The Supreme Court has dismissed the appeal filed by the Ministry of Food and Drug Safety’s Seoul office, maintaining a lower court's decision to suspend the ban on selling and making Botulax, Hugel's botulinum toxin.
According to Hugel, the ministry’s order to ban the sales and manufacture of Botulax will be suspended until 30 days after the court makes a final ruling regarding the cancellation lawsuit filed by Hugel against the Seoul District Ministry of Food and Drug Safety and Hugel will continue to manufacture and sell its BTX until that date.
On Nov. 10, the Ministry of Food and Drug Safety announced that it would revoke the licenses of BTX products of Hugel and ban the sales and manufacture of the products because the company did not get lot release certificates before selling them in the Korean market.
The ministry said it would cancel permits for four types of Botulax products – Botulax Inj. Botulax Inj. 50, Botulax Inj. 150, and Botulax Inj. 200.
Immediately after the ministry's announcement, Hugel applied for two injunctions to the court to stop the regulator's administrative discipline.
On Nov. 12, the Seoul Administrative Court accepted the company's request and ordered a temporary suspension of the ministry's decision to revoke Botulax's license and ban the manufacture and sales of the product.
Then the ministry asked the Supreme Court to step in and overturn the lower court's decision to dismiss the suspension orders. Still, the top court dismissed the regulator's appeal on Tuesday.
"The Supreme Court's ruling showed that the ministry’s move was due only to difference in the legal interpretation of indirect export under the Pharmaceutical Affairs Act and had nothing to do with the quality of the BTX products manufactured by Hugel," a company official said. "Botulax is a product with proven quality with no problems in safety and efficacy through 1,500 domestic shipment approvals over the past decade."
Products affected by the disposition of the Ministry of Food and Drug Safety were export medicines produced and sold for export, not subject to domestic shipping approval, she added.
The official stressed that the company has no reason to evade or circumvent the national shipping approval process intentionally and faithfully complied with the ministry’s guidelines and the Foreign Trade Act.