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 medicinal products for veterinary use
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":
- 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 and veterinary use
- Volume 6 - Notice to applicants and regulatory guidelines for medicinal products for veterinary use
- Volume 7 - Scientific guidelines for medicinal products for veterinary use
- Volume 8 - Maximum residue limits
- Volume 9 - Guidelines for pharmacovigilance for medicinal products for human and veterinary use
- Volume 10 - Guidelines for clinical trial
Medicinal products for paediatric use, orphans, herbal medicinal products and advanced therapies are governed by specific rules.
ID 11081 | Update news 09.12.2022 / Documento in allegato
Il 31 Dicembre 2022 termina il periodo transitorio di vali...
ID 21395 | 20.02.2024 / In allegato
L’art. 16 del D. Lgs. 133/2009 (Disciplina sanzio...
Direttiva 2001/82/CE del Parlamento europeo e del Consiglio, del 6 novembre 2001, recante un codice comunitario relativo ai medicinali veterinari
(GU L 311, 28.11.2001)
Recepimento: ...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024