Legal framework

The European Union (EU) legal framework for pharmaceuticals is aimed at ensuring a high level of protection of public health. It is based on the principle that the placing of a medicine on the market is subject to the granting of a marketing authorisation by the competent authorities.

The EU legislation for veterinary and human medicines is set out in Regulation (EU) No 2019/6, Regulation (EC) No 726/2004 and Directive 2001/83/EC. They provide the legal framework for the authorisation, manufacture, and distribution of medicines in the EU. This legal framework has been amended and enhanced over time by legal acts covering specific areas of pharmaceutical law.

Centralised marketing authorisation

The centralised marketing authorisation procedure for human and veterinary medicines is based on two pieces of EU legislation which lay down the rules for the authorisation of medicines and their placing on the EU market.

These are Regulation (EC) No 726/2004 (as amended), which enabled the establishment of EMA, and Regulation (EU) No 2019/6.

Specialised medicines sectors

These sectors refer to:

Paediatric medicines - medicines for children, with the legal framework established by Regulation (EC) No 1901/2006
Advanced-therapy medicines - legal framework layed down on Regulation (EC) No 1394/2007, amending Regulation (EC) No 726/2004, and Directive 2001/83/EC
Orphan medicines - legal framework can be found in Regulation (EC) No 141/2000 and a number of other relevant legal acts
Traditional herbal medicines - regulated by Directive 2004/24/EC, amending Directive 2001/83/EC

Pharmacovigilance legislation

In 2010, a package of legislation was adopted whose main aim is to reinforce pharmacovigilance in the EU. This was supplemented by further legislation in 2012.

The main legal acts are:

Regulation (EU) No 1235/2010 and Regulation (EU) No 1027/2012 - amending Regulation (EC) 726/2004 as regards pharmacovigilance
Directive 2010/84/EU and Directive 2012/26/EU - amending Directive 2001/83/EC as regards pharmacovigilance
Commission Implementing Regulation No 520/2012 - related to certain operational aspects implementing the new pharmacovigilance legislation

Other relevant legislation

: A legal framework for the regulatory fees payable by pharmaceutical companies was first established in the 1990s and has since been amended.
Commission Regulation (EC) 2049/2005 features rules regarding the payment of fees and the receipt of administrative assistance from the EMA by micro, small and medium sized enterprises.

: Regulation (EU) No 536/2014 refers to clinical trials on human medicines, repealing Directive 2001/20/EC.
It improves conducting clinical trials in the EU by upholding the highest safety standards for participants and increased transparency of trial information.
This piece of legislation is one of the first achievements of the pharmaceutical strategy, and a further step towards a stronger European Health Union.

: Regulation (EC) No 470/2009 highlights the procedures to establish maximum residue limits of pharmacologically active substances in foodstuffs of animal origin.

: Commission Regulation (EC) 1234/2008 provides the legal framework for handling of post-authorisation variations in the context of marketing authorisations for human medicines. It was amended by Commission Regulation (EU) 712/2012.

: Commission Regulation (EC) 2141/96 highlights rules concerning the examination of application for the transfer of marketing authorisations.

: Directive 2011/62/EU amends Directive 2001/83/EC to provide a legal framework for managing the risk of falsified medicines entering the legal supply chain .

: Commission Regulation (EC) No 658/2007 (as amended) provides an EU penalties regime for the failure to comply with various aspects of Regulation (EC) No 726/2004.

: Regulation (EU) No 2017/745 and Regulation (EU) No 2017/746 changed the EU legal framework for medical devices, introducing new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical devices.

Regulation (EU) No 2022/123 on a reinforced role for the EMA in crisis preparedness and management of medicinal products and medical devices in crisis situation, including medicine shortages.

For more information, see:

Crisis preparedness and management

Please note that this list is not exhaustive. For a more comprehensive list of EU legislation related to medicinal products for human and veterinary use, please see:

EU legislation - Eudralex

Table of contents

Centralised marketing authorisation

Specialised medicines sectors

Pharmacovigilance legislation

Other relevant legislation

Related EU legislation

Related content

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