[Asia Economy Reporter Yoo Hyun-seok] The Daejeon High Court has granted a stay of execution on the cancellation of the product approval for Medytox's botulinum toxin preparation 'Medytoxine'.
On the 14th, the Daejeon High Court accepted Medytox's request for a stay of execution against the Ministry of Food and Drug Safety's cancellation of product approval and recall/disposal order.
As a result, the MFDS's cancellation of Medytoxine's approval will be suspended until the 30th day from the date of the main lawsuit's judgment.
Currently, Medytox is proceeding with the main lawsuit on the same issue. Medytoxine will be available for sale during the period the main lawsuit is ongoing. The lawsuit typically takes more than one year.
This acceptance is the result of the Daejeon High Court accepting Medytox's appeal against the Daejeon District Court's ruling. Previously, the 1st Administrative Division of the Daejeon District Court dismissed Medytox's request for a stay of execution on July 9.
On June 18, the MFDS announced it would cancel the product approval for three types of Medytoxine (50 units, 100 units, 150 units). It judged that Medytox violated the Pharmaceutical Affairs Act by using unauthorized raw materials from 2012 to 2015 and submitting manipulated data to obtain national batch release approval.
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