e-PIL Pilot Project
It is supported by the Belgian and Luxembourg competent authorities and has been authorized by the European Commission.
This pilot project, unique in Europe, was initiated by the associations of the innovative pharmaceutical industry in Luxembourg and Belgium.
Together the IML (formerly APL - Association Pharmaceutique Luxembourgeoise) and pharma.be, with the support of the Luxembourg and Belgian Ministries of Health, have set up electronic package inserts for certain hospital products.
The project aims to study the advantages and disadvantages of using the user information leaflet in electronic form compared to the paper version included in the packaging. This pilot project has also been validated by the European Commission.
In this context, we propose here a link to a Belgian database on electronic package inserts and to the portal of the Luxembourg Ministry of Health containing the product inserts of the products participating in this unique pilot in Europe.
The pharmaceutical industry launched this project in 2018 in Belgian and Luxembourg hospitals. Initially planned for a limited period of 24 months, the project has been extended. In 2020, this project has been extended to more drugs.
Based on the positive interim results of this experiment, the European Commission has allowed a new extension of this pilot project for three years, until August 1, 2025, and the extension of its scope to new medicines exclusively used in hospitals. The third call for applications to participate in the e-PIL pilot project is open from August 17, 2022, to November 17, 2022, to holders of marketing authorisations for medicines registered in Belgium and/or Luxembourg.
This pilot project is limited to certain medicines reserved for use in hospitals.
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for more detailed information about the adhesion steps, please, contact us by mail firstname.lastname@example.org .