Veterinary Medicinal Products Regulation
The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) updated the rules on the authorisation and use of veterinary medicines in the European Union (EU) when it became applicable on 28 January 2022. The European Medicines Agency (EMA) works with the European Commission and other EU partners in implementing the Regulation.
It contains measures to support the availability and safety of veterinary medicines and enhanced EU action against antimicrobial resistance.
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 (veterinary limited markets);
- 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) 2019/5 amended the EU pharmaceutical legal framework set out by Regulation (EU) 726/2004 and created a legal framework specific to veterinary products. The new provisions apply from 28 January 2022, when Regulation (EU) 2019/6 replaced Directive 2001/82/EC.
The European Parliament and European Council adopted the Regulation in December 2018. It took effect on 28 January 2022.
Consult the Regulation:
EMA's scientific and technical recommendations supporting delegated and implementing acts to implement the Regulation
You can send us a query via EMA ServiceNow to:
- request support to solve a technical issue;
- report a bug;
- ask for help to solve issues accessing EMA IT systems, including the Union Product Database and Union Pharmacovigilance Database.
For any general questions about the implementation of the , use our online form:
- 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 contributed to discussions on implementing and delegated acts, which the European Commission prepared as part of the implementation of the Regulation. In particular, the Agency provided scientific and technical recommendations as and when requested by the European Commission.
EMA was 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 serves as a single source of 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 apply from 28 January 2022, to take account of the Veterinary Medicines Regulation. For more information, seeFees payable to the European Medicines Agency.
EMA publishes the Veterinary Medicines Highlights every three months.
This newsletter includes updates and interviews from the the Agency's Veterinary Medicines Division.
Issues from September 2023 (Issue 13) onwards are available at the link below:
Previous issues are available on EMA's website in PDF format:
Use the link below to receive Veterinary Medicines Highlights by email: