{"id":12661,"date":"2023-04-10T15:30:52","date_gmt":"2023-04-10T15:30:52","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12661"},"modified":"2023-11-30T09:17:46","modified_gmt":"2023-11-30T09:17:46","slug":"botswana-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/es\/whitepapers\/botswana-regulatory\/","title":{"rendered":"Botswana Regulatory"},"content":{"rendered":"
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Botswana 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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MEDICINES TRACEABILITY VISION AND STRATEGY\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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REGULATORY AGENCY<\/strong><\/td>The Botswana Medicines Regulatory Authority (BoMRA)<\/td><\/tr>
REGULATION NAME<\/strong><\/td>Medicines traceability vision and strategy<\/td><\/tr>
COMPLIANCE DATES<\/strong><\/td>The government will set up requisite regulatory instruments in 2022-2023 timeframe at which point it will become clear the traceability model to be adopted and other relevant information.<\/td><\/tr>
APPLIES TO<\/strong><\/td>Drug manufacturers who have manufacturing and\/or packaging facilities within Botswana, and who export drugs to any other countries.<\/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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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)\n\n<\/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\n<\/strong><\/td>\nLinear, or 2D Datamatrix following GS1 standards<\/td>\n<\/tr>\n
BARCODE CONTENTS<\/strong><\/td>\n\n
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  • Serial number<\/li>\n \t
  • Batch number<\/li>\n \t
  • Expiry date<\/li>\n<\/ul>\n

    \"\"<\/p>\n<\/td>\n<\/tr>\n

SERIAL NUMBER RANDOMIZATION<\/strong><\/td>\nNo<\/td>\n<\/tr>\n
SERIAL NUMBER REUSE<\/strong><\/td>\n\n
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Not Specified<\/p>\n\n<\/div>\n<\/div><\/td>\n<\/tr>\n

HUMAN READABLE EXPIRY DATE FORMAT\n<\/strong><\/td>\n\n
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YYMMDD<\/p>\n\n<\/div>\n<\/div><\/td>\n<\/tr>\n

BARCODE DATA ENCODING<\/strong><\/td>\n\n
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GS1 Standards<\/p>\n\n<\/div>\n<\/div><\/td>\n<\/tr>\n

PRODUCT CODE NOTES\n<\/strong><\/td>\n\n
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In the case of \u201cmono cartons\u201d, a manufacturer or exporter shall affix the bar code on mono cartons containing one primary pack on an optional basis until further notice<\/p>\n\n<\/div>\n<\/div><\/td>\n<\/tr>\n

FREE SAMPLES MUST BE MARKED?<\/strong><\/td>\n\n
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TERTIARY 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 shipper containing one or more secondary packs)\n\n<\/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\u00a0\u00a0 SYMBOLOGY<\/strong><\/td>\nGSl -128linear<\/td>\n\"\"<\/td>\n<\/tr>\n
BARCODE CONTENTS<\/strong><\/td>\nProduct code (use of the GS1 GTIN is now optional), Lot Number,Expiration Date, GS1 SSCC (SSCC may appear in a separate barcode)<\/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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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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\n\nPARENT-CHILD MAPPING AGGREGATION CAPTURE?<\/strong>\n\n<\/div>\n
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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?\n<\/strong><\/td>\nNo<\/td>\n<\/tr>\n
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?\n<\/strong><\/td>\n\n
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As applicable<\/p>\n\n<\/div>\n<\/div><\/td>\n<\/tr>\n

SEND UNIT DATA TO TRADING PARTNER?\n<\/strong><\/td>\n\n
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As applicable<\/p>\n\n<\/div>\n<\/div><\/td>\n<\/tr>\n

SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?\n<\/strong><\/td>\nNo<\/td>\n<\/tr>\n
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?\n<\/strong><\/td>\n\n
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As applicable<\/p>\n<\/div>\n<\/div><\/td>\n<\/tr>\n

SEND AGGREGATION DATA TO TRADING PARTNER?\n<\/strong><\/td>\n\n
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As applicable<\/p>\n\n<\/div>\n<\/div><\/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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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>Proposed<\/td><\/tr>
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?
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Yes (Exports)<\/p><\/div><\/div><\/td><\/tr>

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?
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No (Future)<\/p><\/div><\/div><\/td><\/tr>

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?
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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>\nNo<\/td>\n<\/tr>\n
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?\n<\/strong><\/td>\n\n
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No<\/p>\n<\/div>\n<\/div><\/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\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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Botswana Regulatory Regulatory For Pharma MEDICINES TRACEABILITY VISION AND STRATEGY REGULATORY AGENCY The Botswana Medicines Regulatory Authority (BoMRA) REGULATION NAME Medicines traceability vision and strategy COMPLIANCE DATES The government will set up requisite regulatory instruments in 2022-2023 timeframe at which point it will become clear the traceability model to be adopted and other relevant information. […]<\/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-12661","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":"botswana-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":"Botswana pharma 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