A single submission procedure applies to seek authorization under the clinical trials framework and under the GMO framework (submission to the State Medicines Control Agency.

Additional information can be found at:
- Ministry of Health
- State Medicines Control Agency (SMCA)

Application forms to seek authorisation for the GMO aspects
Information on GMO aspects should be submitted together with the clinical trial application form but there is not a specific form regarding GMO aspects.

Public consultation
There is no public consultation on GMO aspects prior to granting authorization.

National authorities involved

Ministry of Health: Competent authority responsible for medicinal products for human use containing or manufactured from GMOs.
Vilniaus Street No 33, LT-01506
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

State Medicines Control Agency
Žirmūnų Street No 139A, LT-09120 Vilnius
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Specific queries on clinical trials: This email address is being protected from spambots. You need JavaScript enabled to view it.

Bioethics commitee
Vilniaus Street No 16, LT-01402 Vilnius
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

(Last reviewed by the Competent Authority: December 2017)