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.
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.
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
State Medicines Control Agency
Žirmūnų Street No 139A, LT-09120 Vilnius
Specific queries on clinical trials:
Vilniaus Street No 16, LT-01402 Vilnius
(Last reviewed by the Competent Authority: December 2017)