Guidance

Veterinary Medicines Regulations

Sets out legal text on the manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines.

The Veterinary Medicinal Products Directive 2001/82/EC (as amended) sets out the controls on the manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines applicable in all European Member States.

The Directive provides the basis for the UK controls on veterinary medicines, which are set out nationally in the Veterinary Medicines Regulations (VMR). The VMR are periodically revoked and replaced after consultation with interested groups to ensure that they are up-to-date and fit for purpose.

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

UK Legislation

The Veterinary Medicines Regulations 2013 SI 2033 came into force on 1 October 2013.

Maximum Residue Limits in GB

MRLs listed in Commission Regulation (EC) 37/2010 or published in the Official Journal prior to 31 December 2020 will continue to have effect in GB and included on the list of GB approved MRLs from 1 January 2021.

EU Veterinary Medicines Directives:

  • Directive 2001/82/EC - Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
  • Directive 2004/28/EC - Amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
  • Directive 2009/9/EC - Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use

Medicated Feed and Feedingstuffs Directives:

  • Council Directive 90/167/EEC - laying down the conditions governing the preparation, placing on the market and the use of medicated feedingstuffs in the Community

Residue control Directives:

EU Veterinary Medicines Regulations:

  • Regulation EC/470/2009 - 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/37/2010 - Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (Under the Northern Ireland Protocol, NI will apply this regulation)
  • Commission Regulation (EU) 122/2013 of 12 February 2013 amending Regulation (EC) No 1950/2006 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 was published in the Official Journal on 22 December 2006
  • Regulation EC/1234/2008 - Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products

Medicated Feed and Feedingstuffs Regulations:

  • Regulation (EC) No 767/2009 - Placing on the market and the use of feed
  • Regulation (EC) No 183/2005 - Laying down requirements for feed hygiene
  • 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
  • Regulation (EC) No 1831/2003 - On additives for use in animal nutrition
  • Regulation (EC) No 178/2002 - Laying down the general principals and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
  • Regulation (EC) No 152/2009 - Laying down the methods of sampling and analysis for the official control of feed

Defra welcomes your views on how we can simplify our existing regulations. Anyone can put forward simplification suggestions and are advised to visit the Regulatory Delivery for guidance on how to submit proposals.

Published 14 April 2014
Last updated 31 January 2020 + show all updates
  1. 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

  2. List of relevant Regulations updated

  3. First published.