1.0Tilleke & Gibbinshttps://www.tilleke.comErichttps://www.tilleke.com/author/eric/Vietnam Issues New Regulations on Drug Registration - Tilleke & Gibbinsrich600338<blockquote class="wp-embedded-content" data-secret="HQ1rjTJUZt"><a href="https://www.tilleke.com/insights/vietnam-issues-new-regulations-on-drug-registration">Vietnam Issues New Regulations on Drug Registration</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.tilleke.com/insights/vietnam-issues-new-regulations-on-drug-registration/embed/#?secret=HQ1rjTJUZt" width="600" height="338" title="“Vietnam Issues New Regulations on Drug Registration” — Tilleke & Gibbins" data-secret="HQ1rjTJUZt" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript">
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On May 16, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (Circular 12). Circular 12 will come into effect on July 1, 2025, replacing Circular No. 08/2022/TT-BYT (as amended), which provides the current regulations on drug registration, along with Circular No. 16/2023/TT-BYT on registration of drugs under toll manufacturing and technology transfer, and Circular No. 07/2017/TT promulgating the list of non-prescription drugs. Some of the key stipulations of Circular 12 are outlined below. Regulation of non-prescription drugs Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated in Circular No. 07/2017/TT-BYT. Instead of relying on a fixed list for classification, Circular 12 introduces a new framework based on principles, criteria, and specific methods for determining the status of non-prescription/OTC drugs. This approach aims to enhance safety, ensure timely access, reflect actual usage and supply conditions, and align with international