02 September 2020 - Authored by:Tine Carmeliet
On 17 August 2020, the Federal Agency for Medicines and Health Products (FAMHP) announced its support for the pilot project on electronic patient information leaflets, e-PIL, a project replacing the traditional paper package leaflet for certain medicines with electronic leaflets on trusted websites, which was initiated by the Belgian and Luxembourgian pharmaceutical industry in 2018. The aim of the project is to demonstrate the equivalence of an electronic leaflet to a paper leaflet in its function of providing information to patients and healthcare professionals about the safe and effective use of medicines.
To date, two surveys evaluating the effectiveness of the e-PIL project have been conducted in Belgian and Luxembourg hospitals, while a third survey is ongoing. Given the positive feedback so far, the e-PIL project has been extended until 1 August 2022 and new medicines have been included in the scope of the project. The deadline for Belgian and Luxembourg marketing authorisation holders to apply to take part in the pilot project was 15 September 2020.
This article was co-authored by Margaux Dejonghe.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2020 Issue (Thomson Reuters).