The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the deliberate release framework- Part B of Directive 2001/18. A single submission procedure applies to seek authorization under the clinical trials framework and under the GMO framework (submission to EOF).
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
Authorization of clinical trials:
National Organization for Medicines (EOF): responsible for evaluation of the clinical trial protocol and the initial evaluation of ERA.
Mesogeion 284, 155 62, Athens
Authorisation of GMO aspects:
Ministry of Environment & Energy: responsible for completion of the ERA in case that the initial evaluation performed by EOF indicates outstanding issues.
17 Amaliados str., 115 23 Athens
(Last reviewed by the Competent Authority: December 2017)