2026-05-27 [ePI] Newly appointed ePI NCA SMEs

In a significant step utilising the collaboration and expertise within the European Medicines Regulatory Network, the ePI team has expanded its network of subject matter experts (SMEs). The next cohort brings representation from AGES, Austria; FAMHP, Belgium; HALMED, Croatia; ANSM, France; NNGYK, Hungary; VVKT, Lithuania; Infarmed, Portugal; Ravimiamet, Estonia; and HPRA, Ireland. These experts join the existing SMEs from Sweden, Denmark, Germany and Italy, further strengthening cross-network input into the future implementation of ePI. 

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. These 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.