Gene Therapy Legislation in Germany

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A single submission procedure applies to seek authorization under the clinical trials framework and under the GMO framework (submission to PEI).</p> <p>Additional information can be found at:<br> - <a href="https://www.pei.de/EN/information/license-applicants/clinical-trial-authorisation/gmo/clinical-trial-gmo-node.html" target="_blank">https://www.pei.de/EN/information/license-applicants/clinical-trial-authorisation/gmo/clinical-trial-gm o-node.html</a><br> - <a href="https://www.pei.de/cln_043/nn_432310/SharedDocs/Downloads/gesetze/arzneimittelgesetz,templateId=raw,property=publicationFile.pdf/arzneimittelgesetz.pdf" target="_blank">German Drug Law</a><br> - <a href="https://www.pei.de" target="_blank">Paul-Ehrlich-Institut</a><br> - <a href="https://www.bmg.bund.de/" target="_blank">Bundesministerium f眉r Gesundheit</a><br> - <a href="https://www.bvl.bund.de" target="_blank">Bundesamt f眉r Verbraucherschutz und Lebensmittelsicherheit</a><br> - <a href="https://www.dg-gt.de/docs/gtdeutschland.pdf" target="_blank">Gene Therapy in Germany, an Interdisciplinary Survey. <i>Supplement of the German Gene Technology Report.</i> November 2008.</a> This report attempts to give a comprehensive account of the current state of research and of the potential of gene therapy in Germany as well as an interdisciplinary analysis, taking into account scientific and medical facts, the legal framework, ethical implications and the perception and assessment by the public. </p> <p><b>Application forms to seek authorisation for the GMO aspects</b><br> Application forms can be found at: <a href="https://www.pei.de/SharedDocs/Downloads/EN/pu/clinical-trials/formular-gvo-en.html?nn=3253628" target="_blank">https://www.pei.de/SharedDocs/Downloads/EN/pu/clinical-trials/formular-gvo-en.html?nn=3253628</a>. This is a form requesting additional information on activities with GMO.</p> <p><b>Public consultation</b><br> Publication on the JRC website after the clinical trial has been authorised.</p> <hr><p><b>National authorities involved</b></p> <p><i>Authorization of clinical trials:</i><br> Paul-Ehrlich-Institut (PEI) is responsible for the assessment and approval of the Clinical Trial Applications; a release permission is included in the authorisation of the clinical trial.<br> Clinical trial section, Paul-Ehrlich-Str. 51-59, D-63225 Langen.<br> e-mail: <joomla-hidden-mail is-link="1" is-email="1" first="Y3Q=" last="cGVpLmRl" text="Y3RAcGVpLmRl" base="" >This email address is being protected from spambots. You need JavaScript enabled to view it.</joomla-hidden-mail><br> <a href="https://www.pei.de" target="_blank">www.pei.de</a></p> <p><i>Authorisation of GMO aspects:</i><br> Federal Office of Consumer Protection and Food Safety (Bundesamt f眉r Verbraucherschutz und Lebensmittelsicherheit) (BVL). is involved in an internal process without involvement of the applicant.<br> Mauerstra脽e 39-42, 10117 Berlin<br> <a href="https://www.bvl.bund.de">www.bvl.bund.de</a></p> <p><i>(Last reviewed by the Competent Authority: December 2017)</i></p> <center> <div class="moduletable "> <div class="mod-banners bannergroup"> <div class="mod-banners__item banneritem"> <a href="/component/banners/click/159.html" target="_blank" rel="noopener noreferrer" title="10thAnnualInnateKillerSummit-mrt2025"> <img src="https://www.genetherapynet.com/images/banners/10thAnnualInnateKillerSummit-mrt2025.png#joomlaImage://local-images/banners/10thAnnualInnateKillerSummit-mrt2025.png?width=468&height=60" alt="10thAnnualInnateKillerSummit-mrt2025" > </a> </div> </div> </div> <br /><br /></center> <div align="right"><a href="#top"><font size="1">^ Back to Top</font></a></div></div> <div class="uk-margin-top"><a href="/europe/germany.html" class="el-link uk-button uk-button-default">Read more</a></div> </div></div> </div> </div> </div> <div class="uk-width-1-2 uk-width-1-4@m uk-width-1-5@l rechts"> <div> <div class="uk-grid uk-child-width-1-1 uk-grid-row-small"> <div> <div class="uk-panel _menu menulist" id="module-42"> <h3> Legislation Menu </h3> <ul class="uk-nav uk-nav-default uk-nav-accordion" uk-nav="targets: > .js-accordion"> <li class="item-44"><a href="/united-states-of-america.html"> United States of America</a></li> <li class="item-45 uk-active uk-parent"><a href="/europe.html"> Europe <span uk-nav-parent-icon></span></a> <ul class="uk-nav-sub"> <li class="item-46"><a href="/europe/austria.html"> Austria</a></li> <li class="item-60"><a href="/europe/belgium.html"> Belgium</a></li> <li class="item-61"><a href="/europe/bulgaria.html"> Bulgaria</a></li> <li class="item-62"><a href="/europe/cyprus.html"> Cyprus</a></li> <li class="item-63"><a href="/europe/czech-republic.html"> Czech Republic</a></li> <li class="item-64"><a href="/europe/denmark.html"> Denmark</a></li> <li class="item-65"><a href="/europe/estonia.html"> Estonia</a></li> <li class="item-66"><a href="/europe/finland.html"> Finland</a></li> <li class="item-67"><a href="/europe/france.html"> France</a></li> <li class="item-68 uk-active"><a href="/europe/germany.html"> Germany</a></li> <li class="item-69"><a href="/europe/greece.html"> Greece</a></li> <li class="item-70"><a href="/europe/hungary.html"> Hungary</a></li> <li class="item-71"><a href="/europe/iceland.html"> Iceland</a></li> <li class="item-72"><a href="/europe/ireland.html"> Ireland</a></li> <li class="item-73"><a href="/europe/italy.html"> Italy</a></li> <li class="item-74"><a href="/europe/latvia.html"> Latvia</a></li> <li class="item-75"><a href="/europe/lithuania.html"> Lithuania</a></li> <li class="item-76"><a href="/europe/luxembourg.html"> Luxembourg</a></li> <li class="item-77"><a href="/europe/malta.html"> Malta</a></li> <li class="item-78"><a href="/europe/netherlands.html"> Netherlands</a></li> <li class="item-79"><a href="/europe/norway.html"> Norway</a></li> <li class="item-80"><a href="/europe/poland.html"> Poland</a></li> <li class="item-81"><a href="/europe/portugal.html"> Portugal</a></li> <li class="item-82"><a href="/europe/romania.html"> Romania</a></li> <li class="item-83"><a href="/europe/slovak-republic.html"> Slovak Republic</a></li> <li class="item-84"><a href="/europe/slovenia.html"> Slovenia</a></li> <li class="item-85"><a href="/europe/spain.html"> Spain</a></li> <li class="item-86"><a href="/europe/sweden.html"> Sweden</a></li> <li class="item-87"><a href="/europe/switzerland.html"> Switzerland</a></li> <li class="item-88"><a href="/europe/united-kingdom.html"> United Kingdom</a></li></ul></li> <li class="item-89 js-accordion uk-parent"><a href> Asia <span uk-nav-parent-icon></span></a> <ul class="uk-nav-sub"> <li class="item-90"><a href="/asia/australia.html"> Australia</a></li> <li class="item-91"><a href="/asia/china.html"> China</a></li></ul></li></ul> </div> </div></div></div> </div></div> </div> </div> </main> <footer> <style class="uk-margin-remove-adjacent">style="margin-top: -80px;" style="position: relative;" </style> <div id="footer#1" class="uk-section-muted uk-section uk-padding-remove-bottom"> <div class="uk-container"> <div class="uk-grid tm-grid-expand uk-grid-margin" uk-grid> <div class="uk-width-1-2@s uk-width-2-5@m"> <div> <div class="uk-grid uk-child-width-1-1"> <div> <div class="uk-panel" id="module-249"> <div class="uk-margin-remove-last-child custom" ><p>漏 2024 Gene Therapy Net.<br /><a href="/contact-gene-therapy-net.html" style="color: #000000; 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Gene Therapy Legislation in Germany