{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-33A/paragraph-35",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-33A/paragraph-35.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/33A/paragraph/35",
  "kind": "paragraph",
  "number": "35",
  "heading": "Transitional provision in respect of Plasma Master Files",
  "text": "(1) This paragraph applies in relation to a UK marketing authorisation or EU marketing authorisation—\n(a) which was granted before IP completion day;\n(b) the application for which made reference to a Plasma Master File within the meaning of paragraph 1.1(a), first indent, of Part III of Annex I to the 2001 Directive which was certified by the EMA in accordance with paragraph 1.1(c) of that Part of the Annex; and\n(c) which remains in force as a UK marketing authorisation on and after IP completion day.\n(2) A holder of the UK marketing authorisation to which this paragraph applies may, subject to complying with the obligations in sub-paragraph (3), continue to refer to the Plasma Master File as certified by the EMA, notwithstanding the modifications to paragraph 1.1(c) of Part III of Annex I to the 2001 Directive in Schedule 8B, subject which that paragraph is to be read on and after IP completion day.\n(3) The holder of a UK marketing authorisation to which this paragraph applies must notify the licensing authority of—\n(a) the outcome of the annual update and recertification of the Plasma Master File by the EMA within 4 weeks beginning with the completion of that update and recertification;\n(b) any application for changes to the terms of the Plasma Master File which the holder seeks from the EMA, within 4 weeks beginning with the date of the application; and\n(c) the outcome of any application referred to in paragraph (b), within 4 weeks beginning with the date on which the holder is notified of that outcome.\n(4) The licensing authority may at any time review the terms of a Plasma Master File to which reference is made in accordance with sub-paragraph (2), with a view to exercising its powers under these Regulations in relation to the UK marketing authorisation.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/33A/paragraph/35",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}