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1. Introduction to the legal framework for medicines regulation
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:
For the interested:
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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 and can be downloaded here: https://op.europa.eu/en/publication-detail/-/publication/b8e0e2bb-8cf5-11e5-b8b7-01aa75ed71a1 |
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