{
  "url": "https://openlegislation.uk/medicines-marketing-authorisations-etc-amendment-regulations-2005/schedule/paragraph-6",
  "json_url": "https://openlegislation.uk/medicines-marketing-authorisations-etc-amendment-regulations-2005/schedule/paragraph-6.json",
  "legislation": "uksi/2005/2759",
  "legislation_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005",
  "legislation_url": "https://openlegislation.uk/medicines-marketing-authorisations-etc-amendment-regulations-2005",
  "path": "schedule/paragraph/6",
  "kind": "paragraph",
  "number": "6",
  "heading": null,
  "text": "In the Health Service Medicines (Control of Prices of Branded Medicines) Regulations 2000 in regulation 2 (interpretation), in paragraph 1—\n(a) after the definition of “branded health service medicine” insert the following definition—\n““Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”;\n(b) in the definition of “marketing authorisation”—\n(i) for sub-paragraph (a), substitute the following—\n“(a) by the competent authority of the United Kingdom in accordance with Directive 2001/83/EC and includes an authorisation granted by the competent authority in accordance with Article 126a of Directive 2001/83; or”, and\n(ii) in sub-paragraph (b), after “Evaluation of Medicinal Products” insert “or Regulation (EC) No. 726/2004 of the European Parliament and 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”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 2000/123; relevant amending instruments are S.I. 2002/236 and S.I. 2004/3224."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/2759/schedule/paragraph/6",
    "retrieved_at": "2026-10-29T04:49:21.883121+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."
}