Bahrain’s NHRA-MVC System Upgrade: What It Means for Pharmaceutical Compliance

 

Bahrain’s National Health Regulatory Authority (NHRA) has officially launched its upgraded NHRA-MVC system, marking a crucial step in ensuring compliance with Legislative Decree No. 41 (2017) for pharmaceutical track-and-trace. This upgrade strengthens Bahrain’s commitment to secure, transparent, and efficient medicine supply chain management, supporting uninterrupted operations within the national Track & Trace System.

 

The new system introduces critical improvements for marketing authorization holders (MAHs), distributors, and dispensers, requiring timely action to ensure compliance and operational continuity.

 

What’s Changing with the NHRA-MVC System?

 

The enhanced NHRA-MVC system brings new functionalities, including a Blockchain-based Mobile App that pushes the boundaries of pharmaceutical traceability. This innovation allows GS1 serialized data, previously delivered to the NHRA-MVC Hub, to play a greater role in securing the industry and protecting patients.

 

Key next steps for stakeholders include:

 

1. User Login and Access for Agents, Distributors, and Dispensers • NHRA-MVC will provide registered users with login credentials and a sign-in guide to ensure seamless access to the upgraded system.

 

2. Mandatory NHRA-MVC End User Seminars

• NHRA-MVC will host a series of training seminars on February 2, 3, and 4, inviting all relevant stakeholders.
• These sessions will introduce the upgraded portal, explain new features, and provide compliance guidelines.

 

3. On-Site Training and Support

• NHRA-MVC’s global senior support teams will be available at the seminars for hands-on training and Q&A.
• One-on-one on-site training sessions will be scheduled to help distributors maximize the system’s capabilities and provide feedback.

 

4. Pre-Release Registration for the NHRA-MVC Blockchain Mobile App • NHRA-MVC is introducing a first-of-its-kind Blockchain-based Mobile App to further strengthen serialization data security.

• End users are encouraged to participate in the pre-release program by signing up during the training seminars.

 

Immediate Action Required for Compliance

 

To ensure continued compliance and system access, pharmaceutical companies must take the following steps:

• Marketing Authorization Holders (MAHs) • MAHs that have not yet transitioned to the new API must expedite EPCIS data flow migration to the upgraded NHRA-MVC Traceability Hub.
• Please refer to the official guidance here: NHRA-MVC Upgrade Letter to MAHs • Distributors and Dispensers • NHRA-MVC will directly coordinate training, seminar invitations, and support to ensure a smooth transition.

 

Why This Matters for Pharma Compliance

 

With Bahrain’s pharmaceutical compliance landscape evolving, the NHRA-MVC system upgrade ensures a future-proof track-and-trace ecosystem. By integrating advanced serialization technologies, Bahrain strengthens its commitment to supply chain security and regulatory alignment.

 

SoftGroup is here to support companies navigating these regulatory changes. Our serialization and compliance solutions help pharmaceutical businesses adapt to evolving standards while ensuring operational efficiency. Our experts are ready to assist if you need guidance on the NHRA-MVC upgrade.

 

 

References:

1. 1. Legislative Decree No. 41 of 2017 Issuing a Track and Trace System for the Supply Chain of Medicine within the Kingdom of Bahrain2. Subject: System Upgrade on NHRA-MVC Platform – Immediate Action Required from 2nd December 2024- https://nhra-mvc.bh/wp-content/uploads/2025/01/NHRA-MVC-major-system-upgrade-letter-to-MAHs.pdf

   3. Important Update – Major NHRA-MVC Platform Technology Upgrade from 13st January 2025 – NHRA-MVC-Major-System-Upgrade-Letter_Important-Status-Update_13Jan2025.pdf

 

Want to ensure your pharmaceutical operations meet compliance standards?  Contact us today!