Gene Therapy Legislation in Poland

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Authorization of GMO aspects is required prior to the submission of the clinical trial application.</p> <p>Additional information can be found at:<br> - <a href="https://www.mos.gov.pl/" target="_blank">Ministry of Environment</a><br> - <a href="https://www.mz.gov.pl/" target="_blank">Ministry of Health</a></p> <p><b>Application forms to seek authorisation for the GMO aspects</b><br> Application forms can be found at: <a href="https://gmo.ekoportal.pl/wzory.html" target="_blank">https://gmo.ekoportal.pl/wzory.html</a></p> <p><b>Public consultation</b><br> 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鈥檚 are subject to public consultation. The application are available for public consultation via the website of the GMOs register (<a href="https://gmo.ekoportal.pl/" target="_blank">https://gmo.ekoportal.pl/</a>). The period for consultations is 30 days.</p> <hr><p><b>National authorities involved</b></p> <p><i>Authorization of clinical trials:</i><br> The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products<br> Al. Jerozolimskie 181C, 02-222 Warszawa</p> <p><i>Authorisation of GMO aspects:</i><br> Ministry of the Environment<br> GMO Unit, Department Nature Conservation, Wawelska 52/54, 00-922 Warszawa<br> Ms. Joanna Rybak: <joomla-hidden-mail is-link="1" is-email="1" first="am9hbm5hLnJ5YmFr" last="bW9zLmdvdi5wbA==" text="am9hbm5hLnJ5YmFrQG1vcy5nb3YucGw=" base="" >This email address is being protected from spambots. You need JavaScript enabled to view it.</joomla-hidden-mail><br> Mr. Marcin Grabowski: <joomla-hidden-mail is-link="1" is-email="1" first="bWFyY2luLmdyYWJvd3NraQ==" last="bW9zLmdvdi5wbA==" text="bWFyY2luLmdyYWJvd3NraUBtb3MuZ292LnBs" base="" >This email address is being protected from spambots. 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Gene Therapy Legislation in Poland