Module 9 2021

GTMPs

Basic EU regulatory documents • 2009/120/EC Directive • CHMP/GTWP/671639/2008 Contains or consists of a recombinant nucleic acid • Naked or complexed non viral nucleic acid • Modified viral vectors • Genetically modified cells Therapeutic, prophylactic or diagnostic effect directly related with the genetic modification Vaccine against infectious diseases are not included

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

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