Bahrain

v. 28 – Q4 2023

Major Update: Joint GHC (Gulf Health Council) e-leaflet pilot, fully mandated by 2025.

Market Executive Summary Use of National Data Catalogue based on GS1 standard to improve data quality and facilitate trade.
The Kingdom of Bahrain’s National Health Regulatory Authority (NHRA) believes that the global standards for automatic identification provide an opportunity to make the healthcare supply chain safer as well as more efficient.
The NHRA is adopting and mandating the use of GS1 DataMatrix on the packaging of pharmaceutical products. All products must be compliant with this new regulation by 31st December 2019.
A national traceability hub NHRA-MVC Traceability Hub will be established, with MAHs to register by 1st January 2021.
Key Dates
  • June 30, 2023: All invoicing companies (MAHs, Manufacturers, Exporting Distributors) must include the invoice number referenced in the NHRA Sehati-DUR record, in the EPCIS file sent to the Traceability Hub after 30 June 2023.
  • June 1, 2022: Customs agents, agents and distributors and dispensers to start scanning 2D barcodes.
  • May 1, 2022: For all medicines shipped to Bahrain, serialization aggregation and reporting to the NHRA-MVC Traceability Hub is mandatory.
  • December 31, 2021: For all medicines shipped to Bahrain, serialization and reporting to the NHRA-MVC Traceability Hub is mandatory. Aggregation is not mandatory for this deadline.
  • October 1, 2021: All MAHs to be fully certified
  • January 1, 2021: All MAHs to be registered in the NHRA-MVC Traceability Hub
  • January 1, 2020: No Medicine will be imported to Bahrain unless master data has been uploaded on the BrandSync Portal.
  • December 31, 2019: 2D DM with Item-level serialisation required for certain product categories
  • July 31, 2018: Provision of master data to National Product Catalogue, operated by GS1 UAE: GS1 UAE’s Portal (known as BrandSync) for all existing and new products supplied to the NHRA. BrandSync will be the single source of information for all product master data supplied to the NHRA. (https://brandsync.secure.force.com/BSForm/)

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