[GMP Update] Remaining Validity for Batch Periodic Applications.

MFDS stated that the interpretation manual would recommend batch periodic audit applications for sites with no more than one year remaining on their certificates, reflecting the three-year audit cycle.

Because batch applications are intended to reduce the burden on companies with multiple sites, lengthy extensions to corrective-information deadlines should be avoided.

Under Article 24(2) of the Enforcement Decree of the Civil Petitions Treatment Act, the authority may recalculate a supplementary-information deadline only when the extension request clearly explains the basis and time needed. Unnecessary extension requests should be avoided.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=3&&pstSno=3&bbsSno=1339