Regulator
National Health Regulatory Authority (NHRA)
System
Traceability
https://www.nhra-mvc.bh/
Legislative Decree No. 41 of 2017
Issuing a Track and Trace System for the Supply Chain of Medicine within the Kingdom of Bahrain.
Law No. 2 of 2018 concerning the Registration and Control of Pharmaceutical Products. This law stipulates that all pharmaceutical products sold in Bahrain must be marked with a unique Datamatrix code and a serial number. The law has been enforced since June 2019, and it applies to all pharmaceutical products, including prescription drugs, over-the-counter medications, and nutritional supplements. Any pharmaceutical company that fails to comply with the marking requirement may face penalties, including fines and suspension of their operating licenses.
Legislative Decree No. 41 of 2017
Issuing a Track and Trace System for the Supply Chain of Medicine within the Kingdom of Bahrain.
Law No. 2 of 2018 concerning the Registration and Control of Pharmaceutical Products. This law stipulates that all pharmaceutical products sold in Bahrain must be marked with a unique Datamatrix code and a serial number. The law has been enforced since June 2019, and it applies to all pharmaceutical products, including prescription drugs, over-the-counter medications, and nutritional supplements. Any pharmaceutical company that fails to comply with the marking requirement may face penalties, including fines and suspension of their operating licenses.
Branding
A Two-Dimensional Barcode shall be printed on the packaging of the product in accordance with the specimen issued by Global Standards One (GS1). NHRA requires both the case/shipper and the pallet tertiary packaging aggregation barcodes & serialization.
Aggregation defines the relationship between the parent and child barcodes allowing the receiver of the product to scan one code and understand exactly what is in the whole shipment — every case or individual carton. The tertiary labeling known as Serialized Shipping Container Codes (SSCC) is designed so that scanning the SSCC label will indicate what is contained within the case of pallet.
Aggregation defines the relationship between the parent and child barcodes allowing the receiver of the product to scan one code and understand exactly what is in the whole shipment — every case or individual carton. The tertiary labeling known as Serialized Shipping Container Codes (SSCC) is designed so that scanning the SSCC label will indicate what is contained within the case of pallet.
Comply with regulations, protect public health, boost supply chain performance and consumer engagement with Utrace Solutions
The key to supply chain success
Other countries:
More countries coverage is coming soon...
A comprehensive package of products to meet your Track & Trace challenges
An analytical tools to monitor and optimize supply chain performance and customer engagement. Comply with industry regulations, reduce environmental impact, improve quality and safety standards, and enhance customer loyalty and satisfaction
Originica
Qualified data management specialists control the correctness of serialization data exchange, the timeliness and completeness of reporting to L5, help administer the system and support users and solve problems with violations of reporting and failures in exchange
Data Governance
The most automated L4 cloud solution for complex labeling management in the pharmaceutical industry
Utrace HUB
Challenges
Managing and verifying large volumes of serialized data across upstream & downstream partners and platforms
Aggregation management
Warehousing operations with serialized products to avoid double scanning and warehouse operations due to smart WMS integrations
Different regulatory requirements within the different regions. Maintaining and exchanging accurate and secure master data for each product, source and destination
Managing and verifying large volumes of serialized data across upstream & downstream partners and platforms (hierarchy exchange)
Utrace Solutions uses a multi-stage data validation system that eliminates errors in alerts to the regulator. It also integrates with popular L2, L3, L4 and ERP systems (Wipotec OCS, Syntegon L2, ARC L3, SAP ATT, Tracelink, and others) to ensure seamless data exchange across the supply chain.
Aggregation management
Utrace Solutions enables its clients to manage aggregation processes at different levels of packaging hierarchy, such as bundle, case, pallet, etc. It also supports different aggregation methods, such as manual scanning, automatic scanning, or mixed scanning.
Warehousing operations with serialized products to avoid double scanning and warehouse operations due to smart WMS integrations
Utrace Solutions provides a solution for warehousing operations with serialized products in the MENA region. The solution integrates with WMS systems in a smart way to automate and optimize warehouse processes and data exchange. Utrace Solutions helps its customers to meet industry regulations, digitize supply chain traceability, and gain insights from supply chain data.
Utrace Solutions allows its clients to automate warehouse processes with serialized products and avoid double scanning. It supports warehouse operations and provides real-time visibility of the inventory status of the serialized products.
Utrace Solutions allows its clients to automate warehouse processes with serialized products and avoid double scanning. It supports warehouse operations and provides real-time visibility of the inventory status of the serialized products.
Different regulatory requirements within the different regions
Utrace Solutions has decentralized country-specific engines that provide fast, stable and efficient connection to Governmental Verification systems in different regions, such as EMVS (Europe), MDLP (Russia), IS MPT (Turkey), GIS MT (Egypt), IS MPT (Iran), ASL BELGISI (Belgium) and others1. It also helps its clients to maintain and exchange accurate and secure master data for each product, source, and destination.
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