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Listed and assessed listed medicines: Application and submission user guide
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Submission
Pressing the 'Proceed to submission' button after validation, will take you to the submissions window:
Eligible applications must have successfully passed validation in order to appear in this window. All application types are displayed including their product name, application ID, date/time of validation, application type and associated fee.
Submissions can also be made from the TBS portal under 'Listed medicines, Create applications and submissions, Submissions'.
Submitting your application
- Select the checkbox next to the application you wish to submit. The 'Certification/Declaration' will open:
- Read the Certification/Declaration. Select either the 'Agree' or 'Disagree' button.
Note: by clicking on 'Agree', you declare that the information given in the application is correct.
The Certification/Declaration will be different for assessed listed and general listed medicine applications.
- Once you have agreed, the selected application will be highlighted. Repeat steps 1 and 2 to add subsequent applications to your submission. All selected applications will be submitted in a single submission.
Note: Only one application for assessed listed, assessed composite pack and 9D(1) variation for a general listed medicine can be submitted at a time.
- Each of the applications selected for submission will display 'Yes' in the submit column under 'Eligible applications':
- Select the 'Submit' button in the bottom right hand corner. Successful submission will take the submitter to the 'Notification page'.
- Select the 'Print invoice' button in the bottom right hand corner to print an invoice for this submission:
- The invoice can also be accessed from TBS portal, in the '$My Finances' window:
