{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-III/paragraph-4",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-III/paragraph-4.json",
  "legislation": "uksi/1995/1116",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1995",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995",
  "path": "schedule/1/part/III/paragraph/4",
  "kind": "paragraph",
  "number": "4",
  "heading": "Marketing authorizations",
  "text": "Subject to paragraph 5, where a marketing authorization has been granted in accordance with an application to which Section G of Part 4 of the Annex to Council Directive 75/318/EEC applies, the fee in connection with the first application for variation of that marketing authorization made within 5 years of the date of the grant of that marketing authorization, so as to authorise use of the medicinal product in a new therapeutic area, shall, in addition to the fee payable under regulation 7(1), be the difference between the fee paid in connection with that application and the fee which would have been payable had the application been a major application.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L147, 9.6.75, p. 1. The Directive was amended by Directives 89/341/EEC (OJ No. L142, 25.5.89, p. 11), 91/507/EEC (OJ No. L270, 26.9.91, p. 32) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22)."
    }
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    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/schedule/1/part/III/paragraph/4",
    "retrieved_at": "2026-10-29T13:10:38.932521+00:00"
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  "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."
}