Product information is important in aiding healthcare professionals in making decisions and assisting patients in getting medical information related to medicines. Medical product information is a form of a summary of the product characteristics, labelling and the product information based on conclusive research and data.
Moving towards global advancement, Malaysia has been adapting many digital trends into the healthcare system on par with other Asian countries and the latest implementation is e-labelling. E-labelling has been proven may benefit the country in terms of arrangeability, accessibility, searchability and ecological. Hence, on 6 April 2023, The Drug Control Authority of Malaysia agreed on the implementation of electronic labelling (e-labelling) for pharmaceutical products. The voluntary implementation of e-Labelling will affect immediately starting on 1 May 2023 until 31 December 2026.
E-labelling has been defined in the regulation as “the provision of approved product information that includes the package insert (PI) and/or Consumer Medication Information Leaflet (RiMUP) electronically via a readable machine Quick Response (QR) code on the outer carton/inner label of the product that links to the NPRA Quest3+ system.”
The implementation of e-labelling is applied to the registered pharmaceutical products for human use under the category of biologic, new drugs and scheduled generic poison medicines and it is voluntary participation.
The e-labelling format is not allowed to be in video form. All the information stated in the pdf format must be equally displayed in the NPRA Quest3+ system page. The QR code labelling can be either on the outside of the product packaging or inner of the packaging, as long as if the QR code is using the sticker labelling, the product registration holder (PRH) must ensure the sticker labelling would not cover other information, not easily peel off and the sticker manufacturing process must comply with the Good Manufacturing Practise (GMP) or Good Distribution Practice (GDP) requirements.
Furthermore, PRH has to ensure the approved information in the e-labelling should not be modified without any notification. For any registered pharmaceutical products in the market that are interested for e-labelling, the PRH may apply for submission under Minor Variation Notification (MiV-N): E-labelling Verification. The PRH is responsible for informing the e-labelling usage to the healthcare facilities and healthcare professionals via Dear Healthcare Provider Letter (DHCP). On top of that, the PRH also must prepare the physical printed copy of the PI or/and RiMUP if there are any requests from healthcare facilities or medical practitioners.
While for any new pharmaceutical products or drug registration, the PRH may include the e-labelling application together with the dossier submission. There are no differences with the current product registration process. The implementation effect will be revised by the authority after one or two implementation years.
Source: NPRA
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