Six Pharmaceutical Companies Prosecuted for Indirect Botox Exports Without Approval
Allegations of Violating the Pharmaceutical Affairs Act
[Asia Economy Reporter Choi Taewon] Six Botox manufacturers who sold Botox drugs without national approval to domestic export companies have been brought to trial.
The Food and Drug Crime Investigation Division of the Seoul Western District Prosecutors' Office (Chief Prosecutor Park Hyeyoung) announced on the 14th that it has indicted without detention 12 employees of six pharmaceutical companies who sold Botox drugs to domestic export companies on charges of violating the Pharmaceutical Affairs Act.
The six pharmaceutical companies are accused of selling botulinum toxin biological drugs to domestic export companies without obtaining national batch release approval from around December 2015 to December 2021 for economic reasons such as rapid fund procurement. National batch release approval is a system in which the government directly manages the quality of drugs used domestically to ensure that citizens can use safe and effective medicines.
The prosecution regarded the transfer of drugs by the pharmaceutical companies as a completed sale and judged that it was subject to national batch release approval.
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A prosecution official stated, "The transactions between the six pharmaceutical companies and the export companies involve a certain method of exchanging payment for the drugs, after which the exporters decide the export counterparties, export prices, and whether to resell domestically according to their own calculation methods," adding, "The Seoul Western District Prosecutors' Office, as a specialized food and drug safety-focused prosecution office, will continue to strive to establish a sound drug distribution order based on its expertise."
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