{
  "url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/note",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/note.json",
  "legislation": "uksi/1996/683",
  "legislation_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1996",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996",
  "path": "note",
  "kind": "note",
  "number": null,
  "heading": "Explanatory note",
  "text": "(This note is not part of the Regulations)\nThese Regulations amend the Medicines (Products for Human Use—Fees) Regulations 1995 (“the principal Regulations”). The principal Regulations make provision for the fees payable under the Medicines Act 1971 in respect of marketing authorizations, licences and certificates relating to medicinal products for human use.\nThese Regulations (regulation 3 and the Schedule) vary some of the fees payable for applications for marketing authorizations, clinical trial certificates and export certificates; for variations and renewals of clinical trial certificates; and periodic fees in connection with the holding of such authorizations and licences. They also vary the fees payable in respect of inspections of sites carried out in connection with applications for, or during the currency of, such authorizations and licences. The overall effect of these changes is a reduction of 2 per cent. in fee levels. Some application fees and inspection fees are reduced by 5 or 20 per cent.; the capital fee for complex applications is increased by 7.5 per cent. Periodic fees relating to new and complex drugs are reduced by 5 and 20 per cent. respectively; those for prescription only medicines are increased by 5 per cent.\nThese Regulations also make a number of miscellaneous amendments:\nregulation 2 extends the definition of “change of ownership application” to include certain applications for manufacturer’s or wholesale dealer’s licences; regulation 4 makes provision for the continuation of periodic fees where such applications are made and regulation 5(1) and (2) introduces capital fees of £180 and £210 (that is, reductions respectively of £1,510 and £570 from the fees which would otherwise be payable in the case of applications for manufacturer’s and wholesale dealer’s licences);\nregulation 5(3)(a) amends the definition of “Type II Application” so as to permit the fees for such variations to apply to the variation of product licences of right and regulation 5(3)(b) amends the definition of “Type II complex variation” so as to exclude from that definition—\n(a) changes to medicinal products which can only be authorized where an application for a further marketing authorization is made (see Commission Regulation (EC) No. 541/95, OJ No. L55, 11.3.95, p. 7); and\n(b) certain applications relating to new manufacturers of active ingredients;\nregulation 6(1) amends the definition of “maintenance fee” to provide that in calculating such a fee regard is had to a fee period rather than to a calendar year; regulation 6(2) aligns the categories of fee payable for the variation of marketing authorizations with those which apply on the grant of such authorizations and in place of fees of £5,950 and £3,575 introduces fees of £4,800 and £3,400; regulation 6(3) removes spent transitional provisions; and regulation 6(4) removes a provision under which a single fee has applied to several marketing authorizations which relate to homoeopathic or anthroposophic products derived from the same mother tincture or combination of mother tinctures;\nregulation 7 makes further provision for the partial refund or waiver of fees where applications are withdrawn, cannot be assessed or where the provisions of one marketing authorization are included in another.\nAn assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament and further copies of which may be obtained from the Medicines Control Agency, Department of Health, Room 1207, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1996/683/note",
    "retrieved_at": "2026-10-29T12:48:48.755279+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."
}