Alerts

The department has published new import conditions in the ‘Veterinary therapeutics and veterinary therapeutic ingredients’ BICON case for semi-synthetic, fermentation derived active ingredients.

The new conditions facilitate imports of goods that are semi-synthetic, fermentation derived active ingredients listed by the department (with or without plant extracts/oils) that satisfy the following requirements:

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).

Importers now have the option to apply for a standard permit where goods they intend to import are compliant with the standard conditions above.

Please note: Additional information (e.g. product names, approved arrangement sites) cannot be considered during assessment of an application for a standard permit.

An application for a non-standard permit will need to be submitted by the importer if standard permit conditions cannot be met.

Who does this alert affect:
Importers of semi-synthetic, fermentation-derived active ingredients (with or without plant extracts/oils) for veterinary or human therapeutic use and department staff.

Further information:
Please contact Client Contact Group Canberra on 1800 900 090 or email imports@awe.gov.au.