Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells - Scientific guideline
Table of contents
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.
Keywords: Advanced therapy medicinal products, genetically modified cells, CAR-T cells,CD34+ cells, core SmPC, core labelling, core package leaflet
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Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (PDF/465.69 KB)
Adopted
First published: 26/10/2022
EMA/CAT/CHMP/158266/2021 -
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Overview of comments received on draft 'Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells' (EMA/CAT/CHMP/158266/2021) (PDF/743.88 KB)
First published: 26/10/2022
EMA/CAT/CHMP/679290/2021 -
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Draft guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (PDF/719.12 KB)
Draft: consultation closed
First published: 30/07/2021
Consultation dates: 30/07/2021 to 31/10/2021
EMA/CAT/CHMP/158266/2021