With new measures for increasing the availability and safety of veterinary medicines it should also enhance EU action against antimicrobial resistance. Regulation (EU) 2019/6 repealed Directive 2001/82/EC. Furthermore, it amended the provisions of Regulation (EU) 726/2004 relating to the authorisation and supervision of veterinary medicines, which currently governs the centralised marketing authorisation procedure for both human and veterinary medicines.
In accordance with Regulation (EU) 2019/6, the European Commission added two standalone GDP regulations to Eudralex Volume 4:
The documents are compiled analogously to the GDP guidelines for medicinal products for human use and their active substances. All documents can be found in Eudralex Volume 4.
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