Zetema Initiates Legal Procedures Against 'MFDS Botulinum Toxin Administrative Sanctions'... "Filing Invalidity Lawsuit"

[Asia Economy Reporter Lee Gwan-joo] Zetema, which was administratively sanctioned by the Ministry of Food and Drug Safety (MFDS) for selling botulinum toxin products domestically without national shipment approval, has begun formal legal proceedings.

On the 2nd, Zetema issued an official statement saying, "On the day of the sanction, the 1st, at 7:30 PM, we completed filing a lawsuit for nullification and cancellation of the sanction, a request for suspension of execution of the sanction, and a request for provisional suspension of effect against the MFDS."

The MFDS announced the previous day that Zetema's 'Zetema The Toxin Injection', Korea BMI's 'HiTox Injection', and Korea BNC's 'Bionox Injection' had not received shipment approval, and initiated procedures to cancel product licenses and recall and dispose of the three products. Additionally, a six-month suspension of manufacturing operations was imposed.

Zetema responded, "These products are toxin pharmaceuticals approved by the MFDS in June 2020 for export purposes only, with all units exported. They are also products undergoing domestic Phase 3 clinical trials. Therefore, the national shipment approval claimed by the MFDS is fundamentally not applicable, and these pharmaceuticals cannot be subject to violations of the Pharmaceutical Affairs Act."

They added, "Zetema’s products have never been distributed domestically and have been entirely exported overseas. We have actively clarified that there was no risk posed to public health and that efforts were made for national export achievements. However, the MFDS unreasonably expanded and over-interpreted the Pharmaceutical Affairs Act to impose excessive sanctions, which is very regrettable. We have promptly initiated legal procedures against this administrative sanction and plan to proceed with clinical trials for formal domestic approval without disruption."

Separately from the legal proceedings, Zetema plans to continue separate explanatory procedures such as filing objections to each sanction by the MFDS.

This content was produced with the assistance of AI translation services.