Module 9 2021

Definitions of ATMPs

Restore physiological functions through a metabolic or pharmacological, immunological or metabolic action (art 1 2001/83/EC) Basic EC documents for ATMPs: • 1394/2007/EC: The ATMP Directive • 2009/120/EC Directive: Amend Part IV 2001/83/EC • 668/2009 EC: The certification procedure Contain or consist of a recombinant nucleic acid or living cells • Autologous, allogeneic, or xenogenic use • Non homologous use – change of functional and biological properties in processed cells (1394/2007 Art 1(c) & Part I – 2.2) • More than minimally manipulated cells or tissues (Art. 2(1)(c)

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

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