{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-6",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-6.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/6",
  "kind": "paragraph",
  "number": "6",
  "heading": null,
  "text": "Any person who sells or supplies a relevant medicinal product in accordance with any of paragraphs 1 to 4 shall maintain, and keep for a period of at least 5 years, a record showing—\n(a) the source from which that person obtained that product;\n(b) the person to whom and the date on which the sale or supply was made;\n(c) the quantity of each sale or supply;\n(d) the batch number of the batch of that product from which the sale or supply was made; and\n(e) details of any suspected adverse reaction to the product so sold or supplied of which he is aware.",
  "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/6",
    "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."
}