23 August 2019 | News
Pertaining to new serialization requirements from the Saudi Food and Drug Authority
rfxcel, the global leader in supply chain track and trace solutions, will exhibit at this year’s CPhI Middle East & Africa (MEA) conference in Abu Dhabi, United Arab Emirates. The company is cultivating business in the region, particularly pertaining to new serialization requirements from the Saudi Food and Drug Authority (SFDA).
More than 4,900 suppliers and buyers from across the worldwide pharma supply chain are scheduled to attend CPhI MEA, which will be held September 16–18 at Abu Dhabi’s National Exhibition Centre. The annual event is a chance for pharma professionals to network and see the latest in pharmaceutical technology.
“rfxcel is going to CPhI MEA for several reasons,” rfxcel CEO Glenn Abood said.“Of course, we’re excited to meet people and let them know about our innovative track and trace and compliance solutions. But we also want the industry to know we’re serious about working in the region and have proven technology to meet serialization requirements there, in Saudi Arabia, for example.”
The SFDA initiated a Drug Track and Trace System (RDS) to track both imported human registered drugs and those made in Saudi Arabia. The system adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. All drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, the GS1 Global Trade Identification Number (GTIN), the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to a national Drug Track & Trace System (DTTS), and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).
Furthermore, every registered drug in the Saudi market will be assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.
“The SFDA and SDC requirements are complex and will be challenging for pharma companies,” Abood said. “But rfxcel has experience around the world — in Russia, India, China, Brazil, the EU, and the United States — and has unrivalled track and trace and compliance capabilities that we want to bring to Saudi Arabia and other MEA countries. An array of stakeholders will be affected by the Saudi regulations. We want them to know rfxcel has the powerful solutions they need to be compliant.”