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Medicine shortages/discontinuations - Electronic notification form: User guide

21 December 2018

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Accessing a notification form

  • 'Draft' notification forms can be viewed, edited, copied, printed, validated or deleted. They are listed in the 'View Drafts' link located on the TBS Navigator.
  • 'Passed Validation' notification forms can be viewed, edited, copied, printed, deleted or submitted. They are listed in the 'View Drafts' link located on the TBS Navigator and in the 'Submission' link also located on the TBS Navigator.
  • 'Submitted for assessment' notification forms can only be printed and viewed via print preview. They are listed in the 'View Lodged Submissions' link located on the TBS Navigator.
  • 'TGA Assessed' notification forms can be printed and viewed via print preview. They can also be updated through a vary notification action. They are listed in the 'Medicine Shortages' link under the 'Your TGA Information' link located on the TBS Navigator.

Drafts

You find your drafts by opening your portal and clicking on 'View Drafts'.

screenshot showing location of View Drafts in menu

Within this section, medicine shortages notification drafts can be seen, as well as drafts from all other TBS areas such as 'Biologicals' and 'Over The Counter Medicines' sections. The list of drafts can be filtered by 'Approval Area', 'Sponsor' and by 'Date', these filters are located at the top of the page.

All Medicine Shortages listings in drafts can be distinguished from other drafts as their identifier begins with an MS (for example, 'MS-2014-NT-00053-1').

To view a medicine shortages draft click on it under any of the five column headings:

screenshot showing 5 column headings: Date, Identifier, Client Reference, Information, Sponsor

To print preview, copy or delete the notification click on the drop-down arrow at the far-left of the listing and select the appropriate action.

Any submitted notifications that are returned by the TGA as push backs will appear here in 'View Drafts' - these will be highlighted in red.

Submissions

You can find this view by opening your portal and clicking on 'View Lodged Submissions'.

screenshot showing location of View Lodged Submissions in the menu

Within this section, medicine shortages notification submissions can be seen, as well as submissions from all other TBS areas such as 'Biologicals' and 'Over The Counter Medicines' sections. The list of notifications submitted can be filtered by 'Approval Area', 'Sponsor' and by 'Date', these filters are located at the top of the page.

All Medicine Shortages listings in drafts can be distinguished from other drafts as their identifier begins with an MS (for example, 'MS-2014-NT-00052-1').

Information for each medicine shortages submitted notification is listed under these six column headings:

screenshot showing 6 column headings: Received, Identifier, Workflow Status, Description, Product Name, Sponsor

To view or print the submitted notification click on the drop-down arrow at the far-left of the listing and select the 'Print Preview' button.

The status of the notification can be determined by looking at 'Workflow Status' column:

screenshot showing location of Workflow Status column
  • 'Submitted - Pending Review': notification form has yet to be received by the TGA.
  • 'Pending Assessment': notification form has been received by the TGA.
  • 'Notification Finalised': notification form has been assessed by the TGA.

A notification form submitted to the TGA can be returned during assessment if the sponsor requests it or if TGA requests the sponsor revise the notification form. This is termed a 'Push Back'. If a notification form is returned the status changes back to 'Draft' and it is located back in the 'Drafts' list and highlighted red for easier identification:

screenshot showing highlighted form

Changes can now be made to the notification form and it can be validated and then resubmitted again to the TGA for re-assessment. Once a notification form clears TGA assessment it moves 'Medicine Shortages' located under 'Your TGA Information' in the TBS Navigator.

Medicine Shortages

You find this view by opening your 'Portal' drop-down arrow and opening 'Your TGA information', then clicking on 'Medicine Shortage'.

screenshot showing location of Medicines Shortage option in the menu

Within this section all medicine shortages notifications that have completed TGA assessment are listed. The list of submitted notifications that are visible can be filtered by 'Sponsor' and by 'Date', these filters are located at the top of the page.

Assessed medicine shortages notifications list information under the following seven column headings:

screenshot showing 7 column headings: Received, Identifier, Impact, Product Name, Active Ingredient, Published, Sponsor

To vary the notification or view and print the assessed notification, click on the drop-down arrow at the far-left of the listing and select the appropriate action. This is where you would submit an updated notification from, by choosing 'Vary' and making the relevant changes, for example updating the dates of the shortage, and then re-submitting to the TGA.

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