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 Regulation (VMR). The VMR are revoked and replaced on a regular basis 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.

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 (Official Journal L 311, 28/11/2001 p. 1 - 66). (consolidated version : 18/7/2009)
  • 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 (Official Journal L 136, 30/4/2004 p. 58 - 84)
  • Consolidated Directive - Consolidated 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 as amended by Directive 2004/28/EC
  • Directive 2009/53/EC - amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (Official Journal L 168, 30/6/2009, p. 33 - 34)
  • 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 (Official Journal L 44, 14/2/2009 p. 10 - 61).

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
  • Council Directive 79/373/EEC - on the marketing of compound feedingstuffs
  • Council Directive 76/371/EEC - establishing Community methods of sampling for the official control of feedingstuffs

Residue control Directives:

  • Directive 96/22 - Concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists.
  • Directive 96/23 - Measures to monitor certain substances and residues thereof in live animals and animal products

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. (Official Journal L 152, 16/6/2009 p. 11 - 22).
  • 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 (Text with EEA relevance).
  • Regulation EC/1950/2006 - Commission Regulation (EC) No 1950/2006 of 13 December 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 (Official Journal L 334, 12/12/2008 p. 7 - 24).
  • Regulation EC/1085/2003 - Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (Official Journal L 159, 27/6/2003 p. 24 - 45)
  • Regulation EC/1084/2003 - Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (Official Journal L 159, 27/6/2003 p. 1 - 23)

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 882/2004 - 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

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

For more information on the Veterinary Medicines Regulations please contact Denise Burge at d.burge@vmd.defra.gsi.gov.uk or telephone 01932 338312.