Malaysia’s Pharma Serialization and Turkey Similarity

Malaysia’s Pharma Serialization and Turkey Similarity

Malaysia’s Pharma Serialization and Traceability practices are not new. The Ministry of Health (MOH) Malaysia has been conducting studies on pharmaceutical traceability since 2018. Malaysia has built traceability by conducting various workshops before formalizing the studies. The National Pharmaceutical Regulatory Agency (NPRA), which is part of the Ministry of Health, is the authority responsible for Malaysia’s Pharma Serialization and Traceability practices.

The pilot project regarding the vaccines was started in Malaysia in 2020. Malaysia’s Pharma Serialization and Traceability have been initiated to protect the supply chain from counterfeit medications, taking human health into account. The reputation of pharmaceutical manufacturers is also taken into consideration in this respect.

Details on Malaysia’s Pharma Serialization and Traceability

The state was working to ensure security in the supply chain before the Malaysia’s Pharma Serialization and Traceability studies. An example of this is that all medications are registered with the Drug Control Authority (DCA) before they are marketed. The registration number applied to packages between 1985 and 2005 has been replaced by a holographic security label with the registration number applied since 2005. Knowing that Malaysia’s Pharma Serialization and Traceability will form a safer supply chain, MOH has recently developed its work in this direction.

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Timeline of Malaysia’s Pharma Serialization and Traceability

A timeline has been published for pharmaceutical supply chain stakeholders to comply with as a consequence of the studies of the authorities in Malaysia. The vaccine traceability pilot project, which started in 2020, covered all vaccines at the beginning of 2023. For other drugs:

  • By the end of 2027, all prescription medicines must fully meet traceability requirements.
  • By the end of 2028, traceability requirements will be mandatory for over-the-counter (OTC) medicines.
Malaysia's Pharma Serialization Timeline Mobile
Malaysia's-Pharma-Serialization-Timeline-Web

How Similar Are Malaysia and Turkey in Pharma Traceability?

The Ministry of Health Malaysia shows a similar approach to the Pharmaceutical Track and Trace System (İTS) organized by the Turkish Medicines and Medical Devices Agency (TİTCK) of the Ministry of Health of Turkey regarding pharmaceutical traceability. Establishing a system similar to that in Turkey, which is the first in the world in terms of pharmaceutical traceability, will undoubtedly provide multidimensional advantages.

First of all, the official authorities of both countries are the founders of the traceability system. The equivalent of the Turkish Medicines and Medical Devices Agency (TİTCK) in Malaysia is the National Pharmaceutical Regulatory Agency (NPRA). While the Pharmaceutical Track and Trace System is used in Turkey for traceability, MyMediTRACE is used in Malaysia for the same purpose.

Similarities in Practice:

TurkeyMalaysia
Host SystemİTSMyMediTRACE
Serialization (Implementation to Label or Directly to Packaging)YesYes
Aggregation, Reporting & NoticeYesYes
ObligationYes2028

Barcode Requirements:

TurkeyMalaysia
GTINYesYes
Serial NumberYesYes
Expiry DateYesYes
Batch NumberYesYes

The only approved 2D code for medical products is the GS1 Data Matrix code. Data matrix code was preferred for pharmaceutical serialization in Turkey and Malaysia. Other reasons for preference include the fact that imitation of the code is almost impossible, it can be applied to small areas, and even if it is worn, it gives complete information when scanned.

The Journey of the Serialized Product through the Supply Chain

After the implementation of data matrix code and human-readable data to product packaging in Turkey and Malaysia, the product’s journey through the supply chain is quite similar. You can find more information on the Pharmaceutical Track and Trace System in Turkey here.

In Malaysia, the data is reported to the central system after the product has been serialized by the manufacturer or importer. Distributors or wholesalers report hierarchical data and distribute. Medicines to be given to the consumers reach hospitals or pharmacies. Also in this stage, information is processed, inventory is updated, authentication is performed during distribution, and consumption notification is sent. All notifications are made to the authorized system, MyMediTRACE. Thanks to this system, consumers can authenticate via mobile applications or text messages.

Fully Meeting the Traceability Requirements

We now know that pharmaceutical traceability started in Turkey for the first time in the world. Having a history of solutions for traceability requirements in Turkey is the most concrete proof of the experience. VISIOTT, in this respect, is always proud to be a pioneer in traceability technologies.

With this experience, VISIOTT, which develops solutions that are fully compatible with many countries and regulations around the world, also draws attention to its wide service network. VISIOTT’s innovative solutions are fully compatible with Malaysia’s Pharma Serialization and Aggregation requirements. VISIOTT offers labelling and serialization solutions regardless of product packaging and serialization method.

Malaysia’s Pharma Serialization Solutions

VBL-300 Vial Labeling and Serialization Station, developed by VISIOTT for products that use vial packaging, performs labelling and serialization at high speed. The VBL-300 allows the labelling/serialization of products of different sizes with its star wheel-shaped design. VISIOTT, which also develops solutions for bottles, offers easy labelling and data matrix solutions for bottles of various sizes with the easily adjustable and customizable BLS-100 Bottle Labeling Station.

ISS-100 Carton Serialization Station draws attention with its high speed and ergonomic design and it is typically preferred for Malaysia’s Pharma Serialization processes. Also bearing companies preferring unfolded boxes in mind, VISIOTT has developed a practical solution for the pharmaceutical industry with the FCSS-100 Flat Carton Serialization Station. Combining 2D code implementation and product security, ISSTE-200 Carton Serialization with Tamper Evident Labeling provides an organized solution by serializing products and implementing a security label.

Making Traceability Efficient with Aggregation

The National Pharmaceutical Regulatory Agency has mandated aggregation along with Malaysia’s Pharma Serialization to make traceability productive. VISIOTT-designed aggregation stations are easy-to-integrate solutions that meet Malaysia’s Pharma Serialization and Traceability requirements.

Resolving even low-quality QR codes with a high success rate thanks to its special image system, MAS-100 Horizontal Manual Aggregation Station is a rare solution. MAS-200 Vertical Manual Aggregation Station, which has the same features, is produced for practical and fast data processing with its ergonomic structure. Produced for companies that package their products manually, SMAS-100 Semi-Automatic Aggregation Station performs the aggregation process using the data of serialized products in all layers. SACP-100 Semi-Automatic Case Packer with Aggregation combines product packing and aggregation processes. SACP-100 places the packaged products that are put into the system by the operator and the aggregation process is carried out.

Qualified to meet Malaysia’s Pharma Serialization and Traceability requirements, VISIOT’s solutions are not limited to this. We have software solutions that perform communication and management between hardware, add serial numbers and handle MyMediTRACE notifications; image processing technologies that are key actors in quality control; and many other integrated solutions.

Thanks to its all-in-one concept, VISIOTT delivers solutions developed for Malaysia’s Pharma Serialization and Traceability requirements quickly. VISIOTT offers 24/7 support to its customers. Production-resistant materials are used in VISIOTT stations and therefore they are long-lasting and spare parts are easily accessible. VISIOTT offers a customer-oriented service-level agreement to conduct this process smoothly.

Contact our experts to learn more about Malaysia’s Pharma Serialization and Traceability requirements and the solutions we develop!

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