{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-158",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-158.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/158",
  "kind": "regulation",
  "number": "158",
  "heading": "Application of these Regulations",
  "text": "The following provisions of Part 5 (marketing authorisations) apply to an Article 126a authorisation as they apply to a marketing authorisation—\n(a) regulation 62 (classification of marketing authorisation);\n(b) regulation 63 (frequency of periodic safety update reports);\n(c) regulation 68 (revocation etc of marketing authorisation) and Schedule 11 (advice and representations in connection with revocations etc) so far as relating to that regulation;\n(d) regulation 69 (suspension of use etc of medicinal product);\n(e) regulation 71 (withdrawal of medicinal products from the market);\n(f) regulation 72 (sale etc of suspended medicinal product);\n(g) regulation 80 (urgent safety restrictions); and\n(h) regulations 98 (general offence of breach of provision of this Part), 99 (penalties) and 101(1) and (2) (defences), so far as relating to the regulations mentioned in sub-paragraphs (a) and (e) to (f).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/158",
    "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."
}