{"id":12549,"date":"2023-04-10T13:19:57","date_gmt":"2023-04-10T13:19:57","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12549"},"modified":"2026-02-27T09:45:46","modified_gmt":"2026-02-27T09:45:46","slug":"malaysia-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/malaysia-regulatory\/","title":{"rendered":"Malaysia Regulatory"},"content":{"rendered":"
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Malaysia 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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Malaysia<\/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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Malaysia Regulatory Requirements<\/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>\nNational Pharmaceutical Regulatory Agency (NPRA) Under the Ministry of Health Malaysia.<\/td>\n<\/tr>\n
Regulation Name<\/strong><\/td>\n

Drug Registration Guidance Document (DRGD)<\/b> \u2013 labeling and registration rules <\/p>\n

NPRA Product Barcode & Traceability Requirements
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Malaysia uses GS1 barcoding requirements <\/b>for pharmaceuticals, but does not currently operate a full national end-to-end serialization
repository system<\/b> like EU, KSA, or Brazil.<\/p><\/td>\n<\/tr>\n

Compliance Dates<\/strong><\/td>\n

Barcode (GTIN) requirement:<\/b> Implemented for registered pharmaceutical products over the past decade (mandatory GS1 barcode on outer packaging).<\/p>\n

No nationwide mandatory serialization (unique serial number per pack) requirement as of current regulations.
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Malaysia currently mandates product-level barcoding<\/b>, not full
serialization with centralized reporting<\/p><\/td>\n<\/tr>\n

Applies to<\/strong><\/td>\n

All registered pharmaceutical<\/b> products (prescription and OTC) marketed in Malaysia. <\/p>\n

Applies to manufacturers, importers, and Marketing Authorization Holders (MAHs).<\/p><\/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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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>\n \n GS1 1D (EAN-13) or GS1 DataMatrix (depending on packaging configuration)\n <\/td>\n <\/tr>\n
Barcode Content<\/strong><\/td>\n GTIN (product identifier only)<\/td>\n <\/tr>\n
Serial Number Randomization<\/strong><\/td>\n Not required (no mandatory serialization)<\/td>\n <\/tr>\n
Serial Number Reuse<\/strong><\/td>\n Not applicable<\/td>\n <\/tr>\n
Human Readable Expiry Date Format <\/strong><\/td>\n \n As per NPRA labeling rules (typically MM\/YYYY or DD\/MM\/YYYY)\n <\/td>\n <\/tr>\n
Barcode Data Encoding<\/strong><\/td>\n GS1 GTIN standard<\/td>\n <\/tr>\n
Product Code Notes <\/strong><\/td>\n \n GTIN must be registered with GS1 Malaysia and linked to NPRA\n registration.\n <\/td>\n <\/tr>\n
Free Samples must be marked?<\/strong><\/td>\n \n Yes \u2013 must be labeled \u201cFree Sample \u2013 Not for Sale\u201d per labeling\n regulations\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
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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>\n GS1-128 (SSCC) \u2013 if used for logistics<\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n SSCC or GTIN (logistics use)<\/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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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<\/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 No<\/td>\n <\/tr>\n
\n Send Unit Data to Third-Party Repository? <\/strong>\n <\/td>\n Optional (company systems only)<\/td>\n <\/tr>\n
Send Unit Data to Trading Partner? <\/strong><\/td>\n Commercially optional<\/td>\n <\/tr>\n
\n Send Aggregation Data to Government Repository?<\/strong>\n <\/td>\n No<\/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 Commercially optional<\/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 Who Offers Data Repository for Authentication?<\/strong>\n <\/td>\n None (no national serialization repository)<\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n No<\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n No<\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Shipment?\n <\/strong>\n <\/td>\n No<\/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 No<\/td>\n <\/tr>\n
\n Downstream Trading Partner Activity Reported?<\/strong>\n <\/td>\n No<\/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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Malaysia Regulatory Regulatory For Malaysia Malaysia Regulatory Requirements Regulatory Agency National Pharmaceutical Regulatory Agency (NPRA) Under the Ministry of Health Malaysia. Regulation Name Drug Registration Guidance Document (DRGD) \u2013 labeling and registration rules NPRA Product Barcode & Traceability Requirements Malaysia uses GS1 barcoding requirements for pharmaceuticals, but does not currently operate a full national end-to-end […]<\/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-12549","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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