Module 9 2021

TEPs

Administered to repair, regenerate or replace human tissue Contains or consists of engineered cells • Subjected to susbstantial manipulation OR non-homologous use • Physiology and structure relevant to intended function • Intended to regenerate, repair or replace a human tissue • May contain a non-biological component

Basic EU regulatory Documents • 1394/2007/EC: The ATMP Directive • Annex I (2009/120/EC Directive) • 2004/23 EC – Tissue and cells directive Example and applications

• Wound healing (Appligraf – diabetic foot ulcers) • Cardiovascular disorders (MSC or cardiomyocytes) • Orthopedic disorders (Chondrocelect) • Neurologic disorders (Stem cells)

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

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