Vietnam

Regulation name
Circular 23/2023/TT-BYT (November 30, 2023) amending Circular 01/2018/TT-BYT on drug labeling and package inserts
Serialization status
Serialization MANDATORY and ACTIVE since Jan 15, 2024; Full compliance required Jan 1, 2025 for unique serialization. National reporting system PLANNED but NOT YET OPERATIONAL. Products must carry unique serial numbers; data submission platform under development.

Aggregation requirement: Not specified yet

Track & Trace requirement: Codes must enable product tracing from production to consumer

Official governing body: Vietnam Reporting System (planned, not yet operational); DAV online portal for drug registration: https://dichvucong.dav.gov.vn

Implementation deadline / enforcement date: Serialization MANDATORY and ACTIVE since Jan 15, 2024; Full compliance required Jan 1, 2025 for unique serialization. National reporting system PLANNED but NOT YET OPERATIONAL. Products must carry unique serial numbers; data submission platform under development.

MAH / CMO responsibilities: Manufacturers (local and foreign) - must record serial numbers; Vietnamese LAR/Distributor - reports to DAV on behalf of foreign MAH; Foreign companies CANNOT report directly to DAV; Reporting mechanism/portal NOT YET OPERATIONAL

Serialized product scope: Prescription drugs (Rx); Imported pharmaceuticals; Locally manufactured pharmaceuticals

Serialization exemption rules: Exemptions not clearly defined in published regulations; radioactive drugs have modified labeling requirements

Market coding requirements:

GS1-compliant codes MANDATORY (2Data Matrix)

GTIN, Unique Serial Number, Expiry Date, Batch/Lot Number

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