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Once the TGA has assessed a submitted notification form it will move out of the 'Submission' list (located in the 'View Lodged Submissions' link on the TBS Navigator) and into the 'Medicine Shortage' list (within the 'Your TGA Information' link located on the TBS Navigator). It is from this list that a notification form can undergo a variation.
To vary a notification form, click the drop-down arrow, located at the far-left of each individual assessed notification listed, and then click 'Vary Notification'.
Please note: You are NOT able to vary a resolved notification. If you need to submit a notification of a shortage for a product that has previously been in shortage and resolved you will need to create a new notification. If the previous shortage is still published on the MSII website under the 'Resolved' tab you will need to contact the Medicine Shortages team (email medicine.shortages@health.gov.au or phone 02 6232 8850) to unpublish and archive that notification. You will not be able to submit the new notification until the next day.
If you have a medicine shortage that you think is of critical patient impact and are not able to create a medicine shortage notification immediately because there is still a published resolved notification, you will need to contact the TGA as soon as possible using the above contact details. Medicine Shortages Section will take action to archive the notification immediately. This immediate archiving will enable the sponsor to be able to create and submit a new notification within two hours of notifying the Medicine Shortages Section.
The notification form will open for editing; its status changes to 'Draft' and it is located in the Drafts list found via the 'View Drafts' link located on the TBS Navigator.
The fields that can be varied are outlined in the tables in Appendix 1.
The varied notification form will need to be validated before it can be submitted to the TGA for assessment.
The original notification that was varied remains listed in 'Medicine Shortages' until the varied notification completes TGA assessment and then replaces the original. If a 'Vary Notification' is attempted again while the first variation is still in 'Draft' or being assessed the following message will appear:
If the original notification had information published on the MSII website, any variations made will be reflected on the website on completion of the assessment by the TGA.