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Data overview for national marketing authorisations variations

National Variations to Marketing Authorisation

Type IAType IAINType IBType II
Assessment duration30 days30 days30 days30/60/90 days
Start of assessmentFrom submission of Type IA variation notificationFrom submission of Type IAIN variation notificationFrom confirmation of acceptance of valid Type IB notification (validation)From confirmation of acceptance of valid Type II application (validation)
Submission of Czech texts by MAHTogether with Type IA notificationTogether with Type IAIN notificationTogether with Type IB notificationTogether with Type II application
Revision dateDate of implementation or date of completion of assessment if implementation is in the futureDate of implementation or date of completion of assessment if implementation is in the futureDate of completion of assessmentDate of completion of assessment
Implementation deadline for SÚKL6 months6 months6 months2 months
Implementation deadline for MAHWithin 12 months before submission or within 6 months after approvalWithin 14 days before submission or within 3 months after approvalWithin 6 months after approvalWithin 6 months after approval; immediately if safety-related