The purpose of this procedure is to allow applicants to clarify whether a given product based on genes, cells or tissues meets the scientific criteria which define ATMPs, in order to address questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops.
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European Medicines Agency. Committee for Advanced Therapies (CAT). Procedural Advice on the Provision of Scientific Recommendation on Classification of Advanced Therapy Medicinal Products in Accordance with Article 17 of Regulation (EC) No 1394/2007. EMA/CAT/99623/2009 Rev.2. 5 November 2021
Published by EMA
Comittee for Advanced TherapiesScientific Recommendation
