{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-23",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-23.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "schedule/2/paragraph/23",
  "kind": "paragraph",
  "number": "23",
  "heading": "Type II Complex Variation Application",
  "text": "A Type II Complex Variation Application is an application for a variation of a marketing authorization, other than an Extended Type II Complex Variation Application, which relates to a change—\n(a) in the formulation of a medicinal product comprising one or more of the following changes, other than a change to which paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to EC Regulation No. 1234/2008 applies—\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) which is considered a “major variation of type II” within the meaning of Article 2(3) of EC Regulation No. 1234/2008 and which is—\n(i) supported by data which comprises or includes the results of clinical trials or physicochemical, biological, microbiological or pharmacological and toxicological tests; or\n(ii) accompanied by evidence relating to post-marketing experience which is information of any type described in paragraph 5.2.6 of Part I of Annex I to the 2001 Directive (clinical documentation); or\n(c) in the composition, manufacture or use of a medicinal product to which—\n(i) sub-paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in paragraph 5 of this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product; or\n(ii) sub-paragraph (i) of that definition would so apply and the change is not a minor variation of type IA or a minor variation of type IB within the meaning of EC Regulation No. 1234/2008.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/23",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}