🇧🇭Bahrain Active
NHRA-MVC Traceability Hub National Health Regulatory AuthoritySerialization Requirements
| Level | Required | Identifier Type | Description |
|---|---|---|---|
| Unit | Required | SGTIN |
GS1-compliant Data Matrix with GTIN |
| Case/Bundle | Required | SSCC |
Case-level aggregation mandatory |
| Pallet/Shipper | Required | SSCC |
Pallet aggregation mandatory |
Reporting Obligations
| Event Type | Required | Timing | Description |
|---|---|---|---|
| Commissioning | Required | Before shipment | Serial generation and EPCIS reporting to NHRA-MVC Hub |
| Shipping | Required | At shipment | Dispatch event |
| Receiving | Required | Upon receipt | Receipt event |
| Authentication | Required | Real-time | Scanning and authentication by customs, distributors, pharmacies |
Technical Requirements
- EPCIS Version
- v@Model.TechnicalRequirements.EpcisVersion
- Data Format
XML- Integration Method
- API
- Barcode Type
- DataMatrix (GS1)
- Required Fields
- GTIN Serial Number Batch/Lot Expiry Date
Product Scope
- Prescription pharmaceutical products
- Vaccines
- Biological products
- OTC medicines (from 2026)
Key Deadlines
Legislative Decree No. 41
Jan 01, 2017
Legislative framework for pharmaceutical track-and-trace
Phase 1 - Serialization & EPCIS
Dec 31, 2021
Serialization and EPCIS reporting to NHRA-MVC Hub (MAHs)
Phase 2 - Aggregation
May 01, 2022
Mandatory aggregation to cases and pallets (MAHs)
Phase 3 - Full Authentication
Jun 01, 2022
Scanning and authentication by customs, distributors, pharmacies
Phase 4 - Prescription Medicines
Jan 01, 2025
Serialization mandatory for all prescription medicines
Phase 5 - OTC Extension
Jan 01, 2026
Aggregation and reporting extended to OTC medicines
Notes
NHRA-MVC is a blockchain-based end-to-end traceability hub - first of its kind in the GCC. System upgraded in January 2025 with enhanced capabilities. Labels must be in English and Arabic. Real-time product verification available for stakeholders.
Last updated: December 25, 2024