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Gene Therapy Legislation in Bulgaria
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In addition, the premises of the hospitals and other facilities where the clinical trials will take place should comply with the safety requirements for contained use of the specific class but no special notification is needed. In some cases, when the whole clinical trial takes place in a hospital, it might be considered entirely under the framework for contained use.</p> <p>Authorization of GMO aspects is required prior to the submission of the clinical trial application: the opinion of MoEW related GMO aspects of the application should be issued before further steps are taken in front of BDA.</p> <p><b>Application forms to seek authorisation for the GMO aspects</b><br> The Environmental Risk Assessment and related technical information are usually submitted in the format of Annex II and Annex IIIA of Directive 2001/18/EC. The other relevant national forms (currently only in Bulgarian) are available at <a href="https://www.moew.government.bg/bg/priroda/obrazci-na-zayavleniya-i-uvedomleniya/gmo/" target="blank">https://www.moew.government.bg/bg/priroda/obrazci-na-zayavleniya-i-uvedomleniya/gmo</a></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> Bulgarian Drug Agency (BDA), 8 Damyan Gruev St., 1303 Sofia<br> e-mail: <joomla-hidden-mail is-link="1" is-email="1" first="YmRh" last="YmRhLmJn" text="YmRhQGJkYS5iZw==" 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 and Water (MoEW), 22 Maria-Luiza Blvd., 1000 Sofia<br> e-mail: <joomla-hidden-mail is-link="1" is-email="1" first="ZWRub19naXNoZQ==" last="bW9ldy5nb3Zlcm5tZW50LmJn" text="ZWRub19naXNoZUBtb2V3LmdvdmVybm1lbnQuYmc=" base="" >This email address is being protected from spambots. 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