{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-28",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-28.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/28",
  "kind": "regulation",
  "number": "28",
  "heading": "Amendment of Schedule 5 (fees for certificates of registration)",
  "text": "For the table in Schedule 5, substitute—\n“\nColumn 1\nType of application\nColumn 2\nFees for applications in respect of products prepared from not more than 5 homoeopathic stocks\nColumn 3\nFees for other applications\n1\nAn application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation.\n£159\n£393\n2\nAn application in respect of a product which is either—\n£478\n£704\n(a)\nPrepared solely from repeat stocks; or\n(b)\nIs of a repeat formulation.\n3\nA mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associate application under the unfettered access route for a COR(GB).\n£501\n£638\n4\nA decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a COR(GB).\n£430\n£563\n5\nAny other application.\n£790\n£1,034\n”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/28",
    "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."
}