{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/note",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/note.json",
  "legislation": "uksi/2006/2407",
  "legislation_title": "The Veterinary Medicines Regulations 2006",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2006",
  "path": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2005. They also amend the Medicines Act 1968, the Medicines Act 1971 and associated legislation so that they no longer apply to veterinary medicinal products.\nPrincipal changes to the 2005 Regulations\nThe principal changes to the 2005 Regulations are as follows.\nThe Regulations re-introduce requirements for recording specific batches of veterinary medicinal products administered to food-producing animals (regulations 18 and 19).\nThey introduce provisions for the approval of a manufacturer of a veterinary medicine for administration under the cascade (Part 4 of Schedule 2).\nThey clarify the existing regulations in respect of retail supply by veterinary surgeons, pharmacists and suitably qualified persons (Part 1 of Schedule 3).\nThey re-introduce requirements in respect of labelling veterinary medicinal products at the time of retail supply to avoid essential safety warnings and other information being obscured (Schedule 3 paragraph 11).\nThey extend the requirement to hold a Certificate of Competence from those purchasing a product to those who are engaged in dipping sheep (Part 3 of Schedule 3).\nThey introduce a provision that the incorporation of veterinary medicinal products into feed for animals for domestic consumption or non-food animals no longer requires approval (Schedule 5 paragraph 6).\nThey change the way that fees are charged for a marketing authorisation to reflect more accurately the work involved in any individual application (Schedule 7).\nThe Regulations\nThe Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.\nThey implement Directive 2001/82/EC of the European Parliament and of the Council on the Community Code relating to veterinary medicinal products (OJ No. L311, 28.11.2001, p. 1), as amended by Directive 2004/28/EC (OJ No. L136, 30.4.2004, p. 58).\nThey also identify the competent authority for, and provide for enforcement of, Regulations (EC) No. 178/2002 (OJ No. L31, 1.2.2002, p. 1), (EC) No. 1831/2003 (OJ No. L268, 18.10.2003, p. 29), (EC) No. 882/2004 (corrected version at OJ No. L191, 28.5.2004, p. 1) and (EC) No. 183/2005 (OJ No. L35, 8.2.2005, p. 1), in so far as they apply to veterinary medicinal products used in feedingstuffs, and to the following additives used in feedingstuffs:\n(a) coccidiostats;\n(b) histomonostats;\n(c) all other zootechnical additives except—\n(i) digestibility enhancers;\n(ii) gut flora stabilisers; and\n(iii) substances incorporated with the intention of favourably affecting the environment.\nIn addition they implement Council Directive 90/167 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (OJ No. L92, 7.4.90, p. 42) so far as they are not rendered spent by Regulation (EC) No. 183/2005.\nThey provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1).\nThey specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2).\nThey regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3).\nThey provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the “cascade” (regulation 8 and Schedule 4).\nThey control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12).\nThey control wholesale dealing (regulation 13).\nThey control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5).\nThey provide for exemptions (regulation 15 and Schedule 6).\nThey provide for fees (regulation 16 and Schedule 7).\nThey require records to be kept (regulations 17 to 24).\nThey create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27).\nThey make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for a representations procedure in the case of a refusal, etc., of a marketing authorisation (regulation 29).\nThey create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41).\nUnder regulation 42 breach of the Regulations is an offence punishable—\n(a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or\n(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.\nA Regulatory Impact Assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance, new legislative developments”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2006/2407/note",
    "retrieved_at": "2026-10-29T04:22:09.984208+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}