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(영문) 대법원 1987. 2. 24. 선고 85누376 판결
[의약품제조업허가사항변경신청반려처분취소][공1987.4.15.(798),551]
Main Issues

(a) Whether a person may apply for a change in the name of permission for manufacture of medicines on behalf of another;

B. Whether a civil judgment constitutes a related document evidencing the acquisition necessary for the application for change of representative under Article 53(2) of the Enforcement Rule of the Pharmaceutical Affairs Act

(c) The nature of the act of permission, alteration of permission under Article 26 of the Pharmaceutical Affairs Act and Article 53 of the Enforcement Rule of the same Act;

(d) Whether Article 53(1) of the Enforcement Decree of the Pharmaceutical Affairs Act, which attached a permit to file an application for permission for modification, is a mandatory provision

Summary of Judgment

A. If Gap filed a lawsuit against the pharmaceutical company seeking the implementation of change of name due to the transfer of the right to permit the manufacture of medicines against the pharmaceutical company, and the judgment in favor of Gap becomes final and conclusive, the above final and conclusive judgment becomes the cause of the application for change of the name of a pharmaceutical manufacturing business license and also becomes the document proving the transfer of the name, and thus Gap can file a subrogation application for change of name, and thus the disposition which the administrative agency rejected on the ground that Gap

B. Where a representative applies for permission to change the transfer of a drug manufacturing business pursuant to Article 53(2) of the Enforcement Rule of the Pharmaceutical Affairs Act, the relevant documents proving the transfer should be attached, but such documents are not necessarily necessary to be a sales contract, and a civil judgment shall also be a document proving the transfer.

C. With respect to the permission for modification of matters to be permitted 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 where the permission is in conformity with the requirements of the above Act, and the permission shall be refused in the sense that it is not necessary for the public interest.

D. Article 53(1) of the Enforcement Decree of the Pharmaceutical Affairs Act provides that an application for permission to change this is required as a single standard to facilitate the determination of the identity of the person who obtained the permission or permission, and cannot be considered as the standard of mandatory provisions to determine whether to grant permission.

[Reference Provisions]

(a)Article 53(2) and Article 53(d) of the Enforcement Rule of the Pharmaceutical Affairs Act; Article 53(1)(c) of the Enforcement Rule of the Pharmaceutical Affairs Act; Article 26 of the Pharmaceutical Affairs Act; Article 27 of the Administrative Litigation Act

Reference Cases

Supreme Court Decision 85Nu674 Decided December 10, 1985

Plaintiff-Appellee

[Judgment of the court below]

Defendant, the superior, or the senior

The Minister of Health and Welfare (Attorney Jeong-tae, Counsel for defendant-appellant)

Intervenor joining the Defendant

[Defendant-Appellant] Defendant Defendant’s Attorney Song Jin-jin et al.

Judgment of the lower court

Seoul High Court Decision 84Gu632 delivered on March 22, 1985

Text

The appeal is dismissed.

The costs of appeal are assessed against the defendant.

Reasons

The grounds of appeal are examined (to the extent of supplement in case of supplemental appellate briefs not timely filed by the supplementary intervenor).

1. As to the first ground for appeal:

(1) According to the reasoning of the judgment of the court below, the court below, based on the adopted evidence, transferred the drug manufacturing license of this case to the non-party 1 on November 25, 1978, and repurchased it again on July 6, 1981. The above non-party 1 did not change the name of permission to the plaintiff before the plaintiff and became the representative director on October 28, 1982, and then changed the above name of permission to the above company before the above company. The plaintiff filed a lawsuit against the above company with the Suwon District Court for demanding the performance of the procedure for change of name on July 6, 1981, and the judgment in favor of the plaintiff became final and conclusive around December 13, 198 (after the above company filed an appeal to the non-party 1 on July 13, 1981, the court below rejected the above application by subrogation to the defendant on the ground that the above defendant's application for change of the name of permission was unlawful.

In light of the records, the above fact-finding and judgment of the court below are just, and there is no misconception of facts, incomplete deliberation, or illegality in the reasoning for lack of reasons, such as the theory of litigation.

As pointed out in the theory that the above final civil judgment is not bound by the defendant, but the court below held that the above civil judgment becomes the cause of subrogation application and also the documents evidencing takeover, and the above civil judgment does not bind the defendant. In addition, where the above civil judgment applies for change of the representative to transfer the pharmaceutical industry pursuant to Article 53 (2) of the Enforcement Decree of the Pharmaceutical Affairs Act, the documents must be attached to the relevant documents proving the takeover. However, the above civil judgment does not necessarily require a sales contract, and the above civil judgment shall be a document evidencing the takeover. Therefore, the argument is groundless.

(2) In the case of permission for modification of matters to be permitted 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 permission unless there are special circumstances where the application for permission conforms to the requirements of the above Act, and in the sense that the permission is not denied despite the need for public interest, the decision to grant permission belongs to the binding discretion (see, e.g., Supreme Court Decision 85Nu674, Dec. 10, 1985). Thus, there is no argument that the above permission for modification can not be subject to

2. On the second ground for appeal:

(1) The court below held that the civil judgment that became final and conclusive as the defendant of the above company on the premise that the defendant is not a representative of the relevant company, not a representative of the relevant company, but a representative of the relevant company, and that even if the representative of the above company was changed after the above judgment, the application for subrogation can be made. The above judgment of the court below is just, and there is no error in the misapprehension of the legal principles as to the person subject to permission on pharmaceutical manufacturing business on the premise that the person subject to permission on pharmaceutical manufacturing business is not the above company and the representative of the above company. (See the above judgment of the party

(2) The above application for permission of change is a new argument that the application itself is unlawful because it does not accompany a permit under Article 53(1) of the Enforcement Rule of the Pharmaceutical Affairs Act, and it cannot be a legitimate ground for appeal. Moreover, the above provision of the Pharmaceutical Affairs Act requires that the application for permission of change be attached as a single standard to facilitate judgment on the identity of the person who has obtained permission or permission, and it cannot be viewed as a basis for the mandatory provision that determines whether to grant permission (see the above case’s party members). Thus, the application for permission of change cannot be returned because it did not formally attach a permit (see the above case’s party members).

3. 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 Yoon Il-young (Presiding Justice)

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