{"id":12759,"date":"2023-04-10T16:37:15","date_gmt":"2023-04-10T16:37:15","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12759"},"modified":"2026-02-03T12:31:15","modified_gmt":"2026-02-03T12:31:15","slug":"egypt-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/egypt-regulatory\/","title":{"rendered":"Egypt Regulatory"},"content":{"rendered":"
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Egypt 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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Pharma<\/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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Regulatory Agency<\/strong><\/td>\n \n
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Egyptian Drug Authority (EDA)<\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/td>\n <\/tr>\n
Regulation Name<\/strong><\/td>\n \n
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\n Unified Track & Trace Decree (Decree No. 475 of 2025,\n published August 2025)\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/td>\n <\/tr>\n
Compliance Dates<\/strong><\/td>\n \n \n \n \n \n \n \n
Effective Phase<\/b><\/th>\n Applicability<\/b><\/th>\n Key Requirements<\/b><\/th>\n <\/tr>\n
Phase 1<\/b><\/td>\n Imported Finished Products<\/b> (from 1 Feb 2026)<\/td>\n \n Serialization, reporting & system connectivity for all fully\n finished imported products.\n <\/td>\n <\/tr>\n
Phase 2<\/b><\/td>\n \n Locally Manufactured \/ Repackaged Products<\/b> (from 1 Aug\n 2026)\n <\/td>\n \n Mandatory serialization & reporting for products\n manufactured, packed, or repacked in Egypt.\n <\/td>\n <\/tr>\n <\/tbody>\n <\/table>\n Products already circulating before deadlines may continue to be sold\n until expiry, but any products introduced after the compliance dates\n must be registered and electronically traceable in the EDA system\n <\/td>\n <\/tr>\n
Applies to<\/strong><\/td>\n \n

\n All human pharmaceutical and biological products manufactured or\n imported into Egypt.\n <\/p>\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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Free Samples must be marked? <\/strong><\/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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SECONDARY PACKAGING\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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(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>GS1-compliant 2D DataMatrix code<\/b><\/td><\/tr>
Barcode Content<\/strong><\/td>


Unique Identifiers: Each sellable unit must include a GS1-compliant 2D
DataMatrix code containing:<\/b><\/p>

  • GTIN<\/b><\/li>
  • Serial Number<\/li>
  • Batch\/Lot Number<\/li>
  • Expiry Date<\/li><\/ul>

    Hierarchy:<\/b> Serialization applies to secondary packaging and tertiary
    shipping levels with aggregation logic.<\/p><\/td><\/tr>

Serial Number Randomization<\/strong><\/td>NA<\/b><\/td><\/tr>
Serial Number Reuse<\/strong><\/td>No<\/b><\/td><\/tr>
Human Readable Expiry Date Format <\/strong><\/td>YYMMDD<\/b><\/td><\/tr>
Barcode Data Encoding<\/strong><\/td>GS1 Standard<\/b><\/td><\/tr>
Product Code Notes <\/strong><\/td>NA<\/b><\/td><\/tr>
Free Samples must be marked?<\/strong><\/td>No<\/b><\/td><\/tr><\/tbody><\/table>\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\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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Parent-Child Mapping Aggregation Capture?<\/strong><\/div><\/td>
 Parent-child relationships must be captured between primary, secondary, and tertiary packaging levels. <\/b><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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DATA EXCHANGE\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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Send Unit Data to Government Repository? <\/strong><\/td>EDA<\/b><\/td><\/tr>
Send Unit Data to Third-Party Repository? <\/strong><\/td>As Applicable<\/b><\/td><\/tr>
Send Unit Data to Trading Partner? <\/strong><\/td>As Applicable<\/b><\/td><\/tr>
Send Aggregation Data to Government Repository? <\/strong><\/td>No<\/b><\/td><\/tr>
Send Aggregation Data to Third-Party Repository? <\/strong><\/td>As Applicable<\/b><\/td><\/tr>
Send Aggregation Data to Trading Partner? <\/strong><\/td>As Applicable<\/b><\/td><\/tr><\/tbody><\/table>\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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Who Offers Data Repository for Authentication?<\/strong><\/td>\nEDA<\/b><\/td>\n<\/tr>\n
Manufacturers Must Register Shipments in Repository? <\/strong><\/td>\nNo<\/b><\/td>\n<\/tr>\n
Downstream Trading Partners Must Authenticate on Receipt?\n<\/strong><\/td>\n\nDownstream participants (distributors, pharmacies) are expected to\nauthenticate product data on receipt through electronic scans linked to the EDA database.\n<\/b><\/td>\n<\/tr>\n
Downstream Trading Partners Must Authenticate on Shipment?\n<\/strong><\/td>\n Downstream participants (distributors, pharmacies) are expected to\nauthenticate product data on shipment through electronic scans linked to the EDA database. <\/b><\/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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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>
Companies must report unit and aggregation events (production, packaging, shipment, receipt, etc.) to the Electronic Track & Trace System.
<\/b>Reporting may be done through API connectivity or direct
platform submission; real-time reporting is expected for key event
types.<\/td><\/tr>
Downstream Trading Partner Activity Reported? <\/strong><\/td>Yes<\/td><\/tr><\/tbody><\/table>\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\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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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\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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Egypt Regulatory Regulatory For Pharma Regulatory Agency Egyptian Drug Authority (EDA) Regulation Name Unified Track & Trace Decree (Decree No. 475 of 2025, published August 2025) Compliance Dates Effective Phase Applicability Key Requirements Phase 1 Imported Finished Products (from 1 Feb 2026) Serialization, reporting & system connectivity for all fully finished imported products. Phase 2 […]<\/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-12759","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 escogerla.","pluginReviewed":false,"postSettings":{"linkSuggestions":true,"useFocusKeyword":false},"frontEndScore":false,"postName":"egypt-regulatory","permalinkFormat":"https:\/\/kevision.in\/es\/%pagename%\/","showLockModifiedDate":true,"assessor":{"focusKeywordLink":"https:\/\/kevision.in\/wp-admin\/edit.php?focus_keyword=%focus_keyword%&post_type=%post_type%","hasTOCPlugin":true,"primaryTaxonomy":false,"serpData":{"title":"","description":"","focusKeywords":"Egypt 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