8. Post-Approval

2.4. Type IB variations – ‘Tell, Wait and Do’ procedure

Type IB is a minor variation which is neither a Type IA variation nor a Type II variation nor an Extension.

• These variations must be notified to all relevant authorities by the MAH before implementation, but do not require a formal approval.
• The respective authority has 30 days in which to respond to the MAH that the notification has not been accepted.
• Upon acknowledgement of receipt of a valid notification, the MAH must wait for a period of 30 days to ensure that the notification is deemed acceptable by the relevant authority before implementing the change.