by Zsuzsanna Sipos
The TGA implemented a new regulatory framework for
complementary medicines in 2018, to take full effect in 2021. The new
framework applies to all medicines listed under section 26A of the Therapeutic
Goods Act 1989 (the Act). This includes complementary medicines and
What has Changed
- There will no longer be a ‘free-text field’ for
sponsors to enter their medicine indications when applying to list the medicine
on the ARTG.
- Sponsors applying to list a new medicine will be
required to select from a list of permitted indications.
- Sponsors can apply to have a new indication
considered for inclusion in the Permissible Indications Determination. An application fee will apply.
Key Transition Dates
- The fee-free period for sponsors to transition
existing products ends on 6 September 2019. After this, an application
fee of $840 will apply to transitioning products.
- The transition period for existing listed
medicines ends 6 March 2021. All Listed Medicines must only contain
Permitted Indicated from this date.
If you require assistance to implement these please contact
our team at DTS Regulatory Consulting ([email protected]).
Further information can be found at https://www.tga.gov.au/permitted-indications-listed-medicines