e-PIL project 2020

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.

Thanks to the positive results (see annex for a summary of the results) observed in the intermediate analysis of the pilot project, the Belgian and Luxembourg’s authorities agreed to request an extend of the project to the European authorities, which has been approved for again a period of 24 months (until 01 August 2022) and for inclusion of more products.

Once validated by the National Competent Authorities in Belgium (FAMHP) and in Luxembourg (Health Directorate), the batches of the additional medicines newly included in the pilot after this second call for candidates can be released without any paper PIL.

The pilot project will be closed after 48 months for analyses of the results, on 01 August 2022 which means that the last release of the batches of the medicines without any paper PIL in the packaging should thus happen before 01 August 2022.

A communication will be sent to the attention of the hospital pharmacists to inform them about the extension of the pilot project and provide them the list with all medicines included. 

Additional information can be found in attached document.

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