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 is required to develop secondary legislation, known as delegated and implementing acts. These acts outline further and more specific requirements. Progress on this work is available on the European Commission website.
New national legislation on veterinary medicines is being developed by the Department of Agriculture, Food and the Marine. Progress on this work is available on the DAFM website.
Consultation on common rules for the manufacture of veterinary medicines
In accordance with Regulation 2019/6, the EU Commission is currently elaborating two Implementing Acts (IAs) on the manufacture of veterinary medicines:
- Draft IA on the rules on good manufacturing practices
- Draft IA on good manufacturing practice for active substances used as starting materials in veterinary medicines
There is a public consultation for stakeholder feedback in respect of both draft IAs. The deadline for feedback is 19 February 2025.
Frequently asked questions
This section answers questions from industry about the practical application of the Regulation. The content will be updated on the basis of new developments.