Import case details - public listing 		New Search
Commodity: Human tissues and fluids (excluding human antibodies and cell lines)
Scientific name:
Country: All countries
End use: Therapeutic
Date printed: Jul 31 2010
The information here covers AQIS quarantine requirements only and is current on the date of transmission but may change without notice. AQIS makes no warranties or representations with respect to the accuracy or completeness of that information and will bear no liability with respect to that information. Importers must satisfy quarantine concerns and comply with quarantine conditions applicable at the time of entry. The Commonwealth through AQIS is not liable for any costs arising from or associated with decisions of importers to import based on conditions presented here which are not current at the time of importation. It is the importer’s responsibility to verify the accuracy and completeness of the information at the time of importation.

It is the importer’s responsibility to identify and to ensure it has complied with, all requirements of any other regulatory and advisory bodies prior to and after importation including the Australian Customs Service, Therapeutic Goods Administration, Department of Health and Ageing, Department of the Environment, Water, Heritage and the Arts, Australian Pesticides & Veterinary Medicines Authority and any State agencies such as Departments of Agriculture and Health and Environmental Protection authorities.

Importers should note that this list is not exhaustive. Importers should also note that all foods imported into Australia must comply with the provisions of the Imported Food Control Act 1992 , an Act which is administered by AQIS.

Notification of the import must be provided to AQIS for all imported goods other than goods imported as accompanied baggage or goods imported via the mail and not prescribed under the Customs Act 1901. Notification must be consistent with Quarantine Regulations 2000 (examples include a Quarantine Entry or a Quarantine declaration).

Condition  C5405 A quarantine entry is not required for most human tissues and fluids, apart from faeces, cell lines and DNA

Non-commercial

All conditions under the Commercial section apply.

Commercial

1.      An Import Permit is not required for human tissues, DNA, proteins or fluids, (excluding human antibodies and cell lines), for therapeutic use. An Import Permit is required for all other end uses.  Import Permit applications must be sent to AQIS Canberra office for assessment, prior to importation.

2.      Product must be labelled ‘product of human origin’, or be accompanied by supporting documentation from the exporter or supplier (e.g. invoice or letter), to confirm the origin.

3.      A declaration from the importer must be provided at the time of importation stating that the products are for therapeutic use only as defined in the Therapeutic Goods Act 1989.

Definition of Therapeutic Use

Under Section 3 of the Therapeutic Goods Act 1989, therapeutic use means use in or in connection with:

(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
(b) influencing, inhibiting or modifying a physiological process in persons or animals; or
(c) testing the susceptibility of persons or animals to a disease or ailment; or
(d) influencing, controlling or preventing conception in persons; or
(e) testing for pregnancy in persons; or
(f) the replacement or modification of parts of the anatomy in persons or animals.

For example: Pathology specimens for the diagnosis of diseases/ailments are considered as being used for therapeutic use and therefore do not require an import permit. 

Tissue/fluid samples being imported for research purposes or in-vitro use, not connected to the diagnosis of disease in an individual, are not considered to meet this definition of therapeutic use.  As such an import permit will be required.

Note: Products for veterinary therapeutic use must meet the requirements of the ICON case “Veterinary therapeutics and medicines”

For information relating to human antibodies and cell lines, please refer to the ICON case ‘Human antibodies and cell lines’.

Applications for products which are infected with microorganisms known or with the potential to pose a human quarantine risk will be referred to the Department of Health and Ageing for advice.  This includes, but is not restricted to, products infected with human quarantinable diseases as listed below from Table 9, Section 21 of the Quarantine Proclamation 1998.

Human Quarantinable Disease

Also Known As

Cholera

Vibrio cholerae

Plague

Yersinia pestis

Rabies

Lyssavirus

Severe Acute Respiratory Syndrome

SARS

SARS associated Coronavirus

Smallpox

Variola virus
Poxvirus variola

Viral haemorrhagic fevers of humans

Ebola haemorrhagic fever (Filoviridae)
Marburg virus (Filoviridae)
Lassa Fever (Arenaviridae)
Crimean-Congo hemorrhagic fever (Nairovirus)

Yellow fever

Flavivirus

Highly Pathogenic Avian Influenza in Humans

HPAIH, Bird Flu, H5N1

 
Condition  C9000 The importer must comply with all international (eg IATA) and domestic requirements concerning the safe handling, transport and labelling of biological material

The importer must comply with all international (eg IATA) and domestic requirements concerning the safe handling, transport and labelling of biological material. Safety precautions shall also be maintained during shipment and handling to prevent dissemination of pathogens.
Entry Management  EM0184

AQIS minimum documentary requirements to support assessment of all documentation 

All documentation presented to AQIS as part of the import process must meet the requirements of the Minimum Documentary Requirements Policy. These requirements include:

  1. Overarching Requirements (e.g. legible, in English, signed, dated, linked to the consignment);
  2. Document Format Requirements (e.g. as per nationally accepted practice and standards, or on company letterhead); and
  3. Prescribed Information Requirements (e.g. treatment certificates must include a description of the goods/packaging treated)

 
Entry Management  EM0185

AQIS information requirements to support assessment of non-commodity concerns associated with imported cargo

All documentation presented to AQIS to assist in determining the level of quarantine risk posed by transportation pathways and packaging must meet the requirements of the Non-Commodity Information Requirements Policy. These requirements address:

  1. Container cleanliness;
  2. Packaging concerns (e.g. presence of timber or prohibited packaging material); and
  3. Destination concerns (e.g. destined for a rural unpack location).

 
Import Permit Fee  IPF0003

Import Permit Fees (where applicable) – Category 2

This commodity is classified as a Category 2 assessment for the purposes of determining the Import Permit fee rate that applies. The fee rate is $80.00 (for any assessment period up to 1 hour) and $40.00 for each quarter hour, or part of a quarter hour, after the 1-hour period. Note that in addition to the assessment fee, an electronic lodgement fee of $85.00 or a manual lodgement fee of $150.00 also applies.

An assessable item means an item identified on an Import Permit application as consisting of goods of a class imported, or to be imported, from a particular country for a particular use.

Further information on AQIS fees and charges can be found on the AQIS website. Import Permit issuing fees are specified in the Quarantine Service Fees Determination 2005.
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URL: http://www.aqis.gov.au/icon32/asp/ex_casecontent.asp

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