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(영문) 수원지방법원 2017.12.21 2017고정2794
약사법위반
Text

The defendant is innocent. The summary of this judgment shall be notified publicly.

Reasons

1. The summary of the facts charged is a person who operates a website of a mail order business establishment.

Unless a permit or report has been obtained to the Agency for Food and Drug Safety, no advertisement shall be made on the name, manufacturing method, efficacy or performance of drugs, etc.

Although the Defendant did not obtain the permission or report of the Food and Drug Administration, on March 2017, the Defendant made an advertisement, such as explaining the efficacy and effect of approximately 99 pharmaceutical products and non-pharmaceutical drugs, including shocked and Broin salting drugs, on the above Internet site.

2. Determination

A. Article 95(1)10 of the Pharmaceutical Affairs Act provides that "a person who violates Article 68" shall be punished by imprisonment with prison labor for not more than one year or by a fine not exceeding ten million won. Article 68(5) of the same Act provides that "Article 31(2) and (3) or Article 42(1) shall not advertise the name, manufacturing method, efficacy, or performance of a drug, etc. without obtaining permission or making a report pursuant to Article 31(2) and (3) or 42(1).

Article 42 (1) of the same Act provides that "any person who intends to engage in the business of importing drugs, etc. (hereinafter referred to as "importer") shall report the import business to the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister, and each item shall be permitted or reported by the Minister for Food and Drug Safety, as prescribed by Ordinance of the Prime Minister.

"........"

Therefore, it is a problem whether the defendant operating the Internet shock site should have obtained permission or reported on the drug, etc. because he/she falls under "importer" as defined in Article 42 (1) of the Pharmaceutical Affairs Act in advertising the drug, etc. in Japan, such as the statement in the facts charged.

B. According to the evidence duly adopted and examined by this court, the Defendant entered into a contract for the supply of goods and business operation with the Japanese company (E) around March 20, 2017, and operated the Internet site as stated in the facts charged.

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