{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-34/paragraph-69",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-34/paragraph-69.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/34/paragraph/69",
  "kind": "paragraph",
  "number": "69",
  "heading": null,
  "text": "(1) The Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 is amended as follows.\n(2) In article 1(2) insert after the definition “ the 1987 Act ” the following definition—\n““the 2012 Regulations” means the Human Medicines Regulations 2012;”.\n(3) In Schedule 1—\n(a) in paragraph 1 omit “, II” and “, VI”;\n(b) after paragraph 1 insert the following paragraph—\n“1A Functions of the Ministers under the 2012 Regulations (except those under Part 15 (British Pharmacopeia) of those Regulations), subject to paragraph 11 below.”.\n(c) in paragraph 2 for “Part II of the 1968 Act “ substitute “Parts 3 to 8 of the 2012 Regulations”;\n(d) for paragraph 3 substitute—\n“3 Functions of the Commission on Human Medicines, whose continuation is provided for in regulation 9 of the 2012 Regulations (except those under Part 15 (British Pharmacopoeia) of those Regulations).”;\n(e) for paragraph 4 substitute—\n“4 Functions of any expert committee appointed by the licensing authority under the 2012 Regulations.”.\n(f) for paragraph 8 substitute—\n“8 Functions of reviewers appointed under the 2012 Regulations.”.\n(g) omit paragraphs 9A, 9C and 9D;\n(h) in paragraph 10(c) for “and of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994” substitute “ and of the 2012 Regulations ” and\n(i) in paragraph 11—\n(i) after “Paragraphs 1” insert “ , 1A ”, and\n(ii) after “under it” insert “ or under the 2012 Regulations ”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 1989/684, as amended by S.I. 1995/871, S.I. 2004/1031 and S.I. 2005/2754. There are other amendments, but none is relevant."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/34/paragraph/69",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}