{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-22",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-22.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/22",
  "kind": "regulation",
  "number": "22",
  "heading": "Factors relevant to determination of application for manufacturer's or wholesale dealer's licence",
  "text": "(1) In dealing with an application for a manufacturer's licence the licensing authority must in particular take into consideration—\n(a) the operations proposed to be carried out under the licence;\n(b) the premises in which those operations are to be carried out;\n(c) the equipment which is or will be available on those premises for carrying out those operations;\n(d) the qualifications of the persons under whose supervision the operations will be carried out; and\n(e) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled in pursuance of the licence.\n(1A) In dealing with an application for a manufacturer’s licence (MM) the licensing authority must, in addition to the matters specified in paragraph (1), take into consideration the arrangements made, or to be made, for—\n(a) supervising and controlling operations at a modular unit specified in the application; and\n(b) ensuring that manufacture or assembly is under appropriate control so that the MM medicinal product consistently meets the requirements in the MM master file when manufactured at that modular unit.\n(1B) In dealing with an application for a manufacturer’s licence (POC) the licensing authority must, in addition to the matters specified in paragraph (1), take into consideration the arrangements made, or to be made, for—\n(a) supervising and controlling operations at a POC site specified in the application; and\n(b) ensuring that manufacture or assembly is under appropriate control so that the POC medicinal product consistently satisfies the requirements in the POC master file when manufactured at that POC site.\n(2) In dealing with an application for a wholesale dealer's licence the licensing authority must in particular take into consideration—\n(a) the premises on which medicinal products of the descriptions to which the application relates will be stored;\n(b) the equipment which is or will be available for storing medicinal products on those premises;\n(c) the equipment and facilities which are or will be available for distributing medicinal products from those premises; and\n(d) the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored on or distributed from those premises.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 22(1A)(1B) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 8"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/22",
    "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."
}