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:

In this section

 

Union Product Database

Information on the Union Product Database, including guidance for national competent authorities and marketing authorisation holders

Scientific and technical recommendations

EMA's scientific and technical recommendations supporting delegated and implementing acts to implement the Regulation

Contacting EMA about technical and regulatory matters

For technical matters related to an IT system set up under the Regulation, please contact the VMP Regulation support service.

These systems and services include the Union Product Database, EudraVigilance Veterinary and the EudraGMDP functionalities developed to support the Regulation, including its integration with the Organisation Management Service (OMS).  

For technical questions related other EMA IT systems, use the EMA service desk.

For support with regulatory matters relating to the Regulation, use our online form:

For any other queries regarding implementation on the Regulation, contact vetchange.programme@ema.europa.eu.

Key benefits of 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's role in implementing the Regulation

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, see Fees payable to the European Medicines Agency

Progress updates

The Veterinary Medicinal Products newsletter is published quarterly and provides an update on progress towards implementing the Regulation.

To subscribe, write to vetchange.programme@ema.europa.eu.

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