{
  "url": "https://openlegislation.uk/medicines-for-human-use-fees-and-miscellaneous-amendments-regulations-2003/regulation-8",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-fees-and-miscellaneous-amendments-regulations-2003/regulation-8.json",
  "legislation": "uksi/2003/2321",
  "legislation_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-fees-and-miscellaneous-amendments-regulations-2003",
  "path": "regulation/8",
  "kind": "regulation",
  "number": "8",
  "heading": "Amendment of regulation 2 of the General Fees Regulations",
  "text": "(1) Regulation 2 of the General Fees Regulations (interpretation) is amended as follows.\n(2) In paragraph (1)—\n(a) in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and\n(b) in the definition of “variation” for “Article 2.1 of Commission Regulation (EC) No. 541/95” substitute “ Article 3.1 of Commission Regulation (EC) No. 1084/2003 ”.\n(3) After paragraph (2) insert the following paragraph—\n“(3) In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2003/2321/regulation/8",
    "retrieved_at": "2026-10-29T05:59:50.951233+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."
}