{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-6/paragraph-5",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-6/paragraph-5.json",
  "legislation": "uksi/1994/3144",
  "legislation_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994",
  "path": "schedule/6/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": null,
  "text": "Until 31st March 1995 the Medicines (Products for Human Use—Fees) Regulations 1991 shall have effect as if—\n(a) any reference to a product licence or to licences under Part II of the Act included a reference to a United Kingdom marketing authorization;\n(b) in regulation 2(1), the definition of “medicinal product” included a reference to a relevant medicinal product;\n(c) in regulation 7, the reference to an application under section 30 of the Act to vary a product licence included a reference to an application under regulation 4 above to vary a United Kingdom marketing authorization; and\n(d) in head 1(a)(i) in Column 1 of the Table in Part II of Schedule 1, paragraphs 2 and 2A of Part III of that Schedule and in the definition of “limited use drug” in paragraph 1 of Part I of Schedule 3, the references to paragraph 5 of Schedule 2 to the Applications Regulations included references to section G of Part 4 of the Annex to Council Directive 75/318/EEC.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 1991/1474. The relevant amending instruments are S.I. 1992/756 and 1994/691."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "The Annex to Council Directive 75/318/EEC was replaced by Council Directive 91/507/EEC."
    }
  ],
  "outstanding_effects": [
    {
      "type": "inserted",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2004/3224",
      "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3144/schedule/6/paragraph/5",
    "retrieved_at": "2026-10-29T13:21:07.489272+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."
}