Pharma (Bahrain)

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1 May 2019 – Master Data – The requirement to submit the product information to the BrandSync Portal is part of the Medicines Barcoding and Serialization Guideline.

31 December 2019 – Serialisation SSU – All Products must be labeled in compliance with Legislative Decree No. 41 of 2017.

1 January 2021 – Registration – Register in the NHRA-MVC Traceability Hub, which requires a signed Participation Agreement with NHRA-MVC.

1 January 2022 – Reporting – All Invoicing Companies representing Manufacturers/MAHs are required to fully report traceability events.

1 May 2022 – Aggregation – All Invoicing Companies representing Manufacturers/MAHs are required to be compliant with Aggregation reporting requirements.

Who is affected?

All Invoicing Companies with NHRA-MVC Traceability Hub will need to sign up

The manufacturer or their CMO
Wholesaler and Distributor in the Kingdom of Bahrain
Hospital or Pharmacy in the Kingdom of Bahrain

Bahrain Track & Trace regulations for pharmaceuticals

A pharmaceutical product that is distributed in the Kingdom of Bahrain for human consumption is registered with BrandSync Portal. MAH or CMO which ships directly to the Kingdom of Bahrain is registered and onboarded with NHRA-MVC Traceability Hub.

The product is serialized at the manufacturing location outside of Bahrain by applying a 2D DataMatrix on a saleable unit pack with info: GTIN, Unique random serial number, Lot Number, and Expiry Date. Each pack is further aggregated into cases and pallets uniquely identified with SSCC coding. MAH holder sends the EPCIS Envelope, which contains Commissioning, Aggregation, and Shipping events, to NHRA-MVC Traceability Hub as soon as the shipping is performed.

If another distribution company ships the goods to the Kingdom of Bahrain, the MAH provides the EPCIS Message with Commissioning and Aggregation to the logistic partner. The Product is shipped to a 3PL in Bahrain. MAH holder sends the EPCIS Envelope, which contains Commissioning, Aggregation, and Shipping events, to NHRA MVC Traceability Hub as soon as the shipping is performed.

3PL (Receiver) receives the goods shipped from a MAH holder and sends the 'Receiving' EPCIS message to NHRA-MVC Traceability Hub after the goods are physically received at the warehouse.

3PL further ships the product to the distributor and sends a 'Shipping' message to NHRA-MVC Traceability Hub at the time of shipping.

The distributor receives the goods shipped from 3PL and sends the 'Receiving' event to NHRA-MVC Traceability Hub after the goods are physically received at the location.

Distributor further ships the product to dispensers such as hospitals and sends a 'Shipping' event to NHRA-MVC Traceability Hub at the shipping time.

Despenser receives the goods shipped from the distributor and sends the 'Receiving' event to NHRA-MVC Traceability Hub after the goods are physically received at the location.

Dispenser consumes the product by administering the medicine to patients and sends the 'Dispensation' event to NHRA-MVC Traceability Hub.

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