The Therapeutic Goods Administration (TGA) is conducting a public consultation on potential options for the regulation of biologicals manufactured in Australia for export only (and not for supply in Australia).
Currently, biologicals included in the Australian Register of Therapeutic Goods (ARTG) can be exported, but they are not permitted to vary from the product supplied in Australia. This means that ‘export only’ biologicals cannot have different indications, release specifications, or labels to the product approved by the TGA, even if the importing country has assessed and approved the product independently.
We are seeking feedback on:
For more information and to have your say, please view the consultation paper and complete the online survey on the TGA Consultation Hub.
The public consultation opened on 15 November 2021 and closes on 20 December 2021.
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