The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
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)
Origin/Publisher:
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL
Document Type:
EC Guidance Document
Content:
This guidance outlines the level of evidence required to support extended marketing protection period based on a new therapeutic indication.
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