{
  "url": "https://openlegislation.uk/eu-decision-2020-569/annex-III/part-B/division-B/division-10/division-10.3",
  "json_url": "https://openlegislation.uk/eu-decision-2020-569/annex-III/part-B/division-B/division-10/division-10.3.json",
  "legislation": "eudn/2020/569",
  "legislation_title": "Commission Implementing Decision (EU) 2020/569 of 16 April 2020 establishing a common format and information content for the submission of the information to be reported by Member States pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes and repealing Commission Implementing Decision 2012/707/EU (notified under document C(2020) 2179) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2020-569",
  "path": "annex/III/part/B/division/B/division/10/division/10.3",
  "kind": "division",
  "number": "10.3",
  "heading": "Regulatory use and Routine production",
  "text": "10.3.1. ‘Regulatory use’ covers the use of animals in procedures with a view to satisfying regulatory requirements, that is to say for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed.\n10.3.2. This includes tests carried out in respect of products/substances for which a regulatory submission was foreseen but ultimately not made, for instance because they were deemed unsuitable for the market by the developer and thus fail to reach the end of the development process.\n10.3.3. ‘Routine production’ includes animals used in the manufacturing process of products such as antibodies and blood based products, for example, animals used in the manufacturing of serum-based medicinal products shall be included within this category.\n10.3.4. Efficacy testing during the development of new medicinal products is excluded and shall be reported under category ‘Translational and applied research’.",
  "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/eudn/2020/569/annex/III/part/B/division/B/division/10/division/10.3",
    "retrieved_at": "2026-11-01T15:12:17.611205+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."
}