Deadlines applying to the PMCF/PMPF notification
Key date/event | Process description | Deadline | Possibility of extension? |
|---|---|---|---|
Submission date | Minimum period for sponsor to notify PMCF/PMPF investigation/study to the MSC | 30 days before starting PMCF/PMPF | No |
Maximum period for CA to acknowledge receipt of the notification (and to provide comments to sponsor) | 30 days of submission date | No |