[GMP Update] Ending the Sales-Suspension Grace Period (September 2023).

MFDS explained that a grace period had previously allowed sales where audit backlogs prevented completion before certificate expiry. With additional review bodies and auditors, it considered such backlogs unlikely to continue.

The former grace period should therefore cease, with periodic audits completed before expiry and action taken according to their results.

MFDS warned that unlimited postponements could extend beyond the periodic audit cycle, and that sales might continue despite inadequate quality management where an initial audit decision requested corrective information, creating safety concerns.

It emphasised ending grace measures operated without a legislative basis and completing GMP audits within the prescribed time limits.

To avoid confusion after long-standing use of the grace measure, MFDS considered a notice period of about 90 days appropriate.

Regional MFDS offices and review bodies were asked to explain the change during reviews and enquiries. The notice stated that applications from 1 January 2024 would no longer benefit from the grace period.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=2&&pstSno=8&bbsSno=1339