Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
This procedure updates the existing regulation on how medicines are authorised and supervised in the EU. It aims to ensure high standards for both human and veterinary medicines, maintaining public and animal health.
The changes affect the European Medicines Agency and the pharmaceutical industry. It ensures consistent rules across the EU for medicines, impacting their availability and safety for consumers and animals.
Documents
[IT] decreto legislativo 6 febbraio 2025, n. 10 recante “Adeguamento della normativa nazionale alle disposizioni del regolamento delegato (UE) 2016/161 della Commissione del 2 ottobre 2015, che integra la — https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2025-02-06;10
national transposition · IT · 2026-08-24
Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
position · EN · 2026-05-18
Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
position · EN · 2026-05-18
Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
proposal · EN · 2026-05-18
Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
report · EN · 2026-05-18