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(영문) 서울고등법원 2012.02.22 2011나30088
손해배상(기)
Text

1. Of the judgment of the first instance court, the part against Defendant A, B, C, D, E, F, G, and H is revoked, and that part is revoked.

Reasons

1. The following facts:

(a)bee;

(h) Each fact described is not disputed between the parties, or is recognized in accordance with the purport of Gap evidence 1-1, 2, 4, 6, 8, 12-18, Eul evidence 2-1, Eul evidence 5-1, Eul evidence 6, 7, Eul evidence 8-1, Eul evidence 8-1, and Eul evidence 12, as a whole.

A. The Plaintiff is a corporation established with the purpose of contributing to the improvement of public health and the promotion of social security by carrying out businesses such as the imposition and collection of insurance premiums and the payment of insurance benefit costs under the National Health Insurance Act.

(2) Defendant Samcheon Pharmaceutical Co., Ltd. (hereinafter referred to as “Defendant Samcheon Pharmaceutical Co., Ltd.”) and Defendant Samcheon Medicine Co., Ltd. (hereinafter referred to as “Defendant Samcheon Medicine Co., Ltd.”) are companies engaged in the manufacture, sale, etc. of drugs.

(3) Defendant A Co., Ltd. (hereinafter “Defendant A”) is a company engaging in pharmaceutical analysis business. Defendant B’s representative director, Defendant C’s technical adviser, Defendant D’s business director, Defendant E, and F were the test director, Defendant G, and H analysis researcher.

(b) Biological equivalence test (1) Biological equivalence test (hereinafter referred to as “biological equivalence test”) means a test conducted for the purpose of proving that, as a part of a biological equivalence test, the two preparations in the same administration route containing the same major ingredient are statistical equivalent in terms of the utilization rate of the human body with respect to a medicine in which the major ingredient is absorbed into the clibal blood, and indicating efficacy.

The Korean Food and Drug Administration (hereinafter referred to as the "Food and Drug Administration") has established the "biological equivalence test standards" by the notification of the Food and Drug Administration, and has set the procedures, methods, etc. necessary for conducting the same-sex test and are appropriate for the operation thereof.

The same-sex test is the area below the blood concentration of active ingredients by collecting blood from subjects who have implemented the test medication and the large treaty.

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