Medytux Fined 456 Million Won for Illegal Botox Manufacturing

Ministry of Food and Drug Safety Imposes Fine Instead of Suspension of "Meditoxin" Manufacturing Operations

Medytux has been fined approximately 400 million won by the Ministry of Food and Drug Safety for violating the Pharmaceutical Affairs Act.

On September 22, the Ministry of Food and Drug Safety announced that it had imposed a fine of 456.05 million won on Medytux, replacing a suspension of manufacturing operations, for producing the botulinum toxin product "Meditoxin" using unapproved raw materials. This penalty is less severe than the original measures, which included cancellation of product approval and suspension of manufacturing and sales.

The reasons for the administrative action are: ▲ manufacturing and selling pharmaceuticals without changing the approved manufacturing method, ▲ failing to meet standards in potency test results, and ▲ falsifying test reports.

The Ministry of Food and Drug Safety explained, "Medytux falsified the national lot release test reports for three Meditoxin products (50, 100, and 150 units), failed to meet standards in potency test results, and manufactured the products using methods different from those originally approved. The fine is being imposed in accordance with the court's ruling, which recognized these three violations."

Previously, in April and June 2020, the Ministry of Food and Drug Safety ordered suspension of manufacturing and sales and cancellation of product approvals for three products, citing that Medytux had violated the Pharmaceutical Affairs Act by falsifying documents to make it appear as though approved raw materials were used in the production of Meditoxin between 2012 and 2015, and by falsely reporting that products and raw materials that failed potency tests met standards.

In response, Medytux filed an administrative lawsuit in June 2020, arguing that the raw materials had not been changed, that the changes in manufacturing methods were minor, and that there were no issues with safety or efficacy, making the product approval cancellation excessively harsh. Both the first and second trials ruled in favor of Medytux, and in March of this year, the Supreme Court's Special Division 1 dismissed the Ministry's appeal. As a result, the cancellation of product approvals and suspension of manufacturing and sales for the three Meditoxin products were ultimately overturned.

An official from the Ministry of Food and Drug Safety stated, "There were some differences in opinion between the Ministry's original decision and the court's ruling regarding quality and safety management of botulinum toxin products. However, we have made this decision in respect of the court's judgment that the cancellation of product approval was excessive."