[1] The concept of medicine under the Pharmaceutical Affairs Act and the criteria for its determination

[2] The case holding that "Chowon" constitutes "non-pharmaceutical drugs" under Article 55 (2) of the Pharmaceutical Affairs Act

[3] The meaning of "advertisement" under Article 55 (2) of the Pharmaceutical Affairs Act

[4] The standard for determining whether the contents of an advertisement of health-subsidized food violate Article 55 (2) of the Pharmaceutical Affairs Act

[5] The purport of Article 16 of the Criminal Code

[1] Medicines under the Pharmaceutical Affairs Act are used for the purpose of the diagnosis, treatment, mitigation, treatment, or prevention of diseases of human beings or animals, other than those listed in the Korean Pharmacopoeia, or for the purpose of exerting pharmacological functions in the structure or function of human body (excluding machinery, apparatus, cosmetics). (Article 2(4) of the Act does not necessarily require any efficacy in the pharmacological action, the name, shape (container, packing, packing, etc.), name, shape (container, packing, etc.), and the purpose of use indicated therein, efficacy, effect, usage, volume, publicity or explanation at the time of sale, etc., except for those recognized as food as being used for the above purpose, or if it is recognized as being used for such purpose or it is claimed as having efficacy. (Article 2(4) of the Act).

[2] The case holding that "Chowon" constitutes "non-pharmaceutical drugs" under Article 55 (2) of the Pharmaceutical Affairs Act

[3] The advertisement prohibited under Article 55 (2) of the Pharmaceutical Affairs Act (the same shall apply to the case of Article 61) is not limited to the case where the contents of the advertisement are stated on containers, packages, or appended notes, but it is interpreted that it is subject to regulation not only to other printed matters, but also to propaganda or explanation that is likely to mislead consumers into drugs, etc. at the time of sale, etc.

[4] In the case of health-subsidized foods, whether the contents of the advertisement violate Article 55 (2) of the Pharmaceutical Affairs Act shall be determined based on whether the contents of the advertisement constitute a false and exaggerated advertisement for health-subsidized foods under Article 6 (2) [Attachment 3] of the Enforcement Rule of the Food Sanitation Act, namely, (1) an expression mainly for the promotion of the general function of physical organization within the scope not including matters concerning the prevention and treatment of diseases, (2) an expression of facts officially recognized as food nutrition such as the dissemination of pregnancy and organic nutrition, the dissemination of nutrition for the elderly, etc., (3) an expression of the food nutrition function and effect of the major nutrition ingredients contained in the products, and (4) an expression of simple recommended contents not referring to a specific disease.

[5] Article 16 of the Criminal Code provides that "the act of misunderstanding that one's act does not constitute a crime under the law shall not be punishable only when there is a justifiable reason for misunderstanding." It is generally a crime, but it is generally a mistake that one's act does not constitute a crime under the law, and if there is a justifiable reason for misunderstanding of misunderstanding, it shall not be punishable.

[1] Article 2 (4) and / [2] Article 5 (2), Article 74 (1) and / [3] Article 55 (2), Article 59, Article 61 of the Pharmaceutical Affairs Act / [4] Article 55 (2) and / [5] Article 16 of the Criminal Act

[1] [1] [4]

[Plaintiff-Appellant] Plaintiff 1 and 1 other (Law Firm Gyeong, Attorneys Park Jae-soo et al., Counsel for plaintiff-appellant)

[1] Supreme Court Decision 84Do2892 delivered on March 12, 1985 (Gong1985, 582)

[Plaintiff, Appellant] Plaintiff 1 and 1 other (Law Firm Gyeong, Attorneys Park Jong-soo et al., Counsel for plaintiff-appellant)

[Plaintiff, Appellant] Plaintiff 1 and 1 other (Law Firm Han, Attorneys Han-soo et al., Counsel for plaintiff-appellant)

[5] Supreme Court Decision 95Do1351 delivered on August 25, 1995 (Gong1995Ha, 3312)

[Plaintiff, Appellant] Plaintiff 1 and 1 other (Law Firm Gong1997Sang, 1694 others, Counsel for plaintiff-appellant)

[Plaintiff, Appellant] Plaintiff 1 and 1 other (Law Firm Gong1998Ha, 2035 decided June 23, 1998)

[Plaintiff, Appellant] Plaintiff 1 and 1 other (Law Firm Han, Attorneys Park Jong-soo et al., Counsel for plaintiff-appellant)

Defendant 1 and one other

Defendants

Attorney Go Jong-hee

Jeju District Court Decision 98Ra1751 delivered on January 7, 1999

The Defendants’ appeal is dismissed.

1. Summary of grounds for appeal;

The gist of the first appeal by the defendants' defense counsel is that although the defendants were not medical supplies, the court below found the defendants guilty of all the charges on the grounds that they indicated or advertised that they had medical efficacy and effects, but they were not medical supplies, they did not err by misapprehending the legal principles as stated in Article 55 (2) of the Pharmaceutical Affairs Act (hereinafter referred to as the "Act"), since the defendants' acts of 6 gambling products such as panty, pacts, learning sportss, blicks, blicks, blicks, blicks, etc. do not fall under the category of "non-pharmaceutical drugs" under Article 55 (2) of the Act (hereinafter referred to as the "Act"), and therefore, the court below found that the defendants' acts of 190s of this case were not likely to mislead or mislead that they had medical efficacy and effects similar to the drugs, and that the defendants' acts of 200s of this case were not subject to regulation under Article 55 (2) of the Act (1) of the Act) of this case.

2. Determination:

A. Judgment on the misunderstanding of legal principles or misconception of facts concerning the Pharmaceutical Affairs Act

(1) The Defendants’ assertion that since the investigative agency, up to the trial of the court of the first instance, it is not subject to regulation under Article 5(2) of the Act prohibiting labeling or advertising that is likely to mislead the medical efficacy, effect, etc. similar to that of a drug, even if it is not a drug, since it falls under the “pharmaceutical” under Article 2(4) of the Act.

In addition to those listed in the Korean Pharmacopoeia, drugs referred to in the Act are intended to be used for the purpose of the diagnosis, treatment, mitigation, treatment, or prevention of diseases of human beings or animals, or for the purpose of exerting pharmacological functions in the structure or function of human body (excluding machinery, tools, cosmetics). (See Article 2(4) of the Act), regardless of the existence of any efficacy in the pharmacological action, the name, shape (container, packing, packing, etc.), name, shape (container, packing, etc.), efficacy, efficacy, effect, volume, publicity or explanation at the time of sale, etc. of the drugs, except for those recognized as food as being used for the above purpose or claimed as having efficacy (see, e.g., Supreme Court Decision 97Do2925, Feb. 13, 1998).

However, in this case, according to the evidence duly examined and adopted by the court below, the source of this case added KIKO ingredients to beverages with raw materials such as ginseng as its main ingredient, and obtained patents to increase the effectiveness as its main ingredient, kidic acid-containing beverages. Defendant 1 also sold kidic acid-containing beverages with business type as food sale business. The source of this case contains posium (70mm per 1 per 70mm) and 60 per madic type and above. The source of this case's 2nd side of the box of this case's box "G beverage" or 2nd 1,000 per day for health promotion, and it is hard to view it as the content of this case's walkic walkic walkic walkic walkic walkic walkic walkic walkic walkic walkic wal walkic wal walk.

(2) In addition, the Defendants’ application of Article 55(2) of the Act is unfair and variable because it does not fall under so-called 6 panty, mass, mining straws, hackers, hacks, hacks, hacks, and hacks that may not fall under 'non-medical appliances' under the concept of ‘non-medical appliances.'

The term "medical appliances" means instruments, machinery, or equipment designated by the Commissioner of the Korea Food and Drug Administration as those used for the purpose of diagnosis, treatment, mitigation, measure, or prevention of diseases of human beings or animals, and for the purpose of affecting the structure and functions of human beings or animals (Article 2(9) of the Act). Since panty, panty, joints, mining strings, booms, belts, brings, beers, and beers are similar to instruments, machinery, or equipment, the concept of which is conceptually similar to those of this case, it is problematic whether the above products constitute medical appliances, and, if not, if they correspond to medical appliances, whether they can be punished in accordance with Articles 74(1) and 55(2) of the Act.

However, Article 55 (2) of the Act provides that "non-pharmaceutical drugs shall not put an indication or advertisement which might lead to misunderstanding that they have medical efficacy, efficacy, or effect on containers, packages, or appended documents, and shall not sell, store or display for sales purposes items indicated or advertised similar to such drugs." Article 59 of the Act provides that "non-pharmaceutical drugs shall apply mutatis mutandis to non-pharmaceutical drugs or cosmetics. In this case, drugs shall be deemed non-pharmaceutical drugs or cosmetics." Article 61 of the Act provides that "Article 59 shall apply mutatis mutandis to medical appliances and cosmetics. In this case, non-pharmaceutical drugs or cosmetics shall be deemed as medical appliances or sanitary supplies." Article 74 (1) of the Act provides that "non-pharmaceutical drugs or cosmetics that are not medical appliances or medical appliances shall be deemed as applicable mutatis mutandis to such non-pharmaceutical drugs, and any person who violates Article 54 (1) of the Act shall be punished by imprisonment with prison labor for not more than 5 years or by a fine not exceeding 50 (1), (3) of the Act, Article 16 (1) and (4) of the Act.

In the case of this case, it is not necessarily clear that the facts charged are stated in the indictment, and it is stated only in Articles 74(1) and 55 of the Act, but also in the indictment that the applicable provisions of this case are stated in the indictment, but if it is advertised that panty, pagos, mining strings, booms, booms, bed, bed, which is clear in its form or nature, and that it is not medical appliances, and furthermore, it is a subject of regulation under Articles 74(1) and 55(2) of the Act if it is advertised that there is medical efficacy, effect, etc. that it is obvious that it is not medical appliances, and that it is not medical appliances, as seen later. Accordingly, panty, etc. of this case also constitutes "non-medical appliances subject to regulation under Article 55 subparag. 2 (including Article 61) of the Act."

(3) In addition, Article 55(2) of the Act, from the investigative agency to the court of the trial, prohibits only the case where the defendants make an advertisement that is likely to mislead consumers into thinking medical efficacy, efficacy, effect, etc. other than medicines, etc., on the containers, packages, and annexes of the product. As in the instant case, the defendants made a copy of the newspaper articles or the newspaper articles concerning 'KIKOsan', which is the component of the instant product, and made it possible for the defendants to divide and explain them to the mother.

It is reasonable to interpret that the contents of an advertisement prohibited under Article 55 (2) of the Act (the same shall apply to the case of Article 61) are subject to regulation not limited to cases where the contents of an advertisement are indicated on containers, packages, or appended notes, but also to cases where the advertisement or explanation that is likely to mislead consumers into drugs, etc. is not made orally at the time of sale, as well as other printed materials. In addition, in the case of health auxiliary foods such as the "Triwonwon", whether the contents of an advertisement violate Article 55 (2) of the Act shall not be deemed as false or exaggerated advertisements for health auxiliary foods, etc. under [Attachment 3] of Article 6 (2) of the Enforcement Rule of the Food Sanitation Act. In other words, whether the contents of an advertisement violate Article 6 (2) [Attachment 3] of the Food Sanitation Act to the extent that it does not include matters concerning the prevention and treatment of diseases, (2) the expression of food and nutrition officially approved, such as the dissemination of nutrition, the dissemination of nutrition, and the expression of major nutritional ingredients contained in products (3).

In the case of this case, according to the evidence duly examined and adopted by the court below, the defendants gather more than 70 persons from 10 to 100 persons at each of the crimes of this case, and list them to 30 persons, and kidic acid is a beverage containing kidic acid, and kidic acid is a beverage containing kidic acid, such as brain and urology, prevention and treatment of adult diseases such as kidr, and publicity that there is an effective effect in kidrum, kidrum, urine, bale, beer, beer, beer, etc., and the defendants' act includes 1 kidic acid, 5 kidic acids, 6 kidic acids or vexic acids, etc., and the defendants' act of using 6 kidic acids or vexic acids, etc. as a matter of course, are included in the examination or treatment, treatment, treatment or prevention of vexic acid, etc.

(4) Ultimately, the Defendants’ misapprehension of legal principles or misapprehension of legal principles as to the Pharmaceutical Affairs Act is without merit.

B. Judgment on the misapprehension of the legal principles under Article 16 of the Criminal Act

The Defendants changed to the purport that Defendant 1 was aware of the fact of the instant crime from the investigative agency to the court of the trial, and Defendant 2 was not subject to any punishment at the Seocho Police Station around February 1996, the Jeju Police Station around the beginning of February 1997, but did not receive any punishment. Defendant 2 was aware that Defendant 1 was not punished as such, and thus, Defendant 1 was not aware of the fact that the instant act was committed, and there was a justifiable reason to believe that the instant act was committed.

In general, Article 16 of the Criminal Act provides that "the act of misunderstanding that one's own act does not constitute a crime under the Acts and subordinate statutes shall not be punishable only when there are justifiable grounds for such misunderstanding." However, in one's special circumstances, if it is recognized that it does not constitute a crime under the Acts and subordinate statutes, and there are justifiable grounds for such misunderstanding, it shall not be punishable (see, e.g., Supreme Court Decision 97Do337, Oct. 13, 1998).

According to the records of this case, the facts that the product of this case was patented or certified, and some of them were sent to an international exhibition and exported, and Defendant 1 was under suspicion that they sold health assistance food to the male and female older than 50 years old while making an excessive publicity on around March 1998, and the products were patented or quality guarantee, but were promoted and sold through sanitary education from the Health and Food Association. However, even if the defendants were aware of the above acts of the defendants' acts in violation of this Act, it cannot be seen that there were no justifiable grounds to believe that the above acts of the defendants were in violation of this Act.

3. Conclusion

Therefore, the appeal by the defendants is dismissed in accordance with Article 364 (4) of the Criminal Procedure Act, since all of the appeals by the defendants are without merit. It is so decided as per Disposition.

Judges Kim Jong-sung (Presiding Judge)