Implementation of the new veterinary regulation (Regulation 2019/6)

Regulation 2019/6, commonly 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, applied in all EU Member States from 28 January 2022. The new legislation represents a substantial change in how veterinary medicinal products are authorised, monitored and controlled in the European Union. The Regulation followed the adoption of a proposal in 2014 to develop fit-for-purpose veterinary legislation which would no longer be based on the equivalent human medicines authorisation system.

The timeline for the development and implementation of the Regulation is outlined here.

The legislation repeals Directive 2001/82/EC and is intended to:

  • harmonise the internal EU market for veterinary medicinal products

  • reduce the administrative burden on companies and 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 to this dedicated section of the website to keep stakeholders up to date with developments related to the implementation of the Regulation. Please click on the headings below to visit the relevant pages.

Monthly updates were provided throughout 2021 to communicate information on key legislative, regulatory, ICT and procedural changes relating to veterinary medicinal products. In 2022, several updates were published to provide stakeholders with information about emerging developments.

This section answers questions about the practical application of the Regulation. The content will be updated on the basis of new developments and the HPRA will seek to expand the information following feedback from industry.

The HPRA has hosted a number of webinars to provide information to veterinary stakeholders. This page contains materials from the webinars, including video recordings and Q&A documents.

The new veterinary regulation will lead to changes being made to application forms and their associated guidance documents. This page contains up-to-date information on these changes.

This page provides links to view the full text of the legislation in relation to the Regulation.