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Market/Country:

South Korea

Classification of Products Affected

All prescription and narcotic drugs imported or exported in South Korea.

Market Overview

Regulatory Bodies Driving Serialization Compliance: The Korean Pharmaceutical Information Service (KPIS), Korea Food and Drug Administration (KFDA), Ministry of Health & Welfare (MoH)Compliance Deadlines: January 1, 2012: Data carrier containing GTIN, expiry date, lot number must be affixed on all narcotic drugs. (labeling requirement)January 1, 2013: Data carrier containing GTIN, expiry date, and lot number must be affixed on the prescription drugs. (labeling requirement)October 31, 2014: Companies intending to shipping into this market are advised to submit an implementation plan to the Korean Ministry of Health by October 2014.January 1, 2015: Companies must serialize the products accounting for the 30% of registered product with KFDA. Data carrier containing a serial number, GTIN, expiration, and lot must be affixed on the narcotic and prescription drugs. (Serialization requirement) Note: Psychotropic drugs and Biologicals must be serialized by January 1, 2015 deadline.

January 1, 2016: All Pharmaceutical Product must be serialized.

Implementation dates pertain to manufacturing date for domestically manufactured pharmaceuticals, and customs clearance date for imported pharmaceuticals

Requirements for Labels of the Saleable Units

Carrier: GS1 Data Matrix or GS1-128 linear bar code. Labeling requirements as of January 2013 require data carrier to contain GTIN, Expiration Date, and lot number. Serialization requirements in 2015 will require addition of serial number. Human Readable Text may be omitted if there is not enough room on the packaging label.

Requirements for Labels Above the Saleable Unit

Carrier: GS1 Data Matrix or GS1-128 linear bar code will be required to meet 2015 Serialization Requirements. To meet 2015 requirements, GTIN, expiration date, lot, and serial number must be encoded in the data carrier. Human Readable Text may be

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Global Market Intelligence Service August 14, 2014 Version 3.0

omitted if there is not enough room on packaging label.

Additional Notes

Aggregation requirements are delayed.

GTIN 14 is derived directly from Korean Drug Code. See embedded white paper for explanation.

The 2015 grace period for non-serialized products will be granted to companies that submit a serialization implementation plan to Korean Ministry of Health.

References/Links

Excellis Health Solutions White Paper- Serialization Regulation Report- United States

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History of Document Updates

September 16, 2013: Version 2- Jon Galinskie and Gordon Glass

August 15, 2014: Version 3- Sal Paparone

 

Proprietary and Confidential

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Korean_Serialization_phases_Announcement_7aug14.pdf

Translated_Serialization_phases_Announcement_7aug14.pdf