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Guide pratique — Mars 2018

GUIDE PRATIQUE DE SOUMISSION DES DOSSIERS D’HOMOLOGATION DES REACTIFS BIOMEDICAUX
CameroonMinistère de la Santé Publique / Direction de la Pharmacie, du Médicament et des LaboratoiresRegistrationCurrentness under review
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GUIDE PRATIQUE DE SOUMISSION DES DOSSIERS D’HOMOLOGATION DES REACTIFS BIOMEDICAUX is published by Ministère de la Santé Publique / Direction de la Pharmacie, du Médicament et des Laboratoires. This document is identified by its title; no separate official document code is recorded.

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Guide pratique — Mars 2018
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GUIDE PRATIQUE DE SOUMISSION DES DOSSIERS D’HOMOLOGATION DES REACTIFS BIOMEDICAUX

Full twelve-page March2018 IVD reagent dossier guide including initial/renewal/variation, analytical-performance composition changes, labelling/IFU and application-template fields. Printed citation says2October1998 whereas the decree original says22October1998; not silently corrected. Page6 numbering omits3. Guide requiresEnglish AND French labels/IFU, whereas archivedAnnexeI PartsII/III saysEnglish OR French; hierarchy, subsequent revisions and present fees remain unresolved. Fee and sample quantities are historical source statements, not a verified current instruction.

This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.

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