In March 2018, the European Commission published revised guidelines for excipients in the labelling and package leaflets of medicinal products for human use. An excipient is a constituent of a medicine other than the active substance, added to the formulation for a specific purpose. Such constituents may include colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring or aromatic substances. The guidelines are meant for authorities, marketing authorisation holders and applicants who are required to list excipients on the medicine’s labelling under Directive 2001/83/EC. The revised guidelines explain amongst others how excipients must be displayed and which information must be provided in the package leaflet. Furthermore, the revised guidelines include a timeline for the implementation of the annex and updated explanatory notes. For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex