Bahrain Medicines Compliance

NHRA Track and Trace Requirements

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

Bahrain requires pharmaceutical manufacturers, importers and distributors to serialize and track medicines through the NHRA Track and Trace System. All human medicines imported into Bahrain must carry GS1 DataMatrix barcodes and must be reported at key steps in the supply chain.

Bahrain’s model is similar to the systems used across the GCC region, aiming to improve patient safety and prevent counterfeit medicines. While less complex than Russia or Kazakhstan, Bahrain still requires accurate serialization, aggregation and event reporting for customs clearance and distribution.

Labelling Requirements 

Each sellable pack must carry a GS1 2D DataMatrix containing:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

Human readable data must match the barcode.

Cases and pallets should include SSCC barcodes to support aggregation for shipment reporting.

Regulatory Timeline 

  • 2020 – Bahrain begins serialization readiness activities.
  • 2021 – GS1 DataMatrix serialization becomes mandatory on all medicines.
  • 2022 – Reporting through NHRA platform required for imports and distribution.
  • 2023 onward – Strong enforcement of shipment-level reporting and aggregation.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial, Batch, Expiry
Before dispatch
Aggregation
Parent SSCC and Child Serials
Before dispatch
Shipment Dispatch
Sender, Receiver, SSCC or Serial List
Before dispatch
Receiving
SSCC or Serial List
At arrival in Bahrain
Distribution
Serial list
When supplying to pharmacy or hospital
Returns
Serial and return status
When goods are returned
Decommission
Serial and reason
For expired, damaged or destroyed units

Operational Timelines for Industry 

  1. Register with the NHRA platform and obtain reporting credentials.
  1. Configure GTINs and update artwork for serialized DataMatrix codes.
  1. Print serialized labels during packaging.
  1. Build SSCC aggregation for every shipment.
  1. Report commission, aggregation and shipping before dispatch.
  1. Complete import reporting before customs inspection.
  1. Report receiving, distribution, returns and decommission events on time.

Reporting Hub

  • Reporting is done to the NHRA Track and Trace System.
  • Integration is supported through API connectivity or manual upload.
  • Importers must ensure shipment-level reporting before products enter the market.
  • Local distributors must report receiving, shipping and supply operations.

Aggregation Requirements 

  • Aggregation is strongly required to avoid reporting failures.
  • Parent child hierarchy must be complete for each shipment.
  • SSCCs must be unique and must not be reused.
  • Missing or incorrect aggregation may delay customs clearance.

Common Errors to Avoid 

  • Missing SSCC aggregation for cases and pallets.
  • Incorrect sender or receiver location information.
  • Serial mismatch between label and reported message.
  • Reuse of SSCC identifiers.
  • Late reporting causing customs delays.
  • Incomplete data for returns or decommission operations.

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EPCIS Data Encoder,Capital Wholesale Drug
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