{"id":5323,"date":"2022-03-15T13:02:08","date_gmt":"2022-03-15T17:02:08","guid":{"rendered":"https:\/\/spharm-inc.com\/wp2021\/?p=5323"},"modified":"2025-03-28T16:37:13","modified_gmt":"2025-03-28T20:37:13","slug":"est-ce-que-les-promoteurs-sont-tenus-davoir-un-representant-legal-residant-au-canada","status":"publish","type":"post","link":"https:\/\/spharm-inc.com\/fr\/est-ce-que-les-promoteurs-sont-tenus-davoir-un-representant-legal-residant-au-canada\/","title":{"rendered":"Est-ce que les promoteurs sont tenus d\u2019avoir un repr\u00e9sentant l\u00e9gal r\u00e9sidant au Canada?"},"content":{"rendered":"\t\t
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Est-ce que les promoteurs sont tenus d\u2019avoir un repr\u00e9sentant l\u00e9gal r\u00e9sidant au Canada?<\/h1>

\u00a0<\/strong><\/span><\/p>

EST-CE QUE SANT\u00c9 CANADA EXIGE QUE LES PROMOTEURS AIENT UN REPR\u00c9SENTANT L\u00c9GAL R\u00c9SIDANT AU CANADA?<\/strong><\/span><\/p>

Un responsable scientifique ou m\u00e9dical r\u00e9sidant au Canada, qui repr\u00e9sente le promoteur et qui est responsable de fournir une attestation relative \u00e0 la demande d\u2019essai clinique ou \u00e0 une \u00e9ventuelle modification, est requis. Il n\u2019y a pas d\u2019information suppl\u00e9mentaire disponible dans les r\u00e8glements ou les directives concernant l\u2019agent canadien. Par cons\u00e9quent, tout membre du personnel scientifique canadien autoris\u00e9 par le promoteur \u00e0 pr\u00e9senter la demande en son nom et \u00e0 \u00eatre le repr\u00e9sentant peut \u00eatre le signataire. Normalement, l\u2019agent r\u00e9glementaire ou l\u2019ORC peut signer la demande d\u2019essai clinique pour le compte du promoteur.<\/p>

En ce qui concerne l\u2019obligation des promoteurs d\u2019avoir un repr\u00e9sentant l\u00e9gal r\u00e9sidant au Canada pour le processus d\u2019homologation, Sant\u00e9 Canada ne l\u2019exige pas. N\u00e9anmoins, si le promoteur n\u2019est pas \u00e9tabli au Canada, un importateur canadien doit \u00eatre d\u00e9sign\u00e9 et sa licence d\u2019\u00e9tablissement de m\u00e9dicaments (LEM) doit \u00eatre soumise ou modifi\u00e9e au moins 3 mois avant la pr\u00e9sentation de la demande d\u2019autorisation de mise en march\u00e9 (PDN ou PADN) au Canada. C\u2019est l\u2019une des exigences des bonnes pratiques de fabrication.<\/p>

Cela \u00e9tant dit, avoir un point de contact r\u00e9glementaire au Canada constitue un avantage par rapport au langage r\u00e9glementaire particulier \u00e0 Sant\u00e9 Canada et pour traiter rapidement les questions, \u00e9tant dans le m\u00eame fuseau horaire que l\u2019agence r\u00e9glementaire.<\/p>

\u00a0<\/p>

\u00a0<\/h3>

Pour toute question sur le processus canadien d\u2019examen et de r\u00e9glementation des m\u00e9dicaments qui n\u2019est pas couverte dans cette section, n\u2019h\u00e9sitez pas \u00e0 communiquer directement avec nous<\/a>.<\/h3>
\u00a0<\/div>
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Est-ce que les promoteurs sont tenus d\u2019avoir un repr\u00e9sentant l\u00e9gal r\u00e9sidant au Canada? \u00a0 EST-CE QUE SANT\u00c9 CANADA EXIGE QUE LES PROMOTEURS AIENT UN REPR\u00c9SENTANT L\u00c9GAL R\u00c9SIDANT AU CANADA? Un responsable scientifique ou m\u00e9dical r\u00e9sidant au Canada, qui repr\u00e9sente le promoteur et qui est responsable de fournir une attestation relative \u00e0 la demande d\u2019essai clinique […]<\/p>\n","protected":false},"author":3,"featured_media":6584,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[242],"tags":[],"class_list":["post-5323","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-reglementation-de-sante-canada"],"acf":[],"yoast_head":"\nUn repr\u00e9sentant l\u00e9gal au Canada est-il requis pour promoteurs ?<\/title>\n<meta name=\"description\" content=\"Apprenez si Sant\u00e9 Canada impose aux promoteurs \u00e9trangers d'avoir un repr\u00e9sentant l\u00e9gal domicili\u00e9 au Canada pour leurs essais.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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