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A MAH has a confirmed signal that requires an urgent safety restriction before a formal variation can be completed. Commercial wants to wait for the normal Type II timetable. What is the correct postapproval approach?
Use the urgent safety restriction route where justified, then regularise through the formal variation process.
Wait for the next Type II timetable because temporary restrictions are not permitted.
Implement promotional restrictions only and leave the SmPC unchanged.
Close the signal if a formal variation would take too long.
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