본 영문본은 리걸엔진의 AI 번역 엔진으로 번역되었습니다. 수정이 필요한 부분이 있는 경우 피드백 부탁드립니다.
대법원 1990. 5. 11. 선고 90누1069 판결

[의약품제조허가품목에대한허가취소처분취소][공1990.7.1.(875),1281]

Main Issues

(a) Whether the standards for administrative disposition under attached Table 1 of Article 17 of the Guidelines for Quality Management Business, which is a assistant director’s instruction, are applicable (negative)

(b) The case holding that the revocation of marketing approval for manufacturing for reasons of falling short of the content of medicines does not constitute abuse of discretionary power;

Summary of Judgment

A. The criteria for administrative disposition provided for in attached Table 1 of the Ministry of Health and Welfare under Article 17 of the Ministry of Health and Welfare, which is a guide for the quality management business, are stipulated in the administrative agency's internal rules for handling affairs, and it shall be deemed that the binding of the administrative agency's employees and the citizens, including manufacturers of medical supplies, etc.,

B. Whether a punitive administrative disposition deviates from or abused the scope of discretion should be determined by comprehensively taking into account the substance of the violation as the grounds for the disposition, the degree of the violation, the necessity of the public interest to be achieved by the disposition in question, the disadvantage that the individual suffers, and other various relevant circumstances. Considering that the lack of sulfur content by the Plaintiff’s products manufactured is not intentionally reduced due to a defect in the manufacturing process, but the disadvantage that the Plaintiff would suffer due to the cancellation of the permission for the products manufactured by the Yellow Dust, even though considering the fact that the disadvantage that the Plaintiff would suffer due to the cancellation of the permission for the products manufactured by the Yellow Dust is considerable, it cannot be said that the public interest needs of the instant disposition to improve the public health by securing the uniformity, safety, and effectiveness of medicines, and the Plaintiff is not more than three times from November 1, 1986 to October 198, the permission for manufacturing or manufacturing items for lack of content of the drugs similar to that of the Yellow Yellow him and the above disposition cannot be seen as an abuse of discretion than 6% of the above imposed discretionary power.

[Reference Provisions]

(a)Article 69(1)(b) of the Pharmaceutical Affairs Act;

Plaintiff-Appellee

[Defendant-Appellee] Plaintiff 1 et al., Counsel for defendant-appellee

Defendant-Appellant

1. The Minister of Health and Welfare

Judgment of the lower court

Seoul High Court Decision 88Gu11454 delivered on December 21, 1989

Text

The judgment below is reversed and the case is remanded to Seoul High Court.

Reasons

We examine the grounds of appeal.

(1) The criteria for the administrative disposition prescribed in the attached Table 1 of the Ministry of Health and Welfare under Article 17 of the Ministry of Health and Welfare are stipulated in the regulations on the administrative affairs inside the administrative agency, and it shall be deemed that there is no binding effect on the people including manufacturers of drugs, etc., who are the parties to the administrative disposition or the court.

(2) The court below found, based on the quoted evidence, that the plaintiff analyzed the sulfur content of the Yellow Cheongwon manufactured on July 23, 1987 with the permission of item from the defendant, and found that 6% below 90% of the marked content which is below the permissible sulfur content, was below 90%, and the defendant revoked the permission of the manufacture of the Yellow Posiwon by applying Article 56 subparagraph 2 of the Pharmaceutical Affairs Act and Article 69 (1) subparagraph 3 of the same Act to the plaintiff on the ground that the sulfur content is insufficient, and the above shortfall was not intentionally reduced due to the manufacturing process error, and the plaintiff was subject to the disposition of the suspension of the business from January 1, 1986 to December 31, 198, the plaintiff was subject to the disposition of the suspension of the business from the defendant on December 1, 198 and the disposition of the suspension of the business from the defendant on December 31, 198, which was found to be unlawful.

Whether a punitive administrative disposition deviates from or abused the scope of discretionary authority or not shall be determined by comprehensively taking into account the substance of the violation as the ground for the disposition, degree of the violation, necessity of the public interest to be achieved by the disposition concerned, disadvantage to individuals, and various relevant circumstances. Considering that the circumstances leading to the violation of the Pharmaceutical Affairs Act, such as original adjudication, and that the disadvantage suffered by the Plaintiff due to the cancellation of permission for manufacturing the products of the Yellow Cheongwon, is considerable, it cannot be said that the public interest needs of the disposition of this case to improve the public health by securing the equal quality, safety, and effectiveness of the medicine, and considering the evidence No. 6 of this case and evidence No. 7-1 and No. 2 of this case, the Plaintiff's suspension of manufacturing for one month by the Defendant on November 1, 1986, and the extent of the lack of sulfur content of the Plaintiff's permission to manufacture the products of this case for 10% on the grounds of the lack of sulfur content and the lack of sulfur content of 18% on the grounds of the lack of sulfur content of this case.

In light of the public interest needs of the instant disposition and the content and degree of the instant violation, even if the Plaintiff considered losses, the instant disposition cannot be deemed an illegal disposition that deviates from the scope of its discretion or abused its discretion, but the lower court, which held that the instant disposition was an abuse of discretionary authority, shall be deemed to have committed an unlawful act of misapprehending the legal doctrine on deviation or abuse of discretionary authority. Therefore, the argument on this point is with merit

Therefore, the judgment of the court below is reversed, and the case is remanded to the court below. It is so decided as per Disposition by the assent of all participating Justices.

Justices Park Yong-dong (Presiding Justice)