Article 26 (7) of the Pharmaceutical Affairs Act (amended by Act No. 5454 of Dec. 13, 1997) provides that "the subject matters, standards, conditions, management, etc. of permission shall be determined by the Ordinance of the Ministry of Health and Welfare". Article 21 (3) 1 of the Enforcement Rule of the Pharmaceutical Affairs Act (amended by the Ordinance of the Ministry of Health and Welfare No. 30 of Jul. 196; hereinafter referred to as the "Enforcement Rule of the Pharmaceutical Affairs Act") provides that "the name of a product which may be mistaken for other products shall not be the subject matters of permission". Article 26 (7) of the same Act provides that "the new guidelines for permission for manufacturing and importing drugs, etc. (amended by the Ordinance No. 5454 of Dec. 13, 199) (the revised by the Ministry of Health and Welfare No. 1994-53 of Oct. 5, 194) shall be the same as the guidelines for permission for the use of a similar name or the same guidelines.

Thus, if the provisions of Article 6 (1) and 6 (2) of the Guidelines of this case are merely the administrative agency's internal business management rules, and there is no external effect as a law binding upon the court or the general public. Thus, whether the disposition of manufacturing drugs is a legitimate disposition that complies with the permission standards for the name is not uniformly determined depending on whether the name satisfies the "same or similar name examination standards as provided by Article 6 (1) and [Attachment 2] of the Guidelines of this case, but whether it constitutes " another product" as provided by Article 21 (3) 1 of the Enforcement Rule of the Act, and therefore, unless there is a concern that it is likely to be mistaken as another product, it shall not be deemed an illegal disposition that violates the permission standards for the manufacture of drugs only on the ground that the name is contrary to the "same or similar name examination standards as provided by the Guidelines of this case."

Examining the reasoning of the judgment below in light of the aforementioned legal principles and records, the decision of the court below is not to make a determination on whether the product approval disposition of this case complies with the permission standards for the product manufacture of this case merely because it does not violate the provisions of Article 6 (1) and attached Table 2, but it should be made on the basis of whether the name is "any name likely to be mistaken as another product" as provided by Article 21 (3) 1 of the Enforcement Decree of the Act. The plaintiff's Bo Jong-young and the defendant's assistant's assistant exchange of the same kind and the same-sex exchange of the defendant's assistant corporation can easily distinguish them only with the name of the business, so it cannot be viewed as an unlawful disposition against the permission standards for the product manufacture of this case with regard to the name of Bo Jong-sung's general exchange, and therefore, the decision of the court below is not erroneous in the misapprehension of legal principles as to the product inspection guidelines of this case and the judgment of the court below as to the product of this case, and there is no concern that there is no other error in the defendant's grounds of appeal 1.

Therefore, the appeal is dismissed, and the costs of appeal are assessed against the defendant joining the defendant, and the remainder is assessed against the defendant who is the appellant. It is so decided as per Disposition with the assent of all Justices who reviewed the appeal.

Justices Lee Yong-woo (Presiding Justice)