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 19092 | 01.03.2023
Regolamento (UE) 2023/441 della Commissione del 28 febbraio 2023 che modifica l’allegato I del regolamento (CE) n. 1334/2008 del Parlamento europeo e del ...
Version March 4.2 2021
This document describes specific provisions for the labelling and packaging of chemical substances and mixtures under T...
CEFIC, 2020
L'Alleanza intersettoriale su COVID-19 ha messo a disposizione una guida pratica volta a sostenere l'industria e le autorità per garantire una fornitura...
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