2. Legal framework – EU legislation - EudraLex
1. Introduction to the legal framework for medicines regulation
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A large body of legislation has been developed around the principle of marketing medicines only when authorised. This is underlined by the progressive harmonisation of requirements for the granting of marketing authorisation, and post-marketing monitoring, implemented across the entire European Economic Area (EEA) (all 27 member states plus Liechtenstein, Norway and Iceland).
Today, medicines are authorised at EU level by the European Commission or at national level by the national competent authorities of EU countries (National Competent Authorities (NCA)). Special rules exist for the authorisation of medicines for paediatric use, orphan medicines, traditional herbal medicines, vaccines and advanced therapies. Once placed on the market, the safety of a medicine continues to be monitored throughout its entire lifespan through the EU system of pharmacovigilance.
An overview of the legal framework for medicines in the EU is given in the following table (Table 1), abbreviated and adapted from the European Commission website on ‘the EU legal framework for medicines’, supplemented by detailed information on applicable European Regulations/Directives from https://www.ema.europa.eu/en/about-us/what-we-do/legal-framework#comment-66138.
The main EU legal framework for pharmaceuticals is based on:
Regulation (EC) No 726/2004, laying down Community procedures for the authorisation and supervision of medicines for human and veterinary use and establishing a European Medicines Agency, as amended.
26 January 2007
Regulation (EC) No 141/2000 and a number of other relevant legal acts
date of applicability of the Clinical Trials Regulation on 31 January 2022
amending Directive 2001/83/EC
Directive 2001/83/EC (Title IV Manufacture and Importation)
Directive 2001/20/EC (Article 13 Manufacture and import of IMPs)
Directive 2003/94/EC (GMP)
Medicines and the environment
International cooperation on pharmaceuticals