Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'

This document is the Annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use. It contains the information which should appear in the package leaflet for the excipients known to have a recognised action or effect. The annex is effective from 22 November 2019.

For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.

For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within 3 years after the publication of the revised annex

KeywordsExcipients, package leaflet, labelling

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