{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-63",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-63.json",
  "legislation": "ukdsi/2019/9780111179185",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/63",
  "kind": "regulation",
  "number": "63",
  "heading": "Amendment of Schedule 11 (advice and representations)",
  "text": "(1) Schedule 11 is amended as follows.\n(2) In paragraph 1 (application of Part 1)—\n(a) in sub-paragraph (1)—\n(i) in sub-paragraph (b) omit “and”, and\n(ii) at the end insert—\n“(d) a proposal to agree, or to refuse to agree, a paediatric investigation plan;\n(e) a proposal to grant, or to refuse to grant, or to revoke, a waiver or deferral of the initiation or completion of some or all of the measures set out in a paediatric investigation plan; and\n(f) a proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.”;\n(b) after sub-paragraph (1) insert—\n“(1A) Paragraphs 12 and 13 of this Part also apply to—\n(a) an application for the grant of a parallel import licence;\n(b) an application to renew a parallel import licence;\n(c) a proposal to revoke, vary or suspend a parallel import licence (including variation by the variation or removal of a condition to which a parallel import licence is subject) other than a proposal to vary the licence on the application of or by agreement with its holder; and\n(d) a refusal to vary a parallel import licence following an application for a variation by the holder.”; and\n(c) omit sub-paragraph (2).\n(3) In paragraph 12 (licensing authority decision in other cases), in sub-paragraphs (1), (2) and (5)—\n(a) insert “, parallel import licence” after “UK marketing authorisation” in each place it appears; and\n(b) insert “, licence” after “the authorisation” in each place it appears.\n(4) In paragraph 14(a) (application of Part 2), for the words from “Article 2(3)” to the end, substitute “paragraph 1 of Schedule 10A; and”.\n(5) In paragraph 15(2) and (3)(b), insert “UK” before “marketing authorisation”.\n(6) In paragraph 16—\n(a) in sub-paragraph (2)(b), insert “UK” before “marketing authorisation”; and\n(b) in sub-paragraph (5), omit the words from “or in any Directive” to the end.\n(7) Omit paragraph 17.\n(8) In Part 3 (referral to the Committee for Herbal Medicinal Products)—\n(a) in the heading to Part 3, for “Committee for Herbal Medicinal Products” substitute “appropriate committee for traditional herbal registrations”;\n(b) in paragraph 24—\n(i) in sub-paragraph (1), for the words from “Committee” to the end substitute “appropriate committee in accordance with regulation 130A(1)”; and\n(ii) omit sub-paragraph (2); and\n(c) in paragraph 29(1), for “proceed with its proposal” substitute “grant or refuse the application”.\n(9) Omit Part 4 (exceptions to Schedule).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/63",
    "retrieved_at": "2026-10-30T15:01:32.040145+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."
}