{
  "url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/regulation-5",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/regulation-5.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": "regulation/5",
  "kind": "regulation",
  "number": "5",
  "heading": "Amendment of Schedule 1 to the principal Regulations",
  "text": "(1) For paragraph 5(1)(b) (manufacturer’s licences) of Part II of Schedule 1 (capital fees for applications for marketing authorizations, licences and certificates) to the principal Regulations substitute—\n“(b) in the case of a change of ownership application, £180;\n(c) in any other case, £1,690.”.\n(2) In paragraph 6 (wholesale dealer’s licences) of Part II of Schedule 1 to the principal Regulations—\n(a) in sub-paragraph (1) for “sub-paragraph (2)” substitute “sub-paragraphs (2) and (4)”;\n(b) in sub-paragraph (2) for “The fee payable” substitute “Subject to paragraph (4), the fee payable”;\n(c) after sub-paragraph (3) add\n“(4) The fee payable under regulation 4(a) in connection with a change of ownership application shall be £210.”.\n(3) In paragraph 1 (marketing authorizations) of Part III (capital fees for variations) of Schedule 1 to the principal Regulations—\n(a) in the definition of “Type II Application” omit “or a product licence of right”;\n(b) in the definition of “Type II complex variation”—\n(i) in sub-paragraph (a) after “following” insert “changes, other than a change to which paragraph 1 (changes to active substances) or paragraph 3 (changes to strength, pharmaceutical form and route of administration) of Annex II to Commission Regulation (EC) No. 541/95 applies”;\n(ii) at the end of sub-paragraph (b) insert “or”;\n(iii) for sub-paragraph (c) substitute—\n“(c) in the composition, manufacture or use of a medicinal product to which—\n(i) paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product; or\n(ii) paragraph (i) of that definition would so apply and the change is not a minor variation which satisfies the condition specified in point 11 (specifications, synthetic route and quality control procedures the same as those already approved or a European Pharmacopoeia Certificate of suitability covering the active substance submitted) of Annex I to Commission Regulation (EC) No. 541/95.”.\n(4) In paragraph 6(a) (fees for variation of marketing authorizations (parallel import)) of Part III of Schedule 1, after sub-paragraph (v) insert the following sub-paragraph—\n“(vi) the addition or deletion of the name and address of the suppliers of the medicinal product to which the authorization relates, or a change in the name, the address, or both the name and address, of the suppliers of that product;”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L55, 11.3.95, p. 7."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1996/683/regulation/5",
    "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."
}