EMA: Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00)

The current guideline on Excipients in the Label and Package Leaflet of Medicinal Products for Human Use (CPMP/463/00) contains warning statements relating to the presence of certain excipients in medicinal products. This is a Commission guideline pursuant to Article 65 of Directive 2001/83/EC. Article 54(d) of the above Directive requires that all excipients need to be declared on the labelling if the medicinal product is an injectable, or a topical or an eye preparation.