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 Community codes for veterinary and human medicines are set out in Directive 2001/82/EC and Directive 2001/83/EC respectively. They provide the legal framework for the authorisation, manufacture and distribution of medicines in the EU. The centralised authorisation procedure for human and veterinary medicines is based on Regulation (EC) No 726/2004, which established the European Medicines Agency (EMA).

The EMA began operating on 26 January 1995.

This legal framework has been amended and enhanced over time by further legal acts that cover specific areas of pharmaceutical law.

The main EU legal framework for pharmaceuticals is based on:

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:

More information can be found in 2010 pharmacovigilance legislation.

Specialised medicines sectors

Other relevant legislation

Please note that this list is not exhaustive. For a more detailed list, please refer to EU legislation - Eudralex.

How useful was this page?

Add your rating
7 ratings
1 rating
1 rating