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:

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:

Other relevant legislation

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: 

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