This document intends is to be included in:
The rules governing medicinal products in the European Union
Volume 10
Clinical Trials
Notice to Applicants
Chapter V Additional Information

and intends to clarify and provide additional guidance on the definition of investigational medicinal products and to provide specific guidance about the use of non-investigational medicinal products, in accordance with the applicable EU legislation. It complements the “Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial " and the “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".

Załączniki: guidance-on-imp_nimp_04-2007.pdf