Data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of regulation (EC) No 470/2009 - Scientific guideline

This document provides guidance on the data that the CVMP would expect to see in support of a request to include an excipient in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.

Keywords:  Consumer safety, excipients

Current effective version

Guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009

AdoptedReference Number: EMA/CVMP/516817/2009

Document history

Overview of comments received on draft guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009

AdoptedReference Number: EMA/CVMP/SWP/513604/2010

Draft guideline on the data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of regulation (EC) No 470/2009

Consultation dates: 11/11/2009 to 31/05/2009Draft: consultation closedReference Number: EMEA/CVMP/516817/2009

Concept paper on guidance on the approach on how to demonstrate whether a substance is capable of pharmacological action or not

Reference Number: EMEA/CVMP/SWP/139646/2005