[1] The concept and standard of determining "pharmaceuticals" subject to the Pharmaceutical Affairs Act

[2] The meaning of "manufacture" and "preparation" of medicines under the Pharmaceutical Affairs Act

[3] In a case where the Defendant was indicted for violating the former Act on Special Measures for the Control of Public Health Crimes on the ground that he manufactured and sold an unauthorized drug, the case affirming the judgment below convicting the Defendant on the same purport on the ground that the Defendant’s act of manufacturing and selling the drug constitutes a drug “non-brupted drug” made by mixing various medicinal substances to meet the demand of the general public with a high interest in physical quantity, and that the act of manufacturing and selling the drug constitutes a manufacturing and selling, not a drug preparation

[1] Article 2 subparag. 4 of the Pharmaceutical Affairs Act / [2] Articles 2 subparag. 11, 23(1), and 31(1) of the Pharmaceutical Affairs Act / [3] Articles 2 subparag. 4 and 11, and 31(1) of the Pharmaceutical Affairs Act, Article 3(1)2 and (2) of the former Act on Special Measures for the Control of Public Health Crimes (Amended by Act No. 10579, Apr. 12, 201)

[1] Supreme Court Decision 2001Do1429 Decided January 15, 2004 (Gong2004Sang, 368), Supreme Court Decision 2006Do988 Decided August 23, 2007, Supreme Court Decision 2009Do4785 Decided October 14, 2010 (Gong2010Ha, 2113)

Defendant

Defendant

Law Firm Shin, Attorneys Choi Young-sik et al.

Seoul High Court Decision 2011No2694 decided December 23, 2011

The appeal is dismissed.

The grounds of appeal are examined.

In light of the legislative purpose and purport of the Pharmaceutical Affairs Act, and the contents and purport of Article 2 subparag. 4 of the Pharmaceutical Affairs Act that define drugs, the term “drugs” under the Pharmaceutical Affairs Act includes both those used for the purpose of diagnosing, treating, alleviating, treating, or preventing human or animal diseases other than those listed in the Korean Pharmacopoeia, or those used for the purpose of exerting pharmacological influence upon the structure and function of human or animal. It is interpreted that the term “drugs” under the Pharmaceutical Affairs Act includes all the elements, shapes (container, packaging, design, etc.), name, regardless of the efficacy or efficacy in the pharmacological action, and the purpose of use indicated, efficacy, efficacy, effect, usage, volume, publicity or explanation at the time of sale, etc., and where it is recognized or claimed that they are used for the above purpose in light of the general public, it constitutes “drugs” and thus becomes subject to regulation under the Pharmaceutical Affairs Act (see, e.g., Supreme Court Decision 2001Do1429, Jan. 15, 2004).

In addition, the term "manufacture" of medicines under Article 31 (1) of the Pharmaceutical Affairs Act refers to the act of manufacturing medicines to meet the general demand widely, and the term "preparation of medicines" under Article 23 (1) of the Pharmaceutical Affairs Act refers to the act of preparing medicines to use them for the purpose of treating or preventing specific diseases of a specific person in accordance with a specific usage method by mixing two or more medicines or dividing one kind of medicines into certain quantity according to a certain prescription (Article 2 (11) of the Pharmaceutical Affairs Act).

According to the reasoning of the judgment of the court of first instance maintained by the court below, the defendant is equipped with various equipment, such as extraction and frying machines, etc., and then divided them into three stages in the extraction season by means of a specific quantity, small-scale, gymnasium, gym, gymnasium, yellow, gymnasium, gymnasium, yellow, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, etc., gymnasium, gymnasium, gymnasium, gymnasium, gymnasium, etc., gymar.

Examining this in light of the aforementioned legal principles, the term “non-brupt drugs” of this case is a drug that was made by the Defendant according to certain work to meet the demand of the general public with a high interest in physical weight, and constitutes a drug under Article 2 subparag. 4 of the Pharmaceutical Affairs Act. The Defendant’s act of manufacturing and selling the “non-brupt drugs” of this case by the above method constitutes an act of manufacturing and selling drugs under Article 31(1) of the Pharmaceutical Affairs Act.

In the same purport, the judgment of the court below that the defendant's act constitutes the manufacture of medicines, not the preparation of medicines, is just, and there is no violation of law that affected the conclusion of the judgment by misunderstanding the legal principles on the manufacture or preparation of medicines, as

Meanwhile, the Defendant asserts to the effect that the Defendant’s act of manufacturing the “non-soft drugs” of this case is merely a manufacturing of the pharmacy medication without reporting it. However, the “non-soft drugs” of this case manufactured by the Defendant is not included in the pharmaceutical medication publicly notified by the Minister of Health and Welfare pursuant to Article 41 of the Pharmaceutical Affairs Act and Article 18 of the Enforcement Rule of the Pharmaceutical Affairs Act. Therefore, the aforementioned assertion on the premise different from the foregoing is without merit, without having to further examine it.

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

Justices Ahn Dai-hee (Presiding Justice)