Bahrain
| Regulatory Agency | National Health Regulatory Authority (NHRA) |
| Regulation Name |
|
| Compliance Dates | 2019–2020: Initial implementation phase for barcoding and serialization. Full implementation mandatory for serialized pharmaceutical products placed on the Bahraini market thereafter. Ongoing enforcement for manufacturers, importers, and distributors. |
| Applies to | All registered human pharmaceutical products (prescription and OTC) marketed in Bahrain. Applies to manufacturers, Marketing Authorization Holders (MAHs), importers, distributors, and pharmacies. |
| Barcode Symbology | GS1 2D DataMatrix |
| Barcode Content |
|
| Serial Number Randomization | Yes – unique and randomized |
| Serial Number Reuse | Not permitted |
| Human Readable Expiry Date Format | Typically MM/YYYY or DD/MM/YYYY consistent with labeling |
| Barcode Data Encoding | GS1 Application Identifiers (01, 17, 10, 21) |
| Product Code Notes | GTIN required and must be registered with GS1 and linked to NHRA registration. |
| Free Samples must be marked? | Yes – must comply with labeling and serialization if distributed within supply chain |
| Barcode Symbology | GS1-128 (SSCC – AI 00) | |
| Barcode Contents | SSCC and parent-child aggregation data | |
| Parent-Child Mapping Aggregation Capture? | Yes |
| Send Unit Data to Government Repository? | Yes – serialized unit data reported to NHRA system |
| Send Unit Data to Third-Party Repository? | Optional (internal enterprise systems) |
| Send Unit Data to Trading Partner? | Commercial exchange expected between partners |
| Send Aggregation Data to Government Repository? | Yes |
| Send Aggregation Data to Third-Party Repository? | Optional |
| Send Aggregation Data to Trading Partner? | Commercially expected |
| Who Offers Data Repository for Authentication? | NHRA national Track & Trace system |
| Manufacturers Must Register Shipments in Repository? | Yes – commissioning and shipment events must be reported |
| Downstream Trading Partners Must Authenticate on Receipt? | Yes – distributors required to scan and confirm receipt |
| Downstream Trading Partners Must Authenticate on Shipment? | Yes |
| Manufacturer Activity Reported? | Yes |
| Downstream Trading Partner Activity Reported? | Yes |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
