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(영문) 대법원 1994. 6. 14. 선고 93누19559 판결

[화장품및의약부외품제조품목허가신청반려처분취소][공1994.7.15.(972),1971]

Main Issues

Whether an application for marketing approval of non-pharmaceutical drugs or cosmetics may be refused on the ground that the name of the product is the same as the already permitted name.

Summary of Judgment

Article 5 (1) 2 of the former Pharmaceutical Affairs Act (amended by Act No. 4731 of Jan. 7, 1994) and the Enforcement Rule of the same Act (amended by Act No. 891 of Jun. 30, 1992) and the Guidelines for Manufacturing and Manufacturing Drugs (Public Health and Social Department Notice No. 91-80 of Jun. 30, 199) referred to as "drugs, etc." together with drugs, non-pharmaceutical drugs, cosmetics, medical appliances, or sanitary articles. Unlike Article 5 (1) 2 of the same Guidelines, Article 5 (1) 2 of the same Guidelines only stipulate the name of "pharmaceuticals, etc." as the name of "pharmaceuticals, etc." and thus, Article 5 (1) 2 of the same Guidelines cannot be applied to non-pharmaceutical drugs or cosmetics for which the application for permission for manufacturing is filed, and thus, the application for permission cannot be rejected on the grounds that the application for permission for manufacturing is unlawful on the grounds that the content of the guidelines, such as marketing approval, etc.

[Reference Provisions]

Article 26 (7) of the Pharmaceutical Affairs Act; Article 26 (1) of the former Pharmaceutical Affairs Act; Article 12 of the Enforcement Rule of the former Pharmaceutical Affairs Act; Article 5 (1) 1 of the Guidelines for Manufacturing and Product License, etc. of Drugs; Article 5 (1) 2 of the Guidelines for Manufacturing and Product License, etc. of Drugs, etc.

Reference Cases

Supreme Court Decision 85Nu674 delivered on December 10, 1985 (Gong1986,265) 85Nu376 delivered on February 24, 1987 (Gong1987,551)

Plaintiff-Appellee

Johnson Co., Ltd., Ltd., Counsel for the defendant-appellant-appellant

Defendant-Appellant

The Minister of Health and Welfare

Intervenor joining the Defendant

Colonel Business Corporation

Judgment of the lower court

Seoul High Court Decision 92Gu18353 delivered on July 22, 1993

Text

The appeal is dismissed. The costs of appeal are assessed against the defendant.

Reasons

The grounds of appeal Nos. 1 through 4 of the defendant litigation performers are examined together.

1. On December 27, 191, the lower court determined that the Defendant’s provision of Article 2 of the former Pharmaceutical Affairs Act, which provides that the name of manufacturing business and/or pharmaceutical products under Article 17 of the former Pharmaceutical Affairs Act, which is no longer than 5 of the former Pharmaceutical Affairs Act, shall be deemed to have been permitted under Article 17 of the former Pharmaceutical Affairs Act, and that the Defendant’s provision of Article 1 of the latter Pharmaceutical Affairs Act, which is no longer necessary for the first time for manufacturing business and/or 2 of the same Act, shall be deemed to have been permitted under Article 17 of the former Pharmaceutical Affairs Act, and that the latter’s provision of Article 9 of the former Pharmaceutical Affairs Act, which is no longer necessary for the first time for manufacturing business and/or 1 of the same Act, shall be deemed to have been amended by Article 17 of the former Pharmaceutical Affairs Act, and that the latter’s provision of the same Act, which is no longer necessary for the first time for manufacturing business and/or 2 of the same Act, shall be deemed to have been amended to the latter.

2. The "Act", "Rules", and "Permission Guidelines" refer to drugs, non-pharmaceutical drugs, cosmetics, medical appliances, or sanitary supplies of this case as well as "drugs, etc.", unlike Article 5 (1) 2 of the "Permission Guidelines" only provide for the name of "drugs, etc.". Thus, Article 5 (1) 2 of the "Permission Guidelines" cannot be applied to non-pharmaceutical drugs or cosmetics for which the plaintiff applied for permission of manufacture, and therefore, Article 5 (1) 2 of the "Permission Guidelines" cannot be rejected on the grounds of Article 5 (1) 2 of the "Permission Guidelines", and the defendant's disposition cannot be rejected on the grounds of other relevant Acts and subordinate statutes, such as the "Act" and "Permission Guidelines", and the respective provisions of the "Permission Guidelines" are examined as to the application for permission of manufacture of non-pharmaceutical drugs or cosmetics, which were already made to a third party under the same name, and thus, the defendant's application for permission of manufacture cannot be rejected on the ground that the plaintiff's application for permission of manufacture does not constitute a false name or exaggerated name.

3. Thus, although the reasoning of the judgment of the court below is not somewhat insufficient, the conclusion of the judgment below which judged the disposition of this case to be illegal is just, and it cannot be deemed that there was an error of incomplete deliberation, misunderstanding of legal principles or omission of judgment, such as the theory of lawsuit, and there

Therefore, the defendant's appeal is dismissed and all costs of appeal are assessed against the losing defendant. It is so decided as per Disposition by the assent of all participating Justices.

Justices Ahn Yong-sik (Presiding Justice)