The national pharmaceutical serialization system is a policy to affix serial number encoded barcodes and RFID tags on every prescription pharmaceutical drug package, by unit, much in the way every citizen has their own individual social security number. Through the serial number, looking up batch number and expiration date will become easier, and overall tracking of any item would become simpler.
Labeling packaging with serial numbers enables accurate tracing of the transaction phases of that product, eliminating potential illegal/counterfeit production; it also allows for an easier recall of any medical product deemed problematic. As a result, citizen will be able to use a transparent pharmaceutical system ensuring usage safety while streamlining efficient distribution management with cost reduction.
With the rise of social awareness for the need and use of global pharmaceutical serial numbers, Korea’s serialization regulation will safeguard the Korean people while rebranding domestic pharmaceuticals with new global values and competitive edges.
SUB) Korea, a leading country of pharmaceutical supply chain
TITLE) “Transparent Pharmaceutical Supply Chain for a Healthier Korea”
The South Korean government has been planning the implementation of the pharmaceutical serialization regulation for five years since relevant laws were passed in 2011; in all prescription pharmaceutical drug packages manufactured in or imported to Korea required affixing serial number encoded barcodes, and as of January 2016, all prescription pharmaceutical drug packages must be registered to the Korea Pharmaceutical Information Service at the time of shipment.
Going forward, the identification and tracking of supply chain of pharmaceuticals will be systematically managed via the information maintained within the Korea Pharmaceutical Information System, or KPIS.
The system mandates manufacturers and distributors to report by law, pharmaceuticals with affixed serial number encoded barcodes and their distribution information; the manufacturer or importer is required to affix and register serial numbers on every item before releasing them into the market, and distributors must report serial numbers and relevant information to KPIS upon shipment
SUB) Guideline for pharmaceutical serialization system
SUB) Ministry of Health & Welfare
The Pharmaceutical Serialization System is a structure operated by KPIS together with manufacturers, distributors and hospitals and pharmacies.
SUB) Korea Pharmaceutical Information Service, the Hub of Pharmaceutical Distribution Information
The Korea Pharmaceutical Information System is in charge of overall policies and decisions regarding the supply chain of pharmaceuticals together with the Ministry of Health and Welfare, and manages affixing barcode or RFID tagging, collection & management of distribution information, and the serialization of all prescription drugs within an established system
SUB) Pharmaceutical Manufacturers
Once a pharmaceutical company begins making drugs, each drug packaging is affixed with serial number encoded barcodes, and registered with KPIS
Manufacturers-1 [Affixing Serial Number Encoded Barcodes or RFID tag]
The law states that all drug packaging at its smallest unit for wholesale have a standardized barcode and/or RFID tag. Barcoding requires the encoding of a GTIN, batch number, expiration date, and serial number, while RFID tags also require a GTIN and serial number only, for manufacturers.
Manufacturer-2 [Aggregated Packaging]
Also, for logistical convenience, all aggregated packages require an aggregation code [such as a Serial Shipping Container Code, or GTIN-14+serial number]. All information, digitally converted, needs to be reported into the KPIS
Manufacturers [Product Shipping & Registration]
Stored packages with barcodes or RFID tags in warehouses need to have their GTIN and serial numbers reported with the authorities when shipping [for verification and registration purposes]. For convenience, the format for registering the shipment of serialized products consists of a master and sub template, which both are completed and managed. Packages can only be shipped after registering with the KPIS via file upload, manual entry, or ESB agent.
Distributors-1 Receiving Shipments & Use of Information
KPIS provides manufacturer submitted information to distributors, for which distributors can efficiently verify relevant information before stocking inventory. GTIN and serial numbers of inventory items or being managed by the system, it’s an effective way to manage expiration dates, or in issuing a prompt and accurate recall of products deemed defective. In the event distributors ship products with aggregation codes such as an SSCC, GTIN-14 & serial number, the KPIS is able to provide detailed information including GTIN and serial numbers.
Distributors-2 [Registration of Supply Records]
As of July, 2017, distributors or wholesalers will be required by law to register shipment information prior or upon shipping. (Registration information identical to that required by manufacturers.)
hospitals and pharmacies – 1 [Usage of Pharmaceutical Distribution Information]
Hospitals and pharmacies can now obtain information regarding a product’s manufacture and distribution via KPIS, including the item’s expiration date and batch number, for systematic organization and prevention of counterfeit and illegal drugs.
Patient-Satisfaction Guarantee Service
Pharmacies, now able to manage the GTIN and serial numbers of drug, contribute to an effective way of inventory control while saving costs.
The Korea Pharmaceutical Information System uses registered pharmaceutical data from manufacturers, importers, and distributors by providing a safe supply chain service, ensuring safety and satisfaction [of the products] for the people.
We are leading a new era of pharmaceutical logistics…
Transparency in management, down to the individual pill,
Ensuring the safety of 50 million citizens[, and a new paradigm for pharmaceutical distribution]!
The Pharmaceutical Serialization System, a database managing product and distribution information, strengthens the competitive edge (or future) of our manufacturers, distributors, and the people.