v. 28 – Q4 2023

v.28 Q4 2023 update: Draft guidance added; Updated e-PIL information

Market Executive Summary Early stages of discussions regarding Circular regulating the registration of drugs and drug raw materials requiring the use of a “QR code on the outer box of product”

Note: Although the publication states that a QR Code is being suggested, inquiry has determined that this is a misunderstanding of the data carrier specifications and likely this will be changed to match the EGS preference for a GS1 DataMatrix.

No current regulations being enforced, though there are Voluntary Vietnam National Standards (TCVN) that cover items including, and other than, pharmaceuticals within Vietnam. The Voluntary Vietnam National Standards are based on corresponding GS1 general specifications.

As per regulation DAV (Drug Administration Vietnam) is to issue roadmap for implementation. So far, no roadmap has been shared.

There are rumours that Vietnamese Authorities would push for QR codes and Vietnamese national code instead of following Global Emerging Standards.

Draft technical guidance’s were issued in November 2023 for review.

Much is still to be clarified over the next couple of months.

Key Dates None Defined

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