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:

• Directive 2001/82/EC, on the Community code relating to veterinary medicinal products, as amended. The amendments are incorporated into the consolidated text of Directive 2001/82/EC;
• Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended. The amendments are incorporated into the consolidated text of Directive 2001/83/EC;
• Regulation (EC) No 726/2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended. The amendments are incorporated into the consolidated text of Regulation (EC) No 726/2004.

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, as regards pharmacovigilance, Regulation (EC) No 726/2004;
• Directive 2010/84/EU and Directive 2012/26/EU amending, as regards pharmacovigilance, Directive 2001/83/EC.
• Commission Implementing Regulation No 520/2012, which concerns operational aspects of implementing the new legislation.

More information can be found in 2010 pharmacovigilance legislation.

Specialised medicines sectors

• A legal framework for traditional herbal medicines was established by Directive 2004/24/EC, amending Directive 2001/83/EC. More information can be found in Herbal medicinal products.
• The EMA plays an important role in the development of paediatric medicines (medicines for children). The legal framework for paediatric medicines is based on Regulation (EC) 1901/2006. More information can be found in Medicines for children.
• A legal framework for advanced-therapy medicines was established by Regulation (EC) No 1394/2007, amending Regulation (EC) No 726/2004 and Directive 2001/83/EC. More information can be found in Advanced therapies.
• The EMA plays a central role in the development and authorisation of orphan medicines (medicines for rare diseases). The legal framework for orphan medicines is based on Regulation (EC) No 141/2000 and a number of other relevant legal acts. More information can be found in Legal background: orphan designation.

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. More information can be found in Fees payable to the European Medicines Agency.
• Commission Regulation(EC) No 2049/2005 laying down rules regarding the payment of fees to, and the receipt of administrative assistance from the EMA by micro, small and medium-sized enterprises. More information can be found in SME office.
• Directive 2001/20/EC establishes a legal framework for the conduct of clinical trials in the EU. More information can be found in Clinical trials in human medicines.
• Regulation (EC) No 470/2009 lays down Community procedures for the establishment of maximum residue limits of pharmacologically active substances in foodstuffs of animal origin. More information can be found in Maximum residue limits.
• Commission Regulation (EC) No 1234/2008 provides the legal framework for handling of post-authorisation variations to the terms of marketing authorisations for human and veterinary medicines. It was amended by Commission Regulation (EU) No 712/2012.
• Commission Regulation(EC) No 2141/96 lays down rules concerning the examination of an application for the transfer of a marketing authorisation.
• Directive 2011/62/EU provides a legal framework for managing the risk of falsified medicines entering the legal supply chain by amending Directive 2001/83/EC. More information can be found in Falsified medicines.
• Regulation (EC) No 658/2007 provides an EU penalties regime in respect of failure to comply with various aspects of Regulation (EC) No 726/2004.

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