Successful pilot paves the way for implementation of ePI

The report of a pilot exploring the creation and testing of e PIs (electronic product information) in real regulatory procedures was published today. The pilot found that the EU regulatory system is generally prepared for the introduction of e PI and can move towards its phased implementation in regulatory procedures, while first recognising the need for more development, including additional functionalities and integration with current IT systems. Work on this additional development will be carried out in 2025. After this, the report recommends a phased approach to implementation beginning with voluntary adoption for centrally authorised products, and progressively expanding to nationally authorised products based on Member States’ readiness and available resources. The product information of a medicine includes its summary of product characteristics, labelling and package leaflet. These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used. They can all be found, often as a PDF document, on the websites of EU regulators, with a printed package leaflet also provided in the medicine’s box. The introduction of product information in an electronic format (e PI) compatible with digital platforms opens new possibilities for patients and healthcare professionals to access and interact with vital, up-to-date information about their medicines. The report looked at key indicators such as time taken to create e PI, the percentage...