Guidance

Veterinary medicines legislation

The legal text underpinning the regulation of manufacture, authorisation, marketing, distribution, use and post-authorisation surveillance of veterinary medicines and medicated feed.

From:
Veterinary Medicines Directorate
Published
14 April 2014
Last updated
17 May 2024 — See all updates

There are several pieces of legislation which set out the controls on veterinary medicines and medicated feed and form the basis for their regulation in the UK. Under the Windsor Framework, separate legislation on veterinary medicines applies in Great Britain and in Northern Ireland.

For the text of the relevant legislation go to legislation.gov.uk.

Legislation in GB

Veterinary medicines and medicated feed

The Veterinary Medicines Regulations 2013 (S.I. 2013/2033; VMR) set out the legislative regime for veterinary medicines and medicated feed and came into force on 1 October 2013. The VMR as originally made extended to the UK. However, under the Windsor Framework, EU law on veterinary medicines and medicated feed applies in respect of Northern Ireland. Accordingly, changes were made to the VMR following EU Exit which applied in GB but not in NI, and vice versa.

The VMR (as amended) set out the controls on the manufacture, authorisation, possession, distribution, use and post-authorisation surveillance of veterinary medicines and medicated feed. The VMR are periodically amended after consultation with interested stakeholders to ensure that they are up-to-date and fit for purpose.

The latest amendments for GB were made by the Veterinary Medicines (Amendment, etc.) Regulations 2024.

The following assimilated law with relevance for veterinary medicines applies in GB:

The following assimilated law relevant to medicated feed applies in GB:

Maximum Residue Limits

Maximum Residue Limits (MRLs) that were listed in Commission Regulation (EU) 37/2010 or published in the Official Journal of the European Union prior to 31 December 2020 continue to have effect in GB and were included on the list of GB approved MRLs from 1 January 2021.

MRLs are established for the active substance in GB in accordance with assimilated law Regulation (EC) No 470/2009 of the European Parliament and of the Council.

For more information on applying for MRLs in GB, see Guidance for the veterinary pharmaceutical industry on applying for MRLs in the UK.

Residue control and monitoring

For more information on our monitoring programme for residues of veterinary medicines and prohibited substances, see the guidance on residues surveillance.

The following legislation relevant to residues monitoring applies in GB:

Legislation in NI

Veterinary medicines and medicated feed

Under the Windsor Framework, EU law on veterinary medicines and medicated feed applies in respect of Northern Ireland.

Aspects of the Veterinary Medicines Regulations 2013 (S.I. 2013/2033; VMR) still apply in NI to complement and enact certain aspects of the EU law.

The following EU Regulations with relevance for veterinary medicines and medicated feed apply in NI:

  • Regulation (EU) 2019/6 (as amended) of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
  • Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC

Both Regulations are complemented by a suite of implementing (for veterinary medicines) and delegating acts (for veterinary medicines) and (for medicated feed).

  • Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council
  • Regulation (EC) No 1950/2006 (as amended) establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae

Maximum Residue Limits

Maximum Residue Limits (MRLs) are listed in Commission Regulation (EU) 37/2010.

MRLs are established for the active substance in NI in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council.

For more information on applying for MRLs in NI, see Guidance for the veterinary pharmaceutical industry on applying for MRLs in the UK.

Residue control and monitoring

For more information on our monitoring programme for residues of veterinary medicines and prohibited substances, see the guidance on residues surveillance.

The following legislation relevant to residues monitoring applies in NI:

Published 14 April 2014
Last updated 17 May 2024 + show all updates

  1. Updated to reflect changes to the VMR.

  2. Updated to included Regulation (EC) No - (EU) 2017/625 Official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

  3. List of relevant Regulations updated

  4. First published.

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