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.
Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities
ISO/TR 22411:2008 pr...
Pubblicata il 29 Luglio 2020 la UNI/PdR 95.3:2020 "Linee guida relative alle misure per il conten...
della Commissione del 6 novembre 2017 volta a mantenere nella Gazzetta ufficiale dell'Unione europea il riferimento della norma armonizzata EN 13341:2005 + A1:2011 sui serbatoi...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024
