{
  "url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-35",
  "json_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-35.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/35",
  "kind": "regulation",
  "number": "35",
  "heading": "Amendment to paragraph 11",
  "text": "In paragraph 11 (time limits for marketing authorisations – pharmacologically equivalent products)—\n(a) in sub-paragraph (1) for “pharmacologically equivalent” substitute “generic veterinary medicinal”;\n(b) for sub-paragraph (3) substitute—\n“(3) The product may not be placed on the market until the end of the longest of the following periods which is relevant—\n(a) subject to sub-paragraph (3A), 10 years in the case of a veterinary medicinal product authorised for major species;\n(b) 18 years in the case of a veterinary medicinal product authorised for bees; and\n(c) 14 years for a veterinary medicinal product authorised for all other species.\n(3A) Where the product—\n(a) is intended for administration to a major species; and\n(b) contains an active substance which is an antimicrobial which has not been an active substance in a veterinary medicinal product previously subject to a marketing authorisation in Great Britain,\nthe period mentioned in sub-paragraph (3)(a) is 14 years.\n(3B) Where a patent in relation to a reference product has lapsed, the summary of product characteristics of the relevant generic product must be updated in order to include the protected information.\n(3C) Where, as a result of a variation to an existing marketing authorisation a product is accorded a new marketing authorisation number any relevant protection period applies in relation to that product.\n(3D) In this regulation “major species” means cattle, sheep (for meat production), pigs, chickens, dogs and cats.”;\n(c) in the heading for “pharmacologically equivalent” substitute “generic veterinary medicinal”.",
  "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/35",
    "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."
}