※ Article 49 of the Regulation on the Safety of Pharmaceuticals, etc. (Reporting of Production, Export, and Import Records of Pharmaceuticals, etc.)

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① Pursuant to Article 38(2) of the Act, individuals who have obtained marketing authorization for pharmaceuticals and manufacturers of "quasi-drugs" shall report their annual production and export records to the Minister of Food and Drug Safety through corporations, such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, organized under Article 67 of the Act, in accordance with the guidelines prescribed and announced by the Minister of Food and Drug Safety. However, for finished pharmaceuticals [including "non-narcotics" but excluding medical compressed gases], quarterly reports of production or import records must be submitted to the Minister of Food and Drug Safety and to the head of the Comprehensive Information Center for Pharmaceuticals under Article 47-3(1) of the Act.