{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-amendment-regulations-2000/regulation-4",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-amendment-regulations-2000/regulation-4.json",
  "legislation": "uksi/2000/292",
  "legislation_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-amendment-regulations-2000",
  "path": "regulation/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Amendment of Schedule 3 to the principal Regulations",
  "text": "(1) After paragraph 1 of Schedule 3 to the principal Regulations (offences, penalties etc.) there shall be inserted the following paragraph—\n“1A In respect of any product which is a relevant medicinal product, where, following a determination under regulation 3A(4) or (5), the licensing authority serve a notice in respect of that product on any person under regulation 3A(6) requiring him—\n(a) to stop marketing the product from a date specified in the notice unless or until a marketing authorization is granted in respect of that product, if after the date specified—\n(i) he places that product on the market, or\n(ii) in the course of a business carried on by him, he sells, supplies to a member of the public or procures for sale or for supply to a member of the public that product,\nwithout a marketing authorization having been granted in respect of that product, he shall be guilty of an offence;\n(b) not to place the product on the market unless or until a marketing authorization is granted in respect of that product, if he thereafter places the product on the market without a marketing authorization having been granted in respect of that product, he shall be guilty of an offence.”.\n(2) In paragraph 6(c) of Schedule 3 to the principal Regulations (offences, penalties etc.—obligations of holders of marketing authorizations), after the words “those Articles” there shall be added the words “or paragraph C.a of Part 2 of the Annex to Council Directive 75/318/EEC”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2000/292/regulation/4",
    "retrieved_at": "2026-10-29T09:21:15.854764+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."
}