Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated the industry on plans to run a pilot project for an end-to-end track and trace platform designed to improve on the existing hologram safety label system.
The Malaysian government is developing a system that covers the entire supply chain, from product registration holders, manufacturers and importers through to the end user and will begin a six-month pilot program in January.
According to NPRA, the system is designed to ensure the supply chain only contains products registered with the Ministry of Health; ensure the availability of supplies and improve distribution efficiency; terminate existing security label contracts; comply with international standards; combat counterfeits; and improve the ability to control medication errors.
In a recent update, NPRA explained that the new system will store and verify product release data. The pilot phase will use two data carriers, the GS1 DataMatrix 2D barcode and the hologram FarmaTag security label and cover all vaccines in Malaysia’s national immunization program. NPRA said the use of international standards is important to ensuring effective integration activities, information sharing and system interoperability.
The program includes vaccines against hepatitis B, measles, mumps and rubella, typhoid and other pathogens. Exactly what is expected of importers and manufacturers of the products depends on whether they use the GS1 barcode or FarmaTag label. When working with the GS1 barcodes, direct serialization must be carried out, either at the factory in the country of origin, for imports, or at an approved Malaysian plant. Users of the holograms need to attach the security labels and submit the product data.
Scanning the unique identification codes will enable the uploading of data on product registration and movement to the government database. The data will support the tracking of products, and verification of their authenticity, at each stage in the supply chain. Records of product-related movements and activities must be implemented at each step of the supply chain.
NPRA will revise the information provided to date based on the needs and development of the system. Full implementation guidelines for the system are planned for after the completion of the pilot project in June 2023.
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