{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-4/paragraph-13",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-4/paragraph-13.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/4/paragraph/13",
  "kind": "paragraph",
  "number": "13",
  "heading": null,
  "text": "Where—\n(a) animals are used in the production of medicinal products; and\n(b) in the case of a product for sale or supply—\n(i) in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or\n(ii) in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,\ncontains provisions relating to them,\nthe manufacturer's licence holder must arrange for the animals to be housed in such premises, and managed in such a manner, as facilitates compliance with those provisions.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 4 para. 13(b) substituted (31.12.2020) by S.I. 2019/775, reg. 20(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 14(a))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/4/paragraph/13",
    "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."
}