Huzel, who had benefited from the Medytox controversy, was investigated by health authorities for violating the Pharmaceutical Affairs Act.
According to the pharmaceutical industry on the 3rd, the Ministry of Food and Drug Safety’s Central Investigation Team for Hazard Crimes initiated an investigation after receiving a charge from the prosecution of Huzel’s sale of a botulinum toxin formulation, Botulex (Chinese export name Retibo), without state approval.
National shipment approval is a system in which the Ministry of Food and Drug Safety checks product quality through tests and document reviews before distribution and sale on the market for biological products such as vaccines, blood products, and antitoxins that require special attention in health and hygiene. General pharmaceuticals can be sold if they obtain product permission from regulatory agencies in each country, but vaccines and Botox administered to healthy people must undergo a national verification procedure in advance.
Even in the urgent situation of the Corona 19 pandemic, the flu vaccine as well as the Corona 19 vaccine are also required to go through the national shipment approval process like other vaccines. If you sell pharmaceutical products in Korea without obtaining national shipment approval, you are subject to cancellation of product permission due to violation of the Pharmaceutical Affairs Act.
In recent years, related industries have been accused of distributing some of Huzel’s botulinum toxin preparations, such as products exported to China, without national shipment approval, and the prosecution initiated an investigation and delivered the contents to the investigation team of the Ministry of Food and Drug Safety.
If Huzel’s alleged violation of the Pharmaceutical Affairs Act is found to be true, it is expected that items will be approved like Medytox’s Medytoxin and Coretox.
Meanwhile, in November of last year, the Ministry of Food and Drug Safety licensed 50 units, 100 units, 150 units, 200 units of Medytox, and Coretox, which are related products, on charges of exporting a botulinum toxin formulation to China without obtaining national shipping approval from Medytox. I made a decision to cancel.