{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-38",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-38.json",
  "legislation": "ukdsi/2020/9780348213980",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020",
  "path": "schedule/2/paragraph/38",
  "kind": "paragraph",
  "number": "38",
  "heading": null,
  "text": "In regulation 50 (amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation))—\n(a) in paragraph (2)—\n(i) in paragraph (a), after “in the United Kingdom” insert “or a member State”;\n(ii) for paragraph (b) substitute—\n“(b) for sub-paragraph (b) substitute—\n“(b) the country (which must be either the United Kingdom or a member State) in which the appropriately qualified person resides and carries out his or her tasks;”;”;\n(iii) for paragraph (c) substitute—\n“(c) for paragraph (e) substitute—\n“(e) a reference to the physical location where the pharmacovigilance system master file for the medicinal product can be accessed electronically, which must be in the United Kingdom.”.”;\n(b) in paragraph (3), for the inserted paragraph 18, substitute—\n“18. Where—\n(a) in the case of a UKMA(NI) or a UKMA(UK), an application for authorisation for the medicinal product to be placed on the market is under consideration in one or more member States—\n(i) a list of the member State or States concerned, and\n(ii) in relation to each such application, a copy of the summary of the product characteristics, and the package leaflet, proposed by the applicant;\n(b) in the case of a medicinal product for sale or supply in Great Britain, an application for authorisation for the medicinal product to be placed on the market is under consideration in a country other than the United Kingdom, or by the EMA, notification of that fact.”;\n(c) for paragraph (4) substitute—\n“(4) In paragraph 19, for “a member State or by a third country” substitute “, in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission”.”;\n(d) for paragraph (5) substitute—\n“(5) In paragraph 20, after “Where” insert “, in the case of a medicinal product for sale or supply in Northern Ireland,”.”;\n(e) for paragraph (6) substitute—\n“(6) For paragraph 21 substitute—\n“21. Where an authorisation for the medicinal product to be placed on the market has been refused—\n(a) in the case of a medicinal product for sale or supply in Northern Ireland, by a member State or by a country other than an EEA State, or\n(b) in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom,\ndetails of that decision and of the reasons for it.”.”;\n(f) for paragraph (7) substitute—\n“(7) In paragraph 22 for “A copy of any” substitute “In the case of a medicinal product for sale or supply in Northern Ireland, a copy of any”.”;\n(g) for paragraph (8) substitute—\n“(8) For paragraph 23 substitute—\n“23. For medicinal products included on the list referred to—\n(a) in the case of a medicinal product for sale or supply in Northern Ireland, in Article 23 of Regulation (EC) No 726/2004, the symbol and statement “▼ This medicinal product is subject to additional monitoring”, or\n(b) in the case of a medicinal product for sale or supply in Great Britain, in regulation 202A, the symbol and statement “▼ This medicinal product is subject to additional monitoring”.”.”;\n(h) in paragraph (9), in the inserted paragraph 25A, after “advanced therapy medicinal product ” insert “for sale or supply in Great Britain”;\n(i) in paragraph (10), in the inserted paragraph 36, after “advanced therapy medicinal product ” insert “for sale or supply in Great Britain”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/38",
    "retrieved_at": "2026-10-30T14:48:26.477695+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."
}