{
  "url": "https://openlegislation.uk/eu-regulation-2019-6/article-73",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-6/article-73.json",
  "legislation": "eur/2019/6",
  "legislation_title": "Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2019-6",
  "path": "article/73",
  "kind": "article",
  "number": "73",
  "heading": "Union pharmacovigilance system",
  "text": "1. Member States, the Commission, the Agency and marketing authorisation holders shall collaborate in setting up and maintaining a Union pharmacovigilance system to carry out pharmacovigilance tasks with respect to the safety and efficacy of authorised veterinary medicinal products in order to ensure continuous assessment of the benefit-risk balance.\n2. Competent authorities, the Agency and marketing authorisation holders shall take the necessary measures to make available means to report and encourage reporting of the following suspected adverse events:\n(a) any unfavourable and unintended reaction in any animal to a veterinary medicinal product;\n(b) any observation of a lack of efficacy of a veterinary medicinal product following its administration to an animal, whether or not in accordance with the summary of product characteristics;\n(c) any environmental incidents observed following the administration of a veterinary medicinal product to an animal;\n(d) any noxious reaction in humans exposed to a veterinary medicinal product;\n(e) any finding of a pharmacologically active substance or marker residue in a product of animal origin exceeding the maximum levels of residues established in accordance with Regulation (EC) No 470/2009 after the set withdrawal period has been respected;\n(f) any suspected transmission of an infectious agent via a veterinary medicinal product;\n(g) any unfavourable and unintended reaction in an animal to a medicinal product for human use.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/6/article/73",
    "retrieved_at": "2026-11-01T14:43:40.425754+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."
}