Saudi Arabia Regulatory Update on Aggregation Requirements
Pharmaceutical manufacturers that supply the Saudi Arabia market have been serializing drug products since 2017 in accordance with the Saudi Food & Drug Authority (SFDA) Drug Barcoding Specifications originally released in March 2013.
A circular recently released in February 2019 furthers the SFDA Track and Trace mission by requiring manufacturers to aggregate product by October 1, 2019.
While it was recommended for manufacturers to aggregate, to date there was no regulatory requirement.
Currently, manufacturers need to provide shipment data to their agents in Saudi Arabia, including the serial numbers of the packages. Local agents are then responsible for reporting that data to SFDA.
The October deadline does not give manufacturers much time to implement aggregation capabilities if they are not already installed.
It’s important that manufacturers prepare to aggregate all products for the Saudi Arabia market as well as to establish data exchange capabilities and expectations with their in-country distribution network.
Serialization in Saudi: Are you all set to address reporting requirements?
Based on the published regulations and announcements to date, there are reporting requirements for each transaction in the supply chain. Reporting starts with manufacturers after finished good batches are created and continues for every change in ownership in the product lifecycle through consumption (e.g. hospitals) or dispensing (e.g. pharmacies).
Aggregation may streamline inbound and outbound processes for logistics operations, but managing aggregated hierarchies adds a lot of complexity to the IT systems and material management processes.
Also, the SFDA specifically indicates that errors in aggregation need to be fixed by the sender. This issue will no doubt flow upstream to the manufacturer, and it will be difficult to fix aggregation errors once product is in Saudi Arabia. For this reason, it is critical that manufacturers have robust aggregation systems and processes in place.
Adents has posted information on the serialization regulatory requirements in Saudi before. If your company has any questions on readiness or compliance issues, download our comprehensive global serialization regulatory map below.