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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.

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 role in implementing the Regulation

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.

Implementing the Union Product Database

A?draft implementation guide for the Union Product Database?is available for public consultation.

It contains guidance for?marketing authorisation holders?and national competent authorities?on?the submission of data on veterinary?medicines?to the Union Product Database using standardised data formats and terminologies throughout the EU.

The different chapters of the guide explain the?timelines, requirements, process, technical specification, data elements and associated business rules for?submitting these data.

The UPD will draw on the four SPOR data management services for the centralised management of master data in the EU. For more information, seeSubstance, product, organisation and referential (SPOR) master data.

Stakeholders should send their comments to?vetchange.programme@ema.europa.eu by 21 March 2021 using the form provided below. They should fill in a separate form for commenting on each chapter.

The access policy for the Union Product Database sets out the types of information different user groups will?be allowed to access once the database becomes operational in January 2022.

The final access policy is available below together with the outcome of a public consultation.?

Progress updates

EMA’s newsletter, published every two months in?2021, provides an update on progress towards implementing the Regulation.

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

EMA recommendations on delegated and implementing acts

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 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.

Marketing authorisation

Union Product Database

Antimicrobial sales and use


Good distribution practice (GDP)

Oral routes of administration

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