{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-5",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-5.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/5",
  "kind": "regulation",
  "number": "5",
  "heading": "Classification of medicinal products",
  "text": "(1) In these Regulations references to a medicinal product subject to general sale are to a product that is not a prescription only medicine or a pharmacy medicine but is—\n(a) a product that is covered by an authorisation of which it is a term that the product is to be available on general sale.\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(2) In paragraphs (1)(a) and (5)(a) “authorisation” means—\n(a) a UK marketing authorisation;\n(b) a certificate of registration;\n(c) a traditional herbal registration; or\n(d) in the case of a medicinal product for sale or supply in Northern Ireland, an Article 126a authorisation.\n(3) In these Regulations references to a prescription only medicine are to any of the following—\n(a) a medicinal product that is covered by an authorisation of which it is a term that the product is to be available only on prescription;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) a medicinal product that is a prescription only medicine by virtue of Part 1 of Schedule 1; or\n(d) a medicinal product that is the result of—\n(i) the assembly, or\n(ii) the reformulation (including the combining with other substances),\nof a medicinal product that is a prescription only medicine by virtue of sub-paragraph (a) ....\n(4) In paragraph (3)(a) “authorisation” means—\n(a) a UK marketing authorisation; or\n(b) in the case of a medicinal product for sale or supply in Northern Ireland (that is not a listed NIMAR product), an Article 126a authorisation.\n(5) In these Regulations references to a pharmacy medicine are to a medicinal product that is not a prescription only medicinal product or a medicinal product subject to general sale but is—\n(a) covered by an authorisation of which it is a term that the product is to be available only from a pharmacy;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) available only from a pharmacy by virtue of Part 2 of Schedule 1; or\n(d) the result of—\n(i) the assembly, or\n(ii) the reformulation (including the combining with other substances),\nof a medicinal product that is a pharmacy medicine by virtue of sub-paragraph (a) ....",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 5(1)(a): full stop substituted for word (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(a)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 5(1)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(a)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 5(2)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 7(3)(b) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(b)(ii)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 5(3)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(b)(i)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 5(3)(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(b)(ii)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in reg. 5(4)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 7(5) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(d)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in reg. 5(4)(b) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 3"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Reg. 5(5)(b) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(c)(i)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Words in reg. 5(5)(d) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 6(c)(ii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/5",
    "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."
}