Second call for candidates for e-PIL


With the support of the Belgian and Luxembourg Competent Authorities, the pharmaceutical industry has launched in 2018 the pilot project "e-PIL" in Belgian and Luxembourg hospitals for the conduct of which a derogation has been 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), but this leaflet can be consulted online on trusted websites (e-PIL). This pilot project aims to demonstrate that the electronic leaflet is equivalent to the paper leaflet to provide information on the safe and effective use of medicines to patients and healthcare professionals.

Because of the positive intermediate results the European Commission agreed to extend the pilot project with another 2 years and to include more products. A second call for candidates to participate in this pilot is therefore launched to the attention of the Belgian and Luxembourg marketing authorization holders from 17 August until 15 September.