{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-298",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-298.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/298",
  "kind": "regulation",
  "number": "298",
  "heading": "Free samples for persons qualified to prescribe or supply medicinal products",
  "text": "(1) A person (“the supplier”) may not supply a free sample of a medicinal product to another person (“the recipient”) unless the following conditions are met.\n(2) Condition A is that the recipient—\n(a) is qualified to prescribe medicinal products; and\n(b) receives the sample for the purpose of acquiring experience in dealing with the product in question.\n(3) Condition B is that the sample is supplied to the recipient—\n(a) on an exceptional basis; and\n(b) in response to a request from, and signed and dated by, the recipient.\n(4) Condition C is that, taking the year in which the sample is supplied as a whole, only a limited number of samples of the product in question are supplied to the recipient in that year.\n(5) Condition D is that the sample—\n(a) is no larger than the smallest presentation of the product that is available for sale—\n(i) in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or\n(ii) in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;\n(b) is marked “free medical sample – not for resale” or bears a similar description; and\n(c) is accompanied by a copy of the summary of the product characteristics.\n(6) Condition E is that the sample does not contain—\n(a) a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or\n(b) a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).\n(7) Condition F is that the supplier maintains an adequate system of control and accountability in relation to the supply of free samples.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 298(5)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 215A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 174)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/298",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}