Medytox said on the 23rd it will contest the penalty surcharge of 456.05 million won imposed by the Ministry of Food and Drug Safety.
The previous day, the ministry imposed a penalty surcharge of 442.75 million won, in lieu of suspending manufacturing operations for 3 months and 25 days, on the Medytoxin 50-unit product, and a penalty surcharge of 13.3 million won, in lieu of suspending manufacturing operations for 2 months and 10 days, on the Medytoxin 150-unit product.
Earlier, the ministry ordered a halt to manufacturing and sales in 2020 and revoked item approvals, citing reasons such as the company's manufacture and sale of the botulinum toxin product "Medytoxin" without changing the approved details (manufacturing method), failure to meet standards in potency test results, shipment of products with failed test results, and manipulation of test certificates.
The company filed a lawsuit to cancel the administrative dispositions, and in Mar., the Supreme Court sided with Medytox. The ministry's position is that it lowered the level of the dispositions in accordance with that ruling. Medytox, on the other hand, says the penalty surcharge disposition is also unjust.
The company said it plans to clarify the facts through legal procedures regarding the latest disposition by the ministry. A company representative said, "We won at both the first and second instances in the administrative lawsuit with the ministry over the Medytoxin ingredient change, and in Mar., the Supreme Court also dismissed the ministry's appeal, resulting in a final ruling in our favor," adding, "We will also respond legally to this penalty surcharge disposition."
Earlier in Mar., the Supreme Court's First Division for Special Cases dismissed the ministry's appeal in the final appeal of the lawsuit filed by Medytox against the head of the Daejeon Regional Office of Food and Drug Safety seeking to cancel the item approval revocations and the manufacturing and sales suspensions for three Medytoxin products (50, 100, and 150 units). The Daejeon District Court at first instance and the Daejeon High Court at second instance also both sided with Medytox.