UREDBA (EZ) BROJ 1394/2007 EVROPSKOG PARLAMENTA I SAVETA O LEKOVIMA ZA NAPREDNU TERAPIJU

Stojanović Anđela (Институт за међународну политику и привреду, Београд),

Regulation (EC) No 1394/2007 on advanced therapy medicinal products supplements the general provisions of EU law governing medicinal products for human use and Community procedures for the authorisation and supervision of medicinal products for human and veterinary use. The Regulation specifically governs gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products. The Regulation introduces new specific rules for tissue engineered products. Also, it sets up a Committee for Advanced Therapies within the European Medicines Agency.

Keywords: advanced medicinal products, gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products, Committee for Advanced Therapies