{
  "url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-69",
  "json_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-69.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/69",
  "kind": "regulation",
  "number": "69",
  "heading": "Amendment to paragraph 57",
  "text": "In paragraph 57 (adverse reactions to product administered in UK)—\n(a) in sub-paragraph (1)—\n(i) in paragraph (a) for “serious adverse reaction” substitute “adverse event in respect of an animal”;\n(ii) in paragraph (b)—\n(aa) for “adverse reaction” substitute “adverse event”;\n(bb) omit “or”;\n(iii) after paragraph (c) (and immediately before the words “following the administration”) insert—\n“(d) occurrence of an adverse environmental event, or\n(e) lack of efficacy,”;\n(iv) omit “in the United Kingdom”;\n(b) after sub-paragraph (1) insert—\n“(1A) A marketing authorisation holder must also act in accordance with this paragraph where—\n(a) after the end of the withdrawal period a product of animal origin is found to include a pharmacologically active substance or marker residue exceeding the maximum residue limit established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council; or\n(b) there is evidence in published scientific literature of an adverse event in connection with the product.”;\n(c) in sub-paragraph (3) for “15” substitute “30”;\n(d) in sub-paragraph (4) for “reaction” substitute “event”;\n(e) after sub-paragraph (4) insert—\n“(4A) The Secretary of State may require the marketing authorisation holder—\n(a) to collect specific pharmacovigilance data (in addition to the data mentioned in sub-paragraph (4)) and submit those data to the Secretary of State; and\n(b) to carry out specific post-marketing surveillance studies.\n(4B) Where the Secretary of State exercises the power mentioned in sub-paragraph (4A), the Secretary of State must—\n(a) state the reason for the requirement; and\n(b) state the time by which, or the period during which, the requirement must be complied with.”;\n(f) omit sub-paragraph (5);\n(g) for the heading substitute—\n“Adverse events following administration of a veterinary medicinal product”.",
  "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/69",
    "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."
}