Court Grants Suspension of Execution for Temporary Manufacturing and Sales Ban on Botulex

[Asia Economy Reporter Hyungsoo Park] Hugel announced on the 26th that the suspension of execution application for the 'provisional manufacturing and sales suspension order and recall and disposal order' filed with the Seoul Administrative Court has been accepted. The administrative disposition imposed on Hugel by the Ministry of Food and Drug Safety will be suspended until the 30th day from the date of the main lawsuit judgment.

According to the decision document, the Seoul Administrative Court explained, "Based on the materials submitted by the applicant, it is difficult to see that the suspension of effect corresponds to a case that would seriously affect public welfare."

Earlier, on the 10th, the Ministry of Food and Drug Safety announced that it would initiate administrative actions including cancellation of product approvals and recall and disposal procedures for four Botulex products due to domestic sales without national shipment approval. Hugel immediately filed a cancellation and suspension of execution application for the 'provisional manufacturing and sales suspension order and recall and disposal order' with the Seoul Administrative Court. Subsequently, on the morning of the 11th, it also applied for a provisional suspension of execution for the disposition, which was accepted on the same day.

A Hugel official said, "We have grown into the number one domestic company based on a management philosophy grounded in quality and trust," adding, "We are striving to enhance the status of K-Toxin and K-Bio in the global market." He continued, "The administrative disposition arose from differences in interpretation regarding distribution methods," and added, "We will do our best to sufficiently clarify this through legal procedures."

Hugel was the first domestic company last year to obtain product approval for botulinum toxin products from Chinese health authorities. It is expected to obtain approval in the European market this year as well. In March, it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and completed a GMP inspection in August.