MFDS Cancels Export Botulinum Products and Suspends Manufacturing for 3 Companies
Companies Protest Decisions... Situation Likely to Prolong
[Asia Economy Reporter Lee Gwan-joo] Companies that received cancellation orders for export-use botulinum toxin product approvals from the Ministry of Food and Drug Safety have launched a counterattack after courts consecutively granted provisional injunctions to suspend enforcement. It is expected that full-scale legal actions will follow.
Korea BNC announced on the 12th that the Daegu District Court approved its provisional injunction application to suspend the Ministry of Food and Drug Safety’s cancellation of product approval, recall and disposal order, and six-month manufacturing suspension.
The court stated, "It is recognized that there is an urgent need to suspend the effect of the order to prevent irreparable damage to the plaintiff caused by the enforcement of the order." Accordingly, the Ministry of Food and Drug Safety’s order against Korea BNC will be suspended until the 30th of this month.
Earlier, on the 5th, Jetema also received a court ruling suspending the effect of the product approval cancellation, six-month manufacturing suspension, recall and disposal order, and recall announcement order until January 20 of next year.
Following the court decisions, these companies are now able to resume manufacturing and sales of the botulinum toxin products currently in production.
Previously, the Ministry of Food and Drug Safety had canceled product approvals and imposed manufacturing suspensions on Jetema, Korea BNC, and Korea BMI for violating national batch release approval requirements for botulinum toxin products. The companies protested that the Ministry’s actions were excessive and immediately initiated legal responses.
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