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Culture Media
The following information is a guide to the information that is to be submitted with applications for Import Permits for Culture Media.
- Culture media less than 20g/ml per individually packaged unit or less than 20g/ml of animal derived material per individually packaged unit.
- Complete contents list of product (including percentages/weights of ingredients);
- Volume of any animal derived material; and
- Size of each individually packaged unit.
- Diagnostic culture media for strictly in-vitro laboratory use only. Media in this category will be diagnostic tools, highly selective media, or indicator media. This does not apply to non-selective nutritive media and culture media with a potential for in-vivo or field use or for tissue culture.
- End use of culture media (and in what setting eg. clinical pathology laboratory); and
- Is there a potential in-vivo application for the product? (Manufacturer’s statement, catalogue listing or package insert may be useful to confirm this).
Please note if this information cannot be supplied or does not satisfy AQIS that there is no possibility of the product being used for in-vivo purposes, the information required under the relevant criteria below will apply.
- Media in volumes of greater than 20g or 20ml (where criteria 1 or 2 do not apply) – Bulk culture media.
- Complete contents list of product;
- Species and country of origin of all animal derived ingredients;
- Tissue/source of any bovine or ovine ingredients (eg skeletal muscle, casein); and
- Manufacturing details of all animal derived ingredients.
Applications for large numbers of culture media are often very detailed and may take longer than usual to assess, particularly those with multiple products. Providing the information in table format so it can be easily referenced will assist AQIS in the timeliness of the assessment. An example is given below:
Table A - List of products
|
Product Name |
Animal derived material |
Selective/ |
Contains <20g/ml animal derived material in each individually packaged unit |
Other – Refer to Table B for further information |
|---|---|---|---|---|
|
Product A |
Yes |
Yes |
NA |
NA |
|
Product B |
Yes |
NA |
Yes |
NA |
|
Product C |
Yes |
NA |
NA |
See Table B |
|
Product D |
No |
NA |
NA |
NA |
Table B – Products that contain > 20g/ml animal derived material and are not strictly selective/differential
|
Porcine (USA/Can) |
Ovine (NZ) |
Bovine (USA) |
Bovine (Aust) |
Processing/ |
|
|---|---|---|---|---|---|
|
Product C |
X |
X - Bile |
|||
|
Product E |
X - Spleen |
||||
|
Product F |
X |
X - Casein |
|||
|
Product G |
X |
X - Serum |
Government veterinary certification for bulk culture media
Bulk culture media (criteria 3 above) require government veterinary certification relating to the animal derived ingredients. There are two certification options for bulk culture media:
- Standard permit, which requires government certification with each consignment relating to the animal derived ingredients in each imported product; or
- Permit which does not require government certification with each consignment. To qualify for this permit condition, in addition to the product information above, the following requirements must be met at the time of application.
A declaration from the Managing Director of the exporting company certifying that:
- For the products containing animal materials, the company has complied with AQIS requirements concerning the animal species and country of origin and the treatment for the raw material used in the products;
- The Australian importing company will be notified of any changes in sourcing and/or processing of animal components and will seek AQIS approval prior to shipment to Australia; and
- The manufacturer adheres to Good Manufacturing Practices (GMP) as administered by the relevant Government regulatory authorities in the country of manufacture, and continues to be certified under ISO9000 standards relating to quality systems.
This declaration must be endorsed by a government veterinary officer or witnessed by a notary.