Frequently Asked Questions about Biological Products

Import Procedure:
Permit application process:
Other:

Do you have another question about importing biological products? Contact Biologicals Program for assistance.

Answers:

Import Procedure:
  • How do I know if I need an Import Permit?

    Check AQIS's Import Conditions Database (ICON). This database lists the Quarantine conditions under which various commodities may be imported into Australia. If an AQIS Import Permit is required, or if any other specific conditions apply, ICON will specify this. The information available on ICON is the same information that AQIS's clearing officers use when inspecting and clearing goods arriving into the country. It is therefore essential that importers refer to this database regularly to keep up to date with any policy changes by AQIS.

  • What do I do with my Import Permit when I get it?

    When you receive your Import Permit, please read it carefully to ensure you understand all the conditions. The Import Permit is generally valid for two years and may be used any number of times during this period. The Import Permit will dictate conditions under which the product may enter Australia. It is important that the importer reads these conditions before importing. To arrange AQIS clearance of imported goods, the Import Permit (or a means of identifying such as the Import Permit number) and all associated documentation must be presented to the AQIS regional office in the state/territory of entry.

  • Can you give my Import Permit application priority?

    The Biologicals Program receives literally hundreds of requests each day by post, fax, phone and email. An 'urgent' request will only be considered if there is a medical emergency or where the importer has a valid Import Permit on which the Biologicals Program has made an error. It is not fair to disadvantage importers who have lodged their applications on time. In instances where an importer is having trouble meeting a condition, the importer should either:

    1. request (permanent) amendment to their Import Permit; or
    2. request special dispensation. In this case the Import Permit will not be amended and all future consignments being imported under that Permit must meet all conditions.

    In both instances the requests will be processed within 10 working days as per our service charter. Importers/exporters should ensure that all paperwork is in order before the product leaves the exporting country.

  • What is a Quarantine Entry?

    A Quarantine Entry (QE) is an electronic document created to record information regarding the clearance and movement of goods under quarantine control. Under the Quarantine Act 1908, importers are required to notify AQIS of the proposed importation. A Quarantine Entry, raised on the AQIS Information Management System (AIMS), is one method that is used to give notice of an import. Other methods include completing a passenger declaration card or completing a parcel declaration for international mail. For consignments imported via sea and airfreight, QEs are automatically generated via the ACS COMPILE system during the Customs entry process. If a consignment is flagged subject to quarantine (via profiling), the COMPILE system will generate an AIMS entry. In some cases, a commodity may not have been profiled as “subject to quarantine” and a manual AIMS entry can be generated. The decision to raise a QE is based on the way the commodity is imported and the operational program responsible for clearing the consignment through quarantine. For example, a QE is generally not raised for non-commercial consignments imported through the mail, however a QE is raised for non-commercial consignments imported via air express carriers (e.g. Fed-Ex, DHL). If you require further information about Quarantine Entries, costs or logistics contact your local AQIS office.

  • AQIS is not releasing my goods. Why not?

    If AQIS has not released your goods, it could be for several reasons. It may be that an Import Permit and/or other documentation is required, or the product may be required to undergo post-entry treatment. If in doubt, check ICON for current import conditions. Even if an Import Permit is not required, there may still be conditions required for importation.

    If you are still not sure why your goods are being held, contact your local AQIS Office. When you do so, please have available a reference number for your consignment (e.g. Quarantine Entry number, seizure notice). If your goods are handled by a freight clearance agent or air courier (e.g. FedEx, TNT, UPS, etc.), you should ask them to provide you with the quarantine direction, or specific ICON condition that applies to your goods. Please note that AQIS will authorise the release of your goods as soon as documentation and/or goods are presented for inspection. Any subsequent delays would be due to the logistics of transport, rather than extended AQIS detention.

  • Does my product need to be kept at a Quarantine Approved Premises?

    Quarantine Approved Premises (QAPs) are registered for the storage, use or further processing of high-risk products that are subject to quarantine. Examples of biological products that may require QAP containment include: highly pathogenic/exotic microorganisms; samples for laboratory analysis (food, water, soil, etc); agricultural products requiring further processing. Your Import Permit will specify if your product needs to be held at a QAP, and the class of the QAP required.

  • How do I transfer material between QAPs?

    Goods subject to continued quarantine must be contained at a QAP unless prior written approval is obtained from AQIS. For transfer of biological products between QAPs, an Application for Transfer of Quarantine Material must be submitted to the Biologicals Program.

  • Why aren't XYZ listed on my Import Permit?

    If a product listed on an application does not actually require an Import Permit (as specified on ICON), this product will not be listed on an Import Permit. It is important to note that ICON conditions still apply. If you have received an Import Permit that appears to be missing some commodities, first check ICON to see if a permit is actually required. If you still believe that the commodity should be listed, or you are unable to meet the ICON conditions, contact the AQIS office that has issued your Import Permit.

  • Can someone else take my Import Permit to clear the product?

    An Import Permit is the financial and legal responsibility of the importer. It can not be borrowed, hired, lent, or given to another party. The documentation on imported goods (importer details, exporter details) must correspond exactly to those listed on the permit. If in doubt, contact AQIS in advance to ensure trouble free clearance of your goods.

  • What does it cost to have my goods inspected/tested?

    There are a number of different types of inspection, testing and treatments that AQIS uses to mitigate potential quarantine risk. A general guide to the costs involved is available from the fees and charges section of the AQIS website. If you are still having difficulty working out the costs, please contact your local AQIS Office.

  • Where and how do I get these government veterinary certifications?

    Government Veterinary Certification is issued by the government of the exporting country. In order to obtain this certification, you will need to contact the relevant government authority in that country. The local embassy or consulate of your exporting country will be able to provide you with further details of their export authorities

  • What if I'm just bringing samples or small quantities for my company/buyers to try? Do I still need certification for these?

    Unless you are able to satisfy the 'non-commercial' import requirements as specified on ICON, commercial samples are treated in the same manner as commercial quantities. This means that they will be subject to the 'commercial' conditions as specified on ICON. If in doubt, please check with your local AQIS office prior to importation.

Import Permit Application Process:

  • I've got the application form but I don't know how to fill it out! Can you help?

    Please refer to the Checklist for importing biological materials and How to fill in your permit application form.

  • Where do I send my application?

    Many Import Permits can be issued by the AQIS Regional Offices, however some applications must be submitted to the Canberra Office. AQIS's Import Conditions Database (ICON) will usually specify where your permit application can be lodged. If in doubt, please contact your local AQIS office.

  • How long does it take to receive my Import Permit after submitting an application?

    Most Import Permits will be issued in less than 10 working days once payment and all necessary information has been received. Many commodities will take considerably less time than this.

  • How much does it cost for an Import Permit?

    There are two components that make up the permit cost: an application/administrative fee, and an assessment fee. The administrative fee is standard across all commodities. The assessment fee covers the costs associated with the assessment of individual commodities, and varies according to the type and number of products on the application form.

  • When do I need to pay for my Import Permit?

    Payment should accompany your application form. Your application will not be processed until full payment has been received.

  • How can I pay for my Import Permit?

    You can pay by mailing a cheque/money order or by faxing a completed credit card payment form to the Biologicals Program.

  • How can I get a receipt for my payment?

    AQIS will issue a letter of acknowledgement that we have received your application. This will be sent to the fax/email details listed on your application form. This letter includes the ABN and is to be used as an official tax receipt. The Biologicals Program can also send out a receipt to an alternative contact person, if specifically requested on your application form.

  • How do I amend a current Import Permit to add extra commodities or change importer/exporter details?

    The importer will need to send a request in writing to amend the Import Permit. The request should refer to the Import Permit number and clearly describe the amendment required. Please note that an amended permit will have the same expiry date as the original.

    For the fees associated with an Import Permit amendment, importers should contact the Biologicals Program.

  • How do I renew an expired (or soon to expire) Import Permit?

    Prior to issuing a new Import Permit, the Biologicals Program must undertake a new assessment of the quarantine risks associated with the products. This means that a new application form must be submitted to the Biologicals Program. The new application form should state that the application is a renewal of a previous Import Permit and should provide reference to the old Import Permit number. However all relevant product information (ingredients, manufacturing processes, etc.) must accompany the application. Please remember to allow at least 10 working days (2 weeks) when submitting your application to ensure that the new Import Permit is ready before the old one expires.

  • How do I know if more than one application is required for the products I want (eg. high risk products from different exporters, or different types of commodities/end uses on the same application)?

    Please refer to 'How to fill in your permit application form' and the 'Checklist for importing biological materials'. If in doubt, it is preferable for the products to be listed on separate application forms.

  • Can I put other products on my application that are not listed on the biologicals website (e.g. plant products, timber)?

    No. Other commodities must be listed on a separate application form, as they are assessed by other sections of AQIS, and a separate Import Permit will be issued for them.

  • Can I have an Import Permit with more than one exporter?

    An Import Permit can often be issued listing more than one exporter, however this is dependent on the type of commodity. When submitting your permit application please request ‘various exporters’ or list them on a separate attachment.

  • If my application is rejected, can I get my money back?

    Under the existing fee schedule, Import Permit applications have two associated charges: an application (or administrative) fee and an assessment fee. The administrative fee covers the costs associated with logging the application into a database, ensuring correct payment is received, typing, faxing and mailing the Import Permit. The assessment fee covers the costs associated with the assessment. The following rules apply to refunds that can be issued by the Biologicals Program:

    i) If an application is received, logged into our database and payment processed (but has not yet been assessed), only the assessment fee can be refunded. The application fee will not be refunded.
    ii) If the application has been assessed (more information requested, application rejected etc), no money will be refunded.

  • How do I arrange a refund/credit for excess payment?

    A letter of credit will be faxed or emailed if the application has excess funds (when paid by cheque or money order only). This credit can then be used for any future fee charged by the Biologicals Program. On credit card payments, only the lesser amount will be deducted. Refunds will only be issued in exceptional circumstances, when a written request is submitted to the Biologicals Program. A request for refund must refer to the application number or Import Permit number, and clearly explain why a refund is necessary.

  • Do I have to answer the genetically manipulated material question? How?

    This question only needs to be addressed if the product is for in vivo or environmental end use. If the product is genetically manipulated, the manufacturer or supplier will be able to provide you with the necessary details.

Other:
  • What is a Quarantine Approved Premises?

    A Quarantine Approved Premises (QAP) is a specific facility approved by AQIS to receive quarantine goods of a high risk nature. This type of premise must be audited by AQIS staff on a regular basis, as part of a comprehensive risk management process. Further information regarding QAPs, including how to apply for registration, is available from the QAP information section of the AQIS website, or your local AQIS office.

  • Who do I contact regarding Australian food safety requirements?

    The Imported Food Inspection Scheme (IFIS) within AQIS monitors imported food safety. If you have any queries regarding food safety issues please contact IFIS.

    Importers and brokers should be aware that all imported food must comply with the requirements of the Imported Food Control Act 1992, as well as Australia's quarantine laws (Quarantine Act 1908). The applicable standards for food under the Imported Food Control Act 1992 are those set down in the Australian Food Standards Code (FSC), and these same standards apply to foods manufactured in Australia. The FSC is administered by Food Standards Australia New Zealand (FSANZ) and they publish the code on the Internet at the following address http://www.foodstandards.gov.au. It is the importer's responsibility to ensure that all imported food complies with the Food Standards Code

  • How do I register with AQIS as a salmon processing establishment?

    Companies wishing to process imported salmon must be registered with AQIS if they receive imported salmon trunks (head off, gilled and gutted) or process for retail sale imported salmonid product in amounts less than 300kg/day. Note: Processing premises that have entered into a compliance agreement arrangement with AQIS and permit holders for the importation of salmon are automatically registered to receive imported salmon. Registration forms for salmon processing facilities should be submitted to the QAP officers at your local AQIS office.

    Registration forms for salmon processing facilities PDF icon PDF [42kb]
    Registration forms for salmon processing facilities MS Word icon Word [85kb]

  • Who is the Competent Authority for seafood export certification?

    The Competent Authorities for seafood export certification for various countries are listed on several ICON cases. For example refer to the ICON case for "finfish" for the specific details of your exporting country.

  • How do I arrange an AQIS audit/inspection of overseas manufacturing facilities?

    Audits and inspections of overseas facilities can only be conducted once the facility has satisfied a Quality Assurance assessment conducted by the Canberra Office. All costs associated with AQIS audit and inspection are borne by the importer. For full details, contact Biologicals Program.

  • Where can I find information regarding emigrating/moving to Australia?

    If you are moving to Australia and importing many different types of goods, it is important that you understand all of AQIS's import requirements. A professional clearance agent or broker may be able to provide assistance for large amounts of goods. Also refer to ICON for details on specific products. Further information is also available from our webpage: Emigrating/Moving to Australia.

  • I think the inspection is wrong—what can I do?

    If you disagree with the results of an AQIS inspection of your goods, you will first need to contact your local AQIS office that conducted the inspection. You may be able to arrange further inspection, or treatment of your goods to address quarantine concerns. If you are unable to reach an agreement, your local AQIS office can contact the Biologicals Program to discuss alternative arrangements. The Biologicals Program will only consider exceptional circumstances, and will not over-rule the decision of your local AQIS office.

Last reviewed:
30 Jun 2010
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