{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-10A/paragraph-9",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-10A/paragraph-9.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/10A/paragraph/9",
  "kind": "paragraph",
  "number": "9",
  "heading": "Elements to be submitted",
  "text": "An application or notification under this Schedule must include—\n(a) a list of all the UK marketing authorisations affected by the notification or application;\n(b) a description of all the variations submitted, including—\n(i) in the case of minor variations of type IA, the date of implementation for each variation described,\n(ii) in the case of minor variations of type IA which do not require immediate notification, a description of all minor variations of type IA made in the last 12 months to the terms of any affected UK marketing authorisation, such period beginning with the day on which the application or notification is submitted, and which have not been already notified,\n(iii) any documents specified in guidance published under regulation 65C(4) or (6) (as the case may be), insofar as relevant to the type of variation notified or applied for,\n(iv) where a variation leads to or is the consequence of other variations to the terms of the same UK marketing authorisation, a description of the relationship between those variations, and\n(v) the relevant fee provided for in the Fees Regulations.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 10A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 5; 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/10A/paragraph/9",
    "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."
}