Detailed guidance on the application format and ...

0 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, ENTR/CT 2 Revision 1 Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use February 2006 1 Table of contents Page 1. Introduction 2 2.

medicinal product for human use to the competent authorities in the European Union, notification of substantial amendments and the declaration of the end of a clinical trial’2, in several cases. The application form for the request for the start of the clinical trials, the notification of the

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  Human, Clinical, Trail, Clinical trials, Human use

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