Things have been relatively quiet with Saudi pharma compliance. The country’s Food and Drug Authority (SFDA) established the Drug Track and Trace System (RSD) to track all human registered drugs that are manufactured in Saudi Arabia or imported. Regulations that took effect in January 2019 have changed how the Saudi drug supply chain operates.
The RDS is a standardized identification system that tracks drugs from the manufacturer to the patient. It adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. According to GS1, the SFDA is working on similar requirements for medical devices and cosmetics.
The SFDA’s goal is to create a safer and more efficient pharmaceutical supply chain. To succeed in the Saudi market, companies that produce, distribute, and dispense pharmaceuticals must fully understand and comply with the regulations. Let’s take a look at what’s been happening.
New Aggregation Deadline
Aggregation has been a sticking point in the Saudi pharma compliance requirements, with many delays for enactment. Here’s a quick timeline:
- July 2019: The SFDA published guidelines for barcodes that included details for packaging hierarchies. This included barcoding, serialization, and pallet-level aggregation.
- August 2019: The SFDA published a reminder about an upcoming October aggregation deadline.
- December 2019: The SFDA moved the aggregation deadline to March 31, 2020.
- April 2020: The SFDA moved the aggregation deadline to June 30, 2020.
- June 28, 2020: The SFDA once again moved the aggregation deadline, this time till August 20, 2020.
So, as of today, companies have a little more than a month to comply with the aggregation requirements. This means they’ll have to prepare their packaging lines, coordinate with their trading partners, and have systems that can capture and report data to the RSD.
Overview of Saudi Pharma Compliance
Here’s quick rundown of what’s required for Saudi pharma compliance.
Data Matrix barcodes
Saudi regulations stipulate that all drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, a 14-digit Global Trade Identification Number (GTIN-14), a serial number, 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 the RSD, and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).
Saudi Drug Code
Every registered drug in the Saudi market is 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.
Global Location Numbers
From March 2018, companies had to register the locations of their factories and warehouses using their Global Location Numbers (GLNs).
RSD Stakeholder Management and Operation Portals
Companies use the Stakeholder Management Portal for initial registration in the RSD. The Stakeholder Operation Portal is where companies and their stakeholders report movements of drugs inside the supply chain. This ensures that information about all shipments are reported to Saudi authorities.
According to the SFDA website, after a company has integrated its system with the RSD, all drug movements will be recorded automatically; companies/stakeholders won’t have to log in to the Stakeholder Operation Portal manually or register transactions manually.
Saudi pharma compliance is complex. Manufacturers, warehouses, and pharmacies have a lot to think about. Though the date for implementing aggregation requirements has changed a few times, you should assume the August 20 deadline will hold firm.
The time to start preparing is now. rfxcel can help you be ready for all Saudi pharma compliance requirements. Our signature rfxcel Traceability Platform (rTS) can help you keep track of all the products in your supply chain and ensure you’re complying with all SFDA requirements — or regulations in any country.
Contact us for more information. Our supply chain experts are ready to help!