Prosecution Indicts Botox Companies for Violation of Pharmaceutical Affairs Act

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A bunch of Botox makers have been put on trial. Six pharmaceutical companies and 12 of their employees will face trial on March 14 for allegedly selling Botox to an exporter not approved by the Korean government (a violation of the Pharmaceutical Affairs Act).

In a press release sent to reporters on March 15, Hugel, No. 1 player in the Korean Botox industry, said, “The company supplied medicines to Korean trading companies in the process of indirectly exporting medicines, but the Ministry of Food and Drug Safety regarded them as domestic sales and canceled approved for the item permit,” adding, “We are actively responding to this issue through an administrative lawsuit against the Ministry of Food and Drug Safety.”

“Indirect export products are drugs for export that can be sold at the request of an importer without obtaining shipment approval from the Korean government,” Hugel said in protest. “We will diligently participate in all legal procedures and actively respond by clearly revealing these facts while sincerely participating in all legal proceedings.”

According to the prosecution, the pharmaceutical companies that sold Botox, such as Hugel, are suspected of selling drugs to exporters that did not go through national shipping approval between December 2015 and December 2021. The national release approval system makes it obligatory for the Ministry of Food and Drug Safety to review medicines made from biological materials before their sales to determine their safety. If a medicine not approved by the Korean government is sold in Korea, it is subject to the cancellation of item permit. The prosecution found that most Korean Botox companies sold unapproved Botox products abroad through wholesalers and traders beginning from the mid-2000s on the grounds that the Botox products were not sold in Korea.

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