{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-170",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-170.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/170",
  "kind": "regulation",
  "number": "170",
  "heading": "Record-keeping requirements",
  "text": "(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.\n(1) Where the sale or supply of a medicinal product relies on the exemptions under regulations 167, 168 or, subject to paragraph (4), 169, the person who sells or supplies the product must maintain for at least five years a record showing—\n(a) the source from which and the date on which the person obtained the product;\n(b) the person to whom and the date on which the sale or supply was made;\n(c) the quantity of the sale or supply;\n(d) the batch number of the batch of that product from which the sale or supply was made; and\n(e) details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.\n(2) The person must make the records available for inspection by the licensing authority on request.\n(3) The person must notify the licensing authority of any suspected adverse reaction to the medicinal product which is a serious adverse reaction.\n(4) In the case of a medicinal product that is sold or supplied in reliance on the exemption in regulation 169—\n(a) the reference in paragraph (1)(a) to “the product” means all the medicinal products that were mixed in the course of the manufacture of the product; and\n(b) paragraph (1)(d) shall not apply.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 170(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 22"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/170",
    "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."
}