{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-7/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-7/paragraph-3.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "schedule/7/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Variation of a traditional herbal registration",
  "text": "Where at the specific written request of the licensing authority, or in response to the imposition of an urgent safety restriction under regulation 8 of the Herbal Regulations, an application is made for the variation of a traditional herbal registration so as to—\n(a) restrict any one or more of the indications, dosage or target population; or\n(b) add a new contraindication or a warning or both of these,\nas a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 18(1) shall be refunded or, if it has not yet been paid, shall be waived.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/schedule/7/paragraph/3",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}