Division 3.1 Specific requirements for all advanced therapy medicinal productsF1F2

A description of the traceability system that the marketing authorisation holder intends to establish and maintain to ensure that the individual product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the hospital, institution or private practice where the product is used, shall be provided.

The traceability system shall be complementary to, and compatible with, the requirements established in Directive 2004/23/EC of the European Parliament and of the Council ^f1 , as regards human cells and tissues other than blood cells, and Directive 2002/98/EC, as regards human blood cells.