Body of European Union legislation
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union":
- Volume 1 - EU pharmaceutical legislation for medicinal products for human use
- Volume 5 - EU pharmaceutical legislation for veterinary medicinal products
Guidelines
The basic legislation is supported by a series of guidelines that are also published in the following volumes of "The rules governing medicinal products in the European Union".
Please note that Volume 4 applies to veterinary medicinal products only until 15 July 2026, and Volumes 7, 8 and 9 no longer apply. More detailed explanations on the current status are provided on the respective pages for each volume.
- Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use
- Volume 3 - Scientific guidelines for medicinal products for human use
- Volume 4 - Guidelines for good manufacturing practices for medicinal products for human use and veterinary medicinal products
- Volume 6 - Guidance to applicants for veterinary medicinal products
- Volume 7 - Scientific guidelines for veterinary medicinal products
- Volume 8 - Maximum residue limits
- Volume 9 - Guidelines for pharmacovigilance for medicinal products for human use and veterinary medicinal products
- Volume 10 - Guidelines for clinical trials for medicinal products for human use
Medicinal products for paediatric use, orphan medicinal products, herbal medicinal products and advanced therapies are governed by specific rules.
See also:
- EudraBook
This EudraBook V1 was published in May 2015 and no longer current. The most up-to-date information can be found in the links above.
