The Therapeutic Goods Amendment Bill No.1. of 2017 received royal ascent on Monday 5th March, as such the proposed reforms have now begun to be implemented.
As of midday yesterday (6th March 2018), the TGA have temporarily closed the application section of the eBS website for listed medicines and are no longer accepting free text listings, as such any medicines not listed on the ARTG will now only be able to be entered using legislated permitted indications.
The list of permitted indications is yet to be provided and dates for implementation have not been specifically set by the TGA, except to say that it will (likely) be 2-5 business days depending on the finalisation of the permitted indications legislative instrument and the update to eBS.
Any free text indications previously provided to any of our clients for medicines that have already been listed on the ARTG may be used for the next 3 years, however they will need to be updated before the end of the 3 year phase in period to permitted indications. During the phase in period there will be an 18 month fee free period whereby sponsors will not be required to pay TGA fees to update their listings, after the 18 month fee free period sponsors will be required to pay $800 to update listings. Any products not updated to permitted indications in that time will be cancelled from the ARTG.
Please note that any free text indications AWRS have provided for products that have not yet been listed on the ARTG are no longer valid and sponsors will need to have indications and evidence packages updated to permitted indications before products can be listed on the ARTG.
If you require any further information please do not hesitate to contact Rachael or Nadine.