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Renewal and Periodic Re-Inspection

KGMP certificate validity​

KGMP certificates have a validity period of approximately 3 years. Renewal application must be submitted before expiry.

Renewal process​

  1. Submit renewal application via MFDS eSubmission portal before expiry
  2. MFDS schedules a periodic re-inspection
  3. Re-inspection may be lighter than initial certification if quality record is good

Periodic surveillance inspections​

MFDS may conduct unannounced or scheduled surveillance inspections at any time during the certificate validity period.

Lapsed certification consequences​

  • Cannot supply new products to the Korean market
  • Existing supply chain stock: short transition period may apply
  • MFDS may suspend or cancel associated 품목허가