{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-3.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/1/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": null,
  "text": "(1) Subject to the following sub-paragraphs, regulation 3(1) shall not apply to anything done—\n(a) by a doctor or dentist which relates to a relevant medicinal product specially prepared by him, or to his order, for administration to one or more patients of his or, where that doctor or dentist is a member of a group of doctors or dentists working together to provide general medical or dental services, to one or more patients of any other doctor or dentist of that group, and consists of procuring the manufacture or assembly of a stock of the product with a view to administering the product to such patients; or\n(b) in a registered pharmacy, a hospital or health centre and is done there by or under the supervision of a pharmacist, and consists of procuring the manufacture or assembly of a stock of relevant medicinal products with a view to dispensing them in accordance with paragraph 1.\n(2) The exemption conferred by sub-paragraph (1) shall not apply to procuring the manufacture of relevant medicinal products unless those products are to be manufactured by the holder of a manufacturer’s licence which relates specifically to the manufacture or assembly of relevant medicinal products to which paragraph 1 applies.\n(3) The exemption conferred by sub-paragraph (1) shall not apply to anything done by a doctor or dentist in relation to a stock held by him of such relevant medicinal products in excess of a total of 5 litres of fluid and 2.5 kilograms of solids of all relevant medicinal products to which that sub-paragraph relates.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "am",
      "affecting": "uksi/2005/768",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2004/865",
      "affecting_title": "The General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2006/562",
      "affecting_title": "The General Dental Services, Personal Dental Services and Abolition of the Dental Practice Board Transitional and Consequential Provisions Order 2006"
    },
    {
      "type": "am",
      "affecting": "uksi/2009/3063",
      "affecting_title": "The Medicines for Human Use (Miscellaneous Amendments) (No.2) Regulations 2009"
    },
    {
      "type": "words revoked",
      "affecting": "uksi/2010/1882",
      "affecting_title": "The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010"
    },
    {
      "type": "substituted",
      "affecting": "uksi/2004/1031",
      "affecting_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "substituted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2005/2759",
      "affecting_title": "The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "wsi/2004/1016",
      "affecting_title": "The General Medical Services Transitional and Consequential Provisions (Wales) (No. 2) Order 2004"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3144/schedule/1/paragraph/3",
    "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."
}