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Tech Alert: Permitted Indications - Reminders and clarifications for remaining 3 week transition

12 Feb 2021 9:54 AM | Anonymous member (Administrator)

There are 3 weeks remaining until the final date to transition to permitted indications on 5 March. There are approximately 13% of all listed medicines remaining to either transition or be cancelled.

From member inquiries and TGA feedback, CMA would like to update members on the following key information to be aware of:

 - Please make the transition before the 5 March if you are able. Leaving the change to the last few days may risk problems with a slow TGA IT system or validation issues with your product.

 - If you are waiting to transition, please ensure you have a draft listing which has been successfully validated (refer to the Application and Submission User guide). This should help to avoid last minute issues for medicines failing to validate, which could risk them being inadvertently cancelled on 6 March if time is needed to ensure the listing meets all validation requirements. Cancellations of medicines on the 6 March are unable to be appealed so it will be important to prevent unexpected issues arising.

 - Please be aware that some retailers may check to see whether there are current listings on the ARTG when assessing their inventory. It is prudent to change a listing to permitted indications to keep the AUST L listing active on the ARTG if you are concerned about retailers stock-keeping. However, changing to permitted indications on or before 5 March remains free, meaning that a listing can stay active until the expiry of the annual charge already paid by the sponsor, to the end of June. At this time sponsors may choose to cancel their products or pay the annual charge for the next year.

 - Sponsors should retain evidence of submitting their application to transition to permitted indications on or before 5 March 2021.

 - If you are intending for a discontinued medicine to be automatically cancelled by the TGA on 6 March, please be aware that it may be preferable to cancel your own medicine, if you do not wish for the cancellation to appear on this TGA cancellation webpage. 

 - From 6 March, changes to indications on existing ARTG listings will again attract a grouping application fee of $860. If you have a listing with permitted indications but you wish to make additional changes, this can be done without charge until 5 March.

Additional Resources:

 - CMA’s October 2020 technical alert  with information on transitioning during the final phase.

 - CMA’s January 2021 technical alert summarising the update to permitted indications in  with 3 new indications.

- The TGA will send sponsors another reminder in the coming week.


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