# OnCo record eu-regulation-726-2004 (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/eu-regulation-726-2004/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "eu-regulation-726-2004" ;
  schema:name "Regulation (EC) No 726/2004: the EU centralised procedure"@en ;
  schema:alternateName "Regulation 726/2004"@en, "centralised procedure"@en, "centralised marketing authorisation"@en, "Community marketing authorisation"@en, "EU marketing authorisation"@en, "CHMP opinion"@en, "Article 83 compassionate use"@en, "PRIME scheme"@en ;
  schema:description "The 2004 EU regulation under which every new cancer medicine is assessed once by the European Medicines Agency and authorised for all member states by the European Commission, and which also carries the rules for conditional authorisation and compassionate use."@en ;
  schema:url <https://onco.cc/terms/eu-regulation-726-2004/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:citation <https://eur-lex.europa.eu/eli/reg/2004/726/oj>, <https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation> ;
  onco:tag "law", "eu" ;
  onco:related <https://onco.cc/terms/conditional-approval/>, <https://onco.cc/terms/regulatory-agencies/>, <https://onco.cc/terms/bla-nda/>, <https://onco.cc/terms/eu-orphan-regulation/>, <https://onco.cc/terms/eu-paediatric-regulation/>, <https://onco.cc/terms/eu-pharma-package/>, <https://onco.cc/terms/expanded-access/>, <https://onco.cc/terms/eu-data-exclusivity/>, <https://onco.cc/terms/eu-hta-regulation/>, <https://onco.cc/terms/project-orbis/> ;
  onco:institutions <https://onco.cc/institutions/ema/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .