ePI - Two new ePI NCA SMEs appointed
date: 02/09/2024
In a significant step harnessing the collaboration and expertise within the European Medicines Regulatory Network, two new subject matter experts have been appointed to the ePI team. One expert from AIFA in Italy and one from BfArM in Germany will join the current SMEs from Denmark and Sweden.
SMEs will be required to assume a leading role in drafting, reviewing, updating, and finalizing new business processes for the incorporation of ePI into NAP, MRP, and DCP procedures. They will contribute to the development of product features and artifacts. Moreover, SMEs will be drafting and advising on guidance and processes related to national procedures. Their duties will include participating in user acceptance testing, coordinating input from their own and other NCAs, managing NCA change impact assessments, and collaborating with teams to mitigate any impacts.
These appointments are an important milestone in our ongoing commitment to delivering harmonised ePI to provide up-to-date, electronic medicines information to patients and healthcare professionals across Europe. As the ePI pilot closes, with learnings to be taken forward, SMEs will play a crucial role in shaping the future implementation of ePI by continuing to ensure that standards and tooling can be applied across Europe.