[1] The purport of strictly regulating the manufacture and sale of non-pharmaceutical drugs by reporting the manufacture of non-pharmaceutical drugs and obtaining permission by item under the Pharmaceutical Affairs Act / The meaning of “manufacture of non-pharmaceutical drugs” under Article 31(4) of the Pharmaceutical Affairs Act and the method of determining whether the manufacture of non-pharmaceutical drugs constitutes an act of manufacturing non-pharmaceutical drugs in cases where non-pharmaceutical drugs are removed and re-sealeded

[2] In a case where Defendant B, a substantial representative and employee of Defendant A Co., Ltd., opened a package of quasi-drugs supplied by another manufacturer without reporting the manufacturing business, and then packages of non-pharmaceuticals, such as destroyed spawn and spawn, which were newly produced by Defendant A Co., Ltd., and was prosecuted for violating the Pharmaceutical Affairs Act by arbitrarily stating the name and effective period, the case holding that, in full view of all the circumstances, there is room to regard the Defendants as the manufacturing of non-pharmaceuticals, the lower court erred by misapprehending the legal doctrine

[1] Strict legal regulations on manufacture and sale of non-pharmaceutical drugs, such as manufacturing of non-pharmaceutical drugs, and obtaining permission by item, are aimed at preventing harm to public health and hygiene by ensuring the quality, effectiveness, and safety of non-pharmaceutical drugs by placing the name, manufacturer, date of manufacture, ingredients, etc. on the packaging of non-pharmaceutical drugs in order to ensure the quality, effectiveness, and safety of non-pharmaceutical drugs.

In light of the above legislative intent, the "manufacture of quasi-drugs" under Article 31 (4) of the Pharmaceutical Affairs Act is an act of calculating goods other than medicines and designated by the Minister of Food and Drug Safety according to certain work to meet the general demand.

The determination of whether a product constitutes an act of manufacturing quasi-drugs shall also be made by taking into account the composition and appearance of the product, manufacturing facilities, and manufacturing methods, the indication of the product packaging, the explanation and publicity details at the time of sale, the awareness of the general public, and other factors. The determination of whether a product constitutes an act of manufacturing non-pharmaceutical drugs should also be made by taking into consideration the possibility of being mistaken for the product originally in the re- packing process, including the product name, the date of manufacture, etc., and the possibility of being mistaken for a separate product.

[2] In a case where Defendant A, a substantial representative and employee of Defendant A, opened the package of quasi-drugs supplied by other manufacturers without filing a manufacturing report, and then packages new products were manufactured and sold by arbitrarily stating the name, effective period, etc. as if they were newly manufactured by Defendant A, the case held that the lower court erred by misapprehending the legal principles as to Defendant A’s act of manufacturing and selling non-pharmaceutical products on the ground that Defendants were supplied with non-pharmaceutical products sealed by multiple manufacturers, and then packages in the form of finished products using packaging machines, etc. at Defendant A’s workplace. The case held that the lower court erred by misapprehending the legal principles as to Defendant A’s act of manufacturing and selling non-pharmaceutical products on the sole ground that Defendant A’s act of manufacturing and selling non-pharmaceutical products was included in the package of the product as if Defendant A’s products were manufactured.

[1] Article 31(4) of the Pharmaceutical Affairs Act, Article 93(1)4 of the former Pharmaceutical Affairs Act (Amended by Act No. 13114, Jan. 28, 2015) / [2] Article 31(4) of the Pharmaceutical Affairs Act, Article 93(1)4 and Article 97 of the former Pharmaceutical Affairs Act (Amended by Act No. 13114, Jan. 28, 2015)

Defendant 1 and one other

Prosecutor

Suwon District Court Decision 2015No7192 decided November 18, 2016

The non-guilty part of the judgment of the court below against the Defendants shall be reversed, and this part of the case shall be remanded to Suwon District Court.

The grounds of appeal are examined.

1. The reason why strict legal regulations on the manufacture and sale of non-pharmaceuticals under the Pharmaceutical Affairs Act, such as manufacturing of non-pharmaceuticals, and obtaining permission by item, are to prevent hazards to public health and hygiene by ensuring the quality, effectiveness, and safety of non-pharmaceuticals by placing the name, manufacturer, manufacturing date, ingredients, etc. on the packaging, etc. of non-pharmaceuticals in order to ensure the quality, effectiveness, and safety of non-pharmaceuticals.

In light of the above legislative intent, the "manufacture of quasi-drugs" under Article 31 (4) of the Pharmaceutical Affairs Act is an act of calculating goods other than medicines and designated by the Minister of Food and Drug Safety according to certain work to meet the general demand.

The determination of whether a product constitutes an act of manufacturing quasi-drugs shall also be made by taking into account the composition and appearance of the product, manufacturing facilities, and manufacturing methods, the indication of the product packaging, the explanation and publicity details at the time of sale, the awareness of the general public, and other factors. The determination of whether a product constitutes an act of manufacturing non-pharmaceutical drugs shall also be made by taking into consideration the possibility of deterioration of the product, the name of the product, the date of manufacture, etc., whose identity with the original product has been lost in the re- packing process, and thus,

2. A. Of the facts charged in the instant case, the lower court acquitted the Defendant on this part of the charges on the violation of the Pharmaceutical Affairs Act, on the following grounds: (a) as to the violation of the Pharmaceutical Affairs Act, which was manufactured and sold by arbitrarily stating the name, effective period, etc. as if they were newly manufactured by the Defendant Company, without filing a manufacturing report, after opening the packaging of the non-pharmaceutical products, such as the destroyed spawn, supplied by other manufacturers; and (b) on the ground that the opening of the name, effective period, etc. and the pharmaceutical products, etc. that may cause chemical changes in the process of packing such as

B. However, we cannot accept the judgment of the court below for the following reasons.

(1) The evidence duly admitted by the lower court reveals the following facts.

① The Defendants supplied a product in which the packaging was sealed by a large number of quasi-drugs manufacturers as well as semi-finished products in a semi-finished or packaged state, and then packaged the product in the form of finished-finished products using packaging machines, etc. at the Defendant Company’s workplace. They opened the sealed package in the process or packaged the boxes separately produced by the Defendant Company after individual packaging to the necessary number of boxes.

② In the packaging of the product, as if the Defendant Company was manufactured, the name of the Defendant Company was indicated on the outer surface, and the use, usage, volume, validity period, etc. of the product was indicated on the outer surface, and the name of the Defendant Company was indicated on the product, such as part of the Bande.

③ On the Internet homepage of the Defendant Company, the Defendant Company indicated the manufacture of drugs as well, and advertised and sold the Defendant Company as if it were manufacturing chain by indicating the manufacturer of individual non-pharmaceutical drugs as “production of an original trademark”.

④ In the case of a part of the product, the manufacturer indicated that the product is not an enterprise eligible for the government-certified quality pharmaceutical product, or the manufacturer falsely stated the original use, quality, effective period, product name, etc. of the product, such as marking contact lenses products as a product for the disinfection of the product for the treatment of the product.

(5) In light of the status of the place of work, etc. of a defendant company, the possibility of deterioration of the nature, etc. of the original product may not be excluded due to infection, etc. in the packaging stage of a product which has not been sealed or sealed individually.

(2) Therefore, in light of the general public’s view, it is highly likely that the Defendant company will be mistaken for the manufacturer company or lost its identity with the original product, and thus, the Defendants’ second packaging act may be deemed an act of manufacturing quasi-drugs. Nevertheless, the lower court’s determination that the act of manufacturing quasi-drugs does not constitute an act of manufacturing quasi-drugs is erroneous by misapprehending the legal doctrine as to the act of manufacturing quasi-drugs under the Pharmaceutical Affairs Act, and thereby failing to exhaust all necessary deliberations, thereby adversely affecting the conclusion of the judgment.

3. Therefore, the non-guilty part of the judgment below is reversed, and that part of the case is remanded to the court below for a new trial and determination. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Cho Jae-chul (Presiding Justice)