A. Criteria for determining whether a pharmaceutical product is subject to the regulation of the Pharmaceutical Affairs Act

(b) The case holding that the fact is that the rocketing viol is a drug in light of its raw material, appearance, shape, use at the time of sale, publicity of efficacy, etc.

A. Medicines under the Pharmaceutical Affairs Act, other than those listed in the Korean Pharmacopoeia under Article 2 (4) 1 of the Pharmaceutical Affairs Act, are used for the purpose of diagnosing, treating, alleviating, treating, or preventing diseases of human beings or animals, or for the purpose of exerting pharmacological functions in the structure or functions of human body or animals (excluding machinery, appliances, cosmetics). It is essential to interpret all of them as subject to regulation under the Pharmaceutical Affairs Act by considering the following as a whole: the component, shape (container, packing, etc.), shape (container, packing, packing, etc.), name, shape, efficacy, effect, usage, volume, publicity or explanation at the time of sale, etc. as indicated, unless they are visually perceived as food as being used for the above purpose, and if they are recognized as being used for the above purpose and claimed as having such effect or efficacy, all of them shall be considered as medicine and interpreted as subject to regulation under the Pharmaceutical Affairs Act.

B. Even if the facts of rocketing biphenyl have been preventive materials, if they are manufactured by mixing the biphenyls listed in the Korean Pharmacopoeia with the heavy luxsium, and have the appearance and shape similar to those of other medicines because they were contained in the medicinal disease, and if they are manufactured for the purpose of selling them as disinfection or luxal medicine and sold them for the purpose of selling them, they constitute drugs under Article 2 (4) 2 of the Pharmaceutical Affairs Act.

Article 2 of the Pharmaceutical Affairs Act

A. Supreme Court Decision 84Do2892 delivered on March 12, 1985 (Gong1985,582)

Defendant

Defendant

Seoul High Court Decision 89No1827 delivered on March 23, 1990

The appeal is dismissed.

We examine the grounds of appeal.

With respect to No. 1:

In light of the records, we affirm the reasoning of the court below's findings of fact in the first instance court or its maintenance, and there is no error of law such as incomplete deliberation or violation of the rules of evidence.

In addition, according to the records, the defendant recognized the establishment of the protocol of interrogation of the defendant prepared by the prosecutor in the first instance court and recognized the voluntariness of the protocol, and the reasoning of the court below that recognized the voluntariness of the protocol is acceptable. The court below cannot be said to be erroneous for the court below to have conducted the above fact-finding by making the protocol of interrogation of the defendant's interrogation of the defendant prepared by the prosecutor

With respect to the second ground:

In light of the purpose and purport of the Pharmaceutical Affairs Act and the contents and purport of Article 2 (4) (f) of the same Act that define drugs, the above provisions of the Pharmaceutical Affairs Act include all the concepts including the purpose of using them for 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 or animals (excluding machinery, apparatus, cosmetics). It does not necessarily have any effect in the pharmacological action, and it does not have any relation with the content, shape (container, container, package, packing, etc.), name indicated, and the purpose of use, efficacy, effect, efficacy, volume, size, publicity or explanation at the time of sale, etc., and if it is recognized or claimed that such drugs are used for the above purpose except as food, it shall be interpreted that all of them are subject to the regulation of the Pharmaceutical Affairs Act.

According to the reasoning of the judgment of the court below, the court below, based on such opinion, judged that the ingredients, manufacturing methods and manufacturing purposes of the instant case, the appearance, shape, sale and publicity methods of the container constitutes drugs under Article 2 (4) 2 of the Pharmaceutical Affairs Act. In light of the records, the court below's findings of fact and decision of the court below are justified, and there are no errors in the misapprehension of the legal principles of pharmaceutical products under Article 2 (4) of the Pharmaceutical Affairs Act.

위 ‘쏘페놀 비'가 가사 소론과 같이 사실은 방부제였다고 하더라도 원심이 인정한 바와 같이 대한약전에 수재되어 있는 페놀과 중조소다를 적당한 비율로 물에 혼합 희석하여 제조하고 그 용기는 약병에 담겨져 다른 의약품과 유사한 외관 형상을 갖추고 있으며 이를 살균제 또는 무좀약으로 판매할 목적으로 제조한 다음 일반인들에게 직접 판매하거나 약국의 약사들에게 판매 의뢰하여 이를 비치 판매하고 그 재품의 설명서 또는 약국에서의 제품광고믈 등에 ‘쏘페놀 비'가 세균, 곰팡이, 박테리아 등의 살균, 박멸에 효과가 있는 다목적살균제이고 이울러 발냄새, 암내제거에는 물론 무좀치료에 특효가 있다고 선전 판매한 것이라면 이는 약사법 제2조 제4항 제2호 소정의 의약품을 제조한 경우에 해당한다고 보아야 한다. 논지도 이유없다.

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

Justices Kim Young-ju (Presiding Justice)