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.
10 nuove sostanze aggiunte alla Candidate List
Helsinki, 27 giugno 2018
L' ECHA ha aggiunto otto nuove SVHC all'elenco delle sostanze candidate dopo il processo di...
della Commissione del 26 novembre 2018 che modifica l'allegato V del regolamento (CE) n. 1223/2009 del Parlamento europeo e del Consiglio sui prodotti cosmetici
GU L 300/1 de...
ID 18835 | 26.01.2023 / In allegato
L'arsenico ha uno spiccato effetto neurotossico, letale ad alte dosi. A dosi più basse, l’esposizione prolunga...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024