Defendant 1 and one other

Defendants

The transfer owner, public relations personnel, and public trial

Attorney Kim Sung-soo in charge of law Firm

Suwon District Court Decision 2015Ra205 Decided November 23, 2015

The judgment of the court below is reversed.

Defendant 1 shall be punished by imprisonment with prison labor for six months, by a fine of ten thousand won,00,000 won.

However, for two years from the date this judgment became final and conclusive, the execution of the above sentence against Defendant 1 shall be suspended.

Defendant 2 shall be ordered to pay an amount equivalent to the above fine to Defendant 2.

Of the facts charged against the Defendants, the manufacturing and sales of non-reported quasi-drugs shall be acquitted.

1. Summary of grounds for appeal;

A. Defendant 1

1) misunderstanding of facts: Defendant 1 opened the package of the non-pharmaceutical product manufactured or imported by another quasi-pharmaceutical manufacturer or collector, and only packages them, and did not have manufactured the non-pharmaceutical product. Therefore, among the judgment below, Defendant 1 erred by misconception of the fact that the non-reported quasi-pharmaceutical product was manufactured and sold, and thereby, it affected the conclusion of the judgment.

2) Unreasonable sentencing: The lower court’s imprisonment (ten months of imprisonment and two years of suspended execution) is too unreasonable.

B. Defendant 2 corporation

1) misunderstanding of facts: Defendant 1, an employee of Defendant 2 Co., Ltd. (hereinafter “Defendant Company”), cannot be found to have manufactured non-pharmaceutical drugs; thus, Defendant Company may not be punished pursuant to both punishment provisions. Therefore, the judgment of the court below is erroneous in the misapprehension of facts regarding the manufacture and sale of non-reported quasi-pharmaceutical drugs, which affected the conclusion of the judgment.

2) Unreasonable sentencing: The lower court’s sentence (fine 15,000,000) is too unreasonable.

2. Judgment on the defendants' assertion of mistake of facts

A. Facts charged

1) Defendant 1

A person who intends to engage in the business of manufacturing quasi-drugs shall install necessary facilities in accordance with the facility standards prescribed by Presidential Decree and report the manufacturing business to the Minister of Food and Drug Safety, and shall obtain marketing approval or report item by item, and no person shall sell quasi-drugs manufactured without filing a report on the manufacturing business, store or display them for sale.

Nevertheless, the Defendant, without filing a manufacturing report with the Minister of Food and Drug Safety on April 17, 2009, opened two packages of other quasi-drugs manufacturers or importers of non-pharmaceutical products at the business establishment of the Defendant 2, Inc. from January 1, 2009 to October 8, 2014. After putting five parts of the above box in a single box (emergency box) separately manufactured at the above business establishment, and then putting them in an emergency box separately manufactured at the above business establishment, and then manufactured the "SPE locks" by arbitrarily stating the name, directions for use, effective time limit, etc. as if they were manufactured at the above business establishment, as if they were manufactured, and 671 won per unit price were sold to ○○○○, and 36 won per unit price, from January 1, 2009 to ○○, to 2009, 300 air bags, 50 air bags, etc., 200 air bags, 300 air bags, 380 air bags, etc.

2) Defendant Company

The defendant is a corporation established for the purpose of developing and selling disaster preparedness products.

Defendant 1, who is the substantial representative of the defendant, manufactured and sold non-reported non-pharmaceutical drugs at the same time and at the same place as above 1.

B. The judgment of the court below

The court below found Defendant 1 guilty of this part of the facts charged against the Defendants on the ground that Defendant 1 manufactured quasi-drugs by taking account of the evidence presented in its judgment.

C. Judgment of the court below

1) The term “manufacture” of a medicine under the Pharmaceutical Affairs Act refers to the act of calculating the drug that has been recovered or has not been recovered in accordance with a certain work to meet the general demand, and it includes not only chemically transforming or refining the drug by the chemical method but also processing that does not cause chemical change by combining a small quantity of the drug and a small amount of the drug. It does not constitute a processing as mentioned above (see Supreme Court Decision 92Do1683, Sept. 8, 1992), but it does not constitute an act of manufacturing the drug by separating and packaging the drug in a box (see Supreme Court Decision 92Do1683, Sept. 8, 1992) but it does not necessarily constitute an act of manufacturing the drug by putting it in a box, and it does not necessarily constitute an act of manufacturing the drug. The determination should be made by comprehensively taking into account all the circumstances such as manufacturing facilities, manufacturing methods, product appearance and product quality, publicity methods, and possibility of sale, awareness and possibility of sale by the general public, etc. (see Supreme Court Decision 98Do198Do198, etc.).

This legal principle can also be applied to the manufacture of quasi-drugs under the Pharmaceutical Affairs Act, but when determining whether the defendant's act is the manufacture of non-pharmaceutical drugs, it is necessary to consider different methods and limits of regulations on the manufacture, sale, etc. of non-pharmaceutical drugs.

2) According to the evidence duly adopted and examined by the court below, it can be acknowledged that Defendant 1 received a finished product or semi-finished product from the manufacturer or importer of non-pharmaceutical products, such as the destroyed womb, destroyed womb, etc., Defendant 1 opened part of the finished product out of the destroyed womb and destroyed womb, and then re-sealed the product or semi-finished product that the above company’s trade name was stored in the packaging container of the above non-pharmaceutical product, or packages the finished product or semi-finished product that was not packed out of the above non-pharmaceutical product in the above manner as above. Defendant 1 explained the use of non-pharmaceutical product or stated the validity period or directions for use by attaching the above packaging photograph

3) However, in full view of the circumstances described in paragraphs (1) through (6) above, Defendant 1 cannot be deemed to have manufactured non-pharmaceutical drugs only on the ground of the facts found in paragraph (2) above. Thus, the Defendants’ assertion of mistake of facts is with merit.

(1) The Pharmaceutical Affairs Act is punishable for selling the sealed containers or packages after opening them (Article 95 (1) 8-2 of the Pharmaceutical Affairs Act). However, there are no penal provisions for selling the sealed containers or packages after opening them (Article 95 (1) 8-2 of the same Act).

② The Pharmaceutical Affairs Act handles the manufacture of quasi-drugs and the act of sealing containers or packages of quasi-drugs as separate acts (Articles 66 and 63 of the Pharmaceutical Affairs Act). In other words, the Pharmaceutical Affairs Act stipulates that “manufactured drugs” should be sealed in a certain manner, thereby deeming the sealing to be an act done after the manufacture, not in manufacture.

(3) The opening and packaging of a wall or bareboat specified in the facts charged does not require a consistent technology.

④ Drugs may have chemical changes in the opening and packaging process. However, the headets or Banbs indicated in the facts charged, which the Defendant packaged after opening, are less likely to cause chemical changes, and even if there are any changes, the degree of such changes is not significant. Moreover, the Defendant did not add other drugs or quasi-drugs that may cause chemical changes in packaging.

⑤ Although Defendant 1’s packaging process increased the “capacity” of the locking or bareboat on a certain packing unit, there was no increase in the “capacity” or change in usage.

6. Although Defendant 1 entered false or misleading matters in the course of the (re-Packing) package, Defendant 1 was punished as a crime under paragraph (2) of the judgment of the court below regarding the above act, the fact that the above act was committed is irrelevant to the manufacture of quasi-drugs.

3. Conclusion

The Defendants’ appeal on the manufacture and sale of non-reported quasi-drugs among the facts charged in the instant case must be pronounced not guilty on the grounds that the Defendants’ appeal on the manufacture and sale of non-reported non-pharmaceutical drugs is with merit. The lower court rendered a single sentence by each Defendant on the facts charged and the crimes in paragraphs 2 and 3 of the judgment below. Therefore, the lower judgment is reversed in its entirety. Accordingly, without examining the Defendants’ assertion on unfair sentencing, the lower judgment is reversed pursuant to Article 364(6)

Since the facts charged by this court are the same as those stated in paragraphs (2) and (3) of the original judgment, they are quoted in accordance with Article 369 of the Criminal Procedure Act.

The summary of the evidence of the facts constituting the crime recognized by this court is the same as that of the judgment of the court below, and thus, it is cited in accordance with Article 369 of the Criminal Procedure Act.

1. Article relevant to the facts constituting an offense and the selection of punishment;

(a) Defendant 1: Articles 93(1)10, 61(1)1, subparagraph 1 of Article 60 (a) of the Pharmaceutical Affairs Act (a point of storage of quasi-drugs for the purpose of selling quasi-drugs) and Articles 95(1)10 and 68(1) (a) of the Pharmaceutical Affairs Act (a point of false non-pharmaceutical drugs or exaggerated advertisements) of the same Act, and the choice of imprisonment for each sentence of imprisonment;

(b) Defendant Company: Articles 97, 93(1)10, 61(1)1, subparagraph 1 (a) of Article 60, Article 97, Article 95(1)10, and Article 68(1) (a) of the Pharmaceutical Affairs Act (a point of storage for sale of quasi-drugs) of the Pharmaceutical Affairs Act, the selection of fines for each of them;

1. Aggravation for concurrent crimes;

Defendants: former part of Article 37, Article 38(1)2, and Article 50 of the Criminal Act

1. Suspension of execution;

Defendant 1: Article 62(1) of the Criminal Act

1. Order of provisional payment;

Defendant Company: Article 334(1) of the Criminal Procedure Act

The crime of this case is a case that may threaten the health of quasi-drugs consumers, and is disadvantageous to others, such as the nature of the crime, the crime has not been mitigated, the crime has been committed for a long time, and the scale of the crime is significant. However, it is favorable for others, such as the violation of the crime, and the absence of the same criminal record. Other factors such as the motive and background of the crime, the circumstances after the crime, the age and character of Defendant 1, the character and conduct, and the environment, etc., of all the sentencing conditions as shown in the records and arguments,

This part of the facts charged against the Defendants is identical to the above 2-A, and as seen in 2-C above, there is no proof of criminal facts, and thus, the Defendants are acquitted pursuant to the latter part of Article 325 of the Criminal Procedure Act.

[Attachment]

Judge Lee Dong-soo (Presiding Judge)