{
  "url": "https://openlegislation.uk/tobacco-and-related-products-regulations-2016/regulation-39",
  "json_url": "https://openlegislation.uk/tobacco-and-related-products-regulations-2016/regulation-39.json",
  "legislation": "uksi/2016/507",
  "legislation_title": "The Tobacco and Related Products Regulations 2016",
  "legislation_url": "https://openlegislation.uk/tobacco-and-related-products-regulations-2016",
  "path": "regulation/39",
  "kind": "regulation",
  "number": "39",
  "heading": "Vigilance requirements",
  "text": "(1) A producer of electronic cigarettes or refill containers must establish and maintain a system for collecting information about all of the suspected adverse effects on human health of the product.\n(2) Paragraphs (3) and (4) apply where a producer of electronic cigarettes or refill containers considers or has reason to believe that an electronic cigarette or refill container which is in its possession and is intended to be supplied, or which has been supplied, is not—\n(a) safe;\n(b) of good quality; or\n(c) in conformity with this Part of the Regulations.\n(3) The producer must (as appropriate)—\n(a) immediately take the corrective action necessary to bring the product into conformity with this Part of the Regulations;\n(b) withdraw the product;\n(c) recall the product.\n(4) The producer must immediately inform the Secretary of State and , where the product is an NI related product, the competent authority of each member State in which the product has been supplied or is intended to be supplied, giving details of, in particular—\n(a) the risk to human health and safety;\n(b) any corrective action taken; and\n(c) the results of any corrective action taken.\n(5) The Secretary of State or , where the product is an NI related product, the competent authority of any member State may request additional information from a producer of electronic cigarettes or refill containers, including information on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.\n(6) A producer must comply with a request made of it under paragraph (5) by the date reasonably required by the Secretary of State.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 39(4) substituted (31.12.2020) by S.I. 2019/41, reg. 6(24)(a) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(29) (with reg. 5))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 39(5) substituted (31.12.2020) by S.I. 2019/41, reg. 6(24)(b) (as substituted by The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1316), regs. 1(3), 3(29) (with reg. 5))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/507/regulation/39",
    "retrieved_at": "2026-11-10T03:36:22.754234+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."
}