{
  "url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1997/regulation-10",
  "json_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1997/regulation-10.json",
  "legislation": "uksi/1997/1469",
  "legislation_title": "The Medicines (Products for Animal Use—Fees) Regulations 1997",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1997",
  "path": "regulation/10",
  "kind": "regulation",
  "number": "10",
  "heading": "Fees relating to site inspections",
  "text": "(1) Subject to the following provisions of these Regulations, in respect of any inspection carried out in connection with an application for the grant, variation or renewal of a manufacturer’s licence there shall be payable by the applicant the relevant fee prescribed in Schedule 2.\n(2) Subject to paragraph (4), the holder of a manufacturer’s licence shall pay the relevant fee prescribed in Schedule 2 in respect of any inspection of a site relating to that licence (except for any inspection for which a fee is payable relating to the grant, variation or renewal of a licence).\n(3) Where a manufacturing site outside the European Union is specified, and the site is inspected, the fee prescribed in Schedule 2 shall be payable by the marketing authorisation or product licence holder; and if there is more than one marketing authorisation or product licence holder, a fee shall be payable by each marketing authorisation or product licence holder, which shall be the amount prescribed in Schedule 2 divided between the holders of the marketing authorisations or product licences, as the case may be, in proportion to the number of marketing authorisations or product licences held.\n(4) No fee shall be payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether alterations or improvements to the premises concerned, which were required in writing by the relevant authority as the result of that previous inspection, have been implemented.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1997/1469/regulation/10",
    "retrieved_at": "2026-10-29T12:07:19.034510+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."
}