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.


Posted on the EMA website on 30 June 2014