{
  "url": "https://openlegislation.uk/eu-regulation-2019-6/article-42",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-6/article-42.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/42",
  "kind": "article",
  "number": "42",
  "heading": "Scope of the centralised marketing authorisation procedure",
  "text": "1. Centralised marketing authorisations shall be valid throughout the Union.\n2. Centralised marketing authorisation procedure shall apply in respect of the following veterinary medicinal products:\n(a) veterinary medicinal products developed by means of one of the following biotechnological processes:\n(i) recombinant DNA technology;\n(ii) controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells;\n(iii) hybridoma and monoclonal antibody methods;\n(b) veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;\n(c) veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;\n(d) biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells;\n(e) novel therapy veterinary medicinal products.\n3. Points (d) and (e) of paragraph 2 shall not apply to veterinary medicinal products consisting exclusively of blood components.\n4. For veterinary medicinal products other than those referred to in paragraph 2, a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union.",
  "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/42",
    "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."
}