Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
Date: 2025-03-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU production, investment, medicinal product, public health, public procurement, security of supply, shortage, supply chain

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   EUROPEAN COMMISSION  Strasbourg, 11.3.2025  COM(2025) 102 final 2025/102 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (Text with EEA relevance)  
 
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The EU has  a strong and competitive pharmaceutical  sector, which is  a  global leader in  the 
production  of  medicines  and  a  major  contributor  to  the  EU  economy  and  directly  employs 
around  800  000  people1.  It  is  particularly  strong  in  the  research  and  development  of 
innovative medicines. However, the landscape for pharmaceutical manufacturing has evolved 
in  recent  decades.  Pharmaceutical  production  in  the  EU  has  focused  on  more  complex 
products,  which  require  high-tech  infrastructure,  a  skilled  workforce  and  sophisticated 
processes. Production of inputs for generic medicines has increasingly moved outside Europe. 
At the same time, almost 70% of the medicines dispensed in Europe are generics2. 

The EU faces increasing challenges to secure a stable and resilient supply of medicines that 
are  critical  to  ensure  the  health  of  the  EU  patients.  Recent  global  events,  including  the 
COVID-19 pandemic and  Russia’s war  against  Ukraine, have exposed vulnerabilities in  the 
EU’s pharmaceutical  supply chains.  Shortages of critical  medicines  present  substantial  risks 
to patients and public health and undermine the functioning of healthcare systems.  

The root causes of shortages have shown themselves to be complex and multifactorial, with 
challenges  identified  along  the  entire  pharmaceutical  value  chain,  from  quality  and 
manufacturing  problems,  commercial  decisions,  and  complex  supply  chains  to  industry’s 
competitiveness. Specifically, shortages of medicines result from supply chain disruptions due 
to  lack  of  diversification  of  key  suppliers  and  vulnerabilities  affecting  the  supply  of  key 
ingredients and components.  

When looking at the causes of shortages of critical medicines, which are medicines for which 
no  appropriate  alternative  is  available  and  for  which  insufficient  supply  would  result  in 
serious harm or risk of harm to patients, it is important to distinguish between off-patent or 
generic  medicines3  and  innovative  or  on-patent4  medicines.  Some  of  the  market  dynamics, 
which are observable for generic medicines do not necessarily apply to innovative medicines. 
EU health systems have made increasing use of generic medicines and tend to procure these, 
based on lowest cost, to reduce the burden on national healthcare budgets.  

Industrial challenges have been pointed out as impacting the availability of critical medicines 
in  the  EU  including  the  lack  of  investments  in  EU  manufacturing  capacity  which  has 
contributed  to  the  increased  supply  dependency  from  outside  the  EU.  Fragmented 
procurement practices across the Member States constitute a challenge and do not contribute 
to creating the most favourable conditions for investments. Additionally, workforce shortages 
and  the  need  for  specialised  skills  in  pharmaceutical  manufacturing  further  strain  the 
industry’s capacity to ensure a stable supply of critical medicines.  

The  COVID-19  pandemic  clearly  exposed  significant  vulnerabilities 
the  EU’s 
pharmaceutical supply chain, in particular the heavy dependence on foreign sources for active 
substances.  Export  restrictions  imposed  by  some  countries  during  the  pandemic  revealed 
limitations  in  Europe’s  ability  to  independently  produce  certain  medicines,  putting  public 

in 

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Impact  assessment  report  and  executive  summary  accompanying  the  revision  of  the  general 
pharmaceutical legislation, annex 5, 2023. 
IQVIA White paper. Beneath the Surface: Unravelling the True Value of Generic Medicines April 2024 
Generic and hybrid medicines | European Medicines Agency (EMA) 
Patent protection in the EU - European Commission 

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health across the EU at  risk. This  situation underscored the critical  importance of economic 
security,  as  disruptions  in  global  supply  chains—whether  due  to  pandemics,  geopolitical 
tensions,  or  other  factors—can  have  severe  implications  for  national  and  regional  security, 
economic resilience, and public health.  

The pandemic highlighted how vital certain sectors, especially medicines, are for maintaining 
the  EU's  economic  security.  As  Europe  is  facing  rising  geopolitical  tensions  and  global 
disruptions which may become more frequent, ensuring the stability and reliability of critical 
supply chains, including those for medicines, is essential. By addressing these vulnerabilities, 
the  EU  can  enhance  its  preparedness  and  resilience,  safeguarding  the  well-being  and  public 
health of its citizens and strengthening its overall security. 

A survey conducted by the EU4Health programme-funded Joint Action of Member States on 
shortages  (CHESSMEN)5  identified  that  over  50%  of  reported  shortages  are  caused  by 
manufacturing issues, a category which includes shortages related to the availability of active 
substances. 

Figure 1: Root causes of medicines shortages in 2022 and 2023 in EU/EEA countries, grouped according to SPOC 
working party classification (CHESSMEN joint action) 

Furthermore, for some medicines such as those for rare diseases, access can vary considerably 
from  Member  State  to  Member  State.  Due  to  various  factors,  including  the  size  of  the 
markets, companies market medicines differently across  the EU. As a result, patients across 
the  EU  may  not  have  equal  access  to  the  medicines  they  need  and  market  failures  remain, 
including  within 
that  can  help  address 
antimicrobial resistance.  
Shortages  of  medicines  have  been  on  the  EU’s  political  agenda  for  almost  a  decade6.  The 
pharmaceutical  strategy  for  Europe  in  20207  acknowledged  the  need  to  create  a  future-

the  development  of priority antimicrobials 

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CHESSMEN (2024) Analysis Report on root-causes.  
See  for  instance  the  European  Parliament  resolution  of  2  March  2017  on  EU  options  for  improving 
access to medicine and the EPSCO Council Conclusions (2021/C 269 I/02) 
A pharmaceutical strategy for Europe - European Commission (europa.eu) 

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proof regulatory pharmaceutical framework and give additional support to the pharmaceutical 
industry in promoting research, innovation and technologies that meet the therapeutic needs of 
patients while ensuring affordable access to medicines for patients.  
The  pharmaceutical  strategy  also  included  the  launch  of  a  structured  dialogue8  on  the 
industrial  dimension  of  security  of  supply.  Starting  in  2021,  this  initiative  brought  together 
stakeholders from the pharmaceutical industry (including manufacturers of active substances), 
wholesalers, healthcare professionals and patients, and Member State authorities.  

Subsequently,  the  Commission  published  a  staff  working  document  on  vulnerabilities  of 
the  global  supply  chains  of  medicines  in  20229  which  presented  the  main  findings  of  the 
structured  dialogue  with  the  aim  of  informing  further  actions  to  improve  the  security  of 
supply  and  the  availability  of  critical  medicines,  active  substances  and  raw  and  starting 
materials for pharmaceuticals. 

Additional steps have been taken since to address the above-mentioned challenges, including 
the  challenge  of  ensuring  supply-chain  security  of  critical  medicines.  These  steps  relate  in 
particular to the proposed revision of the EU pharmaceutical general legislation10, which is 
being negotiated by the co-legislators and the extended mandate of the European Medicines 
Agency (EMA)11.  

In 2023, the Commission published a Communication on addressing medicine shortages 
in  the  EU12, setting  out  a  number  of  actions  to  better  prevent  and  mitigate  critical 
medicine shortages in the EU. While pharmaceutical companies are responsible for ensuring 
sufficient  supply  of  medicines  to  cover  the  needs  of  patients,  Member  States  ensure  the 
supervision of medicines supply in their territory. Most shortages are managed and resolved at 
the  national  level.  However,  to  prevent  and  mitigate  critical  shortages  where  no  alternative 
medicines are available and that cannot be solved at the national level,  coordinated action is 
needed  to  address  supply  challenges  and  to  make  Europe’s  medicine  supply  chains  more 
resilient in the long run.  

The 2023 Communication therefore put a particular focus on the most critical medicines, for 
which  security  of  supply  in  the  EU  must  be  ensured  at  all  times.  It  highlighted  the  need  to 
publish  a  Union  list  of  critical  medicines  prior  to  the  adoption  of  the  revised  EU 
pharmaceutical  legislation.  The  first  Union  list  of  critical  medicines,  identified  by 
combining  the  criteria  of  seriousness  of  the  disease  and  the  availability  of  alternative 
medicines,  was  published  by  the  European  Commission,  the  EMA  and  the  Heads  of 
Medicines  Agencies  of  the  Member  States  in  December  2023  and  reviewed  in  December 
202413. It provides a first list from which to analyse the vulnerabilities in the supply chain of 
these medicines and where further actions are needed to reinforce these supply chains. The list 

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Structured dialogue on security of medicines supply - European Commission (europa.eu) 
mp_vulnerabilities_global-supply_swd_en.pdf (europa.eu) 
Reform  of  the  EU  general  pharmaceutical  legislation  (europa.eu):  the  proposals  include  actions  to 
address  systemic  shortages  and  improve  security  of  supply  of  critical  medicines  at  all  times  by 
introducing  stronger  obligations  on  supply,  earlier  notification  and  a  stronger  role  for  EMA  in 
coordinating this with the Member States. Actions are also proposed to strengthen the supply chains of 
critical medicines by introducing a European alert system for shortages and shortage prevention plans 
for all medicines. 
Regulation  (EU)  2022/123  of  the  European  Parliament  and  of  the  Council  of  25  January  2022  on  a 
reinforced  role  for  the  European  Medicines  Agency  in  crisis  preparedness  and  management  for 
medicinal products and medical devices. 
Communication_medicines_shortages_EN_0.pdf 
Union list of critical medicines | European Medicines Agency (EMA) 

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includes  over  270  active  substances,  covering  treatments  for  various  illnesses  such  as 
infections, cardiovascular diseases, mental health conditions and cancer. 

As  a  key  measure  towards  boosting  the  security  of  supply  of  critical  medicines,  the 
Commission  also  announced  in  its  Communication  the  launch  of  a  ‘Critical  Medicines 
Alliance’14.  This  Alliance  was  formally  launched  in  April  202415  and  follows  an  approach 
successfully  used  by  the  Commission  in  other  areas  (batteries,  semiconductors,  critical  raw 
materials).  The  main  objective  of  the  Alliance  was  to  ‘identify  challenges  resulting  from 
vulnerabilities and the most appropriate actions and instruments to address the vulnerabilities 
in the supply chains of critical medicines, with the primary public health goal of reducing the 
risk of shortages of those critical medicines’. It brought together over 300 organisations (from 
patient  and  scientific  communities  to  healthcare  providers,  industry  and  public  authorities). 
Following  intensive  consultations  with  its  members  during  2024,  the  Alliance  published  its 
Strategic Report including a set of recommendations on 28 February 202516. 

This proposed Regulation delivers on the political commitment of President von der Leyen to 
propose  a  Critical  Medicines  Act  to  address  severe  shortages  of  medicines  and  reduce 
dependencies linked to critical medicines and ingredients, as well as to ensure the supply of 
affordable medicines17. The proposed Regulation will be an important stage in completing the 
European  Health  Union;  it  builds  on  (1)  the  measures  proposed  as  part  of  the  ongoing 
revision of the pharmaceutical legislation of the EU; (2) the extended mandate of the EMA in 
the  realm  of  crisis  preparedness  and  management  of  medicines;  (3)  key  actions  towards 
completing  a  European  Health  Union  in  which  all  EU  Member  States  prepare  and  respond 
together  to  health  crises  and  in  which  medical  supplies  are  available,  affordable  and 
innovative18;  and  (4)  new  industrial  policy  measures  that  recently  came  into  force  in  other 
‘critical’ domains19.  

Scope and objectives 

In  light  of  the  current  geopolitical  situation  and  the  importance  of  a  viable  European  based 
pharmaceutical  industry  for  the  EU’s  economic  security,  the  proposed  Regulation  aims  to 
complement  the  measures  proposed  in  the  revision  of  the  EU  pharmaceutical  legislation  in 
order to address the supply chain vulnerabilities of critical medicines and support the security 
of supply and availability of these medicines.  

The scope of the proposed Regulation is primarily focused on critical medicines on the Union 
List  of  Critical  Medicinal  Products  which  is  formally  established  in  the  proposed 
pharmaceutical Regulation. Following the 2023 Communication, a first Union List of Critical 
Medicines  was  compiled  with  the  expertise  of  the  Heads  of  Medicines  Agencies  of  the 
Member  States,  the  European  Commission,  and  the  EMA  in  consultation  with  key 
stakeholders,  including  patient  organisations  and  industry  associations.  This  list  was 
published for the first time in December 2023 and updated one year later.  

The proposed Regulation also introduces actions to improve access to and availability of other 
medicines  of  common  interest,  to  ensure  patients  across  the  EU  can  benefit  from  these 

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Critical Medicines Alliance - European Commission 
https://ec.europa.eu/commission/presscorner/detail/en/ip_24_2229 
3da9dfc0-c5e0-4583-a0f1-1652c7c18c3c_en 
https://commission.europa.eu/document/download/b1817a1b-e62e-4949-bbb8-
ebf29b54c8bd_en?filename=Mission%20letter%20-%20VARHELYI.pdf 
European Health Union - European Commission 
European Critical Raw Materials Act and The Net-Zero Industry Act, for instance. 

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medicines when and where they need them. These medicines can include medicines for rare 
diseases (orphan medicinal products)20 or novel antimicrobials.  

General and specific objectives 

The  general  objective  of  this  Regulation  is  to  strengthen  the  security  of  supply  and  the 
availability of critical medicines within the EU, thereby ensuring a high level of public health 
protection  and  supporting  the  security  of  the  Union,  and  to  improve  the  availability  and 
accessibility  of  other  specific  medicines,  where  the  functioning  of  the  market  does  not 
otherwise sufficiently ensure their availability and accessibility to patients, whilst giving due 
consideration to the appropriateness to ensure the affordability of medicinal products. 

The specific objectives of the initiative are: 

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to  facilitate  investments  in  manufacturing  capacities  for  critical  medicines,  their 
active substances and other key inputs in the EU; 

to  lower  the  risk  of  supply  disruptions  and  strengthen  availability  by  incentivising 
supply chain diversification and resilience in the public procurement procedures for 
critical medicines and other medicinal products of common interest; 

to  leverage  the  aggregated  demand  of  participating  Member  States  through 
collaborative procurement procedures;  

to support the diversification of supply chains  also by facilitating the conclusion of 
strategic partnerships. 

Consistency with existing policy provisions in the policy area 

The  proposal  aims  to  ensure  consistency  with  several  existing  EU  policy  provisions  and 
initiatives  in  the  health  and  pharmaceutical  areas,  therefore  ensuring  a  high  level  of  human 
health protection in the definition and implementation of EU policy.21 

The  proposed  Regulation  complements  the  ongoing  revision  of  the  EU  pharmaceutical 
legislation22  and  the  main  actions  of  the  pharmaceutical  strategy  for  Europe23.  It  aligns 
with  its  objectives  of  increasing  access  to  medicines,  improving  security  of  supply,  and 
addressing  shortages,  whilst  giving  due  consideration  to  the  affordability  of  medicinal 
products.  It  complements  the  main  provisions  on  the  availability  and  security  of  supply  of 
medicinal products as proposed in the new pharmaceutical legislation24. While the revised EU 
pharmaceutical  framework  strengthens  obligations  for  marketing  authorisation  holders  to 
prevent  shortages  and  introduces  EU  coordinated  actions  to  mitigate  critical  shortages,  this 
proposed  Regulation  creates 
investments,  procurement 
coordination – to proactively reduce dependencies and strengthen EU production capacity.  

the  necessary  conditions  – 

The  proposed  Regulation  upholds  the  “once-only”  principle  by  preventing  duplication  of 
provisions  and  requirements  related  to  data  collection  for  identifying  critical  medicines  and 
assessing supply chain vulnerabilities. The proposed Regulation builds on the Union List of 
Critical  Medicinal  Products  established  in  Article  131  of  the  proposed  pharmaceutical 
Regulation. In addition, the proposed Regulation builds on the data collection framework and 
the  methodology  for  identifying  vulnerabilities  in  the  supply  chains  of  critical  medicines 

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Orphan medicinal products - European Commission 
Consolidated version of the Treaty on European Union (Consolidated Version) 
Reform of the EU pharmaceutical legislation - European Commission 
A pharmaceutical strategy for Europe - European Commission (europa.eu) 
Regulation COM(2023) 193 final, Chapter X. 

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proposed  to  be  drawn  up  under  the  EU  pharmaceutical  legislation.  This  guarantees  that  the 
assessment of supply chain vulnerabilities is based on a harmonised and scientifically robust 
methodology developed at the EU level. 

Furthermore, the proposed Regulation builds upon the outcomes of the structured dialogue 
on pharmaceuticals25, and the staff working document on vulnerabilities of the global supply 
chains  of  medicines26,  with  actions  to  address  vulnerabilities  in  the  pharmaceutical  supply 
chain. 
The proposed Regulation also builds on the EMA’s extended mandate27. In this respect, the 
launch  of  the  European  Shortages  Monitoring  Platform28  was  a  key  requirement  of  this 
extended mandate to enhance the monitoring of shortages across the EU. This platform will 
enable both marketing authorisation holders and national competent authorities to submit data 
on  the  supply,  demand  and  availability  of  centrally  and  nationally  authorised  medicines 
during  crises  and  preparedness  situations.  The  platform  will  be  further  expanded  in  the 
context of the revision of the EU’s pharmaceutical legislation. 

The  measures  in  the  proposed  Regulation  regarding  collaborative  procurement  are 
complementary  to  the  existing  collaborative  procurement  tools  under  Regulation  (EU) 
2022/2371  on  serious  cross-border  threats  to  health29,  Regulation  (EU)  2022/2372  on  a 
framework of measures for ensuring the supply of crisis-relevant medical countermeasures in 
the  event  of  a  public  health  emergency  at  Union  level30.  The  measures  for  collaborative 
procurement  of  medicinal  products  of  common  interest  also  build  on  the  joint  clinical 
assessments  and  voluntary  cooperation  among  Member  States  under  Regulation  (EU) 
2021/2282 on health technology assessment31. 

The  proposed  Regulation  takes  into  consideration  the  work  of  the  Critical  Medicines 
Alliance32, focusing on addressing vulnerabilities in the supply chains of critical medicines. 

Finally, this proposal takes into account all funding opportunities available under the current 
MFF that can support the objectives of this proposed Regulation. 

• 

Consistency with other EU policies 

This  proposal  is  consistent  with  the  EU’s  innovation  and  competitiveness  policy,  in 
particular  with  the  Competitiveness  Compass33.  This  Communication  lists  the  proposed 
Regulation as one of the flagship actions under Pillar 3 (reducing excessive dependencies and 
increasing security). It also mentions critical medicines as one of the possible selected areas 
for  pilot  cases  where  the  Commission  will  propose  to  coordinate  EU  and  Member  States’ 
policies.  The  proposed  Regulation  will  have  an  indirect  positive  impact  on  the  EU’s 
competitiveness by fostering a more stable and predictable market environment, encouraging 
investment  and  supporting  innovation  in  the  pharmaceutical  sector,  which  has  traditionally 

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Structured dialogue on security of medicines supply - European Commission 
mp_vulnerabilities_global-supply_swd_en.pdf (europa.eu) 
Regulation  (EU)  2022/123  of  the  European  Parliament  and  of  the  Council  of  25  January  2022  on  a 
reinforced  role  for  the  European  Medicines  Agency  in  crisis  preparedness  and  management  for 
medicinal products and medical devices. 
European  Shortages  Monitoring  Platform  (ESMP)  |  European  Medicines  Agency  (EMA)  –  Platform 
fully operational as of January 2025.  
Regulation - 2022/2371 - EN - EUR-Lex 
Regulation - 2022/2372 - EN - EUR-Lex 
Regulation - 2021/2282 - EN - EUR-Lex 
Critical Medicines Alliance - European Commission 
A  Competitive  Compass  which  includes  new  plans  for  Europe's  sustainable  prosperity  and 
competitiveness. See also: Competitiveness - European Commission 

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played a fundamental role in the EU’s competitiveness34. The provisions under the proposed 
Regulation may be supported by Horizon Europe Partnerships35, which provide funding for 
areas such as research and innovation in technologies with the potential to become essential 
enablers in the production process.  
Furthermore,  the  European  Industrial  Strategy36  aims  to  strengthen  the  single  market's 
resilience  and  addresses  the  EU's  strategic  dependencies.  The  proposed  Regulation  supports 
these  objectives  by  strengthening  the  pharmaceutical  supply  chain's  resilience  and  reducing 
dependence on non-EU sources for critical medicines and active pharmaceutical ingredients. 
The proposed Regulation is also consistent with the Commission communication on a Clean 
Industrial  Deal37,  which  outlines  concrete  actions  to  turn  decarbonisation  into  a  driver  of 
growth, in particular for energy-intensive industries. This includes demand side measures to 
create  the  right  conditions  for  companies  to  thrive,  similar  to  those  proposed  in  this 
Regulation.  

The  EU’s  Financial  Regulation  is  the  main  point  of  reference  for  the  principles  and 
procedures  governing  the  EU  budget,  including  on  joint  procurement  and  procurement  on 
behalf of, or in the name of Member States. Last year, the recast of the Financial Regulation 
entered into force38. The proposed Regulation provides a sector-by-sector basis for these types 
of  procurement  to  be  conducted  for  critical  medicines  and  other  medicines  of  common 
interest, being consistent with the procedural framework set out in the Financial Regulation, 
but setting specific conditions under which the joint procurement and procurement on behalf 
or in the name of Member states can be launched. These specific conditions related to certain 
threshold of Member states participating in the procedure and eligibility criteria as regards the 
medicinal  products,  reflect  the  assessment  of  where  the  Commission  intervention  would  be 
the most appropriate in the light of the objectives of the act.  

An  evaluation  of  the  EU’s  public  procurement  directives  is  currently  ongoing39  and  the 
Commission  will  make  a  proposal  to  revise  the  framework  in  2026.  It  will  allow  for 
sustainability,  resilience  and  European  preference  criteria  in  EU  public  procurement  for 
strategic  sectors.  The  proposed  Regulation  would  introduce  measures  related  to  national 
public  procurement  of  certain  pharmaceuticals  in  line  with  the  objectives  of  this  upcoming 
revision,  to  help  ensure  security  of  supply  and  enable  preference  for  European  products  in 
public  procurement  for  critical  medicines  and  other  medicines  of  common  interest,  to  the 
extent this is necessary and in line with the Union’s international commitments. 

The  proposed  Regulation  is  consistent  with  broader  efforts  to  modernise  and  adapt  EU 
legislation  to  current  challenges  since  it  aims  at  reducing  administrative  burdens  and 
facilitating permit-granting processes for strategic projects. The proposed Regulation is in line 

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See also Chapter 1. Medicines - a strong ecosystem at an important crossroads (Pharmaceutical Strategy 
for Europe).   
Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing 
Horizon Europe – the Framework Programme for Research and Innovation 
A New Industrial Strategy for Europe 
Clean Industrial Deal - European Commission 
EU Financial Regulation - European Commission 
Commission  launches  call  for  evidence  and  public  consultation  on  the  evaluation  of  the  Public 
Procurement Directives - European Commission 

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with the Omnibus Proposal40 and aims to address vulnerabilities of medicine supply chains 
without increasing the overall burden on industry. 

Digital 

The  proposed  Regulation  is  aligned  with  recent  key  European  digital  initiatives  (Artificial 
Intelligence  (AI)  and  NIS  2  Directive)  that  aim  to  promote  secure  and  interoperable  data 
exchange, the use of advanced technologies and a high common level of cybersecurity across 
the Union. The AI Act41 and the NIS 2 Directive42 provide frameworks for responsible AI use 
and a high common level of cybersecurity.  

Furthermore, the Interoperable Europe Act43, along with dedicated tools like the European 
reusable  components,  supports 
(EIF)  Toolbox  and 
Interoperability  Framework 
standardised  data  exchange  across  Member  States.  The  recently  redesigned  Tenders 
Electronic  Daily  portal44  (‘TED’)  serves  as  an  efficient  tool  for  sharing  and  monitoring 
procurement procedures.  

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union 
(TFEU).  This  is  consistent  with  the  legal  basis  of  existing  EU  pharmaceutical  legislation. 
Article  114(1)  has  as  its  object  the  establishment  and  functioning  of  the  internal  market.  In 
accordance  with  Article  114(3)  TFEU,  the  proposal  takes  as  a  base  a  high  level  of  health 
protection. 

• 

Subsidiarity (for non-exclusive competence)  

The  objectives  of  this  proposal  cannot  be  sufficiently  achieved  by  Member  States  acting 
individually, as the challenges of medicine shortages and supply chain vulnerabilities extend 
beyond  national  borders.  EU-level  action  is  needed  to  ensure  a  coordinated  and  effective 
response  to  these  cross-border  issues.  The  proposal  takes  into  account  this  principle  in  the 
design  of  the  individual  actions,  particularly  when  procuring  critical  medicines  and  other 
medicinal products of common interest. 

• 

Proportionality 

The proposal  targets  critical  medicines  for which there is  a demonstrated need to  intervene, 
and  the  selected  intervention  can  lead  to  an  effective  reduction  in  the  risk  of  shortages. 
Specific measures also apply to other medicines of common interest affected by market access 
issues in Member States.  

40 

41 

42 

43 

44 

Commission  simplifies  rules  on  sustainability  and  EU  investments,  delivering  over  €6  billion  in 
administrative relief - European Commission 
Regulation  (EU)  2024/1689  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  laying 
down harmonised rules on artificial intelligence 
Directive  (EU)  2022/2555  of  the  European  Parliament  and  of  the  Council  of  14  December  2022  on 
measures  for  a  high  common  level  of  cybersecurity  across  the  Union,  amending  Regulation  (EU)  No 
910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive) 
Regulation  (EU)  2024/903  of  the  European  Parliament  and  of  the  Council  of  13  March  2024  laying 
down measures for a high level of public sector interoperability across the Union (Interoperable Europe 
Act) 
TED – EU Tenders, the Supplement to the Official Journal - TED 

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• 

Choice of the instrument 

The proposal takes the form of a Regulation of the European Parliament and of the Council. 
The  selection  of  a  Regulation  over  a  Directive  is  driven  by  the  need  for  immediate  and 
uniform application across the EU. This choice ensures legal certainty by minimising the risk 
of  divergent  interpretations  and  implementations  by  Member  States.  In  addition,  the  cross-
border implications of the legislation require a cohesive and consistent approach, achievable 
through a Regulation.  

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

The growing issue of medicines shortages poses an immediate and alarming threat to public 
health.  Without  swift  action  to  address  vulnerabilities  in  the  supply  of  critical  medicines, 
disruptions could have severe consequences for patient care, including delayed treatments for 
life-threatening  conditions.  Our  heavy  reliance  on  non-EU  suppliers,  fragile  global  supply 
chains,  and  geopolitical  tensions  exacerbate  the  risk  of  shortages,  making  this  a  pressing 
challenge.  

A  rich  evidence  base  and  extensive  stakeholder  input  concerning  medicine  shortages  and 
critical  medicines  have  been  gathered  and  analysed  in  preparation  for  the  revision  of  the 
the  proposed  Regulation  was  preceded  by 
pharmaceutical 
comprehensive consultations with stakeholders through the structured dialogue on the security 
of medicines supply46 and the Critical Medicines Alliance47.  

In  addition, 

reform45. 

Given that security of supply and addressing medicine shortages were a central focus during 
the  evidence-gathering  activities  for  the  above  initiatives,  along  with  the  pressing  need  for 
urgent  action,  no  dedicated  impact  assessment  or  online  public  consultation  could  be 
conducted ex-ante for this proposed Regulation.  
The evaluation of the EU pharmaceutical legislation48 highlighted that medicine shortages are 
an  increasing  problem  in  the  EU  and  that  they  have  grown  worse  since  the  COVID-19 
pandemic.  Overall,  there  has  been  a  marked  increase  in  the  number  of  reported  shortages 
across the EU. These shortages are placing a significant burden on health systems and health 
professionals, putting patients at risk of sub-optimal care and health systems at risk of higher 
healthcare costs49.  

Supporting evidence 

The  analysis  and  supporting  evidence  including  studies  commissioned  by  the  Commission 
will  be  summarised  in  a  staff  working  document  and  published  within  three  months  of  the 
proposal’s publication. 

• 

Ex-post evaluations/fitness checks of existing legislation 

Not applicable 

45 
46 
47 
48 
49 

Reform of the EU pharmaceutical legislation - European Commission 
Structured dialogue on security of medicines supply - European Commission 
Critical Medicines Alliance - European Commission 
Reform of the EU pharmaceutical legislation - European Commission 
Future-proofing pharmaceutical legislation - Publications Office of the EU. 

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• 

Stakeholder consultations 

In February 2021, the Commission brought stakeholders together in a structured dialogue on 
security of medicines supply50. Participants in this dialogue included: (i) actors in the supply 
chains of critical medicines; (ii) public authorities; (iii) patient and health non-governmental 
organisations;  and  (iv) the  research  community.  This  dialogue  further  deepened  the 
understanding of global pharmaceutical supply chains.  

Consultations for the EU pharmaceutical  reform in the domain of shortages also  explored 
the  stakeholders’  view  on  this  topic51.  These  consultations  confirmed  that  stakeholders  (in 
particular, civil society organisations and healthcare professionals) see medicine shortages as 
a  crucial  issue.  In  the  targeted  surveys,  civil  society,  public  authorities  and  health  service 
stakeholders considered that the area that legislation was the least effective in addressing was 
issues  related  to  security  of  supply  and  medicine  shortages.  They  also  gave  their  view  on 
policy measures, such as shortage prevention plans, a shortage monitoring system at EU level 
or the shortage notification. Furthermore, a dedicated validation workshop was held on supply 
chains 
that 
diversification of the supply chain is challenging and not always feasible due to the difficulty 
of finding alternative suppliers upstream in the supply chain52.  

this  workshop,  various  stakeholders  explained 

in  April  2022.  During 

More  than  300  stakeholders  of  critical  medicine  supply  chains,  as  members  of  the  Critical 
Medicines  Alliance  that  includes  industry  representatives,  trade  associations,  patient 
organisations, medical  profession organisations and Member States, have been consulted on 
key topics of interest  for critical  medicines’ supply chain  strengthening. After the launch of 
the Alliance in 2024, technical discussions took place at working group level throughout the 
rest  of the year, aiming  to  prepare recommendations of actions to  strengthen manufacturing 
capacity and diversify supply chain through partnerships with like-minded non-EU countries. 
The  results  of  these  recommendations,  compiled  by  the  Steering  Board  in  its  Strategic 
Report53,  provide  for  actions  on  vulnerability  assessment,  incentives  for  investments  in 
manufacturing  capacity,  contingency  stocks  and  procurement  approaches,  as  well  as 
leveraging  partnerships  with  non-EU  countries.  In  particular,  the  Alliance  recommends:  (i) 
establishing a European list of Critical Vulnerable Medicines;  (ii) implementing a European 
Investment  plan  to  strengthen  production  capacities  for  critical  medicines  in  Europe  by 
combining  EU  funding  programmes  and  State  aid;  (iii)  implementing  a  comprehensive 
harmonised  and  balanced  framework  on  contingency  stocks;  (iv)  promoting  virtuous  public 
procurement  practices  by  means  of  applying  specific  ‘MEAT’  criteria54  and  making  further 
use of joint procurement; and (v) promoting a level playing field for environmental and social 
standards, as well as fair competition between critical medicines manufactured in the EU and 
in  the  rest  of  the  world.  On  partnerships  with  non-EU  countries,  the  Alliance  specifically 
recommends making use of the developed methodology  to  assess the prospects  of countries 
for  different  types  of  partnerships.  Finally,  the  Alliance  recommends  that  the  MSSG 
(Executive  Steering  Group  on  Shortages  and  Safety  of  Medicinal  Products)  formalises  the 

50 

51 
52 

53 
54 

The list of organisations can be consulted here: 
https://health.ec.europa.eu/document/download/bd92f46c-4c55-4fed-8642-
81b0aa30ff22_en?filename=structured-dialogue_lp_en.pdf  
Reform of the EU pharmaceutical legislation - European Commission 
See  Annex  2  synopsis  report  (stakeholder  consultation)  for  the  reform  of  the  EU  pharmaceutical 
legislation: GP_Annexes 1 to 4 - 6 to 9 - 14 to 16_v28102022 
Critical Medicines Alliance - European Commission 
Most  economically  advantageous  tender  which  allows  for  more  prominence  to  be  given  to  quality 
beyond price considerations alone.  

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possibility  for  outreach  to  non-EU  country  jurisdictions,  as  part  of  the  Voluntary  Solidarity 
Mechanism. 

A general consultation on the proposed Regulation was launched in a Call for Evidence that 
was published on 30 January 202555.  

The Commission received 121 valid contributions, submitted by business associations (26%), 
company/businesses (25%), non-governmental organisations (22%), EU citizen (5%), public 
authorities  (5%),  trade  unions  (4%),  consumer  organisations  (2%),  academic/research 
institutions (1%), and other (9%).  

The  responses  came  from  22  countries  (including  5  non-EU  countries).  Among  these, 
Belgium  is  the  most  represented  (32%)  as  most  European  business  associations  and  civil 
society organisations are headquartered in the country,  followed by Germany (15%), France 
(7%), Italy (6%) and Spain (5%). 

A broad majority of the responses supported the Commission in tabling a Critical Medicines 
Act, seeing it as a crucial tool to address shortages of critical medicines. To highlight some 
key  considerations,  the  various  stakeholders’  groups,  companies  and  business  associations 
noted the persistent dependencies on non-EU suppliers, particularly for active pharmaceutical 
ingredients (APIs), and the resulting increased risk of medicine shortages. They welcomed the 
to  securing  supply  chains,  and  called  for  a 
European  Commission's  commitment 
comprehensive  legal  framework,  promoting  EU-based  production  of  APIs,  coupled  with  an 
improved  access  to  funding  mechanisms.  To  ensure  transparency,  accountability  and 
efficiency,  many  NGOs  proposed  regular  risk  assessments  and  vulnerability  analyses  of  the 
pharmaceutical  supply  chains  and  a  coordinated  monitoring  system  taking  into  account 
existing national systems, to avoid duplications. Public authorities in particular supported the 
voluntary joint procurement of critical medicines. Responses from various stakeholder groups 
noted  the  need  to  address  fragmentation  stemming  from  national  stockpiling  requirements. 
The importance of global partnerships aimed at maintaining robust supply chains was widely 
emphasised. A more detailed analysis of the responses will be included in the staff working 
document  to  be  produced  that  will  be  published  by  the  second  quarter  of  2025.  The 
Commission has also commissioned a study by an external contractor regarding the proposed 
regulation, which includes targeted consultations with various stakeholders. 

• 

Collection and use of expertise 

The  Union  List  of  Critical  Medicines56  was  compiled  with  the  expertise  of  the  Heads  of 
Medicines  Agencies  of  the  Member  States,  the  European  Commission,  and  the  EMA  in 
consultation with key stakeholders, including patient organisations and industry associations. 
Published for the first time in December 2023 and updated one year later, the list contains 276 
active substances used in medicines for human  use that are deemed critical  using an agreed 
methodology, based on two key criteria: 

• 

• 

The medicine's therapeutic indication targeting a serious condition; 

The limited availability of appropriate alternatives. 

Medicines are  included  on the Union list  if they meet  the  above-mentioned criteria on their 
critical  status  and  if  they  meet  additional  criteria,  such  as  the  number  of  Member  States 
considering  the  medicine  critical  or  the  marketing  status  of  the  medicine.  It  is  important  to 

55 
56 

Critical Medicines Act 
Union list of critical medicines | European Medicines Agency (EMA) 

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note  that  inclusion  on  the  list  does  not  necessarily  indicate  an  imminent  shortage,  rather  it 
prioritises prevention efforts for these critical medicines. 

The Commission conducted a technical assessment of supply chain vulnerabilities for critical 
medicines57. The analysis focused on a selection of 11 critical medicines from the Union list. 
The  issues  identified  by  the  pilot  included  the  significant  dependences  on  non-EU  active 
substances suppliers for 4 of the 11 molecules and risks stemming from market concentration. 
The  pilot  pointed  to  the  need  to  strengthen  resilience,  such  as  diversifying  supply  sources, 
increasing production capacity flexibility and developing robust risk management frameworks 
to  handle  economic  and  market  variability  effectively.  The  outcomes  of  this  pilot  exercise 
also  showed  some  limitations,  such  as  the  lack  of  legal  basis  for  data  collection  and 
information  sharing,  the  absence  of  harmonised  data  format  and  standards  leading  to 
interoperability  issues,  and  the  hesitancy  of  pharmaceutical  companies  to  share  highly 
sensitive commercial data. 

Studies: a study by an external contractor is being conducted that focuses on the assessment 
of  policy  options  in  the  realm  of  three  main  policy  strands:  horizontal  (scope,  governance, 
data);  enabling conditions  for investments  in critical  medicines; demand-side measures. The 
interim  report  of  the  study  has  been  taken  into  account  in  the  preparation  of  this  proposed 
Regulation, and further results of the study will feed into the staff working document that will 
be published by the second quarter of 2025 to provide the analysis and all supporting evidence 
underpinning this proposal.  
The  Study  on  best  practices  in  the  public  procurement  of  medicines58,  published  in  2022, 
mapped  and  analysed  practices  in  the  public  procurement  of  medicines  across  32  European 
countries. The report presents findings on organisational forms of procurement and the use of 
different  forms  of  procedures  and  techniques  (including  the  use  of  different  procurement 
requirements, such as the Most Economically Advantageous Tender). The possible impacts of 
public  procurement  of  medicines  on  access  to  medicines,  affordability  and  availability  of 
medicines and security of supply were assessed.  

Through  the  work  of  the  Alliance,  several  studies  have  also  been  used  as  evidence  for  the 
preparation  of  the  recommendations,  including  the  Advancy  study  on  ‘Strengthening  API 
production  industry  in  France  and  Europe’59.  This  study  highlights  the  significant 
competitiveness  deficit  faced  by  the  European  pharmaceutical  sector,  particularly  in  the 
production of essential  medicines and  active substances.  Furthermore, the OECD Report on 
‘Shortages  of  medicines  in  OECD  countries’60  also  served  as  evidence  to  the  Alliance;  this 
study  examined  the  nature  and  extent  of  medicine  shortages  pre-COVID  and  explored  the 
reasons  for  this  global  problem.  It  concludes  that  a  global  multistakeholder  approach  is 
necessary, involving all relevant actors, also beyond healthcare. 

• 

Impact assessment 

Given  the  urgent  need  to  address  the  policy  challenges  identified,  the  proposed  Regulation 
will be proposed without an impact assessment. However, its provisions are based on existing 
analyses,  stakeholder  consultations,  and  lessons  learned  from  past  initiatives  to  ensure  a 
proportionate  and  evidence–  based  approach.  To  further  assess  its  expected  impacts,  a  staff 
working  document  will  be  published  within  three  months  of  the  proposal’s  adoption, 

57 

58 
59 
60 

Commission  assessment  shows  the  need  to  reinforce  resilience  of  critical  medicines  supply  chains  - 
European Commission 
https://op.europa.eu/s/z1Rz  
https://efcg.cefic.org/wp-content/uploads/2025/01/Advancy-Sicos-report-extract-protected.pdf 
https://www.oecd.org/en/publications/shortages-of-medicines-in-oecd-countries_b5d9e15d-en.html 

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providing  a  summary  of  available  evidence  on  the  expected  impacts  of  the  proposed 
Regulation and the analysis underpinning the proposal. 

• 

Regulatory fitness and simplification 

The  proposal  does  not  envisage  significant  additional  regulatory  burden.  For  undertakings 
developing  a  strategic  project,  it  will  facilitate  the  creation  or  expansion  of  manufacturing 
capacities  of  critical  medicines,  their  active  substances  and  key  inputs  in  the  EU  by  fast-
tracking  permit-granting  procedures,  streamlining  environmental  assessments  and  providing 
targeted  support  when  needed.  For  national  public  administrations,  certain  reporting 
obligations are foreseen in relation to financial support provided to strategic projects, national 
programmes  to  ensure  sustainability  and  resilience  in  public  procurement  and  collaborative 
procurement  initiatives.  Nevertheless,  the  proposed  Regulation  will  also  generate  further 
synergies and ensure efficient coordination and collaboration between Member States to reach 
the Union’s strategic objective to strengthen the security of supply and availability of critical 
medicines.  

• 

Fundamental rights 

The proposal helps achieve a high level of human health protection and is therefore consistent 
with Article 35 of the Charter of Fundamental Rights of the European Union (‘the Charter’). 
Article 16 of the Charter provides for the freedom to conduct a business. The measures under 
this proposal support creation or expansion of manufacturing capacity and foster demand for 
critical medicines and other medicines of common interest with resilient supply chains, which 
can reinforce the freedom to conduct  a business in accordance with Union law and national 
laws and practices. 

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.  The  costs  of  this  proposal  will  be  fully  covered  through  redeployments  within 
existing financial envelopes of the current multiannual financial framework. For the duration 
of the 2021-2027 MFF61, the Strategic Projects may be supported by EU funding, including 
but  not  limited  to  EU4Health  Programme62,  Horizon  Europe63,  and  the  Digital  Europe 
programme64,  provided  that  they  comply  with  the  requirements  provided  for  in  these 
instruments. 

The indicative overall budgetary impact of the proposal is EUR 83.02 million for the period 
2026-2027  under  Heading  2b.  This  amount  will  finance  manufacturing  investments  and 
manufacturing capacity and will also cover expenses for meetings. These appropriations will 
be  redeployed  within  the  existing  financial  envelope  of  the  EU4Health  programme.  This 

61 

62 

63 

64 

Council  Regulation  (EU,  Euratom)  2024/2093  laying  down  the  multiannual  financial  framework  for 
years 2021 to 2027, as amended (OJ LI 433, 22.12.2020) 
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) 
Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing 
Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for 
participation  and  dissemination,  and  repealing  Regulations  (EU)  No  1290/2013  and  (EU)  No 
1291/2013, OJ L170, 12.5.2021, p. 1. 
Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing 
the Digital Europe Programme and repealing Decision (EU) 2015/2240, OJ L166, 11.5.2021, p. 1. 

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amount will also cover the increase to the EU contribution to EMA (EUR 1.4 million), due to 
increased  EMA  costs  for  staff,  IT  investments,  and  meeting  costs.  The  increased  EU 
contribution to EMA will be covered by the EU4Health programme's budgetary envelope in 
2026 and 2027.  

The  budgetary  impact  under  Heading  7  amounts  to  EUR  5,5.  This  amount  will  cover  staff 
costs and missions’ costs and will be covered through internal redeployment. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The  Commission  will  evaluate  the  impact  of  this  proposed  Regulation  and  whether  its 
objectives have been achieved by five years after the date of application and every five years 
thereafter. The main findings of the evaluation will be presented in a report to the European 
Parliament and the Council, which will be made public.  

This  proposal  introduces  a  requirement  for  Member  States  to  inform  the  Critical  Medicines 
Coordination  Group  about  their  intention  to  provide  national  financial  support  to  strategic 
projects, as well as for the Commission to inform periodically the Critical Medicines Group of 
the Strategic Projects that benefited from financial support from the Union and of setting up 
any  new  funding  possibilities.  The  data  gathered  is  necessary  to  monitor  and  evaluate  the 
success of this Regulation over time. 

• 

Detailed explanation of the specific provisions of the proposal 

This proposal consists of a proposal for a new regulation. The proposed Regulation includes 
the following main areas: 

General provisions 

Chapter I presents the objectives and subject matter of the proposed Regulation. The proposal 
establishes a framework for strengthening the security of supply and the availability of critical 
medicines  as  well  as  the  availability  of  and  accessibility  to  certain  other  medicines.  It  also 
clarifies the scope of the proposed Regulation.  While the proposal applies mainly to critical 
medicines  on  the  Union  List  of  Critical  Medicinal  Products  which  is  established  in  the 
proposed Pharmaceutical Regulation, some provisions of the proposed Regulation also apply 
to medicines of common interest facing market access issues in a number of Member States, 
especially  demand-side  measures.  Finally,  key  definitions  used  throughout  the  proposed 
Regulation are introduced.  

Strengthening the EU’s security of supply  

Chapter  II  clarifies  that  the  security  of  supply  and  availability  of  critical  medicines  for  all 
patients is one of the EU’s strategic objectives. This objective requires a coordinated approach 
from the Member States and the Commission.  

Enabling conditions for investment  

Criteria and procedure for the recognition of strategic projects  

Section I of Chapter III defines criteria for recognising some projects as Strategic Projects and 
describes  the  steps  to  recognise  such  projects  at  Member  State  level.  A  Member  State’s 
authority is designated to assess and confirm, upon request, whether the specific project meets 
the criteria laid down.  

Facilitating administrative and permit-granting processes  

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Section II of Chapter III provides for a priority status for Strategic Projects that are considered 
to  be  in  the  public  interest,  in  the  context  of  permit-granting  processes.  To  ensure  the  fast-
tracking  of  permit-granting  processes,  Strategic  Projects  may  also  request  to  be  granted  the 
status of highest national significance in Member States where such status exists and request a 
coordinated or joint procedure when an environmental assessment is required under different 
EU  legislation.  Finally,  the  proposal  also  provides  for  the  possibility  for  Strategic  Projects 
promotors  to  request  administrative,  regulatory  and  scientific  support  from  the  relevant 
authorities.  

Financial incentives 

Section III of Chapter III provides for the possibility for Member States to prioritise financial 
support  for  strategic  projects  that  address  a  supply  chain  vulnerability  and  requires  due 
consideration to the outcome of vulnerability evaluations and the strategic orientations of the 
Critical  Medicines  Group.  Strategic  projects  may  be  supported  by  EU  funding  under  the 
current MFF, if strategic projects fulfil the conditions and requirements of the calls under the 
available programmes. Finally, exchange of information on strategic projects that have or will 
receive financial support at Member State or EU level is  ensured  via the Critical Medicines 
Group.  

Demand side measures  

Award criteria and other procurement requirements and related measures  

Section I of Chapter IV imposes the use of procurement requirements other than price in the 
context  of  public  procurement  procedures  by  contracting  authorities  in  the  Member  States, 
unless  justified  by  market  analysis  and  considerations  related  to  the  financing  of  health 
services.  The  proposal  also  requires,  in  specific  cases,  when  justified  by  a  vulnerability 
analysis, that the contracting authorities apply procurement requirements that favour suppliers 
that manufacture a significant portion of these critical medicines in the EU. The compliance 
with  Union’s  international  commitments  should  be  ensured.  Finally,  Member  States  will  be 
required to develop national programmes to ensure security of supply of critical medicines via 
procurement,  and,  possibly,  pricing  and  reimbursement  practices.  When 
imposing 
contingency stocks on supply chain actors, Member States shall ensure these requirements are 
proportionate and respect the principles of transparency and solidarity. 

Collaborative procurements  

Section  II  of  Chapter  IV  provides  a  framework  for  Member  States  to  request  Commission 
support in the use of different collaborative procurement tools for critical medicines and other 
medicines  of  common  interest,  depending  on  the  context  and  respecting  the  principles  of 
subsidiarity  and  proportionality.  This  includes  Commission  facilitation  of  cross-border 
procurement between Member States, Commission procurement on behalf of or in the name 
of  Member  States,  as  well  as  the  Commission  and  Member  States  engagement  in  Joint 
Procurement.  

Critical Medicines Coordination Group  

Chapter V established the Critical Medicines Coordination Group, which is composed of the 
Commission and Member States’ representatives. The Critical Medicines Group’s main task 
is  to  facilitate  the  application  of  the  Regulation  including  by  facilitating:  a)  discussion  on 
strategic  orientation  for  financial  support  of  Strategic  Projects;  b)  exchanges  and,  where 
appropriate,  cooperation  on  national  procurement  policies;  c)  discussion  on  a  need  for 
collaborative procurement  initiatives;  d) advice on the order of priority  for  the vulnerability 
evaluation of critical medicines;. The Critical Medicines Group will also enable a discussion  
on strategic partnerships.  

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International cooperation  

Chapter  VI  requires  the  Commission  to  investigate  the  possibility  of  establishing  strategic 
partnerships.  

Final provisions 

Chapter VII contains provisions amending Regulation (EU) 2024/795. Chapter VIII imposes 
an obligation on the market actors to provide the information necessary for the application of 
the  proposed  regulation.  It  also  defines  the  timeline  for  the  evaluation  of  the  proposed 
Regulation and sets the dates of entry into force and application of the different provisions.  

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2025/102 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying a framework for strengthening the availability and security of supply of critical 
medicinal products as well as the availability of, and accessibility of, medicinal products 
of common interest, and amending Regulation (EU) 2024/795 

(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 114 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,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

Pursuant  to  Article  9  of  the  Treaty  on  the  Functioning  of  the  European  Union 
(‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union 
(the ‘Charter’), the Union is  to  ensure  a high  level  of human health protection in  all 
Union  policies  and  activities.  The  availability  of  safe,  efficacious  and  high-quality 
medicinal  products  is  vital  to  achieving  this  objective  and  to  safeguarding  public 
health across the Union. 

In  recent  years,  the  Union  has  experienced  an  increasing  number  of  shortages  of 
medicinal  products,  including  shortages  of  medicinal  products  for  which  insufficient 
supply results in serious harm or risk of serious harm to patients.  

Shortages of medicinal products can have very different and complex root causes, with 
challenges  identified  along  the  entire  pharmaceutical  value  chain.  In  particular, 
shortages  of medicinal  products can  result  from  supply  chain  disruptions  and 
vulnerabilities affecting the supply of key ingredients and components. These include 
existing  dependencies  on  a  limited  number  of  suppliers  globally  and  lack  of  Union 
capacities  to  produce  certain  medicinal  products,  their  active  substances  or  key  raw 
pharmaceutical materials. Through diversification of supply sources and investment in 
local production, the Union can reduce its risk of exposure to shortages of medicinal 
products. 

(4) 

Industrial  challenges  and  a  lack  of  investments  in  manufacturing  capacities  in  the 
Union  have  contributed  to  increased  dependency  on  third  country  suppliers,  in 
particular, for key raw pharmaceutical materials and active substances. Setting up new, 

1 

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EN 

17 

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or  modernising  existing  manufacturing  capacities  in  the  Union  for  critical  medicinal 
products, their key inputs and active substances, which have often been on the market 
for a long time and are considered to be relatively inexpensive, is currently not seen as 
a  sufficiently  attractive  option  for  private  investment,  also  in  view  of  lower  energy 
costs,  lesser  environmental  and  other  legal  requirements  elsewhere  in  the  world.  
in  pharmaceutical 
Workforce  shortages  and 
manufacturing further add to the industrial challenges to manufacturing in the Union. 
Targeted  financial  incentives,  simplified  administrative  processes,  and  better  Union-
level  coordination  can  contribute  to  supporting  efforts  to  increase  manufacturing 
capacities in the Union and strengthen the supply chains for critical medicines. 

the  need  for  specialised  skills 

To enhance the security of supply for medicinal products and thereby contribute to a 
high level of public health protection, the Union has implemented a range of measures 
that  contribute  to  building  a  European  Health  Union.  In  particular,  Regulation  (EU) 
2022/123 of the European Parliament and of the Council2 has reinforced the European 
Medicines Agency’s (‘the Agency’) mandate by enhancing monitoring, coordination, 
and  reporting  mechanisms  to  prevent  and  mitigate  supply  disruptions  of  critical 
medicinal  products  across  Member  States.  That  Regulation  also  established  the 
Agency’s  Executive  Steering  Group  on  Shortages  and  Safety  of  Medicinal  Products 
(‘the  MSSG’),  which  brings  together  representatives  from  the  Agency  and  Member 
States, to coordinate urgent actions within the Union to manage existing shortages and 
issues related to the quality, safety, and efficacy of medicinal products.  
In addition, Regulation (EU) …/… of the European Parliament and of the Council3 No 
[reference to be added after adoption cf. COM(2023) 193 final] further strengthens the 
continuity  of  supply  and  availability  of  medicinal  products  through  developing  the 
core tasks already granted to the Agency by Regulation (EU) 2022/123 and setting out 
a framework for the activities to be deployed by the Member States and the Agency to 
improve the Union capacity to react efficiently and in coordinated manner to support 
the shortages management and security of supply of medicinal products, including by 
strengthening  the  obligations  of  marketing  authorisation  holders  as  it  regards  the 
shortages prevention and reporting.  

However, despite regulatory obligations on marketing authorisation holders to ensure 
the  continuous  supply  of  medicinal  products  to  meet  patients’  demand  and  the 
additional regulatory mechanism introduced by Regulation of the European Parliament 
and of the Council (EU) 2022/123 and Regulation (EU) …/… [reference to be added 
after  adoption  cf.  COM(2023)193  final]  to  mitigate  and  respond  to  shortages,  the 
functioning  of markets  alone does not  always guarantee the availability of medicinal 
products.  This  risk  is  particularly  evident  in  cases  of  supply  chain  disruptions, 
especially when the supply of a given medicinal product relies on a limited number of 
global  suppliers  and  production  facilities  or  where  there  is  a  high  dependency  on  a 
single or a limited number of third countries.  

products 

and  medical 

Regulation  (EU)  2022/123  of  the  European  Parliament  and  of  the  Council  of  25  January  2022  on  a 
reinforced  role  for  the  European  Medicines  Agency  in  crisis  preparedness  and  management  for 
medicinal 
1, 
devices 
ELI: http://data.europa.eu/eli/reg/2022/123/oj) 
Regulation (EU) …/… of the European Parliament  and of the Council laying down Union procedures 
for  the  authorisation  and  supervision  of  medicinal  products  for  human  use  and  establishing  rules 
governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation 
(EU)  No  536/2014  and  repealing  Regulation  (EC)  No  726/2004,  Regulation  (EC)  No  141/2000  and 
Regulation (EC) No 1901/2006 (OJ … [OP: Please complete publication references]). 

31.2.2022, 

(OJ 

20, 

p. 

L 

(5) 

(6) 

(7) 

2 

3 

EN 

18 

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(8) 

(9) 

As the Union market  for medicinal products  remains  fragmented, there is a need  for 
better coordination between Member States to leverage in full the Union’s potential to 
strengthen the security of supply of medicinal products, without calling into question 
Member  States’  responsibilities  for  the  organisation  and  delivery  of  health  services 
and medical care. Uncoordinated national measures risk disrupting the internal market, 
fail to address broader supply chain issues, and are insufficient to resolve cross-border 
issues, including the Union's dependency on third countries. The regulatory framework 
for  medicinal  products  therefore  needs  to  be  complemented  by  targeted  actions 
providing for further harmonisation. 

Some  medicinal  products  of  common  interest  which  are  key  for  the  provision  of 
adapted care to patients, while not affected by supply security issues, may still not be 
available  to  patients  in  some  Member  States.  This  may  be  caused  by  a  variety  of 
factors, including product or geographical demand market size, which can impact the 
timely availability of medicinal products in certain Member States. 

(10)  The smooth functioning of the internal market and a high level of protection of human 
health  should  be  ensured  as  regards  medicinal  products  and  it  should  be  aimed  to 
complementing other Union pharmaceutical legislation by providing for a harmonised 
framework supporting Member States’ coordinated efforts to encourage investments in 
new and existing manufacturing capacities for critical medicinal products, encouraging 
the strategic use of public procurement instruments by the Member States as well as 
the  coordination  of  the  Member  States’  approaches,  including  through  leveraging 
aggregated  demand 
through  Commission  facilitated  collaborative  procurement 
procedures of critical medicinal products and medicinal products of common interest. 
Due to the international dimension of the security of supply, in particular taking into 
account  that  diversification  of  supply  chains  and  an  overall  increase  of  supply  are 
elements  of  a  solution  for  ensuring  the  security  of  supply,  international  cooperation 
should be encouraged.  

(11)  The  measures  introduced  by  this  Regulation  are  without  prejudice  to  marketing 
authorisation  holders’  obligations,  in  particular  under  Directive  (EU)  …/…  of  the 
European  Parliament  and  of  the  Council  [reference  to  be  added  to  corresponding 
Article after adoption of cf. COM(2023)192 final],  Regulation (EU) …/… [reference 
to be added after adoption cf. COM(2023) 193 final] and Regulation (EU) 2022/123, 
including the obligation to ensure sufficient supplies of medicinal products, within the 
limits  of  their  responsibility.  These  measures  are  aligned  with  the  principles  of  the 
internal  market.  This  Regulation  is  without  prejudice  to  Union  competition  law, 
including antitrust, merger and State aid rules. 

(12)  While the primary objective of this Regulation should be to strengthen the security of 
supply  and  ensure  the  availability  of  critical  medicinal  products  and  of  medicinal 
products of common interest, given a lack of critical medicinal products can affect the 
functioning  of  the  economy  as  a  whole,  this  Regulation  should  also  support  the 
Union’s  competitiveness  by  fostering  a  more  stable  and  predictable  market 
environment, encouraging investment and supporting innovation in the pharmaceutical 
sector. Ensuring the security of supply and availability of critical medicinal products 
and the availability and accessibility of other medicinal products of common interest 
should moreover contribute to the Union’s preparedness, resilience, and economic and 
overall security, including when cross-border supply chains risk being disrupted.  

EN 

19 

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(13)  Taking into account the different root causes of the availability issues affecting critical 
medicinal products and medicinal products of common interest, some measures should 
apply to critical medicinal products only. 

(14)  The availability and the security of supply of critical medicinal products are essential 
to  safeguard  public  health  and  the  economic  and  overall  security  of  the  Union  and 
therefore should be considered strategic objectives of the Union. 

(15)  A  well-defined  list  of  critical  medicinal  products  is  essential  to  ensure  that  the 
measures  are  targeted,  effective,  and  proportionate.  The  critical  medicinal  products 
covered  by  this  Regulation  should  be  those  for  which  insufficient  supply  results  in 
serious harm or risk of serious harm to patients. For this reason this Regulation should 
apply to critical medicinal products on the Union list of critical medicinal products, as 
established  by  Regulation  (EU)  …/…  [reference  to  be  added  after  adoption  cf. 
COM(2023)  193  final].  That  list  builds  upon  the  experiences  of  the  European 
Medicines  Agency and  Member States’  Agencies that in  2024, in  anticipation  of the 
reform  of  pharmaceutical  legislation,  identified  a  list  of  276  critical  medicinal 
products.  

(16)  To  ensure  that  the  measures  are  applied  where  justified  and  proportionate,  it  is 
necessary  to  demonstrate  that  some  measures  address  a  vulnerability  in  the  supply 
chains  of  a  given  critical  medicinal  product.  This  Regulation  should  rely  on  the 
vulnerability  evaluation  performed  for  the  purpose  of  the  application  of  the  general 
pharmaceutical  legislation  as  per  Regulation  (EU)  No  …/…  [reference  to  be  added 
after adoption cf. COM(2023) 193 final]. To detect a vulnerability in the supply chains 
it is  necessary to  look  at aggregated data across  all medicinal products  authorised in 
the  Union  and  containing  the  same  active  substance,  route  of  administration  and 
formulation.  Such  an  approach  allows  for  the  determination  whether,  for  a  critical 
medicinal product with a given active substance, the Union is highly dependent on  a 
single or a limited number of third countries, or a limited number of sites, for active 
substances, key inputs, or finished dosage forms. 

(17)  Certain projects can have a positive impact on security of supply as they increase the 
Union’s  manufacturing  capacity  for  critical  medicinal  products  and  strengthen  the 
resilience of the Union’s supply chains.  In order to encourage private investments in 
these projects, the concept of strategic projects should be introduced. Given their role 
in ensuring the Union’s security of supply for critical medicinal products, the relevant 
permitting authority should consider strategic projects to be in the public interest. To 
ensure  their  expedient  implementation,  national  authorities  should  ensure  that  the 
relevant permit granting processes are carried out in the fastest way possible making 
available,  in  particular  any  form  of  accelerated  procedures  that  exists  in  applicable 
Union  and  national  law.  National  authorities  should  consider,  when  possible,  their 
streamlining as well as enable digital submission of required information. 

(18)  To avoid unnecessary delays and the creation of additional administrative layers, the 
verification  of  whether  a  project  fulfils  the  strategic  project  criteria  should  be 
performed by any Member State authority requested to provide advantages offered in 
this Regulation. A designated authority should, when solicited, verify whether a given 
project  is  a  strategic  project.  In  order  to  accelerate  and  facilitate  their  deployment, 
strategic  projects  should  benefit  from  streamlined  administrative  processes,  priority 
status  in  the  context  of  permit  granting  procedures  and  related  dispute  resolution 
procedures,  as  well  as,  be  offered  targeted  regulatory  support.  In  this  context,  the 

EN 

20 

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Member States should give particular attention to small and medium sized enterprises 
(SMEs) which should have a fair chance to initiate strategic projects. 

(19)  The  production  of  medicinal  products  has  environmental  implications  and  may 
negatively  impact  not  only  the  environment  itself  but  also  human  health.  The 
environmental  assessments  and  authorisations  required  under  Union  law  are  an 
integral  part  of  the  permit-granting  process  for  strategic  projects  and  an  essential 
safeguard  to  ensure  negative  environmental  impacts  are  prevented  or  minimised. 
However, to ensure that permit-granting processes for strategic projects are predictable 
and  timely,  it  should  be  possible  to  streamline  the  required  assessments  and 
authorisations by the relevant authority, while not lowering the level of environmental 
protection.  

(20)  Land  use  conflicts  can  create  barriers  to  the  deployment  of  strategic  projects.  The 
relevant national, regional or local authority responsible for preparing zoning, spatial 
and  land  use  plans  should  consider  whether  to  introduce  in  these  plans  certain 
provisions related to strategic projects. Those plans have the potential to help balance 
the  public  interest  and  common  good,  decreasing  the  potential  for  conflict  and 
accelerating the sustainable deployment of strategic projects in the Union.  

(21)  Given  the  capital-intensive  nature  of  pharmaceutical  production,  including  the 
establishment  or  expansion  of  manufacturing  sites  for  critical  medicinal  products, 
active substances, and key inputs, targeted financial support can play a crucial role in 
incentivising  production  within  the  Union.  To  strengthen  the  security  of  supply  of 
critical  medicinal  products,  and  where  private  investment  alone  is  not  sufficient, 
financial support of investments  in  manufacturing capacity within the Union may be 
justified.  Member  States  should  be  able  to  prioritise  financial  support  for  strategic 
projects that address specific vulnerabilities in the supply chains, while ensuring that 
such  support  complies  with  the  Union’s  State  aid  rules.  For  this  purpose,  specific 
guidance to  clarify the  application of EU State aid  rules to  assist  the Member States 
has been provided by the Commission services and will be updated as necessary.  

(22)  Union-level  funding  may  be  leveraged  to  facilitate  investments  in  strategic  projects. 
Strategic projects may benefit from access to existing EU funding instruments, such as 
the  EU4Health  Programme4,  Digital  Europe  Programme5  and  Horizon  Europe6 
(relevant, for example, for active substances referred to in Article 5(d) of Regulation 
(EU)2021/695),  as  well  as  the  Strategic  Technologies  for  Europe  Platform  (STEP), 
when they fulfil the criteria established in these instruments.  Authorities in charge of 
the  Union  programmes  covered  by  Regulation  (EU)  2024/795  of  the  European 
Parliament  and  of  the  Council7  (STEP)  should  in  particular  consider  supporting 

4 

5 

6 

7 

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, 
ELI: http://data.europa.eu/eli/reg/2021/522/oj) 
Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing 
the  Digital  Europe  Programme  and  repealing  Decision  (EU)  2015/2240(  OJ  L166,  11.5.2021,  p.  1, 
ELI: http://data.europa.eu/eli/reg/2021/694/2023-09-21) 
Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing 
Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for 
participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 
(OJ L170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj) 
Regulation  (EU)  2024/795  of  the  European  Parliament  and  of  the  Council  of  29 February  2024 
amending 
establishing 

the  Strategic  Technologies 

for  Europe  Platform 

(STEP), 

and 

EN 

21 

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strategic projects addressing a vulnerability in the supply chains of critical medicinal 
products and therefore Regulation (EU) 2024/795 should be amended. 

(23)  To  allow  for  a  more  coordinated  approach  to  financial  support,  it  is  appropriate  that 
Member States and the Commission exchange the information on financial support to 
strategic  projects.  As  regards  the  strategic  projects  that  have  benefitted  from  EU 
funding,  the  beneficiaries  should  follow  the  relevant  communication  and  visibility 
rules8. 

(24)  Given that public authorities or entities are the principal buyers of medicinal products 
for  the  inpatient  sector  and  that  the  public  procurement  of  medicinal  products  is  a 
powerful  tool  to  improve  security  of  supply  and  the  availability  and  accessibility  of 
other  medicinal  products  of  common  interest,  it  is  necessary  to  establish  rules  that 
require  the  use  of  the  procurement  requirements  referring  to  Most  Economically 
Advantageous  Tender  (MEAT)  that  take  into  account  the  supply  security  and 
availability  considerations.  Procurement  requirements  based  on  such  considerations 
should include stockholding obligations, a number of diversified suppliers, state of the 
art  monitoring  of  supply  chains,  their  transparency  to  the  contracting  authority  and 
contract  performance  clauses  on  timely  delivery  and  measures  in  case  of  non-timely 
delivery.  

(25) 

Inconsistent use of  procurement requirements in  public procurement procedures may 
have  negative  impact  on  the  internal  market  as  it  creates  obstacles  to  cross-border 
participation  and a lack  of predictability for bidders.  In order to  avoid  such negative 
outcomes, the use of MEAT criteria should be mandatory.  

(26)  To  ensure  a  high  level  of  health  protection  and  security  of  supply,  it  is  necessary  to 
procure  in  a  way  that  promotes  diversification  of  suppliers  where  dependency  on  a 
single  or  a  limited  number  of  third  countries,  threatening  the  security  of  supply,  has 
been  established  through  a  vulnerability  evaluation.  In  such  situations,  contracting 
authorities  in  the  Member  States  should  introduce  procurement  requirements  that 
favour suppliers of critical medicinal products that manufacture a significant portion of 
these products in the EU. Moreover, the contracting authorities in the Member States, 
when  justified  by  market  analysis  and  public  health  considerations,  may  apply 
procurement  requirements  that  favour    suppliers  of  medicinal  products  of  common 
interest that manufacture a significant portion of these medicinal products in the EU. 
These measures should be designed and applied in line with the Union's international 
obligations including the principles of non-discrimination and proportionality. 

(27)  The  application  of  procurement  requirements  should  take  into  account  the  specific 
market  conditions  and  public  health  needs  of  each  procurement  procedure,  whilst 
bearing  in  mind  the  considerations  related  to  affordability  of  medicinal  products. 
Certain  procurement  requirements  may  not  be 
in 
they  result 
disproportionate cost for procurers or discourage participation, leading to no bids. 

justified 

if 

(28) 

In  accordance  with  Article  168(7)  TFEU  Member  States’  responsibilities  for  the 
definition of their health policy and for the organisation and delivery of health services 
and medical care, including the allocation of  financial resources, are to be respected. 
The  contracting  authorities  should  therefore  retain  the  ability,  where  justified  by  the 

Directive 2003/87/EC  and  Regulations  (EU) 2021/1058,  (EU) 2021/1056,  (EU) 2021/1057,  (EU) 
No 1303/2013,  (EU)  No 223/2014,  (EU) 2021/1060,  (EU) 2021/523,  (EU) 2021/695,  (EU) 2021/697 
and (EU) 2021/241, (OJL 2024/794, 29.2.2024,  ELI: http://data.europa.eu/eli/reg/2024/795/oj) 
Communication and visibility rules - Publications Office of the EU 

8 

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considerations related to the market analysis or considerations related to financing of 
health services, to adopt procurement approaches that differ from those set out in this 
Regulation as long as they are in line with the Union’s international obligations.  

(29)  The  Commission  intends  to  issue  guidelines  designed  to  support  Member  States  in 
implementing  their  obligations  to  use  procurement  requirements  including  award 
criteria  beyond  price  considerations  with  a  view  to  strengthening  the  security  of 
supply,  building  on  best  practices  identified  in  the  context  of  the  cooperation  of 
national  competent  authorities  on  pricing  and  reimbursement  and  public  health  care 
payers  and  detailing  procurement  practices  that  support  availability  and  security  of 
supply is appropriate.  

(30)  The procurement of medicinal products is organised differently across Member States, 
involving  various  actors.  To  strengthen  the  security  of  supply  chains  for  critical 
medicinal  products,  Member  States  should  establish  national  programmes  that 
promote  the  consistent  use  of  procurement  criteria  by  contracting  authorities  within 
their territory, including the application of multi-winner approaches where beneficial, 
based  on  thorough  market  analysis.  To  ensure  a  comprehensive  approach,  and 
considering  that  critical  medicinal  products  are  also  relevant  for  outpatient  sector 
where  they  are  often  not  purchased  through  public  procurement,  these  programmes 
may also encompass measures to strengthen supply chain resilience and sustainability 
through  measures  related  to  pricing  and  reimbursement,  where  appropriate.  The 
programmes  should  be  shared  with  the  Commission  and  the  Critical  Medicines 
Coordination Group, established by this Regulation, to facilitate the exchange of best 
practices  and  coordination  between  the  Member  States.  This  cooperation  should 
enhance  the  overall  effectiveness  of  the  various  measures  put  forward  to  secure  the 
supply  of  critical  medicinal  products,  while  respecting  the  principles  of  subsidiarity 
and proportionality.  

(31)  Obligations  imposed  by  the  Member  States  on  companies  in  the  pharmaceutical 
supply  chain  to  hold  contingency  stocks  can  have  a  serious  negative  impact  on  the 
internal market and other Member States. To avoid such an impact, these obligations 
should  be  designed  taking  into  consideration  the  principles  of  proportionality, 
transparency  and  solidarity.  The  Member  States  should  give  due  consideration  to 
forthcoming  Commission  guidelines  designed  to  facilitate  the  fulfilment  of  Member 
States’  obligations  as  regards  the  absence  of  any  negative  impact  on  the  internal 
market when proposing and defining the scope and timing of any form of requirements 
for companies to hold such stocks. 

(32)  Availability and access disparities exist for critical medicinal products and  medicinal 
products of common interest throughout the Union, disproportionately affecting some 
Member  States.  The  collaborative  procurement  of  critical  medicinal  products  and  of 
medicinal  products  of  common  interest  can  be  a  powerful  tool  to  improve  their 
security of supply and accessibility. 

(33)  Directive 2014/24/EU of the European Parliament and of the Council9 provides for the 
possibility  of  procurement  involving  contracting  authorities  from  different  Member 
States.  Whereas  it  has  been  found  helpful  to  make  small  markets  attractive  for 
its 
suppliers, 

thereby  achieving  better  availability  of  medicinal  products, 

9 

Directive  2014/24/EU of  the European  Parliament  and of  the  Council of 26  February  2014 on public 
(OJ  L  94,  28.3.2014,  p.  65,  ELI: 
procurement  and 
http://data.europa.eu/eli/dir/2014/24/oj). 

repealing  Directive  2004/18/EC 

EN 

23 

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implementation  is  time-  and  resource-intensive,  especially  in  the  starting  phase,  and 
considered  a  limiting  factor.  To  facilitate  the  deployment  of  procurement  initiatives 
involving  contracting  authorities  from  different  Member  States,  the  Commission, 
when requested, should provide its assistance during the preliminary phase of setting 
up such a procurement initiative. 

(34)  Taking  into  account  experiences  resulting  from  the  implementation  of  joint 
procurement  of  medical  countermeasures  pursuant  to  Regulation  (EU)  2022/2371  of 
the European Parliament and of the Council10 and of COVID-19 vaccines, pursuant to 
Council Regulation (EU) 2016/36911 in the context of the EU Vaccines Strategy and 
acknowledging potential benefits that leveraging of several Member States demand in 
one procurement procedure may have, Member States should be able to consider the 
use of joint procurement or to consider requesting the Commission to procure on their 
behalf, or in their name, where such procurement could contribute to the achievement 
of the objectives of this Regulation.  

(35)  To ensure that the collaborative procurement initiatives contribute to the achievement 
of the objectives of this Regulation, while fully respecting the principle of subsidiarity, 
the Commission’s involvement in joint procurement and procurement on behalf, or in 
the  name  of  the  Member  States,  should  be  limited  to  defined  cases.  For  this  reason 
derogations  from  Article 168 (2) and (3) of Regulation  (EU, Euratom) 2024/2509  of 
the European Parliament and of the Council12 should be provided.  

(36)  To ensure transparency, legal clarity, and effective coordination, structured agreement 
between  the  Member  States  and  the  Commission  should  govern  procurement 
procedures  under  this  Regulation  that  rely  on  an  active  Commission  involvement. 
Such  agreement  should  set  out  the  division  of  responsibilities,  decision-making 
processes,  the  information  to  be  shared  as  relevant  to  the  procurement  procedure, 
including information on Member States’ participation in parallel negotiations through 
different  channels  in  relation  to  the  same  medicinal  products  or  the  same  active 
substances  as  appropriate,  and  liability  provisions,  ensuring  a  fair  and  efficient 
framework  for  participating  Member  States  while  preventing  market  distortions  and 
supply  disruptions.  This  Regulation  is  without  prejudice  to  and  does  not  prevent  the 
use of joint procurement procedures established under Regulation (EU) 2022/2371 of 
the European Parliament and of the Council for those critical medicinal products and 
the  definition  of  medical 
other  medicinal  products 
countermeasures  as  set  out  in  that  Regulation.  For  such  medicinal  products,  the 
objective  of  the  joint  procurement  initiative  should  determine  the  applicable 
framework. Where a joint procurement procedure is initiated with the aim of advance 
purchasing of these medicinal products as medical countermeasures to prepare for and 
respond to serious cross-border threats to health, such a procurement procedure should 
be  carried  out  in  accordance  with  Regulation  (EU)  2022/2371.  This  Regulation  is 

fall  within 

that  also 

10 

11 

12 

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on 
serious cross-border threats to health and repealing Decision  No 1082/2013/EU (OJ L 314, 6.12.2022, 
p. 26,  ELI: http://data.europa.eu/eli/reg/2022/2371/oj). 
Council Regulation (EU) 2016/296 of 15 March 2016 on the provision of the emergency support within 
the Union (OJ L 70, 13.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/369/oj)  
Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 
2024 on the financial rules applicable to the general budget of the Union (OJ L, 2024/2509, 26.9.2024, 
ELI: http://data.europa.eu/eli/reg/2024/2509/oj). 

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without  prejudice  to  Council  Regulation  (EU)  2022/237213  setting  the  framework  of 
measures  for  ensuring  the  supply  of  crisis-relevant  medical  countermeasures  in  the 
event of a public health emergency at Union level.  

(37)  Ensuring a structured and coordinated approach to strengthening the security of supply 
of  critical  medicinal  products  requires  collaboration  between  the  Member  States  and 
the  Commission.  To  facilitate  this,  the  Critical  Medicines  Coordination  Group  (‘the 
Critical  Medicines  Group’)  should  be  established  to  facilitate  effective  coordination 
across the relevant policy areas. The Critical Medicines Group should be composed of 
high-level  representatives  of  Member  States  with  expertise  in  medicinal  product 
procurement  policies,  industrial  policy  related  to  pharmaceuticals  and  public  health. 
The Commission should be a member of the group. To ensure structured discussions, 
the Commission should chair the Critical Medicines Group and perform the functions 
of its secretariat.  

(38)  To  ensure  coordinated  implementation  of  this  Regulation,  the  Critical  Medicines 
Group should enable exchanges of information related to funding of strategic projects 
and  facilitate  the  strategic  orientation  of  financial  support  for  strategic  projects.  The 
Critical  Medicines  Group  should  also  facilitate  the  exchange  of  information  on 
national programmes, including on the approach to contingency stock requirements in 
public  procurement  contracts.  When  relevant,  the  Critical  Medicines  Group  should 
facilitate  the  coordination  of  national  programmes.  The  Critical  Medicines  Group 
should  furthermore  facilitate  discussions  on  the  need  to  launch  a  collaborative 
procurement  initiative  and  the  need  to  prioritise  the  vulnerability  evaluation  for 
specific critical medicinal products.  

(39)  The  Union  could  further  enhance  the  availability  and  security  of  supply  of  critical 
medicinal  products by  providing  access  to  alternative  sources  of  supply  in  third 
countries  through  international  trade  agreements  or  other  forms  of  international 
cooperation.  The  Union  could,  to  that  end,  rely  on  its  network  of  existing  trade 
agreements  and  additionally  pursue  strategic  partnerships  with  third  countries  to 
further  deepen  bilateral  cooperation,  especially  with  candidate  countries.  In  this 
context,  the  Commission  should  assess  whether  existing  partnerships  effectively 
address the intended aims or could be further improved or upgraded, and what types of 
potential partnerships could be concluded with the most relevant third countries. This 
should be done without prejudice to the prerogatives of the Council in accordance with 
the Treaties.  

(40)  To  ensure  the  application  of  this  Regulation,  it  is  necessary  that  economic  operators 
make available information and data to public authorities. The Member States and the 
Commission must therefore be able to request, when necessary and avoid duplication 
of  information  requests,  the  information  necessary  for  the  application  of  this 
Regulation,  including  its  evaluation,  from  any  economic  operator  in  the  supply  and 
distribution chains  of critical  medicinal products  and medicinal products  of common 
interest.  

(41) 

In order to ensure that this Regulation effectively meets its objectives, it is essential to 
assess its implementation and impact over time. The Commission should carry out an 
evaluation  of  this  Regulation  five  years  after  its  application  and  every  five  years 

13 

Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the 
supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union 
level (OJ L 314, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj) 

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thereafter.  This  evaluation  should  include  an  assessment  of  the  extent  to  which  the 
Regulation’s  objectives,  as  set  out  in  Article  1,  have  been  achieved,  including  its 
impact on stakeholders, regulatory procedures, and market dynamics. In particular, the 
Commission’s  evaluation  should  take  into  account  the  views  of  Member  States, 
economic  operators,  and  other  relevant  stakeholders,  ensuring  that  their  feedback 
contributes to the continuous improvement of the regulatory framework. The results of 
this  evaluation  should  be  presented  to  the  European  Parliament,  the  Council,  the 
European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions.  In 
order to facilitate this evaluation, national  authorities and economic operators should 
provide  relevant  data  and  information  upon  request  to  support  the  Commission’s 
assessment. 

(42)  Since  the  objectives  of  this  Regulation  to  establish  a  framework  to  strengthen  the 
availability and security of supply of critical medicinal products within the Union and 
to improve the availability and accessibility of medicinal products of common interest 
through  coordinated  and  targeted  action  of  Member  States  cannot  be  sufficiently 
achieved by the Member States acting alone, but can rather, by reason of its scale, be 
better achieved at Union level, the Union may adopt measures in accordance with the 
principle of subsidiarity, as set out in Article 5 of the  TFEU. 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 its objectives. 

HAVE ADOPTED THIS REGULATION: 

Chapter I 
General provisions 

Article 1 

Objectives and subject matter  

1. 

The  objective  of  this  Regulation  is  to  strengthen  the  security  of  supply  and  the 
availability of critical medicinal products within the Union, thereby ensuring a high 
level  of  public  health  protection  and  supporting  the  security  of  the  Union.  The 
objective  of  this  Regulation  is  also  to  improve  the  availability  and  accessibility  of 
other  medicinal  products,  where  the  functioning  of  the  market  does  not  otherwise 
sufficiently  ensure  the  availability  and  accessibility  of  those  medicinal  products  to 
patients,  whilst  giving  due  consideration  to  the  appropriateness  to  ensure  the 
affordability of medicinal products.  

2. 

To  achieve  the  objectives  referred  to  in  paragraph  1,  the  Regulation  sets  out  a 
framework to: 

(a) 

(b) 

facilitate investments in manufacturing capacity for critical medicinal products, 
their active substances and other key inputs in the Union; 

lower the risk of supply disruptions and strengthen availability by incentivising 
supply  chain  diversification  and  resilience 
the  public  procurement 
procedures  of  critical  medicinal  products  and  other  medicinal  products  of 
common interest; 

in 

(c) 

leverage  the  aggregated  demand  of  participating  Member  States  through 
collaborative procurement procedures, and 

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26 

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(d) 

support the diversification of supply chains also by facilitating the conclusion 
of strategic partnerships. 

Article 2 

Scope 

1. 

2. 

This Regulation applies to the critical medicinal products listed in the Union List of 
Critical  Medicinal  Products  referred  to  in  Article  131  of  Regulation  (EU)  …/… 
[reference to be added after adoption cf. COM(2023) 193 final]. 

Chapter IV and Article 26(2) point (c) also apply to medicinal products of common 
interest. Chapter III does not apply to medicinal products of common interest. 

Article 3 

Definitions 

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

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

‘medicinal  product’  means  a  medicinal  product  as  defined  in  Article  4  point  (1)  of 
Directive (EU) …/… of the European Parliament and of the Council [reference to be 
added to corresponding Article after adoption of cf. COM(2023)192 final];  

‘key  input’  means  input  material  other  than  an  active  substance  required  in  the 
manufacturing  process  of  a  given  medicinal  product,  including  primary  packaging 
materials, excipients, solvents and reagents; 

‘active  substance’  means  an  active  substance  as  defined  in  Article  4  point  (3)  of 
Directive (EU) …/… [reference to be added to corresponding Article after adoption 
of cf. COM(2023)192 final]; 

‘critical medicinal product’ means a medicinal product for which insufficient supply 
results in serious harm or risk of serious harm to patients as defined in Article 4 point 
(13) of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 
193 final]; 

‘medicinal  product  of  common  interest’  means  a  medicinal  product,  other  than  a 
critical medicinal product, for which in three or more Member States the functioning 
of the market does not sufficiently ensure the availability and accessibility to patients 
in the quantities and presentations necessary to cover the needs of patients in those 
Member States;  

‘vulnerability  in  the  supply  chains’  means  risks  and  weaknesses  within  the  supply 
chains  of  critical  medicinal  products,  identified  at  the  aggregated  level,  taking  into 
account  all  authorised  medicinal  products  in  the  EU  and  grouped  under  a  common 
name  with  the  same  route  of  administration  and  formulation,  that  compromise  the 
continuous supply of such medicinal products to patients in the Union; 

‘vulnerability  evaluation’  means  the  evaluation  of  the  supply  chains  of  critical 
medicinal  products  to  identify  their  vulnerabilities  performed  by  the  MSSG  in 
accordance  with  Regulation  (EU)  …/…  of  the  European  Parliament  and  of  the 
Council14 [reference to be added after adoption cf. COM(2023) 193 final]; 

14 

Regulation (EU) …. of the European Parliament and of the Council laying down Union procedures for 
the authorisation and supervision of medicinal products for human use and establishing rules governing 

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(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(15) 

(16) 

(17) 

(18) 

(19) 

‘common  name’  means  a  common  name  as  defined  in  Article  4  point  (48)  of 
Directive (EU) …/… of the European Parliament and of the Council [reference to be 
added to corresponding Article after adoption of cf. COM(2023)192 final]; 

‘contracting  authorities’  means  contracting  authorities  as  defined  in  Article  2(1) 
point (1) of Directive 2014/24/EU; 

‘strategic  project’  means  an  industrial  project  identified  pursuant  to  the  criteria  set 
out in Article 5; 

‘project promoter’ means any undertaking or consortium of undertakings developing 
a strategic project; 

‘permit granting process’ means a process covering all relevant permits to build and 
operate a strategic project, including building, chemical and grid connection permits 
and  environmental  assessments  and  authorisations  where  those  are  required  and 
encompassing all applications and procedures; 

‘innovative  manufacturing  process’  means  a  novel  manufacturing  process  and 
technology or novel application of an existing technology, including, but not limited 
to,  decentralised  manufacturing,  continuous  manufacturing,  Artificial  Intelligence, 
platform techniques, 3D manufacturing;  

‘Member States’ cross-border procurement’ means a procurement procedure initiated 
between  the  contracting  authorities  from  different  Member  States  on  the  basis  of 
Article 39 of Directive 2014/24/EC; 

‘procurement  on  behalf  of  or  in  the  name  of  the  Member  States’  means  a 
procurement procedure initiated at the request of Member States and mandating the 
Commission to act as a central purchasing body on behalf of, or in the name of, the 
requesting  Member  States,  as  provided  for  in  Article  168(3)  of  Regulation  (EU) 
2024/2509;  

‘joint  procurement’  means  a  procurement  procedure  carried  out  jointly  by  the 
Commission  and  Member  States,  as  provided  for  in  Article  168(2)  of  Regulation 
(EU) 2024/2509; 

‘supplier’  means  the  manufacturer  or  marketing  authorisation  holder  of  finished 
dosage forms, or manufacturer of key inputs or active substances; 

‘strategic partnership’ means a commitment between the Union and a third country, 
group of third countries or international organisations to increase cooperation related 
to one or more critical medicinal products that is established through a non-binding 
instrument  and  which  facilitates  beneficial  outcomes  for  both  the  Union  and  the 
relevant third country, group of third countries or international organisation. 

the  European  Medicines  Agency,  amending  Regulation  (EC)  No  1394/2007  and  Regulation  (EU)  No 
536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation 
(EC)  No  1901/2006  (OJ  …)  [D.G.:  Title  according  to  COM(2023)  193  final.  Please  check  against 
latest version of this draft Regulation]. 

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Chapter II 
Strengthening the Union’s security of supply 

Article 4 

Strategic objective of the Union 

1. 

2. 

The security of supply and availability of critical medicinal products for patients is a 
strategic objective of the Union.  

The  Member  States  and  the  Commission  shall  work  together  to  strengthen  the 
security  of  supply  and  continuous  availability  of  critical  medicinal  products  in  the 
Union  through  measures  that  take  full  advantage  of  the  potential  of  the  internal 
market.  

3. 

The Commission shall support the coordinated efforts of the Members States.  

Chapter III 
Enabling conditions for investment 

SECTION I 

CRITERIA AND PROCEDURE FOR THE RECOGNITION OF STRATEGIC 
PROJECTS 

Article 5 

Strategic Projects 

A  project  located  in  the  Union  and  related  to  creating  or  increasing  manufacturing  capacity 
shall be considered as a strategic project if it meets at least one of the following criteria: 

(a) 

(b) 

(c) 

(d) 

it  creates  or  increases  manufacturing  capacity  for  one  or  more  critical  medicinal 
products or for collecting or manufacturing their active substances; 

it  modernises  an  existing  manufacturing  site  for  one  or  more  critical  medicinal 
products  or  their  active  substances  to  ensure  greater  sustainability  or  increased 
efficiency;  

it  creates  or  increases  manufacturing  capacity  for  key  inputs  necessary  for  the 
manufacturing of one or more critical medicinal products or their active substances;  

it  contributes  to  the  roll-out  of  a  technology  that  plays  a  key  role  in  enabling  the 
manufacturing of one or more critical medicinal products, their active substances or 
key inputs. 

Article 6 

Recognition of Strategic Projects 

1. 

Each Member State shall designate an authority (‘the designated authority’) that shall 
assess and verify whether or not a project meets at least one of the criteria set out in 
Article 5 and therefore constitutes a strategic project. 

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29 

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A  promoter  may  request  the  designated  authority  to  assess  whether  a  project  is  a 
strategic project. 

Any  Member  State  authority  may  request  the  designated  authority  to  verify  its 
determination of whether a project is a strategic project.  

Member  States  shall  communicate  to  the  Commission  what  is  the  designated 
authority for the purposes of paragraph 1.  

The  Commission  shall  provide  a  simple,  accessible  webpage  on  which  the  contact 
details and other relevant information on the Member States’ designated authorities 
shall be clearly listed.  

Any  other  Member  State  authority  that  receives  a  request  from  a  promoter 
concerning Articles 8 to 14 shall assess whether that given project meets the criteria 
to be considered a strategic project as provided for in Article 5 and where necessary, 
request the verification of its determination from the designated authority.  

Where the verification whether a project is a strategic project has been performed by 
an  authority  in  accordance  with  this  Article,  any  other  authority  shall  rely  on  that 
verification.  

2. 

3. 

4. 

5. 

SECTION II 

FACILITATING ADMINISTRATIVE AND PERMIT-GRANTING PROCESSES 

Article 7 

Priority status of strategic projects 

Strategic  projects  shall  be  considered  as  contributing  to  the  security  of  supply  of  critical 
medicinal products in the Union and, therefore, to be in the public interest.  

The  Member  States’  authorities  shall  ensure  that  the  relevant  permit  granting  processes 
related  to  strategic  projects  are  carried  out  in  the  fastest  way  possible,  making  available,  in 
particular,  any  form  of  accelerated  procedures  that  exists  in  applicable  Union  and  national 
law.  

Article 8 

Administrative support 

1. 

Upon  request  of  a  project  promoter,  a  Member  State  shall  provide  to  a  strategic 
project located on its territory all the administrative support necessary to facilitate its 
timely and effective implementation, including assistance: 

(a)  with  regard  to  compliance  with  applicable  administrative  and  reporting 

obligations; 

(b)  with  regard  to  informing  the  public,  with  the  aim  of  increasing  public 

acceptance of the strategic project; 

(c) 

along the permit-granting process.  

2. 

When  providing  the  administrative  support  and  the  assistance  referred  to  in 
paragraph  1,  the  Member  State  shall  pay  particular  attention  to  small  and  medium 

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30 

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size  enterprises  (SMEs)  and,  where  appropriate,  establish  a  dedicated  channel  for 
communication with SMEs to provide guidance and respond to queries related to the 
implementation of this Regulation.  

Article 9 

Request for granting the status of highest national significance  

1. 

2. 

A  project  promoter  may  request  that  their  application  for  a  permit  is  granted  the 
status of the highest national significance, when such a status exists in national law, 
and be treated accordingly.  

National  authorities  shall  grant  the  status  of  the  highest  national  significance  to  an 
application for a permit without prejudice to obligations provided for in Union law. 

Article 10 

Procedures relating to dispute resolution 

A project promoter may request that any dispute resolution procedure, litigation, appeal and 
proceedings  on  judicial  remedies  related  to  the  permit-granting  process  and  the  issuance  of 
permits  for  a  strategic  project  in  the  Union  before  any  national  courts,  tribunals  or  panels, 
including with regard to mediation or arbitration, where they exist in national law, is treated 
as urgent if and to the extent to which national law provides for such an urgency procedure. 
The  applicable  rights  of  defence  of  individuals  or  of  local  communities  shall  be  respected 
during such urgency procedure.  

The project promoter shall participate in such urgency procedures, where applicable.  

Article 11 

Regulatory and scientific support from medicines agencies and pharmaceutical 
inspectorates 

Upon request of a project promoter, a Member State shall provide regulatory support 
to  a  strategic  project  located  on  its  territory,  including  by  prioritising  Good 
Manufacturing  Practices 
for  approval  of  new  and  extended 
manufacturing sites and for the manufacturing sites modernised in the context of the 
concerned strategic project. 

inspections 

Upon request of a project promoter, the European Medicines Agency (‘the Agency’) 
shall provide dedicated advice to assist project promoters developing projects relying 
on innovative manufacturing processes. 

Article 12 

Environmental assessments and authorisation 

A  project  promoter  may  request,  where  the  obligation  to  assess  the  effects  on  the 
environment  arises  simultaneously  from  two  or  more  of  Council  Directive 
92/43/EEC15, Directive 2000/60/EC of the European Parliament and of the Council16, 

Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna 
and flora (OJ L 206, 22.7.1992, p. 7, ELI: http://data.europa.eu/eli/dir/1992/43/oj). 

1. 

2. 

1. 

15 

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Directive  2001/42/EC  of  the  European  Parliament  and  of  the  Council17,  Directive 
2008/98/EC of the European Parliament and of the Council18, Directive 2009/147/EC 
of  the  European  Parliament  and  of  the  Council19,  Directive  2010/75/EU  of  the 
European  Parliament  and  of  the  Council20,  Directive  2011/92/EU  of  the  European 
Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament 
and of the Council22, that a coordinated or joint procedure fulfilling the requirements 
of those Union legislative acts are applied. 

Under  the  coordinated  procedure  referred  to  in  the  first  subparagraph,  a  competent 
authority  shall  coordinate  the  various  individual  assessments  of  the  environmental 
impact of a particular project required by the relevant Directive. 

Under the joint procedure referred to in the first subparagraph, a competent authority 
shall  provide  for  a  single  assessment  of  the  environmental  impact  of  a  particular 
project required by the relevant Directive.  

Member  States  shall  ensure  that  the  competent  authorities  issue  the  reasoned 
conclusion referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the 
environmental  impact  assessment  within  45  days  of  receiving  all  necessary 
information.  

In exceptional cases, where the nature, complexity, location or size of the proposed 
project so requires, Member States may extend the time limit referred to in paragraph 
2 once by a maximum of 15 days, before its expiry and on a case-by-case basis. In 
that event, the competent authority shall inform the project promoter in writing of the 
reasons justifying the extension and of the deadline for its reasoned conclusion.  

The deadlines for consulting the public concerned as referred to in Article 1(2), point 
(e),  of  Directive  2011/92/EU  and  the  authorities  referred  to  in  Article  6(1)  of  that 
Directive on the environmental  impact  assessment  report referred to  in  Article 5(1) 
of  that  Directive  shall  not  be  longer  than  85  days  and  not  shorter  than  the  30  day 
period referred to in Article 6(7) of that Directive.  

With regard to the environmental impacts or obligations referred to in Article 4(7) of 
Directive  2000/60/EC,  Article  9(1),  point  (a),  of  Directive  2009/147/EC,  Articles 

certain 

repealing 

Directives 

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a 
framework  for  Community  action  in  the  field  of  water  policy  (OJ  L  327,  22.12.2000,  p.  1,  ELI: 
http://data.europa.eu/eli/dir/2000/60/oj). 
Directive  2001/42/EC  of  the  European  Parliament  and  of  the  Council  of  27  June  2001  on  the 
assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 
30, ELI: http://data.europa.eu/eli/dir/2001/42/oj). 
Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste 
and 
ELI: 
http://data.europa.eu/eli/dir/2008/98/oj). 
Directive  2009/147/EC  of  the  European  Parliament  and  of  the  Council  of  30  November  2009  on  the 
conservation of wild birds (OJ L 20, 26.1.2010, p. 7, ELI: http://data.europa.eu/eli/dir/2009/147/oj). 
Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24  November  2010  on 
industrial  emissions  (integrated  pollution  prevention  and  control)  (OJ  L  334,  17.12.2010,  p.  17,  ELI: 
http://data.europa.eu/eli/dir/2010/75/oj). 
Directive  2011/92/EU  of  the  European  Parliament  and  of  the  Council  of  13  December  2011  on  the 
assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, 
p. 1, ELI: http://data.europa.eu/eli/dir/2011/92/oj). 
Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of 
major-accident hazards involving dangerous substances, amending and subsequently repealing Council 
Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2012/18/oj). 

22.11.2008, 

312, 

(OJ 

3, 

p. 

L 

2. 

3. 

4. 

5. 

16 

17 

18 

19 

20 

21 

22 

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6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15) 
and  Article  5(11)  and  (12)  of  Regulation  (EU)  2024/1991  strategic  projects  in  the 
Union  may  be  considered  to  have  an  overriding  public  interest  and  to  serve  the 
interests of public health and safety provided that all the conditions set out in those 
acts are fulfilled. 

Article 13 

Planning 

1. 

2. 

1. 

National,  regional  and  local  authorities  responsible  for  preparing  plans,  including 
zoning,  spatial  plans  and  land  use  plans,  shall  consider  including  in  such  plans, 
where  appropriate,  provisions  for  the  development  of  Strategic  Projects,  as  well  as 
the  necessary  infrastructure.  To  facilitate  the  development  of  strategic  projects, 
Member States shall ensure that all relevant spatial planning data is available. 

Where  plans  including  provisions  for  the  development  of  strategic  projects  are 
subject  to  an  assessment  pursuant  to  Directive  2001/42/EC  of  the  European 
Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC, 
those  assessments  shall  be  combined.  Where  applicable,  the  combined  assessment 
shall  also  address  the  impact  on  potentially  affected  water  bodies  referred  to  in 
Directive  2000/60/EC.  Where  Member  States  are  required  to  assess  the  impacts  of 
existing  and  future  activities  on  the  marine  environment,  including  land-sea 
interactions, in  accordance with  Article 4 of Directive 2014/89/EU of the European 
Parliament  and  of  the  Council23,  the  combined  assessment  shall  also  cover  those 
impacts. 

Article 14 

Applicability of UNECE Conventions 

This  Regulation  is  without  prejudice  to  the  obligations  under  the  United  Nations 
Economic Commission for Europe (UNECE) Convention on Access to Information, 
Public  Participation  in  Decision-making  and  Access  to  Justice  in  Environmental 
Matters,  signed  at  Aarhus  on  25  June  1998,  and  under  the  UNECE  Convention  on 
environmental impact assessment in a transboundary context, signed at Espoo on 25 
February  1991  and  its  Protocol  on  Strategic  Environmental  Assessment,  signed  in 
Kyiv on 21 May 2003. 

2. 

All decisions adopted pursuant to the Articles in this section shall be made publicly 
available. 

23 

Directive  2014/89/EU  of 
the  Council  of  23  ELI: 
the  European  Parliament  and  of 
http://data.europa.eu/eli/dir/2014/89/oj  July  2014  establishing  a  framework  for  maritime  spatial 
planning (OJ L 257, 28.8.2014, p. 135, ELI: http://data.europa.eu/eli/dir/2014/89/oj). 

EN 

33 

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SECTION III 

FINANCIAL INCENTIVES 

Article 15 

Financial support by Member States 

Without  prejudice  to  Articles  107  and 108  TFEU,  Member  States  may  prioritise 
financial support to strategic projects that address a vulnerability in the supply chains 
of critical medicinal products identified following a vulnerability evaluation and with 
due  consideration  to  the  strategic  orientations  of  the  Critical  Medicines  Group 
referred to in Article 26(2) point (a). 

For  as  long  as  the  critical  medicinal  product  is  on  the  Union  List  of  Critical 
Medicinal  Products,  an  undertaking  that has benefitted from  financial support for a 
strategic  project  shall  prioritise  supply  to  the  Union  market  and  use  its  very  best 
efforts to ensure that the critical medicinal product remains available in the Member 
States where it is being marketed. 

The Member State that provided financial support to a strategic project may request 
such  undertaking  to  provide  the  necessary  supplies  of  a  critical  medicinal  product, 
active substance or key inputs, as applicable, to the Union market to avoid shortages 
in one or several Member States.  

Any  Member  State  that  encounters  a  threat  of  shortages  of  the  critical  medicinal 
product in question may demand the Member State that provided financial support to 
submit a request on its behalf.  

Article 16 

Financial support from the Union 

For  the  duration  of  the  Multiannual  Financial  Framework  2021-202724  strategic 
projects may be supported by Union funding, including but not limited to such Union 
programmes  as  the  EU4Health  Programme25,  Horizon  Europe26,  and  the  Digital 
Europe Programme27 provided that such support is in line with the objectives set out 
in the regulations establishing those programmes.  

to 

as 

LI 

(OJ 

433, 

2021 

2027, 

amended 

22.12.2020, 

Council  Regulation  (EU,  Euratom)  2020/2093  laying  down  the  multiannual  financial  framework  for 
years 
p.11, 
ELI: http://data.europa.eu/eli/reg/2020/2093/oj) 
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, 
ELI: http://data.europa.eu/eli/reg/2021/522/oj) 
Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing 
Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for 
participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 
(OJ L170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj) 
Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing 
the  Digital  Europe  Programme  and  repealing  Decision  (EU)  2015/2240(  OJ  L166,  11.5.2021,  p.1, 
ELI: http://data.europa.eu/eli/reg/2021/694/2023-09-21) 

1. 

2. 

3. 

1. 

24 

25 

26 

27 

EN 

34 

  EN 

 
 
2. 

1. 

2. 

At  the  request  of  a  project  promoter,  justified  by  necessity  to  provide  results  of 
vulnerability  evaluation  for  the  purpose  of  an  application  for  Union  funding,  the 
designated authority shall assess whether a strategic project addresses a vulnerability 
in the supply chains identified following the vulnerability evaluation. The designated 
authority shall provide its assessment to a project promoter within 15 working days 
of  its  request.  The  designated  authority  shall  inform  the  Commission  about  the 
strategic  projects  identified  as  addressing  an  existing  vulnerability  in  the  supply 
chains without delay.  

Article 17 

Exchange of information on funded projects 

Member States shall inform the Critical Medicines Coordination Group (‘the Critical 
Medicines  Group’)  referred  to  in  Article  24  of  the  intention  to  provide  financial 
support to strategic projects sufficiently in advance to allow the group to carry out its 
coordination task as set out in Article 25. 

The  Commission  shall  inform  periodically  the  Critical  Medicines  Group  of  the 
strategic projects that benefited from financial support from the Union. 

The  Commission  may  inform  the  Critical  Medicines  Group  of  the  intention  to 
propose  the  establishment  of  funding  possibilities  specifically  designed  to  address 
vulnerabilities in the supply chains as well as inform of any other programmes that 
may  benefit  the  availability  of  critical  medicinal  products,  under  specific  rules  and 
conditions of these Union funding programmes.  

Chapter IV 
Demand side measures 

SECTION I 

AWARD CRITERIA AND OTHER PROCUREMENT REQUIREMENTS AND RELATED 
MEASURES 

Article 18 

Incentivising resilience, sustainability and positive social impacts in public procurement 
procedures  

1. 

For  award  procedures  of  critical  medicinal  products  falling  within  the  scope  of 
Directive  2014/24/EU  of  the  European  Parliament  and  of  the  Council,  contracting 
authorities  in  the  Member  States  shall  apply  procurement  requirements  other  than 
price-only  award  criteria  such  as  procurement  requirements  that  promote  the 
resilience of supply in the Union. Those procurement requirements shall be defined 
in accordance with Directive 2014/24/EU and may relate to stockholding obligations, 
the number of diversified suppliers, monitoring of supply chains, their transparency 
to the contracting authority and contract performance clauses on timely delivery. 

2. 

With  regard  to  critical  medicinal  products  for  which  a  vulnerability  in  the  supply 
chains  has  been  confirmed  through  a  vulnerability  evaluation  pointing  to  the  high 

EN 

35 

  EN 

 
 
3. 

4. 

5. 

1. 

2. 

level  of  dependency  on  a  single  or  a  limited  number  of  third  countries,  the 
contracting  authorities  shall,  where  justified,  apply  procurement  requirements  that 
favour suppliers that manufacture a significant proportion of these critical medicinal 
products  in  the  Union.  These  requirements  shall  be  applied  in  compliance  with  the 
Union’s international commitments. 

With  regard  to  other  medicinal  products  of  common  interest,  where  justified  by 
market  analysis  and  public  health  considerations,  the  contracting  authorities  may 
apply  procurement  requirements  that  favour  suppliers  that  manufacture  at  least  a 
significant proportion of these medicinal products in the Union. These requirements 
shall be applied in compliance with the Union’s international commitments. 

This  Article  shall  not  preclude  contracting  authorities  from  using  additional 
qualitative  requirements,  including  in  relation  to  environmental  sustainability  and 
social rights. 

Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 
where justified by market analysis or considerations related to the financing of health 
services.  

Programmes supporting sustainability and resilience in public procurement procedures 

Article 19 

By  6  months  after  entry  into  force  of  this  Regulation  each  Member  State  shall 
establish  a  national  programme  supporting  security  of  supply  of  critical  medicinal 
products,  including  in  public  procurement  procedures.  Such  programmes  shall 
promote  the  consistent  use  of  procurement  requirements  by  contracting  authorities 
within a given Member State as well as multi-winner approaches, where beneficial in 
light of the market analysis. Such programmes may also include measures for pricing 
and reimbursement supporting security of supply of those critical medicinal products 
that are not purchased through public procurement procedures. 

Member  States  shall  notify  their  programmes  to  the  Commission  in  its  role  of  the 
secretariat  of  the  Critical  Medicines  Group.  The  Commission  shall  ensure  the 
distribution to  all members  of  the  Critical  Medicines  Group  forthwith.  The  Critical 
Medicines  Group  shall  facilitate  a  discussion  aiming  to  ensure  coordination  of 
national  programmes  including  as  regards  the  application  of  criteria  mentioned  in 
Article 18(2) and may issue opinions. Where the Critical Medicines Group issues an 
opinion  concerning  the  national  programmes,  Member  States  shall  give  it  due 
consideration and may take it into account when revising their programmes. 

Article 20 

Safeguards related to Member States’ contingency stocks requirements and other security of 
supply measures 

Measures on security of supply applied in one Member State shall not result in any negative 
impact in other Member States. Member States shall, in particular, avoid such an impact when 
proposing  and  defining  the  scope  and  timing  of any  form  of  requirements  for  companies  to 
hold contingency stocks.  

Member  States  shall  ensure  that  any  requirements  they  impose  on  companies  in  the  supply 
chain to hold contingency stocks are proportionate and respect the principles of transparency 
and solidarity.  

EN 

36 

  EN 

 
SECTION II 

COLLABORATIVE PROCUREMENTS 

Article 21 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

1. 

28 

Commission facilitated Member States’ cross-border procurement   

Upon  a  reasoned  request  of  three  or  more  Member  States  (‘the  request’),  the 
Commission  may  act  as  facilitator  for  the  requesting  Member  States’  cross-border 
procurement as laid down in Article 39 of Directive of the European Parliament and 
of the Council 2014/24/EC28 for medicinal products of common interest.  

Having received the request, the Commission shall inform all other Member States of 
the  initiative  and  set  an  appropriate  deadline  for  them  to  declare  interest.  Such  a 
deadline shall not exceed three weeks. 

The Commission shall assess the request in light of the objectives of this Regulation. 
The Commission shall communicate to the interested Member States its decision on 
whether  it  agrees,  or  not,  to  facilitate  the  proposed  initiative  within  three  weeks  of 
receiving the request.  

If the Commission declines the request, it shall provide reasons for the refusal.  

If the Commission accepts the request, the Commission shall provide secretarial and 
logistical  support  to  the  interested  Member  States.  The  Commission  shall  facilitate 
communication  and  cooperation  between  the  involved  Member  States  and  provide 
advice  on  applicable  Union  public  procurement  rules  and  on  regulatory  matters 
related to medicinal products. 

The  facilitation  offered  by  the  Commission  shall  be  limited  in  time  and  end  at  the 
latest  upon  signature  of  the  procurement  contract  by  the  participating  contracting 
authorities.   

The Commission shall not be responsible, nor held liable, for any breaches of Union 
or  national  procurement  laws  by  the  participating  contracting  authorities.  The 
Commission  shall  not  bear  any  liability  associated  with  the  conduct  of  the 
procurement  procedure  by  interested  Member  States  and  implementation  of  the 
contract resulting from the procedure. 

Article 22 

Commission procurement on behalf of or in the name of Member States 

By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 
where  nine  or  more  Member  States  jointly  request  the  Commission  to  procure  on 
their behalf, or in their name, the Commission may initiate a procurement procedure 
under the conditions set out in this Article when the procurement relates to medicinal 
products belonging to one of the following categories below; 

Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public 
procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65, 
ELI: http://data.europa.eu/eli/dir/2014/24/2024-01-01 ). 

EN 

37 

  EN 

 
 
 
(a) 

critical medicinal products for which a vulnerability evaluation has identified a 
vulnerability in the supply chains or for which the MSSG has recommended a 
common procurement initiative;  

(b)  medicinal  products  of  common  interest,  for  which  a  joint  clinical  assessment 
report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 
of  the  European  Parliament  and  the  Council  29,  or  which  have  undergone  a 
clinical assessment carried out under the voluntary cooperation among Member 
States as per Article 23(1) point (e) of that Regulation. 

The joint request referred to in paragraph 1 shall only be made where the medicinal 
product  concerned  fulfils  one  of  the  criteria  set  out  in  that  paragraph  and  if  the 
requested  procurement  procedure  will  help  to  improve  the  security  of  supply  and 
availability of critical medicinal products in the Union or ensure the availability and 
accessibility of medicinal products of common interest, as applicable.  

The participation in the procurement procedure shall be open to all Member States. 
The Commission shall inform all Member States of the request, through the Critical 
Medicines Group, and invite them to join the procedure.  

The Commission shall assess the utility, necessity and proportionality of the request 
and whether the request is justified in light of the objectives of this Regulation. The 
Commission  shall  in  particular  verify  whether  the  procurement  could  constitute 
discrimination or restriction to trade or a distortion to competition. 

The Commission shall inform the interested Member States within one month of the 
request of its decision and state its reasons in case of a refusal. 

If  in  light  of  the  Commission  assessment,  it  is  necessary,  in  order  to  achieve  the 
objectives  of  this  Regulation,  to  conduct  the  procurement  as  exclusive  for  the 
Member  States  or  to  agree  to  minimum  binding  quantities,  the  Commission 
agreement  to  pursue  the  procedure  may  be  conditioned  upon  acceptance  of  these 
conditions by interested Member States.  

Except for the derogations provided for in this Regulation, the procurement referred 
to in this Article shall be carried out in accordance with Article 168 (3) of Regulation 
(EU, Euratom) 2024/250930.  

Article 23 

Joint Procurement 

Under  conditions  laid  down  in  this  Article  and  by  way  of  derogation  from  Article 
168(2)  of  Regulation  (EU,  Euratom)  2024/2509,  if  a  contract  is  necessary  for  the 
implementation of the joint action between the Commission and Member States, the 
Commission and at least nine Member States may engage, as contracting parties, in a 
joint procurement procedure. 

Regulation  (EU)  2021/2282  of  the  European  Parliament  and  the  Council  of  15  December  2021  on 
health  technology  assessment  and  amending  Directive  2011/24/EU  (OJ  L  458,  22.12.2021,  ELI: 
http://data.europa.eu/eli/reg/2021/2282/oj) 
Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 
2024 on the financial rules applicable to the general budget of the Union (recast) (OJ L, 26.9.2024, p. 1, 
ELI: http://data.europa.eu/eli/reg/2024/2509/oj). 

2. 

3. 

4. 

5. 

6. 

7. 

1. 

29 

30 

EN 

38 

  EN 

 
 
2. 

A joint procurement procedure may be organised following a request by the Member 
States  or  at  the  Commission’s  initiative  when  the  procurement  relates  to  medicinal 
products belonging to one of the categories below: 

(a) 

critical medicinal products for which a vulnerability evaluation has identified a 
vulnerability in the supply chains or for which the MSSG has recommended a 
common procurement initiative;  

(b)  medicinal  products  of  common  interest,  for  which  a  joint  clinical  assessment 
report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 
of  the  European  Parliament  and  the  Council  31,  or  which  have  undergone  a  
clinical assessment carried out under the voluntary cooperation among Member 
States  as per Article 23(1) point (e) of that Regulation. 

The  Commission  may  decide  to  conduct  the  joint  procurement  procedure  if  the 
procurement  procedure  helps  to  improve  the  security  of  supply  and  availability  of 
critical medicinal products in the Union or ensure the availability and accessibility of 
medicinal products of common interest, as applicable. 

The participation in the procurement procedure shall be open to all Member States. 
The Commission shall inform all Member States of the request through the Critical 
Medicines Group and invite them to join the procedure.  

The Commission shall assess the necessity of a joint action and whether the request 
is  justified  in  light  of  the  objectives  of  this  Regulation.  The  Commission  shall  in 
particular  verify  whether  the  procurement  could  constitute  discrimination  or 
restriction to trade or a distortion to competition.  

If  in  light  of  the  Commission  assessment,  it  is  necessary,  in  order  to  achieve  the 
objectives  of  this  Regulation,  to  conduct  the  procurement  as  exclusive  for  the 
Member  States  or  to  agree  to  minimum  binding  quantities,  the  Commission 
agreement  to  pursue  the  procedure  may  be  conditioned  upon  acceptance  of  these 
conditions by interested Member States.  

The Commission shall inform the interested Member States within one month of the 
request of its decision and state its reasons in case of a refusal. 

Except  for  the  derogations  provided  for  in  this  Regulation,  the  joint  procurement 
procedure shall be carried out by the Commission in accordance with Article 168 (2) 
of Regulation (EU, Euratom) 2024/2509.  

Article 24 

Agreement concerning procedures under Articles 22 and 23 

Member  States  participating  in  the  procurement  procedures  covered  by  Articles  22 
and  23  shall  share  with  the  Commission  any  information  relevant  for  the 
procurement  procedure.  Member  States  shall  provide  resources  necessary  for  the 
successful  conclusion  of  the  procedure,  in  particular  through  involvement  of  staff 
with expertise and knowledge. 

Regulation  (EU)  2021/2282  of  the  European  Parliament  and  the  Council  of  15  December  2021  on 
health  technology  assessment  and  amending  Directive  2011/24/EU  (OJ  L  458,  22.12.2021,  ELI: 
http://data.europa.eu/eli/reg/2021/2282/oj) 

3. 

4. 

5. 

6. 

7. 

8. 

1. 

31 

EN 

39 

  EN 

 
 
2. 

An agreement between the Member States  and the Commission shall determine the 
practical  arrangements  governing  the  procurement  procedure,  liabilities  to  be 
assumed and the decision-making process.  

Chapter V 
Critical Medicines Coordination Group  

Article 25 

Establishment of Critical Medicines Coordination Group 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

1. 

2. 

A  Critical  Medicines  Coordination  Group  (‘Critical  Medicines  Group’)  is  hereby 
established.   

The  Member  States  and  the  Commission  are  Members  of  the  Critical  Medicines 
Group.  Each  Member  State  shall  appoint  a  maximum  of  two  high-level  permanent 
representatives, with the expertise relevant for implementing all the different measures 
set  out  in  this  Regulation.  Where  relevant  as  regards  the  function  and  expertise, 
Member  States  may  appoint  different  representatives  in  relation  to  different  tasks  of 
the  Critical  Medicines  Group.  Appointed  permanent  representatives  shall  ensure  the 
necessary coordination within their respective Member State. The Agency shall have 
an observer status.  

The  Critical  Medicines  Group  shall  work  closely  with  the  MSSG,  the  Agency,  and 
national  authorities  responsible  for  medicinal  products.  For  discussions  where  input 
from  the  medicines  regulatory  authorities’  perspective  is  necessary,  the  Critical 
Medicines Group may organise joint meetings with the MSSG.  

The  Commission  shall  organise  and  coordinate  the  work  of  the  Critical  Medicines 
Group by means of the Secretariat. 

A representative of the Commission shall chair the meetings of the Critical Medicines 
Group.  

The Critical Medicines Group, at the proposal of the Chair or any its members, may 
decide to establish a working group. 

The Critical Medicines Group shall use its best endeavours to reach consensus, where 
possible.  Members  with  diverging  positions  may  request  that  their  positions  and  the 
grounds  on  which  they  are  based  be  recorded  in  the  Critical  Medicines  Group’s 
position. 

Article 26 

Tasks of the Critical Medicines Coordination Group 

The Critical Medicines Group shall facilitate coordination in the implementation of 
this  Regulation  and,  where  appropriate,  advise  the  Commission,  so  as  to  maximise 
the  impact  of  the  measures  envisaged  and  to  avoid  any  unintended  effects  on  the 
internal market.  

In  order  to  attain  the  objectives  referred  to  in  paragraph  1,  the  Critical  Medicines 
Group shall perform the following tasks: 

EN 

40 

  EN 

 
 
(a) 

(b) 

(c) 

(d) 

facilitate  coordination  on  strategic  orientation  of  the  financial  support  for 
strategic  projects,  including  by  exchanging  information  on  the  manufacturing 
capacity  for  a  given  critical  medicinal  product,  existing  or  planned,  in  the 
Member States and facilitate discussion on the capacity needed in the Union to 
strengthen  its  supply  security  and  availability  of  critical  medicinal  products 
within the Union; 

facilitate exchanges  on  the  national  programmes  referred  to in  Article 19 and 
enable cooperation on and coordination of Member States public procurement 
policies with regard to critical medicinal products; 

facilitate discussion of the need for a collaborative procurement initiative for a 
given medicinal product; 

advise the MSSG to provide the order of priority of critical medicinal products 
for  vulnerability  evaluation,  and  propose  a  review  or  an  update  of  existing 
evaluations where necessary.  

The Critical Medicines Group shall enable the exchanges of information between the 
Member  States  and  the  Commission  as  referred  to  in  Article  17  and  shall  enable, 
where necessary, a coordination of respective actions aiming to attain the objectives 
of this Regulation.  

The Critical Medicines Group shall periodically discuss the potential contribution of 
strategic  partnerships  to  the  objectives  of  this  Regulation,  prioritisation  of  third 
countries  for  this  purpose,  and  the  consistency  and  potential  synergies  between 
Member States’ cooperation with relevant third countries and the actions carried out 
by the Union.  

The Critical Medicines Group, at the Commission’s request, may provide an opinion 
on matters related to the application of this Regulation in the context of performing 
tasks as referred to in this Article. 

3. 

4. 

5. 

Chapter VI 
International cooperation  

Article 27 

Strategic partnerships 

Without  prejudice  to  the  prerogatives  of  the  Council,  the  Commission,  shall  explore 
possibilities  of  concluding  strategic  partnerships  aiming  to  diversify  sourcing  of  critical 
medicinal products, their active substances and key inputs to increase the security of supply of 
critical medicinal products in the Union. The Commission shall also explore the possibility of 
building on existing  forms  of cooperation, when possible, to  support security of supply  and 
reinforce efforts to strengthen the production of critical medicinal products in the Union. 

EN 

41 

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Chapter VII 
Amendments to Regulation (EU) 2024/795 

Regulation (EU) 2024/795 is amended as follows: 

Article 28 

(a) 

in Article 2, (1) point (a), subparagraph (iii) is replaced by the following: 

‘(iii)  biotechnologies,  and  any  other  technologies  relevant  for  manufacturing 
of critical medicinal products as defined in Critical Medicines Act *; 

_________ 

* 

Regulation (EU) … of the European Parliament and of the Council laying 
down  a  framework  for  strengthening  the  availability  and  security  of 
supply  of  critical  medicinal  products  as  well  as  for  improving  the 
availability of, and access to, medicinal products of common interest, and 
amending Regulation (EU) 2024/795.’ [D.G.: reference to be completed 
with  the  definitive  title  of  the  ‘Critical  Medicines  Act’  and  with  its 
publications references once they are available];’ 

(b) 

in Article 2, the following subparagraph is added in paragraph 3: 

‘By way of derogation from the first subparagraph of this paragraph, the value 
chain  for  the  development  or  manufacturing  of  medicinal  products  that  fall 
within  the  scope  of  the  [Critical  Medicines  Act]  and  that  are  referred  to  in 
paragraph  1,  point  (a)(iii)  of  this  Article,  relates  to  finished  dosage  forms,  as 
well as to active pharmaceutical ingredients and other key inputs necessary for 
the  production  of  the  finished  dosage  forms  of  critical  medicinal  products  as 
defined in the Regulation.’; 

(c) 

in article 2, paragraph 8 is added:  

‘8.  Strategic projects  designated in  accordance with  the [Critical  Medicines 
Act] that address a vulnerability in the supply chains of critical medicinal 
products shall be deemed to contribute to the STEP objective referred to 
in paragraph 1, point (a)(iii).’; 

(d) 

in Article 4, paragraph 7 is replaced by the following:  

‘7.  Strategic projects  recognised in  accordance  with  the relevant  provisions 
of  the  Net-Zero  Industry  Act,  the  Critical  Raw  Materials  Act  [and  the 
Critical  Medicines  Act]  that  fall  within  the  scope  of  Article  2  of  this 
Regulation and that receive a contribution under the programmes referred 
to  in  Article  3  of  this  Regulation  may  also  receive  a  contribution  from 
any other Union programme, including funds under shared management, 
provided that those contributions do not cover the same costs. The rules 
of  the  relevant  Union  programme  shall  apply  to  the  corresponding 
contribution  to  the  strategic  project.  The  cumulative  funding  shall  not 
exceed  the total  eligible costs of the strategic project.  The support from 
the different Union programmes may be calculated on a pro rata basis in 
accordance with the documents setting out the conditions for support.’; 

(e) 

in Article 6, paragraph 1, point c is replaced by the following: 

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(c) 

details  of  projects  that  have  been  recognized  as  strategic  projects  under 
the  Net-Zero  Industry  Act,  the  Critical  Raw  Materials  Act  and  the 
[Critical Medicines Act], to the extent that they fall within the scope of 
Article 2 of this Regulation.  

Chapter VIII 
Final provisions 

Article 29 

1. 

2. 

3. 

1. 

2. 

3. 

Obligation of the market actors to provide information 

Marketing  authorisation  holders  and  other  economic  operators  in  the  supply  and 
distribution chains of critical medicinal products including their key inputs and active 
substances or medicinal products of common interest shall upon request provide the 
Commission or national authorities, as relevant, the requested information necessary 
for the purpose of application of this Regulation. 

The  Commission  and  national  authorities  of  the  Member  States  shall  aim  to  avoid 
duplication of the information requested and submitted. 

The  Commission  and  national  authorities  of  the  Member  States  shall  assess  the 
merits of duly substantiated confidentiality claims made by marketing authorisation 
holders  and  other  economic  operators,  requested  to  provide  information  per 
paragraph  1,  and  shall  protect  any  information  that  is  commercially  confidential 
against unjustified disclosure. 

Article 30 

Evaluation 

By  [OP  please  insert  the  date  of:]  five  years  after  the  date  of  application  of  this 
Regulation  and  every  five  years  thereafter,  the  Commission  shall  evaluate  this 
Regulation and present a report on the main findings to the European Parliament, the 
Council,  the  European  Economic  and  Social  Committee,  and  the  Committee  of  the 
Regions. 

The Commission  shall in  its evaluation  assess the impact  of this  Regulation and to 
what extent its objectives as established in Article 1 have been achieved. 

The national authorities and the economic operators shall, upon request, provide the 
Commission with any relevant information they have and that the Commission may 
need for its assessment pursuant to in paragraph 1.  

Article 31 

Entry into force and application 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

It shall apply from [….]. 

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This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Strasbourg, 

For the European Parliament 
The President 

For the Council 
The President 

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LEGISLATIVE FINANCIAL AND DIGITAL STATEMENT 

1. 

1.1. 

1.2. 

1.3. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE ................................................. 3 

Title of the proposal/initiative ...................................................................................... 3 

Policy area(s) concerned .............................................................................................. 3 

Objective(s) .................................................................................................................. 3 

1.3.1.  General objective(s) ..................................................................................................... 3 

1.3.2.  Specific objective(s) ..................................................................................................... 3 

1.3.3.  Expected result(s) and impact ...................................................................................... 3 

1.3.4. 

Indicators of performance ............................................................................................ 3 

1.4. 

1.5. 

The proposal/initiative relates to: ................................................................................. 4 

Grounds for the proposal/initiative .............................................................................. 5 

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 ............................................................ 5 

1.5.2.  Added value of EU involvement (it may result from different factors, e.g. 

coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this section 'added value of EU involvement' is the value resulting 
from EU action, that is additional to the value that would have been otherwise 
created by Member States alone. ................................................................................. 5 

1.5.3.  Lessons learned from similar experiences in the past .................................................. 5 

1.5.4.  Compatibility with the multiannual financial framework and possible synergies with 
other appropriate instruments ....................................................................................... 5 

1.5.5.  Assessment of the different available financing options, including scope for 

redeployment ................................................................................................................ 6 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.2.1. 

2.2.2. 

Duration of the proposal/initiative and of its financial impact .................................... 7 

Method(s) of budget implementation planned ............................................................. 7 

MANAGEMENT MEASURES................................................................................... 8 

Monitoring and reporting rules .................................................................................... 8 

Management and control system(s) ............................................................................. 8 

Justification of the budget implementation method(s), the funding implementation 
mechanism(s), the payment modalities and the control strategy proposed .................. 8 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them............................................................................................................ 8 

2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio between 

the control costs  and the value of the related funds managed), and assessment of the 
expected levels of risk of error (at payment & at closure) ......................................... 10 

2.3. 

3. 

3.1. 

Measures to prevent fraud and irregularities .............................................................. 10 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 12 

Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected ....................................................................................................................... 12 

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3.2. 

Estimated financial impact of the proposal on appropriations ................................... 13 

3.2.1.  Summary of estimated impact on operational appropriations.................................... 13 

3.2.1.1.  Appropriations from voted budget ............................................................................. 13 

3.2.1.2.  Appropriations from external assigned revenues ....................................................... 16 

3.2.2.  Estimated output funded from operational appropriations......................................... 16 

3.2.3.  Summary of estimated impact on administrative appropriations ............................... 18 

3.2.3.1. Appropriations from voted budget .............................................................................. 18 

3.2.3.2.  Appropriations from external assigned revenues ....................................................... 18 

3.2.3.3.  Total appropriations ................................................................................................... 18 

3.2.4.  Estimated requirements of human resources.............................................................. 19 

3.2.4.1.  Financed from voted budget....................................................................................... 19 

3.2.4.2.  Financed from external assigned revenues ................................................................ 20 

3.2.4.3.  Total requirements of human resources ..................................................................... 20 

3.2.5.  Overview of estimated impact on digital technology-related investments ................ 23 

3.2.6.  Compatibility with the current multiannual financial framework.............................. 23 

3.2.7.  Third-party contributions ........................................................................................... 24 

3.3. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

Estimated impact on revenue ..................................................................................... 24 

DIGITAL DIMENSIONS .......................................................................................... 24 

Requirements of digital relevance .............................................................................. 24 

Data ............................................................................................................................ 25 

Digital solutions ......................................................................................................... 27 

Interoperability assessment ........................................................................................ 27 

Measures to support digital implementation .............................................................. 28 

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1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying  a  framework  for  strengthening  the  availability  and  security  of  supply  of 
critical  medicinal  products  as  well  as  the  availability  of,  and  accessibility  of, 
medicinal products of common interest, and amending Regulation (EU) 2024/795.  

1.2. 

Policy area(s) concerned  

Heading 2: Cohesion, Resilience and Values 

EU4Health 

1.3. 

Objective(s) 

1.3.1.  General objective(s) 

The general objective of this Regulation is to strengthen of the security of supply and 
the availability of critical medicines within the EU, thereby ensuring a high level of 
public  health  protection  and  supporting  the  security  of  the  Union.  It  is  also  to 
improve  the  availability  and  accessibility  of  other  specific  medicines,  where  the 
functioning of the market does not otherwise sufficiently ensure the availability and 
accessibility  of  those  medicines  to  patients,  whilst  giving  due  consideration  to  the 
appropriateness to ensure the affordability of medicines. 

1.3.2. 

Specific objective(s) 

The specific objectives of the initiative are: 

to facilitate investments in manufacturing capacity for critical medicines, their 

a) 
active substances and other key inputs in the EU; 

b) 
to  lower  the  risk  of  supply  disruptions  and  strengthen  availability  by 
incentivising  supply  chain  diversification  and  resilience  in  the  public  procurement 
procedures for critical medicines and other medicines of common interest; 

to  leverage  the  aggregated  demand  of  the  interested  Member  States  through 

c) 
collaborative procurement procedures;  

to  support  the  diversification  of  supply  chains  also  by  facilitating  the 

d) 
conclusion of strategic partnerships. 

1.3.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The  proposed  act  is  expected  to  strengthen  the  resilience  of  the  EU's  medicines 
supply  chains,  contributing  to  improved  security  of  supply.  It  should  also  reduce 
shortages  of  critical  medicines  and  enhance  public  health  and  trust.  Economically, 
the  proposal  is  expected  to  strengthen  the  manufacturing  base  of  critical  medicines 
through 
and  make 
diversification. On a social level, the proposed act should improve access to critical 
medicines and certain other medicines for EU patients. These outcomes will directly 
contribute  to  achieving  Sustainable  Development  Goal  (SDG)  3,  ‘Good  health  and 
well-being’.  Besides  the  public  health-related  benefits,  the  proposal  is  expected  to 
mostly  affect  the  pharmaceutical  industry  involved  in  the  supply  of  critical 

the  pharmaceutical  sector  more  competitive, 

including 

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medicines,  as  the  industry  may  benefit  from  administrative  and  regulatory  support 
and access to funding for certain strategic projects. In addition, the proposed act will 
likely  affect  national  administrative  authorities  and  procurers  active  in  the  public 
procurement of critical medicines and other medicines of common interest. 

1.3.4. 

Indicators of performance 

Specify the indicators for monitoring progress and achievements. 

Objective  

Indicator 

Target and baseline 

/ 

/ 

/ 

# of critical medicinal products on the Union 
List of Critical Medicinal products  

# of critical shortages escalated to the SPOC 
WP for the critical medicinal products on the 
Union list 

Proportion (%) of critical shortages escalated 
to the SPOC WP that corresponded to a critical 
medicinal product listed on the Union list. 

276 – this number is expected to 
increase then plateau 
The number of reported shortages of 
critical medicines is dependent on the 
reporting rate. Shortages of critical 
medicines may be driven by external 
forces (such as increased demand due 
to a new pandemic), therefore any 
trends in this number should be 
interpreted with prudence. 
Of the 63 INN critical shortages 
received by EMA from EU/EEA 
countries in 2024, 29 (~45%) 
corresponded to the critical medicines 
on the Union list. The proportion s 
expected to decrease. 

Data source and 
availibility 
EMA/Union List of 
Critical Medicines 
already available 

EMA/already available 

EMA/already available 

Specific 
objective a)  

# of strategic projects identified as addressing 
an existing vulnerability in the supply chains of 
critical medicinal products  

0 / target: highly dependent on 
demand  

MS reporting as 
defined in article 16 

Specific 
objective a) 

# of strategic projects for critical medicines 
that benefit from national financial support 

0 / target: highly dependent on 
demand and 

MS reporting as 
defined in article 17 

Specific 
objective a) 

Specific 
objective a) 

# of strategic projects for critical medicines 
that benefit from financial support from the 
Union 
# of dedicated advice provided by EMA to 
project promoters of Strategic Projects with 
innovative manufacturing processes 

0 / target: highly dependent on 
demand 

 MS reporting as 
defined in article 17 

0 / target: highly dependent on 
demand 

EMA 

Specific 
objective b)  # of national programmes issued  

 0  / target: 27  

# of cross-border procurement, procurement on 
behalf or joint procurements for critical 
medicines and other medicines of common 
interest  
# countries benefiting from cross-border 
procurement, procurement on behalf or joint 
procurements for critical medicines and other 
medicines of common interest 

Specific 
objective c) 

Specific 
objective c)  

0 / target: highly dependent on 
demand 

0 / target: highly dependent on 
demand 

MS reporting as 
defined in article 19 

as procurement would 
be done by the EC, data 
will be easily available   

as procurement would 
be done by the EC, data 
will be easily available   

1.4. 

The proposal/initiative relates to:  

 a new action  
 a new action following a pilot project / preparatory action96  

96 

As referred to in Article 58(2), point (a) or (b) of the Financial Regulation. 

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 the extension of an existing action  

 a merger or redirection of one or more actions towards another/a new action 

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 adoption is expected for Q4 2025 and the implementation will start in 2026.  

1.5.2.  Added  value  of  EU  involvement  (it  may  result  from  different  factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the  purposes  of  this  section  'added  value  of  EU  involvement'  is  the  value  resulting 
from  EU  action,  that  is  additional  to  the  value  that  would  have  been  otherwise 
created by Member States alone. 

Medicine  shortages  have  hit  every  Member  State  in  the  EU  over  the  last  decade. 
While an individual Member State can act to improve its supply of certain medicines, 
these  efforts  are  fragmented  and  insufficient  to  address  the  broader,  cross-border 
supply  chain  problems,  including  dependency  on  certain  non-EU  countries.  To 
address  these  challenges  and  to  achieve  a  secure  and  reliable  supply  of  critical 
medicines, a common effort at EU level is needed through this proposed Act. Adding 
to this issue, access problems can also exist for other medicines of common interest, 
disproportionately  affecting  some  Member  States,  such  as  those  with  a  smaller 
market  size.  To  improve  the  availability  of  and  access  to  these  medicines,  this  Act 
therefore  proposes  measures  to  leverage  the  aggregated  demand  of  the  interested 
Member States through collaborative procurement procedures.  

1.5.3.  Lessons learned from similar experiences in the past 

The Union List of Critical Medicines, created collaboratively by Member States, the 
European  Medicines  Agency  and  the  European  Commission,  identifies  medicines 
crucial for treating serious conditions with limited alternatives. Initially published in 
December  2023  and  updated  a  year  later,  it  includes  276  active  substances.  The 
Commission’s  analysis  of  supply  chain  vulnerabilities  for  11  representative 
medicines  found  reliance  on  non-EU  suppliers  and  market  concentration  risks, 
underscoring  the  need  for  strategic  interventions  to  bolster  resilience  through 
diversified supply sources, flexible production capacity, and robust risk management.  

Some Member States have been involved in cross-border procurement of medicinal 
products,  pursuant  to  the  public  procurement  directive.  Whereas  it  has  been  found 
helpful  to  make  small  markets  attractive  for  suppliers,  thereby  achieving  better 
availability of medicinal products, its implementation is time and resource-intensive, 
especially  in  the  starting  phase,  what  is  considered  a  limiting  factor.  The  potential 
benefits  that  leveraging  of  several  Member  States  demand  in  one  procurement 
procedure  may  have  is  also  illustrated  by  the  experiences  resulting  from  the 
implementation  of  joint  procurement  of  medical  countermeasures  and  COVID-19 
vaccines.  

1.5.4.  Compatibility with the multiannual financial framework and possible synergies with 

other appropriate instruments 

For  the  duration  of  the  Multiannual  Financial  Framework  2021-2027,  the  strategic 
projects  may  be  supported  by  EU  funding,  including  but  not  limited  to  EU4Health 
programme,  Horizon  Europe,  and  the  Digital  Europe  Programme,  in  line  with  the 

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objectives  set  out  in  the  Regulation  establishing  those  programmes.  Authorities  in 
charge  of  the  Union  programmes  covered  by  the  STEP  Regulation  should  in 
particular  consider  supporting  Strategic  projects  addressing  vulnerability  in  the 
supply  chain  of  critical  medicinal  products.  These  projects  should  be  deemed  to 
contribute to STEP. 

1.5.5.  Assessment  of  the  different  available  financing  options,  including  scope  for 

redeployment 

N/A 

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1.6. 

Duration of the proposal/initiative and of its financial impact 

 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.  

 unlimited duration 

–  Implementation with a start-up period from 2026 to 2027, 

–  followed by full-scale operation as of 2027. 

1.7.  Method(s) of budget implementation planned97  

 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  

 Indirect management by entrusting budget implementation tasks to: 

–   third countries or the bodies they have designated 

–   international organisations and their agencies (to be specified) 

–   the European Investment Bank and the European Investment Fund 

–   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 are provided with 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  are  provided  with 
adequate financial guarantees 

–   bodies or persons entrusted with the implementation of specific actions in the 
common  foreign  and  security  policy  pursuant  to  Title  V  of  the  Treaty  on 
European Union, and identified in the relevant basic act 

–   bodies  established  in  a  Member  State,  governed  by  the  private  law  of  a 
Member  State  or  Union  law  and  eligible  to  be  entrusted,  in  accordance  with 
sector-specific  rules,  with  the  implementation  of  Union  funds  or  budgetary 
guarantees,  to  the extent that such bodies are controlled by public law bodies or 
by bodies governed by private law with a public service mission, and are provided 
with adequate financial guarantees in the form of joint and several liability by the 
controlling bodies or equivalent financial guarantees and which may be, for each 
action, limited to the maximum amount of the Union support. 

Comments  

97 

Details of budget implementation methods and references to the Financial Regulation may be found on 
the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-
implementation/Pages/implementation-methods.aspx. 

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2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Annual monitoring foreseen on the defined indicators  

The  proposal  relies  on  existing  workstreams  in  the  European  Commission  and  the 
European  Medicinal  Agency,  which  will  facilitate  monitoring  of  several  indicators. 
For these, continuous data/information will be available. 

2.2.  Management and control system(s)  

2.2.1. 

Justification  of  the  budget  implementation  method(s),  the  funding  implementation 
mechanism(s), the payment modalities and the control strategy proposed 

The actions for strengthening of the security of supply and the availability of critical 
medicinal  products  within  the  Union  and  for  improving  the  availability  and 
accessibility of other medicinal products,  where the functioning  of the market  does 
not otherwise sufficiently ensure the availability and accessibility of these medicinal 
products  to  patients,  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; 

and 

ex-ante 

cover  project 
Operational,  monitoring 
final 
implementation,  public  procurement,  pre-financing, 
payments,  management 
the 
guarantees;  Ex-post 
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 

interim  and 
at 
controls 

controls 

that 

of 

2.2.2. 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them 

The  proposal  will  be  implemented  through  grants  and  public  procurement,  taking 
into  account  the  funding  opportunities  facilitated  by  the  Strategic  Technologies  for 
Europe Platform (‘STEP’), and those offered by, inter alia, the InvestEU programme, 
the  Recovery  and  Resilience  Facility,  Horizon  Europe,  EU4Health,  Digital  Europe 
Programme  and  cohesion  policy  programmes  as  well  as  the  Technical  Support 
Instrument. The grants and procurements will mainly be awarded and concluded to 
support  Strategic  Projects,  as  well  as  to  support  activities  to  non-governmental 
organisations, respective competent authorities of the Member States. 

The main risks are the following: 

•  Risk  of  not  fully  achieving  the  objectives  of  the  Regulation  due  to  insufficient 
uptake or quality/delays in the implementation of the selected projects or contracts; 

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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. 

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2.2.3.  Estimation  and  justification  of  the  cost-effectiveness  of  the  controls  (ratio  between 
the control costs and the 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 

10 

  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 

11 

  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. 

Budget line 

Type of 
expenditure 

Contribution  

Heading of 
multiannual 
financial 
framework 

Number  

Diff./Non-
diff.98 

from 
EFTA 
countries
99 

from 
candidate 
countries 
and 
potential 
candidates
100 

From 
other 
third 
countries 

other assigned 
revenue 

06 06 01 - EU4Health Programme 

2 

Diff. 

YES 

YES 

YES 

NO 

98 
99 
100 

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 

12 

  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  

–   The proposal/initiative requires the use of operational appropriations, as explained below 

The allocations will be redeployed within the existing envelope of the EU4Health programme 

3.2.1.1.  Appropriations from voted budget 

EUR million (to three decimal places) 

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

TOTAL 
MFF 
2021-2027 

Operational appropriations  

06 06 01 - EU4Health Programme 

06 10 03 Union contribution to the European 
Medicines Agency 

Commitments 

Payments 

Commitments 

Payments 

(1a) 

(2a) 

(1b) 

(2b) 

40,405 

28,284 

0,651 

0,651 

41,213 

40,971 

0,758 

0,758 

Appropriations of an administrative nature financed from the envelope of specific programmes 
Budget line 

(3) 

TOTAL appropriations 

Commitments 

=1a+1b+3 

Payments 

=2a+2b+3 

0,000 

0,000 

0,000 

0,000 

41,056 

28,934 

41,971 

41,729 

81,618 

69,254 

1,408 

1,408 

0,000 

83,027 

70,663 

EN 

13 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
EUR million (to three decimal places) 

TOTAL operational appropriations  
(including 
to 
decentralised agency) 

contribution 

Commitments 

Payments 

Ÿ  TOTAL  appropriations  of  an  administrative 
nature  financed  from  the  envelope  for  specific 
programmes  

(4) 

(5) 

(6) 

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

TOTAL 
MFF 
2021-2027 

0,000 

0,000 

41,056 

41,971 

83,027 

0,000 

0,000 

28,934 

41,729 

70,663 

0,000 

0,000 

0,000 

0,000 

0,000 

TOTAL appropriations 
under HEADING 2 
of the multiannual financial 
framework 

EUR million (to three decimal places) 

Commitments 

=4+6 

0,000 

0,000 

41,056 

41,971 

83,027 

Payments 

=5+6 

0,000 

0,000 

28,934 

41,729 

70,663 

TOTAL 

• 
appropriations 
headings) 

operational 
operational 

(all 

Commitments 

Payments 

•  TOTAL  appropriations  of  an  administrative 
nature  financed  from  the  envelope  for  specific 
programmes (all operational headings) 

(4) 

(5) 

(6) 

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

TOTAL 
MFF 
2021-2027 

0,000 

0,000 

0,000 

0,000 

41,056 

41,971 

28,934 

41,729 

83,027 

70,663 

0,000 

0,000 

0,000 

0,000 

0,000 

TOTAL appropriations 
Under Heading 1 to 6 
of the multiannual financial 
framework 
(Reference amount) 

Commitments 

=4+6 

0,000 

0,000 

41,056 

41,971 

83,027 

Payments 

=5+6 

0,000 

0,000 

28,934 

41,729 

70,663 

EN 

14 

EN 

 
 
 
  
 
 
Heading of multiannual financial  framework  

7 

‘Administrative expenditure’101 

EUR million (to three decimal places) 

Ÿ Human resources  

Ÿ Other administrative expenditure  

Total 

Appropriations  

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

1,793 

0,035 

1,828 

3,586 

0,070 

3,656 

TOTAL 
MFF 
2021-2027 
5,379 

0,105 

5,484 

TOTAL appropriations 
under HEADING 7 
of the multiannual financial framework  

(Total 
commitments 
= Total 
payments) 

0,000 

0,000 

1,828 

3,656 

5,484 

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

TOTAL 
MFF 
2021-2027 

EUR million (to three decimal places) 

TOTAL appropriations 
under HEADINGS 1 to 7 

Commitments 

0,000 

0,000 

42,884 

45,627 

88,511 

of the multiannual financial framework  

Payments 

0,000 

0,000 

30,762 

45,385 

76,147 

101 

The necessary appropriations should be determined using the annual average cost figures available on the appropriate BUDGpedia webpage. 

EN 

15 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
3.2.1.2.  Appropriations from external assigned revenues 

N/A 

3.2.2.  Estimated output funded from operational appropriations (not to be completed for decentralised agencies) 

Indicate objectives and 
outputs 

 

06 06 01 - EU4Health 
Programme 

Year 

2026 

Year 

2027 

TOTAL 
2021-2027 

OUTPUTS 

Type 

Average 
cost 

No 

Cost 

No 

Cost 

No 

Cost 

OBJECTIVE No 1: Security of supply and the availability of critical medicinal products 

A. facilitate investments in 
manufacturing capacities  

Grants  

A. facilitate investments in 
manufacturing capacities  

B.  National public 
procurement criteria 

Meetings 

Meetings 

C.  collaborative procurement 
procedures 

 Meetings 

D. International Cooperation 

Meetings 

Subtotal for objective No 1 

OBJECTIVE  2: Availability and accessibility of certain other medicinal products 

B.  National public 
procurement criteria 

C.  collaborative procurement 
procedures 

Subtotal for objective No 2 

 Meetings 

 Meetings 

EN 

40,000 

40,800 

0 

0 

0 

80,800 

0,055 

0,055 

0,028 

0 

0,055 

0,028 

0,028 

0,028 

0,027 

0,027 

0,027 

0,027 

0 

40,108 

0 

40,910 

0 

0,027 

0,270 

0,297 

0 

0,028 

0,275 

0,303 

0 

0 

0 

0 

16 

0,055 

81,018 

0,055 

0,545 

0,600 

EN 

 
 
                                                                                                                     
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
TOTALS 

0 

40,405 

0 

41,213 

0 

81,618 

Indicate objectives and outputs 

 

06 10 03 Union contribution to 
the European Medicines 
Agency 

Year 

2026 

Year 

2027 

TOTAL 
2021-2027 

EUR million (to three decimal places) 

OUTPUTS 

Type 

Average 
cost 

No 

Cost 

No 

Cost 

No 

Cost 

OBJECTIVE No 1: Security of supply and the availability of critical medicinal products 

A. facilitate investments in 
manufacturing capacities -  

A. facilitate investments in 
manufacturing capacities 

A. facilitate investments in 
manufacturing capacities  

Subtotal for objective No 1 

TOTALS 

EMA Staff 
costs 

IT 

 Meetings 

0,524 

0,100 

0,027 

0,651 

0,651 

0 

0 

0,628 

0,102 

0,028 

0,758 

0,758 

0 

0 

0 

0 

0 

1,152 

0,202 

0,055 

1,408 

1,408 

0 

0 

EN 

17 

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  

–   The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below 

3.2.3.1. Appropriations from voted budget 

VOTED APPROPRIATIONS 

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

TOTAL 
2021 - 
2027 

EUR million (to three decimal places) 

HEADING 7 

Human resources  

Other administrative expenditure  

0,000 

0,000 

0,000 

0,000 

1,793 

0,035 

3,586 

0,070 

5,379 

0,105 

Subtotal HEADING 7 

0,000 

0,000 

1,828 

3,656 

5,484 

Outside HEADING 7 

Human resources  

0,000 

0,000 

0,000 

0,000 

0,000 

Other expenditure of an administrative nature 

0,000 

0,000 

0,000 

0,000 

0,000 

Subtotal outside HEADING 7 

0,000 

0,000 

0,000 

0,000 

0,000 

TOTAL 

0,000 

0,000 

1,828 

3,656 

5,484 

3.2.3.3.  Total appropriations 

TOTAL 
VOTED APPROPRIATIONS  
+ 
EXTERNAL ASSIGNED REVENUES 

Year 

Year 

Year 

Year 

2024 

2025 

2026 

2027 

TOTAL 
2021 - 
2027 

HEADING 7 

Human resources  

0,000 

0,000 

1,793 

3,586 

5,379 

Other administrative expenditure  

0,000 

0,000 

0,035 

0,070 

0,105 

Subtotal HEADING 7 

0,000 

0,000 

1,828 

3,656 

5,484 

EN 

0 

  EN 

 
  
 
Outside HEADING 7 

Human resources  

0,000 

0,000 

0,000 

0,000 

0,000 

Other expenditure of an administrative nature 

0,000 

0,000 

0,000 

0,000 

0,000 

Subtotal outside HEADING 7 

0,000 

0,000 

0,000 

0,000 

0,000 

TOTAL 

0,000 

0,000 

1,828 

3,656 

5,484 

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. 

3.2.4.  Estimated requirements of human resources  

–    The proposal/initiative does not require the use of human resources  

–   The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below 

3.2.4.1.  Financed from voted budget 

Estimate to be expressed in full-time equivalent units (FTEs)1 

VOTED APPROPRIATIONS 

Year 

2024 

Year 

2025 

Year 

2026 

Year 

2027 

POST 

2027 

 Establishment plan posts (officials and temporary staff) 

20 01 02 01 (Headquarters and Commission’s Representation Offices) 

20 01 02 03 (EU 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) 

20 02 01 (AC, END from the ‘global envelope’) 

20 02 03 (AC, AL, END and JPD in the EU Delegations) 

Admin. Support 
line 
[XX.01.YY.YY] 
[2] 

- at Headquarters 

- in EU Delegations  

01 01 01 02 (AC, END - Indirect research) 

 01 01 01 12 (AC, END - Direct research) 

Other budget lines (specify) - Heading 7 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

9 

0 

0 

0 

0 

1 

0 

0 

0 

0 

0 

0 

18 

18 

0 

0 

0 

0 

2 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

2 

0 

0 

0 

0 

0 

0 

1 

Please specify below the table how many FTEs within the number indicated are already assigned to the 
management of the action and/or can be redeployed within your DG and what are your net needs. 

EN 

1 

  EN 

 
  
 
 
  
  
 
Other budget lines (specify) - Outside Heading 7 

TOTAL 

0 

0 

0 

0 

0 

10 

0 

20 

0 

20 

3.2.4.2.  Financed from external assigned revenues 

N/A 

3.2.4.3.  Total requirements of human resources  

TOTAL 
VOTED APPROPRIATIONS  
+ 
EXTERNAL ASSIGNED REVENUES 

 Establishment plan posts (officials and temporary staff) 

20 01 02 01 (Headquarters and Commission’s Representation Offices) 

20 01 02 03 (EU 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) 

20 02 01 (AC, END from the ‘global envelope’) 

20 02 03 (AC, AL, END and JPD in the EU Delegations) 

Admin. Support line 
[XX.01.YY.YY] [2] 

- at Headquarters 

- in EU Delegations  

01 01 01 02 (AC, END - Indirect research) 

 01 01 01 12 (AC, END - Direct research) 

Other budget lines (specify) - Heading 7 

Other budget lines (specify) - Outside Heading 7 

TOTAL 

The staff required to implement the proposal (in FTEs):  

Year 

Year 

Year 

Year 

2024 

2025 

2026 

2027 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

9 

0 

0 

0 

0 

1 

0 

0 

0 

0 

0 

0 

0 

18 

0 

0 

0 

0 

2 

0 

0 

0 

0 

0 

0 

0 

10 

20 

To be covered by 
current staff 
available in the 
Commission 
services  

Exceptional additional staff* 

To be financed 
under Heading 7 
or Research 

To be financed 
from BA line 

To be financed 
from fees 

Establishment 
plan posts 

2026: 9 posts 

2027: 18 post 

Post MMF: 18 posts 

N/A 

EN 

2 

  EN 

 
 
 
 
 
 
 
 
 
External 
staff 
(CA, SNEs, INT) 

2026: 1 CA 

2027: 2 CA 

Post MFF: 2 CA 

3.2.4.4.  Total requirements of human resources EMA 

EMA 

Temporary agents 
(AD+AST) 
Contract agents 

Seconded National Experts 

Total staff 
Appropriations covered by 
the EU Budget 
Appropriations covered by 
fees 
Appropriations co-financed 
(if applicable) 
TOTAL appropriations 

Year 
2024 

Year 
2025 

Year 
2026 

Year  TOTAL 
2021 - 
2027 
2027 

0 

0 

0 

0 

0 

0 

0 

0 

32 

0 

0 

3 

3 

0 

0 

3 

0,000 

0,000 

0,524 

0,628 

1,152 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,000 

0,524 

0,628 

1,152 

Year 

Year 

Year 

Year 

Total  
2021-2027 
MFF 

2024 

2025 

2026 

2027 

0,314 

0,419 

0,733 

0,209 

0,209 

0,419 

 EMA 

Temporary 
agents (AD 
Grades) 

Temporary 
agents (AST 
grades) 

2 

For the 1st year the costs of the 1 AD for the scientific advice is accounted for 50% as it is expected that 
implementation of strategic projects will not fully kick in in 2026. For the rest of the FTEs the cost is 
accounted in full.  

EN 

3 

  EN 

 
 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
 
Contract 
staff 

Seconded 
National 
Experts 

Total 

0,000 

0,000 

0,524 

0,628 

1,152 

Staff requirements (FTE): Total posts Union funded  

Year 
2026 

Year 
2027  

TOTAL 

Temporary agents (AD Grades) 

Temporary agents (AST grades) 

Contract staff as of 

Seconded National Experts 

23 

1 

TOTAL 

3 

Description of tasks to be carried out by: 

2 

1 

3 

2 

1 

3 

Officials and temporary staff 

1 AD to provide scientific advice in accordance to article 11 stating that EMA 
shall provide dedicated advice to assist project promoters developing projects 
relying on innovative manufacturing processes  , 1 AD and 1 AST to address 
the  increased  volume  of  vulnerability  analysis  plus  provision  of  aggregated 
data (AD) 

External staff 

3 

For the 1st year the costs of the 1 AD for the scientific advice is accounted for 50% as it is expected that 
implementation of strategic projects will not fully kick in in 2026. For the rest of the FTEs the cost is 
accounted in full 

EN 

4 

  EN 

 
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.5.  Overview of estimated impact on digital technology-related investments 

Compulsory: the best estimate of the digital technology-related investments entailed 
by the proposal/initiative should be included in the table below.  

Exceptionally,  when  required  for  the  implementation  of  the  proposal/initiative,  the 
appropriations under Heading 7 should be presented in the designated line.  

The appropriations under Headings 1-6 should be reflected as “Policy IT expenditure 
on operational programmes”. This expenditure refers to the operational budget to be 
used to re-use/ buy/ develop IT platforms/ tools directly linked to the implementation 
of the initiative and their associated investments (e.g. licences, studies, data storage 
etc).  The  information  provided  in  this  table  should  be  consistent  with  details 
presented under Section 4 “Digital dimensions”. 

TOTAL Digital and IT appropriations 

Year 

Year 

Year 

Year 

2024 

2025 

2026 

2027 

TOTAL 
MFF 
2021 - 
2027 

HEADING 7 

IT expenditure (corporate)  

Subtotal HEADING 7 

Outside HEADING 7 

Policy IT expenditure on operational 
programmes 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

0.000 

Subtotal outside HEADING 7 

0.000 

0.000 

0.000 

0.000 

0.000 

TOTAL 

0.000 

0.000 

0.000 

0.000 

0.000 

3.2.6.  Compatibility with the current multiannual financial framework  

The proposal/initiative: 

–    can be fully financed through redeployment within the relevant heading of the 

multiannual financial framework (MFF) 

The  increase  of  appropriations  for  EMA  budget  line  06.100301  in  years  2026  and 
2027 by 1,4 million EUR, will be done via internal redeployment within heading 2b, 
i.e. by an equal reduction of the EU4Health budget line 06.0601 for this period. The 
appropriations managed by the Commission will be redeployed withing the existing 
financial envelope of the EU4Health programme.   

–    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 

3.2.7.  Third-party contributions  

The proposal/initiative: 

–    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) 

EN 

5 

  EN 

 
  
 
Year  
2024 

Year  
2025 

Year  
2026 

Year  
2027 

Total 

Specify the co-financing body  

TOTAL appropriations co-
financed  

3.3. 

Estimated impact on revenue  

–    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 

     EUR million (to three decimal places) 

Impact of the proposal/initiative4 

Year 2024 

Year 2025  Year 2026 

Year 2027 

Budget revenue line: 

Article …………. 

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). 

4. 

DIGITAL DIMENSIONS 

4.1. 

Requirements of digital relevance 

Reference 
requirement 

to 

Requirement description  

Stakeholder 
categories 
affected 

High-level  processes 
affected 
this 
by 
requirement  

Category 

Article 6 
paragraph 1 

Recognition 
Projects 

of 

Strategic 

Project promoter 

National 
authority 

Request  recognition  of 
Strategic project 

Data 

Digital Public  

Article 6 
paragraph 2 

to 

States 

shall 
Member 
communicate 
the 
Commission  which  authority 
is  designated  for  assessing 
and 
confirming  Strategic 
Projects;  

EC, MS 

Notify  

Service 

Data 

Digital Public  
Service 

4 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20% for collection costs. 

EN 

6 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Article 6 
paragraph 3 

EC publishes online the list of 
MS designated authorities 

EC, MS 

Publish  

Article 12 

Article 13 

Paragraph 1 

Article 13  

Paragraph 2 

of 
Combination 
environmental 
assessments 
required  under  several  legal 
bases  via  joint  or  coordinated 
procedures 

Project promoter 

National 
authority 

Assess 
strategic 
projects  for  more  legal 
bases 

Availability 
spatial planning data 

of 

relevant 

MS 

Make  available  spatial 
planning data 

Combination 
assessments 

of 

plans 

MS 

Assess  plans  for  more 
legal bases 

Data 

Data  

Digital solution 

Digital public  

service 

Data 

Digital solution 

Data 

Digital public  

service 

Article 16 

Request 
assessment 
addressing vulnerability 

Inform  on  the  existence  of 
Strategic  projects  addressing 
an existing vulnerability  

Chapter IV 

Public  procurement  rules  for 
critical medicine products 

of 

Project promoter, 

Request for assessment 

Data 

Designated 
authority 

Commission 

Inform  on  addressed 
vulnerabilities 

Digital solution 

Digital public  

service 

Member States 

Launch procurement 

Data 

Public 
administrations, 
Economic 
operator 

Article 19 

Notification 
programmes 

of 

national 

Member States  

Commission 

CMG 

Notification of national 
programmes 

Data 

4.2. 

Data 

Type of data  

Reference requirements 

Standard and/or specification  

List of MS Authorities designated 
for  assessing  and  confirming 
Strategic Projects; 

Strategic Project 

Status  of  the  highest  national 
significance for Strategic Projects 

Article 6 

Article 6 

Article 9 

Standard list of MS 

Not defined 

Not defined 

Combined 
assessment 

environmental 

Article 12 

Defined under other legal bases 

Spatial planning data 

Article 13 

Paragraph 1 

Not defined 

Combined urbanistic assessments  Article 13 

Not defined 

Paragraph 2 

Assessment  whether 

strategic  Article 16 

Not defined 

EN 

7 

  EN 

 
 
 
projects  address  a  supply  chain 
vulnerability 

National programmes 

Article 19 

Not defined 

The  list  of  Member  States’  Authorities  designated  for  assessing  and  confirming  Strategic 
Projects  will  be  published  on  the  ec.europa.eu  website,  relying  on  its  standards  for  being 
findable and accessible. 

The act follows the only-once principle by not duplicating data collection for identification of 
critical  medicines  and  evaluation  of  vulnerabilities  in  their  supply  chains,  by  re-using  data 
collected under the Revision of the General Pharmaceutical Legislation.  

Data  related  to  assessments  are  governed  by  the  relevant  legal  basis  that  trigger  the 
assessments. 

Data flows  

Type of data 

Reference(s) to the 
requirement(s) 

Actor who 
provides the 
data 

Actor who 
receives the 
data 

Trigger for the 
data exchange 

Frequency (if 
applicable) 

Article 6 

Member 
States 

Commission 

Not defined 

NA 

List of MS 
Authorities 
designated for 
assessing and 
confirming 
Strategic Projects 

Project 

Article 6 

Project 
promoter 

Designated 
authority 

at the initiative of 
the project 
promoter 

Strategic Project 

Article 6 

Designated 
authority 

Project 
promoter 

At Project promoter 
request 

No deadline set 

Status of the 
highest national 
significance for 
Strategic Projects 

Combined 
environmental 
assessment 

Article 9 

Article 12 

National 
authorities 

Competent 
authority 

Strategic 
Project 
promoter 

Strategic 
Project 
promoter 

No deadline set 

Within 45 days 
after receiving all 
necessary 
information and 
subject to 
exceptions 

EN 

8 

  EN 

 
 
 
 
 
 
Combined 
urbanistic 
assessments 

Request for 
assessment of 
addressing 
vulnerability by 
Strategic 
Projects 

Assessment of 
addressing  
vulnerability by 
Strategic 
Projects 

Assessment of 
addressing 
vulnerability by 
Strategic 
Projects 

Spatial planning 
data 

Article 13 paragraph 1 

Article 13 paragraph 2 

Article 16 paragraph 2 

Member 
States 

Member 
States 
competent 
authorities 

Strategic 
Project 
promoter 

General public 

Strategic 
Project 
promoter 

No deadline set 

Designated 
authority 

At the initiative of 
the project 
promoter 

Article 16 paragraph 2 

Designated 
authority 

Strategic 
Project 
promoter 

Within 15 working 
days  

Article 16 paragraph 2 

Designated 
authority 

The 
Commission 

If Strategic project 
addresses an 
existing 
vulnerability in the 
supply chain. 

No deadline set 

By 6 months after 
entry into force of 
this Regulation 

National 
programmes 

Article 19 paragraph 2 

Member 
States 

Commission 

4.3. 

Digital solutions 

No new digital solution is foreseen.  

4.4. 

Interoperability assessment 

Reference 
to  the  legal 
provision 

Description  of 
requirement 

the 

Effect 
interoperability’  

on 

‘cross-border 

Interaction 
across 
Member 
State 
borders, 
among  EU 
entities 
or 
between  EU 
entities  and 
public  sector 
bodies 

EN 

9 

  EN 

 
 
 
 
 
 
 
 
 
 
 
Article 6 
paragraph 2 

to 

Member  States  shall 
the 
communicate 
Commission  which 
authority is designated 
and 
assessing 
for 
confirming  Strategic 
Projects;  

Article 6 
paragraph 3 

EC  publishes  online 
the 
of  MS 
designated authorities 

list 

No interaction just one simple notification and/or 
publishing 

4.5.  Measures to support digital implementation 

EN 

10 

  EN