[제조품목허가취소처분등취소][공2002.1.15.(146),179]
The meaning of "manufacturing drugs" under Article 26 (1) of the former Pharmaceutical Affairs Act, and in cases where a medicine manufacturer calculates the raw materials to be used as raw materials of the complete medicine he/she manufactures, whether it is necessary to grant marketing approval or report on the raw materials separate from the complete medicine (negative)
Article 26 (1) of the former Pharmaceutical Affairs Act (amended by Act No. 6153 of Jan. 12, 200) provides that a person who intends to engage in the manufacturing business of drugs shall obtain permission for the manufacturing business of drugs by type of business or by place of manufacture, and obtain permission for the manufacture of drugs by item or file a report on the manufacture of drugs by item. Thus, since the manufacturing of drugs refers to the act of calculating drugs according to certain work to meet the general demand, it is reasonable to deem that the manufacturing business of drugs is not required to obtain permission for the manufacture of drugs or file a report on the manufacture items of drugs separately from the manufacture items of drugs in order to meet the general demand, such as the sale to another pharmaceutical manufacturer.
Articles 2(4) and 26(1) of the former Pharmaceutical Affairs Act (amended by Act No. 6153, Jan. 12, 2000)
Supreme Court Decision 83Do1715 delivered on May 27, 1986 (Gong1986, 830) Supreme Court Decision 92Do1683 delivered on September 8, 1992 (Gong1992, 2926) Supreme Court Decision 95Do1081 Delivered on July 28, 1995 (Gong195Ha, 3035)
Co., Ltd.
The Commissioner of Korea Food and Drug Administration
Seoul High Court Decision 2000Nu5915 delivered on September 27, 2000
The appeal is dismissed. The costs of appeal are assessed against the defendant.
We examine the grounds of appeal.
1. Article 26(1) of the former Pharmaceutical Affairs Act (amended by Act No. 6153, Jan. 12, 200) provides that a person who intends to engage in the manufacturing business of drugs shall obtain permission for the manufacturing business of drugs by type of business or by manufacturing factory, and obtain permission for the manufacturing of drugs by item or file a report on the manufacturing of drugs by item. The term "manufacturing of drugs" in this context refers to the act of manufacturing drugs according to certain operations to meet the general demand (see, e.g., Supreme Court Decision 95Do1081, Jul. 28, 1995). Thus, in calculating drugs that are raw materials of complete drugs to meet the general demand, such as selling them to another pharmaceutical manufacturer, it is reasonable to obtain permission for the manufacturing of drugs or file a report on manufacturing items of drugs separately, but it is not reasonable to deem that the manufacturer of drugs is not subject to permission for the complete manufacturing of drugs or file a report on manufacturing items of drugs.
According to the reasoning of the judgment below, the court below held that the defendant's revocation of the manufacture of this case on the ground that since the plaintiff, who is a medicine manufacturer, obtained the manufacture approval for the complete substanceidine which he manufactured, it is not necessary to separately obtain the manufacture approval or report the manufacture item for the purpose of using the full substance substance as the raw material of the requiredidine, and therefore the plaintiff's revocation of the manufacture of this case on the ground that it is illegal for the plaintiff to calculate the hydrosis without the manufacture approval or the manufacture approval report. In light of the above legal principles and records, the judgment of the court below is just, and there is no error in the misapprehension of legal principles as to the manufacture approval object under the Pharmaceutical Affairs
The grounds of appeal disputing this issue are rejected.
2. Furthermore, the lower court determined that the Defendant’s disposition was unlawful as exceeding the scope of discretion granted to the Defendant, taking into account the following circumstances: (a) the Plaintiff’s act of suspension of the manufacture of the requiredidine for seven months and suspension of the business of the requiredidine for five months in addition to the disposition of revocation of the item license of the manufacture of the “Isssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssss
In light of the records and the purport of the relevant statutes, the above judgment of the court below is just and acceptable, and there is no violation of the misapprehension of legal principles as to deviation or abuse of discretionary power.
The grounds of appeal disputing this issue are also rejected.
3. Therefore, the appeal is dismissed, and all costs of appeal are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices on the bench.
Justices Yoon Jae-sik (Presiding Justice)