{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-33",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-33.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/2/paragraph/33",
  "kind": "paragraph",
  "number": "33",
  "heading": "Traditional herbal registrations",
  "text": "(1) Subject to sub-paragraphs (3) to (6), the fee payable under regulation 12(1)(a) in connection with an application for a traditional herbal registration of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.\nFee for application for traditional herbal registration\nColumn 1\nColumn 2\nKind of application\nFee payable\n1. Complex registration application\n(a)\nin respect of a medicinal product containing a single active ingredient\n£5,237\n(b)\nin any other case\n£7,857\n2. Standard registration application\n(a)\nin respect of a medicinal product containing 3 or fewer active ingredients\n£2,619\n(b)\nin any other case\n£3,928\n3. Reduced registration application category II\n(a)\nin respect of a medicinal product containing 3 or fewer active ingredients\n£873\n(b)\nin any other case\n£1,310\n4. Reduced registration application category I\n(a)\nin respect of a medicinal product containing 3 or fewer active ingredients\n£583\n(b)\nin any other case\n£873\n5. Change of ownership application\n£478\n(2) Each reference in sub-paragraphs (3) to (6) to an amount payable under sub-paragraph (1) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.\n(3) Where an application relates to a medicinal product which contains one or more vitamins or minerals which are vitamins or minerals from a new source, a fee of—\n(a) £1,164, if European Pharmacopoeia certificates of suitability covering all the vitamins or minerals which are a vitamin or mineral from a new source have been submitted with the application; or\n(b) £2,328, in any other case,\nis payable in addition to the amount payable under sub-paragraph (1) in respect of that application.\n(4) Where an application relates to a medicinal product which contains one or more new excipients, an amount of £7,767 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.\n(5) Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of £690 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.\n(6) Where an application relates to a medicinal product which is a sterile medicinal product, an amount of £2,328 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.",
  "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/2/paragraph/33",
    "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."
}