2. Legal framework – EU legislation - EudraLex
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| Course: | Regulatory procedures- Marketing-Authorisations and their lifecycle management |
| Book: | 2. Legal framework – EU legislation - EudraLex |
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| Date: | Wednesday, 9 October 2024, 5:19 PM |
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.
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The main EU legal framework for pharmaceuticals is based on: Directive 2001/83/EC 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 |
Regulation (EC) No 1394/2007, amending Regulation (EC) No 726/2004 and Directive 2001/83/EC. |
Directive 2001/83/EC on the Community code relating to medicines for human use, as amended. (consolidated text of Directive 2001/83/EC) |
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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 |
amending Directive 2001/83/EC |
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
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Post-authorisation variations Commission Regulation (EC) No 1234/2008 amended by Commission Delegated Regulation (EU) 2021/756 |
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Medicines and the environment |
International cooperation on pharmaceuticals |
1.1. Legal basis - EudraLex Volume 1: Pharmaceutical legislation for medicines for human use
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 (governing medicines for humans) and in volume 5 (governing medicines for animals) of the publication "The rules governing medicines in the European Union" which comprises:
MiscellaneousFor the interested:
For the interested:
Compendium of EU pharmaceutical law: EudraBook V1 - May 2015
To understand the EU legal framework for medicines it is important to know the applicable provisions of the legislation itself. This E-Book is intended to support readers in this regard by putting together the most recent versions of the key legal instruments on medicines for human use. It provides a useful overview for stakeholders: the pharmaceutical industry, regulatory authorities, legal practitioners, interested citizens, patients and healthcare professionals. The ebook is available at: EudraBook - Publications Office of the EU (europa.eu)
The basic legislation is supported by a series of guidelines that are also published in the following volumes of "The rules governing medicines in the European Union" (the list here is adapted and contains volumes relating to human use):
- Volume 2 - Notice to applicants and regulatory guidelines for medicines for human use
- Volume 3 - Scientific guidelines for medicines for human use
- Volume 4 - Guidelines for good manufacturing practices for medicines for human and veterinary use
- Volume 8 - Maximum residue limits
- Volume 9 - Guidelines for pharmacovigilance for medicines for human and veterinary use In the past the European Commission also published pharmacovigilance guidance for human medicines (Volume 9A) With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency. (Volume 9B remains for veterinary products)
- Volume 10 - Guidelines for clinical trials
Medicines for paediatric use, orphan medicines, herbal medicines, and advanced therapies are governed by specific rules
1.2. Legal basis - EudraLex Volume 2: Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicines for human use
Volume 2 contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet (PL) requirements.
Volume 2 is presented in three parts and is regularly updated:
- Volume 2A dealing with procedures for marketing authorisation
- Chapter 1 - Marketing Authorisation (updated version - July 2019)
- Chapter 2 - Mutual Recognition (updated version - February 2007)
- Chapter 3 - Union Referral Procedures (updated version - November 2018)
- Chapter 4 - Centralised Procedure (deleted - July 2015). This chapter has been deleted because the information related to the centralised procedure is now provided on the EMA website directly
Chapter 5 - Guidelines of 16 May 2013 on the details of the various categories of variations, and on the operation of the procedures - Chapter 6 - Community Marketing Authorisation (updated version - November 2005)
- Volume 2B dealing with the presentation and content of the application dossier incorporating the Common Technical Document (CTD) (May 2008).
- Electronic Application Forms The use of the electronic Application Forms (eAF) is mandatory for all procedures from 1 January 2016. The eAFs must be used for all applications: authorisations, variations and renewals.
- Electronic Common Technical Document (eCTD) EU Module 1 Specification
- Volume 2C dealing with regulatory guidelines