Following the August 2020 consultation on Low-negligible risk changes to Permissible Ingredients- 2020-2021, the TGA have published the outcomes on their website for Easily dissociable magnesium salts and Andrographis paniculata.
CMA are pleased to note that the changes to the original consultation proposal for magnesium salts are more aligned to the evidence base and consumer use profiles of these products and therefore, the warning statements will be less restrictive and apply to a lower number of existing products, helping consumers better identify those products that are more or less likely to have a gastrointestinal effect.
Sponsors of Andrographis products need to be aware that a new statement relating to taste disturbances will be introduced.
The changes to the Permissible Ingredients determination will commence on 1 March 2021 for new listings. Sponsors will be provided a 12- month transition period, until March 2022, to make the necessary changes for existing medicines. Please also see the alert for expected changes to how transition dates are implemented which will be clearer and easier to implement for industry.
Please read today's technical alert for more information on these changes.