Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use

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Download document Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use
Reference number EMA/CHMP/704219/2013
Status draft: consultation closed
First published 2014-08-01
Last updated 2014-08-01

Summary

Wheat starch is produced from wheat flour by removing proteins including gluten, meaning that wheat starch only contains trace amounts of gluten and other proteins. These questions and answers include proposals for new or updated information for the labelling and package leaflet regarding gluten as an excipient in human medicines.