Изворни научни рад
Примљено: 01 Jan 1970
Прихваћено: 01 Jan 1970
УРЕДБА (ЕЗ) БРОЈ 1394/2007 ЕВРОПСКОГ ПАРЛАМЕНТА И САВЕТА О ЛЕКОВИМА ЗА НАПРЕДНУ ТЕРАПИЈУ
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.
Кључне речи: advanced medicinal products, gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products, Committee for Advanced Therapies