Eudralex Volume 2C Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007)
Titel:
Eudralex Volume 2C Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007)
Internet:
Herkunft/Verlag:
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL
Dokumentenart:
EC Guidance Document
Inhalt:
Diese Richtlinie erläutert in welchem Umfang Nachweise zu erbringen sind, um einen verlängerten Patentschutz aufgrund einer neuen therapeutischen Indikation zu erreichen.