{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-11",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-11.json",
  "legislation": "ukdsi/2021/9780348228755",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021",
  "path": "regulation/11",
  "kind": "regulation",
  "number": "11",
  "heading": "Amendment of regulation 60B (submitting of samples and other information: EU marketing authorisations)",
  "text": "(1) Regulation 60B is amended as follows.\n(2) In paragraph (1), in the definition of “the batch testing exemption”, in paragraph (b)(ii), after “United Kingdom” insert “or the European Union”\n(3) In paragraph (2)(a), in each place where it occurs, for “immunological product” substitute “immunological medicinal product”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 60B was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/11",
    "retrieved_at": "2026-10-30T14:46:28.800050+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."
}