{"id":12680,"date":"2023-04-10T15:44:53","date_gmt":"2023-04-10T15:44:53","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12680"},"modified":"2026-03-02T09:51:40","modified_gmt":"2026-03-02T09:51:40","slug":"vietnam-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/vietnam-regulatory\/","title":{"rendered":"Vietnam Regulatory"},"content":{"rendered":"
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Vietnam Regulatory\n<\/h2>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Regulatory For<\/h5>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Vietnam<\/span><\/p>\n\t\t\t\t\n\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Vietnam \u2013 Pharma Serialization & Traceability<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Regulatory Agency<\/strong><\/td>Drug Administration of Vietnam (DAV)<\/b> under the Ministry of Health (MoH).<\/td><\/tr>
Regulation Name<\/strong><\/td>Circular 23\/2023\/TT\u2011BYT<\/b> \u2014 new labeling and traceability requirements for pharmaceutical products.<\/td><\/tr>
Compliance Dates<\/strong><\/td>Effective date: 15 January 2024<\/b> \u2014 serialization requirements came into
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Transition period: <\/b>Medicines manufactured or imported before 01 January 2025<\/b> may use existing labels and inserts until batch expiry<\/td><\/tr>
Applies to<\/strong><\/td>All pharmaceutical products<\/b> manufactured in or imported into Vietnam, including both prescription and OTC drugs.
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Secondary Packaging<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Barcode Symbology <\/strong><\/td>\nGS1 2D DataMatrix<\/b> (other codes such as QR\/RFID may be used as
machine\u2011readable carriers if compliant).<\/td>\n<\/tr>\n
Barcode Content<\/strong><\/td>\n

Must include:<\/p>\n

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  • GTIN<\/b> (GS1 AI 01)<\/li>\n
  • Serial Number<\/b> (GS1 AI 21)<\/li>\n
  • Batch\/Lot Number<\/b> (GS1 AI 10)<\/li>\n
  • Expiration Date<\/b> (GS1 AI 17)<\/li>\n
  • Manufacturing date where applicable (GS1 AI 11)<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Serial Number Randomization<\/strong><\/td>\nYes \u2014 unique identifier per unit required<\/td>\n<\/tr>\n
Serial Number Reuse<\/strong><\/td>\nNot permitted \u2014 each serial must be unique on the Vietnamese market.<\/td>\n<\/tr>\n
Human Readable Expiry Date Format <\/strong><\/td>\nMust be printed in a clear, human\u2011readable format consistent with GS1
AIs (e.g., YYMMDD).<\/td>\n<\/tr>\n
Barcode Data Encoding<\/strong><\/td>\nGS1 standard (DataMatrix with GS1 AIs)<\/td>\n<\/tr>\n
Product Code Notes <\/strong><\/td>\nGTIN must be assigned following GS1 Vietnam standards<\/td>\n<\/tr>\n
Free Samples must be marked?<\/strong><\/td>\nNot specifically detailed in Circular 23\/2023; all products entering
supply chain should be serialized and labeled<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Tertiary Packaging<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Barcode Symbology<\/strong><\/td> GS1\u2011128<\/b> (SSCC) for cartons\/cases (industry practice for logistics).<\/td><\/tr>
Barcode Contents<\/strong><\/td>SSCC and aggregated information (e.g., GTIN, quantity) for logistic
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Aggregation Data Capture<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n Parent-Child Mapping Aggregation Capture?<\/strong>\n <\/td>\n Not required by current regulation.<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Data Exchange<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n Send Unit Data to Government Repository?<\/strong>\n <\/td>\n \n Not yet mandated by Circular 23\/2023. Future frameworks are anticipated\n under broader digital traceability initiatives\n <\/td>\n <\/tr>\n
\n Send Unit Data to Third-Party Repository? <\/strong>\n <\/td>\n \n Optional \u2014 internal systems may store serialization data; not\n regulator\u2011mandated.\n <\/td>\n <\/tr>\n
Send Unit Data to Trading Partner? <\/strong><\/td>\n \n Industry practice \u2014 data sharing with distributors for supply chain\n visibility..\n <\/td>\n <\/tr>\n
\n Send Aggregation Data to Government Repository? <\/strong>\n <\/td>\n No current requirement.<\/td>\n <\/tr>\n
\n Send Aggregation Data to Third-Party Repository? <\/strong>\n <\/td>\n Optional.<\/td>\n <\/tr>\n
\n Send Aggregation Data to Trading Partner?<\/strong>\n <\/td>\n Common industry practice.<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Authentication<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\n \n \n \n \n \n
\n Who Offers Data Repository for Authentication?<\/strong>\n <\/td>\n \n No national repository currently mandated; technologies like NDA Trace\n UID are being explored for broader product traceability beyond just\n pharmaceuticals.\n <\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n Not required under current circular.<\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n \n Not mandated yet \u2014 scanning by distributors occurs for logistics but no\n central authentication required.\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Shipment?\n <\/strong>\n <\/td>\n Not required by current law.<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Government Reporting<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Manufacturer Activity Reported?<\/strong><\/td>\n \n Internal systems record serialization assignment; not sent to\n government.\n <\/td>\n <\/tr>\n
\n Downstream Trading Partner Activity Reported? <\/strong>\n <\/td>\n \n Industry stakeholders may track movements; not regulator\u2011mandated.\n <\/td>\n <\/tr>\n <\/tbody>\n<\/table>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\n\t\t\t\t\t\t\tSource and Credit<\/strong>: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t
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Disclaimer\n<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\tThis information is being provided \u2018As Is\u2019 with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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About Kevision Systems<\/h3>\t\t<\/div>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Kevision Systems,<\/strong> 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\u2019s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.<\/p>

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.<\/p>

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.<\/p>

For Further Information, please contact our Compliance Team at\u00a0info@kevision.in<\/a><\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Vietnam Regulatory Regulatory For Vietnam Vietnam \u2013 Pharma Serialization & Traceability Regulatory Agency Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH). Regulation Name Circular 23\/2023\/TT\u2011BYT \u2014 new labeling and traceability requirements for pharmaceutical products. Compliance Dates Effective date: 15 January 2024 \u2014 serialization requirements came intoforce. Transition period: Medicines manufactured or imported […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":12422,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-12680","page","type-page","status-publish","hentry"],"rankMath":{"parentDomain":"kevision.in","noFollowDomains":[],"noFollowExcludeDomains":[],"noFollowExternalLinks":false,"featuredImageNotice":"La imagen destacada debe tener al menos 200 por 200 p\u00edxeles para que Facebook y otros sitios de redes sociales puedan 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