On 10 April 2018, the FAMHP launched a call for applications for the e-PIL pilot project, namely the project concerning the electronic Patient Information Leaflet. The effectiveness of the pilot project, or, in other words, the outcome of providing patient information in an electronic leaflet, will be studied using online surveys. The surveys will take place at the project’s launch, after 1 year, and after 2 years.
The e-PIL project
The e-PIL project has been launched by the pharmaceutical industry in Belgian and Luxembourgish hospitals. In this project, the Patient Information Leaflets for certain medicinal products marketed on the Belgian and Luxembourgish markets will no longer be included in paper format inside the medicinal product’s packaging, and instead will only be available online on controlled websites.
Objectives of the e-PIL project
The aim of this project is to demonstrate that information on the safe and effective use of medicinal products, traditionally provided in the form of a paper Patient Information Leaflet, is just as effective when communicated to patients and healthcare professionals using an electronic Patient Information Leaflet.
Dispensation to launch the project
For this project, the pharmaceutical industry has obtained a dispensation from the European Commission permitting them to remove the paper Patient Information Leaflet from the packaging of certain medicinal products marketed in Belgium and Luxembourg.
For more information
The e-PIL pilot project can be found on the pharma.be website.
Patient Information Leaflets for all medicinal products authorised in Belgium are available on the FAMHP website.