{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-157",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-157.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/157",
  "kind": "regulation",
  "number": "157",
  "heading": "Requests from EU member States",
  "text": "(1) Paragraph (2) applies where the licensing authority , in relation to a UKMA(NI), is requested by the competent authority of a member State to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—\n(a) the assessment report for a medicinal product as mentioned in regulation 64(5) (duties of licensing authority in connection with determination); and\n(b) the marketing authorisation in force for that product.\n(2) The licensing authority must supply those documents to the competent authority before the end of the period of thirty days beginning on the day after the request is received.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 157(1) inserted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 157(1) substituted (31.12.2020) by S.I. 2019/775, reg. 132A(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 157 heading substituted (31.12.2020) by S.I. 2019/775, reg. 132A(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 99)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/157",
    "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."
}