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