{
  "url": "https://openlegislation.uk/eu-regulation-2019-6/article-26",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-6/article-26.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/26",
  "kind": "article",
  "number": "26",
  "heading": "Terms of the marketing authorisation in exceptional circumstances",
  "text": "1. In the exceptional circumstances referred to in Article 25, a marketing authorisation may be granted subject to one or more of the following requirements for the marketing authorisation holder:\n(a) a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;\n(b) a requirement to notify to the competent authorities or the Agency, as applicable, of any adverse event relating to the use of the veterinary medicinal product;\n(c) a requirement to conduct post-authorisation studies.\n2. Where a veterinary medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety or efficacy has been conducted due to the lack of comprehensive quality, safety or efficacy data.",
  "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/26",
    "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."
}