An important reminder that the transition period for permissible indications ends on 5 March 2021. There are more than 2,000 products, or >20% of listings remaining to be transitioned.
Please read this technical alert for more information about the end of the transition period and implications for sponsors and products.
Critical key points to understand in relation to the transition are that:
- The last day that sponsors will have to submit their application to re-list their medicine with permitted indications is 5 March 2021.
- Changes to indications only, remain free until 5 March 2021 due to the 18 month extension to the ‘fee free’ period previously supplied.
- Any products that do not have updated records by this date will be cancelled from the ARTG and sponsors will no longer be able to supply these medicines.
- An extension to the date cannot occur in the way that occurred for TGO 92, as the date is included in the Therapeutic Goods Act and there are not the same approval mechanisms in place to be able to extend the applicable date on an individual basis.
- There will not be any letters proposing to cancel the listing issued prior to the cancellation.
- Any cancellations that occur are not associated with Section 60 appeal rights.
- If sponsors do not have evidence of submitting their application to transition to permitted indications on or before 5 March 2021, then the medicine is likely to be captured in the automatic cancellation process
- Products that are automatically cancelled on 6 march 2021 that sponsors desire to retain would therefore need to be re-listed as new products.