{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-39",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-39.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/39",
  "kind": "regulation",
  "number": "39",
  "heading": "Further requirements for manufacturer's licence",
  "text": "(1) This regulation applies in relation to any manufacturer's licence.\n(2) The licence holder must maintain such staff, premises, equipment and facilities for the handling, control, storage and distribution of medicinal products under the licence as are appropriate in order to maintain the quality of the medicinal products.\n(3) The licence holder must ensure that any arrangements made for the handling, control, storage and distribution of medicinal products are adequate to maintain the quality of the products.\n(4) Except in the case of an MM medicinal product or a POC medicinal product, the licence holder must not handle, control, store or distribute medicinal products on any premises other than those specified in the licence as approved by the licensing authority for the purpose.\n(5) Except in the case of an MM medicinal product or a POC medicinal product, the licence holder must inform the licensing authority before making a material alteration to the premises or facilities used under the licence, or to the purposes for which those premises or facilities are used.\n(5A) The holder of a manufacturer’s licence (MM) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the MM control site and the modular units specified in the MM master file.\n(5B) The holder of a manufacturer’s licence (MM) must inform the licensing authority before making a material alteration to the premises or facilities at the MM control site, or to any modular unit specified in the MM master file, or to the purposes for which those premises or facilities are used.\n(5C) The holder of a manufacturer’s licence (POC) must ensure that the medicinal products specified in the licence are not handled, controlled, stored or distributed on any premises other than the POC control site and those specified in the POC master file.\n(5D) The holder of a manufacturer’s licence (POC) must inform the licensing authority before making a material alteration to the premises or facilities at the POC control site, or to the purposes for which those premises or facilities are used.\n(5E) Paragraphs (5A) and (5C) do not apply to anything done in the course of the business of a hospital that consists of dealing with a medicine or making it ready for use for the purposes of its final supply or administration to a patient.\n(6) The licence holder must inform the licensing authority of any proposed change to—\n(a) the qualified person; and\n(b) any person named in the licence as having responsibility for quality control.\n(7) For the purposes of enabling the licensing authority to determine whether there are grounds for suspending, revoking or varying the licence, the licence holder must permit a person authorised in writing by the licensing authority to do anything that the licensing authority could have done for the purposes of verifying a statement made in an application for a licence.\n(8) In distributing a medicinal product by way of wholesale dealing, the licence holder must comply with the following as if they are a holder of a wholesale dealer’s licence—\n(a) regulations 43(1), (2) and (5), 43ZA and 44(5) and (6).\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 39(4) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 39(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(2)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 39(5A)-(5E) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 15(3)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 39(8) substituted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 9"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Reg. 39(8)(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), 16(a)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Reg. 39(8)(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), 16(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/39",
    "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."
}