Import case details - public listing
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Commodity: Veterinary therapeutics and medicines
Scientific name:
Country: All countries
End use: Therapeutic
Date printed: Sep 11 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  C9838

Non-Commercial

The conditions under the Commercial section apply.

Please note: Importers of veterinary products for personal use e.g. pet owners importing non-commercial consignments, should review the conditions under the Commercial section thoroughly.

AQIS will not release goods from quarantine unless the conditions under this section can be met i.e. importer can demonstrate, with appropriate documentation, to the AQIS regional office that a permit is not required; or that a valid import permit is presented with supporting documents to the AQIS regional office which allows the goods to be cleared.

If a permit is required to import the veterinary product importers must be able to source the following information from the product manufacturer:

- list of ingredients in the product;

- the country/species/tissue of origin of any animal origin ingredients; and

- any treatments used that might reduce the risk of bacterial/viral contamination.

Without this information AQIS will not be able to assess the product for import permit.

Condition  C18740

Commercial

1. A Quarantine Entry must be lodged for each consignment.

2. An Import Permit is not required for therapeutics that:
a) are 100% synthetic (i.e. contain no ingredients of animal, plant or microbial origin); or
b) do not contain ingredients of animal, plant or microbial origin other than AQIS approved pharmaceutical excipients as specified in C18741 below.

Note: For consignments containing ganoderma powder, bee pollen powder or slippery elm bark powder refer to the separate ICON cases.

3. It is the importer’s responsibility to provide sufficient documentation to satisfy AQIS that the product in each consignment is as stated.

a) For products that are 100% synthetic a manufacturer’s declaration must be provided confirming that “no ingredients of animal, plant or microbial origin have been used at any stage in manufacture of <<Product name>> or are present in the final product”;

b) For products that do not contain ingredients of animal, plant or microbial origin, other than AQIS approved excipients, the following documentation must be provided:

     i) A manufacturer’s declaration stating that “the only ingredients of animal, plant or microbial origin contained in <<Product name>> are AQIS approved excipients”; and

     ii) A full list of ingredients contained in the product.

Importers unable to provide documentation to satisfy these requirements will need to apply for an import permit. In assessing the application for import permit AQIS will require information as outlined in the AQIS Biolcheck website.

4. An Import Permit is required for all therapeutics that do not comply with the conditions above. The Import Permit must be obtained prior to importation. Permit applications must be sent to AQIS Canberra office for assessment.

Note: Capsules/tablets, etc, may still contain unprocessed plant material and may therefore require an AQIS Import Permit.

5. Any product of animal, plant or microbial origin that is to be used for animal feed, and is not considered a veterinary therapeutic, also requires an AQIS Import Permit.

Condition  C18741

List of pharmaceutical excipients

1. Pharmaceutical excipients are highly processed substances that are components of therapeutic products. The following substance groups are considered pharmaceutical excipients:

Alcohols

Amino acids

Essences

Esters

Fish oil (other than salmon oil)

Refined wool fats e.g. Lanolin

Homeopathics

Pectins

Plant acids

Plant extracts

Vinegars

Plant gums

Plant juices

Plant oils

Plant waxes

Vitamins

Resins

Starches

Water

Sugars

Tinctures

 

 

 

 

* Note: The following ingredients are not considered AQIS approved pharmaceutical excipients for use in veterinary therapeutics as they may contain disease agents that can affect plants and animals:

a) Gelatin, polysorbates and stearates derived from animals
b) Plant flours and powders

An AQIS Import Permit is required for veterinary therapeutics containing these ingredients and for these ingredients that are imported for use in veterinary therapeutic manufacture. An AQIS Import Permit is also required if the ingredients are contained in, or being imported for use in animal feed, animal feed supplement or animal vaccine manufacture.

Condition  C5012 The commodity may be subject to Environment Australia legislation

This commodity or species may be subject to Australian Government Department of the Environment, Water, Heritage and the Arts legislation under CITES. Commodities/species known to be, or considered to be covered by CITES will be referred to the Australian Customs Service (Customs) on arrival to Australia, in addition to satisfying quarantine import conditions.

CITES queries can be directed to the Australian Government Department of the Environment, Water, Heritage and the Arts on the details below:

Phone:        02 6274 1900
Fax:            02 6274 1921
Email:         wildlifetrade@environment.gov.au
Internet:      www.environment.gov.au

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  IPF0006

Import Permit Fees (where applicable) – Category 5

This commodity is classified as a Category 5 assessment for the purposes of determining the Import Permit fee rate that applies. The fee rate is $320.00 (for any assessment period up to 4 hours) and $40.00 for each quarter hour, or part of a quarter hour, after the 4-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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