Informazione tecnica HSE / 25 ° anno
/ Documenti disponibili:
44.307
/ Documenti scaricati: 31.899.478
/ Documenti scaricati: 31.899.478
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 21448 | 01.03.2024
Regio Decreto 30 settembre 1938 n. 1706
Approvazione del regolamento per il servizio farmaceutico.
(GU n.259 del 14.11.1938)
_______
Aggiornamen...
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...
ID 16527 | 01.05.2022 / Documento allegato
Update 01.05.2022
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024