--- title: "Pharmaceutical Serialization in the GCC: Spotlight on Bahrain" description: Explore Bahrain’s 2025 pharma serialization rules, NHRA-MVC compliance steps, and how to meet GS1 and EPCIS traceability standards. image: https://blog.cosmotrace.com/hubfs/Pharmaceutical%20Serialization%20in%20the%20GCC%20(Bahrain)%20-%20June%202025%20-%20blog%20-%20Featured%20Image.jpg --- +44 203 097 1597 [info@cosmotrace.com](mailto:info@cosmotrace.com) - - - - [![Cosmotrace](https://blog.cosmotrace.com/hs-fs/hubfs/raw_assets/public/CosmoTrace_Oct2021/images/cosmotrace-2.png?width=630&height=209&name=cosmotrace-2.png "Cosmotrace")](https://www.cosmotrace.com/) - [Home](https://www.cosmotrace.com/) - [About Us](https://www.cosmotrace.com/about-us/) - [Careers](https://www.cosmotrace.com/pages/careers/) - [Services](https://www.cosmotrace.com/our-services/) - Compliance Focused - [Misalignment Exceptions Management (US DSCSA)](https://www.cosmotrace.com/our-services/misalignment-exceptions-management-us-dscsa/) - [EU Alert Management](https://www.cosmotrace.com/our-services/eu-alert-management/) - [Middle East Serialization Consulting](https://www.cosmotrace.com/our-services/middle-east-serialization-consulting/) - [China Reporting Services](https://www.cosmotrace.com/our-services/china-reporting-services/) - Business Operations Focused - [Master Data Management](https://www.cosmotrace.com/our-services/master-data-management/) - [Trade Partner Onboarding](https://www.cosmotrace.com/our-services/trade-partner-onboarding/) - [Level 4 System Validation](https://www.cosmotrace.com/our-services/level-4-system-validation/) - [Serialization System Health Check](https://www.cosmotrace.com/our-services/serialization-system-health-check/) - Business Processes Outsourcing - [Managed Services CoE](https://www.cosmotrace.com/our-services/managed-services-coe/) - [US DSCSA Ti Digitization](https://www.cosmotrace.com/our-services/us-dscsa-ti-digitization/) - [Our Solutions](https://www.cosmotrace.com/solutions/) - [Traceware](https://www.cosmotrace.com/solutions/traceware/) - [nTrack](https://www.cosmotrace.com/solutions/ntrack/) - [Clients](https://www.cosmotrace.com/clients/) - [Blog](https://www.cosmotrace.com/blog/) - [Serialization](https://www.cosmotrace.com/blog/serialization) - [Digital](https://www.cosmotrace.com/blog/digital) - [News](https://www.cosmotrace.com/blog/news/) - [Contact](https://www.cosmotrace.com/contact-us/) - - - - - [Home](https://www.cosmotrace.com/) - [About Us](https://www.cosmotrace.com/about-us/) - [Careers](https://www.cosmotrace.com/pages/careers/) - [Services](https://www.cosmotrace.com/our-services/) - Compliance Focused - [Misalignment Exceptions Management (US DSCSA)](https://www.cosmotrace.com/our-services/misalignment-exceptions-management-us-dscsa/) - [EU Alert Management](https://www.cosmotrace.com/our-services/eu-alert-management/) - [Middle East Serialization Consulting](https://www.cosmotrace.com/our-services/middle-east-serialization-consulting/) - [China Reporting Services](https://www.cosmotrace.com/our-services/china-reporting-services/) - Business Operations Focused - [Master Data Management](https://www.cosmotrace.com/our-services/master-data-management/) - [Trade Partner Onboarding](https://www.cosmotrace.com/our-services/trade-partner-onboarding/) - [Level 4 System Validation](https://www.cosmotrace.com/our-services/level-4-system-validation/) - [Serialization System Health Check](https://www.cosmotrace.com/our-services/serialization-system-health-check/) - Business Processes Outsourcing - [Managed Services CoE](https://www.cosmotrace.com/our-services/managed-services-coe/) - [US DSCSA Ti Digitization](https://www.cosmotrace.com/our-services/us-dscsa-ti-digitization/) - [Our Solutions](https://www.cosmotrace.com/solutions/) - [Traceware](https://www.cosmotrace.com/solutions/traceware/) - [nTrack](https://www.cosmotrace.com/solutions/ntrack/) - [Clients](https://www.cosmotrace.com/clients/) - [Blog](https://www.cosmotrace.com/blog/) - [Serialization](https://www.cosmotrace.com/blog/serialization) - [Digital](https://www.cosmotrace.com/blog/digital) - [News](https://www.cosmotrace.com/blog/news/) - [Contact](https://www.cosmotrace.com/contact-us/) - - - - # Pharmaceutical Serialization in the GCC: Spotlight on Bahrain May 23, 2025 | ![Pharmaceutical Serialization in the GCC: Spotlight on Bahrain](https://blog.cosmotrace.com/hubfs/Pharmaceutical%20Serialization%20in%20the%20GCC%20(Bahrain)%20-%20June%202025%20-%20blog%20-%20Featured%20Image.jpg) Welcome to the third entry in our blog series on pharmaceutical serialization across the Middle East. In this edition, we turn our attention to the Kingdom of Bahrain, a proactive nation in advancing medicine traceability through its NHRA-MVC Traceability Hub. As of May 2025, Bahrain has made significant strides in enforcing a comprehensive serialization and aggregation framework regulated by the National Health Regulatory Authority (NHRA). Since the phased rollout began in late 2021, Bahrain has steadily expanded its compliance requirements, making serialization, aggregation, and centralized EPCIS reporting mandatory for all stakeholders in the pharmaceutical supply chain. In this article, we examine Bahrain’s current regulatory landscape, key milestones, and how the country is positioning itself as a regional leader in pharmaceutical safety and supply chain transparency # **Bahrain Pharmaceutical Serialization: 2025 Compliance Landscape and Implementation Guide** As of May 2025, Bahrain's National Health Regulatory Authority (NHRA) continues to enforce stringent pharmaceutical serialization and traceability regulations through the NHRA-MVC Traceability Hub. These regulations aim to enhance supply chain transparency, ensure patient safety, and prevent counterfeit medicines. ### **Why Serialization in Bahrain?** Serialization ensures every pharmaceutical product is uniquely identified, tracked, and verified at every point in the supply chain. Through integration with the GS1 global standard, Bahrain has adopted a future-proof framework that aligns with international best practices. ### **Implementation Roadmap** Bahrain rolled out serialization requirements in three structured phases: - **Phase 1** – December 31, 2021: Serialization and EPCIS reporting to the NHRA-MVC Hub (MAHs) - **Phase 2** – May 1, 2022: Mandatory aggregation to cases and pallets (MAHs) - **Phase 3** – June 1, 2022: Scanning and authentication required by customs, distributors, pharmacies ## **Key Regulatory Requirements (2025)** 1. **GS1-Compliant Serialization:** All pharmaceutical products must feature GS1 Data Matrix barcodes containing the GTIN, expiration date, batch or lot number, and a unique serial number. 2. **Mandatory Aggregation:** Since May 2022, aggregation is mandatory with hierarchical packaging structures using SSCC, supporting up to five levels. 3. **Centralized Reporting:** Manufacturers, importers, and distributors must report serialization and aggregation data to the NHRA-MVC Traceability Hub. Only packing events are mandatory. 4. **Bilingual Labelling:** Labels must be in both English and Arabic to ensure safe usage. #### **Recent Developments** In February 2025, the NHRA-MVC system underwent significant upgrades to enhance its serialization capabilities and align with global best practices. These enhancements aim to strengthen supply chain security and improve regulatory compliance. #### **Compliance Steps for Stakeholders** 1. **Registration:** MAHs, manufacturers, and distributors must register with the NHRA-MVC Traceability Hub. 2. **Data Submission:** Submit serialization and aggregation data through the NHRA-MVC portal. 3. **Labelling Compliance:** Use GS1-compliant barcodes and bilingual labels as per NHRA guidelines. 4. **Reporting:** Regularly report packing events to maintain compliance. ### **Circular No. (05) 2023: GLN Requirement for Agents and Importers** All agents and distributors engaged in import activities must participate in the GS1 system and acquire a Global Location Number (GLN). This is essential for transacting within Bahrain’s DUR or OFOQ systems and receiving EPCIS events from MAHs. A GLN can be purchased from authorized GS1 providers worldwide, starting at around $30 as a one-time fee. ##### **Conclusion** Bahrain’s serialization initiative showcases its commitment to modernizing healthcare infrastructure and enhancing medicine safety. Companies must integrate with the NHRA-MVC system, follow GS1 standards, and maintain traceability procedures to ensure compliance. Resources: - NHRA-MVC Traceability Hub: [https://nhra-mvc.bh/](https://nhra-mvc.bh/) - NHRA Pharmacy & Pharmaceutical Products Regulation Section: [https://www.nhra.bh/Departments/PPR/](https://www.nhra.bh/Departments/PPR/) Stay tuned for the next blog in our series as we explore serialization developments in Oman Oman is actively enhancing its pharma regulations, influenced by Gulf-wide harmonization efforts. The Ministry of Health (MoH Oman) has shown interest in adopting GS1 standards and digital supply chain systems. Still in earlier stages and less mature than UAE/KSA, however making it a timely and educational topic. ##### How can CosmoTrace help? We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe. We are well versed with the compliance regulations for various markets and can help you with implementing the GCC pharmaceutical serialization requirements. Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity. Disclaimer This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.   [![Contact us for a free consultation](https://no-cache.hubspot.com/cta/default/6755855/3542e820-e987-4b17-8af5-c4b1ddb081e6.png)](https://cta-redirect.hubspot.com/cta/redirect/6755855/3542e820-e987-4b17-8af5-c4b1ddb081e6) #### Search #### Recent Posts - [Egypt’s Pharmaceutical Track and Trace - From 2019 Pilot to 2025 Nationwide Mandate](https://blog.cosmotrace.com/serialization/egypt-pharma-traceability-2025-mandate) - [Algeria’s 2027 Pharmaceutical Serialization & Aggregation](https://blog.cosmotrace.com/serialization/algeria-2027-pharmaceutical-serialization-aggregation) - [Serialization and Traceability in the Middle East: Navigating a Complex Compliance Landscape](https://blog.cosmotrace.com/serialization/middle-east-serialization-traceability-compliance) - [Sri Lanka Extends Barcode Grace Period for Medicines: What MAHs Need to Know](https://blog.cosmotrace.com/serialization/sri-lanka-barcode-grace-period-extension) - [DSCSA Enforcement Timeline: What Trading Partners Need to Know in 2025](https://blog.cosmotrace.com/serialization/dscsa-enforcement-timeline-2025) - - - - © 2020 CosmoTrace - part of ZeeInx Group