All Marketing Authorization Holders of medicines are hereby informed that two copies of the acknowledgement forms should be attached to all variation applications submitted.

For major (MaV) and minor (MiV1)variation applications, the acknowledgement will be completed by the receiving officer at the acceptance point after payment of the relevant fee.

For minor variations for notifications (MaV2), the reviewing assessor will complete the acknowledgement form and indicate whether the notification is accepted, not accepted, or whether additional information is required. After review, the completed acknowledgement will be forwarded to the acceptance point.

For major and minor variation applications, the decision will be communicated to the applicant through an evaluation form.

For minor variations for notification, no separate approval letter will be issued. The completed acknowledgement form, indicating acceptance/non-acceptance of the notification, will be serving as the official confirmation.

• Acknowledgement of application for variation of a medicine

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