[Asia Economy Reporter Seongpil Cho] Medytox has filed an administrative lawsuit against the Ministry of Food and Drug Safety (MFDS), which temporarily suspended the manufacturing and sales of its botulinum toxin products 'Medytoxine' and 'Coretox.'
The Daejeon District Court announced on the 21st that Medytox submitted a complaint the previous day requesting the cancellation of the MFDS's order to suspend the manufacturing and sales of Medytoxine and Coretox and applied for a suspension of execution. Medytoxine and Coretox are botulinum toxin products by Medytox. Botulinum toxin products, also known as Botox, are biopharmaceuticals used in cosmetic procedures such as improving glabellar lines.
Earlier, on the 19th, the MFDS ordered the recall and disposal of these products, citing that Medytox sold Medytoxine and Coretox without obtaining national batch release approval, and initiated administrative actions including the cancellation of product approval. Considering the time required for the administrative process of approval cancellation, the MFDS temporarily ordered the suspension of manufacturing and sales of the products.
The MFDS claims that Medytox exported botulinum toxin products, which require national batch release approval, to China and other countries without obtaining such approval. The issue was raised because Medytox transferred the products to domestic sales agencies without national batch release approval. On the other hand, Medytox argues that export products originally made for overseas sales are not subject to national batch release approval and therefore are not subject to the Pharmaceutical Affairs Act.
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