South Korea serialisation track & trace 1st January 2016

South Korea serialisation track & trace 1st January 2016

In April, the S.Korea Pharmaceutical Information Center (KPIS), held training sessions that described the new requirements for serialisation track and trace in S.Korea, which are intended to come in to force 1st January 2016.

In a recent meeting with KPIS, they emphasized that the purpose of the legislation will be to reduce reimbursement fraud in the country.

The proposed model enhances the existing reporting that is required by supply chain participants to KPIS on the sale of pharmaceutical product throughout the in-country supply chain. Fundamentally, an additional appendix is to be added to the existing report containing the serialisation and aggregation information of the product being sold in the transaction.

KPIS report that the new legislation will be published very shortly, in June. They are proposing to have their system available for supply chain participants to test connections in September/October time, with the final production system being available for connection November/December time.

The serialisation track and trace model is described as follows:

  • Track & trace starts with the first sale in S.Korea
  • The seller of product publishes the sale transaction information, including unit of sale & shipper serialisation and aggregation, to the KPIS system
  • The KPIS system reports the sale to the buyer, so that they have the relevant serialisation information
  • This is then repeated until the point of dispense/use, e.g. hospitals, where they will use the serialisation information to justify payment requests to the government

The proposed messages allow for aggregation of units of sale to shippers. As expected, they also explicitly allow for RFID.

If you would like more information on this, please don’t hesitate to contact me at Stephen.mcindoe@be4ward.com.

Available for request:

Serialisation Lessons Cover     Serialisation Legislation Cover     Booklet image (2)

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