Marketing authorisation holders and applicants are required to list excipients on the medicine's labelling according to the European Commission guideline pursuant to Article 65 of Directive 2001/83/EC.
The European Commission's Notice to Applicants Group has adopted a revised guideline on excipients labelling, following a targeted stakeholder consultation carried out by the European Commission. The revised guideline includes a timeline for the implementation of its annex and updated explanatory notes. The Commission published the revised guideline in March 2018:
Annex to the European Commission guideline
The annex contains a list of all excipients known to have a recognised action or effect that need to be displayed on the label of any medicine authorised in the European Union (EU):
- Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Update: EMA published a new version of the updated annex in November 2019, after a public consultation for each excipient, adoption by EMA's Committee for Medicinal Products for Human Use (CHMP) and endorsement by the European Commission's Notice to Applicants Group.
The annex is effective from its date of publication.
For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.
List of updated excipients and background reviews
All excipient documents can be found in the list below.