The Ministry of Food and Drug Safety expands investigation of’illegal exports’ of Botox companies… Risk of cancellation of product permits in a row

Input 2021.03.17 19:19 | Revision 2021.03.17 19:27

Investigations such as Medytox and Huzel followed by Huons and Pamari Search
‘National shipment approval’ obligation for domestic use… Product permission cancellation in case of violation
Export practices without this procedure through industry and domestic traders
Ministry of Food and Drug Safety “Trade sales, not export, but domestic demand… Procedures must be taken”

The Ministry of Food and Drug Safety announced on the 17th that it has expanded the scope of investigations for “illegal exports” (violation of the Pharmaceutical Affairs Act), which are being conducted jointly with the prosecution, targeting domestic botulinum toxin (Botox) product manufacturers. Medytox (086900), Huzel (145020)Followed by Huons (243070), Pamari Search Bio, etc. were also subject to investigation. If the allegations are admitted as a result of the investigation, product permits may be revoked one after another.

According to the Ministry of Food and Drug Safety, these companies are suspected of exporting Botox products overseas without’national shipment approval’. National shipment approval is a system in which the Ministry of Food and Drug Safety checks the efficacy and safety before distributing drugs. If a drug is sold without national shipment approval, it is subject to cancellation of the product permission due to violation of the Pharmacist Act. However, products for export do not need to go through this procedure.

The problem is that companies have exported overseas through intermediary traders in Korea. Companies have been selling products without national shipping approval because they believe that the products they are handing over to intermediate traders are for export.

On the other hand, the Ministry of Food and Drug Safety is in the position that sales to intermediate traders are domestic sales, so they must undergo national shipment approval. The Ministry of Food and Drug Safety investigated some companies for violating the Pharmaceutical Affairs Act, and in some cases even dismissed them.

Last year, Medytox was the first to be accused of this charge and was investigated by the Ministry of Food and Drug Safety. As a result, five products, including Meditoxin, were subject to cancellation of product permission. If the item permission is cancelled, the production and sale of products is prohibited, and all of the products on the market are recovered. Medytox, which rebelled against, filed an administrative lawsuit asking the Ministry of Food and Drug Safety to stop disposing of it, and the court recently accepted it, and sales of the products have resumed.

The Ministry of Food and Drug Safety launched an investigation earlier this year on Huzel, Huons, and Pamari Search on the same charges, and expanded the scope of the investigation to the entire Botox industry. An official from the Ministry of Food and Drug Safety said on the day, “In addition to these companies, additional investigations are underway.”

The industry is protesting. An official of a company under investigation by the Ministry of Food and Drug Safety said in a call that day, “This is something that the whole Botox industry has been doing for more than 10 years.” Said. He said, “If you revoke product licenses to other companies following Meditox, you will eventually kill the growing new bio-industry,” he said.