{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-53",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-53.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/53",
  "kind": "regulation",
  "number": "53",
  "heading": "Application for UKMA(NI) relating to similar biological medicinal products",
  "text": "(1) This regulation applies if an applicant for a UKMA(NI) for a biological medicinal product is not able to show that product meets a condition for its being a generic version of a similar medicinal product because of any of the reasons described in Article 10(4) of the 2001 Directive.\n(2) The applicant must provide information in accordance with Article 10(4) and (6) of the 2001 Directive.\n(3) Paragraph (2) of regulation 51 applies to the application as it applies in relation to an application made in accordance with paragraph (1) of that regulation.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 53-53B substituted for reg. 53 (31.12.2020) by S.I. 2019/775, regs. 1, 58 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 43)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 53(3) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 40"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/53",
    "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."
}