{
  "url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/division-1/division-8",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-6/annex-II/division-1/division-8.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": "annex/II/division/1/division/8",
  "kind": "division",
  "number": "8",
  "heading": null,
  "text": "In order to monitor the risk/benefit assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the competent authority. After marketing authorisation has been granted, any change to the content of the dossier shall be submitted to the competent authorities in accordance with Commission Regulations (EC) No 1084/2003 or (EC) No 1085/2003 for veterinary medicinal products authorised as defined in Article 1 of those Regulations, respectively.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 159, 27.6.2003, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 159, 27.6.2003, p. 24."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/6/annex/II/division/1/division/8",
    "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."
}