Korea updates medicine serialisation timelines

South Korea has tweaked the implementation timelines for serializing medicines, giving a phased schedule starting on January 1, 2015.

Medicines sold in Korea have been required to carry a 2D datamatrix code containing the Global Trade Item Number (GTIN), lot number and expiry date since the end of 2013.

A unique serial number will have to be incorporated into the code for around a third of all drugs on the market - including all opioid analgesics, psychotropics and biologic drugs for example - by the start of next year.

By January 1, 2016 the serialisation requirement will apply to all pharmaceutical products sold in the country, according to South Korea's Ministry of Health and Welfare (MOHW), which says it will carry out a pilot next year to establish and test a framework for tracking serialized product through the supply chain from manufacturer to the point of dispensing.

Reporting of transaction data will start at the start of 2016, according the new announcement (which is in Korean). Companies should submit details of their serialization implementation plans - including a listing of the products that will be covered by the first phase of the roll-out - by October 1 of this year.

The serialisation scheme will also - uniquely in terms of traceability systems for drugs being implemented or developed around the world - allow the use of radiofrequency identification (RFID) in place of a 2D datamatrix code as the data carrier. Aggregation of the serial numbers as the packages are bundled into cases and pallets remains optional and unchanged in the latest update.

The aims of the track-and-trace system is to improve inventory management by computerizing distribution records and facilitating recalls and the disposal of expired medicines, preventing illicit drugs such as counterfeits and diverted products entering the supply chain, and preventing drug abuse and misuse.

The intention is also to use the serial numbers to help manage medication records and avoid mis-prescribing, according to the MOHW.