Module 9 2021

The ATMPs regulation (1394/2007 EC)

Centralized MA (726/2004/EC) ● Two independent assessment team from CAT and CHMP ● 50% fee reduction for SME ● Use of specific cells (embryonal / xenogenic) regulated at NCA level Hospital exemption

● Members state authorize for custom made non routine prepared ATMPs ● National standards for quality, traceability and pharmacovigilance In force since Dec 30 th , 2008 Transitional period (Art 29) until Dec 2012 ● 31 ATMP legally on the market at 30.12.2008 at national level Significant number of developers with ATMPs did not apply for MA Lack of harmonization across member states for application of exemption and ATMP classification ● Introduce difference in public health protection level according to patient residence ● Unfair competion between developers ● Deterrent to submission of MA and discourage investments ● Hindered free movements

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

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