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 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.
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