{"id":12633,"date":"2023-04-10T13:46:03","date_gmt":"2023-04-10T13:46:03","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12633"},"modified":"2026-03-11T05:32:20","modified_gmt":"2026-03-11T05:32:20","slug":"uae-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/ru\/whitepapers\/uae-regulatory\/","title":{"rendered":"UAE Regulatory"},"content":{"rendered":"
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UAE 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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UAE<\/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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UAE 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>\n Ministry of Health and Prevention, UAE (MoHAP)<\/td>\n <\/tr>\n
Regulation Name<\/strong><\/td>\n \n Tatmeen \u2013 Pharmaceutical Products Traceability (Ministerial Decree No.\n 73 of 2021)\n <\/td>\n <\/tr>\n
Compliance Dates<\/strong><\/td>\n \n
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  • Legislation issued: June 14, 2021.<\/li>\n
  • System operational & enforcement started: Dec 13, 2022<\/b><\/li>\n <\/ul>\n <\/td>\n <\/tr>\n
Applies to<\/strong><\/td>\n \n All conventional pharmaceutical products sold, imported, distributed, or\n stored in the UAE (registered & unregistered)\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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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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(A carton containing one or more primary packs and includes a \u201cmono carton\u201d containing one primary pack)<\/p>\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 DataMatrix<\/b> (2D) per GS1 global standards<\/td>\n <\/tr>\n
Barcode Content<\/strong><\/td>\n \n Encoding Options<\/b>\n
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  • GTIN + SN + EXPIRY DATE + BATCH NUMBER<\/li>\n
  • GTIN + EXPIRY DATE + SN + BATCH NUMBER<\/li>\n
  • GTIN + EXPIRY DATE + BATCH NUMBER + SN<\/li>\n
  • GTIN + BATCH NUMBER + EXPIRY DATE + SN<\/li>\n
  • GTIN + BATCH NUMBER + SN + EXPIRY DATE<\/li>\n
  • GTIN + SN + BATCH NUMBER + EXPIRY DATE<\/li>\n <\/ul>\n <\/td>\n <\/tr>\n
Serial Number Randomization<\/strong><\/td>\n \n Yes \u2014 randomized at unit level<\/b>, typical GS1 practice is high\n entropy (e.g., 1:10,000), random sequence for each serialized unique\n identifier\n <\/td>\n <\/tr>\n
Serial Number Reuse<\/strong><\/td>\n \n Not explicitly defined in publicly available guides \u2014 best practice from\n GS1 is no reuse<\/b> within defined portfolio and lifetime of product.\n Not specified whether UAE explicitly allows reuse; assume adherence to\n GS1 best practice (no reuse) unless guidance states otherwise.\n <\/td>\n <\/tr>\n
Human Readable Expiry Date Format<\/strong><\/td>\n \n Expiry date printed also in human-readable form. Format commonly\n recognized under GS1 is YYMMDD.<\/b>\n <\/td>\n <\/tr>\n
Barcode Data Encoding <\/strong><\/td>\n \n GS1 AIDC DataMatrix encoding with proper application identifiers (AIs)\n per GS1 General Specifications\n <\/td>\n <\/tr>\n
Product Code Notes<\/strong><\/td>\n \n 2D DataMatrix must contain all four data elements in one symbol. If\n linear barcode is also present, it must encode same GTIN.\n <\/td>\n <\/tr>\n
Free Samples must be marked? <\/strong><\/td>\n \n Exempt:<\/b> Free samples do\n not require serialization<\/b> (excluded from mandate)\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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(A shipper containing one or more secondary packs)<\/p>\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 GS1-128 Linear Barcode<\/b> for logistic units & SSCC\n <\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n \n SSCC (Serial Shipping Container Code); optionally GTIN if treated as\n trade item by brand owner\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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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 \n Yes \u2014 manufacturers aggregate smaller units into logistic units using\n SSCC codes; downstream repackers also add SSCC aggregation for\n reconfigured units.\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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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 Yes<\/b> \u2014 serialized unit data must be reported to the Tatmeen<\/b>\n traceability platform.\n <\/td>\n <\/tr>\n
\n Send Unit Data to Third-Party Repository?<\/strong>\n <\/td>\n \n Optional \u2014 for internal systems or supply chain partners (not mandated\n by MoHAP).\n <\/td>\n <\/tr>\n
Send Unit Data to Trading Partner? <\/strong><\/td>\n \n Often done via EPCIS or partner systems; not strictly mandated by\n regulation, but common industry practice.\n <\/td>\n <\/tr>\n
\n Send Aggregation Data to Government Repository? <\/strong>\n <\/td>\n \n Yes<\/b> \u2014 aggregation events must be captured and reported to\n Tatmeen.\n <\/td>\n <\/tr>\n
\n Send Aggregation Data to Third-Party Repository? <\/strong>\n <\/td>\n Optional \u2014 depends on third-party service agreements.<\/td>\n <\/tr>\n
\n Send Aggregation Data to Trading Partner? <\/strong>\n <\/td>\n \n Industry practice encourages sharing via EPCIS; not compulsory by MoHAP\n text.\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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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 \n Tatmeen platform<\/b> (MoHAP digital traceability system); may\n interface with BrandSync or other GS1 data pools for master data\n <\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n \n Yes \u2014 all products must be linked to Tatmeen before importation or\n distribution.\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n \n Stakeholders (distributors, pharmacy, healthcare facilities) must scan &\n capture serialized data for traceability; authentication is expected.\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Shipment?\n <\/strong>\n <\/td>\n \n Yes \u2014 reporting of movement events in Tatmeen or internal archive is\n industry standard; specific MoHAP requirements mandate event capture.\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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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 Yes \u2014 serialization and aggregation events reported.<\/td>\n <\/tr>\n
\n Downstream Trading Partner Activity Reported? <\/strong>\n <\/td>\n \n Yes \u2014 downstream scanning events (receipt, shipment, dispensing) feed\n traceability.\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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UAE Regulatory Regulatory For UAE UAE Regulatory Requirements Regulatory Agency Ministry of Health and Prevention, UAE (MoHAP) Regulation Name Tatmeen \u2013 Pharmaceutical Products Traceability (Ministerial Decree No. 73 of 2021) Compliance Dates Legislation issued: June 14, 2021. System operational & enforcement started: Dec 13, 2022 Applies to All conventional pharmaceutical products sold, imported, distributed, or […]<\/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-12633","page","type-page","status-publish","hentry"],"rankMath":{"parentDomain":"kevision.in","noFollowDomains":[],"noFollowExcludeDomains":[],"noFollowExternalLinks":false,"featuredImageNotice":"\u041f\u043e\u043a\u0430\u0437\u0430\u043d\u043d\u043e\u0435 \u0438\u0437\u043e\u0431\u0440\u0430\u0436\u0435\u043d\u0438\u0435 \u0434\u043e\u043b\u0436\u043d\u043e \u0431\u044b\u0442\u044c \u0440\u0430\u0437\u043c\u0435\u0440\u043e\u043c \u043d\u0435 \u043c\u0435\u043d\u0435\u0435 200 \u043d\u0430 200 \u043f\u0438\u043a\u0441\u0435\u043b\u0435\u0439, \u0447\u0442\u043e\u0431\u044b \u0435\u0433\u043e \u043c\u043e\u0433\u043b\u0438 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