# OnCo record eu-data-exclusivity (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-data-exclusivity/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "eu-data-exclusivity" ;
  schema:name "EU data and market protection (8+2+1)"@en ;
  schema:alternateName "8+2+1"@en, "regulatory data protection"@en, "EU data exclusivity"@en, "EU market protection"@en, "eight years data exclusivity"@en, "Directive 2001/83/EC"@en, "Article 10 Directive 2001/83"@en, "global marketing authorisation"@en ;
  schema:description "In the EU a new medicine's trial data cannot be relied on by a generic or biosimilar for eight years, the copy cannot be sold for ten, and an eleventh year is added for a valuable new indication; it is the target of the 2023 reform."@en ;
  schema:url <https://onco.cc/terms/eu-data-exclusivity/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Test_data_exclusivity> ;
  schema:citation <https://en.wikipedia.org/wiki/Test_data_exclusivity>, <https://eur-lex.europa.eu/eli/dir/2001/83/oj> ;
  onco:tag "law", "eu" ;
  onco:related <https://onco.cc/terms/us-regulatory-exclusivity/>, <https://onco.cc/terms/spc/>, <https://onco.cc/terms/eu-pharma-package/>, <https://onco.cc/terms/eu-orphan-regulation/>, <https://onco.cc/terms/biosimilar/>, <https://onco.cc/terms/hatch-waxman/>, <https://onco.cc/terms/bpcia/>, <https://onco.cc/terms/eu-regulation-726-2004/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-drug-pricing/> .