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(영문) 대법원 1966. 7. 19. 선고 66누64 판결

[의약품제조업허가취소처분취소][집14(2)행,033]

Main Issues

Relation to the permission under Article 26 of the Pharmaceutical Affairs Act and the revocation of permission for the manufacture of medicines;

Summary of Judgment

The permission of this Article does not mean an abstract permission to manufacture a drug, but it refers to a permission to manufacture a drug for a single item, so even if a drug falls short of the calendar price, the permission to manufacture a drug for another item may not be revoked on the ground of this.

[Reference Provisions]

Article 26 of the Pharmaceutical Affairs Act

Plaintiff-Appellant

South Korean Pharmaceutical & Fisheries Corporation

Defendant-Appellee

The Minister of Health and Welfare

original decision

Seoul High Court Decision 65Gu233 delivered on April 7, 1966

Text

The original judgment shall be reversed, and

The case is remanded to Seoul High Court.

Reasons

The ground of appeal No. 2 by the plaintiff's agent is examined.

According to the judgment of the court below, since a manufacturer of medicines has obtained permission for each item of medicines, it is not possible to revoke permission for manufacturing of medicines in violation of Article 26 of the Pharmaceutical Affairs Act, but it is reasonable to interpret the plaintiff's chief as the term "drugs" and "drugs" of medicines, non-pharmaceuticals, cosmetics, medical appliances, sanitary supplies, etc., and it is clear in light of the purport that approval should be obtained for each item of medicines in accordance with Article 28 of the Pharmaceutical Affairs Act. Thus, even if the plaintiff revoked permission for manufacturing of medical products in violation of Article 69 (1) of the Pharmaceutical Affairs Act, even if the plaintiff's permission for manufacturing of medical products in violation of Article 69 of the same Act was revoked, it is not a legitimate act within the scope of authority granted to the defendant pursuant to Article 26 of the same Act. The defendant's disposition is not erroneous.

According to the above decision, although the court below is trying to manufacture drugs pursuant to Article 26 of the Pharmaceutical Affairs Act, it is interpreted that permission for manufacturing drugs is obtained abstractly by leaving one drug, one drug is obtained by Article 28 of the same Act, one product is to be separately approved for manufacturing pursuant to Article 28 of the same Act. However, Article 28 of the same Act is not only to have been deleted by amendment of the Act before this disposition is issued but also to the approval for manufacturing drugs that are not listed in the Korean Pharmacopoeia, even if it is governed by Article 28 of the same Act, and Article 26 of the same Act provides that permission for manufacturing drugs should not be interpreted as meaning of permission for manufacturing abstract drugs based on Article 28 of the same Act, because it is obvious that permission for manufacturing business should be obtained within one year, and it is reasonable to interpret that permission for each item of drugs should be obtained for each item of the manufacturing business under Article 26 of the Pharmaceutical Affairs Act, but it is not clear that it is necessary to permit only one item of the above Article 28 of the same Act.

Therefore, it is wrong that the original judgment is interpreted as only an abstract permit for the manufacture of medicines, regardless of the specific manufacturing drugs, and the defendant's disposition on the premise that it is justified.

In addition, in the case of this case, if the permission for the manufacture of medicines of 25 items for the plaintiff is revoked (or withdrawal in school) on the ground that new reasons arise after a lawful and effective establishment of the permission for the manufacture of medicines has been completed over 10 times, it would be reasonable to apply Article 69 of the Pharmaceutical Affairs Act because the new reasons for the new reasons are related to the manufacture of medicines of 25 items or only to the manufacture of specific medicines. However, the court below did not err in holding that the disposition of the defendant who revoked the permission for the manufacture of medicines for the whole items is justifiable, without confirming whether the restrictions under the conditions are related to the manufacture of 24 items, which are one of the above 25 items.

Therefore, without further proceeding to decide on the other grounds of appeal, the final appeal is justifiable. Thus, according to Article 14 of the Administrative Litigation Act and Article 406 (1) of the Civil Procedure Act, it is so decided as per Disposition by the assent of all participating judges.

[Judgment of the Supreme Court (Presiding Judge) Mag-Jak Park Mag-gu