(a) Whether a person who has obtained permission for the manufacture of cosmetics violates Article 26 of the Pharmaceutical Affairs Act in a case where he manufactures tobacco using a third party’s facility without the approval of the Minister of Health and Welfare;

(b) Whether Article 26 of the Pharmaceutical Affairs Act is applied to cases where a new cosmetic is manufactured by mixing or combining several items already permitted without obtaining permission for change of items;

(c) Whether Article 58 of the Pharmaceutical Affairs Act is violated in cases where the term "Nbone Eyone Eythow Pocil" is written in English without stating "Nbone Ebone Bale", which is a product name permitted for cosmetics containers, etc.

A. Permission under Article 26 of the Pharmaceutical Affairs Act shall be obtained by each factory. When a person who has obtained permission to manufacture cosmetics uses facilities of a third party, other than a permitted factory, he/she shall obtain prior approval from the Minister of Health and Welfare. This approval shall be deemed to be the permission to change permitted matters, and if he/she manufactures tobacco without such approval, he/she violates Article 26 of the Pharmaceutical Affairs Act in cases where he/she manufactures tobacco using facilities of a third party without such approval.

B. A license under Article 26 of the Pharmaceutical Affairs Act should be obtained for each item, so if a person intends to manufacture items other than the permitted items, he/she must obtain permission for modification, and even if the manufactured cosmetics are merely a mixture or combination of items with the already permitted items, it constitutes a new item different from the previous product, manufacturing method and packing unit, and thus, if the manufactured cosmetics are done without obtaining permission for modification of items, it is in violation of Article 26 of the above Act.

C. According to Article 58 of the Pharmaceutical Affairs Act and Article 49 of the Enforcement Rule of the same Act, if the name "None Eyone Eythow Bail" is written in English without stating "Nabone Epiow", which is a product name permitted in containers, packages, etc., it is not a legitimate product name under the above provision.

(b)Article 26, Section 58 of the Pharmaceutical Affairs Act, Article 49 of the Enforcement Rule of the Pharmaceutical Affairs Act;

Defendant

Defendant

Attorney Hah Hyeong-chul

Seoul High Court Decision 84No1029 Decided February 6, 1987

The appeal is dismissed.

The grounds of appeal are examined.

1. In full view of the evidence presented by the court below, it is sufficient to recognize the facts of the crime as stated in its holding, and there is no error of law by misunderstanding the facts against the rules of evidence or by misunderstanding the legal principles as to the public offering. Thus, it is not reasonable to point this out.

2. A person who intends to conduct the manufacturing business or subdivision business of the ......... of the ....... of the ..... of the ..... of the .... of the .... of the ..... of the .... of the .

The same shall apply to the modification of permitted matters. Paragraph (2) of the same Article provides that "any person who intends to obtain permission pursuant to the provisions of the preceding paragraph shall be equipped with necessary facilities in accordance with the facility standards prescribed by the Presidential Decree." Article 9 of the above Paragraph (2) of the Decree provides that "the facility standards for pharmacy and medicine manufacturing business, export-import business and sale business" shall be the facility standards of cosmetics, and Article 10-3 of the above Ordinance provides that the facilities and appliances designated by the Minister of Health and Welfare among facilities and appliances pursuant to Article 9 of the above Act shall be replaced by using facilities and appliances of a third party, and it shall be subject to prior approval of the Minister of Health and Welfare, and it shall not be permitted for the modification of permitted matters in light of the above Article 2 subparagraph 2 (a) of the above Decree, and it shall be permitted to use facilities of a third party without permission for the modification of permitted matters.

3. In addition, according to Article 58 of the Pharmaceutical Affairs Act, all of the cosmetics' containers, packages, and appended notes (only in the case of appended notes) are required to state the name of the product. According to Article 49 of the Enforcement Rule of the same Act, all of the items to be stated under the above Act are to be mixed with Korean or Korean and Chinese characters, and it is possible to make combined entries into a foreign language within the scope determined by the Minister of Health and Welfare. Therefore, the court below's decision that the cosmetic "Nbo-eyeow" was not stated in the name of the product permitted for the cosmetic of this case without stating the "Nbo-Eye" as an English name, and there is no ground for misunderstanding the legal principles of the above Pharmaceutical Affairs Act ( even in the case of the proviso of Article 58 of the Pharmaceutical Affairs Act and Article 46 of the Enforcement Rule of the same Act, the name of the product is omitted).

4. Therefore, the appeal is without merit, and it is dismissed. It is so decided as per Disposition by the assent of all participating judges.

Justices Lee Lee-hee (Presiding Justice)