Veterinary Medicines Regulation
The Veterinary Medicines Regulation (Regulation (EU) 2019/6) will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022. It contains new measures for increasing the availability and safety of veterinary medicines and enhances EU action against antimicrobial resistance. The European Medicines Agency (EMA) is working closely with the European Commission and other EU partners in preparation for the implementation of the Regulation.
The main objectives of the Regulation are to:
- simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines, for example through streamlined pharmacovigilance rules;
- stimulate the development of innovative veterinary medicines, including products for small markets (minor use and minor species);
- improve the functioning of the internal market for veterinary medicines;
- strengthen EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals, including reserving certain antimicrobials for the treatment of infections in people.
Regulation (EU) 2019/6 repeals Directive 2001/82/EC and amends the provisions of Regulation (EU) 726/2004 relating to the authorisation and supervision of veterinary medicines, which currently governs the centralised marketing authorisation procedure for both human and veterinary medicines.
The European Parliament and the European Council adopted Regulation (EU) 2019/6 in December 2018. It will become applicable on 28 January 2022.
EMA's scientific and technical recommendations supporting delegated and implementing acts to implement the Regulation
- Increased availability and access to safe and high-quality medicines for veterinarians, farmers and pet owners to treat and prevent animal diseases
- Reduced administrative burden and better incentives for pharmaceutical companies developing new and innovative veterinary medicines, benefiting in particular micro, small and medium-sized enterprises (SMEs)
- New and enhanced rules to keep antimicrobials (including antibiotics) effective based on a 'One health' approach for the benefit of animal and public heath and every EU citizen
EMA contributes to discussions on implementing and delegated acts, which the European Commission is preparing as part of the implementation of the Regulation. In particular, the Agency provides scientific and technical recommendations as and when requested by the European Commission.
EMA is also responsible for:
- revising its procedures and regulatory and scientific guidance documents, in line with the Regulation and its implementing and delegated acts;
- leading the implementation of Information technology (IT) systems required by the Regulation, including the Union Product Database, which will provide information on all authorised veterinary medicines and their availability in EU Member States;
- implementing the outcomes of the implementing and delegated acts.
New implementing rules to EMA's Fee Regulation will apply from 28 January 2022, to take account of the Veterinary Medicines Regulation. For more information, see Fees payable to the European Medicines Agency.
Veterinary Medicines Regulation highlights - Issue 6 (PDF/1.2 MB) (new)
First published: 29/07/2021
Veterinary Medicines Regulation highlights - Issue 5 (PDF/1.02 MB)
First published: 31/05/2021
Veterinary Medicines Regulation highlights - Issue 4 (PDF/1.2 MB)
First published: 31/03/2021
Veterinary Medicines Regulation highlights - Issue 3 (PDF/865.91 KB)
First published: 28/01/2021
Veterinary Medicines Regulation highlights - Issue 2 (PDF/980.07 KB)
First published: 30/10/2020
Veterinary Medicines Regulation highlights - Issue 1 (PDF/798.65 KB)
First published: 17/07/2020