TraceLink Customers Jump Ahead of South Korea Deadlines With Live Reporting

As of this Friday, July 1, all pharmaceutical manufacturers/importers who sell product into South Korea must begin per-shipment reporting of serialized prescription drug products to the Korean Pharmaceutical Information Service (KPIS). For most companies doing business in South Korea, preparing for this milestone has been a formidable challenge.

For companies on the TraceLink Life Sciences Cloud, however, the ability to submit reporting to KPIS has been in place for several months now. TraceLink partnered with one customer who was eager to get out ahead of the deadline to extensively test and deploy a South Korea compliance solution nearly three months ahead of the government deadline in early April. This customer has already used the TraceLink South Korea Compliance module to successfully upload over 1,400 compliance documents to the KPIS system.

Here’s a look at other milestones achieved in the last 12 weeks, before the deadline has even arrived:

• 1,400 South Korea shipments, with Template A and Template B reports generated for each shipment. 
• For a total of 3.8 million units of product. 
• Sold to 84 unique customers. 
• Shipments have included wholesale distributions and samples distributions. 

Several more TraceLink customers will begin using the module next week.

Many countries that have track and trace regulations in place require government reporting. So, what makes South Korea different, and particularly challenging?

Communicating With a 3PL

One major challenge for South Korea compliance is the significantly added complexity facing companies selling the product in South Korea through third-party logistics providers (3PLs). In contrast to a more traditional country compliance model, serialization in South Korea requires a much higher volume of communication between the solution provider and the three parties (manufacturer, 3PL, and government).

Solution providers must communicate not only with the government, but they also need to communicate product, shipping, and serialization information with the 3PL. That’s because a shipment from a manufacturer to the 3PL is not directly reported to the government.

Solution providers must support data exchange required for compliance reporting as transactions occur during three stages:

• The manufacturer ships product to South Korea. 
• The 3PL receives the customer’s shipped product in South Korea. 
• The 3PL ships the product for sale in South Korea.

The Choreography

An additional complexity in South Korea is how to support interoperability between systems for fast, cost-effective integration. A manufacturer must report to the government in three primary choreography scenarios:

• Sales shipments 
• Received returns 
• Destruction of product 

In the first scenario (sales shipments), the 3PL (managing the distribution warehouse for the manufacturer) provides the manufacturer with the product and serial number information for each sales shipment that they process on behalf of the manufacturer. With the TraceLink solution, the manufacturer receives this information in the South Korea Compliance module, which then verifies the serial numbers, updates the status to shipped, and generates the “South Korea S01 Shipment” reports.

In addition, the TraceLink South Korea Compliance solution supports other information exchange touch points between the manufacturer and the 3PL:

• The manufacturer uses the module to send product and serialization information to the 3PL when the product is shipped to the distribution warehouse so that the 3PL knows what products and serial numbers they need to manage for the manufacturer. 
• The 3PL uses the module to notify the manufacturer when they perform an action on the manufacturer’s products so that the manufacturer has the latest status, enabling them to generate necessary government compliance reports. 
• The 3PL uses the module to send product and serialization data to the manufacturer when they receive product returns from the manufacturer’s customers. 
• The 3PL uses the module to send product and serialization data to the manufacturer when they destroy the product, such as damages and returns.

Addressing Unique Data Format Requirements

The required data format in South Korea is CSV-based, and every shipment of serialized pharmaceutical drugs must use two matching templates. TraceLink engineered a master file template for the South Korea Compliance module with built-in file-management capabilities to ensure the manufacturer’s master file (Template A) and sub-file (Template B) are correctly managed for secure KPIS compliance report submissions. The module also supports the large number of data fields required in South Korea, such as unit price and contract type.

Learn more about the TraceLink South Korea Compliance module, or contact us to discuss your South Korea needs.