[의약품제조업허가사항변경허가신청등반려처분취소][집33(3)특,485;공1986.2.1.(769),265]
A. Appropriateness of a disposition rejecting an application for modification of permitted matters for the manufacture of medicines on the sole ground that a permit under Article 53 of the Enforcement Decree of the Pharmaceutical Affairs Act was not attached
(b) The nature of the act permitted or permitted under Article 26 of the Pharmaceutical Affairs Act and Article 53 of the Enforcement Rule of the same Act;
A. As stated in Article 53(1) of the Enforcement Rule of the Pharmaceutical Affairs Act at the time of the modification of the matters permitted for the manufacture of drugs, etc., the attachment of the relevant permit to the relevant application is required as a single standard to facilitate the determination of the identity of the licensed or licensed persons, and cannot be deemed as the standard of the nature of the mandatory provisions that determine whether to grant permission, and thus, the rejection of the application for modification of the permitted matters is unlawful.
B. With respect to the permission for modification under Article 26 of the Pharmaceutical Affairs Act and Article 53 of the Enforcement Rule of the same Act, the competent administrative agency should grant the permission unless there are special circumstances to the effect that the permission is in conformity with the requirements of the above Article, and that the permission shall not be denied even though there is no need for public interest.
Article 26 of the Pharmaceutical Affairs Act, Article 53 of the Enforcement Rule of the same Act, Article 27 of the Administrative Litigation Act
[Judgment of the court below]
The Minister of Health and Welfare
Seoul High Court Decision 84Gu1198 delivered on June 21, 1985
The appeal is dismissed.
The costs of appeal are assessed against the defendant.
The grounds of appeal are examined.
According to the reasoning of the judgment below, the court below found that the plaintiff company is the plaintiff company and its representative director is changed to the non-party 2, who is the current representative director of the plaintiff company, and that the non-party 2, the representative director of the plaintiff company, on behalf of the plaintiff company, applied for the change of permission for the drug manufacturing business (representative) on the ground that the representative of the plaintiff company was changed to the plaintiff company. The defendant did not attach permission for the above application and did not return the above application to the plaintiff company for the reason that the representative director of the plaintiff company is not the non-party 1 as originally permitted, and therefore, the court below did not err in the misapprehension of legal principles as to the permission for the manufacturing business under the premise that the plaintiff company's name of the plaintiff company is registered in the plaintiff company's registry and the plaintiff company's name is presumed to be the legitimate representative director. Thus, the court below did not err in the misapprehension of legal principles as to the permission under the premise that the plaintiff company's application was not a legitimate one of the reasons for permission for the plaintiff company's permission or the plaintiff company's permission.
Therefore, the appeal is dismissed, and the costs of appeal are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices.
Justices Kang Jin-young (Presiding Justice)