The National Pharmaceutical Regulatory Agency (NPRA), Malaysia, issued an updated Frequently Asked Questions (FAQ) document on 13 May 2026 regarding the implementation of electronic labelling (e-labelling) for pharmaceutical products. The initiative supports the electronic delivery of product information, including Package Inserts (PI), Consumer Medication Information Leaflets (RiMUP), Active Ingredients, Packaging Details, and Registration Number information, through QR code-enabled access on product packaging.
The updated guidance expands the scope of implementation to fully include over-the-counter (OTC) non-scheduled poison products without future implementation date restrictions. It also introduces a significant shift toward electronic communication by discontinuing routine distribution of printed Dear Healthcare Provider (DHCP) letters and printed product information, with printed materials now supplied only upon request.
The implementation framework continues to support the use of the QUEST3+ system for hosting e-labelling information during the voluntary implementation phase from 01 May 2023 to 31 December 2026. Product Registration Holders (PRHs) may implement e-labelling updates following notification submission without requiring additional NPRA approval. The revised framework further aligns with Malaysia’s broader digitalization and environmental sustainability objectives while maintaining existing core regulatory guidance and product information requirements.
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