Changes

As a result of amendments to the Biosecurity (Prohibited and Conditionally Non prohibited Goods) Determination 2021 (the Goods Determination), import conditions in the BICON commodity case ‘Veterinary therapeutics and veterinary therapeutic ingredients’ have changed.

Alternative conditions for semi-synthetic, fermentation-derived active ingredients, which satisfy the following requirements, have been introduced into the Goods Determination:

1. The active ingredient has been manufactured without the use of materials of terrestrial animal or avian origin (including the fermentation culture media used during production of the active ingredient); and
2. The active ingredient does not contain any plant material (other than highly processed and purified plant extracts or oils) and is not on an animal or grain-based carrier; and
3. The active ingredient is derived from a fermentation process which used culture media that was sterilised before use; and
4. The active ingredient was manufactured to be compliant with:
   4.1. the relevant monograph from at least one of the following published standards:
   - United States Pharmacopeia, European Pharmacopoeia, British Pharmacopoeia; or
   4.2. the specifications approved by the Australian Pesticides and Veterinary Medicines Authority (within the meaning of the Agricultural and Veterinary Chemicals (Administration) Act 1992).

Consignments of these goods can now be brought into Australian territory without an import permit. Importers will still need to meet the current conditions as outlined in the ‘Veterinary therapeutics and veterinary therapeutic ingredients’ BICON case.

Who does this notice affect:
Importers of listed semi-synthetic, fermentation-derived active ingredients for veterinary therapeutic use, Client Contact Group, Pathway Operations Cargo – Assessment and Inspections.

Further information:
Please contact the Animal and Biological Imports Branch on 1800 900 090 or email imports@awe.gov.au