{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-22",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-22.json",
  "legislation": "uksi/2016/190",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "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 authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IB” within the meaning of\n(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(5) of Commission Regulation (EC) No 1234/2008;\n(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations\n(2) A Type II Application is an application by a marketing authorisation holder to vary a marketing authorisation (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 authorisation within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008.\n(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(4) of Commission Regulation (EC) No 1234/2008;\n(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations\n(3) For the purposes of sub-paragraph (2)(b), a “Type IA Application” means an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of\n(a) in the case of a UKMA(NI) or UKMA(UK), Article 2(2) of Commission Regulation (EC) No 1234/2008;\n(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 2 para. 22(1)(a)(b) substituted for words in Sch. 2 para. 22(1) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(aa))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 2 para. 22(2)(a)(b)(f) substituted for words in Sch. 2 para. 22(2)(f) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(b) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(bb))"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sch. 2 para. 22(3)(a)(b) substituted for words in Sch. 2 para. 22(3) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(c) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(cc))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/22",
    "retrieved_at": "2026-10-28T23:27:13.215121+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."
}