{
  "url": "https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-3/division-10",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-3/division-10.json",
  "legislation": "eur/2012/520",
  "legislation_title": "Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-520",
  "path": "annex/III/division/3/division/10",
  "kind": "division",
  "number": "10",
  "heading": null,
  "text": "Results: comprising the following subsections:\n10.1.Participants: numbers of study subjects at each stage of study. In the case of a systematic review or meta-analysis, number of studies screened, assessed for eligibility and included in the review with reasons for exclusion at each stage.\n10.2.Descriptive data: characteristics of study participants, information on exposures and potential confounders and number of participants with missing data. In the case of a systematic review or meta-analysis, characteristics of each study from which data were extracted.\n10.3.Outcome data: numbers of study subjects across categories of main outcomes.\n10.4.Main results: unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision. Where relevant, estimates of relative risk shall be translated into absolute risk for a meaningful time period.\n10.5.Other analyses.\n10.6.Adverse events and adverse reactions.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/520/annex/III/division/3/division/10",
    "retrieved_at": "2026-11-01T14:49:23.286977+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."
}