Approval Conditions and Post-Approval Changes
Approval conditions
MFDS may impose conditions such as mandatory PMCF studies, restricted indications, or time-limited approval. Non-compliance may lead to suspension or cancellation.
Post-approval changes
| Change | Required action |
|---|---|
| Minor labelling change | 변경신고 (Change Notification) |
| Intended use change | 변경허가 (Change Authorization — full review) |
| Significant design change | 변경허가 |
| Manufacturing site change | 변경신고 or 변경허가 (depending on significance) |
| New size/variant | 변경허가 |
Renewal
품목허가 certificates do not automatically expire, but must be kept current. Maintain active GMP certificate and notify MFDS of changes.