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Gene Therapy Legislation in Lithuania

In Lithuania no clinical gene therapy trials have been carried out at the moment. There is no specific legislation of gene therapy in Lithuania. General EU requirements are applicable and available under the following link http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm.

For clinical trials in general the consent from the Ministry of Health must be obtained and in addition the consent form of the Ministry of Environment. The State Medicines Control Agency (SMCA) is a governmental body of the Republic of Lithuania. Its main responsibility is the protection of public health, through the evaluation and supervision of medicines for human use including the scientific evaluation of marketing authorization applications, the supervision of manufacturing authorization holders, the supervision of clinical trials.

(Last reviewed by the Competent Authority: 19 May 2011)