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

On 28 January 2022, the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), updating the existing rules on the authorization and use of veterinary medicinal products in the European Union, entered into force.

Regulation (EU) 2019/6 repealed Directive 2001/82/EC; bringing new measures to increase the availability and safety of veterinary medicines, it should also strengthen EU action against antimicrobial resistance. In addition, it amended the provisions of Regulation (EU) 726/2004 on the authorization and supervision of veterinary medicinal products, which currently governs the centralized marketing authorization procedure for both human and veterinary medicinal products.

In accordance with Regulation (EU) 2019/6, the European Commission added two standalone GDP regulations, all documents can be found in Eudralex Volume 4:

• Commission Implementing Regulation (EU) 2021/1248 on good distribution practice for veterinary medicinal products
• Commission Implementing Regulation (EU) 2021/1280 on good distribution practice for active substances used as starting materials in veterinary medicinal products

The documents were developed analogously to the GDP guidelines for for medicinal products for human use and related active substances.