(a) Whether he/she is a medicine falling under Article 2 (4) 3 of the Pharmaceutical Affairs Act;

(b) Requirements for falling under the items of Article 2 (4) 3 of the Pharmaceutical Affairs Act;

A. If the external part of this case carries out a function that prevents organized damage caused by marbling with the human body and makes it easy to put the body into an apparatus, etc. by inserting the apparatus, hand or hand for the purpose of diagnosis or treatment of a disease, etc., the external part of this case can be deemed as a pharmacological action of drugs, and thus, it shall be deemed as a medicine falling under Article 2 (4) 3 of the Pharmaceutical Affairs Act.

B. Article 2 (4) 3 of the Pharmaceutical Affairs Act only provides that “it shall be used for the purpose of exerting pharmacological effect on the structure and functions of human beings or animals” is a medicine and does not necessarily require any efficacy in light of the pharmacological effect.

Article 2 (4) 3 of the Pharmaceutical Affairs Act

Supreme Court Decision 84Do2892 Delivered on March 12, 1985

Defendant

Defendant

Attorney next full-time

Seoul High Court Decision 87No1081 Decided December 23, 1988

The appeal is dismissed.

We examine the grounds of appeal.

As legally determined by the court below, if the external leapcant of this case performs an act which makes it easy to emblize the body body of the parts in case of inserting the apparatus (in the inner border, workplace border, manager, rubber lake, etc.) or hand for the purpose of diagnosis, treatment, etc. of a disease, thereby preventing the structural damage caused by marbling with the human body, and in case of inserting it into the apparatus (in case of internal border, workplace border, manager, rubber lake, etc.), it can be seen as a pharmacological effect of drugs. Thus, the court below did not err in the misapprehension of legal principles as pointed out, since the court below did not err in the misapprehension of legal principles as to the drugs that "for the purpose of exerting pharmacological influence on the structure and function of human or animal" under Article 2 (4) 3 of the Pharmaceutical Affairs Act.

In addition, if used for the above purposes, it does not necessarily require any efficacy in its pharmacological action (see Supreme Court Decision 84Do2892 delivered on March 12, 1985). The argument is without merit.

Therefore, the appeal is dismissed. It is so decided as per Disposition by the assent of all participating Justices.

Justices Ansan-man (Presiding Justice)