The recently published Therapeutic Goods (Listed Medicines - Conditions of Listing) Determination 2022 sets out the standard conditions that will automatically apply to the listing of certain medicines that are listed in ARTG. The information in the General guidance for listed medicines on conditions of listing will be updated in due course.
Guidance for sponsors on the regulatory framework for ‘lower risk’ listed medicines:
Overview listed medicines and listed assessed medicines pathways
Legislative requirements for listing medicines in the ARTG
Application process to list a medicine in the ARTG
Conditions of listing - see information in text box above
How to make a change to a listed medicine’s ARTG entry
