What is the Pilot Project diGItal?

The Pharma Package negotiated at the European level includes, among other things, the introduction of electronic product information leaflet (EPIL) for medicinal products. According to the current state of negotiations in the European Parliament, an electronic version of the product information leaflet will be mandatory in the member states.

The Pilot Project diGItal in Germany is intended to identify and test scenarios for the use of electronic product information leaflets. At the same time, the regulatory debate at the European and national level is being supported by practical experience.

As part of the project, a system is being developed which will serve as a trusted source for all EPILs in Germany in the future. This system will be filled by pharmaceutical companies with EPILs and the data can be accessed by relevant organizations with a legitimate interest via standardized interfaces.