Wheat starch containing gluten - Scientific guideline

This document supports the revision of the annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to wheat starch containing gluten. It includes new information for the package leaflet and needs to be read in conjunction with the background scientific review.

Keywords: Excipients, package leaflet, wheat starch, gluten

Current version

Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/704219/2013 Corr.1

Document history

Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/704219/2013 Corr.1

Overview of comments received on the draft ‘Questions and answers on wheat starch (containing gluten)’

Reference Number: EMA/CHMP/674221/2014

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

Draft: consultation closed Consultation dates: 01/08/2014 to 31/10/2014 Reference Number: EMA/CHMP/704219/2013 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.

Wheat starch (containing gluten) used as an excipient - Report published in support of the ‘Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use’

Reference Number: EMA/CHMP/639441/2013 Corr.2