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Eudralex Volume 2C Guidance on a new therapeutic indication for a well established substance (November 2007)

Origin/Publisher:

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL http://ec.europa.eu/enterprise/index_en.htm

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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