{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8A/paragraph-6",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8A/paragraph-6.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/8A/paragraph/6",
  "kind": "paragraph",
  "number": "6",
  "heading": null,
  "text": "If requested by the licensing authority, a summary of the applicant’s pharmacovigilance system which shall include the following elements—\n(a) proof that the applicant has at the applicant’s disposal an appropriately qualified person responsible for pharmacovigilance who resides and operates in the United Kingdom;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) the contact details of the appropriately qualified person;\n(d) a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Part 11; and\n(e) a reference to the location where the pharmacovigilance system master file for the medicinal product is kept or, if kept in electronic form, from which it can be accessed, which in either case, must be in the United Kingdom.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 8A inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 26 and Sch. 8A inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 26"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 8A para. 6(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 51(a); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sch. 8A para. 6(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 51(b); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Sch. 8A para. 6(e) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 51(c); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/8A/paragraph/6",
    "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."
}