Following the European Commission (EC) decision to revise the annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), a multidisciplinary group of experts involving the Safety Working Party (lead), the Quality Working Party, the Paediatric Committee, the Pharmacovigilance Risk Assessment Committee, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human, the Vaccines Working Party, the Biologics Working Party and the Blood Products Working Party, was created in 2011. The objective of this group is to update the labelling of selected excipients listed in the annex of the above mentioned EC guideline, as well as to add new excipients to the list, based on a review of their safety. The main safety aspects to be addressed were summarised in a concept paper published in March 2012.



Posted on the EMA website on 24 June 2015