Implementation of the Regulation 2019/6
Regulation 2019/6, also known as the new veterinary regulation (NVR), legislates for the authorisation, use and monitoring of veterinary medicinal products in the European Union. The legislation came into effect on 28 January 2019, was applied in all EU Member States from 28 January 2022.
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
Prior to 28 January 2022 and at periodic intervals subsequently, we have added regular updates on the implementation of the Regulation. While the Regulation was applied directly in the EU in January 2022 (and therefore did not require national legislation), a number of national discretionary measures, as well as secondary EU legislation and the development of new EU databases had yet to be implemented. This section of the website is intended to provide stakeholders with up to date information on these developments. Please click on the headings below to visit the relevant pages.
We publish periodic updates regarding key legislative, regulatory, ICT and procedural changes relating to veterinary medicines. We continue to provide further updates as and when there are further developments or new secondary EU legislation or national legislation that impacts on the animal health sector in Ireland.
This section answers questions from industry about the practical application of the Regulation. The content will be updated on the basis of new developments.
This page provides links to view the full text of the legislation in relation to the regulation of veterinary medicines.
For queries in relation to the new veterinary regulation, please contact us on vetinfouser@hpra.ie.