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Pre-submission checklist for annual re-assessment of a marketing authorisation under exceptional cir

The purpose of this checklist is facilitating submission of complete and correct Annual Re-Assessment Applications by marketing authorisation holders (MAHs).

The Agency strongly recommends that this checklist is used in advance of submission of Annual Re-Assessment Applications. You should be able to answer "Yes" to every item listed below unless a specific point is not applicable ("n/a") to the application in question. Please note that this checklist should not be included in the submission.

Click on this link for more information.

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