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.
Disciplina sanzionatoria per la violazione delle disposizioni del regolamento (CE) n. 689/2008 sull'esportazione ed importazione di sostanze chimiche pericolose.
(GU n. 283...
ID 9466 | Update 21.10.2021 / Allegato testo nativo e consolidati
Regolamento (CE) N. 428/2009 del Consiglio del 5 maggio 2009 che istituisce un regime comunitario di contro...
della Commissione del 20 giugno 2018 che modifica l'allegato VI del regolamento (CE) n. 1223/2009 del Parlamento europeo e del Consiglio sui prodotti cosmetici
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Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024
