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Labels for COVID-19 treatments
To enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia.
COVID-19 treatments are manufactured across multiple global sites. Early batches of COVID-19 treatments used in Australia will be manufactured overseas and may be imported into Australia with an international label affixed.
Some information typically present on the Australian label may be absent and/or modified on the international label, as well as additional information present that is not relevant to the Australian context.
Access to Australian-specific information
COVID-19 treatments registered in Australia will be accompanied by Australian Product Information (PI) and Consumer Medicine Information (CMI) documents. Health professionals and consumers should consult the Australian PI and CMI for each COVID-19 treatment for information relevant to Australia.
Important Australian-specific information that is likely to be absent from the international labels includes:
- registration number ('AUST R' number)
- S4 signal heading ('PRESCRIPTION ONLY MEDICINE')
- cautionary statement ('KEEP OUT OF REACH OF CHILDREN')
- contact details of the Australian sponsor.
Assessment of international labels
The TGA assesses the international label for each vaccine, and checks that the label contains key information to allow the safe use of the vaccine in Australia.
The TGA will impose conditions on the Australian sponsor to develop and implement an Australian label as soon as practicable.
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2021
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Roche) (Casirivimab and Imdevimab) Labelling Exemption 2021