Medicinal products

The European Union has established a comprehensive legal framework for medicinal products for human use. Its purpose is to guarantee the quality, safety and efficacy of medicines, protect public health, support the functioning of the internal market and create favourable conditions for pharmaceutical research, innovation and production in Europe.
Medicines may be authorised through national procedures, including mutual-recognition and decentralised procedures, or through the EU centralised procedure. Under the centralised procedure, the European Medicines Agency — EMA — carries out the scientific evaluation and the European Commission grants a marketing authorisation valid throughout the European Economic Area.

EMA coordinates the European medicines regulatory network, which brings together the Commission, the competent national authorities of the EU and EEA countries and scientific experts. Once a medicine has been authorised, its safety continues to be monitored throughout its lifecycle through the EU pharmacovigilance system.
Special legislation applies to orphan medicines, paediatric medicines, advanced-therapy medicinal products, traditional herbal medicines, clinical trials and measures against falsified medicines.


The current general pharmaceutical framework

Until the new pharmaceutical reform is formally adopted and becomes applicable, the general EU framework continues to be based principally on:

1. Directive 2001/83/EC on the Community code relating to medicinal products for human use
2. Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products and establishing the European Medicines Agency

Directive 2001/83/EC governs, among other matters, national marketing authorisations, manufacturing and importation, distribution, advertising, labelling and package leaflets, pharmacovigilance and the placing of medicines on national markets.
Regulation (EC) No 726/2004 establishes the centralised authorisation procedure and the principal rules governing EMA and EU-level supervision of medicines.
When consulting these acts on EUR-Lex, the latest consolidated version should be selected.

Pharmaceutical Strategy for Europe

The Pharmaceutical Strategy for Europe was adopted by the European Commission on 25 November 2020.
The strategy aims to create a future-proof, patient-centred pharmaceutical system that supports public health while strengthening the competitiveness, resilience and sustainability of the European pharmaceutical industry. It also addresses weaknesses exposed by the COVID-19 pandemic, including supply-chain vulnerabilities, shortages and dependence on production outside the EU. 

The strategy is based on four pillars:

1. Ensuring patient access to affordable medicines and addressing unmet medical needs, including rare diseases and antimicrobial resistance.
2. Supporting the competitiveness, innovation and sustainability of the EU pharmaceutical industry and the development of high-quality, safe, effective and environmentally sustainable medicines.
3. Strengthening crisis preparedness and response, diversifying and securing pharmaceutical supply chains and preventing shortages.
4. Reinforcing the EU’s international role by promoting high standards of quality, safety and efficacy.

The strategy is connected with the European Health Union, the EU industrial strategy, the European Green Deal, Europe’s Beating Cancer Plan and the European digital agenda. It covers the entire pharmaceutical lifecycle, from research and clinical development to authorisation, production, distribution, use and disposal. 

Reform of the EU pharmaceutical legislation

On 26 April 2023, the European Commission proposed the most extensive reform of EU pharmaceutical legislation in more than two decades.

The pharmaceutical package consists principally of:

1. Proposal for a new Directive on the Union code relating to medicinal products for human use — COM(2023) 192
2. Proposal for a new Regulation on Union procedures for the authorisation and supervision of medicinal products and on the European Medicines Agency — COM(2023) 193
3. Commission Communication on the reform of pharmaceutical legislation and measures against antimicrobial resistance — COM(2023) 190
4. Council Recommendation of 13 June 2023 on stepping up EU action to combat antimicrobial resistance through a One Health approach

The proposed Directive would replace Directive 2001/83/EC and consolidate the general rules governing medicinal products authorised at national and EU level.

The proposed Regulation would replace Regulation (EC) No 726/2004 and incorporate the main rules currently contained in the legislation on orphan and paediatric medicines. It would also revise EMA’s governance and responsibilities and establish stronger EU-level mechanisms for managing critical shortages and security of supply. 

In December 2025, the European Parliament and the Council reached a political agreement on the reform. The final legal texts must still complete the formal adoption and publication process before the new framework replaces the existing legislation. The agreed framework is intended to improve access to medicines, simplify regulatory procedures, support innovation, facilitate the timely entry of generic and biosimilar medicines and strengthen the monitoring and coordination of shortages. Formal adoption and publication of the final legislative texts are required before the new framework replaces the existing legislation. 

Main objectives of the reform

The reform seeks to:

• provide patients throughout the EU with more timely and equitable access to safe, effective and affordable medicines;
• create incentives for research in areas of unmet medical need;
• maintain an attractive environment for pharmaceutical research, development and manufacturing in Europe;
• simplify and accelerate regulatory procedures;
• adapt the system to scientific and technological developments;
• improve the availability of medicines in all Member States;
• strengthen the prevention, monitoring and coordinated management of shortages;
• facilitate the entry of generic and biosimilar medicines;
• reinforce environmental requirements applying to pharmaceuticals;
• address antimicrobial resistance through a One Health approach;
• integrate the legislation on orphan and paediatric medicines into the general pharmaceutical framework.

The reform would replace:

• Directive 2001/83/EC;
• Regulation (EC) No 726/2004;
• Regulation (EC) No 141/2000 on orphan medicinal products;
• Regulation (EC) No 1901/2006 on medicinal products for paediatric use.

It would also amend parts of the legislation on advanced therapies and clinical trials. 

Access to medicines and regulatory protection

The reform aims to balance two objectives:

• providing predictable incentives for companies that invest in pharmaceutical research and innovation;
• allowing earlier competition from generic and biosimilar medicines in order to improve affordability and the sustainability of health systems.

Regulatory data protection and market protection are distinct from patent protection and supplementary protection certificates. Patents are therefore not simply equivalent to the periods of regulatory protection established by pharmaceutical legislation.
The reform also introduces or strengthens incentives connected with major therapeutic innovation, unmet medical needs and the development of new antimicrobials.

Shortages and security of supply

Medicine shortages and the EU’s dependence on non-EU countries for medicines, active pharmaceutical ingredients and manufacturing inputs have become central elements of European pharmaceutical policy.
The reformed framework strengthens obligations on marketing-authorisation holders, shortage-prevention planning, reporting, monitoring and coordination between national authorities, EMA and the Commission.

These measures complement:

• Regulation (EU) 2022/123 reinforcing EMA’s role in crisis preparedness and the management of shortages;
• the Commission Communication on addressing critical shortages of medicines in the EU;
• the work of the Critical Medicines Alliance;
• the developing EU framework for critical medicines and resilient pharmaceutical supply chains.

Security of supply is increasingly linked to industrial capacity, procurement policy, geographical diversification, strategic production and cooperation among Member States 

Antimicrobial resistance

Antimicrobial resistance — AMR — is addressed through a One Health approach covering human health, animal health and the environment.

The Council Recommendation on combating antimicrobial resistance calls on the EU and Member States to:

• strengthen national One Health action plans;
• improve surveillance of resistance and antimicrobial consumption;
• reinforce infection prevention and control;
• promote antimicrobial stewardship and prudent use;
• establish measurable targets;
• improve professional education and public awareness;
• support research, innovation and access to new antimicrobials;
• increase cooperation at European and international level.

The pharmaceutical reform also provides for incentives intended to stimulate the development of priority antimicrobials. 

Specific EU legislation

Orphan medicinal products
Regulation (EC) No 141/2000 on orphan medicinal products
This Regulation establishes incentives and specific procedures for medicines intended to diagnose, prevent or treat rare diseases. It is to be replaced and integrated into the new pharmaceutical package.

Medicinal products for paediatric use
Regulation (EC) No 1901/2006 on medicinal products for paediatric use
The Regulation promotes the development and availability of medicines appropriately studied and authorised for children. Its rules are also included in the pharmaceutical reform.

Advanced-therapy medicinal products
Regulation (EC) No 1394/2007 on advanced-therapy medicinal products
It applies to gene therapies, somatic-cell therapies and tissue-engineered products and establishes specific evaluation and supervision requirements within the centralised authorisation procedure.

Clinical trials
Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
The Regulation establishes harmonised rules for the authorisation, conduct and supervision of clinical trials in the EU and supports their management through the Clinical Trials Information System.

Traditional herbal medicinal products

• Directive 2004/24/EC on traditional herbal medicinal products

The Directive introduces a simplified registration procedure for traditional herbal medicinal products meeting the required conditions.

Falsified medicines

• Directive 2011/62/EU on the prevention of falsified medicinal products entering the legal supply chain
• Commission Delegated Regulation (EU) 2016/161 on safety features appearing on the packaging of medicinal products

These acts establish measures including unique identifiers, anti-tampering devices, verification systems and rules for authorised online pharmacies.

Pharmacovigilance

• Directive 2010/84/EU amending the pharmacovigilance rules of Directive 2001/83/EC
• Regulation (EU) No 1235/2010 amending the pharmacovigilance provisions of Regulation (EC) No 726/2004

The EU pharmacovigilance system supports the detection, assessment, understanding and prevention of adverse effects and other medicine-related risks throughout the product lifecycle.

Manufacturing standards

• Commission Delegated Regulation (EU) 2017/1569 on good manufacturing practice for investigational medicinal products
• Commission Directive (EU) 2017/1572 on principles and guidelines of good manufacturing practice for medicinal products for human use

Good manufacturing practice requirements apply to the production, quality control, importation and release of medicines.

Changes to marketing authorisations

• Commission Regulation (EC) No 1234/2008 concerning variations to the terms of marketing authorisations
• Commission Delegated Regulation (EU) 2024/1701 amending Regulation (EC) No 1234/2008
• EU Guidelines on variations applicable from 15 January 2026

The revised framework is intended to simplify and modernise the management of post-authorisation changes, including changes affecting manufacturing, quality, safety and product information. (Public Health)

Research, digitalisation and real-world data
Digital technologies, artificial intelligence, computational modelling and real-world data are increasingly important throughout the medicinal-product lifecycle.

They can support:

• medicine discovery and development;
• clinical-trial design;
• regulatory assessment;
• pharmacovigilance;
• personalised medicine;
• monitoring of treatment outcomes;
• post-authorisation evidence generation.

Their use must remain compatible with pharmaceutical legislation, data-protection law, the European Health Data Space and the EU rules governing artificial intelligence.

Environmental sustainability
EU pharmaceutical policy increasingly considers the environmental impact of medicines throughout their lifecycle.
The pharmaceutical reform strengthens the role of environmental risk assessments and aims to reduce the environmental effects of the production, use and disposal of medicinal products.
This approach forms part of the broader EU commitment to One Health, zero pollution, sustainable production and action against antimicrobial resistance.

Institutional responsibilities
The principal actors in the EU pharmaceutical system include:

• the European Commission — Directorate-General for Health and Food Safety;
• the European Medicines Agency;
• the competent national medicines authorities;
• the Heads of Medicines Agencies network;
• the European Parliament;
• the Council of the European Union;
• national health systems and reimbursement authorities.