Vietnam
| Regulatory Agency | Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH). |
| Regulation Name | Circular 23/2023/TT‑BYT — new labeling and traceability requirements for pharmaceutical products. |
| Compliance Dates | Effective date: 15 January 2024 — serialization requirements came into force. Transition period: Medicines manufactured or imported before 01 January 2025 may use existing labels and inserts until batch expiry |
| Applies to | All pharmaceutical products manufactured in or imported into Vietnam, including both prescription and OTC drugs. |
| Barcode Symbology | GS1 2D DataMatrix (other codes such as QR/RFID may be used as machine‑readable carriers if compliant). |
| Barcode Content | Must include:
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| Serial Number Randomization | Yes — unique identifier per unit required |
| Serial Number Reuse | Not permitted — each serial must be unique on the Vietnamese market. |
| Human Readable Expiry Date Format | Must be printed in a clear, human‑readable format consistent with GS1 AIs (e.g., YYMMDD). |
| Barcode Data Encoding | GS1 standard (DataMatrix with GS1 AIs) |
| Product Code Notes | GTIN must be assigned following GS1 Vietnam standards |
| Free Samples must be marked? | Not specifically detailed in Circular 23/2023; all products entering supply chain should be serialized and labeled |
| Barcode Symbology | GS1‑128 (SSCC) for cartons/cases (industry practice for logistics). | |
| Barcode Contents | SSCC and aggregated information (e.g., GTIN, quantity) for logistic operations. | |
| Parent-Child Mapping Aggregation Capture? | Not required by current regulation. |
| Send Unit Data to Government Repository? | Not yet mandated by Circular 23/2023. Future frameworks are anticipated under broader digital traceability initiatives |
| Send Unit Data to Third-Party Repository? | Optional — internal systems may store serialization data; not regulator‑mandated. |
| Send Unit Data to Trading Partner? | Industry practice — data sharing with distributors for supply chain visibility.. |
| Send Aggregation Data to Government Repository? | No current requirement. |
| Send Aggregation Data to Third-Party Repository? | Optional. |
| Send Aggregation Data to Trading Partner? | Common industry practice. |
| Who Offers Data Repository for Authentication? | No national repository currently mandated; technologies like NDA Trace UID are being explored for broader product traceability beyond just pharmaceuticals. |
| Manufacturers Must Register Shipments in Repository? | Not required under current circular. |
| Downstream Trading Partners Must Authenticate on Receipt? | Not mandated yet — scanning by distributors occurs for logistics but no central authentication required. |
| Downstream Trading Partners Must Authenticate on Shipment? | Not required by current law. |
| Manufacturer Activity Reported? | Internal systems record serialization assignment; not sent to government. |
| Downstream Trading Partner Activity Reported? | Industry stakeholders may track movements; not regulator‑mandated. |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
