Malaysia MOH Mandates New FarmaTag Hologram Label for Pharmaceutical Products

Overview of the Regulatory Update

The MOH confirmed that the new FarmaTag hologram label becomes mandatory starting October 2, 2025 for pharmaceutical products. This label is designed to improve product authentication and safeguard against counterfeit medicines.

The authentication functionality for the new hologram label will be integrated into the MyUBAT application beginning January 1, 2026, enabling users to verify products digitally through the updated platform. During the transition period, existing FarmaTag labels remain valid and can continue to be authenticated using the FarmaChecker application. 

Stakeholders are required to ensure that labeling practices align with the updated requirements to maintain compliance, product integrity, and uninterrupted market access.

Feedback Deadline

Not applicable. No public consultation or feedback deadline was announced as part of this update.

Why It Matters

This regulatory update provides greater regulatory clarity around pharmaceutical labeling while supporting digital authentication and traceability through official applications. By standardizing security labels and verification tools, the MOH aims to improve market surveillance efficiency, strengthen patient safety, and minimize compliance risks without introducing unnecessary operational burden.

Who This Is Relevant For

This update is particularly relevant for Quality Assurance, Regulatory Affairs, Supply Chain, IT teams managing regulatory systems, and pharmaceutical manufacturers and distributors responsible for labeling and market compliance in Malaysia.

Next Steps

Stakeholders should review existing labeling and packaging processes to ensure readiness for the mandatory use of the new FarmaTag hologram label by October 2, 2025. Regulatory and operational teams should also plan system updates and user readiness to support MyUBAT authentication functionality by January 1, 2026, while continuing to use FarmaChecker for products bearing existing labels during the transition.

As regulatory requirements around product authentication evolve, maintaining visibility across labeling obligations and digital compliance tools becomes increasingly important. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 140 countries.

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FAQs

What is the new FarmaTag hologram label in Malaysia?

The new FarmaTag hologram security label is a mandatory labeling requirement introduced by the Malaysian MOH to enhance pharmaceutical product authenticity and safety.

When does the new FarmaTag label become mandatory?

The new FarmaTag hologram label is mandatory for pharmaceutical products starting October 2, 2025.

How can the new FarmaTag label be authenticated?

Authentication for the new label will be available through the MyUBAT application starting January 1, 2026, while existing labels can still be verified using FarmaChecker.

How can RegASK help companies manage this update?

RegASK helps regulatory and compliance teams track labeling requirements, monitor effective dates, and coordinate cross-functional readiness through AI-driven regulatory intelligence and automated compliance workflows.