Late last year, Vietnam’s MoH announced Circular 23/2023/TT-BYT which updated the 2018 drug labeling requirements. The new drug labeling law will take effect on January 15, 2024. However, there will be a transition period until January 1, 2025. Therefore, drugs imported or made domestically this year can still use package inserts and labels before the specific batch expires.
Specifically, the new Circular outlines a number of changes. First, to help with the tracking of drugs, a QR code, Data Matrix code, or bar code will need to be added to drug labels. Second, radioactive drugs do not need package inserts and labels to be affixed to their package but must be included when delivered to medical centers. Third, with respect to semi-solid drugs or multi-dose liquid drugs, the weight or volume concentration of active ingredients will now be required. Fourth, to facilitate easier customs clearance, for imported drugs, an additional label or package insert in Vietnamese can be added. Finally, for national defense or emergency drugs, the Circular allows for the packaging inserts to be attached to the outside of the box.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.vietnam-briefing.com/news/vietnam-updates-regulations-on-pharmaceutical-product-labeling.html/