MFDS Establishes Criteria for Revoking Narcotics Handling Permits Obtained Illegally

[Asia Economy Reporter Kim Daehyun] Administrative sanctions criteria have been established to cancel approval or permits for handling narcotics obtained through fraudulent means.

On the 17th, the Ministry of Food and Drug Safety (MFDS) announced that it will enforce the revised and promulgated "Enforcement Rules of the Narcotics Control Act" reflecting this content.

First, administrative sanctions criteria have been established to cancel permits if narcotics handlers, raw material import/export or manufacturing businesses, or narcotics and psychotropic drug manufacturing and import/export entities fraudulently obtain approval or permits for handling narcotics.

The revised enforcement rules also relax administrative sanctions criteria applied when narcotics handlers report the purchase, use, preparation, or administration of narcotics to the MFDS but commit minor violations.

When minor items such as product codes or manufacturing numbers are not reported, the suspension period for narcotics handling operations has been reduced from the previous 7 days to 3 days. If the report is submitted late beyond the deadline, the administrative sanction changes from a 3-day suspension to a warning.

Cases where the narcotics handling report was properly submitted but discrepancies occurred due to system malfunctions are also recognized for mitigation.

If only part of the required information on the narcotics prescription is omitted, the administrative sanction has been eased from a 3-month suspension of narcotics handling operations to 1 month.

When changes occur after the narcotics handling report, the period allowed for submitting change reports after the end date of the handling report has been extended from 5 days to 14 days.

Administrative sanctions criteria have also been clarified for cases where doctors or pharmacists violate permit cancellation rules. Those who automatically become narcotics handling medical practitioners or narcotics retail dealers and commit violations warranting permit cancellation will be subject to a "12-month suspension of operations."

An MFDS official stated, "We will continue to prioritize public health and safety, do our best in narcotics safety management, and revise related systems and laws to prevent illegal distribution and misuse of narcotics."

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