Module 9 2021

Classification: which ATMP?

Basic classification issues reported in 1394/2007 EC ● A product falling within TEP and sCBMP is considered a TEP ● A product falling within GTMP and sCBMP is considered a GTMP ● A TEP containing genetically modified cells is classified as combined gene therapy product ● A product containig autologous and allogeneic cells is considered allogeneic products

A product classified as ATMP may fall in more than category

Novartis Pharma AG- Business use only- not for further distribution

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