Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells

This guideline describes the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.

This applies to allogeneic or autologous, including viral vector modified and genome edited cells.

This draft guideline is open for consultation (Consultation dates: 30/07/2021 to 31/10/2021)

Open Consulation file