{
  "url": "https://openlegislation.uk/animal-test-certificates-regulations-1996/regulation-2",
  "json_url": "https://openlegislation.uk/animal-test-certificates-regulations-1996/regulation-2.json",
  "legislation": "uksi/1996/2194",
  "legislation_title": "The Animal Test Certificates Regulations 1996",
  "legislation_url": "https://openlegislation.uk/animal-test-certificates-regulations-1996",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Interpretation",
  "text": "(1) In these Regulations, unless the context otherwise requires—\n“the Act” means the Medicines Act 1968;\n“approved dossier” means all the particulars submitted in an application for a certificate, or at any subsequent time in connection with a certificate, which have been or which are deemed to have been approved by the licensing authority;\n“certificate” means an animal test certificate;\n“biological product” includes an antigen, toxin, antitoxin, toxoid, serum, antiserum or vaccine or a fraction of any such product;\n“new molecule” means an active ingredient which has not at any time been included in a product in respect of which a product licence under the Act, or marketing authorisation within the meaning of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 has been granted;\n“suspected adverse reaction” means—\n(a) a reaction in an animal treated with a product during a test which is suspected to have been caused by the product, and which has resulted in harm to the animal, or\n(b) a suspected lack of efficacy of a product in an animal so treated; and\n“test” means a medicinal test on animals the subject of a certificate or of an application for the grant thereof.\n(2) Any reference in these Regulations to a numbered regulation or Schedule shall, unless the context otherwise requires, be construed as a reference to the regulation or Schedule bearing that number in these Regulations.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 1994/3142."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1996/2194/regulation/2",
    "retrieved_at": "2026-10-29T12:36:25.493771+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."
}