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(영문) 대전지방법원 2018.08.10 2017구합106977
업무정지처분취소
Text

1. On October 18, 2017, the Defendant’s disposition of suspending the manufacture of non-pharmaceutical drugs (products) issued to the Plaintiff on the three-month basis is revoked.

Reasons

1. Details of the disposition;

A. The Plaintiff is running the business of manufacturing “D and E” and “F, etc. 6 items”, which are over-the-counter drugs, under the trade name of C (hereinafter “instant business”) at a factory located in Gangnam-gu, Dong-gu, Seoul (hereinafter “instant factory”).

B. G pharmacist, who is a manufacturing supervisor of quasi-drugs of the instant enterprise, determined the suitability and non-conformity as a quality control manager and signed on the test report of “D and E (B)”, which is a medicine produced by the instant enterprise, from July 2014 to August 2017.

C. On October 18, 2017, the Defendant: (a) against the Plaintiff on the ground that “Ga, who is a manufacturing supervisor of the instant enterprise, was reported as a manufacturing supervisor of the quasi-drugs; and (b) was unable to engage in any work other than the manufacturing management of the quasi-drugs; (c) was engaged in the manufacturing of D and E, which are pharmaceutical products, as a quality control manager; (d) Article 37(2) of the Pharmaceutical Affairs Act; (e) Article 95 of the former Rules on the Safety of Drugs, etc. (amended by Ordinance of the Prime Minister No. 1353, Jan. 4, 2017; hereinafter “Rules of this case”); and

Ⅱ Pursuant to the individual standard No. 21, a disposition for the suspension of the manufacture of non-pharmaceutical products (products) for three months (hereinafter “instant disposition”).

[Ground of recognition] Facts without dispute, Gap evidence Nos. 1, Eul evidence Nos. 1 and 5, the purport of the whole pleadings

2. Whether the instant disposition is lawful

A. The Plaintiff’s assertion 1) In accordance with Article 3(3) of the Decree on Standards for Facilities of Manufacturers and Importers of Drugs, etc., the Plaintiff obtained permission to manufacture D(s) and E(s) (s) equivalent to drugs at the instant factory to jointly manufacture six items, such as the plant with the plant of plant of plant of plant of manufacturing and importer, and the plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant of plant.

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