Saudi Arabia didn’t have an efficient process to track human registered drugs manufactured or imported from the country until the set up for the SFDA (Saudi Food and Drug Authority) which established the standardized RSD identification system to specifically track and trace drugs.
Although the regulations for this didn’t take effect till the beginning of 2019, they had drastically changed the way the drug supply chains were managed and operated. It adopted GS1 standards for pharmaceutical products (even non-prescription medicines) and to track drugs till they were available for patients. The vision for SFDA has been to create a secure and systematic supply chain for pharmaceuticals. Of course, this goal is only possible to achieve if the set regulations are understood and followed.
One of the biggest challenges in Saudi Arabia compliance has been concerning aggregation and it’s adoption. What started in July 2019 with barcodes, serialization and aggregation, led to aggregation deadlines being delayed and changed repeatedly. The SFDA’s last update moved the aggregation deadline to August 20, 2020. These delays in enactment have left very little time for companies to comply with aggregation requirements until they finally come into effect.
The four factors to keep in mind for Saudi compliance are:
As per the SFDA website, once companies have adopted their systems with the RSD, there won’t be any need to manually register data. As the Saudi Arabia pharma compliance is complex, companies should start getting ready at the earliest.
Team CosmoTrace is experienced in dealing with the compliance requirements for Saudi and can help your business be prepared and ensure you’re ready to adhere to all the SFDA prerequisites.