Allan Bowyer, Director of Industry Marketing, TraceLink09.16.19
As of January 7, 2019, the Saudi Food and Drug Authority (SFDA) initiated reporting requirements that affect all companies producing medicines for the Saudi Arabia market. While SFDA track and trace regulations affect the entire supply chain, manufacturers have specific concerns about the full impact of the SFDA mandates on their businesses as they seek to understand how they can comply immediately with the latest requirements, including aggregation.
This article offers an overview of the impact of serialization regulations and the business and operational challenges companies will now be facing in the Saudi Arabia market. Providing key insights into what the Kingdom’s regulators expect from the drug supply chain, Bowyer shares key considerations for meeting compliance requirements.
Need to know: Deadlines have passed for three primary requirements
Since March 2017, serialized product identifiers have been required for all human and veterinary products sold in Saudi Arabia and include a 14-digit Global Trade Item Number (GTIN-14), serial number, lot number, and expiration date. Beginning in March 2018, companies were required to register factory and warehouse locations via their Global Location Numbers (GLNs).
As of January 2019, organizations, stakeholders, and GTINs for imported products and product manufactured in Saudi Arabia had to be registered through the SFDA’s track and trace system as a requirement for reporting on a range of supply chain operations.
For manufacturers and distributors, these operations include:
System’s official name: RSD
The official name of the SFDA track and trace system is RSD. Company and product (GTIN-14) registrations are completed through the RSD Stakeholder Management Portal. Once registered, companies can use one of three methods for reporting supply chain events:
Saudis expect compliance, industry should expect aggregation next
As SFDA continues to work with companies producing medicines for the Saudi supply chain to streamline the management and reporting of product data, the expectation is that organizations are working toward implementing an integrated connection with the RSD system to enable automated event reporting.
In addition to reducing errors and increasing warehouse efficiency, automated reporting provides companies continued visibility of their product once it enters the Saudi supply chain – and control over a key component of their global compliance operations.
While product serialization has been required for more than two years, the SFDA aggregation requirement means that all individual saleable units must have an identity or data relationship to the case they are shipped in.
To date, however, 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. Nonetheless, requirements are expected to follow GS1 standards closely.
Interoperability in data exchange is also required. One of the key systems for exchanging serialization information between stakeholders is the Saudi-run Package Transfer Service (PTS) System. Currently the PTS format is open-ended and does not specify the data format to be provided to a downstream trade partner. Industry is working on building consensus on formats to ensure interoperable data exchange.
Faced with a compressed timeline until the SFDA issues an aggregation deadline, companies should not wait for final guidance before beginning to prepare their operations and gain a better understanding of how aggregation may affect their supply chain operations.
Operational impact and challenges of aggregation
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 presents several fundamental challenges for manufacturers and their supply chain partners under SFDA regulations; for example, 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. 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 is another consideration for companies. As mentioned earlier, companies may face challenges in ensuring interoperable data exchange with their trade partners.
Required reporting more complex with aggregation
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:
Understanding the regulatory requirements for capturing and reporting aggregation events will be critical for companies seeking best-in-class efficiencies and a more proactive compliance stance. Some countries, including 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, however, if Saudi Arabia will require reporting on aggregation events in addition to reporting on the transfer of aggregated products.
So, how should you prepare? Solutions providers recommend a pre-aggregation assessment that focuses on internal and external processes as well as partners.
First, identify affected products and packaging lines, then determine which products will be sold in Saudi Arabia and whether or not they are on shared or dedicated packaging lines.
Next, assess and understand GS1 requirements for case-level aggregation. SFDA has indicated that aggregation requirements will follow GS1 labelling standards.
Finally, find out if partners are “aggregation aware and enabled.” Survey the touchpoints of partner ecosystems and be sure to engage them in a dialogue about logistics and distribution protocols, process integrity, and service agreements.
Leveraging serialized data effectively can support efficient cost-effective business strategies in the country, the region, and the world.
TraceLink is set to offer global compliance insights and updates at FutureLink Nashville, October 2 – 4, 2019. To register for FutureLink Nashville, and learn more about the event, visit: www.tracelink.com/futurelink-nashville/about.
This article offers an overview of the impact of serialization regulations and the business and operational challenges companies will now be facing in the Saudi Arabia market. Providing key insights into what the Kingdom’s regulators expect from the drug supply chain, Bowyer shares key considerations for meeting compliance requirements.
Need to know: Deadlines have passed for three primary requirements
Since March 2017, serialized product identifiers have been required for all human and veterinary products sold in Saudi Arabia and include a 14-digit Global Trade Item Number (GTIN-14), serial number, lot number, and expiration date. Beginning in March 2018, companies were required to register factory and warehouse locations via their Global Location Numbers (GLNs).
As of January 2019, organizations, stakeholders, and GTINs for imported products and product manufactured in Saudi Arabia had to be registered through the SFDA’s track and trace system as a requirement for reporting on a range of supply chain operations.
For manufacturers and distributors, these operations include:
- Supply: identify products manufactured in Saudi Arabia
- Import: identify products imported into Saudi Arabia
- Dispatch: send a product to another stakeholder
- Accept: receive a product from another stakeholder
- Deactivate: remove an identifier from the system
- Export: product exports previously identified in the system
- Return: Send product back to the sender via SFDA registration and reporting systems
System’s official name: RSD
The official name of the SFDA track and trace system is RSD. Company and product (GTIN-14) registrations are completed through the RSD Stakeholder Management Portal. Once registered, companies can use one of three methods for reporting supply chain events:
- Automated product data exchange through an integrated connection.
- Product data uploaded as a CSV file through the RSD Stakeholder Operation Portal.
- Product data uploaded manually through the RSD Stakeholder Operation Portal.
Saudis expect compliance, industry should expect aggregation next
As SFDA continues to work with companies producing medicines for the Saudi supply chain to streamline the management and reporting of product data, the expectation is that organizations are working toward implementing an integrated connection with the RSD system to enable automated event reporting.
In addition to reducing errors and increasing warehouse efficiency, automated reporting provides companies continued visibility of their product once it enters the Saudi supply chain – and control over a key component of their global compliance operations.
While product serialization has been required for more than two years, the SFDA aggregation requirement means that all individual saleable units must have an identity or data relationship to the case they are shipped in.
To date, however, 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. Nonetheless, requirements are expected to follow GS1 standards closely.
Interoperability in data exchange is also required. One of the key systems for exchanging serialization information between stakeholders is the Saudi-run Package Transfer Service (PTS) System. Currently the PTS format is open-ended and does not specify the data format to be provided to a downstream trade partner. Industry is working on building consensus on formats to ensure interoperable data exchange.
Faced with a compressed timeline until the SFDA issues an aggregation deadline, companies should not wait for final guidance before beginning to prepare their operations and gain a better understanding of how aggregation may affect their supply chain operations.
Operational impact and challenges of aggregation
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 presents several fundamental challenges for manufacturers and their supply chain partners under SFDA regulations; for example, 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. 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 is another consideration for companies. As mentioned earlier, companies may face challenges in ensuring interoperable data exchange with their trade partners.
Required reporting more complex with aggregation
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 aggregated 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 will be critical for companies seeking best-in-class efficiencies and a more proactive compliance stance. Some countries, including 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, however, if Saudi Arabia will require reporting on aggregation events in addition to reporting on the transfer of aggregated products.
So, how should you prepare? Solutions providers recommend a pre-aggregation assessment that focuses on internal and external processes as well as partners.
First, identify affected products and packaging lines, then determine which products will be sold in Saudi Arabia and whether or not they are on shared or dedicated packaging lines.
Next, assess and understand GS1 requirements for case-level aggregation. SFDA has indicated that aggregation requirements will follow GS1 labelling standards.
Finally, find out if partners are “aggregation aware and enabled.” Survey the touchpoints of partner ecosystems and be sure to engage them in a dialogue about logistics and distribution protocols, process integrity, and service agreements.
Leveraging serialized data effectively can support efficient cost-effective business strategies in the country, the region, and the world.
TraceLink is set to offer global compliance insights and updates at FutureLink Nashville, October 2 – 4, 2019. To register for FutureLink Nashville, and learn more about the event, visit: www.tracelink.com/futurelink-nashville/about.