{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-41",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-41.json",
  "legislation": "uksi/2005/2745",
  "legislation_title": "The Veterinary Medicines Regulations 2005",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005",
  "path": "schedule/1/paragraph/41",
  "kind": "paragraph",
  "number": "41",
  "heading": "Application for a marketing authorisation where one already exists in another member State",
  "text": "(1) If a veterinary medicinal product has already received a marketing authorisation in another member State at the time of application, and the holder of the marketing authorisation applies for a marketing authorisation in the United Kingdom, the following procedure (“the mutual recognition procedure”) applies.\n(2) The applicant must submit to the Secretary of State a dossier identical to the one submitted to the competent authority of the member State in which the veterinary medicinal product has been authorised (“the reference member State”).\n(3) If there is a marketing authorisation current in more than one member State the applicant must identify which member State is acting as reference member State.\n(4) If the applicant is applying in more than one member State he must supply the Secretary of State with a list of all the States in which he is applying.\n(5) The Secretary of State shall obtain an assessment report from the reference member State and, if the application is made under paragraph 7 (bibliographic applications) or paragraph 10 (applications for pharmacologically equivalent products) of Part 2, ask for the report to include an explanation of any extension of the protection period generated under paragraph 11 or 12.\n(6) Within 90 days after receipt of the assessment report, the Secretary of State must, subject to the following provisions, either—\n(a) approve the assessment report, the summary of product characteristics, the labelling and the package leaflet, and shall inform the reference member State accordingly; or\n(b) notify the reference member State that she will not approve them, and provide the reference member State with a detailed statement of the reasons.\n(7) She may only refuse an application on the grounds of serious risk to human or animal health or the environment.\n(8) If she approves the assessment report, the summary of product characteristics, the labelling and the package leaflet she shall ensure that she is in a position to decide whether or not to grant a marketing authorisation within 30 days of approving them.\n(9) If the Secretary of State is notified by the reference member State that—\n(a) not all member States concerned have within 90 days approved the assessment report, summary of product characteristics, labelling or package leaflet, and\n(b) the reference member State has sent a detailed statement of the reasons to the other member States involved in the application, the applicant and the coordination group for action in accordance with Article 33(3) of Directive 2001/82/EC,\nthe Secretary of State shall comply with the decision of the coordination group or, if the coordination group refers the matter to the Agency, the decision of the Commission within 30 days.\n(10) If the Secretary of State wishes to do so, she may grant the marketing authorisation even though not all member States have agreed to grant it, but shall revoke or vary the authorisation if this is necessary to comply with the decision of the Commission when it is received.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/2745/schedule/1/paragraph/41",
    "retrieved_at": "2026-10-29T04:49:34.048072+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."
}