{
  "url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1972/regulation-4",
  "json_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1972/regulation-4.json",
  "legislation": "uksi/1972/1226",
  "legislation_title": "The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1972",
  "legislation_url": "https://openlegislation.uk/medicines-standard-provisions-for-licences-and-certificates-amendment-regulations-1972",
  "path": "regulation/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Amendment of Part III of Schedule 1 to the principal regulations",
  "text": "In Part III of Schedule 1 to the principal regulations (standard provisions for animal test certificates) immediately after paragraph 6 there shall be added the following paragraphs:—\n“7 The medicinal test on animals in respect of which the animal test certificate has been issued shall be carried out in accordance with the outline of the medicinal test on animals contained in the application for that certificate subject to any changes thereto which the licensing authority may from time to time approve.\n8 (1) The medicinal product to which the animal test certificate relates shall be administered only by, or under the direction of, the person named in the application for that certificate as the person by whom it was proposed that the medicinal test on animals should be carried out or by or under the direction of such other person approved by the licensing authority for this purpose.\n(2) Where the medicinal product to which the animal test certificate relates is to be administered by, or under the direction of, a person who has not been named in the application for that certificate or where it is intended that there shall be a change of the person so named, the certificate holder shall seek the approval of the licensing authority and for this purpose shall notify the licensing authority in writing of the name, address and qualifications of the person in question.\n(3) In the event of any such named or approved person ceasing to participate in the medicinal test on animals in respect of which the animal test certificate has been issued, the certificate holder shall as soon as is reasonably possible inform the licensing authority and shall give the reason for such cessation.\n9 (1) The medicinal test on animals in respect of which the animal test certificate has been issued shall be carried out only at the location specified in the application for that certificate.\n(2) Where the medicinal test on animals to which the animal test certificate relates is to be carried out at a location that has not been specified in the application or where it is intended that there shall be a change in the location so specified, the certificate holder shall seek the approval of the licensing authority and for this purpose shall notify the licensing authority in writing of the location in question.\n10 Before any administration of the medicinal product to which the animal test certificate relates takes place, the certificate holder shall arrange that the particulars relating to the administration of that medicinal product together with any relevant safety precautions be communicated to each and every person who, in the course of the medicinal test on animals in respect of which that certificate has been issued, is to administer or to direct the administration of that medicinal product.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1972/1226/regulation/4",
    "retrieved_at": "2026-10-29T22:27:49.375745+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."
}