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Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (11 April, 2023) released an updated guideline on " Electronic Labelling (E-Labelling) for Pharmaceutical Products" that plays a vital role in ensuring patient's understanding of their treatments while also supporting HCPs in their decision making.

Based on clinical development and post-marketing data, the product information includes a summary of the product characteristics, a package information leaflet, and labels. These descriptions are written for Healthcare Professionals (HCPs) and for patients.

This document serves as a guide for the implementation of voluntary e-labelling and the product information used shall be approved by the Drug control Authority.

As per this guideline, E-labelling is defined as the provision of approved product information that includes the package insert (PI) and/or Consumer Medication Information Leaflet (RiMUP) electronically via a machine-readable Quick Response (QR) code on the outer carton/inner label of the product that links to the NPRA QUEST system.

The maximum capacity of product information (e-labelling) to be uploaded and hosted in QUEST3+ system shall not exceed 5MB and Product information in video format is currently not allowed.

As specified in the current edition of the Drug Registration Guidance Document (DRGD), e-labelling is subject to the product labelling requirements. Failure to comply with these requirements may result in regulatory action.

To know more information on Products eligible for e-labelling, click this LINK.


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