bahrain traceability system

[Blog] Bahrain Traceability System – mandatory serialization and aggregation in a year

With the end of 2021 also comes the deadline for the traceability system`s development in Bahrain.

 

 

The main objective of the National Health Regulatory Authority (NHRA) was the successful traceability of all pharmaceutical products manufactured, distributed, and dispensed within the Kingdom of Bahrain through the use of GS1 Best Practices and Guidelines.
 
Looking back, the journey of the Kingdom of Bahrain started in 2019 with the publishing of Version 1.1 of the Medicines Barcoding and Serialization Guidelines that included adjustments to the mandatory and optional fields. In 2021 the NHRA  worked on finalizing the Technical Onboarding Guideline, publishing a circular that gave a 90-day grace period to Invoicing Companies, MAHs and exporting distributors to submit reports to the MVC Hub. 31 December 2021 was the deadline marking the mandatory serialization.

 

 

Main required attributes:

 

GS1 Global Trade Item Number (GTIN)

Expiration Date

Serial Number (up to 20 characters)

Batch/ Lot Number

 

 

Aggregation

 

The NHRA requires both the case and pallet packaging aggregation, which is scheduled to become optional to mandatory in June this year.

The aggregation requirements are as following:

 

Serialized Global Trade Identification Number (SGTIN) – should be placed on the case/shipper (unit-level medicines)

Uniquely Identified Serialized Shipping Container Code (SSCC) – should be placed on the pallet (tertiary level)

 

 

Timeline

 

December 31, 2021 – Serialization and EPCIS reporting to MVC Hub required for MAHs

May 1, 2022 – Aggregation Requirements Deadline (cases and pallets)

June 1, 2022 – Scanning for shipment and medicines authentication (Customs, Distributors, Pharmacies, Dispensers)
 
 

NHRA-MVC Program

 

NHRA-MVC should enhance patient safety and secure healthcare, providing end-to-end track and trace supply chain solution (from manufacturing to dispensing) for pharmaceutical products sold within Bahrain. The track and trace supply chain application provides real-time transparency, accountability, and verification, through its website and supply chain event repository (NHRA-MVC Traceability Hub).


 
If you need any assistance or consultation regarding the Bahrain Traceability System and serialization requirements, our experts are a click away >>

 


Sources:

https://www.nhra-mvc.bh/

https://www.nhra.bh/Departments/PPR/MediaHandler/GenericHandler/documents/departments/PPR/Medicines/Guidelines/PPR_Guideline_Medicines%20Barcoding%20and%20Serialization%20Guidelines%202019_V1.2_20190520.pdf

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