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.
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.
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
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