A. “B” sold by the Defendant of mistake of facts or misapprehension of the legal doctrine does not constitute a pharmaceutical product subject to regulation under the Pharmaceutical Affairs Act.

B. The lower court’s sentence of unreasonable sentencing (fine 5 million won) is too unreasonable.

2. Determination

A. In light of the legislative purpose and purport of the Pharmaceutical Affairs Act claiming a mistake of facts or misapprehension of legal principles, and the contents and purport of Article 2 subparag. 4 of the Pharmaceutical Affairs Act that defined a drug, the term “pharmaceuticals” under the Pharmaceutical Affairs Act includes both those used for the purpose of diagnosis, treatment, mitigation, treatment or prevention, or all those used for the purpose of diagnosis, treatment, mitigation, treatment or prevention, or for the purpose of exerting pharmacological effect on the structure and function of human beings or animals, regardless of which efficacy exists in the pharmacological action, the composition, shape (container, package, package, design, etc.), name of the drug, and the purpose of use indicated therein, efficacy, effect, efficacy, volume, advertisement or explanation at the time of sale, etc. of the drug, if it is recognized or claimed to be used for the above purpose in light of the general public, it shall be interpreted that all of them are subject to the regulation of the Pharmaceutical Affairs Act.

(See Supreme Court Decision 2009Do4785 Decided October 14, 2010). According to the evidence duly adopted and examined by the lower court, the Defendant: (a) publicly announced and sold the product “B” purchased from C through the Internet homepage “D”; and (b) the Defendant has the efficacy to improve the sexual function of men by stimulatinging the blood cycle by stimulatinging the bio-energy of the sound cell with both wave energy on the website (products characteristics); (c) using the expression “B” that the product “B” purchased from C has the effect of relaxinging the blood cycle; and (d) the Defendant has the efficacy of improving the sexual function of men by stimulatinging the blood cycle; and (e) using the expression “a strengthened non-child xa x xa, Australia, and the Republic of Korea medicine.”