and  Cells,  and 
Organs,  together  with  implementing  legislation.  Each  Directive  sets  safety  and 
quality standards for all the steps from  donation and collection from  a donor body, 
over  testing,  processing,  storage  and  distribution,  to  eventual  application  in  the 
patients’  body.  The  current  proposal  covers  blood,  tissues  and  cells,  and  has  links 
with  the  Organs  Directive4,  in  particular  regarding  closer  collaboration  between 
Member  States’  competent  authorities  for  blood,  tissues  and  cells,  and  those  for 
organs, and regarding vigilance requirements.  

Where BTC can be used in the manufacture of health products that are regulated by 
other  Union  legislation,  or  as  the  starting  and  raw  material  thereof,  the  SoHO 
framework  applies  on  the  first  activities  in  the  chain  (donation,  collection,  testing) 
while  these  later  activities  (manufacturing,  storage,  distribution  etc.)  are  regulated 
under  these  other  appropriate  legislative  frameworks  (e.g.  medicinal  products, 
including  advanced  therapy  medicinal  products,  or  medical  devices)5.  There  are  in 
place some mechanisms to ensure coherence between the BTC legislation and those 
adjacent  frameworks.  This  proposal  will  reinforce  the  cooperation  among  those 
adjacent frameworks. 

As  part  of  the  Pharmaceutical  Strategy  for  Europe,  there  is  an  ongoing  evaluation 
and  revision  of  the  pharmaceutical  legal  framework6.  This  proposal  will  feed  into 
that work, in particular regarding the regulatory delineation between the BTC sector 
and  the  pharmaceutical  sector.  The  delineating  criteria  are  set  by  definitions  in  the 
pharmaceutical framework and are not altered by this proposal.  

• 

Consistency with other Union policies 

This  initiative  is  part  of  the  EU’s  ambition  to  build  a  stronger  European  Health 
Union,  so  as  to:  (1)  better  protect  the  health  of  our  citizens  (including  patients, 

4 

5 

6 

Directive  2010/53/EU  of  the  European  Parliament  and  of  the  Council  of  7  July  2010  on  standards  of 
quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14). 
Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community  code  relating  to  medicinal  products  for  human  use  (OJ  L  311,  28.11.2001,  p.  67), 
Regulation (EC) No 1394/2007  of the European Parliament and of the Council of 13 November 2007 
on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 
726/2004  (OJ L 324, 10.12.2007, p. 121),  and Regulation (EU) 2017/745 of the  European Parliament 
and  of  the  Council  of  5  April  2017  on  medical  devices,  amending  Directive  2001/83/EC,  Regulation 
(EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC 
and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).  
legislation:  https://ec.europa.eu/info/law/better-
Revision  of 
regulation/have-your-say/initiatives/12963-Revision-of-the-EU-general-pharmaceuticals-legislation_en. 

the  EU  general  pharmaceuticals 

EN 

2 

  EN 

                                                 
donors and offspring); (2) equip the EU and its Member States to better prevent and 
address future pandemics (surveillance, data analysis, risk assessment, early warning 
and response) and (3) improve the resilience of EU health systems (sufficient supply 
of SoHOs). 

The  proposal  further  establishes  links  with  the  European  Centre  for  Disease 
Prevention  and  Control  (ECDC),  for  which  the  mandate  has  been  proposed  to  be 
strengthened7, also in this field of SoHOs.  

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The SoHO legislation is based on Article 168(4)(a) of the Treaty on the Functioning 
of  the  European  Union  (TFEU).  As  a  shared  competence  with  the  Member  States, 
and  in  line  with  the  principle  of  subsidiarity,  this  Treaty  Article  gives  the  EU  a 
mandate  to  set  out  measures  establishing  high  standards  of  quality  and  safety  for 
SoHOs  while  allowing  Member  States  to  maintain  or  introduce  more  stringent 
protective  measures.  Member  States  remain  responsible  for  decisions  of  an  ethical 
and  organisational  nature,  such  as  allowing  the  donation  of  certain  SoHOs  or 
deciding  allocation  of  certain  SoHOs  or  who  may  access  certain  SoHO  therapies 
(e.g., access to in vitro fertilisation therapies). While the EU Charter on Fundamental 
Rights  requires  non-commercialisation  of  the  human  body  which  translates  into  a 
principle  of  voluntary  unpaid  donation  in  the  EU  legislation,  it  is  for  the  Member 
States  to  define  the  detailed  implementation  of  this  principle  within  the  context  of 
each country. When a Member State chooses to allow a particular new practice that 
can  bring  ethical  questions  (such  as  testing  or  storage  of  embryos),  the  safety  and 
quality of this practice are then regulated by the EU SoHO legislation.  

• 

Subsidiarity (for non-exclusive competence)  

Ever-evolving disease threats, such as Zika, Human Immunodeficiency Virus (HIV) 
or  viral  hepatitis  B,  C  and  D,  which  can  be  transmitted  through  SoHOs,  constitute 
cross-border  threats  to  public  health.  In  addition,  the  exchange  of  SoHOs  between 
Member  States  and  with  third  countries  is  necessary  for  ensuring  optimal  patient 
access  and  sufficiency  of  supply.  This  is  in  particular  the  case  for  SoHOs  that  are 
used  as  personalised  therapies  where  it  is  essential  that  a  recipient  is  specifically 
matched with a donor. Increasing cross-border exchanges of SoHOs necessitate ever-
closer cooperation between a number of health professional groups and authorities to 
ensure that SoHOs remain traceable from the donor to the recipient and vice versa.  

Certain  types  of  sector-specific  expertise  may  also  not  be  easily  available  in  every 
Member State.  

By providing a framework for cross-border cooperation, based on a common set of 
rules, and connected to sector-specific expertise, EU-level measures are best placed 
to address such issues effectively. Establishing high standards of quality and safety 
for SoHOs  at EU level facilitates equal access to safe therapies for all EU citizens, 
and encourages circulation of SoHO materials and products between Member States. 

7 

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 
851/2004 establishing a European Centre for disease prevention and control. COM/2020/726 final. 

EN 

3 

  EN 

                                                 
Providing  for  a  common  framework  that  supports  joint  practices  will  promote 
simplification and efficiency.  

• 

Proportionality 

The  overall  initiative  is  limited  to  aspects  that  Member  States  cannot  achieve 
satisfactorily  on  their  own,  and  where  there  is  clear  EU  added  value.  Many  of  the 
pursued objectives can only be met through highly technical rules and guidance that 
require  specific  expertise  for  their  regular  updating.  From  the  three  policy  options 
considered  (see  the  impact  assessment  staff  working  document,  section  5.2),  the 
preferred option requires that blood and tissue establishments meet safety and quality 
standards  by  following  guidelines  developed  and  updated  by  nominated  expert 
bodies such as the ECDC and the European Directorate for the Quality of Medicines 
& HealthCare (EDQM, a Directorate of the Council of Europe). This option provides 
the  highest  effectiveness  and  efficiency,  avoids  the  need  for  re-developing 
guidelines, and can ensure a high level of harmonisation as well as rapid updating of 
standards.  

The  key  added  value  of  the  EU  approach  in  this  proposal  is  to  ensure,  where 
appropriate, that common standards and guidelines make full use of the high level of 
latest scientific and technical expertise, as already available in expert bodies such as 
the  ECDC  and  the  EDQM,  and  therewith  facilitate  cross-border  exchange  of  and 
access to safe SoHOs. In addition, the sharing of data through a common platform, 
and  following  common  guidance,  will  enable  policy  making  based  on  significantly 
more robust data. 

As  stated  in  the  impact  assessment  staff  working  document  (section  7.5),  the 
proposal  does  not  interfere  with  the  right  for  Member  States  to  maintain  and 
introduce  more  stringent  measures  when  they  consider  them  necessary  (Article 
168(4) of the TFEU) but does increase the level of safety and quality to be achieved 
in  all  Member  States,  thus  reducing  the  need  in  most  cases  for  more  stringent 
measures that can create barriers to  cross-border exchange and to patient  access.  In 
addition,  the proposal  will  ensure the adoption of more stringent  measures is  made 
more visible so that exchanges can be more easily organised in full respect of those 
measures.  Given  that  rules  relating  to  ethical  aspects  of  this  field,  or  to  healthcare 
organisation, are not included in the proposal, no special circumstances in individual 
Member  States  were  identified  that  required  a  particular  territorial  variation  in  the 
measures to be applied. 

• 

Choice of the instrument 

The proposal takes the form of a new Regulation repealing two existing basic Acts, 
both  Directives.  A  key  element  of  the  proposal  is  to  establish  more  harmonised 
measures  for  Member  States  and  organisations  involved  in  collection,  testing, 
processing, distribution, application of  SoHOs, from donors to patients.  Insufficient 
minimum  harmonisation  was  identified  as  a  key  reason  for  reduced  trust  between 
Member  States,  resulting  in  reduced  cross-border  exchange  and  sub-optimal  access 
for patients to SoHOs. A Regulation is considered the most suitable instrument since 
it does not require transposition and is directly applicable.  

3. 

• 

EN 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

4 

  EN 

The  evaluation  of  the  BTC  legislation,  published  in  2019,  identified  the  following 
gaps and shortcomings: 

1. 

Patients are not fully protected from avoidable risks: the EU safety and quality 
requirements have not kept up to date with frequently  changing scientific and 
epidemiological  developments  thus  potentially  exposing  patients  treated  with 
BTC  to  avoidable  risks.  The  ECDC  provides  up-to-date  but  non-binding 
guidance  on  safety  measures,  e.g.  to  address  COVID-19  risks.  The  EDQM 
provides  guidance  on  quality  of  BTC  and  many  Member  States  put  more 
stringent  requirements  in  place.  This  situation  can  create  legal  confusion  and 
unequal  levels  of  safety  and  quality  for  patients.  In  addition,  while  new 
therapies have emerged since the BTC legislation was adopted, it is not always 
clear  whether,  and  if  so  which,  of  the  BTC  Directives  apply,  leaving  these 
substances  unregulated  or  regulated  in  divergent  ways  (e.g.,  breast  milk  and 
faecal  microbiota  transplants).  Some  of  these  SoHOs  do  not  meet  the 
definitions of blood, tissues and cells included in the current legislation. 

2.  Divergent  approaches  to  oversight  cause  unequal  levels  of  safety  and  quality 
and  barriers  to  the  exchange  of  BTC  across  the  EU:  divergent  national 
interpretations  and  implementations  of  the  legislation  lead  to  unequal 
protection and a lack of mutual trust between national authorities. This in turn 
creates  barriers  to  cross-border  exchange  and  to  availability  of  BTC.  These 
differences reflect the lack of common provisions for verification of effective 
implementation of inspection, authorisation and vigilance, and inconsistency in 
the  levels  of  capacities,  skills  and  independence  required  of  inspectors 
supervising BTC establishments.  

3. 

4. 

BTC donors and offspring (including children born from donated eggs, sperm 
or  embryos)  are  exposed  to  avoidable  risks:  the  current  BTC  legislation 
contains  only  very  limited  measures  to  protect  and  monitor  BTC  donors  and 
offspring from donated sperm, eggs or embryos. In particular, the requirements 
to report donor adverse reactions are too limited and provisions for testing egg 
and  sperm  donors  for  genetic  conditions  are  out  of  date  with  the  technology 
available.  Growing  demand  by  commercial  companies  (e.g.  egg  banks  for  in 
vitro  fertilisation,  plasma  collectors  for  medicinal  product  manufacture) 
increases  the  pressure  to  donate  and  consequently  the  need  for  robust  donor 
protection measures. 

The BTC legislation lags behind innovation: new ways of processing donations 
in  BTC  establishments  may  bring  significant  benefits.  However,  these  new 
therapies  can  also  put  patients  at  risk,  as  current  authorisation  procedures  for 
new  BTC  processes  do  not  require  evidence  that  risk  is  justified  by  benefits. 
Moreover, this lack of adequate procedures does not inspire trust and prevent 
healthcare actors from developing and adopting innovative processes. Besides 
risks and benefits, safety and quality measures also need to take account of the 
typical  economic  (public/non-profit)  settings  where  BTC  are  developed  and 
prepared,  and  of  the  often  incremental  and  open-access  nature  of  these 
innovations.  In  addition,  there  are  sometimes  difficulties  in  defining  the 
borderlines  for  novel  BTC  with  other  regulatory  frameworks,  in  particular 
where  medicinal  products  and  medical  devices  are  concerned.  This  creates 
administrative  burdens  and  implicit  disincentives  for  BTC  establishments, 
healthcare professionals and academia to innovate. This legal uncertainty issue 

EN 

5 

  EN 

5. 

requires further evidence gathering to allow its extent and consequences to be 
fully assessed. 

The  EU  is  vulnerable  to  interruptions  in  supply  of  some  BTC:  for  some 
essential BTC, the EU is highly dependent on imports to ensure sufficiency. In 
particular, the EU relies on the United States for an adequate supply of plasma 
used  to  manufacture  plasma-derived  medicines.  In  the  current  legislation, 
sufficiency of supply through voluntary unpaid donation is encouraged, though 
without concrete measures to protect or increase supply. This approach has not 
proven  adequate  to  protect  EU  patients  from  the  risk  of  shortages  or  sudden 
supply  disruption. The  lack  of EU  and  national  monitoring provisions for the 
supply of BTC makes it difficult to predict EU supply interruptions and to take 
action to mitigate the risks to patients. 

The proposal therefore provides measures to:  

1. 

2. 

3. 

4. 

5. 

Ensure  safety  and  quality  for  patients  treated  with  SoHO  therapies  and  fully 
protect them from avoidable risks linked to SoHOs. 

Ensure safety and quality for SoHO donors and for children born from donated 
eggs, sperm or embryos. 

Strengthen and allow for harmonisation of oversight practices among Member 
States. 

Facilitate the development of safe and effective innovative SoHO therapies. 

Improve the resilience of the sector, mitigating risk of shortages. 

Objectives  1  and  2  are  closely  linked,  as  they  both  involve  setting  technical 
requirements  for safety  and quality to better protect EU citizens. While the EU has 
no  mandate  to  intervene  directly  in  supply  management,  reliable  monitoring  and 
notification of shortages would help Member States detect sudden drops in supply of 
SoHOs,  trends  towards  shortages  or  dependencies  on  other  Member  States  or  on 
third countries, and would help them to take appropriate mitigation actions. 

• 

Stakeholder consultations 

Stakeholder  consultations  were  a  key  step  in  the  impact  assessment  phase  for  the 
revision  of  the  legislative  framework  on  blood,  tissues,  and  cells.  Consultation 
activities aimed to assess stakeholders’ views and opinions on (i) the validity of the 
findings of the evaluation (2019)8, (ii) the three proposed policy options described in 
an  Inception  Impact  Assessment  (IIA)9  and  (iii)  the  extent  to  which  they  would 
address the shortcomings identified in the evaluation, and their likely impacts.  

Stakeholders  were  consulted  via  (i)  the  IIA  publication  for  feedback,  (ii)  online 
surveys and questionnaires, (iii) hearings and participatory workshops with national 
competent  authorities  and  stakeholders,  (iv)  bilateral  meetings  with  stakeholder 
organisations and (v) interviews with specific stakeholders. 

Overall, there is support among all stakeholders for the common measures proposed 
(revised  legislation  that  allows  for  up-to-date  technical  guidance  and  fills  existing 
legal  gaps;  strengthened  oversight  practices,;  mechanism  for  legal  advice  whether 

8 
9 

https://ec.europa.eu/health/system/files/2019-10/swd_2019_376_en_0.pdf.  
IIA:  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12734-Blood-tissues-and-
cells-for-medical-treatments-&-therapies-revised-EU-rules_en.  

EN 

6 

  EN 

                                                 
and  what  SoHO  requirements  apply  to  a  substance,  if  needed  in  coordination  with 
other  EU  legal  frameworks;  tailored  authorisation  of  SoHOs  used  or  processed  in 
new  ways;  and  crisis  preparedness  and  management).  Stakeholders  also  expressed 
broad support for option 2 (technical rules set by expert bodies), which is seen as the 
most effective approach. Analysis of quantitative data from the public consultations 
confirmed that the degree of conflict among stakeholders was low, as this preference 
was widely agreed between all stakeholder categories. However, sector experts and 
national  authorities  also  highlighted  conditions  that  must  be  met  for  the  option  2 
approach to be a success, including the need for transparent drafting procedures that 
ensure  that  professionals  as  well  as  Member  States  can  provide  inputs,  the  need  to 
allow  for  more  stringent  national  requirements  and  the  need  to  accommodate  for 
geographic differences between the EU and the Council of Europe. 

In  addition,  the  analysis  of  respondents  to  the  consultations  highlighted  once  again 
the  strong  links  between  the  blood  sector  on  the  one  hand  and  the  tissue  and  cell 
sector  on  the  other,  thus  supporting  the  decision  to  combine  both  Directives  into  a 
single legal act on SoHOs (Organs being excluded). 

Donors and patients as well as ethics bodies raised important points to be taken into 
consideration  during  the  implementation  phase  of  the  new  legal  framework, 
regarding for example donor protection, voluntary unpaid donation principles or the 
use of new training opportunities for inspectors about fundamental rights (to further 
enable  them  to  ensure  that  those  are  respected  by  establishments,  and  in  particular 
non-discrimination of donors).  

Many  stakeholders  also  underlined  the  lack  of  legal  clarity  on  the  delineation  with 
other  EU  legal  frameworks  (in  particular  medicinal  products,  including  advanced 
therapy  medicinal  products,  and  medical  devices)  and  indicated  many  cases  where 
they  believe  SoHO-based  therapies  are  not  appropriately  regulated,  including  some 
cases  with  a  negative  impact  on  feasibility  to  supply  and  eventual  patient  access. 
Stakeholders  considered  that  the  eventual  choice  for  the  most  appropriate  legal 
framework  should  aim  in  first  place  to  ensure  safety  and  quality,  but  also  take 
account of the setting of, the costs for and the feasibility of providing access to safe 
and  effective  therapies.  There  was  broad  support  for  a  dedicated  SoHO  legal 
advisory  mechanism  and  for  efficient  coordination  with  advisory  mechanisms  in 
other sectors. It was largely considered that this will allow to strengthen legal clarity 
as  well  as  improve  interplay  where  SoHOs  become  starting  materials  for  therapies 
manufactured under these other legal frameworks.   

Also,  while  supportive,  stakeholders  pointed  out  that  EU-level  supply  monitoring 
and crisis preparedness measures will demand significant efforts, without having any 
direct impact on the risk of shortages of critical SoHO. Finally, National Competent 
Authorities  (NCAs)  and  blood  and  tissue  establishments  expressed  concerns 
regarding  some  specific  measures  that  would  increase  their  costs  or  administrative 
burden.  Consideration  of  EU  level  measures  to  provide  support  was  taken  into 
account when preparing the legal proposal. 

An overview of the activities carried out and the results is available in Annexes 2 and 
18 of the impact assessment staff working document. 

• 

Collection and use of expertise  

The  Commission  used  the  findings  from  the  evaluation  of  the  BTC  legislation 
(2019). The impact assessment has been based on research and analyses done by the 

EN 

7 

  EN 

Commission. The Commission also contracted two external, independent consultant 
teams, to perform: 

– 

– 

A  study,  carried  out  by  ICF  S.A.  supporting  the    impact  assessment  of  the 
policy  options,  which  gathered  information  on  impacts  and  costs  for 
stakeholders  of  the  proposed  measures  and  options,  and  further  documented 
borderline  case  studies.  The  study  also  organised  participatory  workshops 
bringing stakeholders together to discuss various topics. The study was guided 
by  a  steering  group  composed  of  three  senior  experts  in  the  field  of  blood, 
tissues and cells, who supervised the process and validated the study findings.  
The external support study will be published alongside this proposal. 

A feasibility study,  carried out by Deloitte, focusing specifically on the costs, 
benefits  and  optimal  approaches  to  the  digitalisation  of  the  sector.  The 
preliminary  report  from  that  study  is  published  as  Annex  19  of  the  impact 
assessment staff working document. 

Many of the 448 references in the BTC legislation evaluation were articles published 
in  scientific  journals  and  included  data  and  evidence  that  was  still  relevant  for  the 
impact  assessment  of  the  policy  options.  In  addition,  a  number  of  further  scientific 
articles were published more recently and were also used as evidence sources for the 
impact  assessment.  These  represent  high  quality  evidence,  due  to  the  peer  review 
process used by the publishers. 

Evidence  on  costs  is  particularly  difficult  to  gather  in  the  SoHO  sector,  due  to  the 
predominant  role  of  public  sector  organisations  (public  administrations,  hospitals), 
where  real  costs  related  to  SoHO  activities  are  sometimes  absorbed  in  overall 
hospital  or  institutional  budgets.  This  explains  the  high  variety  of  costs  reported 
through  the  survey  performed  by  the  external  study  supporting  the  impact 
assessment, with NCAs and professionals. Sector experts, both from NCAs and from 
public  establishments,  were  therefore  brought  together  to  identify  and  agree  on 
reasonable  average  values  and  validate  key  assumptions  that  have  been  used  to 
calculate costs. 

The  identified  impacts  of  the  proposed  policy  measures  were  subjected  to  a  multi-
criteria decision analysis to compare the effectiveness and efficiency of the options. 
To that end, the impact assessment piloted the tool developed by the Joint Research 
the  European  Commission,  SOCRATES  (SOcial  multi-CRiteria 
Centre  of 
AssessmenT of European policieS), using it to  compare the different  options based 
on previously established criteria. 

• 

Impact assessments 

The  impact  assessment  analysed  three  policy  options  for  the  setting  of  safety  and 
quality standards: 

– 

– 

Option  1  -  Decentralised  regulation: 
tissue 
establishments with the freedom to make reference to a variety of national and 
international  guidance  when  conducting  risk  assessments  of  their  own 
activities, with a view to setting their internal technical methods. 

it  provides  blood  and 

Option  2  -  Joint  regulation:  it  requires  blood  and  tissue  establishments  to 
follow  the  technical  guideline  developed  and  updated  by  nominated  expert 
bodies.  

EN 

8 

  EN 

– 

Option 3 - Central Regulation: it requires blood and tissue establishments to 
follow the safety and quality standards, all provided for in EU legislation. 

The preferred option is Option 2. Joint regulation brings the highest effectiveness and 
efficiency as it builds on established expertise  in the field of SoHOs  to  ensure that 
up-to-date  standards  are  applied  across  the  EU.  Option  1  would  allow  changes  to 
standards to be implemented more quickly, but with a high level of variation across 
the  EU  and  a  high  workload  on  small  blood  and  tissue  establishments.  Option  3 
would allow for the highest level of harmonisation, but would require more time to 
adapt standards and bring additional costs for EU institutions.  

This  proposal  therefore  introduces  high  level  standards  in  the  legislative  text  for 
patient,  donor  and  offspring  protection  and  empowers  the  Commission  to  adopt 
implementing acts on the implementation of those standards if needed. Where there 
are no such implementing acts, professionals should, to meet these standards, apply 
safety  and  quality  guidelines  developed  by  the  EDQM  and  the  ECDC,  in  line  with 
option  2.  However,  in  line  with  option  1,  it  can  also  be  acceptable  to  apply  other, 
equivalent,  guidelines  accepted  by  national  authorities  and  demonstrated  as 
achieving  equivalent  standards  of  safety  and  quality.  In  the  absence  of  a  technical 
guideline  from  expert  bodies,  establishments  can  set  their  own  technical  method 
taking  into  account  internationally  recognised  standards,  scientific  evidence  and  a 
documented risk assessment. This approach will facilitate an efficient and responsive 
implementation  of  safety  and  quality  standards  whenever  risks  and  technologies 
change. It is proportionate in that it ensures EU legislation would be adopted for the 
implementation  of  a  particular  standard  only  when  necessary  and  when  it  adds  EU 
value (option 3).  

In  addition,  a  series  of  common  measures  was  assessed,  in  particular  to  fill  some 
legal gaps in the BTC framework, strengthen oversight, facilitate innovation, through 
advice  on  when  the  SoHO  legislation  is  applicable  and  a  (risk-)  proportionate 
authorisation  pathway  for  new  processes,  and  manage  SoHOs  supply  (crisis).  The 
implementation of some of these common measures will be supported by guidelines 
from expert bodies (option 2). 

Regarding  the  measure  on  establishing  a  SoHO  advisory  mechanism,  this  proposal 
does  not  propose  any  changes  in  the  delineation  of  the  borderline  with  the  legal 
frameworks  for  pharmaceuticals  or  medical  devices.  The  delineating  criteria  are 
defined  in  those  other  frameworks,  in  particular  in  Article  1  of  Regulation  (EU) 
2017/745  (‘devices  manufactured  utilising  derivatives  of  tissues  or  cells  of  human 
origin  which  are  non-viable’),  in  Article  2  of  Directive  2001/83/EC  on  medicinal 
products  (‘intended  to  be  placed  on  the  market’  and  ‘prepared  industrially’),  and 
consequently in  Article  2 of Regulation  (EC) No 1394/2007  on Advanced Therapy 
Medicinal Products (‘substantial manipulation’ and ‘not intended  to be used for the 
same  essential  function’).  This  measure  will  rather  facilitate  coordination  with 
established (or future) advisory mechanisms in those other frameworks.  

The preferred option would ensure that citizens are better protected when donating, 
or being treated with a substance of human origin, with more harmonised and up-to-
date  safety  and  quality  rules  across  the  EU.  In  addition,  offspring  from  medically 
assisted reproduction will be better protected, as will patients treated with currently 
unregulated  SoHOs  (e.g.  therapeutic  use  of  donated  breast  milk  or  bedside 
preparations of SoHOs). 

EN 

9 

  EN 

The preferred option would bring a positive impact for professionals, in particular in 
blood  and  tissue  establishments,  when  working  with  SoHO.  Outdated,  and 
sometimes costly, technical rules for safety and quality will be removed and replaced 
with standards based on the best scientific evidence and expertise available that will 
be  updated  in  a  timely  manner  (bringing  efficiencies  for  establishments).  The 
preferred option also allows for guidance to make common measures more efficient: 
a clear and (risk-) proportionate pathway will facilitate access to SoHOs prepared or 
used  in  new  ways  and  supply-crisis  management  will  be  better  aligned  and 
coordinated.  

The common measures will also strengthen oversight by competent authorities, by 
bringing  in  principles  and  new  or  more-efficient  practices  (e.g.,  joint  inspections). 
Authorities  will  also  benefit  from  more  proportionate  measures  (e.g.,  risk  based 
inspections) and EU level support (e.g. a digital  platform, EU auditing of oversight 
systems, EU training courses for authority personnel). These measures will increase 
mutual  trust  and  facilitate  the  collaboration  between  Member  States,  which  should 
ultimately facilitate the cross-border exchanges of SoHOs, hence patient access. 

Digitalisation will allow for further efficiencies in administrative processes, and the 
possibility for sharing of information will limit duplication of work across Member 
States. 

The  main  costs  relate  to  monitoring  measures  (donor,  offspring,  supply),  to 
registration of bedside preparations of SoHOs and to the risk-proportionate pathway 
to  authorise  SoHOs  processed  or  used  in  new  ways.  Those  costs  mostly  fall  on 
professionals in blood and tissue establishments, hospitals and clinics and, to a lesser 
degree,  on  competent  authorities.  EU  measures  can  be  considered  to  offset  these 
costs  for  professionals  and  authorities,  in  particular  in  the  adjustment  phase  and  in 
particular through supporting digitalisation. 

For  EU  institutions,  the  set-up  of  a  common  IT  platform  (the  EU  SoHO  Platform) 
brings a significant cost, but will allow for a lightening of the (administrative) burden 
for national authorities and professionals. Further EU costs relate to coordination and 
co-funding of expert bodies.  

• 

Regulatory fitness and simplification 

This  initiative  is  part  of  the  Commission  Work  Programme  2021  under  Annex  II 
(REFIT initiatives). 

The  revision  of  the  BTC  legislation,  with  an  approach  proportionate  to  risks  in 
different areas  (authorisation or registration of establishments/entities, authorisation 
of  new  preparation  processes,  health  monitoring  of  certain  SoHO  donors  and 
offspring), brings opportunities for savings in the sector, and for carrying out some 
activities  more  efficiently  with  the  same  resources  (e.g.  risk-based  inspections), 
though  these  opportunities  have  not  always  been  fully  quantified.  The  table  below 
gives an overview of the main opportunities under the preferred option.  

REFIT Cost Savings – Preferred Option 

Description 

Amount 

Comments 

EN 

10 

  EN 

Graded oversight approach allows 
to  oversee  some  establishments 
with  lighter  approach  and  less 
resources than today  

EUR 4 m 

750  establishments  eligible10,  mainly 
saving  on 
for 
inspection 
authorities and for themselves 

costs 

Common  IT-platform 
to  share 
assessments  of  new  SoHOs 
technologies reduces duplications  

>EUR 2 m 

Conservative estimate; 

Requests 
technologies 
assessed in parallel across EU; 

to  authorise  same  new 
and 

introduced 

are 

Sensitive  to  unit  cost  of  assessments 
and authorisations 

Risk-based  schedule  allows 
inspect 
activities/establishments 
efficiently 
activities)  

to 
same 
more 
(targeting  high-risk 

Not quantified  Model has rather assumed this to be a 
the  same 
cost-neutral  measure  as 
number  of 
(inspectors) 
resources 
allow  for  more  oversight  on  most 
complex activities 

Recognition  of  authorisations  of 
importing tissue establishments in 
other  Member  States,  reduces 
need 
import 
authorisations 
different 
Member States 

ad-hoc 
in 

for 

EUR 0.5 m 

Applicable  for  almost  1  000  imports 
per  year  of  blood  stem  cells  (from 
bone  marrow  or  peripheral  blood) 
through  a  central  registry  (World 
Marrow  Donor  Association  registry, 
subject to one joint authorisation) 

Removing  obsolete 
systematic 
from the legislation 

tests  and 
screening  measures 

EUR 2 m 
(example – 
West Nile Virus 
NAT tests11) 

Very  high  potential,  given  that  every 
saving  is  multiplied  by  number  of 
donations.  Other  examples  could  be 
the  screening  for  tattoos/piercings  or 
testing for syphilis. 

Digitalisation  allows  for  more 
efficient  administrative  processes 
in authorities and establishments 

To be further 
quantified 

The  EU  SoHO  Platform,  financed  by 
the  Commission,  will  facilitate  local 
administration  including  registration 
and reporting by professionals as well 
as  authorisations  and  oversight  by 
authorities. 

reporting  costs  are 
E.g.  annual 
estimated  to  go  down  from  current 
EUR 5 000-15 000 to EUR 200-2 000 

10 

11 

This concerns establishments that only do procurement of haematopoietic stem cells, lab testing, import 
or distribution, and are currently authorised as standard tissue/blood establishment. 
Individual NAT test for West Nile Virus can be replaced by pooled NAT test, which is EUR 7 cheaper 
per  tested  donation.  Applicable  to  around  300  000  blood  donations  per  year  in  countries  affected  by 
West Nile Virus, saving estimated based on 2016 calculation by NHSBT (UK blood service), see table 
1 of the Evaluation {SWD (2019) 376 final}, section 5.3.1.2, p. 59. 

EN 

11 

  EN 

                                                 
with an automated reporting tool. 

Digital impacts are also expected, as data in the  SoHO sector can become valuable 
digital  assets  in  the  areas  of  public  health  and  innovation.  A  single  IT  system  will 
bring important benefits as it can host flexible solutions, allowing Member States and 
establishments  to  maintain  and  connect  with  their  own  system  or  re-use  existing 
components. It could become an important node in the EU digital ecosystem, and in 
particular in the future European Health Data Space (EHDS), which aims at opening 
opportunities  and  removing  barriers  to  the  use  and  reuse  of  health  data,  for  the 
provision  of  healthcare,  personalised  medicine,  research  and  innovation,  policy 
making and regulatory activities. To benefit from the EHDS in the future, competent 
authorities  in  the  field  of  SoHOs  could  consider  the  collaboration  with  competent 
bodies  under  the  EHDS  at  national  and  EU  level,  including  for  aspects  related  to 
technical and semantic interoperability. 

• 

Fundamental rights 

The  proposal  would  bring  positive  impacts  on  some  fundamental  rights  of  citizens 
(health  protection,  non-discrimination,  privacy,  informed  consent),  in  particular  by 
strengthening  the  provisions  relating  to  donor  protection  and  vigilance  and  the 
reporting of genetic conditions in children born from medically assisted reproduction 
with  third  party  donation,  and  by  ensuring  that  requirements  for  safety  and  quality 
are  based  on  scientific  evidence.  However,  for  most  of  the  ethical  aspects,  in 
particular the rights of children born from medically assisted reproduction, decisions 
are taken by Member States at national level.  

The  proposal  maintains  the  current  principle  of  voluntary  and  unpaid  donation 
(VUD) in line with Article 3 of the EU Charter of Fundamental Rights that prohibits 
the  commercialisation  of  the  human  body.  However,  the  proposal  harmonises  the 
differing versions in the blood and the tissue and cell Directives and adapts them to 
the  principle  of  ‘financial  neutrality’  recently  recommended  by  the  Council  of 
Europe Committee on Bioethics12. 

4. 

BUDGETARY IMPLICATIONS 

The  legislative  financial  statement  attached  to  this  proposal  sets  out  the  budgetary, 
human  and  administrative  resource  implications.  Appropriations  will  be  reallocated 
within  the  financial  envelope  of  the  EU4Health  Programme13  in  the  Multiannual 
Financial  Framework  (MFF)  2021-2027.  That  Programme  was  established  to 
respond  to  the  need  for  further  action  at  Union  level  to  support  cooperation  and 
coordination  among  the  Member  States.  That  Programme  should  be  a  means  to 
promote strengthened exchange of best practices between Member States, to support 
networks  for  the  sharing  of  knowledge  or  for  mutual  learning,  to  address  cross-

12 

13 

Council of Europe Committee on Bioethics (DH-BIO) Guide for the implementation of the principle of 
prohibition  of  financial  gain  with  respect  to  the  human  body  and  its  parts  from  living  or  deceased 
donors, available at: https://rm.coe.int/guide-financial-gain/16807bfc9a. 
Regulation  (EU)  2021/522  of  the  European  Parliament  and  of  the  Council  of  24  March  2021 
establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the 
period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1). 

EN 

12 

  EN 

 
                                                 
border threats to health so as to reduce the risks of such threats and to mitigate their 
consequences, and to improve efficiency by avoiding the duplication of activities and 
optimising  the  use  of  financial  resources.  In  that  context,  some  activities organised 
jointly  among  Member  States,  such  as 
inspections  or  SoHO  preparations 
assessments, could be eligible for Union financial support. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The Commission will review the monitoring indicators periodically and evaluate the 
impacts of the legislative act after five years. The monitoring will be possible thanks 
to the data from reporting obligations on Member States and SoHO entities. The EU 
SoHO  Platform  will  enable  the  collection  of  all  elements  of  the  continuous 
monitoring  plan  as  it  automates  the  extraction  of  relevant  indicators  without 
additional  input  from  stakeholders.  For  the  evaluation,  additional  data  will  be 
collected, in particular on the costs, the usability and the integration across systems. 
The  data  platform  will  be  used  to  transparently  publish  aggregated  indicators  of 
general 
to  SoHOs, 
insufficiencies of supply or authorised SoHO preparations.  

interest,  such  as  serious  adverse  occurrences  related 

• 

Detailed explanation of the specific provisions of the proposal 

The new Regulation, repealing the Blood Directive 2002/98/EC and the Tissues and 
Cells Directive 2004/23/EC, and their implementing legislation, is structured around 
obligations  for  the  different  stakeholders:  the  national  competent  authorities,  the 
entities handling SoHOs, and the Commission. It includes specific requirements for 
all organisations that carry out activities that can affect the safety, quality or efficacy 
of  SoHOs  used  for  human  application  and  describes  obligations  for  designated 
authorities that will verify the proper implementation of the provisions. It will consist 
of the following main chapters: 

Chapter I: General provisions 

Chapter I contains general provisions of this Regulation. It defines the subject matter 
and the scope of  application of the Regulation.  In recognition  of the importance of 
ensuring  safety  and  quality  of  SoHOs  that  are  not  defined  by  the  terms  ‘blood’, 
‘tissue’  or  ‘cell’,  such  as  breast  milk  and  intestinal  microbiota,  and  to  future-proof 
the legislation in this regard, the scope is defined by the broader term SoHOs.  Solid 
organs continue to be regulated by Directive 2010/53/EU and are excluded from the 
definition of this term. This chapter contains the definitions of the different elements 
of  the  Regulation  and  of  the  terminology  used  throughout  the  text.  Furthermore,  it 
introduces  the  description  of  SoHO  activities  and  describes  the  possible  more 
stringent measures set by Member States, in line with Article 168(4)(a) of the TFEU. 
Certain  exclusions  are  described,  along  with  the  partial  applicability  of  this 
Regulation when SoHOs are used to manufacture products regulated by other Union 
legislation, or as the starting and raw material thereof. 

Chapter II: Competent Authorities 

Chapter II contains the provisions regarding competent authorities for SoHOs, which 
are  responsible  for  the  SoHO  supervisory  activities.  It  covers  the  designation  of 
competent authorities, the possibility to delegate certain SoHO supervisory activities, 
and  general  principles  for  their  functioning  (independence  and  impartiality, 
transparency). It also defines their general responsibilities and obligations. It covers 

EN 

13 

  EN 

the  communication  between  competent  authorities  (within  the  SoHO  sector)  and 
consultation and cooperation with authorities of other regulated sectors. It lays down 
general  obligations  for  authority  personnel  and  provides  for  competent  authorities 
obligations regarding Commission controls. 

Chapter III: SoHO Supervisory Activities  

Chapter  III  covers  all  activities  competent  authorities  undertake  vis-à-vis  SoHO 
entities or processes, with the obligation to maintain a register of SoHO entities and a 
procedure for their registration; the obligation to have a system for the authorisation 
of SoHO preparations, and a procedure for these authorisations, with provisions for 
conducting the assessment of SoHO preparations, possibly in a joint process with one 
or more competent authorities, and further specific obligations for SoHO preparation 
assessors. This Chapter also covers the obligation to have an authorisation system for 
SoHO establishments (specific in case of importing SoHO entities) and a procedure 
for their authorisation (SoHO establishments/importing SoHO entities). It stipulates 
the  obligations  for  inspections  of  SoHO  establishments  and  other  SoHO  entities, 
possibly via joint inspections, and the specific obligations for inspectors. It provides 
for the obligations for competent authorities regarding data publication, traceability, 
vigilance and, SoHO Rapid Alerts. 

Chapter IV: General Obligations on SoHO Entities  

Chapter  IV  outlines  all  the  general  obligations  on  SoHO  entities,  namely  their 
registration,  the  nomination  of  a  Responsible  Person  if  they  release  SoHOs  for 
clinical  use,  the  obligations  regarding  export  of  SoHOs.  It  also  lays  down  the 
obligation for authorisation of SoHO preparations, and the procedure for application 
for  such  authorisation.  It  also  covers  the  obligations  for  importing  SoHO  entities 
regarding their  authorisation,  and the application for such authorisation.  It provides 
for the obligations for SoHO entities regarding activity data collection and reporting, 
traceability and coding, the obligation to apply the Single European Code to SoHOs 
distributed  for  human  application  (except  for  some  specific  SoHOs),  and  vigilance 
notifications.  

Chapter V: General Obligations on SoHO Establishments  

Chapter V lays down the general  obligations on  SoHO establishments,  a sub-set  of 
SoHO entities that process and store SoHOs.  It provides for their authorisation and 
the  application  procedure  for  such  authorisation,  the  obligation  to  have  a  Quality 
Management system in place, and the obligation to designate a physician responsible 
for specific tasks. 

Chapter VI: SoHO Donor Protection 

Chapter  VI  contains  the  provisions  related  to  the  protection  of  SoHO  donors,  with 
standards, and how to implement these standards concerning donor protection. 

Chapter VII: Recipient and Offspring Protection  

Chapter VII contains the provisions related to the protection of patients treated with 
SoHO  (recipients)  and  offspring  from  medically  assisted  reproduction,  with 
standards, and how to implement these standards concerning recipient and offspring 
protection.  It  also  stipulates  conditions  for  the  release  of  SoHOs  for  human 
application, and conditions for exceptional release. 

Chapter VIII: Supply Continuity 

EN 

14 

  EN 

Chapter  VIII  lays  down  provisions  to  ensure  the  continuity  of  supply  of  SoHOs.  It 
covers the obligation for Member States to have national SoHO emergency plans (for 
SoHOs that are critically important for patients) and the responsibilities of competent 
authorities  and  entities  regarding  supply  alerts  for  critical  SoHOs.  It  also  stipulates 
the conditions for derogation from the obligations to authorise SoHO preparations in 
emergencies,  provides  for  additional  emergency  measures  taken  by  Member  States 
and  finally  lays  down  the  obligation  for  SoHO  entities  carrying  out  activities  with 
critical SoHOs to have an emergency plan in place. 

Chapter IX: SoHO Coordination Board 

Chapter  IX  establishes  the  SoHO  Coordination  Board  (SCB)  to  support  Member 
States in the coordination of implementation of this Regulation and the delegated and 
implementing  acts  adopted  pursuant  to  it.  This  chapter  also  provides  for  the 
composition of the Board and how its functioning is organised. 

Chapter X: Union Activities  

Chapter  X  outlines  the  activities  organised  at  Union  level,  regarding  training  and 
exchange of competent  authorities’ personnel, the Commission controls in Member 
States, and the support provided by the Commission to support the implementation of 
the  Regulation.  It  also  refers  to  the  cooperation  with  the  EDQM,  which  should 
address  procedures  for  the  development  and  revision  of  technical  guidelines, 
including evidence gathering, guideline drafting and public consultation.  

Chapter XI: EU SoHO Platform 

Chapter  XI  describes  the  EU  SoHO  Platform  that  will  support  information  sharing 
between authorities and with SoHO entities, and outlines its general functionalities. 

Chapter XII: Procedural Provisions  

Chapter  XII  contains  the  procedural  provisions  of  the  Regulation  with  regard  to 
confidentiality  and  data  protection  obligations.  It  furthermore  contains  provisions 
regarding  the  exercise  of  delegation,  the  urgency  procedure  and  the  committee 
procedure.  Finally,  it  lays  down  the  penalties  applicable  to  infringements  of  the 
provisions of this Regulation to be set by Member States. 

As  regards  delegated  acts,  following  the  adoption  of  the  proposal,  the  Commission 
intends  to  create  an  expert  group  in  line  with  decision  C  (2016)  3301  in  order  to 
advise and assist it in the preparation of delegated acts, as well as on issues related to 
implementation of the Regulation as regards: 

(a) 

preparing opinions at the request of the Commission on the regulatory status of 
a  substance,  product  or  activity  (and  consulting  equivalent  advisory  bodies 
established in other relevant Union legislation); 

(b)  providing expertise relevant for the development of technical guidelines, other 

guidelines and technical methods to the Commission;  

(c) 

(d) 

reviewing reports on activity data and on vigilance data prior to publication by 
the Commission; 

contributing to the continuous monitoring of technical progress and assessment 
of  whether  the  safety  and  quality  requirements  set  out  in  this  Regulation  are 
adequate to ensure safety and quality of SoHOs and SoHO preparations and the 
safety of SoHO donors; 

EN 

15 

  EN 

(e) 

(f) 

(g) 

supporting  the  Commission  to  exchange  views  with  Union  or  international 
level  professional  associations  working  in  the  field  of  SoHOs  on  issues  of 
general  interest  in  relation  to  the  applicability  of  the  provisions  of  this 
Regulation; 

providing  expertise  to  the  Commission  for  the  development  of  guidelines, 
standards or similar on an international level for SoHOs and their quality and 
safety, when appropriate; 

advising  the  Commission  on  the  appropriate  content  and  format  of  Union 
training  programmes  for  competent  authority  personnel  and  supporting  the 
performance of training activities; 

(h)  providing advice and expertise on the preparation of delegated acts. 

The  expert  group  should  also  provide  technical  advice  to  the  Commission  when  it 
considers that the EDQM guidelines are not sufficient to meet a standard for donor 
protection or a standard for recipient and offspring protection as provided for in this 
Regulation. 

Chapter XIII: Transitional Provisions  

This Chapter sets the transitional provisions applicable to establishments and SoHO 
preparations  authorised  under the former  BTC  legislation.  It  stipulates  the status  of 
SoHO  stored  before  the  application  of  this  Regulation.  Finally,  it  contains  the 
transitional  measures  related  to  the  date  of  adoption  of  certain  delegated  and 
implementing acts. 

Chapter XIV: Final Provisions  

The final chapter stipulates the repeal of Directives 2002/98/EC and 2004/23/EC. It 
also sets the provision for the evaluation of the Regulation, and its dates of entry into 
force and application. 

EN 

16 

  EN 

2022/0216 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on standards of quality and safety for substances of human origin intended for human 
application and repealing Directives 2002/98/EC and 2004/23/EC 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 168(4), point (a), thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee1,  
Having regard to the opinion of the Committee of the Regions2,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

In accordance with Article 168(1), first subparagraph, of the Treaty on the Functioning 
of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of 
the  European  Union,  a  high  level  of  human  health  protection  is  to  be  ensured  in  the 
definition and implementation of all Union policies and activities.  

Article 168(4), point (a), TFEU provides that the European Parliament and the Council 
should  adopt  measures  setting  high  standards  of  quality  and  safety  for  organs  and 
substances of human origin (SoHOs), blood and blood derivatives. At the same time, 
Member  States  cannot  be  prevented  from  maintaining  or  introducing  more  stringent 
protective measures.  Pursuant  to  Article 193 TFEU, Member States  are  to  notify the 
Commission of any such measures. According to Article 168(7) TFEU, the measures 
adopted pursuant to Article 168(4), point (a) should not affect national provisions on 
the donation or medical use of organs and blood.  

As  regards  Article  168(4),  point  (a),  TFEU,  standards  for  the  safety  and  quality  of 
organs and SoHOs, blood and blood derivatives should ensure a high level of human 
health  protection.  Therefore,  this  Regulation  aims  at  setting  high  standards  by 
ensuring,  amongst  others,  the  protection  of  SoHO  donors,  taking  into  consideration 
their  fundamental  role  in  the  provision  of  SoHOs  and  for  recipients,  as  well  as 
measures  to  monitor  and  support  the  sufficiency  of  the  supply  of  SoHOs  that  are 
critical for the health of patients. 

1 
2 

OJ C , , p. . 
OJ C , , p. . 

EN 

17 

  EN 

                                                 
(4) 

(5) 

(6) 

(7) 

Directives  2002/98/EC3  and  2004/23/EC4  of  the  European  Parliament  and  of  the 
Council  constitute  the  Union’s  regulatory  framework  for  blood  and  for  tissues  and 
cells, respectively. Although these Directives have harmonised to a certain degree the 
rules  of  Member  States  in  the  area  of  safety  and  quality  of  blood,  tissues  and  cells, 
they  include  a  significant  number  of  options  and  possibilities  for  Member  States  to 
implement the rules they laid down. This results in divergences between national rules, 
which can create obstacles to cross-border sharing of these substances. A fundamental 
revision  of  those  Directives  is  needed  for  a  robust,  transparent,  up-to-date  and 
sustainable  regulatory  framework  for  these  substances,  which  achieves  safety  and 
quality  for  all  parties  involved,  enhances  legal  certainty  and  supports  continuous 
supply,  whilst  facilitating  innovation  for  the  benefit  of  public  health.  In  order  to 
achieve  a  coherent  application  of  the  legal  framework,  it  is  appropriate  to  repeal 
Directives 2002/98/EC and 2004/23/EC and to replace them by a Regulation. 

Directives  2002/98/EC  and  2004/23/EC  are  highly  interconnected  and  contain  very 
similar provisions for oversight and equivalent principles for safety and quality in the 
two  sectors  they  regulate.  In  addition,  many  authorities  and  operators  work  across 
these  sectors.  As  this  Regulation  aims  to  define  high  level  principles  that  will  be 
common to both the blood and of tissues and cells sectors, it would be appropriate that 
it replaces these Directives and merges the revised provisions into one legal act.  

This  Regulation  should  apply  to  blood  and  blood  components,  as  regulated  by 
Directive  2002/98/EC,  as  well  as  to  tissues  and  cells,  including  haematopoietic 
peripheral blood, umbilical-cord blood and bone-marrow stem cells, reproductive cells 
and tissues, foetal tissues and cells and adult and embryonic stem cells, as regulated by 
Directive  2004/23/EC.  Since  donation  and  human  application  of  SoHOs  other  than 
blood, tissues and cells are increasingly common, it is necessary to extend the scope of 
this Regulation to any SoHO, regardless of whether it meets the definition of ‘blood’, 
‘tissue’ or ‘cell’, to avoid that certain groups of donors or recipients are not protected 
by  an  appropriate  Union  level  quality  and  safety  framework.  This  will,  for  example, 
ensure  the  protection  of  donors  and  recipients  of  human  breast  milk,  intestinal 
microbiota, blood preparations that are not used for transfusion, and any other SoHO 
that may be applied to humans in the future.  

Solid  organs  are  excluded  from  the  definition  of  SoHOs  for  the  purposes  of  this 
Regulation  and,  thus,  from  its  scope.  Their  donation  and  transplantation  are 
significantly  different  and  are  regulated  in  a  dedicated  legal  framework,  set  out  in 
Directive 2010/53/EU5 of the European Parliament and of the Council. Shortcomings 
have  not  been  raised  regarding  the  existing  quality  and  safety  provisions  for  organs. 
Nonetheless,  when  organs  are  removed  from  a  donor  for  the  purposes  of  separating 
tissues  or  cells  for  human  application,  for  example  heart  valves  from  a  heart  or 
pancreatic islets from a pancreas, this Regulation should apply. 

3 

4 

5 

Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27  January  2003  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 (OJ L 33, 8.2.2003, p. 30). 
Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  on  setting 
standards of quality and safety for the donation, procurement, testing, processing, preservation, storage 
and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48). 
Directive  2010/53/EU  of  the  European  Parliament  and  of  the  Council  of  7  July  2010  on  standards  of 
quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14). 

EN 

18 

  EN 

                                                 
(8) 

(9) 

Ensuring the quality and safety of SoHOs is crucial, especially where such substances 
interact  with  the  body  of  the  recipient.  Hence,  this  Regulation  should  not  cover  the 
placing  of  a  substance  on  the  body  when  it  does  not  have  any  biological  or 
physiological interaction with that body, such as in the case of wigs made from human 
hair. 

All  SoHOs  that  are  intended  to  be  applied  to  humans  fall  within  the  scope  of  this 
Regulation. SoHOs can be prepared and stored in a variety of ways, becoming SoHO 
preparations,  which  can  be  applied  to  recipients.  In  these  circumstances,  this 
Regulation should apply to all activities from donor recruitment to human application 
and  outcome  monitoring.  SoHOs  or  SoHO  preparations  can  also  be  used  to 
manufacture products regulated by other Union legislation, or as the starting and raw 
material  thereof,  in  particular  on  medical  devices,  regulated  by  Regulation  (EU) 
2017/745  of  the  European  Parliament  and  of  the  Council6,  on  medicinal  products, 
regulated  by  Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council7 
and by Regulation (EC) No 726/2004 of the European Parliament and of the Council8, 
including on advanced therapy medicinal products, regulated by Regulation (EC) No 
1394/2007 of the European Parliament and of the Council9, or on food, regulated by 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council10. The 
criteria  that  define  when  SoHOs  or  SOHO  preparations  become  products  regulated 
under  other  Union  legislation  are  not  defined  in  this  Regulation  but  are  defined  in 
those other acts. In addition, this Regulation should apply without prejudice to Union 
legislation on genetically modified organisms.  

(10)  When SoHOs are used in the autologous setting without any manipulation, processing 
or storage, the application of this Regulation would not be proportionate to the limited 
quality  and  safety  risks  arising  in  such  a  setting.  When  autologous  SoHOs  are 
collected  and  processed  before  being  re-used  in  the  same  person,  risks  appear  that 
should  be  mitigated.  Thus,  there  needs  to  be  an  assessment  and  authorisation  of  the 
processes applied to ensure that they are demonstrated to be safe and effective for the 
recipient. When autologous SoHOs are collected to be processed and also stored, risks 
of  cross-contamination,  loss  of  traceability  or  damage  to  the  biological  properties 
inherent  to  the  substance,  and  necessary  for  efficacy  in  the  recipient,  also  appear. 
Thus, the requirements for SoHO establishment authorisation should apply.  

(11)  When SoHOs are used to manufacture products regulated by other Union legislation, 
or as the starting and raw material thereof, in order to ensure a high level of protection 
and contribute to legal clarity and certainty, this Regulation should apply to the extent 

6 

7 

8 

9 

10 

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 
Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down Union procedures for the authorisation and supervision of medicinal products for human use and 
establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 
on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 
726/2004 (OJ L 324, 10.12.2007, p. 121). 
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on 
the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 
26). 

EN 

19 

  EN 

                                                 
that  the  activities  to  which  they  are  subjected  are  not  regulated  by  the  other  Union 
legislative framework. Without prejudice to other Union legislation, and in particular 
to  Directive  2001/83/EC,  Regulations  (EC)  No  726/2004,  (EC)  No  1925/2006,  (EC) 
No  1394/2007  and  (EU)  2017/745,  this  Regulation  should  at  least  apply  to  the 
recruitment and selection of donors, donation, collection and donor testing as well as 
to release, distribution, import and export when those activities concern SoHOs up to 
the point of their transfer to operators regulated by other Union legislation. This means 
that close interaction between this regulatory framework and other related frameworks 
is  essential  to  ensure  interplay  and  coherence  between  relevant  legal  frameworks, 
without gaps or overlaps.  

(12)  SoHOs can also be combined with other regulated products before human application. 
In these circumstances, close interaction between this regulatory framework and other 
related frameworks is also necessary to ensure a high level of human health protection 
for all cases where these substances are used. 

(13)  Given  the  special  nature  of  SoHOs,  resulting  from  their  human  origin,  and  the 
increasing demands for these substances for human application or for the manufacture 
of  products  regulated  by  other  Union  legislation,  or  as  the  starting  and  raw  material 
thereof, it is necessary to ensure a high level of health protection for donors as well as 
for recipients. SoHOs should be obtained from individuals whose health status is such 
that  no  detrimental  effects  will  ensue  as  a  result  of  the  donation.  This  Regulation 
should therefore include principles and technical rules to monitor and protect donors. 
As different types of donation imply different risks for donors, with varying levels of 
significance, the monitoring of donor health should be proportionate to those levels of 
risk.  This  is  particularly  important  when  donation  involves  some  risk  to  the  donor’s 
health due to a need for pre-treatment with medicinal products, a medical intervention 
to  collect  the  substance  or  a  need  for  donors  to  donate  repeatedly.  Donations  of 
oocytes, bone marrow, peripheral blood stem cells and plasma should be considered to 
imply a significant risk. 

(14)  When a harmful genetic condition is detected in the offspring resulting from medically 
assisted  reproduction  with  third  party  donation,  the  transmission  of  that  information 
enables  the  prevention  of  further  use  of  donations  affected  by  that  genetic  risk.  It  is 
thus  important  that  relevant  information  in  such  cases  is  effectively  communicated 
between SoHO entities and acted upon appropriately. 

(15)  This  Regulation  does  not  prevent  Member  States  from  maintaining  or  introducing 
more  stringent  protective  measures  that  are  compatible  with  Union  law.  Member 
States should notify the Commission of any such measures. More stringent protective 
measures put in place by Member States should be evidence-based and proportionate 
to  the  risk  to  human  health,  for  example  based  on  overall  safety  concerns  and 
corresponding  risks  in  a  Member  State  or  specific  local  risks.  They  should  not 
discriminate  against  persons  on  grounds  of  sex,  racial  or  ethnic  origin,  religion  or 
belief,  disability,  age  or  sexual  orientation,  unless  that  measure  or  its  application  is 
objectively  justified  by  a  legitimate  aim,  and  the  means  of  achieving  that  aim  are 
appropriate and necessary.  

(16)  This  Regulation  should  not  interfere  with  national  legislation  in  the  health  area  with 
objectives other than quality and safety of SoHOs that is compatible with Union law, 
in  particular  legislation  concerning  ethical  aspects.  Such  aspects  arise  due  to  the 
human  origin  of  the  substances,  which  touches  upon  various  sensitive  and  ethical 
concerns for Member States and citizens, such as access to particular services that use 

EN 

20 

  EN 

SoHOs. This  Regulation  should also  not interfere with  decisions of an ethical  nature 
made by Member States. Such ethical decisions might concern the use, or limitation of 
the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive 
cells  and  embryonic  stem  cells.  When  a  Member  State  allows  the  use  of  such  cells, 
this Regulation should apply in full with a view to ensuring safety and quality and to 
protecting human health.  

(17)  This Regulation is not meant to cover research using SoHOs when that research does 
not involve application to the human body, for example in vitro research or research in 
animals.  However,  human  substances  used  in  research  involving  studies  where  they 
are  applied  to  the  human  body  should  comply  with  the  rules  laid  down  in  this 
Regulation.  

(18)  As  a  matter  of  principle,  programmes  promoting  the  donation  of  SoHOs  should  be 
founded on the principle of voluntary and unpaid donation, altruism of the donor and 
solidarity between donor and recipient. Voluntary and unpaid SoHO donation is also a 
factor  which  can  contribute  to  high  safety  standards  for  SoHOs  and  therefore  to  the 
protection of human health. It is also recognised, including by the Council of Europe  
Committee on Bioethics11, that while financial gain should be avoided, it may also be 
necessary  to  ensure  that  donors  are  not  financially  disadvantaged  by  their  donation. 
Thus, compensation to remove any such risk is acceptable but should never constitute 
an  incentive  that  would  cause  a  donor  to  be  dishonest  when  giving  their  medical  or 
behavioural history or to donate more frequently than is allowed, posing risks to their 
own health and to that of prospective recipients. Such compensation should, therefore, 
be  set  by  national  authorities,  at  a  level  appropriate  in  their  Member  State  to  reach 
such objectives.  

(19) 

In order to maintain public trust in SoHO donation and use programmes, information 
that  is  given  to  prospective  donors,  recipients  or  physicians  regarding  the  likely  use 
and  benefits  of  particular  SoHOs  or  SoHO  preparations  when  applied  to  recipients 
should accurately reflect  reliable scientific  evidence. This  should  ensure  that donors, 
or their families, are not coerced to donate by exaggerated descriptions of benefits and 
prospective patients are not given false hopes when making decisions on their options 
for treatment. The verification of compliance with this Regulation through supervisory 
activities is of fundamental importance to ensure that, across the Union, the objectives 
of  the  Regulation  are  effectively  achieved.  The  responsibility  to  enforce  this 
Regulation lies with the Member States, whose competent authorities should monitor 
and  verify,  through  the  organisation  of  supervisory  activities,  that  relevant  Union 
requirements are effectively complied with and enforced.  

(20)  Competent authorities should be designated by the Member States for all the areas that 
fall  within  the  scope  of  this  Regulation.  While  Member  States  are  best  placed  to 
identify  the  competent  authority  or  authorities  for  each  area,  for  example  by 
geography,  topic  or  substance,  they  should  also  be  required  to  designate  a  single 
national  authority  that  ensures  appropriately  coordinated  communication  with  other 
Member States’ competent authorities and with the Commission. The SoHO National 
Authority  should  be  considered  the  same  as  the  designated  competent  authority  in 
Member States where only one competent authority is designated. 

11 

Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of 
prohibition  of  financial  gain  with  respect  to  the  human  body  and  its  parts  from  living  or  deceased 
donors (March 2018). Available at https://rm.coe.int/guide-financial-gain/16807bfc9a. 

EN 

21 

  EN 

                                                 
(21)  For the performance of supervisory activities aimed at verifying the correct application 
of  SoHO  legislation,  Member  States  should  designate  competent  authorities  that  act 
independently and impartially. It is therefore important that their function of oversight 
is  separate  and  independent  from  the  performance  of  SoHO  activities.  In  particular, 
competent authorities should be free from undue political influence and from industry 
interference that might affect their operational impartiality. 

(22)  For the performance of supervisory activities aimed at verifying the correct application 
of SoHO legislation, Member States should designate competent authorities that act in 
the public interest, are appropriately resourced and equipped, and offer guarantees of 
impartiality,  professionalism  and  transparency.  When  infringements  relate  to  direct 
health  risks,  and  the  publication  of  information  regarding  those  infringements  can 
contribute to risk mitigation and the protection of donors, recipients or offspring from 
medically  assisted  reproduction,  competent  authorities  should,  where  necessary,  be 
able  to  prioritise  transparency  of  their  enforcement  activities  over  the  protection  of 
confidentiality of the party that has infringed the Regulation.  

(23)  The  correct  application  and  enforcement  of  the  rules  falling  within  the  scope  of  this 
Regulation  require an appropriate knowledge of  those rules.  It  is  therefore important 
that  the  staff  performing  supervisory  activities  have  an  appropriate  professional 
background and are regularly trained, in accordance with their area of competence, on 
the obligations resulting from this Regulation.  

(24)  When there is  doubt  about  the  regulatory status  of  a particular  substance, product or 
activity under this Regulation, competent authorities should consult with the relevant 
authorities  responsible  for  other  relevant  regulatory  frameworks,  namely  medicinal 
products,  medical  devices,  organs  or  food,  with  the  aim  of  ensuring  coherent 
procedures for the application of this Regulation. Competent authorities should inform 
the SoHO Coordination Board of the outcome of their consultations. When SoHOs or 
SoHO  preparations  are  used  to  manufacture  products  regulated  under  other  Union 
legislation,  or  as  the  starting  and  raw  material  thereof,  competent  authorities  should 
cooperate with the relevant authorities on their territory. This cooperation should aim 
to  reach  an  agreed  approach  for  any  subsequent  communications  between  the 
authorities  responsible  for  SoHO  and  for  the  other  relevant  sectors,  as  needed, 
regarding  authorisation  and  monitoring  of  the  SoHOs  or  the  product  manufactured 
from  SoHOs.  It  should  in  principle  be  the  responsibility  of  the  Member  States  to 
decide  on  a  case-by-case  basis  on  the  regulatory  status  of  a  substance,  product  or 
activity.  However,  in  order  to  ensure  consistent  decisions  across  all  Member  States 
with regard to borderline cases, the Commission should be empowered to, on its own 
initiative  or  at  the  duly  substantiated  request  of  a  Member  State,  decide  on  the 
regulatory status of a particular substance, product or activity under this Regulation.  

(25)  Competent authorities should perform supervisory activities regularly, on the basis of 
a risk assessment and with appropriate frequency, on entities and activities governed 
by this Regulation. The frequency of supervisory activities and the mode, whether on-
site or by remote document review, should be established by the competent authorities, 
having  regard  to  the  need  to  adjust  the  control  effort  to  the  risk  and  to  the  level  of 
compliance  expected  in  the  different  situations,  including  the  possible  violations  of 
this Regulation  perpetrated through fraudulent or other illegal  practices  and previous 
compliance history. Accordingly, the likelihood of non-compliance with all the areas 
of  this  Regulation  should  be  taken  into  account  when  scheduling  supervisory 
activities. 

EN 

22 

  EN 

(26)  Commission experts should be able to perform controls, including audits, in Member 
States  to  verify  the  effective  application  of  the  relevant  requirements  of  competent 
authorities and of the supervisory activity systems.  Commission  controls  should also 
serve  to  investigate  and  collect  information  on  enforcement  practices  or  problems, 
emergencies  and  new  developments  in  Member  States.  Official  controls  should  be 
performed by personnel who are independent, free from any conflict of interest and in 
particular  who are  not  in  a  situation  which,  directly  or  indirectly,  could  affect  their 
ability to carry out their professional duties in an impartial manner. 

(27)  Since  SoHO  preparations  are  subjected  to  a  series  of  SoHO  activities  prior  to  their 
release  and  distribution,  competent  authorities  should  assess  and  authorise  SoHO 
preparations  to  verify  that  a  high  level  of  safety,  quality  and  efficacy  is  achieved 
consistently  by  the  application  of  that  specific  series  of  activities,  performed  in  that 
specific  manner.  When  SoHOs  are  prepared  with  newly  developed  and  validated 
collection,  testing  or  processing  methods,  consideration  should  be  given  to  the 
demonstration  of  safety  and  efficacy  in  recipients  by  means  of  requirements  for 
clinical  outcome  data  collection  and  review.  The  extent  of  such  required  clinical 
outcome  data  should  correlate  with  the  level  of  risk  associated  with  the  activities 
performed  for  that  SoHO  preparation  and  use.  Where  a  new  or  modified  SoHO 
preparation poses negligible risks for recipients (or offspring in the case of medically 
assisted  reproduction),  the  vigilance  reporting  requirements  provided  for  in  this 
Regulation  should  be  adequate  to  demonstrate  safety  and  quality.  This  should  apply 
for well-established SoHO preparations that are introduced in a new SoHO entity but 
have been robustly demonstrated as safe and effective by their use in other entities. 

(28)  With regard to SoHO preparations that pose a certain level of risk (low, moderate or 
high), the applicant should propose a plan for clinical outcome monitoring that should 
fulfil  different  requirements  appropriate  to  the  risk  indicated.  The  most  up-to-date 
guidance  of  the  European  Directorate  for  the  Quality  of  Medicines  &  HealthCare 
(EDQM, a Directorate of the Council of Europe) should be considered relevant in the 
design  of  clinical  follow-up  studies  proportionate  in  extent  and  complexity  to  the 
identified level of risk of the SoHO preparation. In the case of low risk, in addition to 
the mandatory continuous vigilance reporting, the applicant should organise proactive 
clinical  follow-up  for  a  defined  number  of  patients.  For  moderate  and  high  risk,  in 
addition to the mandatory vigilance reporting and the clinical follow-up, the applicant 
should  propose  clinical  investigation  studies  with  monitoring  of  pre-defined  clinical 
end-points.  In  case  of  high  risk,  these  should  include  a  comparison  with  standard 
treatments,  ideally  in  a  study  with  subjects  allocated  to  test  and  control  groups  in  a 
randomised manner. The competent authority should approve the plans before they are 
implemented  and  should  assess  the  outcome  data  as  part  of  a  SoHO  preparation 
authorisation.  

(29) 

In the interests of efficiency, it should be permitted to conduct clinical outcome studies 
using the established framework in the pharmaceutical sector for clinical trials, as set 
out in Regulation (EU) No 536/2014 of the European Parliament and of the Council12, 
when operators wish to do so. Whilst applicants can choose to record the clinical data 
generated  during  the  clinical  outcome  monitoring  themselves,  they  should  also  be 
permitted  to  use  existing  clinical  data  registries  as  a  means  of  such  recording  when 

12 

Regulation  (EU)  No  536/2014  of  the  European  Parliament  and  of  the  Council  of  16  April  2014  on 
clinical  trials  on  medicinal  products  for  human  use,  and  repealing  Directive  2001/20/EC  (OJ  L  158, 
27.5.2014, p. 1). 

EN 

23 

  EN 

                                                 
those registries have been verified by the competent  authority, or are certified by  an 
external institution, in terms of the reliability of their data management procedures.  

(30) 

In  order  to  facilitate  innovation  and  reduce  administrative  burden,  competent 
authorities should share with each other information on the authorisation of new SoHO 
preparations and the evidence used for such authorisations, including for the validation 
of  certified  medical  devices  used  for  SoHO  collection,  processing,  storage  or 
application  to  patients.  Such  sharing  could  allow  authorities  to  accept  previous 
authorisations granted to other entities, including in other Member States and to thus 
significantly reduce the requirements to generate evidence.  

(31)  A  broad  range  of  public  and  private  organisations  influence  the  safety,  quality  and 
efficacy  of  SoHOs,  even  if  they  do  not  maintain  banks  of  those  SoHOs.  Many 
organisations carry out a single SoHO activity, such as collection or donor testing on 
behalf of one or many organisations that maintain banks of SoHOs. The SoHO entity 
concept includes this broad range of organisations, from donor registries to physicians 
that  apply  SoHOs  to  recipients  or  use  SoHO  processing  devices  at  the  recipient’s 
bedside.  The  registration  of  all  such  SoHO  entities  should  ensure  that  competent 
authorities have a clear  overview of the field  and its scale and can take  enforcement 
action  when  deemed  necessary.  A  SoHO  entity  registration  should  refer  to  the  legal 
entity, regardless of the number of physical sites associated with the entity. 

(32)  Competent authorities should review the SoHO entities registered in their territory and 
ensure  that  those  entities  that  carry  out  both  processing  and  storage  of  SoHOs  are 
inspected  and  authorised  as  SoHO  establishments  before  starting  those  activities.  A 
SoHO  establishment  authorisation  should  refer  to  the  legal  entity,  even  when  one 
SoHO  establishment  has  many  physical  sites.  Competent  authorities  should  consider 
the impact on safety, quality and efficacy of the SoHO activities carried out at SoHO 
entities  that do not  meet the definition of  a SoHO establishment  and decide whether 
particular entities should be subject to establishment authorisations due to the risk  or 
scale associated with their activities. Similarly, SoHO entities that have a poor record 
in terms of compliance with reporting or other obligations might be suitable candidates 
for authorisation as SoHO establishments.  

(33)  With  regards  to  standards  concerning  donor,  recipient  and  offspring  protection,  this 
Regulation should provide for a hierarchy  of rules for their implementation. As risks 
and  technologies  change,  this  hierarchy  of  rules  should  facilitate  an  efficient  and 
responsive uptake of the most up-to-date guidelines for implementing the standards set 
out  in  this  Regulation.  As  part  of  that  hierarchy,  in  the  absence  of  Union  legislation 
describing particular procedures to be applied and followed to meet the standards set 
out  in  this  Regulation,  following  the  guidelines  of  the  European  Centre  for  Disease 
Prevention and Control (ECDC)  and the EDQM should be  considered as  a means to 
demonstrate compliance with the standards laid down in this Regulation to ensure high 
level of quality, safety and efficacy. SoHO entities should be permitted to follow other 
guidelines, provided that it has been demonstrated that those other guidelines achieve 
the same level of quality, safety and efficacy. In cases of detailed technical issues for 
which  neither  Union  legislation  nor  the  ECDC  and  the  EDQM  have  defined  a 
technical guideline or rule, operators should apply a locally defined rule that is in line 
with  relevant  internationally  recognised  guidelines  and  scientific  evidence  and  is 
appropriate to mitigate any risk identified.  

(34)  Where  evidence  demonstrates  that  specific  processing  steps  reduce  or  eliminate  the 
risk of transmission of specific infectious or non-infectious disease agents, the quality 

EN 

24 

  EN 

and safety standards for the verification of donor eligibility by means of donor health 
evaluations,  including  testing,  and  the  related  guidelines  for  their  implementation, 
should take this evidence into account.  Thus, in the case of, for example, plasma for 
fractionation,  that  in  a  subsequent  step  in  the  manufacturing  process  of  medicinal 
products  undergoes  sterilisation  steps,  certain  donor  eligibility  criteria  used  for 
donation of plasma for transfusion might not be necessary nor appropriate.  

(35)  The EDQM is a structural part of the Council of Europe working under the European 
Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a 
European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC13, 
is  considered  to  be  the  text  of  the  European  Pharmacopoeia  Partial  Agreement. 
Member  States  of  the  Council  of  Europe  that  have  signed  and  ratified  the  European 
Pharmacopoeia  Convention  are  the  member  States  of  the  European  Pharmacopoeia 
Partial  Agreement  and  are  therefore  the  members  of  the  intergovernmental  bodies 
functioning  within  the  framework  of  this  partial  agreement,  including  among  others: 
the  European  Pharmacopoeia  Commission,  the  European  Committee  on  Organ 
Transplantation  (CD-P-TO),  the  European  Committee  on  Blood  Transfusion  (CD-P-
TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-
P-PH). The European Pharmacopoeia Convention has been signed and ratified by the 
European  Union  and  all  its  Member  States,  all  of  whom  are  represented  in  their 
intergovernmental bodies. In this context, the work of the EDQM on developing and 
updating  guidelines  on  safety  and  quality  of  blood,  tissues  and  cells,  should  be 
considered an important contribution to the field of SoHOs in the Union and should be 
reflected in this Regulation. The guidelines address issues of quality and safety beyond 
the  risks  of  communicable  disease  transmission,  such  as  donor  eligibility  criteria  for 
the prevention of the transmission of cancer and other non-communicable diseases and 
the  assurance  of  safety  and  quality  during  collection,  processing,  storage  and 
distribution.    It  should  therefore  be  possible  to  use  those  guidelines  as  one  of  the 
means to implement the technical standards provided for in this Regulation. 

(36)  The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament 
and  of  the  Council14,  is  a  Union  agency  with  the  mission  of  strengthening  Europe's 
defences  against  communicable diseases.  The work of the  ECDC on developing  and 
updating  guidelines  on  safety  and  quality  of  SoHOs  from  a  communicable  disease 
threat  perspective,  should  be  considered  an  important  contribution  in  the  field  of 
SoHOs in the Union and should be reflected in this Regulation. In addition, the ECDC 
established an expert network for the Microbial  Safety of  SoHOs, which  ensures  the 
implementation of the requirements on the ECDC’s relations with the Union Member 
States  and  EEA  Member  States  stated  in  Regulation  (EC)  No  851/2004,  regarding 
strategic and operational collaboration on technical and scientific issues, surveillance, 
responses  to  health  threats,  scientific  opinions,  scientific  and  technical  assistance, 
collection  of  data,  identification  of  emerging  health  threats,  and  public  information 
campaigns related to the safety of SoHOs. This SoHO expert network should provide 
information  or  advice  in  relation  to  relevant  outbreaks  of  communicable  diseases,  in 
particular  regarding  the  eligibility  and  testing  of  donors  and  the  investigation  of 

13 

14 

Council  Decision  94/358/EC  of  16  June  1994  accepting,  on  behalf  of  the  European  Community,  the 
Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17). 
Regulation  (EC)  No  851/2004  of  the  European  Parliament  and  of  the  Council  of  21  April  2004, 
establishing a European centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1). 

EN 

25 

  EN 

                                                 
(37) 

(38) 

serious  adverse  occurrences  involving  suspected  transmission  of  a  communicable 
disease.  

It is necessary to promote information and awareness campaigns at national and Union 
level  on  the  importance  of  SoHOs.  The  aim  of  these  campaigns  should  be  to  help 
European  citizens  to  decide  whether  to  become  donors  during  their  lifetime  and  let 
their  families  or  legal  representatives  know  their  wishes  regarding  donation  after 
death. As there is a need to ensure the availability of SoHOs for medical treatments, 
Member  States  should  promote  the  donation  of  SoHOs,  including  plasma,  of  high 
quality  and  safety,  thereby  also  increasing  self-sufficiency  in  the  Union.  Member 
States are also urged to take steps to encourage a strong public and non-profit sector 
involvement  in  the  provision  of  SoHO  services,  in  particular  for  critical  SoHOs  and 
the related research and development.  

In order to promote a coordinated application of this Regulation, a SoHO Coordination 
Board (SCB) should be set up. The Commission should participate in its activities and 
chair it. The SCB should contribute to a coordinating the application of this Regulation 
throughout  the  Union,  including  by  helping  Member  States  to  conduct  SoHO 
supervisory  activities.  The  SCB  should  be  composed  of  persons  designated  by  the 
Member  States  based  on  their  role  and  expertise  in  their  competent  authorities,  and 
should also involve experts that are not working for competent authorities, for specific 
tasks where access to necessary in-depth technical expertise in the field of SoHOs is 
required. In the latter case, appropriate consideration should be given to the possibility 
of involving European expert bodies such as the ECDC and the EDQM and existing 
professional,  scientific and donor and  patient  representative  groups at  Union  level  in 
the field of SoHOs. 

(39)  Some  substances,  products  or  activities  have  been  subject  to  different  legal 
frameworks with different requirements in the Member States. This causes confusion 
among operators in the field, and the consequent legal uncertainty is a disincentive to 
professionals  to  develop  new  ways  to  prepare  and  use  SoHOs.  The  SCB  should 
receive  relevant  information  on  national  decisions  made  on  cases  where  questions 
were raised on the regulatory status of SoHOs. The SCB should keep a compendium 
of the opinions issued by the SCB or the competent authorities and of decisions made 
at Member State level, so that competent authorities considering the regulatory status 
under  this  Regulation  of  a  particular  substance,  product  or  activity  may  inform  their 
decision-making  process  by  referring  to  that  compendium.  The  SCB  should  also 
document agreed best practices to support a common Union approach. It  should also 
cooperate with similar Union level bodies established in other Union legislation with a 
view  to  facilitating  coordinated  and  coherent  application  of  this  Regulation  between 
Member  States  and  across  bordering  legislative  frameworks.  These  measures  should 
promote a coherent cross-sectoral approach and facilitate SoHO innovation. 

(40)  The concept of a plasma master file (PMF) was established in Commission Directive 
2003/63/EC15.  Since  that  Directive  provided  for  a  specific  regulatory  role  for  the 
European  Medicines  Agency  (EMA)  in  relation  to  authorisation  of  plasma  for 
fractionation, the SCB should also collaborate with the relevant EMA expert working 
groups to exchange experience and good practices so that criteria for the eligibility of 

15 

Commission Directive 2003/63/EC of 25 June  2003 amending Directive 2001/83/EC of the European 
Parliament  and  of  the  Council  on  the  Community  code  relating  to  medicinal  products  for  human  use 
(OJ L 159, 27.6.2003, p. 46). 

EN 

26 

  EN 

                                                 
donors  of  plasma  for  fractionation  and  of  donors  of  blood  for  transfusion  are 
implemented by Member States in a consistent and coherent way. 

(41) 

In order to limit administrative burden on competent authorities and the Commission, 
the  latter  should  establish  an  online  platform  (the  ‘EU  SoHO  Platform’)  to  facilitate 
timely  submission  of  data  and  reports  as  well  as  improved  transparency  of  national 
reporting and supervisory activities.  

(42)  The  processing  of  personal  data  under  this  Regulation  should  be  subject  to  strict 
guarantees  of  confidentiality  and  should  comply  with  the  rules  on  the  protection  of 
personal data laid down in Regulation (EU) 2016/679 of the European Parliament and 
of the Council  and in Regulation (EU) 2018/1725 of the European Parliament and of 
the Council .   

(43)  As the EU SoHO Platform requires the processing of personal data, it will be designed 
respecting the principles of data protection. Any processing of personal data should be 
limited  to  achieving  the  objectives  and  obligations  of  this  Regulation.  Access  to  the 
EU SoHO Platform should be limited to the extent necessary to carry out supervisory 
activities provided for in this Regulation.  

(44)  This  Regulation  respects  the  fundamental  rights  and  observes  the  principles 
recognised in particular by the Charter of Fundamental Rights of the European Union 
and in particular human dignity, the integrity of the person, the protection of personal 
data, the freedom of art and science and to conduct business, non-discrimination, the 
right  to  health  protection  and  access  to  health  care,  and  the  rights  of  the  child.  To 
achieve these aims, all supervisory and SoHO activities should always be carried out 
in  a  manner  that  fully  respects  those  rights  and  principles.  The  right  for  dignity  and 
integrity  of  donors,  recipients  and  of  offspring  born  from  medically  assisted 
reproduction  should  always  be  taken  into  account,  amongst  others,  by  ensuring  that 
consent  for donation is  freely  given  and donors  or their representatives  are informed 
with regards to the intended use of the donated material, that donor eligibility criteria 
are based on scientific evidence, that the use of SoHOs in humans is not promoted for 
commercial  purposes  or  with  false  or  misleading  information  regarding  efficacy  so 
that  the  donors  and  recipients  can  make  well-informed  and  deliberate  choices,    that 
activities  are  conducted  in  a  transparent  manner  that  prioritises  the  safety  of  donors 
and  recipients,  and  that  allocation  and  equitable  access  to  SoHOs  are  defined  in  a 
transparent  manner,  on  the  basis  of  an  objective  evaluation  of  medical  needs.  This 
Regulation should therefore be applied accordingly.  

(45)  SoHOs,  by  definition,  relate  to  persons,  and  there  are  circumstances  where  the 
processing  of  personal  data  relating  to  donors  and  recipients  may  be  necessary  to 
achieve  the  objectives  and  requirements  of  this  Regulation,  especially  provisions 
relating  to  vigilance  and  communication  between  competent  authorities.  This 
Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the 
conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of 
such personal data. With respect to personal data processed by the Commission, this 
Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the 
conditions  under  Article  10(2),  point  (i),  of  Regulation  (EU)  2018/1725.  Data  on 
safety and efficacy of new SoHO preparations in recipients should also be shared, with 
appropriate protective measures, to allow aggregation at Union level for more robust 
evidence  gathering  on  the  clinical  efficacy  of  SoHO  preparations.  For  all  data 
processing,  such  processing  should  be  necessary  and  appropriate  with  a  view  to 
ensuring  compliance  with  this  Regulation  in  order  to  protect  human  health.  Data  on 

EN 

27 

  EN 

donors,  recipients  and  offspring  should  hence  be  limited  to  the  minimum  necessary 
and  pseudonymised.  donors,  recipients  and  offspring  should  be  informed  of  the 
processing  of  their  personal  data  in  line  with  the  requirements  of  Regulations  (EU) 
2016/679 and (EU) 2018/1725, and in particular as provided for under this Regulation, 
including  the  possibility  of  exceptional  cases  where  circumstances  require  such 
processing. 

(46) 

In order to enable better access to health data in the interests of public health, Member 
States should entrust  competent  authorities as  data controllers  within the meaning of 
Regulation (EU) 2016/679 with powers to take decisions on the access to and re-use of 
such data.  

(47)  The  exchange  of  SoHOs  between  Member  States  is  necessary  for  ensuring  optimal 
patient  access  and  sufficiency  of  supply,  particularly  in  the  case  of  local  crises  or 
shortages.  For  certain  SoHOs  that  need  to  be  matched  between  the  donor  and  the 
recipient, such exchanges are essential to allow patients to receive the treatment they 
need.  In  this  context,  the  objective  of  this  Regulation,  namely  to  ensure  quality  and 
safety  of  SoHOs  and  a  high  level  of  protection  of  donors,  needs  to  be  achieved  at 
Union level, by establishing high standards of quality and safety for SoHOs, based on 
a common set of requirements that are implemented in a consistent manner across the 
Union.  Thus,  the  Union  may  adopt  measures,  in  accordance  with  the  principle  of 
subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In  accordance 
with the principle of proportionality, as set out in that Article, this Regulation does not 
go beyond what is necessary in order to achieve that objective.  

(48) 

In  order  to  be  able  to  supplement  this  Regulation  where  necessary  with  additional  
standards concerning the protection of donors, recipients and offspring from medically 
assisted reproduction to take into account technical and scientific developments in the 
field  of  SoHOs,  and  with  additional  rules  on  the  authorisation  of  importing  SoHO 
entities,  on  obligations  and  procedures  for  importing  SoHO  entities,  on  the 
organisation of Union training and exchange programmes, on technical specifications 
concerning the EU SoHO Platform, and on data protection, the power to adopt acts in 
accordance  with  Article  290  TFEU  should  be  delegated  to  the  Commission.  It  is  of 
particular importance that the Commission carries out appropriate consultations during 
its  preparatory  work,  including  at  expert  level,  and  that  those  consultations  be 
conducted  in  accordance  with  the  principles  laid  down  in  the  Interinstitutional 
Agreement  of  13  April  2016  on  Better  Law-Making16.  In  particular,  to  ensure  equal 
participation  in  the  preparation  of  delegated  acts,  the  European  Parliament  and  the 
Council receive all documents at  the same time as  Member States' experts,  and their 
experts systematically have access to meetings of Commission expert groups dealing 
with the preparation of delegated acts. 

(49) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation 
regarding  the  authorisation  system  for  importing  SoHO  entities,  the  application  for 
importing  SoHO  entity  authorisations,  the  activity  data  collection  and  reporting  by 
SoHO  entities,  the  European  coding  system,  the  establishment,  management  and 
functioning  of  the  SCB,  and  the  general  functionalities  of  the  EU  SoHO  Platform, 
implementing powers should be conferred on the Commission.  

(50) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
including the determination of the regulatory status of a substance, product or activity, 

16 

OJ L 123, 12.5.2016, p. 1. 

EN 

28 

  EN 

                                                 
rules  and  practical  arrangements  in  respect  of  the  consultation  and  cooperation  with 
competent  authorities  of  other  regulatory  sectors,  the  national  registers  of  SoHO 
entities, the registration process of SoHO entities, the SoHO preparation authorisation 
system  and  the  authorisation  of  SoHO  preparations,  the  SoHO  establishment 
authorisation  system,  the  inspections  of  SoHO  establishments,  the  consultation  and 
coordination  related  to  vigilance,  the  quality  management  system  for  SoHO 
establishments,  the  implementation  of  the  standards  concerning  the  protection  of 
donors,  recipients  and  offspring  from  medically  assisted  reproduction,  the  national 
SoHO  emergency  plans,  the  tasks  of  the  SoHO  Coordination  Board,  and  the 
transitional  provisions  concerning  SoHO  preparations,  implementing  powers  should 
be  conferred  on  the  Commission.  Those  powers  should  be  exercised  in  accordance 
with Regulation (EU) No 182/2011 of the European Parliament and of the Council17.   

(51)  Transitional  provisions  should  be  laid  down  in  order  to  ensure  a  smooth  transition 
from the former regimes for tissues and cells and for blood and blood components to 
this new Regulation, in particular in order to adapt practices to the new requirements, 
the  changes  in  SoHO  entities,  SoHO  establishments  and  SoHO  preparations,  and  to 
avoid  that  donated  SoHOs  are  discarded  unnecessarily.  A  transitional  regime  for 
establishments already designated, authorised, accredited or licensed before the date of 
application  of  this  Regulation  should  be  introduced  to  ensure  legal  certainty  and 
clarity.  In  particular,  there  should  be  clarity  for  the  establishments  concerned  as 
regards  their  registration  and  authorisation  status  as  well  as  their  tasks  and 
responsibilities under this Regulation, whilst allowing competent authorities additional 
time to transfer the relevant information to the systems introduced by this Regulation. 
To allow for a smooth transition, it is also appropriate that those preparation processes 
already authorised and lawfully used under the former regimes are still valid, and that 
SoHOs already collected and stored before the date of application of this Regulation 
may  be  used  for  a  certain  period  of  time.  The  European  Data  Protection  Supervisor 
was  consulted  in  accordance  with  Article  42(1)  of  Regulation  (EU)  2018/1725  and 
delivered an opinion on … [date of the opinion]18,  

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 

GENERAL PROVISIONS 

Article 1 

Subject matter 

This  Regulation  establishes  measures  setting  high  standards  of  quality  and  safety  for  all 
substances  of  human  origin  (‘SoHOs’)  intended  for  human  application  and  for  activities 
related  to  those  substances  in  order  to  ensure  a  high  level  of  human  health  protection,  in 
particular  for  SoHO  donors,  SoHO  recipients  and  offspring  from  medically  assisted 
reproduction.  This  Regulation  is  without  prejudice  to  national  legislation  which  establishes 

17 

18 

Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
laying down the rules and general principles concerning  mechanisms for control by Member States of 
the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). 
OJ C , , p. . 

EN 

29 

  EN 

                                                 
rules relating to aspects of SoHOs other than their quality and safety and the safety of SoHO 
donors.  

Article 2 

Scope  

1. 

This  Regulation  shall  apply  to  SoHOs  intended  for  human  application,  to  SoHO 
preparations,  to  products  manufactured  from  SoHOs  and  intended  for  human 
application, to SoHO donors and recipients, and to the following SoHO activities: 

(a)  SoHO donor recruitment; 

(b)  SoHO donor history review and eligibility assessment; 

(c)  SoHO testing of donors for eligibility or matching purposes; 

(d) 

collection of SoHOs from donors or patients; 

(e) 

(f) 

processing of SoHOs; 

quality control testing of SoHOs; 

(g) 

storage of SoHOs; 

(h)  SoHO release; 

(i) 

(j) 

distribution of SoHOs; 

import of SoHOs; 

(k) 

export of SoHOs; 

(l) 

human application of SoHOs; 

(m)  SoHO clinical outcome monitoring.  

2. 

In cases of autologous use of SoHOs where: 

(a)  SoHOs are processed and stored before application, this Regulation shall apply 

in full; 

(b)  SoHOs are processed and not stored before application, only the provisions on 
vigilance referred to in Article 35, on SoHO rapid alerts referred to in Article 
36, on SoHO entity registration referred to in Article 37, on SoHO preparation 
authorisation  referred  to  in  Article  40,    and  on  activity  data  collection  and 
reporting referred to in Article 44 shall apply;  

(c)  SoHOs  are  not  processed  and  not  stored  before  application,  this  Regulation 

shall not apply. 

For  SoHOs  that  are  used  to  manufacture  products  in  accordance  with  Union 
legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal 
products,  regulated  by  Regulation  (EC)  No  726/2004  and  Directive  2001/83/EC, 
including on advanced therapy medicinal products, regulated by Regulation (EC) No 
1394/2007,  or  on  food,  regulated  by  Regulation  (EC)  No  1925/2006,  or  as  the 
starting and raw material thereof, the provisions of this Regulation applicable to the 
activities  of  SoHO  donor  recruitment,  donor  history  review  and  eligibility 
assessment, testing of donors for eligibility or matching purposes,  and collection of 
SoHOs from donors or patients shall apply. Insofar as the activities of SoHO release, 
distribution,  import  and  export  relate  to  SoHOs  prior  to  their  distribution  to  an 

3. 

EN 

30 

  EN 

4. 

operator regulated by the other Union legislation referred to in this subparagraph, the 
provisions of this Regulation shall also apply. 

By  way  of  derogation  from  the  first  subparagraph,  in  cases  where  SoHOs,  SoHO 
preparations,  or  products  manufactured  from  SoHO,  as  referred  to  in  that 
subparagraph,  are  exclusively  for  autologous  use,  only  those  provisions  of  this 
Regulation that concern the collection of SoHOs from patients shall apply.  

Where non-viable SoHOs or their derivatives, as defined in Article 2, point (17), of 
Regulation  (EU)  2017/745,  incorporate,  as  an  integral  part,  a  medical  device,  and 
where  the  action  of  the  non-viable  SoHOs  or  their  derivatives  is  principal  and  not 
ancillary  to  that  of  the  device,  the  non-viable  SoHOs  or  their  derivatives  shall  be 
governed  by  this  Regulation.  If  the  action  of  the  non-viable  SoHOs  or  their 
derivatives is ancillary to that of the device and not principal,  the provisions of this 
Regulation,  insofar  as  they  concern  donor  recruitment,  donor  history  review  and 
eligibility  assessment,  testing  of  donors  for  eligibility  or  matching  purposes, 
collection of SoHOs from donors or patients, shall apply. 

Article 3 

Definitions  

For the purpose of this Regulation the following definitions shall apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and 
carbon dioxide from the tissues of the body; 

‘blood  component’  means  a  constituent  of  blood  such  as  red  cells,  white  cells, 
platelets and plasma, that can be separated from it;  

‘cell’ means a mass of cytoplasm with or without a nucleus, that is bound externally 
by a cell membrane. Usually microscopic in size, cells are the smallest structural and 
functional unit of an organism; 

‘tissue’ means a group of cells that function together as a unit; 

‘substance of human origin’ (SoHO) means any substance collected from the human 
body in whatever manner, whether it contains cells or not and whether those cells are 
living or not. For the purposes of this Regulation, SoHO does not include organs in 
the sense of Article 3, point (h), of Directive 2010/53/EU; 

‘human  application’  means  inserted,  implanted,  injected,  infused,  transfused, 
transplanted, ingested, transferred (as in transfer to the uterus or fallopian tube of a 
woman),  inseminated  or  otherwise  added  to  the  human  body  in  order  to  create  a 
biological, mechanical or physiological interaction with that body; 

‘SoHO activity’ means an action, or series of actions, that has a direct impact on the 
safety, quality or efficacy of SoHOs, as listed in Article 2(1); 

‘SoHO  donor’  means  any  person  who  has  presented  themselves  to  a  SoHO  entity 
with a view to making a donation of SoHOs, whether that donation is successful or 
not; 

‘SoHO recipient’ means the person to whom SoHOs are applied; 

‘medically  assisted  reproduction’  means  the  facilitation  of  conception  by  intra-
uterine insemination of sperm, in vitro fertilisation or any other laboratory or medical 
intervention that promotes conception; 

EN 

31 

  EN 

(11) 

‘offspring from medically assisted reproduction’ means fetuses and children that are 
born following medically assisted reproduction;  

(12) 

‘SoHO preparation’ means a particular type of SoHO that:  

(a) 

has  been  subjected  to  one  or  more  SoHO  activities,  including  processing,  in 
accordance with defined quality and safety parameters; 

(b)  meets a pre-defined specification; and 

(c) 

is intended for application to a recipient for a specific clinical indication or is 
intended for distribution for manufacture of a product regulated by other Union 
legislation, or as the starting and raw material thereof; 

‘donor  recruitment’  means  any  activity  aimed  at  encouraging  persons  to  become 
SoHO donors; 

‘collection’  means  a  process  by  which  SoHOs  are  removed,  procured,  excreted, 
secreted or obtained  by  any  other manner, including any  preparatory steps, such as 
hormone treatment, needed to facilitate the process; 

‘processing’  means  any  operation  involved  in  the  handling  of  SoHOs,  including 
washing, 
sterilisation, 
fertilisation, 
preservation and packaging; 

decontamination, 

separation, 

shaping, 

‘quality  control’  means  several  tests  or  checks  to  confirm  that  a  SoHO  activity  or 
SoHO preparation meets pre-defined quality criteria;  

‘storage’ means  the maintenance of SoHOs under  appropriate controlled conditions 
until distribution; 

‘release’  means  a  process  through  which  it  is  verified  that  a  SoHO  or  a  SoHO 
preparation  meets  defined  safety  and  quality  criteria  and  the  conditions  of  any 
applicable authorisation before distribution; 

‘distribution’  means  transportation  and  delivery,  within  the  Union,  of  released 
SoHOs or SoHO preparations intended for human application or for the manufacture 
of  products  regulated  under  other  Union  legislation,  or  as  the  starting  and  raw 
material thereof, including within the same organisation when SoHOs are delivered 
from a SoHO entity to a unit responsible for human application; 

‘import’ means activities carried out to bring SoHOs or SoHO preparations into the 
Union from a third country, including the organisation of such activities and physical 
verification  of  coherence  with  associated  documentation,  the  appropriateness  of 
transport conditions, the integrity of packaging and the adequacy of labelling before 
release; 

‘export’ means distribution of SoHOs or SoHO preparations to third countries; 

‘clinical outcome monitoring’ means evaluation of the health of a SoHO recipient for 
the purpose of monitoring the results of a SoHO preparation application, maintaining 
care and demonstrating safety and efficacy; 

‘autologous  use’  means  collection  of  SoHO  from  one  individual  for  subequent 
application to the same individual, with or without further SoHO activities between 
collection and application; 

‘SoHO entity’ means an organisation legally established in the Union that carries out 
one or more of the SoHO activities set out in Article 2(1); 

(13) 

(14) 

(15) 

(16) 

(17) 

(18) 

(19) 

(20) 

(21) 

(22) 

(23) 

(24) 

EN 

32 

  EN 

(25) 

(26) 

(27) 

(28) 

‘SoHO  preparation  authorisation’  means  the  formal  approval  by  a  competent 
authority  of  a  SoHO  preparation,  including  the  approval  of  the  chain  of  activities 
carried out to obtain the SoHO preparation; 

‘vigilance’ means a set of organised surveillance and reporting procedures relating to 
adverse occurrences; 

‘adverse occurrence’ means any  incident that caused harm to a living SoHO donor, 
harm to a SoHO recipient or to offspring from medically assisted reproduction or that 
implied a risk of such harm;  

‘serious adverse occurrence’ (SAO) means an adverse occurrence that resulted in, or 
implied a risk of, any of the following: 

(a) 

(b) 

(c) 

death; 

life-threatening,  disabling  or  incapacitating  condition,  including  transmission 
of a pathogen that might cause such condition; 

transmission  of  a  genetic  condition  to  offspring  from  medically  assisted 
reproduction with third party donation;  

(d)  hospitalisation or prolongation of hospitalisation; 

(e) 

(f) 

(g) 

(h) 

the need for a clinical intervention to prevent any of the above; 

loss of a quantity of SoHOs that causes human applications to be postponed or 
cancelled; 

loss of highly matched or autologous SoHOs; 

a  mix-up  of  reproductive  cells  in  such  a  way  that  an  oocyte  is  fertilised  with 
sperm  from  an  individual  other  than  the  intended  individual  or  reproductive 
cells are inseminated or transferred to the uterus or fallopian tube of a woman 
other than the intended recipient; 

(i) 

prolonged  sub-optimal  health  of  a  SoHO  donor  following  single  or  multiple 
donations; 

‘SoHO  rapid  alert’  means  a  communication  regarding  a  SAO,  a  communicable 
disease  outbreak  or  other  information  that  might  be  of  relevance  to  the  safety  and 
quality  of  SoHOs  in  more  than  one  Member  State  and  is  to  be  transmitted  rapidly 
between competent authorities and the Commission to facilitate the implementation 
of mitigating measures; 

‘non-viable’ means having no potential for metabolism or multiplication; 

‘EU  SoHO  Platform’  means  the  digital  platform  established  by  the  Commission  to 
exchange information concerning SoHO activities; 

‘SoHO  supervisory  activity’  means  any  activity  as  provided  for  in  Chapter  III 
performed  by  a  competent  authority  or  by  a  delegated  body  in  order  to  verify  and 
enforce compliance with this Regulation; 

‘the compendium’ means a list kept up-to-date by the SoHO Coordination Board of 
decisions, taken at Member State level, and opinions, issued by competent authorities 
and by the SCB, on the regulatory status of specific substances, products or activities 
and published on the EU SoHO platform; 

(29) 

(30) 

(31) 

(32) 

(33) 

EN 

33 

  EN 

(34) 

(35) 

(36) 

(37) 

(38) 

(39) 

(40) 

(41) 

(42) 

(43) 

(44) 

(45) 

(46) 

(47) 

‘quality management system’ means a formalised system that documents processes, 
procedures,  and  responsibilities  to  support  achieving  defined  quality  standards  in  a 
consistent manner; 

‘delegated body’ means a legal body to which the competent authority has delegated 
certain SoHO supervisory activities in accordance with Article 6; 

‘audit’  means  a  systematic  and  independent  examination  to  determine  whether 
activities  and  the  related  results  of  such  activities  comply  with  legislation  and 
planned arrangements and whether these arrangements are applied effectively and are 
suitable to achieve the objectives; 

‘inspection’  means  a  formal  and  objective  control  by  a  competent  authority  or 
delegated body to assess compliance with this Regulation and other relevant Union 
or national legislation and to identify the need for corrective or preventive action to 
achieve compliance; 

‘Union  training’  means  activities  for  the  personnel  of  competent  authorities  and, 
where appropriate, for personnel of delegated bodies performing SoHO supervisory 
activities; 

‘assessors’  means  personnel  performing  the  assessment  of  SoHO  preparations  as 
referred to in Article 22; 

‘SoHO  establishment’  means  a  SoHO  entity  that  carries  out  both  processing  and 
storage of SoHOs; 

‘critical SoHO’ means a SoHO for which an insufficient supply will result in serious 
harm or risk of harm to patients; 

‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to 
the supply of critical SoHOs and the scale of those activities is such that a failure to 
carry  them  out  cannot  be  compensated  by  activities  of  other  entities  or  alternative 
substances or products for patients;  

‘conditional  authorisation’  means  the  granting  of  permission  by  a  competent 
authority  to  a  SoHO  entity  to  perform  certain  SoHO  activities  under  specific 
conditions defined by that competent authority; 

‘on-site  inspection’  means  an  inspection  carried  out  at  the  premises  of  the  SoHO 
establishment, or other SoHO entity, concerned; 

‘technical guidelines’ means a description of a series of  methodological  procedures 
and  parameters  that,  if  followed,  achieve  a  level  of  quality  and  safety  of  a  SoHO 
activity  or  a  SoHO  preparation  that  is  considered  to  be  acceptable  as  a  means  to 
comply with regulatory standards; 

‘joint inspection’ means an inspection carried out by inspectors from more than one 
Member State; 

‘traceability’  means  the  ability  to  locate  and  identify  SoHOs  during  any  step  from 
collection  through  processing  and  storage  to  distribution  or  disposal,  including  the 
ability to: 

(a) 

identify the SoHO donor and the SoHO entity processing or storing the SoHOs; 

(b) 

identify the recipient at the SoHO entity applying the SoHOs to the recipient; 

(c) 

locate  and  identify  all  relevant  data  relating  to  the  safety  and  quality  of  the 
SoHOs and any materials coming into contact with those SoHOs;  

EN 

34 

  EN 

(48) 

(49) 

(50) 

(51) 

(52) 

(53) 

(54) 

(55) 

(56) 

(57) 

(58) 

(59) 

(60) 

(61) 

(62) 

‘Single European Code’ (SEC) means the unique identifier applied to certain SoHOs 
distributed in the Union; 

‘SAO  notification’  means  the  communication  from  a  SoHO  entity,  a  SoHO 
establishment  or  a  SoHO  donor  or  recipient  to  a  competent  authority,  of  a  serious 
adverse  occurrence  or  a  suspected  serious  adverse  occurrence  associated  with  a 
SoHO donation or human application; 

‘SAO  investigation  report’  means    the  report  from  a  SoHO  entity  or  a  SoHO 
establishment  to  a  competent  authority  on  a  specific  SAO,  describing  the  outcome 
and  including  an  assessment  of  the  seriousness  and  the  level  of  imputability,  the 
likely cause and any corrective action taken; 

‘imputability’  means  the  likelihood  that  a  serious  adverse  occurrence,  in  a  SoHO 
donor, is  related to  the donation process  or, in  a  recipient,  to  the application  of the 
SoHOs; 

‘seriousness’ means the degree of severity of an adverse occurrence, involving harm 
to a SoHO donor, recipient or offspring from medically assisted reproduction, at and 
above which the occurrence shall be notified to a competent authority; 

‘self-reporting’  means  the  notification  of  a  SAO  by  a  SoHO  recipient  or  a  SoHO 
donor directly to the competent authorities; 

‘Annual  SoHO  Vigilance  Report’  means  the  annual  report  published  by  the 
Commission  aggregating  the  summaries  from  the  SoHO  National  Authorities  on 
SAO notifications and SAO investigation reports received; 

‘deferral’  means  temporary  or  permanent  suspension  of  the  eligibility  of  an 
individual to donate SoHO; 

‘responsible  person’  means  the  nominated  individual  in  a  SoHO  entity  that  has 
responsibility for SoHO release; 

‘process  validation’  means  establishing  documented  evidence  that  provides  a  high 
degree of assurance that a specific process will consistently produce results meeting 
predetermined specifications and quality attributes; 

‘equipment  qualification’  means  establishing  documented  evidence  that  provides  a 
high degree of assurance that a specific piece of equipment will consistently perform 
to predetermined specifications; 

‘EDQM  SoHO monograph’ means a specification of the critical  quality  parameters 
of a particular SoHO preparation defined by the European Directorate for the Quality 
of Medicines and HealthCare of the Council of Europe; 

‘Annual  SoHO  Activity  Report’  means  the  annual  report  published  by  the 
Commission  aggregating  the  data  reports  from  SoHO  entities  carrying  out  the 
following  activities:  donor  recruitment,  collection,  distribution,  import,  export  and 
human application of SoHOs; 

‘reproductive cells’ means all cells intended to be used for the purpose of medically 
assisted reproduction; 

‘third party donation’ means a donation of reproductive cells by a person to a person 
or a couple with whom the donor does not have an intimate physical relationship; 

EN 

35 

  EN 

(63) 

(64) 

(65) 

(66) 

(67) 

(68) 

(69) 

(70) 

1. 

2. 

‘within  couple  use’  means  use  of  reproductive  cells  for  medically  assisted 
reproduction  from  two  persons  with  an  intimate  physical  relationship,  where  one 
person supplies their own oocytes and the other person supplies their own sperm; 

‘compensation’ means making good of any losses associated with donation; 

‘allogeneic  use’  means  collection  of  SoHO  from  one  individual  for  subsequent 
application to another individual; 

‘SoHO supply alert’ means a communication regarding a significant interruption to 
the supply of critical SoHOs that is to be transmitted to a competent authority,  and 
when necessary, by a SoHO National Authority to the competent authorities of other 
Member States; 

‘plasma  master  file’  (PMF)  means  a  compilation  of  the  required  scientific  data, 
covering all aspects of the use of plasma, from collection to the creation of a plasma 
pool, on the quality and safety of human plasma relevant to the medicinal products, 
medical  devices  and  investigational  products  that  use  human  plasma  in  their 
manufacture; 

‘plasma for transfusion’  means plasma separated  from  whole blood or  collected by 
apheresis for the purpose of transfusion to a recipient; 

‘plasma for fractionation’ means plasma separated from whole blood or collected by 
apheresis  and  used  as  the  starting  material  for  manufacturing  of  plasma-derived 
medicinal products; 

‘apheresis’  means  a  process  by  which  a  specific  blood  component  or  type  of  stem 
cell is separated from whole blood during the donation, allowing the remaining blood 
components to be returned immediately to the donor. 

Article 4 

More stringent Member State measures 

Member  States  may  maintain  or  introduce  within  their  territories  measures  that  are 
more stringent than the ones provided for in this Regulation on condition that those 
national measures are compatible with Union law, and are proportionate to the risk to 
human health. 

Member States shall make available to the public details of measures put in place in 
accordance  with  paragraph  1  without  undue  delay,  including  on  the  internet.  The 
SoHO National Authority shall submit the details of any more stringent  measure to 
the EU SoHO Platform referred to in Chapter XI.  

CHAPTER II 

COMPETENT AUTHORITIES 

Article 5 

Designation of competent authorities 

1. 

Member States shall designate the competent  authority or authorities to  which they 
confer responsibility for the SoHO supervisory activities provided for in Chapter III. 

EN 

36 

  EN 

The  organisation  or  organisations  designated  shall  be  independent  from  any  SoHO 
entity. 

2. 

For  the  same  territory,  a  Member  State  may  confer  responsibilities  for  SoHO 
supervisory activities to more than one competent authority, at national, regional or 
local level. 

3. 

Member States shall ensure that competent authorities: 

(a) 

have  the  autonomy  to  act  and  make  decisions  independently  and  impartially 
while  respecting  the  internal  administrative  organisational  requirements 
determined by the Constitutions of the Member States; 

(b)  have the necessary powers: 

(i) 

(ii) 

to  properly  perform  their  supervisory  activities,  including  access  to  the 
premises of, and documents and samples kept by, SoHO entities and any 
third parties contracted by a SoHO entity; 

to  order  the  immediate  suspension  or  cessation  of  a  SoHO  activity  that 
poses  immediate  risk  to  SoHO  donors,  SoHO  recipients  or  the  general 
public; 

(iii) 

to take decisions on the access and re-use of personal data; 

(c) 

(d) 

have  sufficient  resources,  operational  capacity,  and  expertise  to  achieve  the 
aims of, and fulfil their obligations under, this Regulation; 

are  governed  by  appropriate  confidentiality  obligations  in  accordance  with 
Article 75. 

4. 

Each Member State shall designate a single SoHO National Authority, in conformity 
with  Member  States’  constitutional  requirements,  responsible  for  coordinating 
exchanges  with  the  Commission  and  with  other  Member  States’  SoHO  National 
Authorities. 

5. 

Member States shall submit to the EU SoHO Platform referred to in Chapter XI: 

(a) 

(b) 

the names and contact details of the competent authorities designated pursuant 
to paragraph 1;   

the names and contact details of their SoHO National Authority referred to in 
paragraph 4. 

Member  States  shall  update  the  EU  SoHO  Platform  without  undue  delay  with  any 
changes to the information referred to in paragraph 5. 

Article 6 

Delegation by competent authorities of certain SoHO supervisory activities 

Member  States  or  competent  authorities  may  delegate  certain  SoHO  supervisory 
activities to one or more delegated bodies in accordance with the conditions provided 
for in Article 10. Member States or competent authorities shall ensure that delegated 
bodies  have  the  powers  needed  to  effectively  perform  any  activities  delegated  to 
them.  

Where  Member  States  or  competent  authorities  decide  to  delegate  certain  SoHO 
supervisory activities to one or more delegated bodies, they shall submit information 

6. 

1. 

2. 

EN 

37 

  EN 

regarding such delegations to the EU SoHO Platform referred to in Chapter XI with 
details of the delegated supervisory tasks. 

Article 7 

Independence and impartiality  

1. 

2. 

Competent  authorities  shall  act  independently,  in  the  public  interest  and  free  from 
any external influence.  

Competent  authorities  shall  ensure  that  their  personnel  have  no  direct  or  indirect 
economic, financial or personal interest that might be considered prejudicial to their 
independence and, in particular, that they are not in a situation that may, directly or 
indirectly, affect the impartiality of their professional conduct. 

3. 

Paragraphs 1 and 2 shall also apply to delegated bodies. 

Article 8 

Transparency 

1. 

2. 

3. 

4. 

1. 

Without  prejudice  to  Article  75,  competent  authorities  shall  carry  out  their 
supervisory  activities  in  a  transparent  manner  and  they  shall  make  accessible  and 
clear to the public decisions taken in cases where a SoHO entity has failed to comply 
with an obligation under this Regulation and where such failure causes or may cause 
a serious risk to human health.  

Paragraph 1 shall not affect national legislation on access to information.  

Competent  authorities  shall  lay  down  practical  arrangements  for  implementing  the 
transparency rules referred to in paragraph 1 in their internal rules. 

Paragraphs 1, 2 and 3 shall also apply to delegated bodies. 

Article 9 

General responsibilities and obligations 

Competent  authorities  shall  be  responsible  for  the  SoHO  supervisory  activities 
referred to in Chapter III in order to verify the effective compliance of SoHO entities 
in their territory with the requirements set out in this Regulation. 

2. 

Competent authorities shall have in place: 

(a) 

a sufficient number of suitably qualified personnel to carry out the supervisory 
functions provided for in this Regulation; 

(b)  procedures  to  ensure  the  independence,  impartiality,  effectiveness,  quality, 
suitability for purpose and consistency of their SoHO supervisory activities; 

(c) 

(d) 

appropriate  and  properly  maintained  facilities  and  equipment  to  ensure  that 
personnel  can  perform  their  SoHO  supervisory  activities  efficiently  and 
effectively; 

a  quality  management  system  for  their  SoHO  supervisory  activities  that 
includes  a  plan  for  continuity  of  their  activities  in  case  of  exceptional 
circumstances. 

3. 

Paragraphs 1 and 2 shall also apply to delegated bodies. 

EN 

38 

  EN 

Article 10 

Conditions for delegating certain SoHO supervisory activities to delegated bodies 

1. 

2. 

Member  States  and  competent  authorities  that  delegate  certain  SoHO  supervisory 
activities  to  a  delegated  body  referred  to  in  Article  6  shall  conclude  a  written 
agreement on the delegation.  

Competent  authorities  shall  ensure  that  the  agreement  referred  to  in  paragraph  1 
includes the following:  

(a) 

a precise description of the SoHO supervisory activities that the delegated body 
is  expected  to  perform,  and  the  conditions  under  which  those  activities  are 
expected to be performed;  

(b) 

the  conditions  to  be  met  by  the  delegated  body,  including  that  the  delegated 
body: 

(i) 

has the expertise, equipment and infrastructure required to perform those 
SoHO supervisory activities delegated to it; 

(ii)  has a sufficient number of suitably qualified and experienced staff; 

(iii)  participates  in  certification  or  other  schemes  at  Union  level,  when 
available,  to  ensure  the  uniform  application  of  principles  of  good 
practices required for their relevant sector; 

(iv)  has  sufficient  powers  to  perform  the  SoHO  supervisory  activities 

delegated to it; 

(c) 

a  precise  description  of  arrangements  ensuring  an  efficient  and  effective 
coordination  between  the  delegating  competent  authorities  and  the  delegated 
body; 

(d)  provisions for the fulfilment of the obligations of the delegated body as set out 

in Articles 11 and 12. 

Article 11 

Obligations of the delegated bodies 

Delegated  bodies  to  which  certain  SoHO  supervisory  activities  have  been  delegated  in 
accordance with Article 6 shall: 

(a) 

(b) 

(c) 

communicate  to  the  delegating  competent  authorities,  on  a  regular  basis  and 
whenever  those  competent  authorities  so  request,  the  outcome  of  the  SoHO 
supervisory activities performed by them; 

immediately  inform  the  delegating  competent  authorities  whenever  the  outcome  of 
the delegated SoHO supervisory activities indicates non-compliance or points to the 
likelihood  of  non-compliance,  unless  specific  arrangements  established  between 
those competent authorities and the delegated bodies provide otherwise; and 

cooperate with the delegating competent authorities, including by providing access to 
their premises and facilities. 

Article 12 

Obligations of the delegating competent authorities 

EN 

39 

  EN 

Competent  authorities  that  have  delegated  certain  SoHO  supervisory  activities  to  delegated 
bodies in accordance with Article 6 shall: 

(a) 

organise  audits  or  inspections  of  such  bodies,  as  necessary  and  taking  into  account 
participation  of  such  bodies  in  certification  or  other  schemes  referred  to  in  Article 
10(2), point (b)(iii);  

(b) 

fully or partly withdraw the delegation without delay in particular in cases where: 

(i) 

(ii) 

there is evidence that such delegated bodies are failing to properly perform the 
activities delegated to them; 

the  delegated  bodies  fail  to  take  appropriate  and  timely  action  to  remedy  the 
shortcomings identified; or 

(iii) 

the independence or impartiality of the delegated bodies has been shown to be 
compromised. 

Article 13 

Communication and coordination between SoHO competent authorities 

Where more than one authority is competent to perform SoHO supervisory activities 
in a Member State pursuant to Article 5(2), the Member State shall ensure efficient 
and  effective  coordination  between  all  SoHO  competent  authorities  involved,  to 
ensure  consistency  and  effectiveness  of  SoHO  supervisory  activities  as  set  by  this 
Regulation across its territory.  

Competent  authorities  shall  cooperate  with  each  other  and  with  the  Commission. 
They  shall  communicate  information  to  each  other  and,  in  particular,  to  the  SoHO 
National Authority as necessary for the effective implementation of the supervisory 
functions provided for in this Regulation. 

In  cases  where  competent  authorities  provide  an  opinion  to  a  SoHO  entity  on  the 
applicability  of  this  Regulation  to  a  particular  substance  or  activity  within  their 
territory,  those  competent  authorities  shall  notify  the  SoHO  National  Authority, 
which,  in  turn,  shall  notify  the  SoHO  Coordination  Board  (‘SCB’)  of  the  opinion 
given to the SoHO entity. 

Following a reasoned request from a competent authority of another Member State, 
the competent  authority shall without undue delay  inform the requesting competent 
authority  of  the  outcome  of  supervisory  activities  concerning  a  SoHO  entity  on  its 
territory,  and,  as  necessary  and  proportionate,  provide  the  records  referred  to  in 
Articles 29 and 30. 

Article 14 

Obligations to consult and cooperate with authorities of other regulatory sectors 

In all cases where questions arise as to the regulatory status of a substance, product 
or  activity,  competent  authorities  shall  consult  with  authorities  established  in  other 
relevant  Union  legislation  referred  to  in  Article  2(3),  as  relevant.  In  such  cases, 
competent authorities shall also consult the compendium referred to Article 3 point 
(33).  

In the course of the consultation referred to in paragraph 1, the competent authorities 
may also submit a request to the SCB for its opinion on the regulatory status of the 

1. 

2. 

3. 

4. 

1. 

2. 

EN 

40 

  EN 

substance, product or activity under this Regulation and shall do so in all cases where 
the competent authorities, after the consultations referred to in paragraph 1, are not in 
a position to take a decision in that respect.  

The  competent  authorities  may  also  indicate  that  they  consider  there  is  a  need  that 
the  SCB  consults,  in  accordance  with  Article  68(1),  point  (b),  with  the  equivalent 
advisory bodies established in other relevant Union legislation referred to in Article 
2(3). 

The competent authorities shall inform the SCB of the subsequent decision taken in 
their  Member  State,  following  the  consultations  referred  to  in  paragraph  1  of  this 
Article,  regarding  the  regulatory  status  of  the  substance,  product  or  activity 
concerned under this Regulation  and on  any consensus  reached as  a result  of those 
consultations for publication in the compendium by the SCB. 

The  Commission  may,  upon  a  duly  substantiated  request  of  a  Member  State 
following  the  consultation  referred  to  in  paragraph  1,  or  on  its  own  initiative,  by 
means of implementing acts, determine the regulatory status of a substance, product 
or activity under this Regulation, in case questions arise in that respect, notably when 
these  questions  cannot  be  resolved  at  the  Member  State  level,  or  in  discussions 
between  the  SCB  and  the  advisory  bodies  established  in  other  relevant  Union 
legislation, in accordance with Article 68(1), point (b).  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

For SoHOs that are intended to be subsequently used to manufacture products under 
other Union legislation, or as the starting and raw material thereof, as referred to in 
Article  2(3),  or  SoHOs  that  are  intended  to  be  combined  with  medical  devices,  as 
referred  to  in  Article  2(4),  the  competent  authority  shall  cooperate  with  the 
authorities  responsible  for  the  supervisory  activities  under  the  relevant  Union 
legislation,  with  a  view  to  ensuring  coherent  oversight.  During  the  process,  the 
competent authorities may seek the assistance of the SCB. 

The  consultation  and  cooperation  referred  to  in  paragraphs  1,  2  and  5  may  also  be 
initiated  on  the  basis  of  a  request  for  advice  from  a  SoHO  entity,  as  referred  to  in 
Article 40.  

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  concerning 
procedures for consultation referred to in paragraph 1 and cooperation referred to in 
paragraph  5  by  the  competent  authorities  when  they  consult  the  authorities 
established in other relevant Union legislation referred to in Article 2(3).  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

3. 

4. 

5. 

6. 

7. 

Article 15 

Right of appeal 

1. 

Where  decisions  are  taken  by  competent  authorities  concerning  natural  or  legal 
persons,  those  decisions  shall  be  subject  to  such  persons’  right  of  appeal  in 
accordance with national legislation. 

EN 

41 

  EN 

2. 

The  right  of  appeal  shall  not  affect  the  obligation  of  competent  authorities  to  take 
prompt  action to  eliminate or contain the risks to human health in  accordance with 
this Regulation. 

3. 

Paragraphs 1 and 2 shall also apply to delegated bodies. 

General obligations concerning the personnel of competent authorities 

1. 

Competent authorities shall: 

Article 16 

(a) 

(b) 

(c) 

have,  or  have  access  to,  a  sufficient  number  of  personnel  so  that  SoHO 
supervisory activities can be performed efficiently and effectively; 

ensure that the personnel performing SoHO supervisory activities are suitably 
qualified and experienced; 

have procedures or arrangements in place to ensure that personnel performing 
SoHO supervisory activities are free from any conflict of interest; 

(d)  have  procedures  in  place  to  ensure  confidentiality  and  maintain  professional 

secrecy. 

2. 

Personnel performing SoHO supervisory activities shall: 

(a) 

(b) 

(c) 

declare in writing any direct or indirect interests referred to in Article 7(2) and 
update that declaration yearly and whenever the declared information changes 
or any new interest arises; 

receive,  for  their  area  of  competence,  appropriate  training  enabling  them  to 
undertake their duties competently and in a consistent manner; 

keep  up-to-date  in  their  area  of  competence  and  receive  regular  additional 
training as necessary; 

(d)  participate in training in the subject matter and on the obligations of competent 
authorities resulting from this Regulation, as referred to in paragraph 3.  

Competent  authorities,  in  cooperation  with  delegated  bodies  as  necessary,  shall 
develop  and  implement  training  programmes  for  the  purpose  of  ensuring  that 
personnel performing SoHO supervisory activities receive the training referred to in 
paragraph 2, points (b), (c) and (d). Competent authorities shall maintain records of 
the  training  undertaken  by  their  personnel.  Competent  authorities  shall  provide 
opportunities  for  their  personnel  to  participate  in  the  Union  training  referred  to  in 
Article 69 where such Union training is available and appropriate. 

3. 

4. 

Paragraphs 1, 2 and 3 shall also apply to delegated bodies. 

Article 17 

Obligations as regards Commission controls 

Competent  authorities  and  delegated  bodies  shall  cooperate  with  the  Commission  for  the 
performance of Commission controls referred to in Article 70. In particular, they shall: 

(a) 

take appropriate follow-up measures to remedy the shortcomings identified through 
the controls provided for in Article 70; 

EN 

42 

  EN 

(b) 

(c) 

give  the  necessary  technical  assistance  and  provide  the  available  documentation, 
upon justified request, and other technical support that Commission experts request 
to enable them to perform controls efficiently and effectively; and 

give the necessary assistance to  ensure that the  Commission experts have access  to 
all premises or part of premises, and to information, including  IT systems, relevant 
for the execution of their duties. 

CHAPTER III 

SoHO SUPERVISORY ACTIVITIES 

Article 18 

Register of SoHO entities 

1. 

2. 

3. 

4. 

5. 

SoHO National  Authorities  shall establish and maintain  a register of SoHO entities 
on their territory.  

Instead  of  establishing  a  register  of  SoHO  entities,  as  referred  to  in  paragraph  1,  a 
SoHO National Authority may use the EU SoHO Platform as referred to in Chapter 
XI.  In  this  case,  the  SoHO  National  Authority  shall  instruct  competent  authorities, 
where necessary, and SoHO entities to register directly on the EU SoHO Platform. 

Competent authorities shall verify that each registered SoHO entity has provided the 
following information: 

(a) 

(b) 

name or business name and address of the SoHO entity, and name and contact 
details of a contact person; 

a  declaration  that  the  SoHO  entity  complies  with  the  obligations  and 
requirements on SoHO entities set out in this Regulation, in particular Articles 
44, 47, 56 and 59, as relevant; 

(c) 

a statement from the SoHO entity that it accepts to be inspected as provided for 
in this Regulation; 

(d) 

a list of the SoHO activities that the SoHO entity is carrying out; 

(e) 

the name and curriculum vitae of the responsible person for release of SoHOs 
as  referred  to  in  Article  38,  if  the  SoHO  entity  releases  SoHOs  or  SoHO 
preparations. 

In  cases  where  SoHO  National  Authorities  establish  their  own  registries  of  SoHO 
entities as referred to  in  paragraph 1, they  shall submit  the information  included in 
the  registries  to  the  EU  SoHO  Platform  as  referred  to  in  Chapter  XI.  Competent 
authorities shall be responsible for ensuring that the information regarding the SoHO 
entities on their territory pursuant to this Article and to Article 19 is congruent in the 
register  of  SoHO  entities  and  in  the  EU  SoHO  Platform,  and  shall  submit  any 
changes to the EU SoHO Platform without undue delay.  

The  Commission  may  adopt  implementing  acts  concerning  the  compatibility  and 
comparability of the registers of SoHO entities for facilitating the submission to the 
EU SoHO Platform.  

EN 

43 

  EN 

1. 

2. 

3. 

1. 

2. 

3. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2).  

Article 19 

Registration of SoHO entities 

Competent  authorities  shall  have  procedures  in  place  for  the  registration  of  SoHO 
entities in accordance with Article 37.  

Competent authorities shall:  

(a) 

acknowledge  receipt  of  the  registration  within  14  working  days  of  its 
submission;  

(b) 

request the SoHO entity to provide supplementary information, if needed; 

(c) 

(d) 

(e) 

inform  the  SoHO  entity  in  cases  where  the  registration  indicates  that  an 
authorisation pursuant to Articles 21, 27 or 28 is required; 

identify  whether  the  entity  is  a  critical  SoHO  entity,  and  inform  the  entity  in 
cases where it is considered a critical SoHO entity; 

submit  any  additional  information  on  the  registration  as  necessary,  including 
the  requirement  for  an  authorisation  pursuant  to  point  (c),  and  whether  the 
SoHO entity is a critical SoHO entity to the EU SoHO Platform referred to in 
Chapter XI. 

The Commission may adopt implementing acts concerning the registration process to 
facilitate  the  compatibility  of  the  registers  of  SoHO  entities  with  the  EU  SoHO 
Platform.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 20 

SoHO preparation authorisation system 

Competent  authorities  shall  establish  and  maintain  a  system  for  receiving  and 
processing  requests  for  the  authorisation  of  SoHO  preparations.  The  system  shall 
allow for the suspension or withdrawal of authorisations. 

Competent authorities shall authorise SoHO preparations pursuant to Articles 21, 22 
and, where applicable, Article 23.  

SoHO preparation authorisations shall be valid throughout the Union for the period 
defined in the terms of the authorisation, when such a time period has been defined, 
or until a competent authority has suspended or withdrawn the authorisation. Where 
a Member State has adopted a more stringent measure, in accordance with Article 4, 
which  relates  to  a  specific  SoHO  preparation,  that  Member  State  may  decline  to 
recognise  the  validity  of  the  SoHO  preparation  authorisation  of  another  Member 
State pending verification that the more stringent measure has been met. 

4. 

The  Commission  may  adopt  implementing  acts  concerning  the  compatibility  and 
comparability of the SoHO preparation authorisation system.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

EN 

44 

  EN 

Article 21 

Authorisation of SoHO preparations  

1. 

Competent  authorities  shall  have  procedures  in  place  to  allow  that  applications  for 
the authorisation of SoHO preparations are submitted in accordance with Article 41. 
They  shall  provide  guidelines  and  templates  for  the  submission  of  applications  for 
SoHO  preparation  authorisation.  When  developing  these  guidelines  and  templates, 
competent  authorities  shall  consult 
the  relevant  best  practices  agreed  and 
documented  by  the  SCB  as  referred  to  in  Article  68(1),  point  (c).  Competent 
authorities  may  establish  simplified  procedures  for  applications  concerning 
modifications to previously authorised SoHO preparations. 

2. 

Upon  receipt  of  an  application  for  the  authorisation  of  a  SoHO  preparation, 
competent authorities shall:  

(a) 

(b) 

(c) 

acknowledge receipt of the application within 14 working days; 

assess  the  SoHO  preparation  pursuant  to  Article  22  and  examine  agreements 
between  the  applicant  SoHO  entity  and  any  third  parties  contracted  by  that 
SoHO entity concerning SoHO activities, where applicable;  

grant  a  conditional  authorisation  for  the  use  of  the  SoHO  preparation  in  all 
cases  where  clinical  outcome  data  is  required  for  authorisation,  pursuant  to 
Article 22(4), points (d) and (e);  

(d)  grant or refuse the authorisation for the SoHO preparation, as appropriate. 

Competent  authorities  shall  submit  information  regarding  SoHO  preparation 
authorisations,  including  a  summary  of  the  evidence  used  to  authorise  each  SoHO 
preparation, to the EU SoHO Platform referred to in Chapter XI, and, for each SoHO 
preparation, amend accordingly the authorisation status of the SoHO entity to which 
the SoHO preparation is linked to in the EU SoHO Platform, including the name and 
contact details of the SoHO preparation authorisation holder.  

Competent  authorities  shall  conclude  the  SoHO  preparation  authorisation  steps, 
referred  to  in  paragraph  2  of  this  Article,  within  3  months  from  receipt  of  the 
application,  excluding  the  time  needed  for  clinical  outcome  monitoring  or  studies. 
They  may  suspend  this  time  limit  for  the  duration  of  the  consultation  processes 
referred to in Article 14(1) and (2).  

Upon  receipt  of  a  request  for  an  opinion  in  course  of  the  conformity  assessment 
procedure  pursuant  to  Article  52  of  Regulation  (EU)  2017/745,  the  competent 
authorities  receiving  the  request  shall  follow  the  relevant  procedure  of  that 
Regulation, and inform the SCB of the opinion provided.  

Competent  authorities  may,  in  accordance  with  national  legislation,  suspend  the 
authorisation  of  a  SoHO  preparation  if  SoHO  supervisory  activities  demonstrate  or 
give reasonable ground for suspecting that:  

(a) 

such preparation, or any of the activities performed for that preparation, do not 
comply  with  the  conditions  of  its  authorisation  or  the  requirements  of  this 
Regulation; and  

(b) 

that non-compliance implies a risk to the safety of SoHO donors, recipients or 
offspring from medically assisted reproduction.  

3. 

4. 

5. 

6. 

EN 

45 

  EN 

7. 

8. 

9. 

10. 

11. 

1. 

2. 

3. 

4. 

Competent  authorities  shall  specify  a  period  of  time  for  the  investigation  of  the 
suspected  non-compliance  and  for  SoHO  entities  to  rectify  a  confirmed  non-
compliance, during which the suspension will remain in place.  

In  cases  where  SoHO  entities  are  not  able  to  rectify  confirmed  non-compliances 
referred to in paragraph 6 in the specified time period, competent authorities shall, in 
accordance  with  national  legislation,  withdraw  the  authorisation  of  the  SoHO 
preparation concerned.  

Competent  authorities  may,  in  accordance  with  national  legislation,  withdraw  the 
authorisation of a SoHO preparation if the competent authorities have confirmed that 
the  SoHO  preparation  in  question  does  not  comply  with  subsequently  updated 
criteria for authorisation or the SoHO entity has repeatedly failed to comply with the 
conditions of its authorisation.  

In cases of authorisation suspension or withdrawal, as referred to in paragraphs 6, 7 
and  8,  competent  authorities  shall,  without  undue  delay,  amend  accordingly  the 
authorisation  status  of  the  SoHO  entity  concerned  in  the  EU  SoHO  Platform  as 
referred to in Chapter XI. 

Competent  authorities  shall  consult  the  relevant  best  practices  agreed  and 
documented by the SCB as referred to in Article 68(1), point (c). 

The  Commission  may  adopt  implementing  acts  concerning  the  procedures  to 
authorise SoHO preparations pursuant to this Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 22 

Assessment of SoHO preparations  

The assessment of a SoHO preparation, shall include a review of all SoHO activities 
that  are  performed  for  that  SoHO  preparation  and  that  might  influence  the  safety, 
quality and efficacy of the SoHO preparation.  

The assessment of SoHO preparations shall be carried out by assessors meeting the 
requirements set out in Article 24. 

In  cases  where  the  SoHO  preparation  subject  to  the  application  for  authorisation 
pursuant to Article 21 has been duly authorised in another SoHO entity in the same 
or  in  another  Member  State,  competent  authorities  may  authorise  that  SoHO 
preparation  in  the  applicant  SoHO  entity,  provided  that  the  competent  authorities 
have  verified  that  the  SoHO  activities  performed  for  the  SoHO  preparation  are 
carried out by the applicant SoHO entity in a manner such that the safety, quality and 
efficacy  results  will  be  equivalent  to  those  demonstrated  in  the  SoHO  entity  where 
the SoHO preparation was first authorised. 

In  cases  where  the  SoHO  preparation,  subject  to  the  application  for  authorisation 
pursuant  to  Article  21,  has  not  been  duly  authorised  in  another  SoHO  entity, 
competent authorities:  

(a) 

(b) 

shall  assess  all  the  information  provided  by  the  applicant  pursuant  to  Article 
41; 

shall  review  the  SoHO  preparation  dossier  referred  to  in  Article  41(2),  point 
(a); 

EN 

46 

  EN 

(c) 

(d) 

(e) 

shall initiate the consultation described in Article 14(1), if during the review of 
the  SoHO  preparation  dossier  referred  to  in  point  (b),  questions  arise  as  to 
whether  the  SoHO  preparation  falls,  in  part  or  fully,  within  the  scope  of  this 
Regulation  or  other  Union  legislation,  taking  into  account  the  activities 
performed for the SoHO preparation and the intended human application; 

shall  review  and  evaluate  the  risk  assessment  performed  by  the  applicant  as 
pursuant to Article 41(2), point (b); 

shall evaluate the plan for clinical outcome monitoring and its proportionality 
to  the  level  of  risk  of  the  SoHO  preparation  as  referred  to  in  Article  41(3), 
points (a), (b) and (c), as applicable; 

(f)  may consult the SCB, pursuant to Article 68(1) on the evidence necessary and 

sufficient for the authorisation of a particular SoHO preparation; 

(g) 

shall assess, in the case of a conditional authorisation pursuant to Article 21(2), 
point (c), the results of the clinical outcome monitoring.  

When  assessing  the  SoHO  preparation  pursuant  to  paragraph  4,  points  (e)  and  (g), 
competent authorities shall consider, in the cases where the applicant has proposed to 
record,  and  recorded,  the  results  of  the  clinical  outcome  monitoring  in  an  existing 
clinical  registry,  that  this  is  an  acceptable  method,  provided  that  those  competent 
authorities have verified that the registry has data quality management procedures in 
place that ensure accuracy and completeness of data.  

Competent authorities shall conduct the assessment steps referred to in paragraphs 3 
and 4 of this Article by means of a remote document review. Competent authorities 
may also, as part of the SoHO preparation assessment, carry out inspections pursuant 
to Articles 29, 30 and 31. 

When  conducting  the  assessment  steps  referred  to  in  paragraph  4  of  this  Article, 
competent authorities shall consult the best practices agreed and documented by the 
SCB as referred to in Article 68(1), point (c). 

Article 23 

Joint SoHO preparation assessments 

At the request of one or more competent authorities, SoHO preparation assessments 
as referred to  in  Article 22 may be carried out  by  competent  authorities from  more 
than one Member State, as a joint SoHO preparation assessment.  

The competent authority receiving a request for a joint SoHO preparation assessment 
may  accept  such  a  request,  and  coordinate  and  support  that  assessment,  where  that 
competent  authority  agrees that there are reasonable grounds for conducting a joint 
assessment.  

Competent  authorities  participating  in  a  joint  assessment  shall  conclude  a  prior 
written agreement on the joint  assessment. The  agreement  shall at least  defines the 
following:  

(a) 

(b) 

the scope of the joint assessment;  

the  roles  of  the  participating  assessors  during  and  following  the  assessment, 
including the designation of an authority leading the assessment; 

(c) 

the powers and responsibilities of each of the authorities. 

5. 

6. 

7. 

1. 

2. 

3. 

EN 

47 

  EN 

4. 

5. 

Member  States  may  set  up  joint  assessment  programmes  to  facilitate  frequent  or 
routine  joint  assessments.  In  such  cases,  competent  authorities  may  sign  a  single 
written agreement provided that agreement meets the requirements in paragraph 3. 

On completion of a joint SoHO preparation authorisation, the competent authority in 
the territory where the SoHO preparation authorisation holder is based shall  submit 
the  information,  as  pursuant  to  Article  21(3),  regarding  the  new  authorised  SoHO 
preparation in the EU SoHO Platform.  

Specific obligations concerning SoHO preparation assessors  

Article 24 

1. 

Assessors shall:  

(a) 

possess a diploma, certificate or other evidence of formal qualifications in the 
field of medical or biological sciences, awarded on completion of a university 
course  of  study  or  a  course  recognised  as  equivalent  by  the  Member  State 
concerned; 

(b)  have expertise in the processes being assessed and the human applications for 

which the SoHO preparations will be used.  

The  assessment  of  SoHO  preparations  as  referred  to  in  Article  22  may  be  done 
jointly  by  a  team  of  persons  which  collectively  have  the  qualifications  and 
experience set out in paragraph 1.  

In exceptional cases, competent authorities may consider that a person’s considerable 
and  relevant  experience  may  exempt  this  person  from  the  requirements  set  out  in 
paragraph 1. 

Before  assessors  take  up  their  duties,  competent  authorities  shall  provide  assessors 
with a specific induction training on the procedures to be followed for the assessment 
of SoHO preparations in accordance with Article 22.  

the  specific 

is 
that 
Competent  authorities  shall  ensure 
complemented  by  specialised  training  for  assessment  of  processing  methods  and 
technologies  used  for  specific  types  of  SoHO  preparations  and  by  continuous 
training, as appropriate, throughout the career of the assessors. Competent authorities 
shall  make  all  reasonable  efforts  to  ensure  that  assessors  that  participate  in  joint 
assessments have completed the relevant Union training referred to in Article 69(1) 
and are included in the list referred to in Article 69(5). 

induction 

training 

Assessors  may  be  assisted  by  technical  experts  provided  that  competent  authorities 
ensure  that  those  experts  comply  with  the  requirements  of  this  Regulation,  in 
particular with the obligations set out in Articles 7 and 76. 

Article 25 

SoHO establishment authorisation system 

Competent  authorities  shall  establish  and  maintain  a  system  for  receiving  and 
processing requests for the authorisation of SoHO establishments.  

Competent authorities shall authorise as SoHO establishments the SoHO entities that 
both process and store SoHOs in accordance with Article 27.  

2. 

3. 

4. 

5. 

6. 

1. 

2. 

EN 

48 

  EN 

3. 

4. 

5. 

6. 

1. 

2. 

3. 

4. 

Competent authorities may decide that certain SoHO entities that do not process and 
store SoHO also need to be authorised as SoHO establishments, in particular SoHO 
entities that:  

(a) 

have significant influence on the safety and quality of SoHOs due to the scale, 
criticality or complexity of the SoHO activities they perform; or 

(b) 

carry out SoHO activities in connection with multiple SoHO establishments. 

Paragraph 3 shall not apply to SoHO entities that import SoHO. 

SoHO establishment authorisations shall be valid throughout the Union for the period 
defined in the terms of the authorisation, when such a time period has been defined, 
or  until  a  competent  authority  has  suspended  or  withdrawn  the  authorisation  or  the 
establishment  has  ceased  to  conduct  SoHO  activities.  Where  a  Member  State  has 
adopted  a  more  stringent  measure,  in  accordance  with  Article  4,  which  relates  to  a 
specific  SoHO  establishment  authorisation,  that  Member  State  may  decline  to 
recognise  the  validity  of  the  SoHO  establishment  authorisation  of  another  Member 
State pending verification that the more stringent measure has been met. 

The  Commission  may  adopt  implementing  acts  to  specify  uniform  procedures  and 
working  methods  for  establishing  and  maintaining  a  SoHO  establishment 
authorisation system.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 26 

Importing SoHO entity authorisation system 

Competent  authorities  shall  establish  and  maintain  a  system  for  receiving  and 
processing requests for the authorisation of importing SoHO entities.  

Competent authorities shall authorise as importing SoHO entities the SoHO entities 
that import SoHOs pursuant to Article 28.  

Importing  SoHO  entity  authorisations  shall  be  valid  throughout  the  Union  for  the 
period defined in the terms  of the authorisation,  when such a time period has been 
defined, or until a competent authority has suspended or withdrawn the authorisation 
or  the  entity  has  ceased  to  conduct  SoHO  activities.  Where  a  Member  State  has 
adopted  a  more  stringent  measure,  in  accordance  with  Article  4,  which  relates  to  a 
specific  importing  SoHO  entity  authorisation,  that  Member  State  may  decline  to 
recognise the validity of the importing SoHO entity authorisation of another Member 
State pending verification that the more stringent measure has been met. 

The  Commission  shall  adopt  implementing  acts  to  specify  uniform  procedures  and 
working  methods  for  establishing  and  maintaining  an  importing  SoHO  entity 
authorisation system. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 27 

Authorisation of SoHO establishments 

EN 

49 

  EN 

1. 

2. 

Competent  authorities  shall  provide  guidelines  and  templates  to  allow  that 
applications from SoHO entities for their authorisation as SoHO establishments are 
submitted  in  accordance  with  Article  49.  When  developing  these  guidelines  and 
templates, competent authorities shall consult the relevant best practices agreed and 
documented by the SCB as referred to in Article 68(1), point (c).  

Upon  receipt  of  an  application  for  the  authorisation  of  a  SoHO  establishment, 
competent authorities shall:  

(a) 

acknowledge receipt of the application within 14 working days; 

(b) 

assess the application; 

(c) 

(d) 

(e) 

(f) 

examine agreements between the applicant SoHO establishment and any third 
parties contracted by that SoHO establishment to perform SoHO activities; 

request  that  the  applicant  SoHO  establishment  provides  supplementary 
information, if needed; 

carry  out  an  on-site  system  inspection  of  the  applicant  SoHO  establishment 
and, where applicable, of third parties contracted by the SoHO establishment to 
perform SoHO activities, pursuant to Article 29; 

inform  the  applicant,  without  undue  delay,  of  the  outcome  of  the  assessment 
and inspections referred to in points (b), (c), (d) when relevant and (e) and of 
the decision on the authorisation;  

(g)  grant  or  refuse  the  authorisation  of  the  applicant  SoHO  establishment  as  a 
SoHO  establishment,  as  appropriate,  and  indicate  which  SoHO  activities  are 
covered by the authorisation and which conditions apply, if any; 

(h) 

(i) 

assess  and,  as  appropriate,  approve  subsequent  changes  made  by  the  SoHO 
establishment to the information provided in the application and communicated 
to them according to Article 49(2); 

submit  information  regarding  the  authorisation  by  amending  accordingly  the 
status  of  the  SoHO  entity  concerned,  and  including  the  name  and  contact 
details  of  the  SoHO  establishment  authorisation  holder,  in  the  EU  SoHO 
Platform as referred to in Chapter XI without undue delay. 

3. 

Competent authorities may suspend the authorisation of a SoHO establishment, or of 
certain  SoHO  activities  the  establishment  is  authorised  to  perform,  if  SoHO 
supervisory activities demonstrate or give reasonable grounds for suspecting, that the 
SoHO establishment in question:  

(a) 

(b) 

does  not  comply  with  the  conditions  of  its  authorisation  or  the  provisions  of 
this Regulation; and 

that non-compliance, or suspected non-compliance, implies a risk to the safety 
of  SoHO  donors  or  recipients  or  offspring  from  medically  assisted 
reproduction.  

Competent  authorities  shall  specify  a  period  of  time  for  the  investigation  of  a 
suspected  non-compliance  and  for  the  SoHO  establishment  to  rectify  a  confirmed 
non-compliance, during which the suspension will remain in place. 

4. 

In cases where competent authorities have confirmed non-compliances referred to in 
paragraph  3  and  SoHO  establishments  are  not  able  to  rectify  them  in  the  specified 

EN 

50 

  EN 

time  period,  competent  authorities  shall,  in  accordance  with  national  legislation, 
withdraw the authorisation of a SoHO establishment.  

Competent  authorities  may,  in  accordance  with  national  legislation,  withdraw  the 
authorisation  of  a SoHO establishment if the  competent  authorities have confirmed 
that  the  SoHO  establishment  no  longer  complies  with  updated  criteria  for 
authorisation  or  the  SoHO  establishment  has  repeatedly  failed  to  comply  with  the 
conditions of its authorisation.  

In cases of authorisation suspension or withdrawal, as referred to in paragraphs 3, 4 
and 5, competent authorities shall amend accordingly the authorisation status of the 
SoHO establishment concerned in the EU SoHO Platform  as referred to in Chapter 
XI without undue delay. 

Article 28 

Authorisation of importing SoHO entities 

Competent  authorities  shall  provide  guidelines  and  templates  to  allow  that 
applications  from  SoHO  entities  for  their  authorisation  as  importing  SoHO  entities 
are  submitted  in  accordance  with  Article  43.  In  developing  these  guidelines  and 
templates, competent authorities shall consult the relevant best practices agreed and 
documented by the SCB as referred to in Article 68(1), point (c). 

Upon  receipt  of  an  application  for  the  authorisation  of  an  importing  SoHO  entity, 
competent authorities shall: 

(a) 

acknowledge receipt of the application within 14 working days; 

(b) 

assess the application; 

(c) 

examine agreements  between the applicant  SoHO entity  and any third parties 
contracted by that SoHO entity to perform SoHO activities; 

(d) 

request that the applicant provides supplementary information, if needed; 

(e) 

(f) 

(g) 

(h) 

inform  the  applicant,  without  undue  delay,  of  the  outcome  of  the  assessment 
and  examinations  referred  to  in  points  (b),  (c)  and  (d)  where  relevant,  and  of 
the decision on the authorisation; 

grant or refuse the authorisation of the applicant as an importing SoHO entity, 
as appropriate, and indicate which SoHOs are covered by the authorisation and 
which conditions apply, if any; 

assess  and,  as  appropriate,  approve  subsequent  changes  made  by  the  SoHO 
importing entity and communicated to them as referred to in Article 43(3); 

submit  information  regarding  the  authorisation,  by  amending  accordingly  the 
status  of  the  SoHO  entity  concerned,  and  including  the  name  and  contact 
details  of  the  importing  SoHO  entity  authorisation  holder,  in  the  EU  SoHO 
Platform as referred to in Chapter XI, without undue delay. 

In  cases  where  the  applicant  intends  to  distribute  the  imported  SoHOs  to  other 
Member  States,  competent  authorities  may  perform  the  actions  set  out  in 
paragraph 2,  points  (b),  (c)  and  (d),  in  consultation  with  the  SoHO  National 
Authorities of the Member States concerned. 

Competent authorities may require to inspect any party in a third country supplying 
SoHOs  to  the  applicant  prior  to  granting  or  refusing  the  importing  SoHO  entity 

5. 

6. 

1. 

2. 

3. 

4. 

EN 

51 

  EN 

authorisation,  in  particular  in  cases  where  the  application  concerns  regular  and 
repeated import of SoHOs from the same party. 

5. 

Competent authorities may suspend the authorisation of an importing SoHO entity if 
SoHO supervisory activities demonstrate or give reasonable grounds to suspect:  

(a) 

(b) 

that  the  SoHO  entity  in  question  does  not  comply  with  the  conditions  of  the 
authorisation or the provisions of this Regulation; and  

that  this  non-compliance,  or  suspected  non-compliance,  implies  a  risk  to  the 
safety of recipients or offspring from medically assisted reproduction.  

Competent  authorities  shall  specify  a  period  of  time  for  the  investigation  of  a 
suspected non-compliance and for the importing SoHO entity to rectify a confirmed 
non-compliance, during which the suspension shall remain in place. In cases where 
competent  authorities  have  confirmed  non-compliances  referred  to  in  paragraph  5 
and  the  importing  SoHO  entity  is  not  able  to  rectify  them  in  the  specified  time 
period,  competent  authorities  shall  withdraw  the  authorisation  of  the  importing 
SoHO entity.  

Competent  authorities  may,  in  accordance  with  national  legislation,  withdraw  the 
authorisation  of  an  importing  SoHO  entity  if  the  competent  authorities  have 
confirmed that the importing SoHO entity no longer complies with updated criteria 
for authorisation or the importing SoHO entity has repeatedly failed to comply with 
the conditions of its authorisation.  

In cases of authorisation suspension or withdrawal, as referred to in paragraphs 5, 6 
and 7, competent authorities shall amend accordingly the authorisation status of the 
SoHO  entity  concerned  in  the  EU  SoHO  Platform  as  referred  to  in  Chapter  XI 
without undue delay. 

By  derogation  from  paragraph  1,  in  case  of  emergency  competent  authorities  may 
authorise  imports  of  SoHOs  for  immediate  application  to  a  specific  recipient  when 
justified by the clinical circumstances on a case-by-case basis.  

The Commission is empowered to adopt delegated acts in accordance with Article 77 
in order to be able to supplement this Regulation by laying down specific criteria for 
the assessments, examinations and inspections in the course of the authorisation.  

Where,  in  the  case  of  risk  to  quality  and  safety  of  imported  SoHOs,  imperative 
grounds of urgency so require, the procedure provided for in Article 78 shall apply to 
delegated acts adopted pursuant to this Article. 

6. 

7. 

8. 

9. 

10. 

11. 

Article 29 

Inspections of SoHO establishments 

1. 

Competent  authorities  shall  carry  out 
establishments, as appropriate: 

the  following 

inspections  on  SoHO 

(a) 

(b) 

announced routine system inspections; 

the  case  of 
announced  or  unannounced 
investigations  of  fraudulent  or  other  illegal  activities,  or  on  the  basis  of 
information  that  might  indicate  non-compliance  with  the  rules  of  this 
Regulation; 

in  particular 

inspections, 

in 

EN 

52 

  EN 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

(c) 

inspections  as  provided  for  in  Article  22(6),  Article  27(2),  point  (d),  Article 
28(4), Article 31 and Article 35(5). 

Competent  authorities  that  during  inspections  identify  non-compliances  with  the 
rules  of  this  Regulation  may  include  follow-up  inspections,  where  necessary  and 
proportionate,  to  verify  that  SoHO  establishments  have  undertaken  effective 
corrective and preventive actions. 

Competent  authorities  of  the  Member  State  in  which  the  SoHO  establishment  is 
located shall carry out the inspections.  

Competent  authorities  shall  carry  out  on-site  inspections  of  SoHO  establishments 
and, where applicable, of any third parties contracted by the SoHO establishment to 
perform SoHO activities. 

By derogation from paragraph 4, competent authorities may conduct inspections, in 
full or in part, by means of a remote document review, provided that: 

(a) 

such inspection mode does not pose a risk to the safety and quality of SoHOs; 

(b) 

such inspection does not prejudice the effectiveness of inspections; and  

(c) 

the  maximum 
paragraph 11 is not exceeded. 

interval  between 

two  on-site 

inspections  pursuant 

to 

Competent  authorities  shall  ensure  that  inspections  are  carried  out  by  inspectors 
meeting the requirements set out in Article 32.  

Inspectors  shall  verify  that  SoHO  establishments  meet  the  general  standards 
concerning SoHO donor protection laid down in Article 53, the standards concerning 
the  voluntary  and  unpaid  nature  of  SoHO  donations  laid  down  in  Article  54,  the 
standards  concerning  information  to  be  provided  prior  to  consent  or  authorisation 
laid down in Article 55 and the general standards concerning recipient and offspring 
protection laid down in Article 58, as applicable.  

In cases where the SoHO establishments follow: 

(a) 

the technical guidelines published by the ECDC and by the EDQM referred to 
in  Articles  56(4),  point  (a),  and  59(4),  point  (a),  as  applicable,  the  inspectors 
shall consider the standards or elements thereof, to be met, insofar as they are 
addressed by the guidelines; 

(b)  other guidelines as referred to in Articles 56(4), point (b), and 59(4), point (b), 
the inspectors shall assess on a case-by-case basis such guidelines in terms of 
level  of  safety,  quality  and  efficacy  achieved,  as  applicable,  and  accept  or 
decline  whether  that  level  is  equivalent  to  the  level  set  by  the  technical 
guidelines referred to in Articles 56(4), point (a), and 59(4), point (a);  

(c) 

other  technical  methods  as  referred  to  in  Articles  56(4),  point  (c),  and  59(4), 
point (c), the inspectors shall evaluate the risk assessment and record provided, 
assess the adequacy of the technical methods applied. 

In cases of paragraph 7, second subparagraph, point (b) where competent authorities, 
prior to the inspection, have accepted the level safety, quality and efficacy achieved 
by  those  other  guidelines,  as  equivalent  to  the  level  set  by  the  technical  guidelines 
referred  to  in  paragraph  7,  second  subparagraph,  point  (a),  the  inspectors  shall 
consider the standards or elements thereof, to be met, insofar as they are addressed 
by the guidelines. 

EN 

53 

  EN 

9. 

Inspectors may carry out one or more of the following activities:  

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

inspect  SoHO  establishment  facilities  and,  where  applicable,  the  facilities  of 
any  third  parties  contracted  by  the  SoHO  establishment  concerning  SoHO 
activities; 

evaluate and verify the procedures and the SoHO activities performed in SoHO 
establishments  and,  where  applicable,  in  facilities  of  third  parties  that  are 
relevant to the requirements of this Regulation; 

examine  any  documents  or  other  records  kept  by  SoHO  establishments  and, 
where  applicable,  third  parties  relating  to  the  requirements  of  this  Regulation 
and in particular Chapter V thereof; 

evaluate the design and  implementation  of the quality management system  in 
place pursuant to Article 50; 

take samples for analysis and copies of documents if required; 

evaluate  the  emergency  plan  in  place  in  accordance  with  Article  66,  where 
applicable; 

(g)  order the suspension or cessation of any procedure or activity where necessary 

and proportionate to the risk detected. 

10. 

Competent authorities shall carry out inspections pursuant to paragraph 1, point (a), 
regularly, on a risk basis and with appropriate frequency, taking account of: 

(a) 

identified risks associated with: 

(i) 

the SoHOs processed and stored; 

(ii) 

the  activities  of  the  SoHO  establishments,  in  particular  the  processes 
carried out; 

the establishments’ past record as regards the outcome of previous inspections 
carried out on them and their compliance with the rules of this Regulation;  

results from certification or accreditation by international bodies, where those 
bodies verify provisions that  are equivalent to those in this Regulation; and 

the reliability and effectiveness of the quality management systems referred to 
in Article 50.  

(b) 

(c) 

(d) 

The interval between two on-site inspections shall not exceed 4 years. 

Competent authorities shall consider on-site inspections carried out in the course of 
the authorisation of an establishment in accordance with Article 27(2), point (d), as 
the first on-site inspection in the sense of this Article.  

Competent  authorities  shall  provide  immediate  preliminary  feedback  on  their 
findings at the request of the SoHO establishment concerned. 

Following  each  inspection,  the  competent  authorities  shall  draw  up  a  report  on  the 
findings  of  the  inspection  that  concern  compliance  with  the  legal  and  technical 
requirements  applicable  under  this  Regulation  and  provide  it  to  the  SoHO 
establishment  concerned.  In  the  report,  the  competent  authorities  may  set  out  any 
corrective  or  preventive  action  needed  or  may  request  the  SoHO  establishment  to 
respond with a proposal for such actions, with associated dates for completion. 

11. 

12. 

13. 

14. 

EN 

54 

  EN 

15. 

16. 

17. 

1. 

2. 

3. 

1. 

2. 

Where more than one authority is competent to perform SoHO supervisory activities 
in  a  Member  State  pursuant  to  Article  5(2),  on  a  reasoned  request  from  another 
competent  authority  in  their  Member  State,  the  competent  authority  shall  forthwith 
communicate the report referred to in paragraph 14 of this Article to the requesting 
competent authority. 

For the purpose of standardised inspections referred to in paragraph 1 of this Article, 
competent  authorities  shall  consult 
the  relevant  best  practices  agreed  and 
documented by the SCB as referred to in Article 68(1), point (c). 

The  Commission  may  adopt  implementing  acts  concerning  the  procedures  to  be 
followed for inspections of SoHO establishments.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 30 

Inspections of other SoHO entities 

Competent authorities may carry out inspections pursuant to Article 29(1) on SoHO 
entities other than SoHO establishments as necessary and proportionate to the risks 
associated with the SoHOs and the SoHO activities registered for that SoHO entity, 
and the SoHO entity’s past record, in particular as regards the outcome of previous 
inspections carried out on it and its compliance with the rules of this Regulation.  

In the cases  referred to  in  paragraph 1,  Article 29  shall  apply,  mutatis  mutandis, to 
the inspection of SoHO entities other than SoHO establishments. 

For the purpose of a standardised approach to the inspection of SoHO entities other 
than  SoHO  establishments,  competent  authorities  shall  consult  the  relevant  best 
practices  agreed  and  documented  by  the  SCB  as  referred  to  in  Article  68(1),  point 
(c). 

Article 31 

Joint inspections 

At a request  of one or  more  competent  authorities, inspections  pursuant to  Articles 
29(1) and 30(1) may be carried out by inspectors from more than one Member State 
as a joint inspection. 

The  competent  authority  receiving  a  request  for  a  joint  inspection,  shall  make  all 
reasonable efforts to accept such request, and coordinate and support that inspection, 
in cases where: 

(a) 

(b) 

(c) 

it  is  demonstrated,  or  there  is  reasonable  ground  for  suspecting,  that  the 
activities carried out on the territory of another Member State pose a risk to the 
safety and quality of SoHOs distributed in the requesting Member State;  

competent  authorities  of  the  requesting  Member  State  require  specialist 
technical expertise of another Member State for that inspection; 

the competent authority of the Member State receiving the request agrees that 
there are other reasonable grounds for conducting a joint inspection.  

3. 

The authorities participating in a joint inspection shall conclude an agreement prior 
to the inspection that defines at least the following:  

EN 

55 

  EN 

4. 

5. 

6. 

1. 

2. 

3. 

(a) 

(b) 

the scope and objective of the joint inspection;  

the  roles  of  the  participating  inspectors  during  and  following  the  inspection, 
including the designation of an authority leading the inspection;  

(c) 

the powers and responsibilities of each of the authorities. 

The  authorities  participating  shall  commit  themselves  in  that  agreement  to  jointly 
accept the results of the inspection.  

The  authority  leading  the  joint  inspection  shall  ensure  that  joint  inspections  are 
carried out in accordance with the national legislation of the Member State in which 
the joint inspection takes place.  

The  competent  authority  for  the  SoHO  entity  or  SoHO  establishment  concerned 
shall, prior to the inspection, inform that SoHO entity or SoHO establishment about 
the  joint  inspection,  unless  the  competent  authorities  concerned  have  reasonable 
grounds to suspect illegal or fraudulent activity. 

Articles  7,  8  and  76  shall  apply  to  all  competent  authorities  involved  in  joint 
inspections.  

Member  States  may  set  up  joint  inspection  programmes  to  facilitate  routine  joint 
inspections. Member States may operate such programmes under a single agreement 
as referred to in paragraph 3. 

Article 32 

Specific obligations concerning inspectors  

Inspectors  shall  possess  a  diploma,  certificate  or  other  evidence  of  formal 
qualifications  in  a  relevant  field,  awarded  on  completion  of  a  university  course  of 
study or a course recognised as equivalent by the Member State concerned. 

In exceptional cases, competent authorities may consider that a person’s considerable 
and relevant experience may exempt this person from the requirement set out in the 
first subparagraph. 

Competent  authorities  shall  provide  inspectors  with  a  specific  induction  training 
before inspectors take up their duties. For the specific induction training, competent 
authorities  shall  consult  the  relevant  best  practices  agreed  and  documented  by  the 
SCB as referred to in Article 68(1), point (c). 

Competent  authorities  shall  ensure  that  the  specific  induction  training  includes  at 
least the following: 

(a) 

(b) 

(c) 

(d) 

the  inspection  techniques  and  procedures  to  be  followed,  including  practical 
exercises;  

an overview of relevant  Union and national inspection guidance,  and the best 
practices  agreed  and  documented  by  the  SCB  as  referred  to  in  Article  68(1), 
point (c); 

on overview of the authorisation systems in the Member State concerned; 

the  applicable  legal  framework  for  the  performance  of  SoHO  supervisory 
activities; 

(e) 

technical aspects concerning SoHO activities; 

EN 

56 

  EN 

(f)  SoHO technical guidelines as referred to in Articles 56 and 59; 

(g) 

(h) 

an  overview  of  the  organisation  and  functioning  of  national  regulatory 
authorities in the field of SoHOs and related fields;  

an overview of the national health system and SoHO organisational structures 
in the Member State concerned. 

that 

the  specific 

is 
Competent  authorities  shall  ensure 
complemented  by  specialised 
types  of 
establishments  and  by  continuous  training,  as  appropriate,  throughout  the  career  of 
the inspectors. Competent authorities shall make all reasonable efforts to ensure that 
inspectors  that  participate  in  joint  inspections  have  completed  the  relevant  Union 
training referred to in Article 69(1) and are included in the list referred to in Article 
69(5). 

inspection  of  specific 

training  for 

induction 

training 

Inspectors  may  be  assisted  by  technical  experts  provided  that  the  competent 
authorities ensure that those experts comply with the requirements of this Regulation, 
in particular with the obligations set out in Articles 7 and 76. 

4. 

5. 

6. 

Paragraphs 1 to 5 shall also apply to delegated bodies.  

1. 

2. 

1. 

2. 

1. 

Article 33 

Activity data extraction and publication  

Competent  authorities  shall  verify  that  SoHO  entities  that  have  activity  data 
collection  and  reporting  obligations  pursuant  to  Article  44  submit  complete  and 
accurate  annual  reports  of  those  activities  to  the  EU  SoHO  Platform  referred  to  in 
Chapter XI. 

Competent  authorities  shall  extract  an  aggregated  annual  report  of  SoHO  activity 
data  for  their  SoHO  entities  from  the  EU  SoHO  Platform.  They  shall  make  that 
report available to the public, including on the internet.  

Article 34 

Traceability 

Competent authorities shall verify that SoHO entities have appropriate procedures in 
place to ensure traceability and coding of SoHOs as referred to in Article 45. 

Competent  authorities  shall  establish  procedures  for  the  unique  identification  of 
SoHO establishments that are subject to the provisions on the Single European Code 
in  Article  46.  Competent  authorities  shall  ensure  that  such  identification  complies 
with  the  technical  standards  defined  for  that  coding  system.  For  this  purpose, 
competent  authorities  may  use  a  SoHO  establishment  identification  code  generated 
by the EU SoHO Platform.  

Article 35 

Vigilance 

Competent  authorities  shall  be  responsible  for  the  management  of  vigilance 
associated with SoHO activities. They shall provide guidance and templates for the 
submission  of SAO notifications and of SAO investigation reports as referred to  in 
Article 47. 

EN 

57 

  EN 

2. 

Upon receipt of a SAO notification, competent authorities shall:  

(a) 

acknowledge receipt of the SAO notification; 

(b)  verify that the SAO notification includes the information referred to in Article 

47(3);  

(c) 

assess the adequacy of the investigation  planned to  establish imputability and 
root cause; 

(d) 

respond to the submitting SoHO entity without undue delay.  

3. 

Competent authorities may provide advice on the investigation planned by the SoHO 
entity.  In  preparing  such  advice,  competent  authorities  may  request  contributing 
advice from the SCB pursuant to Article 68(1). In case the SAO concerns a suspected 
transmission  of  a  communicable  disease,  competent  authorities  shall  inform  the 
ECDC and take into account any advice or information provided by the ECDC or its 
SoHO expert network. 

4. 

Upon receipt of a SAO investigation report, competent authorities shall:  

(a) 

acknowledge receipt of the SAO investigation report; 

(b)  verify  that  the  SAO  investigation  report  includes  the  information  pursuant  to 

Article 47(5);  

(c) 

assess  the  results  of  the  investigation  and  of  the  corrective  and  preventive 
actions described; 

(d) 

inform the submitting SoHO entity of the conclusion of the SAO assessment.  

Competent  authorities  may  carry  out  inspections,  pursuant  to  Articles  29  or  30,  as 
appropriate,  when  the  SAO  notification  or  SAO  investigation  report  received 
indicates,  or  gives  reasonable  grounds  for  suspecting,  that  requirements  of  this 
Regulation have not been complied with, or to verify an accurate implementation of 
corrective and preventive actions planned.  

Upon receipt of a SAO notification with implications for safety, quality or supply of 
a  product  manufactured  under  other  Union  legislation  from  that  SoHO  or  SoHO 
preparation,  competent  authorities  shall  inform,  without  undue  delay,  the  relevant 
authorities competent for that product, pursuant to Article 14(5). 

Upon receipt of information regarding  a serious incident and field safety corrective 
action  according  to  Regulation  (EU)  2017/745,  the  competent  authorities  receiving 
such  information  shall  inform  the  SoHO  entities  concerned.  The  competent 
authorities shall submit that information to their National SoHO Authority, provided 
that the incident meets the definition of a SAO. 

Competent  authorities shall provide a channel  for  self-reporting of SAOs  by  SoHO 
recipients and donors. Upon receipt of such notifications, competent authorities shall 
inform,  as appropriate, the relevant  SoHO  entities  or SoHO establishments  thereof, 
and ensure that an adequate investigation of the occurrence is initiated by the SoHO 
entities  or  establishments  concerned  and  that  adequate  corrective  and  preventive 
action  have  been  taken  by  the  SoHO  entities  or  establishments  concerned  when 
necessary, and respond to the recipient or donor concerned. 

Competent authorities shall ensure that the procedures referred to in paragraphs 1 to 
5 provide for an adequate interconnection between the SAO notifications pursuant to 
this  Article  and  the  reporting  system  established  in  accordance  with  Article  11  of 

5. 

6. 

7. 

8. 

9. 

EN 

58 

  EN 

10. 

11. 

12. 

13. 

1. 

2. 

Directive  2010/53/EU,  for  instances  where  SAO  notifications  relate  to  SoHO 
donations after death, by donors that also donated organs. 

Competent  authorities  shall  submit  to  their  SoHO  National  Authorities  an  annual 
summary  of  the  SAO  notifications  and  SAO  investigation  reports  received.  The 
SoHO  National  Authorities  shall  submit  an  annual  summary  of  those  SAO 
notifications  and  investigation  reports  to  the  EU  SoHO  Platform  referred  to  in 
Chapter  XI  before  31  May  of  the  subsequent  year  and  shall  make  an  aggregated 
version of that summary available to the public in their Member State, including on 
the  internet.  They  shall  include  in  the  annual  summary  the  numbers  and  types  of 
those SAO reported to them that meet thresholds of seriousness and imputability that 
are agreed at Union level within the SCB.   

The  Commission  shall  aggregate  the  annual  summaries  of  the  SoHO  National 
Authorities, prepare and publish an annual SoHO vigilance report after having shared 
the report with the SoHO National Authorities for review and approval.  

For the development of the guidance and templates referred to in paragraph 1 of this 
Article, and for the submission of the annual summaries referred to in paragraph 10 
of  this  Article,  competent  authorities  shall  consult  the  best  practices  agreed  and 
documented by the SCB as referred to in Article 68(1), point (c). 

The  Commission  may  adopt  implementing  acts  concerning  the  procedures  to  be 
followed  for  consultation  and  coordination  between  competent  authorities  and  the 
ECDC concerning relevant SAO notifications and investigations.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 36 

SoHO rapid alerts 

Competent  authorities  shall,  upon  receipt  of  a  notification  of  a  SAO  or  other 
information  with  implications  for  safety  or  quality  or  supply  of  SoHOs  in  one  or 
more Member States, launch a SoHO rapid alert on the EU SoHO Platform referred 
to in Chapter XI. 

Competent authorities shall launch a SoHO rapid alert in particular in the following 
circumstances: 

(a) 

(b) 

(c) 

a risk to the quality or safety of SoHOs has been identified concerning SoHOs 
that  have  been  distributed  from  their  Member  State  to  at  least  one  other 
Member State; 

an outbreak of a communicable disease has occurred in their Member State and 
they have put in place donor deferral or testing measures to mitigate the risks 
of transmission by SoHOs; 

a  defect  or  serious  supply  interruption  has  occurred  concerning  equipment, 
devices,  materials  or  reagents  that  are  critical  for  the  collection,  processing, 
storage  or  distribution  of  SoHOs  and  that  might  be  used  in  other  Member 
States; 

(d)  other  information  is  available  to  the  competent  authorities  that  could 
reasonably be considered useful in other Member States to reduce risks to the 

EN 

59 

  EN 

3. 

4. 

5. 

1. 

2. 

3. 

1. 

safety or quality of SoHOs and where the launch of a SoHO rapid alert would 
be proportionate and necessary. 

The ECDC, with the support of its SoHO expert network, may also launch an alert in 
the EU SoHO Platform when surveillance of communicable diseases indicates a new 
risk  to  the  safety  of  SoHOs.  The  ECDC  may  indicate  in  such  an  alert  that  it  has 
provided guidelines on the mitigation of risks associated with communicable disease 
outbreaks, in particular concerning the eligibility and testing of SoHO donors. 

Competent  authorities  that  receive  a  SoHO  rapid  alert  shall  communicate 
information  to  the  relevant  organisations  representing  groups  of  SoHO  entities  or 
professionals  without  undue  delay  with  a  view  to  ensuring  that  risk  mitigating 
actions  can  be  taken  promptly  and  that  relevant  information  available  at  the  SoHO 
professional  level  can  be  shared  with  the  competent  authorities.  Competent 
authorities  may  also  supplement  the  information  provided  in  the  alert  with  further 
information  such  as  details  of  relevant  mitigating  actions  taken  in  their  Member 
State.  

Competent authorities and the ECDC shall consult the relevant best practices agreed 
and documented by the SCB as referred to in Article 68(1), point (c), when launching 
and handling a SoHO rapid alert. 

CHAPTER IV 

GENERAL OBLIGATIONS ON SOHO ENTITIES 

Article 37 

SoHO entity registration  

Entities shall register  as  a SoHO  entity before commencing  any SoHO activity.  To 
register, they shall provide the information as referred to in Article 18. SoHO entities 
may  request  from  their  competent  authorities  an opinion on the applicability of  the 
registration  requirements  in  this  Chapter  to  the  SoHO  activities  concerned  prior  to 
the registration. 

In  Member  States  where  the  EU  SoHO  Platform  is  used  for  registration  of  SoHO 
entities,  as  referred  to  in  Article  18(2),  organisations  meeting  the  definition  of  a 
SoHO entity shall register directly in the EU SoHO Platform in accordance with their 
competent authorities’ instructions. 

SoHO  entities  that  implement  changes  to  their  SoHO  activities  or  contact  details 
shall register those changes without undue delay. Where such changes imply SoHO 
activities including both processing and storage of SoHOs, those SoHO entities shall 
comply with the requirements of Articles 48 and 49. 

Article 38 

Responsible person for release of SoHOs 

In cases where a SoHO entity releases SoHOs or SoHO preparations for distribution 
for human application, or for the manufacture of products regulated by other Union 
legislation,  or  as  the  starting  and  raw  material  thereof,  as  referred  to  in  Article  60, 
that entity shall designate a person responsible for release. 

EN 

60 

  EN 

2. 

3. 

The  responsible  person  for  release  of  SoHOs  shall  be  in  possession  of  a  diploma, 
certificate  or  other  evidence  of  formal  qualifications  in  the  field  of  medical  or 
biological sciences awarded on completion of a university course of study or a course 
recognised  as  equivalent  by  the  Member  State  concerned  and  shall  have  at  least  2 
years of experience in the relevant field. 

The  responsible  person  for  release  of  SoHOs  may  delegate  the  tasks  specified  in 
paragraph  1  to  other  persons  who  shall  be  qualified  by  training  and  experience  to 
perform  such  tasks.  In  such  cases,  that  person  shall  perform  those  tasks  under  the 
responsibility of the responsible person for release of SoHOs. 

Article 39 

Export 

SoHO  entities  shall  ensure  that  SoHOs  or  SoHO  preparations  exported  or  re-exported  from 
the Union comply with the relevant  requirements of this Regulation unless the SoHO entity 
can  demonstrate  that  the  authorities  of  the  importing  country  or  the  laws,  regulations, 
standards, codes of practice or other legal and administrative procedures as may be in force in 
the  importing  country  indicate  that  a  deviation  from  the  requirements  of  this  Regulation  is 
acceptable. SoHO entities shall not deviate from the standards referred to in Chapter VI. 

Article 40 

SoHO preparation authorisation  

1. 

2. 

3. 

1. 

SoHO  entities  shall  not  release  or,  in  an  autologous  context,  prepare  and  apply 
immediately  to  a  recipient,  SoHO  preparations  without  prior  SoHO  preparation 
authorisation.  In cases where  a SoHO  entity modifies  an activity  carried  out  for  an 
authorised SoHO preparation, it shall obtain an authorisation for that modified SoHO 
preparation. 

SoHO  entities  may  request  advice  from  their  competent  authorities  on  the 
applicability  of  the  authorisation  requirements  in  this  Regulation  to  their  SoHO 
activities prior to submitting an application for a preparation authorisation. 

SoHO  entities  may  request  to  their  competent  authorities  a  derogation  from  the 
requirement  for  a  SoHO  preparation  authorisation  in  the  exceptional  circumstances 
referred to in Article 64. 

Article 41 

Application for the authorisation of SoHO preparations 

SoHO entities shall send applications for the authorisation of a SoHO preparation to 
their competent authorities. The applicant shall provide the name and contact details 
of  the  prospective  SoHO  preparation  authorisation  holder  responsible  for  the 
application. This paragraph shall be without prejudice to Article 38(1).  

2. 

The applicant shall provide the following: 

(a) 

a  SoHO  preparation  dossier  describing  the  details  of  the  SoHO  activities 
performed for that SoHO preparation and including at least: 

(i) 

any specific SoHO donor eligibility or SoHO donor testing procedures; 

(ii) 

any specific SoHO collection procedures; 

EN 

61 

  EN 

(iii)  a description of the processing applied including details of the air quality 
standards maintained in the processing facilities and the rationale for the 
air quality standard applied; 

(iv)  a  description  of  equipment,  reagents  and  materials  used  and  their 
certification status in accordance with Regulation (EU) 2017/745;  

(v) 

any specific storage conditions and storage time limits; 

(vi)  any quality control and release parameters; 

(vii)  data  concerning  procedures  performed  for  process  validation  and 

equipment qualification; 

(viii)  details  of  any  third  parties  contracted  by  the  SoHO  entity  to  perform 

activities for the SoHO preparation;  

(ix) 

the clinical indications for which the SoHO preparation is to be applied; 

(b) 

the  results  of  a  risk  assessment  conducted  on  the  combination  of  SoHO 
activities  performed  for  the  SoHO  preparation,  together  with  the  intended 
clinical indication for which it is intended to be applied, taking into account:  

(i)  whether  the  SoHO  preparation  is  described  in,  and  aligned  with,  an 
EDQM SoHO monograph included in the technical guidelines referred to 
in Article 59(4), point (a); 

(ii)  whether  the  SoHO  preparation  meets  the  defined  quality  criteria  in  the 
EDQM  SoHO  monograph  referred  to  in  point  (i)  and  is  intended  to  be 
used  for  the  indication  and  with  the  mode  of  application  to  which  that 
monograph refers, where such details are provided in that monograph; 

(iii) 

information  regarding  previous  use  and  authorisation  of  the  SoHO 
preparation  in  other  SoHO  entities,  as  available  in  the  EU  SoHO 
Platform; 

(iv)  evidence  generated as  part of the process  of certification, in  accordance 
with Regulation (EU) 2017/745, of any certified medical device used for 
the SoHO preparation, where available; 

(v)  documentation  of  a  systematic  process  of  identification,  quantification 
and evaluation of any risks to the donor or the recipient arising from the 
chain of activities performed for the SoHO preparation; 

(c) 

in cases where the indicated risk is other than negligible, a proposal for clinical 
outcome  monitoring  to  demonstrate  safety,  quality  and  efficacy  of  the  SoHO 
preparation, in line with the results of the risk assessment; 

(d) 

an indication of the data which should be regarded as proprietary accompanied 
by verifiable justification, where appropriate.  

3. 

In  the  proposal  referred  to  in  paragraph  2,  point  (c),  the  applicant  shall  propose  a 
clinical outcome monitoring plan as follows:   

(a) 

(b) 

in cases of low risk, clinical follow-up of a defined number of patients; 

in cases of moderate risk, in addition to point (a), a clinical investigation study 
of  a  statistically  significant  number  of  patients  assessing  pre-defined  clinical 
endpoints; 

EN 

62 

  EN 

4. 

5. 

6. 

1. 

2. 

3. 

1. 

2. 

3. 

(c) 

in cases of high risk, in addition to point (a), a clinical investigation study of a 
statistically  significant  number  of  patients  assessing  pre-defined  clinical 
endpoints with a comparison to standard therapy. 

SoHO  entities  shall  perform  the  clinical  outcome  monitoring  once  a  conditional 
authorisation  has  been  granted  pursuant  to  Article  21(2),  point  (c),  and  submit  the 
results to their competent authorities. In conducting the clinical investigation study as 
referred to  in  paragraph  3, points (b) and  (c), for the SoHO preparation concerned, 
the applicant may use an existing clinical registry to record its results  provided that 
their  competent  authorities  have  verified  that  the  registry  has  data  quality 
management procedures in place that ensure accuracy and completeness of data. 

SoHO entities shall not make any change to the chain of activities performed for an 
authorised SoHO preparation, without the prior written approval of their competent 
authorities. SoHO entities shall also inform their competent authorities of changes in 
the SoHO preparation authorisation holder’s details. 

The  SoHO  preparation  authorisation  holder  shall  be  based  in  the  Union.  In  cases 
where  other  SoHO  entities  carry  out  one  or  more  of  the  processing  steps  for  the 
SoHO  preparation,  the  SoHO  entity  that  holds  the  SoHO  preparation  authorisation 
shall  be  responsible  for  the  release  and  shall  supervise  it,  even  if  the  release 
physically takes place at the site of the other SoHO entities. 

Article 42 

Importing SoHO entity authorisation  

SoHO  entities  shall  not  import  SoHOs  without  a  prior  importing  SoHO  entity 
authorisation.  

In  the  case  of  importing  SoHO  entities  that  only  import  human  plasma  that  is 
intended  to  be  used  for  the  manufacture  of  medicinal  products  regulated  by  other 
Union  legislation  and  is  included  in  a  plasma  master  file  (PMF)  as  referred  to  in 
Directive 2003/63/EC, paragraph 1 of this Article shall not apply. 

The  Commission  shall  adopt  delegated  acts  in  accordance  with  Article  77 
supplementing  this  Regulation  by  laying  down  obligations  and  procedures  for 
importing SoHO entities regarding the import of SoHOs in order to verify equivalent 
standards of quality and safety of such imports. 

Article 43 

Application for importing SoHO entity authorisations  

SoHO entities shall send applications for authorisation as importing SoHO entities to 
their competent authorities. 

The  applicant  SOHO  entity  shall  provide  the  name  and  contact  details  of  the 
prospective  importing  SoHO  entity  authorisation  holder.  This  paragraph  shall  be 
without prejudice to Article 38(1). 

The importing SoHO entity shall not make any substantial changes to the importing 
SoHO activities subject to the authorisation without the prior written approval of its 
competent authority. The same shall apply in case of changes in the importing SoHO 
entity authorisation holder’s details. 

EN 

63 

  EN 

4. 

5. 

6. 

The importing SoHO entity authorisation holder shall be based in the Union, and be 
responsible  for  the  physical  reception  and  visual  examination  and  verification  of 
imported  SoHOs  prior  to  their  release.  The  importing  SoHO  entity  shall  verify 
coherence  between  the  SoHO  received  and  the  associated  documentation  and 
conduct an examination of the integrity of packaging and the compliance of labelling 
and  transport  conditions  with  the  relevant  standards  and  technical  guidelines  as 
referred to in Articles 57, 58 and 59.  

An  authorised  importing  entity  may  delegate  the  physical  reception,  visual 
examination and verification referred to  in  paragraph  4 to  the entity that  will apply 
the SoHO to the recipient in cases where imports are organised for individual named 
recipients. 

The  Commission  shall  adopt  implementing  acts  specifying  the  information  to  be 
provided  in  an  application  for  an  authorisation  for  importing  SoHOs  or  SoHO 
preparations to ensure compatibility and comparability of such data.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 44 

Activity data collection and reporting  

1. 

SoHO  entities  shall  collect  data  relating  to  their  activities  in  cases  where  those 
activities include: 

(a)  SoHO donor recruitment; 

(b) 

collection; 

(c) 

distribution; 

(d) 

import; 

(e) 

(f) 

export; 

human application. 

2. 

3. 

4. 

The data collected pursuant to paragraph 1 shall comprise the elements set out in the 
EU SoHO Platform as referred to in Chapter XI. 

The Commission shall adopt implementing acts laying down technical procedures to 
ensure uniformity and compatibility and comparability for the implementation of this 
Article.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2).  

SoHO entities shall submit to the EU SoHO Platform an annual summary of the data 
collected pursuant  to  this Article.  In cases where national  or international  registries 
collect  activity  data  meeting  the  criteria  defined  in  the  SoHO  platform  and  such 
registries have been verified by competent authorities as having in place data quality 
management  procedures  that  ensure  accuracy  and  completeness  of  data,  SoHO 
entities may delegate the submission of the activity data referred to in this Article to 
such registries. The Commission shall aggregate the annual summaries of the SoHO 
entities, prepare and publish an Annual SoHO Activity Report.  

EN 

64 

  EN 

1. 

2. 

3. 

4. 

1. 

Article 45 

Traceability and coding  

SoHO  entities  shall  implement  a  traceability  system  in  order  to  unmistakably  link 
each  SoHO  donor  to  their  SoHO  donation  and  to  all  documents,  samples,  SoHO 
preparations and SoHO entities that are associated with that SoHO from the point of 
collection  to  human  application  and  outcome  monitoring.  With  regard  to  imported 
SoHOs, importing SoHO entities shall ensure an equivalent level of traceability. 

SoHO entities distributing SoHOs shall generate a code that contains the information 
included in the traceability system referred to in paragraph 1. They shall ensure that 
the code: 

(a) 

(b) 

(c) 

(d) 

is unique within the Union; 

is machine-readable, unless the size or storage conditions mean that a machine-
readable code cannot be applied; 

does not reveal the identity of the donor; 

complies with technical rules for the Single European Code (SEC) for SoHOs, 
referred to in Article 46, where applicable as indicated in that Article. 

SoHO entities shall include the codes referred to in paragraph 2 on the labels to be 
applied to the SoHO or SoHO preparations prior to distribution, or on the documents 
accompanying  the  distributed  SoHO  or  SoHO  preparations  where  it  can  be 
guaranteed  that  such  documents  will  not  be  separated  from  the  SoHO  or  SoHO 
preparation concerned.  

SoHO entities shall use a labelling system that meets the labelling requirements set 
out in the relevant technical guidelines referred to in Articles 56(4) and 59(4). SoHO 
entities  shall  keep  the  data  necessary  to  ensure  traceability  for  a  minimum  of  30 
years. They may store the data in electronic form.  

Article 46 

European coding system 

SoHO  entities  shall  apply  a  Single  European  Code  (‘SEC’)  to  SoHO  preparations 
distributed for human application. In cases where SoHOs or SoHO preparations are 
transferred for further processing in another SoHO entity or released for manufacture 
of products regulated by other Union legislation, or as the starting and raw material 
thereof,  SoHO  entities  shall,  at  least,  apply  the  part  of  the  SEC  that  allows 
identification of the donation. The SEC shall appear on the packaging or on a label 
attached  thereto,  or  on  the  documents  referring  to  the  SoHO  where  it  can  be 
guaranteed that such documents accompany the SoHO concerned.  

2. 

Paragraph 1 shall not apply to: 

(a) 

reproductive cells for within couple use; 

(b)  blood or blood components for transfusion or for the manufacture of medicinal 

products; 

(c)  SoHOs applied to a recipient without being stored; 

(d)  SoHOs  imported  into  the  Union  in  case  of  emergency  authorised  directly  by 

competent authorities pursuant to Article 28(9);  

EN 

65 

  EN 

3. 

1. 

2. 

3. 

4. 

5. 

(e)  SoHOs that are imported to or donated in the same SoHO entity where they are 

applied.  

The Commission shall adopt implementing acts concerning the format of the Single 
European  Code  and 
to  SoHO 
establishments  and  to  SoHOs  at  the  point  of  distribution  or  point  of  transport  and 
delivery for further processing.  

the  requirements  related 

its  application 

to 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 47 

Vigilance and reporting 

SoHO  entities  shall  maintain  a  system  for  detecting,  investigating  and  recording 
information concerning adverse occurrences, including adverse occurrences detected 
during  clinical  outcome  monitoring  as  part  of  a  SoHO  preparation  authorisation 
application as referred to in Article 41.  

Where  applicable,  SoHO  entities  shall  make  all  reasonable  efforts  to  encourage 
prospective  parents  of  children  born  from  third  party  donation  to  commit  to 
communicate  information  concerning  any  genetic  conditions  that  emerge,  as  those 
children  grow  up,  to  the  SoHO  entity  where  they  were  treated.  That  entity  shall 
communicate,  without  undue  delay,  the  information  to  the  SoHO  entity  that 
distributed  or  applied  the  reproductive  cells  with  a  view  to  preventing  further 
distribution of SoHO from the implicated SoHO donor.  

In cases where SoHO entities detect or suspect that an adverse occurrence meets the 
definition  of  a  serious  adverse  occurrence  (SAO),  they  shall  submit  a  SAO 
notification  to  their  competent  authorities  within  five  working  days.  SoHO  entities 
shall include the following in the notification: 

(a) 

a full description of the suspected SAO; 

(b) 

a preliminary assessment of the level of imputability of the suspected SAO; 

(c) 

a  plan  for  an  investigation  to  establish  the  level  of  imputability  and  the  root 
cause; 

(d)  proposed mitigation strategies; 

(e) 

a  preliminary  assessment  of  the  seriousness  of  the  consequences  of  the  SAO 
for a donor, a recipient or the offspring from medically assisted reproduction or 
for public health in general.  

SoHO entities shall have in place a procedure to accurately, efficiently and verifiably 
withdraw  from  distribution  or  use  those  SoHOs  affected  by  adverse  occurrence 
referred to in paragraph 1, as appropriate.  

SoHO entities shall conduct an investigation of each SAO detected. On completion 
of an investigation of a SAO, SoHO entities shall provide a SAO investigation report 
to  their  competent  authorities  pursuant  to  Article  35(4).  The  SoHO  entities  shall 
include in the report:  

(a) 

a  full  description  of  the  investigation  and  the  final  assessment  of  the 
imputability of the SAO to the donation or application of the SoHO;  

EN 

66 

  EN 

(b) 

the final  assessment of the  seriousness of the  consequences of the SAO  for a 
donor,  a  recipient  or  the  offspring  of  medically  assisted  reproduction  or  for 
public health in general; 

(c) 

a  description  of  the  corrective  or  preventive  actions  that  have  been  taken  to 
limit any harm or to prevent recurrence. 

SoHO  entities  shall  report  information  concerning  a  SAO  to  other  SoHO  entities 
engaged  in  the  collection,  processing,  testing,  storage  and  distribution  of  SoHO 
collected  from  the  same  donor,  or  otherwise  possibly  affected  by  the  SAO 
concerned.  They shall only report information necessary and appropriate in order to 
facilitate  traceability  and  ensure  quality  and  safety  in  such  cases,  and  shall,  in 
particular, limit the information to details necessary to take mitigating actions. SoHO 
entities  shall  also  report  such  information  to  organ  procurement  organisations  in 
cases where a donor who is implicated in the SAO has also donated organs. 

CHAPTER V 

GENERAL OBLIGATIONS ON SoHO ESTABLISHMENTS 

Article 48 

SoHO establishment authorisation 

SoHO  establishments  shall  not  carry  out  any  activities  without  prior  SoHO 
establishment authorisation. This shall apply whether all activities are carried out by 
the establishment itself or one or more are contracted to another SoHO entity. 

In cases where SoHO establishments contract other SoHO entities to perform part or 
all  of  certain  SoHO  activities,  the  SoHO  establishments  shall  ensure  that  those 
contracted SoHO entities carry out those contracted activities in compliance with the 
provisions  of  this  Regulation.  Such  contracted  entities  shall  agree  to  be  audited  by 
the  SoHO  establishments  to  verify  that  the  contracted  activities  are  carried  out  in 
compliance with this Regulation. In addition, the contracted entities shall agree to be 
inspected  by  competent  authorities  if  the  authorities  require  such  inspection.  The 
SoHO establishments shall document these agreements. 

The  requirement  to  obtain  a  SoHO  establishment  authorisation  shall  be  without 
prejudice  to  more  stringent  measures  put  in  place  by  a  Member  State  pursuant  to 
Article 4 and directly affecting the activities carried out in the SoHO establishment 
or contracted SoHO entities concerned pursuant to paragraph 2 of this Article. 

Article 49 

Application for SoHO establishment authorisations 

SoHO entities shall send the application for authorisations as SoHO establishments 
to their competent authorities.  

The applicant SoHO establishment shall provide the name and contact details of the 
prospective SoHO establishment authorisation holder responsible for the application 
and  carrying  out  the  SoHO  activities  subject  to  the  authorisation.  This  paragraph 
shall be without prejudice to Article 38(1). The applicant SoHO establishment shall 
not make any substantial changes to the SoHO activities subject to the authorisation 

6. 

1. 

2. 

3. 

1. 

2. 

EN 

67 

  EN 

without the prior written approval of the competent authority. The same shall apply 
in case of changes in the SoHO establishment authorisation holder’s details. 

3. 

SoHO establishment authorisation holders shall be based in the Union. 

1. 

2. 

3. 

4. 

5. 

1. 

Article 50 

Quality management system 

SoHO  establishments  shall  establish,  maintain  and  update,  as  necessary,  a  quality 
management  system  achieving  a  high  level  of  quality  of  SoHOs  by  following,  in 
particular,  the  Good  Practice  Guidelines  published  by  the  EDQM  and  which  are 
included in the technical guidelines referred to in Article 56(4), point (a), and Article 
59(4), point (a). 

SoHO  establishments  shall  design  the  quality  management  system  to  ensure  that 
SoHO  activities  are  carried  out  in  a  consistent  manner,  by  personnel  that  are 
competent to  perform the tasks allocated to  them and in  facilities that are designed 
and  maintained  in  a  manner  that  prevents  SoHO  contamination,  or  cross-
contamination, with infectious agents or loss of traceability. 

SoHO  establishments  shall  put  in  place  procedures  and  specifications  covering  the 
following: 

(a) 

documentation of roles and responsibilities of personnel; 

(b) 

selection, training and competence assessment of personnel;  

(c) 

premises and equipment procurement, qualification and monitoring; 

(d)  quality control, as applicable, of SoHO activities; 

(e)  withdrawal  of  SoHOs  from  the  inventory  of  released  SoHOs  and  recall  of 

unused SoHOs following distribution;  

(f) 

internal audits; 

(g)  management of contracted third parties;  

(h)  management of identified cases where personnel have not followed procedures 

or specifications have not been complied with.  

SoHO  establishments  shall  review  the  quality  management  system  at  regular 
intervals  to  verify  its  effectiveness  and  introduce  corrective  measures  if  deemed 
necessary. 

The  Commission  may  adopt  implementing  acts  regarding  further  details  on  the 
procedures  and  specifications  of  the  quality  management  system  in  order  to  ensure 
uniform quality management.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2).  

Article 51 

Physician 

Each SoHO establishment shall designate a physician who resides and carries out its 
tasks in the same Member State and who shall at least fulfil the following conditions 
and have the following qualifications: 

EN 

68 

  EN 

(a) 

possession of formal qualification as a physician; 

(b) 

at least two years’ practical experience in relevant fields. 

2. 

The  physician  referred  to  in  paragraph  1  shall  be  responsible  for  at  least  the 
following tasks: 

3. 

1. 

2. 

1. 

(a) 

development, review and approval of policies and procedures for  establishing 
and  applying  SoHO  donor  eligibility  criteria  and  criteria  for  the  allocation  of 
SoHOs and SoHOs preparations; 

(b) 

investigation of suspected adverse occurrences in SoHO donors and recipients; 

(c) 

design and supervision of clinical data collection activities to support evidence 
gathering to support applications for SoHO preparation authorisations pursuant 
to Article 41; 

(d)  other  tasks  of  relevance  to  the  health  of  donors  and  recipients  of  SoHOs 

collected or supplied by the SoHO establishment. 

By derogation from paragraph 2, in the case of SoHO entities that are authorised as 
SoHO  establishments  in  accordance  with  Article  25(3),  the  physician  shall  be 
responsible for those tasks that are relevant to the SoHO activities performed by the 
SoHO  entities  and  that  have  a  direct  influence  on  the  health  of  SoHO  donors  and 
recipients. 

CHAPTER VI 

SoHO DONOR PROTECTION 

Article 52 

Objectives regarding SoHO donor protection 

SoHO entities shall ensure high levels of safety of SoHO donors. 

SoHO  entities  shall  protect  the  health  of  living  donors  before,  during  and  after  the 
donation.  

Article 53 

Standards concerning SoHO donor protection 

In case of collection of SoHOs from allogeneic donors, regardless of whether or not 
the donor is genetically related to the intended recipient, SoHO entities shall: 

(a)  meet  all  applicable  consent  or  authorisation  requirements  in  force  in  the 

Member State concerned;  

(b)  provide donors or their relatives or any persons granting authorisation on their 
behalf, in accordance with national legislation, with the information referred to 
in  Article  55  and  in  a  way  that  is  adequate  in  view  of  their  capacity  to 
understand it;  

(c) 

provide donors or their relatives or any persons granting authorisation on their 
behalf,  in  accordance  with  national  legislation,  with  the  contact  details  of  the 
responsible  SoHO  entity  from  which  they  can  request  further  information,  if 
needed; 

EN 

69 

  EN 

(d) 

(e) 

(f) 

safeguard  the  rights  of  the  donor  to  physical  and  mental  integrity,  to  privacy 
and to the protection of the personal data concerning them in accordance with 
Regulation (EU) 2016/679; 

ensure that donation is voluntary and unpaid, pursuant to Article 54; 

verify the eligibility of the donor on the basis of a donor health evaluation that 
aims to minimise any risk that the donation might pose to the donor’s health;  

(g)  document the results of the donor health evaluation referred to in point (f);  

(h) 

(i) 

(j) 

communicate and clearly  explain the results of the donor health evaluation  to 
the donor or  his/her  relatives or any persons granting  authorisation on  his/her 
behalf, in accordance with national legislation; 

identify and minimise any risks to the health of the donor during the donation 
procedure, including exposure to reagents or solutions that might be toxic; 

verify,  by  means  of  a  registry,  that  donors  are  not  donating  more  frequently 
than  indicated  as  safe  in  technical  guidelines  as  referred  to  in  Article  56  and 
demonstrate that their health is not compromised; 

(k)  develop  and  implement  a  plan  for  monitoring  the  donor’s  health  after  the 
donation in cases where the SoHO donations imply a significant risk to a donor 
as referred to in paragraph 3;  

(l) 

in the case of an allogeneic and unrelated donation, refrain from revealing the 
donor’s  identity  to  the  recipient,  apart  from  exceptional  circumstances  where 
such  information  exchange  is  permitted  in  the  Member  State  and  follows  the 
expressed wishes of both parties. 

In  the  course  of  the  donor  health  evaluations  referred  to  in  paragraph  1,  point  (f), 
SoHO  entities  shall  conduct  interviews  with  the  donors  and  gather  information 
concerning the donors’ present and recent state of health and their health histories to 
assure  the  safety  of  the  donation  process  for  those  donors.  SoHO  entities  may 
perform laboratory tests as part of the donor health evaluations. They shall perform 
such  tests  in  cases  where  evaluations  indicate  that  laboratory  tests  are  necessary  to 
establish the eligibility of those donors from the perspective of their own protection. 
The physician, as referred to in Article 51, shall  approve the procedure and criteria 
for donor health evaluations. 

SoHO  entities  that  collect  SoHOs  from  donors  that  are  subjected  to  a  surgical 
procedure in order to donate, that are treated with hormones to facilitate donation, or 
that donate on a frequent and repeated basis, shall register such donors and the results 
of their donor health evaluations in a cross-entity registry that allows interconnection 
with other such registries, as referred to in paragraph 1, point (j). SoHO entities that 
manage such registries shall ensure interconnectivity between them.  

The SoHO entities referred to in paragraph 3 shall ensure that the plan for monitoring 
donor health after donation, as referred to in paragraph 1, point (k), is proportionate 
to  the  risks  associated  with  the  donation.  They  shall  include  in  the  plan  the  time 
period during which the monitoring shall continue.  

In case of collection of SoHOs for autologous use or in the context of individuals or 
couples  from  whom  SoHOs  are  collected  as  part  of  their  own  current  or  future 
medically assisted reproduction treatment, the treating physician shall ensure that any 

2. 

3. 

4. 

5. 

EN 

70 

  EN 

6. 

7. 

1. 

2. 

3. 

1. 

2. 

risks  associated  with  the  collection  are  explained  to  the  individuals  and  are 
outweighed by the potential benefit for those individuals. 

The Commission is empowered to adopt delegated acts in accordance with Article 77 
in order to be able to supplement this Regulation in cases where additional standards 
are needed in order to ensure the protection of donors.  

Where, in the case of risk to the safety of donors, imperative grounds of urgency so 
require,  the  procedure  provided  for  in  Article  78  shall  apply  to  delegated  acts 
adopted pursuant to this Article. 

Article 54 

Standards concerning voluntary and unpaid nature of SoHO donations 

SoHO entities shall not provide financial incentives or inducements to donors or their 
relatives  or  any  persons  granting  authorisation  on  their  behalf,  in  accordance  with 
national legislation. 

Member  States  may  allow  for  the  compensation  or  reimbursement  from  the  SoHO 
entities to donors for losses related to their participation in  donations through fixed 
rate allowances. In such case, Member States shall establish the conditions for such 
allowances in national legislation, including the setting of an upper limit that ensures 
that allowances are financially neutral and consistent with the standards laid down in 
this  Article.  They  may  delegate  the  setting  of  conditions  for  such  allowances  to 
independent bodies that are established in accordance with national legislation. 

SoHO  entities  may  compensate  or  reimburse  donors  as  provided  for  by  their 
competent authorities pursuant to paragraph 2. 

Standards concerning information to be provided prior to consent or authorisation 

Article 55 

SoHO entities shall provide prospective SoHO donors, their relatives or any persons 
granting  authorisation  on  their  behalf,  in  accordance  with  national  legislation,  with 
all  appropriate  information  relating  to  the  donation  and  collection  process  in 
accordance with national legislation, including a general description of the potential 
uses and benefits of the donation.  

SoHO  entities  shall  provide  the  information  referred  to  in  paragraph  1  before  the 
consent  is  given  or  authorisation  is  granted  for  the  donation.  SoHO  entities  shall 
provide the information in an accurate and clear manner, using terms that are easily 
understood  by  the  prospective  donors  or  the  persons  to  consent  or  authorise  the 
donation.  It  shall  not  mislead  the  prospective  donors  or  persons  granting 
authorisation on their behalf, in particular, as to the benefits of the donation to future 
recipients of the SoHO concerned. 

3. 

In case of living donors, SoHO entities shall provide information regarding:  

(a) 

the purpose and nature of the donation; 

(b) 

the consequences and risks of the donation;  

(c) 

the  right  to  withdraw  consent  and  any  restrictions  on  the  right  to  withdraw 
consent following donation; 

EN 

71 

  EN 

(d) 

(e) 

(f) 

(g) 

the intended use of the  donated SoHO, in  particular covering proven benefits 
for the future recipients and any possible research or commercial uses to which 
the donor should consent;  

the  analytical  tests  that  will  be  performed  in  course  of  the  donor  health 
evaluation;  

the  right  of  the  donor  to  receive  the  confirmed  results  of  the  analytical  tests 
when relevant for their health;  

the  recording  and  protection  of  donor  personal  and  health  data  and  medical 
confidentiality, including any potential sharing of data in the interest of donor 
health monitoring and of public health, as necessary and proportionate;  

(h) 

the applicable safeguards intended to protect the donor and their personal data; 

(i) 

the obligation for consent and authorisation, as applicable in the Member State, 
in order for SoHOs collection to be carried out. 

Article 56 

Implementation of the standards concerning SoHO donor protection 

When  the  Commission  deems  it  necessary  to  provide  binding  rules  on  the 
implementation  of  a  particular  standard  or  element  of  a  standard  referred  to  in 
Articles 53, 54 or 55, in order to ensure convergent and high levels of donor safety, 
the Commission may adopt implementing acts describing particular procedures to be 
followed and applied to meet such standard, or element thereof.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2).  

On duly justified imperative grounds of urgency relating to a risk to donor health, the 
Commission  shall  adopt  immediately  applicable  implementing  acts  in  accordance 
with the procedure referred to in Article 79(3). 

In  order  to  apply  the  standards  concerning  donor  protection  or  elements  thereof, 
referred to in Articles 53, 54 and 55, SoHO entities shall follow the procedures laid 
down in any implementing act adopted in accordance with paragraphs 1 and 2 of this 
Article. 

For  those  standards  concerning  donor  protection  or  elements  thereof  for  which  no 
implementing  act  has  been  adopted,  in  order  to  apply  such  standards  or  elements 
thereof, SoHO entities shall follow:  

(a) 

the  most  recent  technical  guidelines,  as  indicated  on  the  EU  SoHO  Platform 
referred to in Chapter XI, as follows: 

(i) 

published  by  the  ECDC  concerning  the  prevention  of  communicable 
disease transmission through SoHO donation; 

(ii)  published  by  the  EDQM  concerning  donor  protection  other  than  from 

transmission of communicable disease through donation; 

(b)  other guidelines accepted by competent authorities, as achieving an equivalent 

level of donor safety as set by the technical guidelines referred to in point (a); 

(c)  where the guidelines referred to in points (a) or (b) do not address a particular 
technical  method,  other  technical  methods  in  line  with  relevant  international 

1. 

2. 

3. 

4. 

EN 

72 

  EN 

5. 

6. 

7. 

guidelines  and  scientific  evidence  in  peer-reviewed  scientific  publications, 
where available.  

In those cases referred to in paragraph 4, point (a), for the purpose of Article 30 in 
conjunction  with  Article  29,  SoHO  entities  shall  be  able  to  demonstrate  to  their 
competent  authorities,  for  each  of  the  standards  or  elements  thereof,  which  and  to 
what extent they follow the guidelines referred to in paragraph 4, point (a). 

In those cases referred to in paragraph 4, point (b), for the purpose of Article 30 in 
conjunction  with  Article  29,  SoHO  entities  shall  demonstrate  to  their  competent 
authorities, for each of the standards or elements thereof, the equivalence of the other 
guidelines applied in terms of the level of safety, quality and efficacy to the level set 
by the technical guidelines referred to in paragraph 4, point (a).  

In those cases referred to in paragraph 4, point (c), for the purpose of Article 30 in 
conjunction  with  Article  29,  SoHO  entities  shall  perform  a  risk  assessment  to 
demonstrate that the technical methods applied achieve a high level of donor safety, 
and record the practice followed to establish the technical methods. They shall make 
the assessment and record available for review by their competent authorities during 
inspection or on specific request of the competent authorities.  

CHAPTER VII 

SOHO RECIPIENT AND OFFSPRING PROTECTION 

Article 57 

Objectives regarding SoHO recipient and offspring protection 

SoHO  entities  shall  protect  the  health  of  SoHO  recipients  and  offspring  from  medically 
assisted reproduction from risks posed by SoHO preparations. They shall do so by identifying, 
minimising or eliminating those risks.  

1. 

2. 

Article 58 

Standards concerning SoHO recipient and offspring protection 

SoHO  entities  shall  establish  procedures  with  measures,  and,  where  necessary, 
combinations  of  measures,  that  ensure  high  levels  of  safety  and  quality  and 
demonstrate  benefits  for  SoHO  recipients  and  offspring  from  medically  assisted 
reproduction that outweigh any risks. They shall, in particular, achieve a high level 
of  assurance  that  pathogens,  toxins  or  genetic  conditions  are  not  transmitted  to 
recipients or offspring from medically assisted reproduction.  

In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of 
communicable disease transmission from  SoHO donors to recipients by combining, 
at least, the following measures:  

(a) 

reviewing  and  evaluating  the  donors’  current  and  past  health,  travel  and 
relevant  behavioural  histories  to  allow  the  application  of  temporary  or 
permanent deferrals when risks cannot be fully eliminated by donor testing;  

(b) 

testing  of  donors  for  communicable  diseases  using  certified  and  validated 
testing methods; 

EN 

73 

  EN 

(c)  when  feasible,  using  processing  technologies  that  reduce  or  eliminate  any 

potential communicable pathogens. 

3. 

In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of 
non-communicable  disease  transmission,  including  genetic  conditions  and  cancer, 
from donors to the recipients or to offspring from medically assisted reproduction by 
combining, at least, the following measures:  

(a) 

reviewing the donors’ current and past health to allow temporary or permanent 
deferral of donors that carry a risk of transmitting cancerous cells or other non-
communicable  diseases  that  might  be  passed  to  a  recipient  by  SoHO 
application; 

(b)  where  the  transmission  of  genetic  conditions  is  an  identified  risk,  and  in 
particular  in  the  case  of  medically  assisted  reproduction  with  third  party 
donation: 

(i) 

(ii) 

testing donors for those conditions, as indicated by prevalence or severity 
as presenting the highest risk; or 

testing  prospective  recipients  to  identify  any  relevant  genetic  risk, 
combined  with  testing  donors  for  such  identified  genetic  conditions  to 
ensure  matching  that  will  prevent  the  concerned  condition  in  the 
offspring. 

In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of 
communicable  or  non-communicable  disease  transmission  to  the  recipients  through 
cross-contamination  of  donations  during  collection,  processing,  storage  and 
distribution  by  measures  that  ensure  that  physical  contact  between  SoHOs  from 
different donors is avoided or, in cases where combining donations is necessary for 
efficacy of the SoHO preparation, is minimised.  

In  the  procedures  referred  to  in  paragraph  1,  SoHO  entities  shall  mitigate  risks 
arising  from  microbial  contamination  of  SoHOs  from  the  environment,  the 
personnel,  the  equipment,  materials  or  solutions  coming  into  contact  with  SoHOs 
during  collection,  processing,  storage  or  distribution.  SoHO  entities  shall  mitigate 
such risks by, at least, the following measures: 

(a) 

(b) 

specifying and verifying the cleanliness of collection areas; 

specifying,  based  on  a  structured  and  documented  risk  assessment  for  each 
SoHO  preparation,  validating  and  maintaining  a  defined  air  quality  in 
processing areas; 

(c) 

specifying, procuring and decontaminating equipment, materials and solutions 
such that their sterility is ensured. 

In  the  procedures  referred  to  in  paragraph  1,  SoHO  entities  shall  mitigate  the  risks 
that  any  reagents  and  solutions  added  to  SoHOs  or  coming  in  contact  with  SoHOs 
during  collection,  processing,  storage  and  distribution  might  be  transmitted  to 
recipients and have a toxic, or other, detrimental effect on their health by combining, 
at least, the following measures: 

(a) 

specifying such reagents and solutions prior to their purchase; 

(b)  verifying any required certifications of such reagents and solutions; 

4. 

5. 

6. 

EN 

74 

  EN 

7. 

8. 

9. 

(c) 

demonstrating  the  removal  of  such  reagents  and  solutions,  when  necessary, 
prior to distribution. 

In  the  procedures  referred  to  in  paragraph  1,  SoHO  entities  shall  mitigate  the  risks 
that inherent properties of SoHOs, necessary for clinical efficacy, have been changed 
by  any  SoHO  activity  performed,  in  a  manner  that  renders  SoHO  preparations 
ineffective  or  less  effective  when  applied  to  recipients  by  combining,  at  least,  the 
following measures: 

(a) 

conducting  comprehensive  process  validation  and  equipment  qualification  as 
referred to in Article 41(2), point (a)(vii); 

(b)  gathering evidence of efficacy as referred to in Article 41(4), when needed. 

In  the  procedures  referred  to  in  paragraph  1,  SoHO  entities  shall  mitigate  the  risks 
that  SoHOs  cause  an  immune  reaction  in  recipients  by  combining,  at  least,  the 
following measures:  

(a) 

accurately  typing  and  matching  of  patients  to  donors,  when  such  matching  is 
necessary; 

(b) 

correctly distributing SoHOs to the correct recipients pursuant to Article 45. 

In the procedures referred to in paragraph 1, SoHO entities shall mitigate  any other 
risk  to  the  health  of  SoHO  recipients  or  of  offspring  from  medically  assisted 
reproduction  arising  from  the  application  of  SoHOs  or  SoHO  preparations  and  not 
addressed  in  paragraphs  2  to  8  by  applying  procedures  that  they  have  validated  as 
safely  and  effectively  mitigating  the  risk  concerned  or  that  are  demonstrated  as 
mitigating the risk by published scientific evidence.  

10. 

SoHO entities shall not: 

(a) 

apply  SoHO  preparations  to  recipients  without  proven  benefit,  except  in  the 
context  of  a  clinical  investigation  approved  in  the  context  of  a  conditional 
authorisation of the SoHO preparation by their competent authority pursuant to 
Article 41(4); 

(b) 

apply SoHO preparations to recipients unnecessarily; 

(c) 

advertise or promote particular SoHO preparations to potential recipients or to 
healthcare professionals  using information  that is  misleading, in  particular, as 
to the potential use and benefits to recipients of the SoHO concerned. 

For  the  measures  referred  to  in  paragraphs  2  and  3,  SoHO  entities  shall  verify  the 
eligibility of a donor by means of an interview with him/her, his/her legal guardian 
or, in case of a donation after death, a relevant individual that is informed regarding 
the  donor’s  health  and  lifestyle  history.  The  interview  may  be  combined  with  any 
interview conducted as part of the evaluation referred to in Article 53(1), point (f).  

For donors that donate repeatedly, the interviews referred to in the first subparagraph 
may  be  limited  to  aspects  that  might  have  changed  and  may  be  replaced  with 
questionnaires.  

In  cases  where  SoHO  entities  or  operators  regulated  by  other  Union  legislation 
intend to subsequently subject the SoHO to a sterilisation process or another process 
that reduces the level of the risks described in paragraphs 2 to 5 of this Article, the 
measures  required  pursuant  to  paragraphs  2  and  3  of  this  Article  concerning  donor 

11. 

12. 

EN 

75 

  EN 

eligibility  verification  may  be  adjusted  in  line  with  the  provisions,  guidelines  or 
methods referred to in Article 59. 

13. 

SoHO entities shall document the results of donor eligibility verification referred to 
in paragraphs 2 and 3, and shall communicate and clearly explain the results of donor 
eligibility  verification  to  donors  or,  where  relevant,  their  relatives  or  any  persons 
granting authorisation on their behalf, in accordance with national legislation.  

In  case  of  donations  after  death,  SoHO  entities  shall  communicate  and  explain  the 
results to the relevant persons in accordance with national legislation.  

14. 

SoHO  entities  applying  SoHOs  to  recipients  shall  obtain  their  consent  for  the 
application of SoHOs.  

SoHO entities shall inform the recipients of, at least, the following: 

(a) 

(b) 

the safeguards intended to protect their data and the data of the offspring in the 
case of medically assisted reproduction; 

the need to  report back  any unintended reactions following the  application of 
SoHOs or any genetic conditions in offspring in the case of medically assisted 
reproduction with third party donation, in line with Article 47(2). 

The Commission is empowered to adopt delegated acts in accordance with Article 77 
in order to be able to supplement this Regulation in cases where additional standards 
are deemed necessary to ensure the protection of SoHO recipients or offspring from 
risks posed by the application of SoHO preparations.  

Where, in the case of risk to SoHO recipients and offspring from medically assisted 
reproduction  arising  from  inadequate  levels  of  safety  and  quality  of  SoHOs, 
imperative  grounds of urgency so  require, the procedure provided for in  Article  78 
shall apply to delegated acts adopted pursuant to this Article. 

Article 59 

Implementation of the standards concerning recipient and offspring protection 

When  the  Commission,  deems  it  necessary  to  provide  binding  rules  on  the 
implementation of a particular standard or element of a standard referred to in Article 
58,  in  order  to  ensure  convergent  and  high  levels  of  the  protection  of  SoHO 
recipients and offspring from medically assisted reproduction, the Commission may 
adopt implementing acts describing particular procedures to be applied and followed 
to meet such standard or element thereof.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2).  

On  duly  justified  imperative  grounds  of  urgency  relating  to  a  risk  to  recipient  or 
offspring  health,  the  Commission  shall  adopt  immediately  applicable  implementing 
acts in accordance with the procedure referred to in Article 79(3). 

In  order  to  apply  the  standards  or  elements  thereof,  concerning  recipient  and 
offspring  protection  as  referred  to  in  Article  58,  SoHO  entities  shall  follow  the 
procedures  laid  down  in  any  implementing  act  adopted  in  accordance  with 
paragraphs 1 and 2 of this Article. 

15. 

16. 

1. 

2. 

3. 

EN 

76 

  EN 

4. 

For  those  standards  or  elements  of  standards  concerning  recipient  and  offspring 
protection  for which no  implementing act  has been adopted, in  order to  apply such 
standards or elements thereof, SoHO entities shall follow:  

(a) 

the  most  recent  technical  guidelines,  as  indicated  on  the  EU  SoHO  Platform 
referred to in Chapter XI, as follows: 

(i) 

published  by  the  ECDC  concerning  the  prevention  of  communicable 
disease transmission through human application of SoHOs; 

(ii)  published  by  the  EDQM  concerning  recipient  and  offspring  protection 
other  than  from  transmission  of  communicable  disease  through  human 
application of SoHOs. 

(b)  other guidelines accepted by competent authorities as achieving an equivalent 
level of safety and quality of SoHOs as set by the technical guidelines referred 
to in point (a);  

(c)  where the guidelines referred to in points (a) or (b) do not address a particular 
technical  method,  other  technical  methods  in  line  with  relevant  international 
standards  and  scientific  evidence  in  peer-reviewed  scientific  publications, 
where available.  

In those cases referred to in paragraph 4, point (a), for the purpose of Article 30 in 
conjunction  with  Article  29,  SoHO  entities  shall  be  able  to  demonstrate  to  their 
competent  authorities,  for  each  of  the  standards  or  elements  thereof,  which  and  to 
what extent they follow the guidelines referred to in paragraph 4, point (a). 

In those cases referred to in paragraph 4, point (b), for the purpose of Article 30 in 
conjunction  with  Article  29,  SoHO  entities  shall  demonstrate  to  their  competent 
authorities, for each of the standards or elements thereof, the equivalence of the other 
guidelines applied in terms of the level safety, quality and efficacy to the level set by 
the technical guidelines referred to in paragraph 4, point (a). 

In those cases referred to in paragraph 4, point (c), for the purpose of Article 30 in 
conjunction  with  Article  29,  SoHO  entities  shall  perform  a  risk  assessment  to 
demonstrate that the technical methods applied achieve a high level of protection of 
recipients and offspring from medically assisted reproduction and record the practice 
followed  to  establish  the  technical  methods.  They  shall  make  the  assessment  and 
record  available  for  review  by  their  competent  authorities  during  inspection  or  on 
specific request of competent authorities.  

5. 

6. 

7. 

Article 60 

SoHO release  

A  SoHO  entity  that  releases  SoHOs  for  human  application  or  for  manufacture  of  products 
regulated by other Union legislation, or as the starting and raw material thereof, shall have a 
procedure in place, under the control of the responsible person for SoHO release as referred to 
in Article 38, to ensure that the standards or elements of a standard referred to in Article 58 
and  their  implementation,  as  referred  to  in  Article  59,  have  been  verified  and  documented 
prior to release and that all conditions included in any applicable authorisations in accordance 
with this Regulation have been complied with.  

EN 

77 

  EN 

Article 61 

Exceptional release 

The  physician  referred  to  in  Article  51  may  authorise  the  responsible  person  for  release  of 
SoHOs  pursuant  to  Article  38,  to  release  a  certain  SoHO  preparation  for  application  to  a 
certain  recipient  in  cases  where  that  SoHO  preparation  does  not  meet  all  of  the  relevant 
standards  and  guidelines  referred  to  in  Article  59,  when  the  significant  potential  benefit  for 
the recipient outweighs the risks and no alternative is available. The physician shall authorise 
such  an  exceptional  release  only  when  the  physician  treating  the  intended  recipient  is  in 
agreement.  The physician referred to  in  Article  51 shall document the decision process  in  a 
risk-benefit assessment. In such circumstances, the intended recipient shall be informed of the 
exceptional release and shall give consent in accordance with national legislation prior to the 
SoHO application.  

CHAPTER VIII 

SUPPLY CONTINUITY 

Article 62 

Establishment of national SoHO emergency plans 

1. 

2. 

Member  States,  in  collaboration  with  National  SoHO  Authorities,  shall  draw  up 
national  SoHO  emergency  plans  setting  out  measures  to  be  applied  without  undue 
delay when the supply situation for critical SoHOs presents or is likely to present a 
serious risk to human health.   

Member  States  shall  make  all  reasonable  efforts  to  promote  public  participation  in 
SoHO donation activities, in particular for critical SoHOs, with a view to ensuring a 
resilient supply and responsive increases in donation rates when risks of shortage are 
detected.  In  so  doing,  they  shall  encourage  the  collection  of  SoHO  with  a  strong 
public and non-profit sector involvement. 

3. 

Member States shall specify the following in the plans referred to in paragraph 1: 

(a) 

potential risks to the supply of critical SoHOs; 

(b) 

the critical SoHO entities to be involved; 

(c) 

(d) 

(e) 

(f) 

the powers and responsibilities of competent authorities;  

channels and procedures for sharing information between competent authorities 
including  competent  authorities  of  other  Member  States  and  other  parties 
concerned, as appropriate;  

a  procedure  for  the  development  of  preparedness  plans  for  specific  identified 
risks, in particular those concerning communicable disease outbreaks; 

a  procedure  for  the  assessment  and  authorisation,  when  justified,  of  requests 
from SoHO entities for derogations to the standards defined in Chapters VI and 
VII. 

4. 

Member  States  shall  ensure  that  any  derogation  granted  in  accordance  with 
paragraph 3, point (f), is time-limited and is justified insofar as it implies risks that 
are lower than the risk of shortage of the specific SoHO. 

EN 

78 

  EN 

5. 

6. 

Member  States  shall  take  into  account  the  guidance  of  the  ECDC,  for  emergencies 
related to epidemiological outbreaks, and of the guidelines published by the EDQM, 
for emergency planning in general.  

Member States shall review regularly their national SoHO emergency plans to take 
into  account  changes  in  the  organisation  of  competent  authorities  and  experience 
gained from implementing the plans and simulation exercises. 

7. 

The Commission may adopt implementing acts describing: 

(a) 

rules for the establishment of the national SoHO emergency plans provided for 
in  paragraph  1  to  the  extent  necessary  to  ensure  the  consistent  and  effective 
management of supply interruptions; 

(b) 

the  role  of  stakeholders  and  the  supportive  role  of  the  ECDC  in  the 
establishment and operation of national SoHO emergency plans. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 63 

Supply alerts for critical SoHOs  

1. 

Critical SoHO entities shall without undue delay launch a SoHO supply alert to their 
competent authorities in case of a significant interruption, indicating the underlying 
reason,  the  expected  impact  on  patients  and  any  mitigating  actions  taken  including 
possible alternative supply channels if appropriate. Interruptions shall be considered 
significant  when  the  application  of  critical  SoHO  is  cancelled  or  postponed  due  to 
unavailability and this poses a serious risk to health.  

2. 

Competent authorities that receive an alert referred to in paragraph 1 shall: 

3. 

1. 

(a) 

communicate the SoHO supply alert to their SoHO National Authority;  

(b) 

implement measures to mitigate the risks, if and to the extent possible; and  

(c) 

take into account  the information received  in  accordance with paragraph  1 of 
this  Article  in  the  regular  review  of  their  national  SoHO  emergency  plans 
referred to in Article 62. 

The  SoHO  National  Authorities  may  submit  to  the  EU  SoHO  Platform  the  SoHO 
supply  alert  received  in  cases  where  the  supply  interruption  might  affect  other 
Member  States  or  where  such  interruption  might  be  addressed  through  cooperation 
between Member States pursuant to Article 62(3), point (d). 

Article 64 

Derogation from the obligations to authorise SoHO preparations in emergency 
situations  

By  way  of  derogation  from  Article  21,  competent  authorities  may  permit,  on  a 
request from a SoHO entity duly justified by a health emergency, the distribution or 
preparation for immediate application of SoHO preparations within their territory in 
cases  where  the  procedures  referred  to  in  that  Article  have  not  been  carried  out, 
provided that the use of those SoHO preparations is in the interest of public health. 
Competent  authorities  shall  indicate  the  period  of  time  for  which  the  permission  is 
granted or shall define conditions enabling to clearly establish that period of time. 

EN 

79 

  EN 

2. 

Competent  authorities  shall inform  the SoHO  National  Authority  of the emergency 
authorisation.  The  SoHO  National  Authority  shall  inform  the  Commission  and  the 
other  Member  States  of  any  decision  to  permit  the  distribution  or  preparation  for 
immediate  application  of  SoHO  preparations  in  accordance  with  paragraph  1,  in 
cases where such SoHO preparations might be distributed to other Member States. 

Article 65 

Additional emergency measures by Member States 

Member  States  may  take  additional  measures  to  the  ones  set  out  in  their  national  SoHO 
emergency plans to ensure critical SoHOs supply in case of shortages on their territory, on a 
case-by-case  basis.  Member  States  taking  such  measures  shall  inform  the  other  Member 
States and the Commission without undue delay and give reasons for the measures taken. 

Article 66 

SoHO entity emergency plans 

Each  SoHO  entity  carrying  out  SoHO  activities  that  concern  critical  SoHOs  shall  have  a 
SoHO  entity  emergency  plan  that  supports  the  implementation  of  the  national  SoHO 
emergency plan as referred to in Article 62.  

CHAPTER IX 

SOHO COORDINATION BOARD 

Article 67 

SoHO Coordination Board 

1. 

2. 

3. 

4. 

5. 

The  SoHO  Coordination  Board  is  hereby  established  in  order  to  promote 
coordination  between  Member  States  concerning  the  implementation  of  this 
Regulation  and  the  delegated  and  implementing  acts  adopted  pursuant  to  it,  and  to 
support  them  in  that  coordination,  as  well  as  to  facilitate  cooperation  with 
stakeholders in that regard.  

Each  Member  State  shall  nominate  two  permanent  members  and  two  alternates 
representing the SoHO National Authority and, where the Member State chooses, the 
Ministry  of  Health.  The  SoHO  National  Authority  may  nominate  members  from 
other  competent  authorities,  but  those  members  shall  ensure  that  the  views  and 
suggestions  they  make  are  endorsed  by  the  SoHO  National  Authority.  The  Board 
may also invite experts and observers to attend its meetings, and may cooperate with 
other  external  experts  as  appropriate.  Other  Union  institutions,  bodies,  offices  and 
agencies shall have an observer role. 

Member States shall submit the names and affiliation of their nominated members to 
the Commission, who shall publish the membership list in the EU SoHO Platform. 

The Commission shall chair the meetings of the SCB. The chair shall not take part in 
votes of the SCB. 

The Commission shall provide the secretariat for the SCB in accordance with Article 
72. 

EN 

80 

  EN 

6. 

The  rules  of  procedure  of  the  SCB  put  forward  by  the  Commission  shall,  in 
particular, lay down procedures for the following: 

(a)  meeting scheduling; 

(b) 

reaching consensus and voting; 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

the adoption of opinions or other positions, including in cases of urgency; 

requesting  advice  to  the  SCB,  including  eligibility  criteria  for  requests  for 
advice to the SCB, and for other communications with the SCB;  

consultation  with  advisory  bodies  established  under  other  relevant  Union 
legislation; 

the  delegation  of  routine  tasks  to  working  groups,  including  on  vigilance, 
inspection,  traceability,  and  on  the  applicability  of  the  provisions  of  this 
Regulation; 

the delegation of ad-hoc tasks to SCB members or technical experts to explore 
and report to the SCB on specific technical topics, as required;  

invitation of experts to take part in the work of the SCB working groups and or 
to  contribute  to  ad-hoc  tasks,  on  the  basis  of  their  personal  experience  and 
expertise  or  on  behalf  of  recognised  Union  level  or  global  professional 
associations;  

invitation  of  individuals,  organisations,  or  public  entities  in  the  capacity  of 
observers;  

the rules for declarations regarding conflict of interests of invited experts;  

the  composition  and  rules  of  procedure  for  the  working  groups  and  the 
delegation of ad-hoc tasks. 

7. 

The  Commission  shall,  by  means  of  implementing  acts,  adopt  the  necessary 
measures for the establishment, management and functioning of the SCB.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 68 

Tasks of the SoHO Coordination Board 

1. 

The SCB shall assist the Member States’ competent authorities regarding any issue 
related  to  the  coordination  of  implementation  of  this  Regulation  and  the 
implementing and delegated acts adopted pursuant to it, by: 

(a) 

preparing opinions  at  the request  of  competent  authorities in  accordance  with 
Article 14(2) first sub-paragraph, on the regulatory status under this Regulation 
of  a  substance,  product  or  activity  and  transmitting  its  opinions  to  the 
compendium; 

(b)  when  preparing  the  opinions  referred  to  in  point  (a)  of  this  paragraph, 
initiating,  at  Union  level,  a  consultation  with  equivalent  advisory  bodies 
established in other relevant Union legislation in accordance with Article 14(2) 
second  sub-paragraph,  and  including  in  the  compendium  the  opinions 
concerning  the  Union  legislation  to  be  applied  in  cases  where  there  is 
agreement with the equivalent advisory bodies; 

EN 

81 

  EN 

(c) 

(d) 

(e) 

exchanging  and  documenting  best  practices  on  the  implementation  of  the 
SoHO  supervisory  activities,  and  publishing  agreed  and  documented  best 
practices on the EU SoHO Platform; 

recording information notified in accordance with Article 14(3), and including 
such information in the compendium;  

liaising for the exchange of experience and good practices, as relevant, with the 
EDQM  and  the  ECDC  regarding  technical  standards,  and  with  the  EMA  on 
authorisations and supervisory activities concerning the implementation of the 
PMF certification pursuant to Directive 2003/63/EC, to support the harmonised 
implementation of standards and technical guidelines;  

(f) 

collaborating for the effective organisation of joint inspections and joint SoHO 
preparation authorisations involving more than one Member State; 

(g)  providing assistance in other matters related to the coordination as referred to 

above.  

2. 

The Commission may adopt implementing acts describing criteria and procedures for 
the  consultation  of  advisory  groups  established  under  other  relevant  Union 
legislation.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2).  

CHAPTER X 

UNION ACTIVITIES 

Article 69 

Union training and exchange of competent authorities’ personnel 

1. 

The  Commission  shall  organise  Union 
Member States concerned. 

training 

in  cooperation  with 

the 

In the Union training organised, the Commission  shall cover  at  least,  the following 
topics, as appropriate: 

(a) 

the implementation of this Regulation; 

(b)  procedures  relevant  for  the  SoHO  supervisory  activities  of  the  competent 

authorities; 

(c) 

the functionality and use of the EU SoHO Platform; 

(d)  other knowledge and skills relevant to facilitate SoHO supervisory activities. 

2. 

The Commission may provide Union training to personnel of competent  authorities 
of EEA Member States and of countries that are applicants or candidates for Union 
membership and to personnel of bodies to whom specific responsibilities for SoHO 
activities  have  been  delegated.  It  may  organise  aspects  of  the  training  in 
collaboration with international organisations and regulators working in the field of 
SoHOs. 

EN 

82 

  EN 

3. 

4. 

5. 

6. 

Competent  authorities  shall  ensure  that  the  knowledge  acquired  through  the  Union 
training  activities  referred  to  in  paragraph 1  of  this  Article  is  disseminated  as 
necessary  and  appropriately  used  in  the  personnel  training  activities  referred  to  in 
Article 16. 

The  Commission  may  support,  in  cooperation  with  the  Member  States,  the 
organisation  of  programmes  for  the  exchange  of  competent  authorities’  personnel 
between two or more Member States and for the temporary secondment of personnel 
from one Member State to the other as part of personnel training. 

The Commission shall maintain a list of the competent authority personnel that have 
successfully completed the Union training referred to in paragraph 1, with a view to 
facilitating joint activities, in particular those referred to in Articles  23, 31, and 71. 
The Commission shall make this list available to the Member States.  

The Commission is empowered to adopt delegated acts in accordance with Article 77 
in  order  to  be  able  to  supplement  this  Regulation  by  laying  down  rules  on  the 
organisation  of  the  training  activities  referred  to  in  paragraph  1  and  of  the 
programmes referred to in paragraph 4. 

Article 70 

Commission controls in Member States 

1. 

The  Commission  shall  perform  controls,  including  audits,  in  the  Member  States  to 
verify the effective application of the requirements relating to:  

(a) 

(b) 

competent authorities and delegated bodies provided for in Chapter II; 

the  SoHO  supervisory  activities  provided  for  in  Chapter  III  as  carried  out  by 
competent authorities and delegated bodies; 

(c) 

the notification and reporting requirements of this Regulation. 

The Commission shall organise the controls referred to in paragraph 1 in cooperation 
with  the  Member  States,  and  shall  carry  them  out  in  a  manner  that  avoids 
unnecessary administrative burden. 

When  performing  the  controls  referred  to  in  paragraph  1,  the  Commission  experts 
shall  consult  the  relevant  best  practices  agreed  and  documented  by  the  SCB  as 
referred to in Article 68(1), point (c), on inspection, vigilance and any other SoHO 
supervisory activities as needed.  

Experts from the Member States may assist the Commission experts in carrying out 
the controls referred to in paragraph 1. The Commission shall select the experts from 
the Member States, whenever possible from the list referred to in Article 69(5), and 
shall give them the same rights of access as the Commission experts. 

2. 

3. 

4. 

5. 

Following each control, the Commission shall: 

(a) 

(b) 

(c) 

prepare  a  draft  report  on  the  findings  and,  where  appropriate,  include 
recommendations on how best to address the shortcomings; 

send a copy of the draft report referred to in point (a) to the concerned Member 
State for its comments; 

take the comments of the Member State referred to in point (b) into account in 
preparing the final report; and 

EN 

83 

  EN 

(d)  make  publicly  available  the  final  report  referred  to  in  point  (c)  and  the 

comments of the Member State referred to in point (b). 

Article 71 

Cooperation with the EDQM 

The Commission shall establish and maintain cooperation with the  EDQM in relation to the 
guidelines published by the EDQM. 

Article 72 

Assistance by the Union 

1. 

To  facilitate  the  fulfilment  of  the  requirements  provided  for  in  this  Regulation,  the 
Commission shall support implementation by: 

(a) 

(b) 

(c) 

providing  secretariat  and  technical,  scientific  and  logistic  support  to  the  SCB 
and its working groups;  

funding  Commission  controls  in  Member  States,  including  the  costs  of 
Member State experts assisting the Commission in such controls; 

providing  funding  from  the  relevant  Union  programme  in  support  of  public 
health to:  

(i) 

(ii) 

support  collaborative  work  between  competent  authorities  and 
organisations  representing  groups  of  SoHO  entities  and  SoHO 
professionals  with 
to  facilitate  effective  and  efficient 
implementation of this Regulation, including for training activities;  

the  aim 

co-finance  a  cooperation  agreement  with  the  EDQM  to  support  the 
development  and  updating  of  technical  guidelines  supporting  the 
coherent implementation of this Regulation. 

With  regard  to  the  support  referred  to  in  paragraph  1,  point  (a),  the  Commission 
shall,  in  particular,  organise  the  meetings  of  the  SCB  and  its  working  groups,  the 
travel  of members of the  SCB, reimbursement  and special allowances for scientific 
experts that participate in those meetings, and ensure the appropriate follow-up.  

Upon request from Member States, technical support may be provided, through the 
Technical  Support  Instrument  established  by  Regulation  (EU)  2021/240  of  the 
European  Parliament  and  of  the  Council19,  for  the  reform  of  national  or  regional 
SoHO  supply  supervision,  provided  those  reforms  aim  to  achieve  compliance  with 
this Regulation.  

In order to perform the activities referred to in paragraph 1 to the mutual benefit of 
the  Commission  and  of  the  beneficiaries,  relating  to  preparation,  management, 
monitoring,  audit,  and  control,  as  well  as  to  support  expenditure,  the  Commission 
shall have recourse to the technical and administrative assistance it might need.  

2. 

3. 

4. 

19 

Regulation  (EU)  2021/240  of  the  European  Parliament  and  of  the  Council  of  10  February  2021 
establishing a Technical Support Instrument (OJ L 57, 18.2.2021, p. 1). 

EN 

84 

  EN 

                                                 
CHAPTER XI 

EU SoHO PLATFORM 

Article 73 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

Establishment, management and maintenance of the EU SoHO Platform  

The  Commission  shall  establish,  manage  and  maintain  the  EU  SoHO  Platform  to 
facilitate effective and efficient exchange of information concerning SoHO activities 
in the Union, as provided for in this Regulation. 

The  Commission  shall  make  a  summary  of  data  of  public  interest  and  make  it 
accessible  to  the  public  on  the  EU  SoHO  Platform  in  aggregated  and  anonymised 
formats. The EU SoHO Platform shall provide a channel for restricted exchange of 
information and data between competent authorities, and between SoHO entities and 
their respective competent authorities. 

The processing of personal data by the Member States and the Commission through 
the EU SoHO Platform and any one of its components shall only be carried out for 
the  purpose  of  performing  SoHOs  related  activities  in  accordance  with  this 
Regulation and in compliance with the applicable data protection legislation. 

The  Commission  shall  adopt  delegated  acts  in  accordance  with  Article  77 
supplementing this Regulation by laying down technical specifications regarding the 
establishment, management and maintenance of the EU SoHO Platform. 

The  Commission  shall  provide  instructions  for  SoHO  entities  and  competent 
authorities on the correct use of the EU SoHO Platform.  

Article 74 

General functionalities of the EU SoHO Platform 

The EU SoHO Platform shall enable SoHO entities, competent authorities, Member 
States  and the Commission  to  process  information, data and documents concerning 
SoHOs,  including  the  submission,  retrieval,  storage,  management,  handling, 
exchange, analysis, publication and deletion of such data and documents as provided 
for in this Regulation.  

The EU SoHO platform shall also provide a secure environment for the exchange of 
information  between  competent  authorities  and  the  Commission,  in  particular  in 
relation  to  SAO  and  rapid  alerts.  It  shall  also  provide  public  access  to  information 
regarding the registration and authorisation status of SoHO entities and shall indicate 
the applicable guidelines to be followed to meet the technical standards laid down in 
Articles 56 and 59. 

The Commission shall adopt implementing acts laying down technical specifications 
for the EU SoHO Platform, including its functions, the roles and responsibilities of 
each of the parties listed in paragraph 1, the retention periods for personal data and 
the  technical  and  organisational  measures  to  ensure  the  safety  and  security  of 
personal data processed. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

EN 

85 

  EN 

CHAPTER XII 

PROCEDURAL PROVISIONS 

Article 75 

Confidentiality 

1. 

2. 

3. 

4. 

5. 

Unless  otherwise  provided  for  in  this  Regulation  or  in  national  legislation  on 
confidentiality,  and  without  prejudice  to  Regulation  (EC)  No  1049/2001  of  the 
European Parliament and of the Council20, each party involved in the application of 
this Regulation shall respect the confidentiality of information and data obtained in 
carrying out their tasks in order to protect the following: 

(a) 

(b) 

personal data in accordance with Article 76; 

the effective implementation of this Regulation, in particular for the purpose of 
authorisations, inspections, investigations or Commission controls. 

Information may be exchanged on a confidential basis between competent authorities 
and  between  competent  authorities  and  the  Commission,  but  shall  not  be  disclosed 
without  the  prior  agreement  of  the  authorities  from  whom  that  information 
originates.  

Paragraphs  1  and  2  shall  not  affect  the  rights  and  obligations  of  the  Commission, 
Member States and competent authorities with regard to the exchange of information 
and the dissemination of alerts, nor the obligations of persons to provide information 
under national criminal law. 

The  Commission  and  Member  States  may  exchange  confidential  information  with 
regulatory  authorities  of  third  countries  as  necessary  and  proportionate  for  the 
protection of human health. 

Competent  authorities  may  publish  or  make  otherwise  available  to  the  public  the 
outcome of SoHO supervisory activities regarding individual SoHO entities provided 
that the following conditions are met: 

(a) 

(b) 

(c) 

the  SoHO  entity  concerned  is  given  the  opportunity  to  comment  on  the 
information that the competent authority intends to publish or make otherwise 
available  to  the  public,  prior  to  its  publication  or  release,  taking  into  account 
the urgency of the situation;  

the  information  which  is  published  or  made  otherwise  available  to  the  public 
takes into account the comments expressed by the SoHO entity concerned or is 
published or released together with such comments; 

the  information  concerned  is  made  available  in  the  interest  of  public  health 
protection  and  is  proportionate  to  the  severity,  extent  and  nature  of  the 
associated risk. 

20 

Regulation  (EC)  No  1049/2001  of  the  European  Parliament  and  of  the  Council  of  30  May  2001 
regarding  public  access  to  European  Parliament,  Council  and  Commission  documents  (OJ  L  145, 
31.5.2001, p. 43). 

EN 

86 

  EN 

                                                 
6. 

Regarding information or data that is, by its nature, covered by professional secrecy 
and  that  is  obtained  by  competent  authorities  in  carrying  out  SoHO  supervisory 
activities, competent authorities may  only  publish or make  that information or data 
available to the public, provided that the following conditions are met: 

(a) 

(b) 

the information or data made available to the public is in the interest of public 
health protection and is necessary and proportionate to the severity, extent and 
nature of the associated risk;  

the  information  or  data  made  available  to  the  public  does  not  unnecessarily 
undermine the protection of commercial interests of a SoHO entity or any other 
natural or legal person; 

(c) 

the  information  or  data  made  available  to  the  public  does  not  undermine  the 
protection of court proceedings and legal advice. 

7. 

The provisions of this Article shall also apply to delegated bodies. 

1. 

2. 

3. 

4. 

Article 76 

Data protection 

Personal  data  required  for  the  application  of  Articles  5(5)  and  6(2),  Article  18(3), 
point (a), Articles 19(2)  and 21(3), Article 27(2), Article 28(2), Articles 35 and 36, 
Article 53(1), points (f) and (g), Article 53(3), Article 58(11), and Articles 63 and 75 
shall be collected for the purpose of identifying the relevant contact persons within 
the relevant SoHO entities, competent authorities or delegated bodies, and shall only 
be processed further for the purpose of ensuring the administration and transparency 
of the supervisory activities and SoHO activities concerned.  

Personal  data,  including  data  concerning  health,  required  for  the  application  of 
Articles  74  and  75  shall  be  processed  in  the  interest  of  public  health  and,  in 
particular, for the following purposes:  

(a) 

to  help  to  identify  and  evaluate  risks  associated  with  a  particular  SoHO 
donation or SoHO donor; 

(b) 

to process relevant information on clinical outcome monitoring.  

Personal  data,  including  data  concerning  health,  required  for  the  application  of 
Articles 35, 36, 41 and 47, Article 53(1), points (f) and (g), Article 53(3), and Article 
58(11), (13) and (14), shall only be processed for the purpose of ensuring safety and 
quality of SoHOs and protecting the concerned SoHO donors, SoHO recipients and 
offspring from medically  assisted reproduction.  Those data shall be directly  related 
to the performance of the supervisory activities and SoHO activities concerned and 
be limited to the extent necessary and proportionate for that purpose.  

All  information  shall  be  processed  by  the  Commission,  Member  States,  competent 
authorities,  including  SoHO  National  Authorities,  delegated  bodies  and  SoHO 
entities, including any third party contracted by a SoHO entity, as applicable, in such 
a way that the personal data of the subjects remain protected in accordance with the 
applicable legislation on personal data protection. The Commission, Member States, 
competent  authorities,  including  SoHO  National  Authorities,  delegated  bodies  and 
SoHO  entities,  including  any  third  party  contracted  by  a  SoHO  entity,  shall,  in 
particular,  minimise  the  risk  that  subjects  can  be  identified  and  shall  limit  the 

EN 

87 

  EN 

5. 

6. 

7. 

8. 

1. 

2. 

3. 

4. 

5. 

6. 

information  processed  to  elements  necessary  and  appropriate  for  carrying  out  their 
tasks and fulfilling their obligations under this Regulation.  

The  Commission,  Member  States,  competent  authorities,  including  SoHO  National 
Authorities, delegated bodies and SoHO entities, including any third party contracted 
by a SoHO entity, shall implement appropriate technical and organisational measures 
to protect information and personal data processed against unauthorised or unlawful 
access,  disclosure,  dissemination,  alteration,  destruction  or  accidental  loss,  in 
particular where the processing involves transmission over a network. 

In  relation  to  their  responsibilities  to  process  personal  data  to  comply  with  the 
obligations  of  this  Regulation,  the  SoHO  entities  and  competent  authorities  of  the 
Member States shall be regarded as controllers as defined in Article 4, point (7), of 
Regulation (EU) 2016/679 and they are bound by the rules of that Regulation. 

In  relation  to  its  responsibility  to  establish  and  manage  the  EU  SoHO  Platform,  as 
referred to  in  Article  73  and the processing of personal  data that might  result from 
that activity, the Commission shall be regarded as controller as defined in Article 3, 
point  (8),  of  Regulation  (EU)  2018/1725  and  it  is  bound  by  the  rules  of  that 
Regulation. 

For  the  purposes  of  this  Article,  the  Commission  is  empowered  to  adopt  delegated 
acts in accordance with Article 77 supplementing this Regulation by laying down the 
retention  periods  for  personal  data  as  appropriate  to  their  purpose  and  specific 
criteria that would allow identification of data relevant for public health protection as 
referred to in paragraph 2. 

Article 77 

Exercise of the delegation  

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article.  

The power to adopt delegated acts referred to in Articles 28(10), 42(3), 53(6), 58(15), 
69(6),  73(4),  and  76(8)  shall  be  conferred  on  the  Commission  for  an  indeterminate 
period of time from  … [OP  please insert the date =  date of  entry into force of  this 
Regulation].  

The delegation of power referred to  in  Articles 28(10), 42(3), 53(6),  58(15), 69(6), 
73(4), and 76(8) may be revoked at any time by the European Parliament or by the 
Council.  A  decision  to  revoke  shall  put  an  end  to  the  delegation  of  the  power 
specified in that decision. It shall take effect the day following the publication of the 
decision  in  the  Official  Journal  of  the  European  Union  or  at  a  later  date  specified 
therein. It shall not affect the validity of any delegated acts already in force.  

Before adopting a delegated act, the Commission shall consult experts designated by 
each  Member  State 
the 
in  accordance  with 
Interinstitutional Agreement of 13 April 2016 on Better Law-Making.  

the  principles 

laid  down 

in 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  

A delegated  act  adopted pursuant  to  the provisions listed in  paragraph 2  shall enter 
into force only if no objection has been expressed either by the European Parliament 
or  by  the  Council  within  a  period  of  two  months  of  notification  of  that  act  to  the 

EN 

88 

  EN 

European  Parliament  and  the  Council  or  if,  before  the  expiry  of  that  period,  the 
European Parliament and the Council have both informed the Commission that they 
will not object. That period shall be extended by two months at the initiative of the 
European Parliament or of the Council.  

Article 78 

Urgency procedure  

1. 

2. 

1. 

2. 

3. 

Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and 
shall apply as long as no objection is expressed in accordance with paragraph 2. The 
notification  of  a  delegated  act  to  the  European  Parliament  and  to  the  Council  shall 
state the reasons for the use of the urgency procedure.  

Either  the  European  Parliament  or  the  Council  may  object  to  a  delegated  act  in 
accordance  with  the  procedure  referred  to  in  Article  77(6).  In  such  a  case,  the 
Commission  shall  repeal  the  act  immediately  following  the  notification  of  the 
decision to object by the European Parliament or by the Council.  

Article 79 

Committee procedure  

The  Commission  shall  be  assisted  by  a  committee.  That  committee  shall  be  a 
committee within the meaning of Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU)  No 
182/2011, in conjunction with Article 5 thereof, shall apply.  

Article 80 

Penalties 

Member  States  shall  lay  down  the  rules  on  penalties  applicable  to  infringements  of  this 
Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are  implemented.  The 
penalties provided for  shall  be effective, proportionate and dissuasive. Member States shall, 
by … [OP please insert the date = 3 years after the date of entry into force of this Regulation], 
notify the Commission of those rules and of those measures and shall notify it, without delay, 
of any subsequent amendment affecting them. 

CHAPTER XIII 

TRANSITIONAL PROVISIONS 

Article 81 

Transitional provisions concerning establishments designated, authorised, accredited or 
licensed under Directives 2002/98/EC and 2004/23/EC 

1. 

Blood establishments designated, authorised, accredited or licensed based on Article 
5(1)  of  Directive  2002/98/EC  and  tissue  establishments  designated,  authorised, 

EN 

89 

  EN 

accredited or licensed on the basis of Article 6(2) of Directive 2004/23/EC before the 
date  of  application  of  this  Regulation  shall  be  deemed  to  be  registered  as  SoHO 
entities  and  deemed  to  be  authorised  as  SoHO  establishments,  in  accordance  with 
this Regulation and shall, as such, be subject to the relevant obligations provided for 
under this Regulation. 

2. 

Tissue  establishments  that  are  designated,  authorised,  accredited  or  licensed  as 
importing tissue establishments on the basis of Article 6(2) of Directive 2004/23/EC 
before the date of application of this Regulation shall be deemed to be authorised as 
importing  SoHO  entities  in  accordance  with  this  Regulation  and  shall,  as  such,  be 
subject to the relevant obligations provided for under this Regulation. 

3. 

For blood establishments referred to in paragraph 1, competent authorities shall: 

(a) 

(b) 

verify whether those establishments meet the definition of SoHO establishment 
in Article 3, point (40); 

submit  the  information  referred  to  in  Article  18(3),  points  (a)  and  (d),  and 
information regarding the registration and authorisation status according to the 
verification referred to in point (a) of this paragraph to the EU SoHO Platform 
as referred to in Chapter XI.  

4. 

For tissue establishments referred to in paragraph 1, the Commission shall: 

(a) 

(b) 

verify whether those establishments meet the definition of SoHO establishment 
in Article 3, point (40); 

the  relevant 

information  from 

the  EU  Tissue  Establishment 
transfer 
Compendium of the EU Coding Platform laid down in Directive 2006/86/EC, 
including  the  information  regarding  the  registration  and  authorisation  status 
according to the verification referred to in point (a) of this paragraph, to the EU 
SoHO Platform as referred to in Chapter XI of this Regulation;  

(c) 

inform  the  competent  authorities  of  the  establishments  that  do  not  meet  the 
definition  of  SoHO  establishment  according  to  the  verification  referred  to  in 
point (a).  

Competent authorities shall inform those establishments not meeting the definition of 
SoHO  establishment,  according  to  the  verification  referred  to  in  paragraph  3,  point 
(a), and paragraph 4, point (a) and based on the information referred to in paragraph 
4,  point  (c),  that  they  are  deemed  to  be  registered  as  SoHO  entities  only  and  that 
they, as such, are subject to the obligations relevant for SoHO entities provided for 
under this Regulation. 

transfer 

For tissue establishments referred to in paragraph 2 of this Article, the Commission 
shall 
the  EU  Tissue  Establishment 
Compendium of the EU Coding Platform laid down in Directive 2006/86/EC to the 
EU SoHO Platform as referred to in Chapter XI of this Regulation.  

information  from 

the  relevant 

Article 82 

Transitional provisions concerning SoHO preparations  

The  preparations  resulting  from  tissue  and  cell  preparation  processes  designated, 
authorised,  accredited  or  licensed  on  the  basis  of  Article  6(2)  of  Directive 
2004/23/EC before the date of application of this Regulation shall be deemed to be 
authorised  as  the  corresponding  SoHO  preparations  in  accordance  with  this 

5. 

6. 

1. 

EN 

90 

  EN 

2. 

3. 

4. 

1. 

2. 

3. 

Regulation  and  shall,  as  such,  be  subject  to  the  relevant  obligations  provided  for 
under this Regulation.  

Blood  components  that  were  verified  by  competent  authorities  as  complying  with 
applicable  quality  and  safety  requirements  for  blood  components  on  the  basis  of 
Article  5(3)  and  Article  23  of  Directive  2002/98/EC  or  with  the  blood  component 
monographs included in the edition of the Guide to the preparation, use and quality 
assurance of blood  components of the EDQM indicated on the  EU SoHO Platform 
on … [OP please insert the date = two years after the date of entry into force of this 
Regulation],  or  that  were  otherwise  designated,  authorised,  accredited  or  licensed 
under national legislation before the date of application of this Regulation, shall be 
deemed to be authorised as the corresponding SoHO preparations in accordance with 
this Regulation and shall, as such, be subject to the relevant obligations provided for 
under this Regulation. 

Competent authorities shall submit the information referred to in paragraphs 1 and 2 
to the EU SoHO Platform, and link those entries to the respective SoHO entities. 

The  Commission  may  adopt  implementing  acts  in  order  to  establish  uniform 
procedures for ensuring that SoHO preparations deemed to be authorised pursuant to 
paragraphs  1  and  2  are  fully  documented  in  line  with  the  requirements  for  SoHO 
preparation authorisation in this Regulation.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 79(2). 

Article 83 

Status of SoHOs released for distribution, distributed or in storage before the 
application of this Regulation 

SoHOs already released for distribution before …  [OP please insert the date = date 
of  application  of  this  Regulation]  shall  not  be  subject  to  the  relevant  obligations 
provided for under this Regulation, provided those SoHOs are distributed at the latest 
by  …  [OP  please  insert  the  date  =  one  year  after  the  date  of  application  of  this 
Regulation] and under the condition that those SoHOs were fully compliant with the 
applicable Union legislation and national law in force at the time when those SoHOs 
were released for distribution.  

SoHOs  which  have  been  distributed  before  …  [OP  please  insert  the  date  =  date  of 
application  of  this  Regulation]  and  kept  under  appropriate  control  conditions  until 
that  date  shall  not  be  subject  to  the  relevant  obligations  provided  for  under  this 
Regulation.  

SoHOs already in storage before … [OP please insert the date = date of application 
of this Regulation],  and for which no alternative  SoHOs are available, in  particular 
because the SoHOs are autologous, intended for within couple use or highly matched 
for  a  specific  recipient,  shall  only  be  subject  to  Article  61.  Those  SoHOs  shall  be 
subject  to  that  Article  from…  [OP  please  insert  date  =  date  of  application  of  this 
Regulation].  

Transitional measures for the adoption of certain delegated and implementing acts  

Article 84 

EN 

91 

  EN 

Without  prejudice  to  the  dates  of  application  referred  to  in  Article  87  and  the  transitional 
provisions provided for in this Chapter, the Commission is empowered to adopt the delegated 
acts referred to in Articles 42(3) and 73(4) and the implementing acts referred to in Articles 
26(4), 43(6), 44(3), 46(3), 67(7) and 74(3)  as  from  … [OP please insert  the date =  one day 
after the date of entry into  force of this Regulation]. Such acts  shall  apply  from the date of 
application in accordance with  Article 87(1), second subparagraph, without prejudice to any 
transitional rules provided for in this Chapter.  

CHAPTER XIV 

FINAL PROVISIONS 

Article 85 

Repeals  

Directives 2002/98/EC and 2004/23/EC are repealed with effect from … [OP please insert the 
date = two years after the date of entry into force of this Regulation]. 

Article 86  

Evaluation 

The  Commission  shall,  by  …  [OP  please  insert  the  date  =  five  years  after  the  date  of 
application of this Regulation] assess the application of this Regulation, produce an evaluation 
report on the progress towards achievement of the objectives  of this Regulation and present 
the  main  findings  to  the  European  Parliament,  the  Council,  the  European  Economic  and 
Social Committee, and the Committee of the Regions.  

The  Commission  shall  use  aggregated  and  anonymised  data  and  information  gathered  from 
supervisory and SoHO activities and information submitted to the EU SoHO Platform for the 
purposes of the evaluation report. 

Member  States  shall  provide  the  Commission  with  additional  information  necessary  and 
proportionate for the preparation of the evaluation report. 

Article 87 

Entry into force and application 

1. 

2. 

This  Regulation  shall  enter  into  force  on  the  twentieth  day  following  that  of  its 
publication in the Official Journal of the European Union.  

Unless  otherwise  provided  for  in  paragraph  2,  it  shall  apply  from  …  [OP  please 
insert the date = two years after the date of entry into force of this Regulation]. 

Article 81(3) to (6) and Article 82(3) shall apply from … [OP please insert the date = 
three years after the date of entry into force of this Regulation].  

EN 

92 

  EN 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

93 

  EN 

LEGISLATIVE FINANCIAL STATEMENT 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE ............................................... 96 

Title of the proposal/initiative .................................................................................... 96 

Policy area(s) concerned ............................................................................................ 96 

The proposal/initiative relates to: ............................................................................... 96 

Objective(s) ................................................................................................................ 96 

1.4.1.  General objective(s) ................................................................................................... 96 

1.4.2.  Specific objective(s) ................................................................................................... 96 

1.4.3.  Expected result(s) and impact .................................................................................... 96 

1.4.4. 

Indicators of performance .......................................................................................... 98 

1.5. 

Grounds for the proposal/initiative ............................................................................ 99 

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative .......................................................... 99 

1.5.2.  Added value of Union involvement (it may result from different factors, e.g. 

coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from Union intervention which is additional to the value that would have been 
otherwise created by Member States alone. ............................................................. 100 

1.5.3.  Lessons learned from similar experiences in the past .............................................. 101 

1.5.4.  Compatibility with the Multiannual Financial Framework and possible synergies 

with other appropriate instruments........................................................................... 101 

1.5.5.  Assessment of the different available financing options, including scope for 

redeployment ............................................................................................................ 102 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.2.1. 

2.2.2. 

Duration and financial impact of the proposal/initiative ......................................... 103 

Management mode(s) planned ................................................................................. 103 

MANAGEMENT MEASURES............................................................................... 104 

Monitoring and reporting rules ................................................................................ 104 

Management and control system(s) ......................................................................... 104 

Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control strategy proposed ...................................... 104 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them........................................................................................................ 104 

2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio of "control 

costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure) ................................................................ 106 

2.3. 

3. 

3.1. 

Measures to prevent fraud and irregularities ............................................................ 106 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE .......... 108 

Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected ..................................................................................................................... 108 

EN 

94 

  EN 

3.2. 

Estimated financial impact of the proposal on appropriations ................................. 109 

3.2.1.  Summary of estimated impact on operational appropriations.................................. 109 

3.2.2.  Estimated output funded with operational appropriations ....................................... 112 

3.2.3.  Summary of estimated impact on administrative appropriations ............................. 114 

3.2.4.  Compatibility with the current multiannual financial framework............................ 116 

3.2.5.  Third-party contributions ......................................................................................... 116 

3.3. 

Estimated impact on revenue ................................................................................... 117 

EN 

95 

  EN 

LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

Regulation  of  the  European  Parliament  and  of  the  Council  on  standards  of  quality 
and  safety  for  substances  of  human  origin  intended  for  human  application  and 
repealing Directives 2002/98/EC and 2004/23/EC  

1.2. 

Policy area(s) concerned  

Heading 2: Cohesion, Resilience and Values 

1.3. 

The proposal/initiative relates to:  

 a new action  
 a new action following a pilot project/preparatory action1  

 the extension of an existing action  

x a merger or redirection of one or more actions towards another/a new action  

1.4. 

Objective(s) 

1.4.1.  General objective(s) 

The overall objective of  this initiative is  to  ensure a high level  of health  protection 
for  EU  citizens  that  donate,  or  are  in  need  of  treatment  with,  substances  of  human 
origin (SoHOs). 

1.4.2. 

Specific objective(s) 

Specific objective No 1  

To  ensure  safety  and  quality  for  patients  treated  with  SoHO  therapies,  for  SoHO 
donors  and  for  offspring  from  medically  assisted  reproduction,  and  enforcement  of 
safety and quality requirements. 

Specific objective No 2 

To optimize access to SoHO therapies, and avoid shortages of SoHOs. 

Specific objective No 3  

To  ensure  the  framework  is  future-proof  and  facilitates  the  development  of 
innovative SoHO therapies that are safe and effective. 

1.4.3.  Expected result(s) and impact 

Protect citizens (specific objective 1)  

Citizens that donate, or are treated with SoHOs, or offspring from medically assisted 
reproduction, will be better protected in the following ways: 

-  common  general  standards  for  safety  and  quality  will  be  defined  for  protecting 
citizens and outdated specific technical provisions will be removed from legislation 

1 

As referred to in Article 58(2)(a) or (b) of the Financial Regulation. 

EN 

96 

  EN 

 
                                                 
and replaced with a responsive implementation of such standards, with reference to 
guidelines  set  primarily  by  expert  bodies  ensuring  that  risks  to  SoHO  donors  and 
SoHO recipients are mitigated promptly; 

- the scope of the Regulation will include all SoHOs applied to human persons with 
specific  exceptions  (organs,  and  autologous  substances  applied  during  the  same 
surgical procedure without processing), ensuring the protection of SoHO donors and 
recipients  of  human  substances  not  currently  regulated  (e.g.  breast  milk,  faecal 
microbiota  transplants  and  autologous  substances  processed  at  the  bedside). 
Improved  reporting  on  adverse  occurrences  will  be  implemented  (including  self-
reporting by SoHO donors and recipients) to improve safety monitoring.  

Optimise access (specific objective 2) 

Strengthen oversight  

Exchange  of  SoHOs  between  Member  States  will  be  facilitated,  resulting  in 
improved  access  for  patients.  This  will  be  achieved  by  increasing  trust  in  Member 
State oversight systems as follows: 

- stronger oversight principles (e.g. independence of inspectors); 

-  a  legal  basis  for  Commission  controls,  including  audits,  of  national  competent 
authorities  and  for  joint  inspections  with  inspectors  from  more  than  one  Member 
State; 

-  implementation  of  a  scheme  for  voluntary  mutual  peer  audits  among  authorities 
with inspector and auditor training and guidance provided by the Commission; 

-  increased  efficiency  of  oversight  through  the  introduction  of  a  graded  approach 
proportionate to the risk level of the establishments/activities carried out.  

Improve resilience, mitigating risk of shortages  

The  sector  will  be  better  equipped  to  manage  crises  in  the  future  through  the 
following changes: 

-  obligations  will  be  introduced  to  ensure  measures  for  crisis  preparedness  at  the 
operator and national levels are in place; 

- obligations  on supply  monitoring will be introduced to support Member States to 
take  measures  in  order  to  address  shortages  and  dependencies  on  other  Member 
States  or  third  countries.  This  will  be  facilitated  by  the  provision  of  an  EU  digital 
platform for data reporting, aggregation, extraction and publication; 

- Member States will be better equipped to intervene to control and adjust supply, as 
necessary,  under  their  national  competence,  and  monitoring  will  allow  evidence-
based support action at EU level.  

Foster innovation (specific objective 3):  

Innovation in the sector will be more robust, with increased patient access to novel 
SoHOs that are safe and effective through the following: 

-  a  risk-based  authorisation  of  SoHOs  processed  or  used  in  new  ways  will  be 
implemented,  with  proportionate  requirements  for  clinical  data  to  demonstrate 
efficacy (benefits) of new SoHO preparations 

EN 

97 

  EN 

- such authorisations will be registered in an EU SoHO Platform and can be referred 
to and accepted by other Member States to facilitate the use of the same process with 
minimal administrative burden 

- a coordination Board will provide advice to Member States on the applicability of 
the  Regulation  for  SoHOs  at  the  borderlines  with  other  regulatory  frameworks 
(including  the  consultation  of  equivalent  advisory  bodies  established  in  these 
frameworks).  

Digital-ready implementation (horizontal across the objectives)   

An EU-wide data system  in  the SoHO sector will  support the use of best  available 
evidence  and  data  for  the  professionals,  health  providers,  innovators,  public 
authorities  and  other  stakeholders  through  federated  interoperable  systems.  The 
development  of  such  a  network  of  resilient,  secure  and  trustworthy  infrastructures 
and  technologies  will  provide  the  framework  for  a  fit-for  purpose,  coherent 
interoperable  and  technology-driven  regulatory  reporting.  Central  investment  in 
common  data  infrastructure  and  services  as  well  as  technical  support  and  capacity 
building  to  local  data  owners  will  maximise  the  use  of  data  to  support  the 
achievement of the objectives of this initiative.   

1.4.4. 

 Indicators of performance 

Protect citizens (objective 1)  

Number of technical guideline updates 

- time between identification of an issue and availability of the procedure or technical 
guidelines to be followed to address it 

-  quality  of  the  standard,  expert  body  guidelines,  measured  by  their  uptake  in  the 
sector 

- serious adverse occurrences reported 

For  the  protection  of  citizens,  there  will  be  continuous  updating  of  technical 
guidelines  to  support  the  achievement  of  high  standards  of  quality  and  safety  for 
SoHOs and concerning the protection of SoHO donors. The appropriate application 
of  guidelines  to  implement  the  standards  will  be  verified  during  inspection.  A 
comprehensive  vigilance  (serious  adverse  occurrences)  reporting  and  monitoring 
system for patients and donors will be put in place. A SoHO Coordination Board will 
support a uniform implementation of the quality and safety rules. This compares to a 
baseline  where 
lag  behind 
epidemiological risk and technology and the up-to-date technical guidelines of expert 
bodies have no legal basis. Timeliness, quality and uptake of new guidelines need to 
be assessed as well. EU vigilance reporting requirements already exist but criteria for 
reporting are unclear, denominators (number of units of blood or blood components 
issued for transfusion or number of tissues and cells distributed) are not reported or 
are reported inconsistently, and there is no obligation to report adverse outcomes in 
donors or offspring from medically assisted reproduction.  

technical  updates 

in  Commission 

legislation 

Optimise access (objective 2) 

Numbers  of  donations,  human  applications,  cross-border  exchanges,  imports 
and exports of critical SoHOs by Member States 

EN 

98 

  EN 

Numbers  of  donations,  human  applications,  cross-border  exchanges,  imports  and 
exports  of  critical  SoHOs  will  be  monitored  at  the  EU  level.  The  administrative 
burden associated with reporting this data will be minimised by the provision of an 
EU level digital platform that can also be used by Member States for monitoring at 
the national level, without the need to recreate a similar monitoring tool. 

Monitoring  should  demonstrate  increased  availability  and  use  of  SoHO  therapies 
resulting from increased inter-Member State confidence in oversight sytems and will 
highlight shortages and dependencies on other Member States or third countries thus 
enabling  Member  States  to  take  appropriate  actions.  The  Commission  will  audit  
competent  authorities’  supervisory  functions.  In  particular,  this  will  help  to  assess 
effective  and  consistent  implementation  as  well  as  exisence  of  robust  emergency 
plans to prepare for effective management of supplies in future crises. 

This  compares  to  a  baseline  where  activity  data  reporting  is  fragmented  or  non-
existent, hampering the ability of the Member States to launch initiatives to increase 
donations  or  reduce  wastage  as  appropriate.  Member  States  conduct  oversight 
functions in variable ways and often place barriers to exchanges with other Member 
States due to a lack of confidence. There is significant dependence on third countries 
for  some  SoHOs  but  the  extent  of  this  is  not  monitored  and  is  not,  therefore, 
transparent. 

Foster innovation (objective 3)  

The number of SoHO preparations authorised at EU level 

Number of SoHO preparations authorisations shared and accepted between Member 
States 

The  number  of  SoHO  preparations  authorised,  and  the  number  of  authorisations 
shared and accepted between Member States, will be monitored to assess the rate of 
innovation  and  the  rate  of  sharing  of  innovation  across  the  EU.  The  number  of 
patients treated with these innovative SoHO preparations will also be monitored, as 
well as the role of the public sector in this innovative cycle.  

This compares to a baseline where developers report challenges relating to knowing 
which  legislative  framework  applies  to  their  substance/product  and  a  lack  of  data 
available on the approval of new SoHO preparations. 

Digital-ready implementation (horizontal across the objectives)  

The  development  of  the  EU  SoHO  Platform  will  be  monitored  (connections  of 
databases  established,  including  more  composite  indicators  on  the  resilience  of  the 
networks;  registered  entities  etc.).  Key  indicator  will  be  the  number  of  connected 
authorities, entities and databases. 

This compares with a baseline where there is limited vigilance data sharing at the EU 
level  and  no  mechanism  for  the  sharing  of  activity  data  or  authorisation  of  new 
SoHO preparations. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative 

The  provisions  in  the  current  Directives  on  safety  and  quality  of  blood  (Directive 
2002/98/EC) and of tissues and cells (Directive 2004/23/EC) have been instrumental 
in  managing  and  avoiding  health  concerns  related  to  the  use  of  these  therapies. 

EN 

99 

  EN 

However the 2019 evaluation has also demonstrated that the provisions are no longer 
able  to  keep  track  of  the  many  biotechnological  developments  and  communicable 
diseases outbreaks. 

The  evaluation  has  also  identified  some  legal  gaps  of  therapies  that  are  currently 
unregulated and a concern that the directives do not facilitate innovation. 

the  evaluation 

Furthermore 
in  national 
transposition and implementation  of the requirements, leading  to  barriers for cross-
border exchange and sub-optimal access for patients to BTC treatments. 

identified  significant  divergences 

The  new  legal  act  will  make  the  framework  future-proof  and  fit  to  accommodate 
innovations in the SoHO sector and ensure their safety and quality. The proposal of a 
regulation will also help increase uniform implementation across the EU.  

The adoption is expected for 2023, with preparatory activities for the implementation 
starting during 2024. 

1.5.2.  Added  value  of  Union  involvement  (it  may  result  from  different  factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from  Union  intervention  which  is  additional  to  the  value  that  would  have  been 
otherwise created by Member States alone? 

Reasons for action at European level (ex-ante) 

Ever-evolving disease threats, such as Zika, Human Immunodeficiency Virus (HIV), 
Viral  Hepatitis  B,  C  and  D, which  can  be  transmitted  through  SoHOs, or  more 
recently COVID-19, constitute cross-border threats to public health. The exchange of 
SoHOs  between  Member  States  and  with  third  countries  is  necessary  for  ensuring 
patient  access  and  sufficiency  of  supply.  The  extent  of  exchange  is  considerable, 
although  it  varies  highly  from  substance  to  substance.  The  BTC  legislation 
evaluation concluded that, in general, the Directives improved the quality and safety 
of  BTC in  a manner  that would  not  have happened, or would  have happened more 
slowly, without EU legislation; indeed intensive activity to raise safety and quality to 
a common level  were seen across the EU following the adoption of the legislation. 
The outdating of technical requirements over the years has led to a diversification of 
standards with more stringent national requirements compensating for shortcomings 
of  the  legislation.  Although  this  is  permitted  by  the  Treaty,  it  limits  exchanges 
between Member States. EU action is required to reinforce the framework, increase 
trust  and  facilitate  that  patients  in  all  Member  States  can  benefit  equally  from  safe 
and effective SoHOs. Increasing cross-border exchanges of SoHOs  necessitate ever 
closer cooperation between a number of health professional groups and authorities to 
ensure that SoHOs remain traceable from the donor to the recipient and vice versa. 
The evaluation  confirmed the benefits  of setting  standards  of quality and  safety  for 
BTC  at  EU  level  although  pointed  to  a  need  for  a  more  responsive  approach  to 
changing risks.  

Also,  some  sector-specific  expertise  might  not  be  easily  available  in  all  Member 
States,  and  it  brings  simplification  and  efficiency  to  provide  for  a  framework 
allowing  and  supporting  joint  practices,  such  as  joint  inspections  of  establishments 
(those  providing  SoHOs  to  many  Member  States,  or  those  having  a  specific 
technology/process in place), joint assessment of new processes etc. This will result 
overall in a stronger implementation of the legislation in all Member States, hence an 
equal level of health protection of EU citizens. 

EN 

100 

  EN 

Expected generated Union added value (ex-post) 

Overall,  for  the  five  problems  highlighted,  more  collaboration  and  support  among 
National  Competent  Authorities  (NCAs)  will  help  to  address  the  issues,  bring 
simplification and improve the effectiveness of the legislation and the efficiency of 
its implementation. Sharing information across Member States at authority level, e.g. 
on the supply of  critical  SoHOs, authorisations  of  SoHO  preparations, or results of 
the inspection of an establishment, will help other Member States. NCAs may re-use 
the  SoHO  preparation  authorisation  already  given  (by  assessing  if  the  procedure  is 
equivalent,  without  re-assessing  the  complete  risk  assessment  or  clinical  evidence 
provided).  Commission  audits  of  competent  authorities  and  increased  collaboration 
among  Member  States  (e.g.  joint  inspections  and  joint  preparation  process 
assessments)  will  lead  to  increased  sharing  of  expertise  and  building  more  trust 
among the them. This will ultimately facilitate exchange of SoHOs, hence access for 
patients.  All  this  will  be  more  efficient  at  EU  level,  compared  to  equivalent 
individual actions being taken by all Member States. 

1.5.3.  Lessons learned from similar experiences in the past 

The evaluation of the BTC legislation demonstrated that adopting legislation in this 
sector  improved  the  safety  and  quality  of  BTC  across  the  EU.  The  legislation, 
adopted  in  2002  for  blood  and  2004  for  tissues  and  cells  was  complemented  by  a 
series of implementing acts during mostly in 2005 and 2006. The legislation overall 
included  many  technical  rules  and  specifications  that  became  outdated  due  to 
changing risks and technologies. Efforts were made to update certain provisions but 
this  proved  slow  compared  to  the  pace  of  change.  The  lesson  learned  was  that  the 
legislation  should  provide  robust  principles  and  oversight  mechanisms,  while  the 
technical rules should be kept up to date in a more dynamic and responsive manner. 

The COVID-19 pandemic highlighted the risks for supply interruptions, the need for 
adequate  SoHO  donor  and  SoHO  recipient  protection,  and  the  need  for  rapid  and 
adequate  authorisations  of  health  innovations  in  the  SoHO  sector.  By  providing  a 
framework for cross-border cooperation, based on a common set of rules, EU-level 
measures are best placed to address such issues effectively. The importance of digital 
tools to support the sharing of big data emerged as a clear lesson. The benefits that 
can  be  achieved  from  pooling  such  data  from  across  27  Member  States  are 
significant  but  need  investment  in  digital  support  to  minimise  the  administrative 
burden at the Member State and professional levels. 

1.5.4.  Compatibility  with  the  Multiannual  Financial  Framework  and  possible  synergies 

with other appropriate instruments 

The  costs  are  foreseen  to  be  funded  from  the  EU4Health  programme  (including 
technical  assistance  to  the  sector  and  IT  costs)  as  per  Article 4,  point  (h)  of  the 
EU4Health  Regulation2.  Part  of  the  actions  (in  particular  on  supply  monitoring  to 
prevent shortages in crisis; emergency update) should be aligned with the activities 
funded under the remit of DG HERA, the new Health Emergency preparedness and 
Response Authority (HERA) created. 

2 

Regulation  (EU)  2021/522  of  the  European  Parliament  and  of  the  Council  of  24 March  2021 
establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the 
period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1). 

EN 

101 

  EN 

                                                 
Furthermore,  automated  reporting  in  the  sector  will  both  support  and  benefit  from 
broader initiatives of the digitalisation of the healthcare (e.g. European Health Data 
Space, common European digital infrastructure). For certain activities – in particular 
investment  in  the  digitalisation  and  interoperability  of  healthcare  records  in  lower-
income EU regions – structural and cohesion funds could be leveraged.  

Finally,  synergies  could  be  explored  with  other  EU  policies  in  particular  related  to 
resilience  building  of  national  healthcare  services  (REFORM,  Recovery  and 
Resilience Facility, European Investment Bank/Fund) and research into personalised 
medicine (Horizon Europe). 

1.5.5.  Assessment  of  the  different  available  financing  options,  including  scope  for 

redeployment 

[N/A] 

EN 

102 

  EN 

 
 
1.6. 

Duration and financial impact of the proposal/initiative 

 limited duration  

–    in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–    Financial  impact  from  YYYY  to  YYYY  for  commitment  appropriations  and 

from YYYY to YYYY for payment appropriations.  

X 

unlimited duration 

–  Implementation as of 2024 

–  followed by full-scale operation. 

1.7.  Management mode(s) planned3  

X 

 Direct management by the Commission 

–   by its departments, including by its staff in the Union delegations;  

–    by the executive agencies  

 Shared management with the Member States  

X 

 Indirect management by entrusting budget implementation tasks to: 

–   third countries or the bodies they have designated; 

–  X international organisations and their agencies (to be specified); 

–   the EIB and the European Investment Fund; 

–  X bodies referred to in Articles 70 and 71 of the Financial Regulation; 

–   public law bodies; 

–   bodies governed by private law with a public service mission to the extent that 

they provide adequate financial guarantees; 

–   bodies governed by the private law of a Member State that are entrusted with 
the  implementation  of  a  public-private  partnership  and  that  provide  adequate 
financial guarantees; 

–    persons  entrusted  with  the  implementation  of  specific  actions  in  the  CFSP 

pursuant to Title V of the TEU, and identified in the relevant basic act. 

– 

If more than one management mode is indicated, please provide details in the ‘Comments’ section. 

Comments  

The European Directorate for the Quality of Medicines & HealthCare (EDQM), a department 
of the Council of Europe (CoE) is proposed to play a technical expert role in the new legal 
framework.  A  similar  and  parallel  role  is  proposed  for  the  European  Centre  for  Disease 
Prevention  and  Control  (ECDC);  however  this  has  been  covered  by  the  ECDC  extended 
mandate. 

3 

Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: 
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx  

EN 

103 

  EN 

 
 
                                                 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

The  proposal  includes  the  set-up  of  a  central  digital  platform  (the  EU  SoHO 
Platform),  which  will  facilitate  the  monitoring  of  several  indicators.  For  these, 
continuous  information  and  data  will  be  available.  For  monitoring  the  progress 
towards the achievement of the objectives of the new Regulation, the proposal plans 
for the preparation of an evaluation report that, in addition to the above information 
and  data,  will  be  based  on  the  information  and  data  collected  via  the  EU  SoHO 
Platform in relation to supervisory and SoHO activities, five years after the date of 
application  of  the  Regulation.  Member  States  will  provide  additional  information 
necessary for such evaluation report.  

2.2.  Management and control system(s)  

2.2.1. 

Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control strategy proposed 

The actions ensuring a high level of health protection for EU citizens that donate, or 
are  in  need  of  treatment  with  SoHOs  will  be  implemented  through  direct 
management, using the implementation modes offered by the Financial Regulation, 
mainly being  grants  and procurement. Direct  management allows to  establish grant 
agreements/contracts with beneficiaries/contractors directly engaged in activities that 
serve Union policies.  The Commission  ensures direct  monitoring over the outcome 
of  the  actions  financed.  The  payment  modalities  of  the  actions  funded  will  be 
adapted to the risks pertaining to the financial transactions.  

In  order  to  ensure  the  effectiveness,  efficiency  and  economy  of  the  Commission 
controls,  the  control  strategy  will  be  oriented  towards  a  balance  of  ex-ante  and  ex-
post  checks  and  focus  on  three  key  stages  of  grant/contract  implementation,  in 
accordance with the Financial Regulation: 

- selection of proposals/tenders that fit the policy objectives of the Regulation 

-  operational,  monitoring  and  ex-ante  controls 

that  cover  project 
implementation,  public  procurement,  pre-financing,  interim  and  final  payments, 
management of guarantees 

- ex-post controls at the beneficiaries/contractors’ sites will also be carried out  
on a sample of transactions. The selection of these transactions will combine a risk 
assessment and a random selection. 

2.2.2. 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them 

The  implementation  of  the  new  Regulation  on  standards  of  safety  and  quality  for 
SoHOs  focuses  on  the  attribution  of  public  procurement  contracts  as  well  as  a 
number of grants for specific activities and organisations. 

The  public  procurement  contracts  will  mainly  be  concluded  in  areas  such  as 
digitalisation, provision of consulting/expertise and training (to support uptake). 

Grants  will  mainly  be  awarded  for  support  activities  to  non-governmental 
organisations,  respective  competent  authorities  of  the  Member  States,  health  and 
healthcare professional organisations, national agencies, etc. The period of execution 
of the subsidised projects and activities varies from one to three years mostly. 

EN 

104 

  EN 

The main risks are the following: 

•  Risk  of  not  fully  achievening  the  objectives  of  the  Regulation  due  to  insufficient 
uptake or quality/delays in the implementation of the selected projects or contracts; 

•  Risk  of  inefficient  or  non-economic  use  of  funds  awarded,  both  for  grants 
(complexity  of  funding  rules)  and  for  procurement  (limited  number  of  economic 
providers with the required specialist knowledge entailing insufficient possibilities to 
compare price offers in some sectors); 

• Reputational risk for the Commission, if fraud or criminal activities are discovered; 
only partial  assurance  can be drawn from  the third parties' internal control  systems 
due to the rather large number of heterogeneous contractors and beneficiaries, each 
operating their own control system. 

The  Commission  put  in  place  internal  procedures  that  aim  at  covering  the  risks 
identified  above.  The  internal  procedures  are  in  full  compliance  with  the  Financial 
Regulation  and  include  anti-fraud  measures  and  cost-benefit  considerations.  Within 
this  framework,  the  Commission  continues  to  explore  possibilities  to  enhance  the 
management and to realise efficiency gains. Main features of the control framework 
are the following:  

Controls before and during the implementation of the projects:  

•  An  appropriate  project  management  system  will  be  put  in  place  focusing  on  the 
contributions of projects and contracts to the policy objectives, ensuring a systematic 
involvement  of  all  actors,  establishing  a  regular  project  management  reporting 
complemented  by  on-site-visits  on  a  case  by  case  basis,  including  risk  reports  to 
senior management, as well as maintaining appropriate budgetary flexibility. 

•  Model  grant  agreements  and  service  contracts  used  are  developed  within  the 
Commission.  They  provide  for  a  number  of  control  provisions  such  as  audit 
certificates, financial guarantees, on-site audits as well as inspections by OLAF. The 
rules  governing  the  eligibility  of  costs  are  being  simplified,  for  example,  by  using 
unit costs, lump sums, contributions not linked to costs and other possibilities offered 
by the Financial Regulation. This will reduce the cost of controls and put the focus 
on checks and controls in high risk areas. 

•  All  staff  sign  up  to  the  code  of  good  administrative  behaviour.  Staff  who  are 
involved 
the  grant 
agreements/contracts  (also)  sign  a  declaration  of  absence  of  a  conflict  of  interest. 
Staff is regularly trained and uses networks to exchange best practices.  

the  selection  procedure  or 

the  management  of 

in 

in 

• Technical implementation of a project is checked at regular intervals at the desk on 
the basis of technical progress reports of the contractors and beneficiaries; in addition 
contractors'/beneficiaries' meetings and on-site-visits are foreseen on a case by case 
basis. 

Controls  at the  end of the project:  Ex-post audits are performed on  a  sample of 
transactions  to  verify  on-the-spot  the  eligibility  of  cost  claims.  The  aim  of  these 
controls  is  to  prevent,  detect  and  correct  material  errors  related  to  the  legality  and 
regularity of financial transactions. With a view to achieving a high control impact, 
the selection of beneficiaries to be audited foresees to combine a risk based selection 
with  a  random  sampling,  and  to  pay  attention  to  operational  aspects  whenever 
possible during the on-site audit.  

EN 

105 

  EN 

2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio of "control 
costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure)  

The yearly costs of the suggested level of controls under the third Health programme 
2014-2020 represented approximately 4 to 7% of the yearly budget of the operational 
expenditure. This is justified by the diversity of transactions to be controlled. Indeed, 
in  the  area  of  health,  direct  management  involves  the  attribution  of  numerous 
contracts and grants for actions of very small to very large sizes, and the payment of 
numerous  operating  grants  to  non-governmental  organisations.  The  risk  related  to 
these  activities  concerns  the  capacity  of  (especially)  smaller  organisations  to 
effectively control expenditure.  

The Commission considers that the average costs of controls is likely to be the same 
for the actions proposed under this Regulation. 

Under the third Health Programme 2014-2020, on a 5 years basis, the error rate for 
the  on-the-spot  audits  of  grants  under  direct  management  was  1.8%  while  for 
procurement contracts it was below 1%. This level of error is considered acceptable, 
as it is under the materiality level of 2%.  

The  proposed  actions  will  not  affect  the  way  the  appropriations  are  currently 
managed. The existing control system proved to  be able to prevent  and/or to detect 
errors and/or irregularities, and in case of errors or irregularities, to correct them. It 
will  be  adapted  to  include  the  new  actions  and  to  ensure  that  residual  error  rates 
(after correction) remain below the threshold of 2%. 

2.3.  Measures to prevent fraud and irregularities  

As  for  its  activities  in  direct  management,  the  Commission  shall  take  appropriate 
measures ensuring that the financial interests of the European Union are protected by 
the application of preventive measures against fraud, corruption and any other illegal 
activities,  by  effective  checks  and,  if  irregularities  are  detected,  by  the  recovery  of 
the  amounts  wrongly  paid  and,  where  appropriate,  by  effective,  proportional  and 
deterrent  penalties.  To  this  effect,  the  Commission  adopted  an  anti-fraud  strategy, 
latest  update  of  April  2019  (COM(2019)  196),  covering  notably  the  following 
preventive, detective and corrective measures: 

The  Commission  or  its  representatives  and  the  Court  of  Auditors  shall  have  the 
power  of  audit,  on  the  basis  of  documents  and  on-the-spot,  over  all  grant 
beneficiaries, contractors and subcontractors who have received Union funds. OLAF 
shall  be  authorised  to  carry  out  on-the-spot  checks  and  inspections  on  economic 
operators concerned directly or indirectly by such funding. 

The Commission also implements a series of measures such as: 

-  decisions,  agreements  and  contracts  resulting  from  the  implementation  of  the 
Regulation will expressly entitle the Commission, including OLAF, and the Court of 
Auditors  to  conduct  audits,  on-the-spot  checks  and  inspections  and  to  recover 
amounts unduly paid and, where appropriate, impose administrative sanctions; 

-  during  the  evaluation  phase  of  a  call  for  proposals/tender,  the  applicants  and 
tenderers are checked against the published exclusion criteria based on declarations 
and the Early Detection and Exclusion System (EDES); 

EN 

106 

  EN 

- the rules governing the eligibility of costs will be simplified in accordance with the 
provisions of the Financial Regulation ; 

-  regular  training  on  issues  related  to  fraud  and  irregularities  is  given  to  all  staff 
involved  in  contract  management  as  well  as  to  auditors  and  controllers  who  verify 
the beneficiaries' declarations on the spot. 

EN 

107 

  EN 

 
 
3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework 

Number  

Budget line 

Type of  
expenditure 

Contribution  

Diff./Non-
diff.4 

from 
EFTA 
countries5 

from 
candidate 
countries6 

from third 
countries 

within the 
meaning of 
Article 21(2)(b) of 
the Financial 
Regulation  

06 06 01 - EU4Health Programme 

2b 

Diff.  

YES 

YES 

YES 

NO 

4 
5 
6 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 

EN 

108 

  EN 

 
 
 
 
                                                 
3.2. 

Estimated financial impact of the proposal on appropriations  

3.2.1. 

Summary of estimated impact on operational appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–  X  The  proposal/initiative  requires  the  use  of  operational  appropriations,  as  explained  below.  Appropriations  will  be  redeployed 

within the financial envelope allocated to the EU4Health programme in the MFF 2021-27. 

EUR million (to three decimal places) 

Heading of multiannual financial  
framework  

2b 

DG: SANTE 

 Operational appropriations  

06 06 01 - EU4Health Programme 

Budget line 

TOTAL appropriations 
for DG SANTE 

Year 
20241 

Year 
2025 

Year 
2026 

Year 
2027 and 
subsequent 
years 

TOTAL 

Commitments 

(1a) 

15.691 

11.600 

9.650 

11.650 

Payments 

Commitments 

Payments 

Commitments 

Payments 

(2a) 

(1b) 

(2b) 

=1a+1b 
+3 

=2a+2b 

+3 

7.846 

13.646 

10.625 

15.691 
7.846 

11.600 
13.646 

9.650 
10.625 

16.475 

11.650 
16.475 

15.691 

11.600 

9.650 

11.650 

48.592 

7.846 

13.646 

10.625 

16.475 

48.592 

48.592 

48.592 

48.592 
48.592 

1 

Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same  for the 
following years. 

EN 

109 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 TOTAL operational appropriations  

Commitments 

Payments 

  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADING 2b 
of the multiannual financial framework 

Commitments 

=4+ 6 

15.691 

11.600 

9.650 

11.650 

Payments 

=5+ 6 

7.846 

13.646 

10.625 

16.475 

48.592 

48.592 

EN 

110 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

7 

‘Administrative expenditure’ 

This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative 
Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes. 

EUR million (to three decimal places) 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 
and 
subseq
uent 
years 

TOTAL 

DG: SANTE 

 Human resources  

 Other administrative expenditure  

0.804 

0.804 

0.804 

0.804 

0.901 

0.901 

0.901 

0.901 

TOTAL DG  SANTE 

Appropriations  

1.705 

1.705 

1.705 

1.705 

TOTAL appropriations 
under HEADING 7 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

1.705 

1.705 

1.705 

1.705 

3.216 

3.603 
6.819 

6.819 

EN 

111 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 
and 
subseq
uent 
years 

TOTAL appropriations  
under HEADINGS 1 to 7 
of the multiannual financial framework  

Commitments 

17.396 

13.305 

11.355 

13.355 

Payments 

9.550 

15.350 

12.330 

18.180 

EUR million (to three decimal places) 

TOTAL 

55.411 

55.411 

3.2.2.  Estimated output funded with operational appropriations  

Commitment appropriations in EUR million (to three decimal places) 

Year 
2024 

Year 
2025 

Year 
2026 

Year 
2027 and 
subsequent years 

OUTPUTS 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost  N

o

Cost 

o
N

Cost 

Indicate 
objectives and 
outputs  

 

Type 

Avera
ge 
cost 

SPECIFIC OBJECTIVE No 1 
Protect citizens 

Number of technical standard 
updates 

0.400 

1.962 

2.141 

Subtotal for specific objective No 1 

0.400 

1.962 

2.141 

SPECIFIC OBJECTIVE No 2 

EN 

2.141 

2.141 

112 

TOTAL 

Total 
No 

Total 
cost 

6.644 

6.644 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Optimise access 

Numbers of donations, human 
applications, cross-border 
exchanges, imports and exports of 
critical BTC by Member state 

1.791 

3.219 

3.255 

Subtotal for specific objective No 2 

1.791 

3.219 

3.255 

SPECIFIC OBJECTIVE No 3 . 
Foster innovation 

The number of BTC processes 
authorised /shared and accepted at  
Subtotal for specific objective No 3 
EU level   

13.500 

13.500 

6.419 

6.419 

TOTALS 

15.691 

11.600 

4.254 

4.254 

9.650 

3.255 

3.255 

6.254 

6.254 

11.650 

11.520 

11.520 

30.427 

30.427 

48.592 

EN 

113 

EN 

 
 
 
  
  
  
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
3.2.3. 

Summary of estimated impact on administrative appropriations  

–    The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature  

–  X  The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below: 

EUR million (to three decimal places) 

TOTAL 

3.216 

3.603 

6.819 

2024 

2025 

2026 

2027 and 
subseque
nt years 

HEADING 7 
of the multiannual 
financial framework 

Human resources  

0.804 

0.804 

0.804 

0.804 

0.901 

0.901 

0.901 

0.901 

1.705 

1.705 

1.705 

1.705 

Other administrative 
expenditure  

Subtotal HEADING 7 
of the multiannual 
financial framework  

Outside HEADING 7 
of the multiannual 
financial framework  

Human resources  

Other expenditure  
of an administrative 
nature 

Subtotal  
outside HEADING 7 
of the multiannual 
financial framework  

TOTAL 

1.705 

1.705 

1.705 

1.705 

6.819 

The  appropriations  required  for  human  resources  and  other  expenditure  of  an  administrative  nature  will  be  met  by 
appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the 
DG,  together  if  necessary  with  any  additional  allocation  which  may  be  granted  to  the  managing  DG  under  the  annual 
allocation procedure and in the light of budgetary constraints. 

EN 

114 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.1.  Estimated requirements of human resources  

–    The proposal/initiative does not require the use of human resources.  

–  X  The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full time equivalent units 

2024 

2025 

2026 

2027 
and 
subse
quent 
years 

Total 

 Establishment plan posts (officials and temporary staff) 

20 01 02 01 (Headquarters and Commission’s Representation 
Offices) 

4 

4 

4 

4 

4 

20 01 02 03 (Delegations) 

01 01 01 01  (Indirect research) 

 01 01 01 11 (Direct research) 

Other budget lines (specify) 

 External staff (in Full Time Equivalent unit: FTE)

1

20 02 01 (AC, END, INT from the ‘global envelope’) 

2 

2 

2 

2 

2 

20 02 03 (AC, AL, END, INT and JPD in the delegations) 

2
XX 01  xx yy zz  

- at Headquarters 

- in Delegations  

01 01 01 02 (AC, END, INT - Indirect research) 

 01 01 01 12 (AC, END, INT - Direct research) 

Other budget lines (specify) 

TOTAL 

06 is the policy area or budget title concerned. 

6 

6 

6 

6 

6 

The human resources required will be met by staff from the DG who are already assigned to management of the 
action  and/or  have  been  redeployed  within  the  DG,  together  if  necessary  with  any  additional  allocation  which 
may  be  granted  to  the  managing  DG  under  the  annual  allocation  procedure  and  in  the  light  of  budgetary 
constraints. 

Description of tasks to be carried out: 

Officials and temporary staff 

External staff 

AD for leading audits, central coordination and chairing of SoHO Coordination Board 
and sub-groups and AST for logistics and administrative tasks 
SNEs with sector expertise 

1 

2 

AC=  Contract  Staff;  AL  =  Local  Staff;  END=  Seconded  National  Expert;  INT  =  agency  staff; 
JPD= Junior Professionals in Delegations.  
Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 

EN 

115 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.4.  Compatibility with the current multiannual financial framework  

The proposal/initiative: 

–  X  can be fully financed through redeployment within the relevant heading of the 

Multiannual Financial Framework (MFF). 

 Appropriations  will  be  redeployed  within  the  financial  envelope  allocated  to  the 
EU4Health programme in the MFF 2021-27 

–    requires use of the unallocated margin under the relevant heading of the MFF 

and/or use of the special instruments as defined in the MFF Regulation. 

–    requires a revision of the MFF. 

3.2.5.  Third-party contributions  

The proposal/initiative: 

–  X  does not provide for co-financing by third parties 

–    provides for the co-financing by third parties estimated below: 

Appropriations in EUR million (to three decimal places) 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6) 

Total 

Specify  the  co-financing 
body  

TOTAL appropriations 
co-financed  

EN 

116 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.3. 

Estimated impact on revenue  

–  X  The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

  on own resources  

  on other revenue 

please indicate, if the revenue is assigned to expenditure lines  

Appropriations 
available for 
the current 
financial year 

Budget revenue line: 

Article …………. 

     EUR million (to three decimal places) 

Impact of the proposal/initiative 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary to show 
the duration of the impact (see point 1.6) 

For assigned revenue, specify the budget expenditure line(s) affected. 

Other  remarks  (e.g.  method/formula  used  for  calculating  the  impact  on  revenue  or  any  other 
information). 

EN 

117 

  EN