EC Unveils Revised Guideline on Pharmaceutical Excipients
The European Commission on Tuesday opened for public comment a revised guideline concerning the list of excipients, defined as any constituents of a medicinal product other than the active substance and the packaging material, which must be included on the labeling of medicines, as well as the way in which these excipients must be indicated.
The guideline’s revision, which the EC says reflects developments since 2003, includes a list of excipients which should be stated on the label and outlines the information for those which must appear on the package leaflet.