EC guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
The European Medicines Agency has published the “Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use”.
This guideline has been revised and provides new text to be included in the package leaflet of medicines containing ethanol as excipient. It contains more detailed information on the effects of ethanol when used as excipient, in particular on babies and children.
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
Please find a link to additional information on the Annex. The rational for revising information on ethanol, which went through public consultation, has also been published: Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).