약사법위반
The judgment below
The non-guilty portion 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 the manufacture of non-pharmaceutical drugs is reported under the Pharmaceutical Affairs Act, and the strict legal regulations on manufacture and sale, such as obtaining permission by item, are likely to cause positive risks to human beings, animals, etc. due to direct or indirect pharmacological action of non-pharmaceutical drugs, and the name of non-pharmaceutical drugs, manufacturer, date of manufacture, ingredients, etc. are indicated on the packaging, etc. of non-pharmaceutical drugs, thereby ensuring the quality, efficacy, and safety of non-pharmaceutical drugs, thereby preventing harm to national health and hygiene.
In light of the above legislative intent, the term “production of non-pharmaceutical drugs” under Article 31(4) of the Pharmaceutical Affairs Act is an act of calculating goods other than pharmaceutical products, which are designated by the Minister of Food and Drug Safety according to certain work to meet the general demand.
I would like to say.
The determination of whether a product constitutes an act of manufacturing non-pharmaceuticals upon removing and repackaginging the packages of non-pharmaceuticals should also be made by taking into account the composition and appearance of the product, manufacturing facilities and manufacturing methods, the labeling details of the product packaging, the explanation and publicity details at the time of sale, the possibility of general public’s awareness, etc.
2. A. As to the violation of the Pharmaceutical Affairs Act, the lower court did not add a drug, etc. that may cause chemical changes in the process of opening a wallet and packaging, etc., which had been supplied by another manufacturer without filing a manufacturing report, after opening a new package of non-pharmaceuticals, such as destroyed spawn, supplied by another manufacturer, and then indicating the name and effective period, etc. as if they were newly produced by the Defendant Company.