Here’s a breakdown of the key aspects of Bahrain’s serialization regulations:

1. Centralized System: NHRA-MVC Traceability Hub

• Bahrain utilizes a centralized system called the NHRA-MVC Traceability Hub as the core of its pharmaceutical regulatory framework.
• All manufacturers, importers, and distributors are required to report complete serialization and aggregation data to this hub, creating an end-to-end track-and-trace capability.

2. GS1-Compliant Serialization:

• All pharmaceutical products must feature GS1 Data Matrix barcodes at the unit level.
• These barcodes must contain critical information, including:
  • GTIN (Global Trade Item Number) – AI (01)
  • Expiration Date (YYMMDD format) – AI (17)
  • Unique Serial Number (up to 20 alphanumeric characters) – AI (21)
  • Batch or Lot Number (up to 20 alphanumeric characters) – AI (10)
• Human Readable Interpretation (HRI) of this data must also be present on the label.

3. Mandatory Aggregation:

• Aggregation is mandatory, ensuring the hierarchical relationship between individual units and their parent packaging (cartons, cases, pallets) remains intact throughout the supply chain.
• This involves using Serialized Shipping Container Codes (SSCC) for cases and pallets, supporting up to five levels of hierarchy.
• Aggregation became mandatory for MAHs (Marketing Authorization Holders) as of May 2022.

4. Transaction Reporting:

• Every transaction, from receiving and packaging to shipping and dispensing, must be meticulously recorded and submitted to the NHRA-MVC Traceability Hub.
• Importantly, only packing events are mandatory to report. Operational events within the warehouse and unpacking events are generally not required to be reported.

5. Bilingual Labeling:

• The NHRA mandates comprehensive bilingual labeling in both English and Arabic for all pharmaceutical products. This ensures clear product identification and proper usage instructions.

6. Scope of Products:

• The regulations primarily apply to:
  • Foreign-produced medicines imported as finished goods.
  • Imported medicines that are repackaged locally.
  • Non-registered medicines with a temporary importation license.
• The reporting responsibility primarily lies with the invoicing company (often the MAH).

7. Key Stakeholders Affected:

• Marketing Authorization Holders (MAHs)
• Manufacturers (including Contract Manufacturing Organizations – CMOs)
• Importers
• Wholesalers and Distributors in Bahrain
• Hospitals, Pharmacies, and Clinics (Dispensers)

8. Implementation Timeline (Phased Rollout):

• November 2017: GTINs made compulsory for all drugs.
• April 2018: Product master data reported to GS1 UAE BrandSync portal.
• December 2019: Registration on MVC made mandatory for all MAHs; Barcoding and serialization requirements.
• January 2021: Registration in the NHRA-MVC Traceability Hub required.
• October 2021: MAHs certified and began sharing shipment information with the MVC Traceability Hub (Phase 1 completed December 2021).
• May 2022: Mandatory aggregation for MAHs (Phase 2).
• June 2022: Scanning and authentication required by customs, distributors, and pharmacies (Phase 3).
• Circular No. (05) 2023: Mandated GLN (Global Location Number) requirement for agents and importers for transactions within Bahrain’s systems.

Compliance Steps for Stakeholders:

• Registration: MAHs, manufacturers, and distributors must register with the NHRA-MVC Traceability Hub.
• Data Submission: Submit serialization and aggregation data through the NHRA-MVC portal.
• Labeling Compliance: Ensure GS1-compliant barcodes and bilingual labels as per NHRA guidelines.
• Reporting: Regularly report packing events to maintain compliance.
• GLN Acquisition: Agents and distributors engaged in import activities must acquire a Global Location Number (GLN) from GS1.

Important Resources:

• NHRA-MVC Traceability Hub: https://nhra-mvc.bh/
• NHRA Pharmacy & Pharmaceutical Products Regulation Section: https://www.nhra.bh/Departments/PPR/
• Medicines Barcoding and Serialization Guideline: Available on the NHRA website