{
  "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004",
  "json_url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004.json",
  "id": "uksi/2004/3224",
  "title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004",
  "short_title": "Medicines (Marketing Authorisations and Miscellaneous Amendments) 2004",
  "long_title": "These Regulations implement certain provisions of Directive 2004/27/EC of the European Parliament and of the Council (“the 2004 Directive”) amending Directive 2001/83/EC on the Community code for medicinal products for human use (“the 2001 Directive”), and make consequential amendments to various enactments following the adoption of Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.",
  "citation": "S.I. 2004/3224",
  "type": "uksi",
  "year": "2004",
  "number": "3224",
  "version": "current",
  "date": "2004-12-07",
  "revised": false,
  "valid_from": null,
  "extent": null,
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/introduction",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/1",
      "kind": "regulation",
      "number": "1",
      "heading": "Citation and commencement",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-1",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/2",
      "kind": "regulation",
      "number": "2",
      "heading": "Amendment of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-2",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/3",
      "kind": "regulation",
      "number": "3",
      "heading": "Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-3",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/4",
      "kind": "regulation",
      "number": "4",
      "heading": "Amendment of the Terrorism Act 2000",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-4",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/5",
      "kind": "regulation",
      "number": "5",
      "heading": "Amendment of the Health Service Medicines (Control of Prices of Branded Medicines) Regulations 2000",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-5",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/6",
      "kind": "regulation",
      "number": "6",
      "heading": "Amendment of the Health Service Medicines (Control of Prices of Specified Generic Medicines) Regulations 2000",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-6",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/7",
      "kind": "regulation",
      "number": "7",
      "heading": "Amendment of the Health Service Medicines (Information on the Prices of Specified Generic Medicines) Regulations 2001",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-7",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/8",
      "kind": "regulation",
      "number": "8",
      "heading": "Amendment of the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-8",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "regulation/9",
      "kind": "regulation",
      "number": "9",
      "heading": "Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/regulation-9",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/signature",
      "extent": null,
      "status": null,
      "parent": null
    },
    {
      "path": "note",
      "kind": "note",
      "number": null,
      "heading": "Explanatory note",
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/note",
      "extent": null,
      "status": null,
      "parent": null
    }
  ],
  "has_text": true,
  "pdfs": [
    {
      "title": "Printed copy",
      "main": true,
      "language": null,
      "date": "2008-12-05",
      "size": null,
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/pdf/uksi_20043224_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/2004/3224/pdfs/uksi_20043224_en.pdf"
    },
    {
      "title": "Explanatory Memorandum",
      "main": false,
      "language": null,
      "date": "2008-12-06",
      "size": null,
      "url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/pdf/uksiem_20043224_en.pdf",
      "source_url": "https://www.legislation.gov.uk/uksi/2004/3224/pdfs/uksiem_20043224_en.pdf"
    }
  ],
  "outstanding_effects": [],
  "made_under": [
    {
      "id": "ukpga/1972/68",
      "title": "European Communities Act 1972 (repealed)",
      "url": "https://openlegislation.uk/european-communities-act-1972-repealed",
      "provisions": []
    }
  ],
  "changes_made_to": 0,
  "changes_made_to_url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/changes.json",
  "changes_made_by": 19,
  "changes_made_by_url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/medicines-marketing-authorisations-and-miscellaneous-amendments-regulations-2004/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/3224",
    "retrieved_at": "2026-10-29T05:13:58.988390+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."
}