Decreto 16 agosto 2016
Decreto 16 agosto 2016
Leggi tuttoModifica dell’allegato al decreto 9 agosto 2016, recante la revoca di autorizzazioni all’immissione in commercio e modifica delle condizioni d’impiego di prodotti fitosanitari co...
European Union legislation on pharmaceutical sector
European Union legislation on pharmaceutical sector
EudraLex - EU Legislation
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.
Articoli correlati Chemicals
RASFF relazione annuale 2023
RASFF relazione annuale 2023
ID 22664 | 04.10.2024 / In allegato
RASFF - Sistema di allerta rapido per alimenti e mangimi, relazione annuale dati anno 2023
A cura di Ministero della Salute - Anno 2023
Il ...
Classification and Labelling Guide in accordance with EC Regulation 1272/2008 (CLP Regulation)
Classification, and Labelling Guide in accordance with EC Regulation 1272/2008 (CLP Regulation)
EIGA Doc 169 known as the «Classification and Labelling Guide» is updated annually in order to take into ...