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Gene Therapy Legislation in the Slovak Republic

The competent authorities in the Slovak Republic are the State Institute for Drug Control (SIDC) and the Ministry of Environment. The SIDC in Bratislava is the institution of the Ministry of Health of the Slovak Republic responsible for ensuring surveillance of the quality, efficacy and safety of medicinal products for human use and medicinal products used in health care. Permits to perform clinical gene therapy trials are needed from both authorities. Also, an ethics committee is involved as with other clinical trials. So far, no clinical gene therapy trials are performed.

(Last reviewed by the Competent Authority: 3 September 2010)