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Your application dossier needs to identify all proposed changes and include relevant supporting information.
Ensure that your application cover letter includes the information described in the guidance on preparing an OTC application cover letter.
You do not need to provide a cover letter for a notification application.
General requirements for your dossier
When compiling your electronic dossier, follow Parts A to D of the General dossier requirements.
Organisation and structure of the dossier
Compile your dossier according to the Common Technical Documentation (CTD).
Checking the application dossier
Check that your application dossier contains all of the administrative and necessary technical data required for the application level and to support the proposed changes so that it will be accepted for evaluation after screening (Step 10). A notification application is not subject to screening.
Ensure your application:
- includes all relevant change codes
- is complete
- is in the required format
- includes the necessary supporting information.