{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-51",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-51.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/51",
  "kind": "paragraph",
  "number": "51",
  "heading": null,
  "text": "In regulation 68 (amendment of regulation 61 (conditions of UK marketing authorisation))—\n(a) in paragraph (2), in the inserted paragraph (4)(b), before “to comply” insert “in relation to a UKMA(GB),”;\n(b) after paragraph (2) insert—\n“(2A) In paragraph (6), after “one medicinal product” insert “authorised by a UKMA(NI) or UKMA(UK)”.”;\n(c) for paragraph (3) substitute—\n“(3) After paragraph (6) insert—\n“(6A) If concerns as described in paragraph (2) apply to more than one medicinal product authorised by a UKMA(GB), the licensing authority—\n(a) must, where the obligation is to conduct a post-authorisation safety study, encourage the UK marketing authorisation holders concerned to conduct a joint study, and\n(b) may, where the obligation is to comply with any other conditions or restrictions, encourage the UK marketing authorisation holders concerned to take co-ordinated action to comply with the conditions or restrictions.”.”;\n(d) after paragraph (3) insert—\n“(3A) In paragraph (7) for “The obligation under paragraph (5) shall” substitute “In relation to a UKMA(NI) or UKMA(UK), the obligation under paragraph (5) must”.”;\n(e) for paragraph (4) substitute—\n“(4) After paragraph (7) insert—\n“(7A) In relation to a UKMA(GB), the obligation under paragraph (5) must—\n(a) be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and\n(b) take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.\n(7B) The Secretary of State may by regulations make provision in respect of Great Britain specifying the situations in which post-authorisation efficacy studies may be required by virtue of the obligation under paragraph (5).\n(7C) Paragraph (7A)(a) ceases to apply on the coming into force of regulations made under paragraph (7B).”.”;\n(f) for paragraph (5) substitute—\n“(5) In paragraph (13), after “notify the EMA” insert “, in relation to a UKMA(NI) or UKMA(UK),”.”.",
  "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/51",
    "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."
}