Korea Sets New Pharmaceutical Serialization Deadlines

Korea's Ministry of Health and Welfare has announced new phase pharmaceutical serialization deadlines. In a publication on August 7, 2014, the MOHW adjusted the serialization dates to allow two phases starting January 1, 2015.

Pharmaceuticals must be serialized according to the following schedule:

• January 1, 2015: 30% of products (by sales), plus all psychotropics, biologics, and drugs that are flammable or explosive.
• January 1, 2016: All pharmaceutical products.
• Companies should submit an implementation plan describing the products to be committed for Phase 1 by October 2014.

Beginning in January 2016, serialized product supply reporting also begins.

The remaining attributes of the Korea serialization regulations (barcoding specification, optional aggregation, etc.) remained unchanged. Korea is also planning to undertake a series of supply chain traceability pilots starting in 2015 to help inform the development of an end-to-end traceability system for Korea.