SMCA - State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania

The State Medicines Control Agency (SMCA) is a governmental body of the Republic of Lithuania with headquarters in Vilnius.   

1. 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 authorisation applications and marketing authorisation (medicines derived from biotechnology and other high-technology processes, medicines containing new active substance intended and for the treatment of HIV/AIDS, cancer, diabetes or neurodegenerative diseases, and orphan medicines can not be approved nationally);
the supervision of manufacturing authorisation holders, wholesale distribution authorisation holders, and pharmacies in Lithuania (inspections, laboratory testing, and licensing);
the supervision of clinical trials and legal turnover of narcotic and psychotropic medicines.
2. The safety of medicines is monitored constantly by the SMCA through a pharmaco­vigilance network. The SMCA takes appropriate actions if adverse drug reaction reports suggest changes to the benefit-risk balance of a medicine.

3. The SMCA is headed by the Director and has about 127 staff members.

4. The Agency brings its own scientific resources together with ones of Kaunas Medical University and Vilnius University in a network of over 50 national experts.    

5. The SMCA is involved in working groups of Ministry of Health of Lithuania as well as in scientific and regulatory bodies of European Union including Committees and working parties of European Medicines Agency (EMEA), European Commission, and European Council.