FAQs

Find answers to common questions about registration, compliance, system navigation, and more.

Does your Company need to Signup with NHRA-MVC to use the Traceability Hub?

Sign up with NHRA-MVC is required to use the Traceability Hub. All Invoicing Companies (MAHs, Manufacturers), Agents/Distributors (Importers), Dispensers (Hospitals, Pharmacies, Clinics) will need to sign up.

  • Invoicing Companies / MAH’s must provide proof of pharmaceutical drug registration in the DUR, and have an assigned Global Location Number and Company Prefix from GS1
  • Invoicing Companies/ MAH’s will need to sign up and pay to have a Participation Agreement in place with the NHRA-MVC Traceability Hub.
  • All Dispensers that include Hospitals, Pharmacies, and Clinics will need to sign up with the NHRA-MVC to use the NHRA-MVC Traceability Hub. The sign-up process is simple and can be completed in a few minutes.

You can sign up on our website at  www.NHRA-MVC.bh

The Supreme Council of Health (SCH) and the National Health Regulatory Authority (NHRA) believe that global standards for automatic identification provide an opportunity to make the healthcare supply chain in the Kingdom of Bahrain safer as well as more efficient and accurate.

The NHRA-MVC Traceability Hub is part of the NHRA program committed to enhancing the lives of the people of Bahrain. For further information regarding this effort please refer to the following:

The requirement to submit your product information to the BrandSync Portal is part of the Medicines Barcoding and Serialization Guideline that was published by the National Health Regulatory Authority (NHRA) in May, 2021.
  • You are required to add your product master information to the BrandSync Portal as part of the GS1 labeling standards Bahrain has implemented.
  • This will not change going forward and should continue to be part of your process as it is today.
The NHRA-MVC Traceability Hub is for tracking all registered medicines; from the time they are shipped to Kingdom of Bahrain, to the point they are dispensed to patients.
  • Each shipment, receipt, sale and dispense transaction will be captured in the NHRA-MVC Traceability Hub using the GS1 barcoding and serialization outlined in the Guideline mentioned above.
  • For registration with BrandSync visit BrandSync

The most important implementation resource for barcode identification are the over 100 GS1 Member Organizations in countries all around the world. There are ten Steps to Barcode Implementation:

  • Step 1 Get a GS1 Company Prefix
  • Step 2 Assign numbers
  • Step 3 Select a barcode printing process
  • Step 4 Select a “primary” scanning environment
  • Step 5 Select a barcode
  • Step 6 Pick a barcode size
  • Step 7 Format the barcode text
  • Step 8 Pick a barcode color
  • Step 9 Pick the barcode placement
  • Step 10 Build a barcode quality plan

This GS1 guide takes new barcode users through the basic steps they must take to begin using barcodes. 10 Steps to barcode your product.

Reference the Medicines Barcoding and Serialization Guideline from the National Health Regulatory Authority (NHRA) to understand the expectations for meeting barcoding and labeling medicines sold in Bahrain.

Aggregation defines the relationship between the parent and child barcodes allowing the receiver of the product to scan one code and understand exactly what is in the whole shipment — every case or individual carton. NHRA requires both the case/shipper and the pallet tertiary packaging aggregation barcodes & serialization.

Serialized Global Trade Identification Numbers (SGTIN) should be used on unit level medicines and for the case /shippers. Uniquely identified Serialized Shipping Container Code (SSCC) should be used for the pallet (tertiary level) aggregation barcodes & serialization.

NHRA requires both the secondary case/shipper and the pallet tertiary packaging aggregation barcodes & serialization. Serialized Global Trade Identification Numbers (SGTIN) should be used on unit level medicines and for the case /shippers. Uniquely identified Serialized Shipping Container Code (SSCC) should be used for the pallet (tertiary level) aggregation barcodes & serialization. NHRA requires both the secondary case/shipper and the pallet tertiary packaging aggregation barcodes & serialization.
All Invoicing Companies / MAHs must sign up with GS1 and have a Global Location Number (GLN) and Global Company Prefix (GCP) assigned. Make sure you know the GS1 Global Location Number (GLN) and Global Company Prefix (GCP) assigned to the manufacturing location of each product.

The NHRA-MVC Traceability Hub registration process for each company has 2 parts – the administrative registration and the technical onboarding.

The technical onboarding consists of

  • Connecting to the TEST hub and submitting specific data files to demonstrate compliance
  • Connecting to the PRODUCTION hub and becoming operational.
  • The commitment by each company to maintain compliance with the reporting requirements and data to be reported.

With confirmation and your successful registration and payment, the Administrative Contact and the Technical Point of Contact (T-POC) will receive an email stating the technical testing will be initiated.

  • The T-POC will be provided with access to the NHRA-MVC Traceability Hub.
  • Each connected entity must demonstrate the ability to send properly formatted data to the TEST NHRA-MVC Traceability Hub.
  • When this is successfully completed, the T-POC will be provided with credentials for the PRODUCTION hub to go live.
The Invoicing Company could be the same company that manufactures and ships the medicine to the Kingdom of Bahrain, or it could be a separate company that handles the invoicing.
  • You can access the BrandSync portal to find the information regarding the invoicing companies. Check the BrandSync website here.

To support this traceability effort and repository, the NHRA requires that all legally registered Invoicing Companies (IC) cover the ongoing cost of the Traceability Hub and its maintenance.

Each Invoicing Company (IC) must sign up with its own information in the NHRA-MVC Traceability Hub, sign the Participation Agreement and pay the required sign up fees. The process is easy to complete by following the steps.

The process is easy to complete by following the steps. Before You Sign-Up
It will be helpful to have the Global Location Number (GLN) used to register in the BrandSync portal. You can access the BrandSync portal to find this information if you are not certain. Check the BrandSync website here. Click the  Sign-up link in the top navigation bar and select Invoicing Company to get started.  Once your email address is verified, you will go to the NHRA-MVC website here to log in with the UserID and password you created. 
  • You will enter your Company information plus the contact information of the Authorized Representative (the person legally authorized to sign the Participation Agreement on behalf of your company) and the Technical Point of Contact.
  • Download the Participation Agreement and review the document.
  • Your Authorized Representative signs the Participation Agreement
  • Log in again to the NHRA-MVC website and pay the fees.
  • Attach the signed Participation Agreement.
The NHRA-MVC team will confirm your payment has been completed and the Participation Agreement has been signed by the Authorized Representative. The NHRA-MVC Support team can begin the technical onboarding and certification of your associated manufacturers and their IT Serialization Partner.