{
  "url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-29",
  "json_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-29.json",
  "legislation": "ukdsi/2024/9780348258523",
  "legislation_title": "The Veterinary Medicines (Amendment etc.) Regulations 2024",
  "legislation_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024",
  "path": "regulation/29",
  "kind": "regulation",
  "number": "29",
  "heading": "Amendment to paragraph 3",
  "text": "For paragraph 3 (summary of product characteristics) substitute—\n“Summary of product characteristics\n3. (1) Subject to sub-paragraph (2), the summary of product characteristics required under paragraph 2(2)(h) must include the following information in the order indicated below—\n1.\nName of the veterinary medicinal product, followed by its strength and pharmaceutical form.\n2.\nQualitative and quantitative composition of the active substances and qualitative composition of excipients and other constituents stating their common name or their chemical description and their quantitative composition, if that information is essential for proper administration of the veterinary medicinal product.\n3.\nClinical information as regards—\n3.1\ntarget species;\n3.2\nindications for use for each target species;\n3.3\ncontra-indications;\n3.4\nspecial warnings;\n3.5\nspecial precautions for use, including in particular special precautions for safe use in the target species, special precautions to be taken by the person administering the veterinary medicinal product to the animals and special precautions for the protection of the environment;\n3.6\nfrequency and seriousness of adverse events;\n3.7\nuse during pregnancy, lactation or lay;\n3.8\ninteraction with other medicinal products and other forms of interaction;\n3.9\nadministration route and dosage;\n3.10\nsymptoms of overdose and, where applicable, emergency procedures and antidotes in the event of overdose;\n3.11\nspecial restrictions for use;\n3.12\nspecial conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance;\n3.13\nif applicable, withdrawal periods, even if such periods are zero.\n4.\nPharmacological information as regards—\n4.1\nthe ATCvet Code;\n4.2\npharmacodynamics;\n4.3\npharmacokinetics.\n5.\nPharmaceutical particulars as regards—\n5.1\nmajor incompatibilities;\n5.2\nshelf-life, where applicable after reconstitution of the medicinal product or after the immediate packaging has been opened for the first time;\n5.3\nspecial precautions for storage;\n5.4\nnature and composition of immediate packaging;\n5.5\nrequirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products.\n6.\nName of the holder of the marketing authorisation.\n7.\nMarketing authorisation number or numbers.\n8.\nDate of the first marketing authorisation.\n9.\nDate of the last revision of the summary of product characteristics.\n10.\nIf applicable, the statement—\n10.1\n“marketing authorisation granted for a limited market and therefore assessment based on customised requirements for documentation”; or\n10.2\n“marketing authorisation in exceptional circumstances and therefore assessment based on customised requirements for documentation”.\n11.\nInformation on the take-back schemes referred to in point 5.5 applicable to the veterinary medicinal product concerned.\n12.\nClassification of the veterinary medicinal product.\n(2) In the case of an immunological veterinary medicinal product or a biological veterinary medicinal product that is not immunological, in place of the information at points 4, 4.1, 4.2 and 4.3, the summary of product characteristics must include immunological information.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/29",
    "retrieved_at": "2026-10-30T14:41:23.789053+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."
}