{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-1/paragraph-1",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-1/paragraph-1.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/1/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": null,
  "text": "The following medicinal products shall be available only on prescription—\n(a) a product for parenteral administration;\n(b) a product that is a controlled drug as defined in section 2(1)(a) of the Misuse of Drugs Act 1971, unless it is covered by a UK marketing authorisation in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale;\n(c) cyanogenic substances, other than preparations for external use;\n(d) medicinal substances that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used;\n(e) a product that—\n(i) is covered by a UK marketing authorisation ..., Article 126a authorisation or parallel import licence in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and\n(ii) consists of or contains aloxiprin, aspirin or paracetamol in the form of non-effervescent tablets or capsules;\n(f) a product that—\n(i) is covered by a UK marketing authorisation ..., Article 126a authorisation or parallel import licence in which the product is classified as a pharmacy medicine or as a medicinal product subject to general sale, and\n(ii) consists of or contains (in any pharmaceutical form) pseudoephedrine salts or ephedrine base or salts; ...\n(g) a product that—\n(i) is not covered by a UK marketing authorisation ..., Article 126a authorisation or parallel import licence, and\n(ii) is a prescription only medicine by virtue of articles 5 and 10 of, and Schedules 1 and 2 to, the Prescription Only Medicines (Human Use) Order 1997 ; ...\n(h) a product which is authorised by the licensing authority on a temporary basis under regulation 174, in circumstances where the licensing authority has attached a condition to that authorisation to the effect that, for the duration of the temporary authorisation, the product is classified as a prescription only medicine ; and\n(i) an EAMS medicinal product, in circumstances where the licensing authority has attached a condition to the EAMS scientific opinion in respect of that product to the effect that, for the duration of that opinion, the product is classified as a prescription only medicine.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 1 para. 1(b) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 10 and words in Sch. 1 para. 1(b) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 10"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in Sch. 1 para. 1(b) inserted (31.12.2020) by S.I. 2019/775, reg. 8(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 1 para. 1(e)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Sch. 1 para. 1(e)(i) 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), 134(a)(i)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in Sch. 1 para. 1(f)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in Sch. 1 para. 1(f)(i) 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), 134(a)(ii)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Word in Sch. 1 para. 1(f) omitted (6.11.2020) by virtue of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(a) and word in Sch. 1 para. 1(f) omitted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(a)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in Sch. 1 para. 1(g)(i) substituted (31.12.2020) by S.I. 2019/775, reg. 8(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 5)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Words in Sch. 1 para. 1(g)(i) 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), 134(a)(iii)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Word in Sch. 1 para. 1(g) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(b) and word in Sch. 1 para. 1(g) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(b)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Word in Sch. 1 para. 1(g) omitted (15.4.2022) by virtue of The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(a) (with reg. 19)"
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Sch. 1 para. 1(h) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 31(2)(c) and Sch. 1 para. 1(h) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 31(2)(c)"
    },
    {
      "type": "F",
      "label": "F13",
      "text": "Word in Sch. 1 para. 1(h) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(b) (with reg. 19)"
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Sch. 1 para. 1(i) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 12(2)(c) (with reg. 19)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 1997/1830, as amended by S.I. 1997/2044, S.I. 1998/108, S.I. 1998/1178, S.I. 1998/2081, S.I. 1999/1044, S.I. 1999/3463, S.I. 2000/1917, S.I. 2000/2899, S.I. 2000/3231, S.I. 2001/2777, S.I. 2001/3942, S.I. 2003/696 and S.I. 2006/915 and these Regulations. 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/1/paragraph/1",
    "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."
}