Implementation of Regulation 2019/6
Regulation 2019/6 outlines the legal basis for the authorisation, use and monitoring of veterinary medicinal products in the European Union.
The legislation aims to:
- harmonise the internal EU market for veterinary medicinal products,
- reduce the administrative burden on companies and EU regulatory authorities,
- enhance the availability of veterinary medicinal products,
- stimulate innovation of new and existing medicines,
- strengthen the EU response to fight antimicrobial resistance.
Key information
The legislation came into effect on 28 January 2019 and was applied in all EU Member States on 28 January 2022. The legislation gave rise to the creation of the Union Product Database, which is managed by the European Medicines Agency.
As part of the implementation of the Regulation, the EU Commission was required to develop secondary legislation, known as delegated and implementing acts. These acts outline further and more specific requirements. Further information is available on the European Commission website (Implementing the EU Regulation on veterinary medicines - Food Safety).
New national legislation on veterinary medicines has been developed by the Department of Agriculture, Food and the Marine. Further information on relevant national legislation is available on the DAFM website (Veterinary Medicine & Residues).
Common rules for the manufacture of veterinary medicines
In October 2025, the EU Commission published two Implementing Acts (IAs) relating to GMP of veterinary medicines:
- Commission Implementing Regulation (EU) 2025/2091 of 17 October 2025 laying down good manufacturing practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 http://data.europa.eu/eli/reg_impl/2025/2091/oj
- Commission Implementing Regulation (EU) 2025/2154 of 17 October 2025 laying down good manufacturing practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 http://data.europa.eu/eli/reg_impl/2025/2154/oj
The date of application for both Implementing Regulations is 16th July 2026.