Regulatory update: The Saudi government has notified registered users of the goverment's drug track and trace system (RSD) that the deadline for aggregation of medicines is now August 20, 2020.
For companies that manufacture and distribute medicines for the Saudi Arabia market, product aggregation is now a priority that cannot be ignored: The Saudi Food and Drug Authority (SFDA) recently announced that serialized product produced for the Kingdom of Saudi Arabia must also be aggregated beginning on October 1, 2019.
While product serialization has been required in Saudi Arabia since 2017, the SFDA aggregation requirement means that all individual saleable units must have an identity or data relationship to the case they are shipped in. But, to date, requirements around creating the aggregations and what will need to be captured and reported to the Saudi Arabia track-and-trace system—or shared with trading partners—have not been issued by SFDA.
Faced with a compressed timeline until the SFDA aggregation deadline, companies can’t afford to wait for final guidance before beginning preparations. It’s important to understand how aggregation may affect your supply chain operations—and what steps you can take today to be ready.
Operational impact: Aggregation challenges under SFDA regulations
Aggregation associates the identifiers of multiple individual units to a single case-level identifier. By making it possible to infer the contents of a case by scanning the case identifier, individual units can be verified without the need to open the case and scan each unit individually. As a result, aggregation can make supply chain operations more efficient.
However, aggregation will present several fundamental challenges for manufacturers and their supply chain partners under SFDA regulations:
- Modifying packaging line systems. Companies will need to retrofit their packaging lines for aggregating products bound for Saudi Arabia, including generating, storing, and commissioning product identifiers with “parent-child” relationships. New software configurations will also require updated validation processes to ensure compliance with industry practices. And companies may also need to modify tertiary (case-level) packaging with tamper-proof features to ensure the integrity of the original aggregation relationships during shipping and warehousing.
- Implementing new logistics and distribution protocols with trade partners. SFDA regulations require reporting whenever a product is sold and “transfer of ownership” takes place. Aggregation makes this more complex, so it’s critical to determine who has the responsibility—or liability—for ensuring the integrity of the aggregated relationships at each step in the supply chain. For example:
- When and where will the product actually be aggregated: at the manufacturer, 3PL, or wholesaler?
- Are specific business or bonding agreements required with 3PLs or shipping companies that handle aggregated products but do not take ownership?
- How can a wholesaler determine if the aggregation relationships within a case arrive as originally configured and documented without opening the case?
- Is a random inspection program of aggregated cases enough to protect the wholesaler from liability?
- Who is liable if there are errors in the aggregation data or packaging that results in non-compliance with SFDA reporting requirements?
- If an individual unit is damaged, is the wholesaler—or another party—able to remove or replace it and reconfigure the parent-child aggregation relationship?
- How would a manufacturer be informed of any aggregation changes that occur in the supply chain—at a 3PL, for example—to ensure that the original data is consistently updated?
- Understanding the regulatory requirements for capturing and reporting aggregation events. Some countries, such as Russia, require reporting on aggregation events in the supply chain—such as “unit pack” and “unit unpack”—as well as change of ownership events. It remains to be seen if Saudi Arabia will require reporting on aggregation events in addition to reporting on the transfer of aggregated products.
Preparing for Saudi Arabia aggregation: What you can do now
Companies can take steps to prepare for the SFDA aggregation requirement, even in the absence of final guidelines. A pre-aggregation assessment should focus on internal and external processes and partners:
- Identify affected products and packaging lines. Determine which products will be sold in Saudi Arabia and if they are on shared or dedicated packaging lines.
- Understand GS1 requirements for case-level aggregation. SFDA has indicated that aggregation requirements will follow GS1 labeling standards. The recently published discussion paper on aggregation in the pharmaceutical supply chain with links to in-depth GS1 documentation provides a good starting point.
- Assess if your partners are “aggregation aware and enabled.” Survey the touchpoints in your partner ecosystem and start the discussion about logistics and distribution protocols, process integrity, and service agreements.
How TraceLink helps
As the leading provider of track and trace solutions for the pharmaceutical industry, TraceLink can help you manage the full range of SFDA serialization requirements. TraceLink’s proven, scalable compliance platform provides the performance, tools, and workflows to handle the complexities of product aggregation.
Contact TraceLink for information about our Saudi Arabia compliance solutions and to learn more about being part of TraceLink’s Saudi Arabia Special Interest Group—the leading forum for TraceLink customers to stay up to date on SFDA regulations.