With a population of around 1.6 million, Bahrain is one of the smaller markets in the Middle East. Nevertheless, the Kingdom plays a much larger role for international pharmaceutical companies than its population size might suggest. Thanks to its central location in the Gulf region, a population with strong purchasing power, and a well-developed healthcare system, Bahrain offers attractive business opportunities for manufacturers looking to market their pharmaceuticals in the region. At the same time, the country is consistently embracing digital processes and modern regulatory requirements. As a result, the implementation of serialization in Bahrain was mandated as early as 2017.
Companies intending to distribute medicines in Bahrain should be familiar with the country’s serialization requirements. A particularly important development is an upcoming regulatory change: in August 2026, Bahrain will transition to a new national traceability system. The following article outlines the implementation timeline for this change and the requirements for serialization codes.
Authority: National Health Regulatory Authority (NHRA)
Regulation: Resolution No. 41 of 2017
Products: Any pharmaceutical product classified, registered, and approved for marketing by the National Health Regulatory Authority (NHRA).
Code Type: 2D DataMatrix
Aggregation: Mandatory using the SSCC (Serial Shipping Container Code)
What Does the Code Contain?
Bahrain introduced a nationwide track-and-trace system through the Supreme Council of Health to enhance the digitalization and security of the pharmaceutical supply chain. The corresponding regulation requires that prescription medicines be uniquely identifiable and traceable throughout their entire lifecycle, from manufacturing to dispensing to the patient.
To achieve this, secondary packaging must be marked with a GS1 DataMatrix code containing:
- GTIN (AI 01)
- Expiry date (AI 17)
- Batch/Lot number (AI 10)
- A unique serial number for each individual pack (AI 21)
With these requirements, Bahrain aligns itself with internationally established GS1 standards and strengthens protection against counterfeit medicines within the pharmaceutical supply chain.
In addition, aggregation of hierarchical packaging units using SSCC has been mandatory since May 2022. Up to five packaging levels are supported.
What Is the Serialization Timeline in Bahrain?
The history of pharmaceutical serialization in Bahrain has been marked by several significant developments. Resolution No. 41 of 2017, published on November 30, 2017, initiated the official NHRA track-and-trace system. Initially, product master data was submitted through the GS1 UAE portal. Towards the end of 2021, the NHRA-MVC Traceability Hub became Bahrain’s primary serialization portal.
The next major change is scheduled for August 11, 2026. On this date, the NHRA-MVC Hub will be fully replaced by TATABU, the country’s new digital traceability platform, which is also used for medical devices.
The implementation of pharmaceutical serialization in Bahrain can be divided into three phases, with Phase 3 representing the migration to TATABU.
1. Phase: Initial Introduction of Serialization and Traceability
| Date | Milestone |
| Nov 30, 2017 | Publication of Resolution No. 41 introducing a national track-and-trace system |
| Nov 2017 – Apr 2018 | Submission of product master data through the GS1 UAE Portal |
| Nov 2017 – Jul 31, 2018 | Assignment of GTINs for medicines destined for Bahrain and submission of master data by manufacturers |
| Jan 1, 2018 | Traceability requirements enter into force |
| Dec 31, 2019 | Mandatory serialization and marking at secondary packaging level |
2. Phase: Migration to the NHRA-MVC Traceability Hub
| Date | Milestone |
| Jan 1, 2021 | Registration of all MAHs completed |
| Sep 1, 2021 | Registration of agents and distributors in the NHRA-MVC Traceability Hub |
| Dec 31, 2021 | Start of EPCIS reporting by manufacturers and MAHs, and reporting of all received pharmaceutical shipments by distributors |
| May 1, 2022 | Deadline for implementation of aggregation requirements |
3. Phase: Migration from the NHRA-MVC Hub to TATABU
| Date | Milestone |
| Jun 21, 2026 | Publication of Circular 16/2026 regarding migration to TATABU |
| Jun 22, 2026 | Mandatory TATABU onboarding begins for all manufacturers, MAHs, and exporting distributors |
| Jul 20, 2026 | Deadline for initial registration in the TATABU system |
| Aug 10, 2026 | Completion of all onboarding, testing, validation, and training activities required |
| Aug 11, 2026 | TATABU replaces the NHRA-MVC Traceability Hub as the sole mandatory production system for regulatory reporting |
Looking for a Pharmaceutical Serialization Provider in Bahrain?
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Disclaimer
The information provided here represents only one possible interpretation of the applicable regulations. Regulatory requirements are continuously evolving, which means that the information in this article may be incomplete or no longer fully up to date. This article does not constitute legal advice. Please refer to the official regulatory documents before making any business decisions. (Information status: July 2026)