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.
UNI EN ISO 20430:2020 Macchine per materie plastiche e gomma - Macchine per stampaggio a iniezione - Requisiti di sicurezza
Data entrata in vi...
Sistemi di gestione ambientale - Linee guida per un approccio flessibile all'implementazione per fasi
Preview in allegato
La norma fornisce le linee guida per un approccio per fasi ...
ID 6405 | Rev. 1.0 2021 del 13.05.2021
In allegato Documento sull’arresto di emergenza di macchine di raccordo tra i requisiti:
1. Direttiva macchine 2006/42/CE al R...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024
