{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-III/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-III/paragraph-1.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/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "Marketing authorizations",
  "text": "In this Part of this Schedule—\n“Type I Application” means an application by a marketing authorisation holder to vary a marketing authorization (not being a marketing authorization (parallel import)) which is a “minor variation” within the meaning of Article 3.1(a) of Regulation (EC) No. 541/95;\n“Type II Application” means any application to vary a marketing authorization (not being a marketing authorization (parallel import) or a product licence of right) which is neither a Type I Application nor an application for a Type II complex variation nor a change to which Annex II to Commission Regulation (EC) 541/95 applies;\n“Type II complex variation” means a variation of a marketing authorization which relates to a change—\n(a) in the formulation of a medicinal product comprising one or more of the following\n(i) a change which necessitates in-vivo bioavailability studies to be performed on that product:\n(ii) a change in that product’s preservative system; or\n(iii) a change in that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or\n(b) in the therapeutic indications of a medicinal product, such as a change in respect of use in a new category of patients or as a treatment for a new category of disease, other than a change to which paragraph 2 (changes to therapeutic indications) of Annex II to Commission Regulation (EC) No. 541/95 applies;\n(c) in the composition, manufacture or use of a medicinal product to which any one or more of paragraphs (c), (e), (g) to (j) or (n) of the definition of complex application would apply where an application for a marketing authorisation is made in respect of a medicinal product.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L55, 11.3.95,p. 7."
    }
  ],
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    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/schedule/1/part/III/paragraph/1",
    "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."
}