A. Whether permission to change under Article 26(1) of the Pharmaceutical Affairs Act should be obtained where a factory of medicines, etc. is transferred (affirmative), and whether permission under Article 26(1) of the Act on Special Measures for the Control of Public Health Crimes includes permission to change under the latter part of Article 26(1) of the same Act (affirmative)

B. Whether manufactured medicines, etc. are harmful to the human body, or whether they affect the composition of a crime of violation of Article 3(1) of the Act on Special Measures for the Control of Public Health Crimes (negative)

C. Whether an employee of a manufacturer is also included in the criminal subject of a violation of Articles 74(1)1, 26(1), 76(1), and 29(1) of the Pharmaceutical Affairs Act (affirmative), and whether an employee who manufactured a drug becomes joint principal offender of a violation of Article 26(1) of the same Act with the manufacturer, knowing that he/she did not obtain a permit to change the manufacture of the drug (affirmative)

A. Since a factory for drugs, etc. is an important matter among the matters to be permitted under the former part of Article 26(1) of the Pharmaceutical Affairs Act, in transferring a factory, it shall obtain permission from the Minister of Health and Welfare as prescribed by the latter part of Article 26(1) of the same Act, and it shall be interpreted that permission under Article 26(1) of the Pharmaceutical Affairs Act, which is stipulated in Article 3(1) of the Act on Special Measures for the Control of Public Health Crimes, includes not only permission under the former part of Article 2

B. According to Article 3(1) of the Act on Special Measures for the Control of Public Health Crimes, where a person manufactures medicines exceeding a certain quantity without obtaining permission pursuant to Article 26(1) of the Pharmaceutical Affairs Act, he/she may be subject to aggravated punishment. As such, whether manufactured medicines, etc. are harmful to human body does not affect the composition of a crime of violation of Article 3(1) of the aforesaid Act.

C. It is apparent in the text of Article 78 of the Pharmaceutical Affairs Act that not only the manufacturers (or subdivisions) but also their employees are included in the crime subject to the violation of Articles 74(1)1, 26(1), 76(1), and 29(1) of the same Act, but also the act of processing the drug in the crime established due to their status relationships is applicable to the co-offenders who have no status relationship. Thus, if the Defendant manufactured the drug of this case knowing that there was no permission of alteration in the factory that did not have yet obtained the permission of alteration after the Defendant participated in the crime of the manufacturer and was aware that there was no permission of alteration in the factory that did not have yet obtained the permission of alteration, it shall constitute a co-principal for the crime of violating

(a)Article 26(1) of the Pharmaceutical Affairs Act, Article 3(1) of the Act on Special Measures for the Control of Public Health Crimes, Article 26(1) of the Pharmaceutical Affairs Act, Article 29(1), Article 74(1)1, Article 76(1), Article 78 of the Pharmaceutical Affairs Act, Article 30 and Article 33 of the Criminal Act;

C. Supreme Court en banc Decision 80Do384 Decided December 9, 1980 (Gong1981, 13473)

Defendant 1 and one other

Defendant 1 Prosecutor (Defendant 2)

Attorney Lee In-person et al.

Seoul High Court Decision 88No1285 delivered on March 31, 1989

The part of the lower judgment against Defendant 2 is reversed, and that part of the case is remanded to the Seoul High Court.

Defendant 1’s appeal is dismissed.

1. Defendant 1’s defense counsel’s grounds of appeal

(1) According to Article 26 (1) of the Pharmaceutical Affairs Act, a person who intends to engage in the business of manufacturing or subdividing drugs, etc. shall obtain permission for manufacturing or marketing of drugs, etc. from the Minister of Health and Welfare by business type under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare. According to Article 26 (2) of the same Act, a person who intends to obtain such permission shall be equipped with necessary facilities in accordance with the criteria as prescribed by the Presidential Decree. Under the above delegation, Article 3 of the Decree on the Standards for Facilities for Manufacturing and Export and Import of Drugs, Etc., Article 26 (1) of the same Act provides detailed criteria for the size, lighting, ventilation, sanitary conditions, classification of manufacturing and marketing of drugs, etc., and various facilities to be equipped by a factory. Thus, in light of the above Article 26 (1) of the Pharmaceutical Affairs Act, permission for manufacturing or marketing of drugs, etc. is legitimate and there is no error in the misapprehension of the legal principles as well as permission for manufacturing or marketing under the latter part of Article 26 (1) of the Pharmaceutical Affairs Act.

The court below has interpreted that even a person who has obtained permission for the manufacture of drugs and permission for the manufacture of drugs should obtain permission for the manufacture of drugs when he transfers the factory, and it is clear that it does not have interpreted that permission for the manufacture of drugs and permission for the manufacture of drugs by item should be obtained again.

(2) On the third and fourth grounds:

According to Article 3(1) of the Act on Special Measures for the Control of Public Health Crimes, Article 26(1) of the Pharmaceutical Affairs Act provides that a person may be subject to aggravated punishment if he manufactures medicines more than a certain quantity without obtaining permission under Article 26(1) of the Pharmaceutical Affairs Act. Whether manufactured medicines, etc. are harmful to human body does not affect the composition of a crime of violating Article 3(1) of the aforesaid Act. In addition, even if Defendant 1 did not directly participate in the transfer business of the pharmaceutical manufacturing plant of this case even though he did not directly participate in the transfer business of the pharmaceutical manufacturing plant of this case, he is the non-indicted and the co-principal who is the representative director, so the judgment below to the same purport is just

All arguments are groundless.

2. The Prosecutor’s ground of appeal Nos. 1 and 2 as to Defendant 2 is also examined.

According to the reasoning of the judgment below, the court below found Defendant 2 as being the manufacturer of the drugs under Article 26 of the Pharmaceutical Affairs Act in order for the Defendant to be subject to the violation of Article 3 (1) of the Act on Special Measures for the Control of Public Health Crimes or the violation of Article 29 (1) of the same Act, and found Defendant 2 as the manufacturer of the drugs under Article 26 of the same Act. The above manufacturer of the drugs refers to the owner of the drug manufacturing business, the manager, or the person in charge of the factory, etc., who is at a location to be responsible for the manufacture of the drugs, or the person to whom the economic benefits accrued, and interpreted that he does not constitute the manufacturer of the drugs under the employment of the above manufacturer and the person employed by the above manufacturer and provided labor only in accordance with the manufacturer's instructions during the manufacturing process. After Defendant 2 was the manufacturer of the non-indicted sculic medicine under the command of the above factory manager, and was manufactured by mixing the raw materials purchased and sent at the head office under the direction of the above defendant 1.

However, not only is it clear in the text of Article 78 of the Pharmaceutical Affairs Act that not only manufacturers (or subdivisions) but also their employees are included in the crime subject of the violation of Articles 74(1)1, 26(1), 76(1), and 29(1) of the same Act (see Supreme Court Decision 80Do384 delivered on December 9, 1980), but also the prosecutor indicted the defendant as joint principal offenders of the crime of violating the above Article 74(1)1, Article 76(1), Article 76(1), and Article 29(1) of the same Act (see Supreme Court Decision 80Do384 delivered on December 9, 1980). Since the act of the defendant prosecuted the defendant as the manufacturer and processed the crime to be established due to his status is applicable to the co-offenders who are not related persons, if the defendant 2 was involved in the crime of the non-indicted (it is necessary to recognize that the defendant had no permission to change the manufacture of the drug of this case at the time).

Nevertheless, the lower court’s finding Defendant 2 not guilty solely on the ground that Defendant 2 cannot be a criminal subject of the above violation of the Pharmaceutical Affairs Act is erroneous and adversely affected the conclusion of the judgment by misapprehending the legal doctrine as to the above penal provision and joint principal offense under the Pharmaceutical Affairs Act. The allegation pointing this out is with merit.

3. Therefore, the part of the judgment of the court below against Defendant 2 is reversed, and that part of the case is remanded to the court below. Defendant 1's appeal is dismissed. It is so decided as per Disposition with the assent of all participating Justices.

Justices Song Man-man (Presiding Justice)