Medytox secured its second consecutive victory in the legal battle against the Ministry of Food and Drug Safety (MFDS) over the issue of indirect exports of botulinum toxin products. Given that other domestic toxin companies are also engaged in legal disputes with the MFDS for similar reasons, the ripple effects on the entire industry are expected to be significant.
The Administrative Division 1 of the Daejeon High Court (Presiding Judge Lee Jun-myeong) on the 13th delivered a second-instance ruling canceling the MFDS's appeal regarding Medytox's lawsuit against the head of the Daejeon MFDS, which sought to revoke the manufacturing and sales suspension order and other related orders. The court annulled the cancellation of product approval, recall and disposal orders, and the order to announce the recall and disposal facts.
Previously, in 2020, the MFDS imposed product approval cancellations, recalls, disposals, and sales suspension orders on some products of Medytox’s toxin formulations, Meditoxin and Coretox, citing reasons such as failure to obtain national batch release approval or violations of labeling regulations. Medytox had exported toxin products indirectly by first supplying them to domestic trading companies or wholesalers, who then re-exported them overseas. However, the MFDS regarded this process as domestic sales and imposed sanctions, arguing that Medytox did not follow the mandatory national batch release approval procedures required for domestic sales.
In response to these sanctions, Medytox filed for a suspension of execution and an administrative lawsuit to cancel the orders. The suspension of execution was granted, and in the first trial held at the Daejeon District Court in July last year, Medytox won all claims.
In this second trial as well, all orders such as product approval cancellation and recall and disposal were canceled as per Medytox’s main demands. However, unlike the first trial where Medytox’s claim was accepted, the second trial ruled that the MFDS’s one-month sales suspension order was lawful.
A Medytox official stated, “We will immediately apply for a suspension of execution regarding the one-month sales suspension order that was upheld, to ensure there is no disruption in sales,” adding, “We will do our best to prove the illegality of the one-month sales suspension order through an appeal to the Supreme Court.” On the other hand, an MFDS official said, “We have not yet received the judgment document,” and added, “We will analyze the judgment and determine a specific response strategy.”
Besides Medytox, most major domestic toxin companies such as Hugel, PharmaResearch, Jetema, Korea BMI, and Korea BNC are engaged in legal disputes with the MFDS for similar reasons. Among them, Hugel and PharmaResearch also won rulings in the first trial against the MFDS’s manufacturing and sales suspension orders.
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