In Lithuania no clinical gene therapy trials have been carried out at the moment. For clinical trials 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.

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