{"id":12581,"date":"2023-04-10T13:28:29","date_gmt":"2023-04-10T13:28:29","guid":{"rendered":"https:\/\/kevision.in\/?page_id=12581"},"modified":"2026-03-02T10:08:40","modified_gmt":"2026-03-02T10:08:40","slug":"bahrain-regulatory","status":"publish","type":"page","link":"https:\/\/kevision.in\/ru\/whitepapers\/bahrain-regulatory\/","title":{"rendered":"Bahrain Regulatory"},"content":{"rendered":"
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Bahrain 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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Bahrain<\/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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Bahrain 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>National Health Regulatory Authority (NHRA)<\/td><\/tr>
Regulation Name<\/strong><\/td>
  • NHRA\u00a0Track & Trace System for Pharmaceutical Products<\/strong><\/li>
  • NHRA Circulars and Serialization & Barcoding Guidelines for Human
    Medicines (Bahrain implemented a national medicine traceability
    system aligned with GS1 standards.)<\/li><\/ul><\/td><\/tr>
Compliance Dates<\/strong><\/td>2019\u20132020:<\/b> Initial implementation phase for barcoding and
serialization.

Full implementation mandatory<\/b> for serialized pharmaceutical products
placed on the Bahraini market thereafter.

Ongoing enforcement for manufacturers, importers, and distributors.<\/td><\/tr>
Applies to<\/strong><\/td>All registered human pharmaceutical products<\/b> (prescription and OTC)
marketed in Bahrain.

Applies to manufacturers, Marketing Authorization Holders (MAHs),
importers, distributors, and pharmacies.<\/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<\/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 2D DataMatrix<\/td>\n <\/tr>\n
Barcode Content<\/strong><\/td>\n \n
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  • GTIN (AI 01)<\/li>\n
  • Serial Number (AI 21)<\/li>\n
  • Expiry Date (AI 17)<\/li>\n
  • Batch\/Lot (AI 10)<\/li>\n <\/ul>\n <\/td>\n <\/tr>\n
Serial Number Randomization<\/strong><\/td>\n Yes \u2013 unique and randomized<\/td>\n <\/tr>\n
Serial Number Reuse<\/strong><\/td>\n Not permitted<\/td>\n <\/tr>\n
Human Readable Expiry Date Format <\/strong><\/td>\n \n Typically MM\/YYYY or DD\/MM\/YYYY consistent with labeling\n <\/td>\n <\/tr>\n
Barcode Data Encoding<\/strong><\/td>\n GS1 Application Identifiers (01, 17, 10, 21)<\/td>\n <\/tr>\n
Product Code Notes <\/strong><\/td>\n \n GTIN required and must be registered with GS1 and linked to NHRA\n registration.\n <\/td>\n <\/tr>\n
Free Samples must be marked?<\/strong><\/td>\n \n Yes \u2013 must comply with labeling and serialization if distributed within\n supply chain\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 AI 00)<\/td>\n <\/tr>\n
Barcode Contents<\/strong><\/td>\n SSCC and parent-child aggregation data<\/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 Yes<\/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 Yes \u2013 serialized unit data reported to NHRA system<\/td>\n <\/tr>\n
\n Send Unit Data to Third-Party Repository? <\/strong>\n <\/td>\n Optional (internal enterprise systems)<\/td>\n <\/tr>\n
Send Unit Data to Trading Partner? <\/strong><\/td>\n Commercial exchange expected between partners<\/td>\n <\/tr>\n
\n Send Aggregation Data to Government Repository?<\/strong>\n <\/td>\n Yes<\/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 expected<\/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 NHRA national Track & Trace system<\/td>\n <\/tr>\n
\n Manufacturers Must Register Shipments in Repository? <\/strong>\n <\/td>\n \n Yes \u2013 commissioning and shipment events must be reported\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Receipt?\n <\/strong>\n <\/td>\n \n Yes \u2013 distributors required to scan and confirm receipt\n <\/td>\n <\/tr>\n
\n Downstream Trading Partners Must Authenticate on Shipment?\n <\/strong>\n <\/td>\n Yes<\/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<\/td>\n <\/tr>\n
\n Downstream Trading Partner Activity Reported? <\/strong>\n <\/td>\n Yes<\/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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Bahrain Regulatory Regulatory For Bahrain Bahrain Regulatory Requirements Regulatory Agency National Health Regulatory Authority (NHRA) Regulation Name NHRA\u00a0Track & Trace System for Pharmaceutical Products NHRA Circulars and Serialization & Barcoding Guidelines for HumanMedicines (Bahrain implemented a national medicine traceabilitysystem aligned with GS1 standards.) Compliance Dates 2019\u20132020: Initial implementation phase for barcoding andserialization. Full implementation mandatory […]<\/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-12581","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 \u0443\u0432\u0438\u0434\u0435\u0442\u044c Facebook \u0438 \u0434\u0440\u0443\u0433\u0438\u0435 \u0441\u0430\u0439\u0442\u044b 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