{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-10A",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-10A.json",
  "legislation": "uksi/2013/2033",
  "legislation_title": "The Veterinary Medicines Regulations 2013",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013",
  "path": "schedule/1/paragraph/10A",
  "kind": "paragraph",
  "number": "10A",
  "heading": "Hybrid veterinary medicinal products",
  "text": "An applicant for a marketing authorisation must provide the results of relevant pre-clinical studies or clinical trials where—\n(a) bioavailability studies are not capable of demonstrating bioequivalence between the veterinary medicinal product for which the authorisation is sought and a reference veterinary medicinal product for the purposes of paragraph 10; or\n(b) the veterinary medicinal product for which the authorisation is sought is not pharmacologically equivalent to a reference veterinary medicinal product for the purposes of paragraph 10 as a result of a difference in relation to—\n(i) the active substance or substances contained in the product;\n(ii) the strength of the product;\n(iii) the indications for use of the product;\n(iv) the pharmaceutical form of the product;\n(v) the route of administration of the product;\n(vi) the withdrawal period for the product.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 1 para. 10A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 34"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/10A",
    "retrieved_at": "2026-10-29T00:44:44.019972+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."
}