Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (Cell and Gene Therapy Catapult – Regulatory Round-up – October 2022)
The guideline was first published on the 26th of October 2022. It defines 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.
See all of Catapult’s Regulatory Round-up for October 2022 here. Published on the 7th of November 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (Cell and Gene Therapy Catapult – Regulatory Round-up – October 2022). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/o672





