Gene Therapy Legislation in Lithuania
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)