Hugel and Pharmaresearch Sell Botox Without Approval... Initiate Product License Cancellation Proceedings

Hugel logo (Photo by Hugel)

[Asia Economy Reporter Lee Chun-hee] Hugel and PharmaResearchBio were found to have sold botulinum products without national batch release approval, prompting the Ministry of Food and Drug Safety to initiate administrative actions including cancellation of product licenses.

The Ministry of Food and Drug Safety announced on the 10th that the Central Investigation Unit for Violations detected that Hugel and PharmaResearch sold six botulinum product items domestically without obtaining national batch release approval, and has begun administrative procedures such as license cancellation and recall and disposal of the affected products.

The items found to have violated national batch release approval include ▲Botulax Injection, Botulax Injection 50 units, Botulax Injection 150 units, Botulax Injection 200 units (Hugel) and ▲Lientox Injection 100 units, Lientox Injection 200 units (PharmaResearch). Notably, PharmaResearch was found to have sold export-only drugs domestically without approval for domestic sales, and is expected to face a six-month suspension of all manufacturing operations.

Currently, for biological products requiring special attention for health and hygiene, to ensure safety and efficacy, the head of the Ministry of Food and Drug Safety must review manufacturing and quality control data and conduct testing and inspection before domestic sales, and batch release approval must be obtained for each manufacturing batch. Additionally, export-only drugs, which are granted approval conditions to manufacture solely for export based on importers' specifications, are prohibited from domestic sales.

The Ministry of Food and Drug Safety has issued recall and disposal orders to prevent the distribution of the violating products domestically, along with initiating administrative actions. Considering the time required for administrative procedures, usage suspension measures have also been taken to protect consumers. Furthermore, a safety alert was distributed to medical professionals such as doctors and pharmacists, requesting cooperation to replace the six license-canceled products with alternatives and to ensure proper product recall. The Ministry also requested the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to guide hospitals and clinics to refrain from using the affected products.

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