{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-181",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-181.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/181",
  "kind": "paragraph",
  "number": "181",
  "heading": null,
  "text": "In regulation 222 (amendment of regulation 331 (findings and reports of inspections))—\n(a) for paragraph (2) substitute—\n“(2) In paragraph (1)—\n(a) for “marketing authorisation” substitute “UK marketing authorisation, EU marketing authorisation”;\n(b) in sub-paragraph (c), at the beginning, insert “in the case of a product authorised under a UKMA(NI) or UKMA(UK),”.”;\n(b) for paragraph (3) substitute—\n“(3) In paragraph (4)—\n(a) for sub-paragraph (b) substitute—\n“(b) the guidelines on good distribution practice—\n(i) in the case of Great Britain, published under, or that apply by virtue of, regulation C17;\n(ii) in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;”;\n(b) after sub-paragraph (c) insert—\n“(d) Schedule 12A; and\n(e) the Implementing Regulation (as defined in regulation 177(5)).”.”.",
  "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/181",
    "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."
}