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

Table of contents

KeywordsConsumer safety, excipients
DescriptionThis 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.


Document history

First version

Current version

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

 

PDF iconConcept paper

In operation: 01/06/2011–present

 

Published: 18/11/2010

 

Published: 17/11/2009

 

Published: 21/11/2005


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