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:
- https://www.mop.gov.si/si/zakonodaja_in_dokumenti/veljavni_predpisi/okolje/zakon_o_ravnanju_z _gensko_spremenjenimi_organizmi/
- https://www.jazmp.si/en/human-medicines/clinical-trials-and-compassionate-use-of-medicinal-pro ducts/clinical-trials-of-medicinal-products/notificationauthorisation-of-clinical-trials/
- Agency for Medicinal Products and Medical Devices (JAZMP)
- Ministry of Health
- Ministry of the Environment

Application forms to seek authorisation for the GMO aspects
Application forms can be found at: https://www.mop.gov.si/si/delovna_podrocja/biotehnologija/postopek_prijave_namernega_sproscanja_gso_v_okolje/

Public consultation
The Slovene GMO act provides for public consultation in the process of a GMO deliberate release authorization. The public is allowed to access the technical documentation and risk assessment. The timelines for public consultation are fixed in the range from 15 to 30 days.

National authorities involved

Authorization of clinical trials:
JAZMP –Agency for Medicinal Products and Medical devices
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Authorisation of GMO aspects:
MESP Ministry of the Environment and Spatial Planning
Dunajska 48, 100 Ljubljana
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(Last reviewed by the Competent Authority: December 2017)