The European Medicines Agency (EMA) publishes background documents on excipients for inclusion in the label and package leaflet of human medicines.
An excipient is a constituent of a medicine other than the active substance, added in the formulation for a specific purpose.
Marketing authorisation holders and applicants are required to list excipients on the medicine's labelling according to the 2003 European Commission guideline pursuant to Article 65 of Directive 2001/83/EC:
An amended version of the guidelines is under public consultation until 22 May 2017 on the website of the European Commission (new March 2017)
The guideline’s annex contains a list of all excipients that need to be displayed on the label of any medicine authorised in the European Union (EU). EMA publishes the annex in all EU languages on its website.
Review of the annex
The Excipients Drafting Group (ExcpDG), set up in 2011 by the Committee for Medicinal Products for Human Use (CHMP), reviews the annex regularly to update the information on excipients or include new excipients.
The ExcpDG prepares a report on each excipient under review, containing a scientific background review and the updated information for the package leaflet. Until 2016, the format was a questions-and-answers (Q&As) document for each excipient and a separate background scientific report where relevant.
All excipient documents can be found in the list below.
The CHMP adopts the final information for the package leaflet following a three month public consultation. The updated excipient information comes into force once integrated in the annex of the guideline.
How useful is this page?
Average rating:Based on 4 ratings
Add your rating:
- See all ratings
1 ratings1 ratings0 ratings1 ratings1 ratings