{
  "url": "https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993/schedule-1/paragraph-5",
  "json_url": "https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993/schedule-1/paragraph-5.json",
  "legislation": "uksi/1993/2398",
  "legislation_title": "The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993",
  "legislation_url": "https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993",
  "path": "schedule/1/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": "Requirements",
  "text": "(1) Subject to sub-paragraph (2) below, the applicant shall comply with the requirements set out in Part 4 (pre-clinical and clinical testing).\n(2) In the case of a trial of a product conducted in the United Kingdom, unless the trial is one under which the product is not to be identified, the labelling of any container and package of the product shall comply with the requirements contained in regulations relating to such product made under section 85(1) of the Act for the time being in force.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "The current Regulations are S.I. 1976/1726 (amended by S.I. 1977/996, 2168, 1981/1791, 1983/1729, 1985/2008 and 1989/1183) and S.I. 1988/1009."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1993/2398/schedule/1/paragraph/5",
    "retrieved_at": "2026-10-29T13:50:12.688736+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."
}