The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the contained use framework. Authorization of GMO aspects is required prior to the submission of the clinical trial application.
Application forms to seek authorisation for the GMO aspects
Application forms can be found at: http://gmo.ekoportal.pl/wzory.html
In compliance with Law of 3 October 2008 about information disclosure and protection, public participation in environmental protection and on environmental impact assessment, applications for contained used of GMO’s are subject to public consultation. The application are available for public consultation via the website of the GMOs register (http://gmo.ekoportal.pl/). The period for consultations is 30 days.
National authorities involved
Authorization of clinical trials:
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warszawa
Authorisation of GMO aspects:
Ministry of the Environment
GMO Unit, Department Nature Conservation, Wawelska 52/54, 00-922 Warszawa
(Last reviewed by the Competent Authority: December 2017)