Glossary Item
AUST R medicines : AUST R
Effective 20 March 2021Preferred Term: AUST R
Other Terms:
Definition:
Australian registered (AUST R) medicines undergo a rigorous and detailed process of assessment and regulation by the TGA. Sponsors of these medicines must provide comprehensive safety, quality and efficacy data.
These medicines may contain ingredients that are not approved for import to Australia under alternative conditions in the Biosecurity (Conditionally Non-prohibited Goods Determination) 2021, i.e. an import permit may be required.