{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-2A",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-2A.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/2A",
  "kind": "paragraph",
  "number": "2A",
  "heading": "Information with the application: format",
  "text": "(1) An application must be submitted electronically.\n(2) Subject to sub-paragraph (3), the application must be structured as a single dossier in four parts—\n(a) Part 1 (administrative information);\n(b) Part 2 (pharmaceutical quality (physicochemical, biological or microbiological) data);\n(c) Part 3 (safety documentation, including safety and residue tests);\n(d) Part 4 (efficacy documentation, including pre-clinical studies and clinical trials).\n(3) An application concerning the release of GMOs must set out the environmental risk assessment in respect of that release as a separate document, and that assessment must be presented in accordance with the following provision of the GMO Deliberate Release Regulations—\n(a) as regards England or Scotland, regulation 6;\n(b) as regards Wales, regulation 7.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 1 paras. 2-2C substituted for Sch. 1 para. 2 (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 28"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/2A",
    "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."
}