{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-194A",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-194A.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/194A",
  "kind": "regulation",
  "number": "194A",
  "heading": "Amendment of regulation 251 (compliance with standards specified in certain publications)",
  "text": "In regulation 251 (compliance with standards specified in certain publications), after paragraph (5) insert—\n“(6) In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—\n(a) the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and\n(b) the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.\n(7) In paragraph (6), “relevant marketing authorisation” means—\n(a) an EU marketing authorisation;\n(b) an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or\n(c) a UKMA(GB) granted under the unfettered access route.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 194A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 149"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 194A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/regulation/194A",
    "retrieved_at": "2026-10-28T22:42:14.621781+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."
}