의약품 품목허가 취소처분 취소
1. The plaintiff's appeal is dismissed.
2. The costs of appeal shall be borne by the Plaintiff.
The purport of the claim and appeal is the purport of the appeal.
1. The reason why the court has used this part of the disposition is as stated in Article 8(2) of the Administrative Litigation Act and the main sentence of Article 420 of the Civil Procedure Act. Thus, this part of the reasoning of the judgment of the court of first instance is cited.
2. Whether the instant disposition is lawful
A. The judgment of the court of first instance is as shown in the relevant statutes.
B. The reason why the court's error in the procedure is used as to this part of the judgment of the first instance is 2.B.
Therefore, in accordance with Article 8(2) of the Administrative Litigation Act and the main sentence of Article 420 of the Civil Procedure Act, this is cited as it is.
The Plaintiff stated in the grounds of appeal No. 6 that the part concerning determination on whether the procedural defect in the first instance is procedural defect is not disputed. However, since it is unclear whether the assertion on procedural defect itself is explicitly withdrawn, it is determined that the argument is maintained as it is.
C. 1) Defect in the substance of the Plaintiff’s assertion 1) The existence of the defect in the establishment of the instant item approval does not have any defect in the establishment of the instant item approval, and the revocation of the instant disposition is in itself unlawful.
B. The conditions of permission added to the instant item approval pursuant to the illegal conditions of permission are unlawful in the following point. Thus, the instant disposition on the ground that the said conditions of permission were not fulfilled is unlawful.
(1) The marketing approval under the Pharmaceutical Affairs Act constitutes a so-called act of discretionary discretion, and thus, it cannot be attached to the subsidiary, and even if the subsidiary is attached, it shall be null and void.
"Conditions for the submission of clinical trial data in the last 2 years" added through the first permission among the conditions attached to the permission of this case is unlawful as an assistant library without any legal basis.
Fidelity is difficult to secure patients necessary for the clinical trial due to the "limited market terms", so it is necessary to secure sufficient clinical trial data within the period required by the defendant.