Hungary's stem cell regulatory framework sits at the intersection of EU-level advanced therapy medicinal product (ATMP) regulation and national legislation rooted in Act CLIV of 1997 on Healthcare and Act XCV of 2005 on Medicinal Products for Human Use. As an EU member state, Hungary is bound by the centralized marketing authorization pathway established under Regulation (EC) No 1394/2007, meaning that stem cell products classified as ATMPs must receive European Medicines Agency (EMA) approval b...
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