{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-22",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-22.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/22",
  "kind": "paragraph",
  "number": "22",
  "heading": "Type IB and Type II Applications",
  "text": "(1) A Type IB Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation of type IB” within the meaning of Article 2(5) of EC Regulation No. 1234/2008.\n(2) A Type II Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is not—\n(a) a reclassification variation;\n(b) a Type IA Application;\n(c) a Type IB Application;\n(d) a Type II Complex Variation Application;\n(e) an Extended Type II Complex Variation Application; or\n(f) an application for an extension of a marketing authorization within the meaning of Article 2(4) of EC Regulation No. 1234/2008.\n(3) For the purposes of sub-paragraph (2)(b), a “Type IA Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of Article 2(2) 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/22",
    "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."
}