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Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic Labelling (E-Labelling) for Pharmaceutical Products" which aims to provide clarity and direction on the use of electronic labelling for pharmaceuticals in Malaysia.

E-labelling is defined as the provision of an 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 implementation of e-labelling is voluntary and applies to new drug products, biologics and generic products containing scheduled poisons for human use only.

Electronic labelling should be easily accessible and readable, complying with relevant Malaysian laws and regulations.

It must include essential information such as product name, active ingredients, dosage form, strength, batch number, expiry date, storage conditions, and any other relevant details mandated by local regulations.

The use of e-labelling is subjected to the product labelling requirements as stipulated in the current edition of the Drug Registration Guidance Document (DRGD). The maximum capacity of product information (e-labelling) to be uploaded and hosted in QUEST3+ system shall not exceed 5MB.

The QR code may be printed or affixed onto the outer carton/inner label using a stick-on label. If the stick-on label method is used, the following criteria should be met:

a) The stick-on label shall not cover any information on the outer carton or inner label.

b) The stick-on label shall be made from good quality materials and is not easily torn or peeled off.

c) This activity shall be carried out in a licensed secondary repacker facility that complies with Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP) requirements.

This guideline on electronic labelling offer a roadmap for implementing electronic labelling for pharmaceutical products in Malaysia. By adhering to these guidelines, manufacturers and distributors can meet Malaysian regulatory requirements while leveraging technological advancements in labelling practices.

For a comprehensive understanding, please refer to the full guidance document by clicking here.


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