e-PIL project 2020: call for candidates

With the support of the Belgian and Luxembourg Competent Authorities, in 2018 the pharmaceutical industry launched the 'e-PIL' pilot project in Belgian and Luxembourg hospitals. The project is the result of a derogation obtained from the European Commission. 

In this pilot project, a selection of medicines on the Belgian and Luxembourg market are not accompanied by their patient paper inserted leaflet (PIL). However, this leaflet can be consulted online on trusted websites (e-PIL). The pilot project aims at demonstrating that the electronic leaflet is equivalent to the paper leaflet in order to provide information about the safe and effective use of medicines to patients and healthcare professionals.

Following to the positive intermediate results, the European Commission agreed to extend the pilot project with 2 additional years and to include more products. A second call for candidates for Belgian and Luxembourg marketing authorization holders (click here) to participate to this pilot is therefore being launched from 17 August until 15 September 2020.

Additional information can be found in attached document.

Medaxes members can find additional information on the Medaxes members platform EZ-AXES.