Eudralex Volume 2C Guidance on a new therapeutic indication for a well established substance (November 2007)
Title:
Eudralex Volume 2C Guidance on a new therapeutic indication for a well established substance (November 2007)
Origin/Publisher:
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL
Document Type:
Notice to Applicants
Content:
This guidance describes “significant preclinical or clinical studies” and outlines the principles and procedure for the assessment in case where an application is made for a new indication for a well established substance in an already authorised medicinal product.