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Gene Therapy Legislation in Slovenia

The new Agency for Medicinal Products and Medical Devices (JAZMP) has replaced the former Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP). The Agency is the Competent Authority for medical products in Slovenia and is a constitutive body of the Ministry of Health. The Agency performs regulatory, professional and inspection activities related to the testing, production and trade of medicines and medical devices The competent authorities for medicinal GMO issues are the Ministry of Health and the Ministry of the Environment. There have been so far no clinical gene therapy applications, so the procedural experience is limited.