{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-12A",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-12A.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/12A",
  "kind": "paragraph",
  "number": "12A",
  "heading": "Time limits – supplementary",
  "text": "(1) Subject to sub-paragraph (3), a study, residue test or pre-clinical study in relation to the establishment of residue limits submitted by an applicant in relation to an application for a marketing authorisation or a variation of a marketing authorisation may not be used for any other such application or variation until the period of five years from that submission has elapsed.\n(2) Subject to sub-paragraph (3), a study, residue test or preclinical study submitted by an applicant for a marketing authorisation or a variation in a marketing authorisation which demonstrates a reduction in antimicrobial resistance in relation to a reference product may not be used for any other such application until a period of four years in addition to the relevant protection period has elapsed.\n(3) Sub-paragraphs (1) and (2) do not apply where an applicant has obtained a written authorisation to access a study, residue test or pre-clinical study mentioned in the relevant sub-paragraph.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 1 para. 12A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 37"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/12A",
    "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."
}