Implementation of the new Veterinary Medicines Regulation
The new 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 new Regulation.
The main objectives of the new 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.
- 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.
Veterinary stakeholders commented on a draft access policy for the Union Product Database. It sets out the types of information different user groups should be allowed to access once the database becomes operational in January 2022:
EMA plans to finalise the access policy in December 2020.
At the request of the European Commission, EMA is preparing scientific and technical recommendations to feed into delegated and implementing acts as part of the implementation of the new Regulation.
Details on the European Commission's requests and EMA's recommendations are included below and are also available on the European Commission's website.
EMA's recommendations are prepared by ad hoc experts groups composed of members of the European network of experts and EMA staff, in collaboration with other EU bodies, where necessary.
EMA updates this page when new recommendations become available.