{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-7/paragraph-2.json",
  "legislation": "uksi/2016/190",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "path": "schedule/7/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Reclassification",
  "text": "(1) Where—\n(a) an application for a marketing authorisation includes a reclassification element within the meaning of paragraph 25 of Part 2 of Schedule 2; and\n(b) the licensing authority is satisfied that the reclassification element does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,\n50% of the additional amount payable under paragraph 25(1)(a) or (b) or 28(4)(a) of Part 2 of that Schedule shall be refunded, or if it has not yet been paid, shall be waived.\n(2) Where—\n(a) an application for variation of a marketing authorisation is a reclassification variation application (not being an application falling within paragraph 40 of Part 4 of Schedule 2); and\n(b) the licensing authority is satisfied that the application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,\n50% of the fee payable under paragraph 38 of Schedule 2 and entry 1(c)(i) of Table 1 referred to in that paragraph or of the fee payable under paragraph 53 (a)(i) of Part 4 of Schedule 2 shall be refunded, or if it has not yet been paid, shall be waived.\n(3) Where—\n(a) an application for variation of a parallel import licence falls within paragraph 42 (1)(a) of Part 4 of Schedule 2; and\n(b) the licensing authority is satisfied that the application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products,\n50% of the fee payable under that paragraph shall be refunded, or if it has not yet been paid, shall be waived.\n(4) For the purposes of sub-paragraphs (1) to (3), a reclassification element or, as the case may be, a variation application does not require consideration by the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products where—\n(a) the licensing authority is satisfied that the application does not require consideration by the Commission, committee or board; and\n(b) the Commission, committee or board are consulted only by virtue of, or in accordance with any Community provision, referred to the Committee for Medicinal Products for Human Use or the Committee on Herbal Medicinal Products for the application of the procedure laid down in Articles 32 to 34 of the Directive.\n(5) In sub-paragraph (4), “Committee for Medicinal Products for Human Use” and “Committee on Herbal Medicinal Products” mean the Committee for Medicinal Products for Human Use and Committee on Herbal Medicinal Products established under Regulation (EC) No 726/2004.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/7/paragraph/2",
    "retrieved_at": "2026-10-28T23:27:13.215121+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."
}