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. Authorization of GMO aspects is required prior to the submission of the clinical trial application.
Additional information can be found at:
- State Institute for Drug Control (SIDC)
Application forms to seek authorisation for the GMO aspects
The details of the application are set in the Decree No. 399/2005 ( https://bch.cbd.int/database/record.shtml?documentid=47486
The Ministry informs the public about applications for approval as well as on issued permits through the Internet (https://www.minzp.sk/postupy-ziadosti/geneticky-modifikovane-organizmy/pripomienky-k-ziadostiam-ohlaseniam/), and by any other appropriate means as well if it is necessary to effectively inform the public, with a call for public comments within a deadline of 30 days.
National authorities involved
Authorization of clinical trials:
The State Institute for Drug Control
Department of Clinical Trials, Kvetná 11, 825 08 Bratislava
Authorisation of GMO aspects:
Ministry of Environment of the Slovak Republic
Department of Environmental Hazards and Biosafety Námestie Ľ. Štúra 1,812 35 Bratislava
(Last reviewed by the Competent Authority: December 2017)