A single submission procedure applies to seek authorization under the clinical trials framework and under the GMO framework (submission to the State Agency of Medicines ("SAM").
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 authorisation.
National authorities involved
State Agency of Medicines (SAM): https://www.ravimiamet.ee/en
Gene Technology Commission: an advisory body established within the area of government of the Ministry of the Environment.
(Last reviewed by the Competent Authority: December 2017)