{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-27",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-27.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/27",
  "kind": "regulation",
  "number": "27",
  "heading": "Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)",
  "text": "In Schedule 2, in paragraph 56—\n(a) in sub-paragraph (a), after “unfettered access route,” insert “provided a corresponding renewal has been made to the related European Union marketing authorisation or UKMA(NI) for the same product,”;\n(b) in sub-paragraph (b), after “(an automatic recognition application),” insert “provided a corresponding renewal has been made to the related European Union marketing authorisation or UKMA(NI) for the same product,”;\n(c) for sub-paragraph (c), substitute—\n“(c) in respect of an application for renewal of a UKMA(UK) or a UKMA(GB) granted under an application other than under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding renewal has been made to the related marketing authorisation or UKMA(NI) for the same product, £747;”;\n(d) at the end insert—\n“(d) in all other cases, £9,682.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Schedule 2 was amended 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/27",
    "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."
}