Advanced Therapy Medicinal Product


Advanced Therapy Medicinal Product


Kristina Dimitrova, Tzvetomir Deliyski
Faculty of Chemistry and Pharmacy, University of Sofia ‘‘St. Kliment Ohridski”


Advanced therapy medicinal products (ATMPs) are rather new group, which is classified according to Article 2(1) of Regulation (EC) No. 1394/2007 and includes: 1) a gene therapy medicinal products; 2) a somatic cell therapy medicinal products and 3) a tissue engineered products. In the present paper attention will be stressed also on Combined ATMPs, Marketing Authorisation procedures and requirements for documentationof ATMPs and Hospital exemptions. The first authorized ATMP products in EC are ChondroCelect and Glybera (alipogene tiparvovec).