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The EU has a legal framework for medicines to ensure quality and safety and the smooth functioning of the internal market. Furthermore, it encourages innovation and competitiveness.

Today, medicines can be authorised by:

  1. competent national authorities, or
  2. by the European Commission with the support of EMA,, obligatory for some products

​The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities which ensure a constant exchange and flow of information on the scientific evaluation of medicines in the EU. Special rules exist for the authorization of pediatric medicines, orphan medicines, traditional herbal medicines, vaccines and clinical trials.

Once placed on the market, the safety of a medicine continues to be monitored throughout its life cycle through the EU pharmacovigilance system.
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Medicines marketed in Europe can benefit from patents lasting 10 years. But the Commission is thinking of reducing the duration of patents from 10 to 8 years. A rule to reduce the shortage of drugs, but which according to Big Pharma would have extremely negative outcomes for the development of new drugs.

EU Legislation on medicinal products


The legal framework is primarily regulated by::
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  1. National/mutual recognition procedure: Directive 2001/83/EC
  2. Centralised procedure: Regulation (EC) No 726/2004

(After clicking on the links above, select the consolidated version of the legislative act)

Other specific rules are listed on the side.
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2023: New EU Legislation is coming


​ On 26 April 2023, the European Commission adopted 3 draft legislative proposals in order to review the current legislation on medical products:

  1. The proposal for a Directive contains all the requirements for authorisation, monitoring, labelling and regulatory protection, placing on the market and other regulatory procedures for all medicines authorised at EU and national level. 
  2. The proposal for a Regulation sets specific rules (on top of the ones in the Directive) for medicines authorised at EU level, in particular the most innovative ones. It sets out the rules on coordinated management of critical shortages and security of supply of critical medicines. It also sets out the rules governing the European Medicines Agency (EMA)
  3. The reform also includes a Council Recommendation on antimicrobial resistance (AMR).​

(See the table below for official texts)

EU Pharmaceutical Strategy


The European strategy was adopted on 25 November 2020 and is based on 4 pillars:

  1. ensure access to affordable medicines for patients and address unmet medical needs (in the areas of antimicrobial resistance and rare diseases,
  2. supporting the competitiveness, innovation and sustainability of the EU pharmaceutical industry and the development of high quality, safe, effective and greener medicines,
  3. improve crisis preparedness and response mechanisms, diversified and secure supply chains, address shortages of medicines,
  4. ensure a strong voice of the EU in the world by promoting a high level of quality, efficacy and safety standards.

​The European strategy aims to respond to the challenges posed by current and future problems, so that:
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  1. citizens can benefit from equal access to safe, modern and affordable therapies
  2. digitization and innovation are at the service of the development and rapid dissemination of medicines, also with the global sharing of data coming from the healthcare and research world
  3. meet the needs of an aging European population who need affordable medical and drug support for all
  4. we can work better globally, as the EU imports more and more medicines and their active ingredients.

Upcoming work

INITIATIVE
GOALS
ACTIONS
NEXT STEP
Legislation on Medicines for children & rare diseases
. Products for specific needs of children and patients with rare diseases 
. Timely access to medicines 
. Efficient assessment & authorisation procedures.
​Commission adopted 3 draft legislative acts
Roadmap/Inception Impact Assessment consultation
(Nov. 2020 - 6 January 2021)
Public consultation on possible solutions
European Parliament and EU Council adoption of the 3 draft legislative acts
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Planned for 2023-2024

Competent bodies:​
  • European Parliament charged its parliamentary sub-committee on Public Health to prepare a draft decision
  • EU Council charged its competent ministerial meeting on Health to discuss and negotiate with European Parliament
Revision of pharmaceutical legislation

• Ensure access to affordable medicines 
• Foster innovation, including in areas of unmet medical need
• Improve security of supply 
• Adapt to new scientific and technological developments 
• Reduce red tape.
​Commission adopted 3 draft legislative acts
​Roadmap/Inception Impact Assessment consultation
(​30 Mar 2021 - 27 Apr 2021) ​
Public consultation on possible solutions
(28 Sept 2021 - 21 Dec 2021)
European Parliament and EU Council adoption of the 3 draft legislative acts
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Planned for 2023-2024

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Competent bodies:
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  • European Parliament charged its parliamentary sub-committee on Public Health to prepare a draft decision
  • EU Council charged its competent ministerial meeting on Health to discuss and negotiate with European Parliament
Dialogue on Security of medicines supply 
Strengthen the resilience of pharmaceutical supply chains and ensure the security of supply of medicine
Stakeholder dialogue
Contributions to future EU legislation revisions
Centralising Product Authorisation
Improving the processes for placing on the European market of medicines with EU authorisations (EMA): Oncology and Orphan medicinal products.
Pilot project
(25 Mar 2021 - Aug 2022)
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‘Market Launch of Centrally Authorised Products’, 
Possible new legislation
Solution to the shortage of medicines
Avoid shortages of medicines, so as not to negatively affect health and the economy.
With its proposals of 26 April 2023, the Commission suggests measures to remedy this problem.
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Study on medicine shortages - Final report
​Member States should transpose articles 23a and 81 of Directive 2001/83/EC. Suggested adoption of 16 solutions, as identified by the Study.

See also info under "revision of pharmaceutical legislation"