2. Legal framework – EU legislation - EudraLex

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1. Introduction to the legal framework for medicines regulation

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

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.

 

Legal framework

The main EU legal framework for pharmaceuticals is based on:

Directive 2001/83/EC
on the Community code relating to medicines for human use, as amended.
(consolidated text of Directive 2001/83/EC);     and

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.
(consolidated text of Regulation (EC) No 726/2004).

Medicines for children.

Paediatric Regulation

26 January 2007

Orphan medicines

Regulation (EC) No 141/2000 and a number of other relevant legal acts

Advanced therapies

Regulation (EC) No 1394/2007, amending Regulation (EC) No 726/2004 and Directive 2001/83/EC.

Pharmacovigilance

Directive 2001/83/EC on the Community code relating to medicines for human use, as amended. (consolidated text of Directive 2001/83/EC)

and (consolidated text of Regulation (EC) No 726/2004)

Clinical trials

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicines for human use, and repealing Directive 2001/20/EC

date of applicability of the Clinical Trials Regulation on 31 January 2022

Falsified medicines

Directive 2011/62/EU

amending Directive 2001/83/EC

Traditional herbal
medicines

Directive 2004/24/EC, amending Directive 2001/83/EC.

Good Manufacturing and Distribution Practices

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)

Commission guideline 2013/C 343/01 on Good Distribution Practice of medicines for human use

 

Post-authorisation variations

Commission Regulation (EC) No 1234/2008 amended by Commission Delegated Regulation (EU) 2021/756 

Medicines and the environment

Pharmaceutical strategy forEurope

International cooperation on pharmaceuticals

Pharmaceutical committee
and expert groups