Importing biological products for use in non-laboratory animals
Laboratory animals, as defined by the department, are guinea pigs, hamsters, mice, rabbits, rodents and micro-organisms, which must be contained under laboratory conditions.
There are two ways that biological goods (e.g. laboratory materials or reagents) can be approved by the department for in vivo use in non-laboratory animals:
Option 1 – Apply for an import permit for in vivo end use
This option is preferable when biological goods have not yet been imported into Australia and there is an immediate need for in vivo use in non-laboratory animals.
Apply for an import permit with the department for in vivo end use in non-laboratory animals. The import permit application will be assessed for compliance with policies and guidelines for this higher risk end use.
Option 2 – Apply for an import permit for in vitro (and in vivo in non-laboratory animals) end use with subsequent application for in vivo approval
This two step option should be considered when there is a need to undertake initial in vitro research that may or may not include research in laboratory animals.
Step 1 Apply for an import permitApply for an import permit with the department. The import permit will restrict the imported product to:
- in vitro/laboratory use only
- in vivo use in laboratory animals only.
Step 2 Lodge an in vivo approval application
A separate application for in vivo approval must be lodged with and approved by the department. Approval for in vivo use must be obtained before non-laboratory research animals are exposed to imported biological goods (or their derivatives). This also applies if goods are to be used in vaccine or veterinary therapeutic manufacture.
Applications for In Vivo Approval must be lodged using the following form:
|Application forms for in vivo approvals (for the use of imported biological material in vivo in non-laboratory animals) DOC||2||240 KB|
If you have difficulty accessing this file, visit web accessibility for assistance.
Completed forms may be emailed to the Imports Services Team.
It should be noted that an In Vivo Approval issued by the department is not an import permit. This means that importers cannot clear goods at the border using an In Vivo Approval. Applicants wanting to import products into Australia for in vivo end use in non-laboratory animals can apply for an import permit:
In vivo approvals – further information
Applications to use biological goods in non-laboratory animals must include:
- the product name and catalogue number
- the name of the supplier and the number of the import permit used to import the product
- a list of all ingredients, including, for ingredients of animal origin, (supported with manufacturer’s declarations) the:
- name and country of origin of all species
- details of any processing or treatments applied prior to importation
- results of any testing for pathogens
- details of any post-entry processing or treatments.
- brief details of the proposed end use of the product(include the species, number of animals, where they will be housed and post-treatment arrangements e.g. euthanasia and disposal of carcasses for trials and experiments in animals).
- the name, address and approval number of the approved arrangement site where the product will be used.
The department uses approved arrangements (AA) to manage the risk associated with importation of many commodities. Conditions on permits can specify that imported biologicals must be contained and/or used only at an AA site. Some institutions (e.g. those regularly using imported biological goods in non-laboratory animals, or those using them to manufacture veterinary medicines have qualified laboratories/manufacturing facilities as AA sites.
AA site applications and enquiries should be directed to an AA site officer in your local office.
Applications to amend in vivo approvals
Submit an application to amend an in vivo approval to the department if circumstances surrounding the end use change and you can no longer comply with conditions outlined on the in vivo approval.
|Application to amend an in vivo approval document PDF||2||224 KB|
|Application to amend an in vivo approval document DOCX||2||128 KB|
If you have difficulty accessing these files, visit web accessibility for assistance.