Official letter No. 3682/QLD-DK
dated April 13th, 2023 of the Drug Administration of Vietnam regarding development of procedures for receiving applications for marketing authorization, renewal of the marketing authorization of drugs on the online public service system regarding drug registration
Posted: 14/4/2023 9:19:55 AM | Latest updated: 17/4/2023 5:56:08 PM (GMT+7) | LuatVietnam: 5679
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According to announcement of the Drug Administration of Vietnam, from May 4th, 2023 it shall receive applications for marketing authorization, renewal of the marketing authorization of drugs wholly on the online public services system (including the first application and supplemented one), except some technical documents enterprises are required to submit the paper-based documents to facilitate validators, including Bioequivalence study documents; Pre-clinical and clinical study documents; Documents serving the GMP conformity assessment.
Establishments registering drugs shall be fully responsible before the law for the accuracy, legitimacy and truthfulness of all documents in the applications for marketing authorization submitted on the online public service system and shall be responsible for archiving at each establishment a full set of paper-based application for marketing authorization for the purpose of post-inspection.
Ms Phuong Thao (VietlawOnline.com)
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