Gene Therapy Legislation in Greece

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A single submission procedure applies to seek authorization under the clinical trials framework and under the GMO framework (submission to EOF).</p> <p><b>Application forms to seek authorisation for the GMO aspects</b><br> Information on GMO aspects should be submitted together with the clinical trial application form but there is not a specific form regarding GMO aspects.</p> <p><b>Public consultation</b><br> There is no public consultation on GMO aspects prior to granting authorisation.</p> <hr><p><b>National authorities involved</b></p> <p><i>Authorization of clinical trials:</i><br> National Organization for Medicines (EOF): responsible for evaluation of the clinical trial protocol and the initial evaluation of ERA.<br> Mesogeion 284, 155 62, Athens<br> email: <joomla-hidden-mail is-link="1" is-email="1" first="dHJpYWxz" last="ZW9mLmdy" text="dHJpYWxzQGVvZi5ncg==" base="" >This email address is being protected from spambots. You need JavaScript enabled to view it.</joomla-hidden-mail></p> <p><i>Authorisation of GMO aspects:</i><br> Ministry of Environment & Energy: responsible for completion of the ERA in case that the initial evaluation performed by EOF indicates outstanding issues.<br> 17 Amaliados str., 115 23 Athens<br> e-mail: <joomla-hidden-mail is-link="1" is-email="1" first="Zy5hbHZhbm9wb3Vsb3M=" last="cHJ2LnlwZWthLmdy" text="Zy5hbHZhbm9wb3Vsb3NAcHJ2LnlwZWthLmdy" base="" >This email address is being protected from spambots. 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Gene Therapy Legislation in Greece