Questions and answers on benzalkonium chloride 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 benzalkonium chloride 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/495737/2013
Status draft: consultation open
First published 30/06/2014
Last updated 30/06/2014
Consultation start date 30/06/2014
Consultation end date 30/09/2014
Email address for submissions excipients@ema.europa.eu

Summary

Following the European Commission decision to revise the annex of the guideline on excipients in the label and package leaflet of medicinal products for human use, a multidisciplinary group of experts was created in 2011. The objective of this group is to update the labelling of selected excipients listed in the annex of this guideline, as well as to add new excipients to the list, based on a review of their safety. Question-and-answer documents (Q&As) on excipients will be progressively released for public consultation. They will include proposals for new or updated information for the labelling and package leaflet. Once a Q&A is finalised, the corresponding background report supporting its review will be also published.