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.
Regolamento (UE) n. 895/2014 della Commissione, del 14 agosto 2014 , recante modifica dell'allegato XIV del regolamento (CE) n. 1907/2006 del Parlamento europeo e del Consi...
ID 18038 | 10.11.2022 / In allegato
The WHO Recommended Classification of Pesticides by Hazard was approved ...
Helsinki, 8 February 2019 - ECHA recommends companies to prepare for a ‘no deal’ scenario ahead of the UK’s withdrawal on 30 Marc...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024
