The report of a pilot exploring the creation and testing of ePIs (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 ePI 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.
