News about GMP/cGMP

07.02.2022

EC: Regulation (EU) 2019/6 and GDP-regulations on veterinary medicinal products in force

EC: Regulation (EU) 2019/6 and GDP-regulations on veterinary medicinal products in force

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) entered into force on 28 January 2022.  It modernises the existing rules on the authorisation and use of veterinary medicines in the European Union (EU). 


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 Regulation (EU) 2019/6 repealed Directive 2001/82/EC.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.


Source:

EC: Eudralex Volume 4


 

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