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.
- 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.
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.
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database (PDF/239.24 KB)
Draft: consultation closed
First published: 21/01/2021
Consultation dates: 21/01/2021 to 21/03/2021
EMA/536780/2020 -
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 1: Registration and data access requirements for the User Interface (UI) and Application Programming Interface (API) (PDF/225.65 KB)
Draft: consultation closed
First published: 21/01/2021
Consultation dates: 21/01/2021 to 21/03/2021
EMA/562455/2020 -
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EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.47 MB)
Draft: consultation closed
First published: 21/01/2021
Consultation dates: 21/01/2021 to 21/03/2021
EMA/106051/2020 -
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information (PDF/259.66 KB)
Draft: consultation closed
First published: 21/01/2021
Last updated: 26/01/2021
Consultation dates: 21/01/2021 to 21/03/2021
EMA/590669/2020 Corr.1 -
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (PDF/560.28 KB)
Draft: consultation closed
First published: 21/01/2021
Consultation dates: 21/01/2021 to 21/03/2021
EMA/557461/2020 -
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications (PDF/213.63 KB)
Draft: consultation closed
First published: 21/01/2021
Consultation dates: 21/01/2021 to 21/03/2021
EMA/597691/2020 -
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Template for the submission of comments on the EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database (DOCX/114.5 KB)
First published: 21/01/2021
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.
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Draft Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 (PDF/154.65 KB)
Draft: consultation closed
First published: 17/07/2020
Consultation dates: 17/07/2020 to 18/09/2020
EMA/198149/2020 -
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Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082 - Overview of comments (PDF/302.84 KB)
First published: 27/01/2021
EMA/633341/2020
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.
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Veterinary Medicines Regulation highlights - Issue 4 (PDF/1.2 MB) (new)
First published: 31/03/2021
Issue 4 -
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Veterinary Medicines Regulation highlights - Issue 3 (PDF/865.91 KB)
First published: 28/01/2021
Issue 3 -
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Veterinary Medicines Regulation highlights - Issue 2 (PDF/980.07 KB)
First published: 30/10/2020
Issue 2 -
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Veterinary Medicines Regulation highlights - Issue 1 (PDF/798.65 KB)
First published: 17/07/2020
Issue 1
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.