Posted on August 8, 2018
In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms.
One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications. All listed medicines must now use the permitted indications on offer or apply to add a new permitted indication to the list. There will be no grandfathering of current claims. No permitted indications will reference prohibited or restricted representations as per the Therapeutic Goods Advertising Code 2015. For medicines listed prior to 6 March 2018, sponsors must submit a grouping application to remove free text and ensure that only current permitted indications are used.
But it’s not all bad news, there is a 3 year window to update claims and labels – before TGA starts cancelling products under section 30 – and for the first 18 months (until 6 September 2019) the TGA fees will be waived.
On the bright side, this is a great opportunity for Sponsors to clean up their TGA listings and ensure that the evidence to support their indications is current and compliant.
If your claim does not fit one of the permitted indications, there is good news for you too! The TGA have released a new tier of listed medicines – the AUST L(A) – Assessed Listed Medicines. To be an assessed listed medicine, the product must comply with the requirements of a listed medicine, but can have intermediate, rather than low level indications. AUST L(A) products will have all their indications assessed and will be issued with a claimer for the product label stating that it has been assessed by TGA.
So, there’s plenty of good news and significant opportunities for sponsors of listed medicines to strengthen claims, consolidate supporting data and ensure a compliant, future focussed product portfolio.