{
  "url": "https://openlegislation.uk/marketing-authorisations-for-veterinary-medicinal-products-regulations-1994/note",
  "json_url": "https://openlegislation.uk/marketing-authorisations-for-veterinary-medicinal-products-regulations-1994/note.json",
  "legislation": "uksi/1994/3142",
  "legislation_title": "The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994",
  "legislation_url": "https://openlegislation.uk/marketing-authorisations-for-veterinary-medicinal-products-regulations-1994",
  "path": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations implement Council Directive 93/40/EEC, which is the latest in a series of amendments to Council Directive 81/851/EEC. They provide for veterinary medicinal products to be placed on the market subject to marketing authorisations rather than the previous system of product licences. These authorisations may be granted either by the Ministers or, in accordance with Council Regulation 2309/93/EEC, by the European Agency for the Evaluation of Medicinal Products (regulation 3).\nThey provide for the form and manner of an application, and the terms on which the Ministers may grant an authorisation (regulations 4 and 5 and Schedules 1 and 2).\nThey place duties on persons responsible for placing products on the market (regulation 6), on person where a product is manufactured outside the EEA (regulation 7) and on an importer who holds a marketing authorisation (regulation 8).\nThere are provisions for the variation, renewal, suspension and refusal of an authorisation (regulations 9 to 13 and Schedule 3), provisions as to confidentiality (regulation 14) and fees (regulation 15).\nBreach of the regulations is an offence under regulation 16, with a defence in regulation 17.\nProvisions of the Medicines Act 1968, under which the system was previously enforced, and provisions of the Trade Descriptions Act 1968 and the Consumer Protection Act 1987, are applied to marketing authorisations in the same way as they previously applied to product licences (regulation 19). Regulation 20 contains transitional provisions.\nSchedule 4 revokes the Medicines (Leaflets for Veterinary Drugs) Regulations 1983, S.I. 1983/1727, the Medicines (Veterinary Medicinal Products) (Applications for Product Licences Regulations) 1993, S.I. 1993/2398 and the Medicines (Veterinary Medicinal Products) (Applications for Product Licences) (Amendment) Regulations 1994, S.I. 1994/2157.\nSchedule 5 makes amendments to statutory instruments consequential on changing from product licences to marketing authorisations.\nA Compliance Cost Assessment has been prepared and placed in the library of each House of Parliament.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3142/note",
    "retrieved_at": "2026-10-29T13:21:09.172084+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."
}