Background

Serialization is one of the most significant information technology challenges to have impacted the pharmaceutical sector in the last decade. Global pharmaceutical distribution networks and supply chains have become more complex and interconnected, with the mandate of it.

Serialization is the process of assigning a unique identifier to products, typically a unique number. The unique serial number, along with other significant information like the GTIN (Global Trade Item Number), batch number and expiry date of the medication are all encoded in a barcode that can be electronically read. Such a system would address consumer concerns especially with the increasing availability of online sources for obtaining medication.

In the United States, serialization was signed into law in 2013 with a 10 year implementation timeline to be effective in November 2023, and currently, over 40 countries are working on track and trace laws and regulations to enhance the security of pharmaceutical product supplies worldwide.

Whether already established or in progress, these mandates vary in scope and formats for event reporting, resulting in a wide range of factors to consider and scenarios to manage when implementing

Implementation in Saudi Arabia

The Saudi Food & Drug Authority initiated the Drug Track and Trace System for pharmaceutical products (RSD) as part of its plan to contribute to the achievement of the kingdom's Vision 2030, adopting new technologies for tracking all human drugs manufactured in Saudi Arabia and imported from abroad to ensure the safety of all drugs, from manufacturing to consumption.

In 2018, Saudi Arabia began rolling out RSD with local manufacturers. Think of Manufactures such as SPIMACO, Tabuk, Jamjoom Pharma, etc.. that started the serialization of each medication box. You will find that any medicine manufactured in Saudi Arabia has its own unique Serial Number (S.N) printed on the box.

The program successfully executed on the next part of the supply chain, with distributors, pharmacies, and hospitals right after. When buying medicine in any pharmacy in the Kingdom, notice how the pharmacist is required to scan the box itself before handing it out, as part of RSD regulations.

Juleb ERP

With rapid changes following the Kingdom’s Vision, serialization in the Kingdom had introduced the challenge of finding the capable tools that enable pharmacies and warehouses to follow these visions. Juleb POS was the first Point of Sale solution to be compatible with RSD integration in 2020.

This milestone positioned Juleb as a leader in pharmacy system innovation and compliance. As a pioneer in the market, Juleb continuously works on improving the user experience for its stakeholders.

Today, Juleb offers an extensive solution covering Pharmacies and Distributor’s operation needs, compliance, and growth. The RSD Reporting module in Juleb offers features to streamline the process of sending data to RSD, handling the regulatory parts on the background of business needs.

Accordingly, users can follow up and view the breakdown of RSD responses with Notification IDs when needed to ensure compliance for each medication movement, and easily recover in case of rejection.

Additionally in 2023, Juleb provided full support for RSD warehouse requirements, handling exponentially larger data with your regular mobile devices through the mobile app Juleb Connect, to cover Packaging needs.

Serialization in the pharmaceutical industry is only expected to have more demands in the future, and we as Juleb position ourselves to be more than ready to take on the new challenges.