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EMA: Scientific guideline: 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.

23.11.2010
This guideline contains guidance relating to the data to be provided in support of a request for the CVMP to consider the inclusion of an excipient in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 (EMEA/CVMP/519714/2009).