Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

Priority review pathway – First registration decision

Alectinib (ALECENSA) is the first medicine to be registered on the Australian Register of Therapeutic Goods (ARTG)(link is external) via TGA’s new Priority review pathway, which came into effect on 1 July 2017. The application extends the previously registered indications to include the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally […]

The Poisons Standard (the SUSMP)

The Poisons Standard(link is external) is a Legislative Instrument for the purposes of the Legislative Instruments Act 2003. The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories. The Poisons Standard also includes model […]

Current list of up-scheduled codeine containing products

This list comprises of previously available over-the-counter (S2, S3) codeine-containing products that have been up-scheduled to prescription medicine (S4) via application to the TGA. You should contact the sponsor to confirm their intention to continue marketing their goods in Australia, after 1 February 2018. Products containing other codeine derivatives, such […]