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(영문) 인천지방법원 2014.12.18 2014고단5529

약사법위반

Text

Defendant

A Imprisonment with prison labor and fines of 2,00,000,000 won, and Defendant B shall be punished by fines of 15,00,000 won.

Reasons

Punishment of the crime

Defendant

A as the representative director of Dong-gu Incheon Metropolitan City D, A has overall control over the manufacture and management of drugs, and the defendant corporation B is a corporation established for the purpose of manufacturing and selling drugs.

1. Defendant A

(a) A person who has obtained marketing approval of drugs and an importer shall enter the trade name or address, name, manufacturing number, effective period, time-limit of use, etc. of a person who has obtained marketing approval of drugs or an importer on the containers or packages of drugs, and shall not sell any product in violation thereof, store or display such product for sale;

Although the above mentioned items are not entirely stated on the containers and containers of E, etc. 16 items for which a product license was granted in the Dispute Resolution Co., Ltd., the Defendant manufactured F 149 boxes (300 boxes) from February 25, 2010 to July 30, 2013, including the manufacturing of F 16 items of E, etc. from February 25, 2010 to July 30, 2013, the Defendant manufactured the total of 9,686 boxes (300 boxes) in E, etc. 68 times, as shown in Appendix I, and around January 4, 2010, up to September 5, 2013, up to 7,305, including the sale of E,1,60 won from around 74,60 won to the Dispute Resolution Co., Ltd., Ltd., as described in Appendix II, and sold the total of E,196,197,1378,167.

(b)The pharmaceutical manufacturers shall preserve all records related to pharmaceutical products and quality control standards for one year after the expiry of the effective period of the product concerned or after the expiration of the use period, and the pharmaceutical manufacturers shall have records of manufacture management and quality control for each production unit and shall keep them for not less than three years from the date of manufacture;

From the second half of 2010 to the second half of 2012, the Defendant manufactured 10 percentage of six items, such as H, I, J, K, L, M, etc. from the date of production, which is three years from the date of production, but the product status is poor, and all records, such as the manufacture management records, quality control records, etc., are discarded.