{
  "url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-11",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014/regulation-11.json",
  "legislation": "uksi/2014/1878",
  "legislation_title": "The Human Medicines (Amendment) (No. 2) Regulations 2014",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2014",
  "path": "regulation/11",
  "kind": "regulation",
  "number": "11",
  "heading": "Amendment of regulation 68",
  "text": "(1) Regulation 68 (revocation, variation and suspension of UK marketing authorisation) is amended as follows.\n(2) For paragraph (4) substitute—\n“(4) Condition C is that the licensing authority thinks that there has been a breach of—\n(a) a term of the authorisation or licence;\n(b) in the case of a UK marketing authorisation, a requirement imposed by Part 13 (packaging and leaflets); or\n(c) in the case of a parallel import licence, a requirement in relation to packaging and leaflets imposed by the licensing authority.”\n(3) For paragraph (5) substitute—\n“(5) Condition D is that the licensing authority thinks that a condition to which—\n(a) the UK marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of UK marketing authorisations or parallel import licence: general); or\n(b) the UK marketing authorisation is subject by virtue of regulations 60 (conditions of UK marketing authorisations: exceptional circumstances) or 61 (conditions of UK marketing authorisations: new obligations post-authorisation),\nhas not been fulfilled.”\n(4) In paragraph (13) for “This” substitute “Except in the case of a parallel import licence, this”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2014/1878/regulation/11",
    "retrieved_at": "2026-10-29T00:09:33.447150+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."
}