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Gene Therapy Legislation in France
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uk-padding-small uk-margin-remove-first-child"> <h3 class="el-title uk-card-title uk-margin-top uk-margin-remove-bottom"> <a href="/europe/france.html" class="uk-link-reset">Gene Therapy Legislation in France</a> </h3> <div class="el-content uk-panel uk-margin-top"><p>The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs can be regulated under the contained use and/or the deliberate release frameworks. A decision is taken case-by-case. Applicants should submit the dossier to the Ministry of Research (Ministère de l'Enseignement supérieur, de la Recherche et de l'Innovation) for the classification and the conditions of contained use of the GMO. The Ministry of Research gives an opinion on the type of contained use regarding manufacturing and administration and it also states whether this research presents a risk of deliberate release of GMO into the environment. When a risk of deliberate release is identified, the applicant should submit a second dossier to the Ministry of Environment (Ministère de la Transition écologique et solidaire) for the deliberate use assessment. The applications to seek authorization under the clinical trials framework and under the GMO framework are not linked; both applications can be submitted in parallel.</p> <p>Additional information on the conduct of clinical trials can be found at:<br> - <a href="https://www.enseignementsup-recherche.gouv.fr/cid66768/o.g.m.-en-milieu-confine-procedure-administrative.html" target="_blank">https://www.enseignementsup-recherche.gouv.fr/cid66768/o.g.m.-en-milieu-confine-procedure-ad ministrative.html</a><br> - <a href="https://www.hautconseildesbiotechnologies.fr/en/demarche/cas-particulier-dossiers-recherche-biomedicale-veterinaire-produits-therapie-genique-ou-0" target="_blank">https://www.hautconseildesbiotechnologies.fr/en/demarche/cas-particulier-dossiers-recherche-bi omedicale-veterinaire-produits-therapie-genique-ou-0</a><br> - <a href="https://ansm.sante.fr/Activites/Medicaments-et-produits-biologiques/Essais-cliniques-portant-sur-les-medicaments-et-produits-biologiques/(offset)/0" target="_blank">https://ansm.sante.fr/Activites/Medicaments-et-produits-biologiques/Essais-cliniques-portant-sur-l es-medicaments-et-produits-biologiques/(offset)/0</a><br> - <a href="https://ansm.sante.fr" target="_blank">Agence Nationale de Sécurité du Médicament et des Produits de Santé</a> (ANSM)<br> - <a href="https://www.hautconseildesbiotechnologies.fr" target="_blank">High Council for Biotechnology</a><br> - <a href="https://www.enseignementsup-recherche.gouv.fr" target="_blank">Minister of Research</a> (MESR), covering the contained use aspect.</p> <p><b>Application forms to seek authorisation for the GMO aspects</b><br> Application forms can be found at: <a href="https://duo.adc.education.fr/duo/connexion.jsp" target="_blank">https://duo.adc.education.fr/duo/connexion.jsp</a></p> <p><b>Public consultation</b><br> There is a public consultation on GMO aspects prior to granting authorization for a period of between 15 to 30 days.</p> <hr><p><b>National authorities involved</b></p> <p><i>Authorization of clinical trials:</i><br> Agence Nationale de Sécurité du Médicament et des produits de Santé (ANSM)<br> 143/147 bld Anatole France 93285 Saint Denis CEDEX<br> e-mail: <joomla-hidden-mail is-link="1" is-email="1" first="YWVj" last="YW5zbS5zYW50ZS5mcg==" text="YWVjQGFuc20uc2FudGUuZnI=" base="" >This email address is being protected from spambots. You need JavaScript enabled to view it.</joomla-hidden-mail> (correspondence should indicate “gene therapy” in the title).<br> <a href="https://ansm.sante.fr" target="_blank">https://ansm.sante.fr</a></p> <p><i>Authorisation of GMO aspects:</i><br> Ministère de l’enseignement supérieur, de la recherche et de l’innovation (MESRI): Competent authority under the contained use framework.<br> e-mail: <joomla-hidden-mail is-link="1" is-email="1" first="b2dtLmNvbmZpbmU=" last="cmVjaGVyY2hlLmdvdXYuZnI=" text="b2dtLmNvbmZpbmVAcmVjaGVyY2hlLmdvdXYuZnI=" base="" >This email address is being protected from spambots. You need JavaScript enabled to view it.</joomla-hidden-mail><br> <a href="https://www.enseignementsup-recherche.gouv.fr/" target="_blank">https://www.enseignementsup-recherche.gouv.fr/</a></p> <p>Ministère de la Transition écologique et solidaire (MTES): Competent authority under the deliberate release framework.<br> e-mail: <joomla-hidden-mail is-link="1" is-email="1" first="YmlvdGVjaA==" last="ZGV2ZWxvcHBlbWVudC1kdXJhYmxlLmdvdXYuZnI=" text="YmlvdGVjaEBkZXZlbG9wcGVtZW50LWR1cmFibGUuZ291di5mcg==" base="" >This email address is being protected from spambots. You need JavaScript enabled to view it.</joomla-hidden-mail><br> <a href="https://www.ecologique-solidaire.gouv.fr/" target="_blank">https://www.ecologique-solidaire.gouv.fr/</a></p> <p>Haut Conseil des biotechnologies (HCB): The HCB is an independent body whose role is to inform public decision-making. It delivers opinions on all biotechnology-related issues.<br> 246, boulevard Saint Germain, 75007 Paris<br> <a href="https://www.hautconseildesbiotechnologies.fr" target="_blank">https://www.hautconseildesbiotechnologies.fr</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/167.html" target="_blank" rel="noopener noreferrer" title="AdvancedTherapiesWeek-jan2025"> <img src="https://www.genetherapynet.com/images/banners/AdvancedTherapiesWeek-jan2025.jpg#joomlaImage://local-images/banners/AdvancedTherapiesWeek-jan2025.jpg?width=1140&height=220" alt="AdvancedTherapiesWeek-jan2025" > </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/france.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 uk-active"><a href="/europe/france.html"> France</a></li> <li class="item-68"><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> <!-- Builder #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>© 2024 Gene Therapy Net.<br /><a href="/contact-gene-therapy-net.html" style="color: #000000; 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