{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-29",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-29.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/29",
  "kind": "paragraph",
  "number": "29",
  "heading": "Authorisation for a national homoeopathic product",
  "text": "(1) In this paragraph—\n“formulation” does not include the formulation of a homoeopathic stock;\n“identical” means—\n(a) in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and\n(b) in relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the test which it is required to undergo;\n“product” includes a series of products each of which is prepared from identical homoeopathic stocks.\n(2) This paragraph does not apply to an application which is a mutual recognition procedure incoming application or a decentralised procedure application.\n(3) In connection with an application for a marketing authorization for a national homoeopathic product prepared from not more than 5 homoeopathic stocks, the fee payable under regulation 12(1)(a) is the amount set out in column 2 in the table below opposite the description in column 1 appropriate to that application.\n(4) In connection with any other application for a marketing authorization for a national homoeopathic product, the fee payable under regulation 12(1)(a) shall be the amount set out in column 3 in the table below opposite the description in column 1 appropriate to that application.\nFees for homoeopathic marketing authorization applications\nColumn 1\nColumn 2\nColumn 3\nDescription of application\nFee for applications in respect of products prepared from not more than 5 homoeopathic stocks\nFee for other applications\n1. An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation\n£558\n£791\n2. An application in respect of a product which is either—\n£874\n£1,096\n(a)\nprepared solely from repeat stocks; or\n(b)\nis of a repeat formulation\n3. Any other application\n£1,176\n£1,418\n(5) Each reference in sub-paragraphs (6) to (8) to an amount payable under sub-paragraph (3) or (4) 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(6) Where an application relates to a national homoeopathic product which is manufactured using a method of sterilisation—\n(a) not used in the manufacture of a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and\n(b) not referred to in the European Pharmacopoeia or any national pharmacopoeia of a Member State,\nan amount of £2,328 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.\n(7) Where an application relates to a national homoeopathic product which contains one or more new excipients, an amount of £7,766 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.\n(8) Where an application relates to a national homoeopathic product which contains one or more TSE risk ingredients from a new source or TSE risk excipients from a new source, an amount of £686 is payable in addition to the amount payable under sub-paragraph (3) or (4) 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/29",
    "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."
}