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
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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
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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 (PDF/90.62 KB)
Adopted
First published: 18/11/2010
Last updated: 18/11/2010
EMA/CVMP/SWP/513604/2010 -
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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 (PDF/62.56 KB)
Draft: consultation closed
First published: 17/11/2009
Last updated: 10/05/2010
Consultation dates: 11/11/2009 to 31/05/2009
EMEA/CVMP/516817/2009 -
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Concept paper on guidance on the approach on how to demonstrate whether a substance is capable of pharmacological action or not (PDF/39.7 KB)
First published: 21/11/2005
Last updated: 21/11/2005
EMEA/CVMP/SWP/139646/2005