ARPANSA - Australian Radiation Protection and Nuclear Safety Agency

This Page:

• Single Shipment Permits
• Twelve Monthly Permits
• Definition of a Medical Radioisotope
• Import Approval Criteria
• Filling out the ARPANSA20 form
• Processing of the ARPANSA20 Form
• Charges for Permits
• Forms
• Contact

Under the Customs (Prohibited Imports) Regulations, a permit from the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is required for the import of radioactive material. Application for the import of radioisotopes for medical use (see definition below)must be made to ARPANSA on the appropriated form.

Single Shipment Permits

The importer may seek approval from ARPANSA for the importation of unsealed radioisotopes or sealed radiation/therapy sources as single shipment permits.

Twelve Monthly Permits

The following procedure may be available for Australian Register of Therapeutic Goods (ARTG) registered radiopharmaceuticals and for most radiochemicals and radioimmunoassay kits. Under this procedure, the importer may seek approval from ARPANSA for the importation of quantities of these agents for a maximum of 12 months. As a condition of this approval, the importing company is required to confirm, prior to supply, that the person(s) requesting the product(s) holds an appropriate State licence and also, at regular intervals, the importing company must provide to ARPANSA a list of all recipients of the imported materials and the quantities supplied. As ARPANSA provides a copy of this list to the appropriate State/Territory authorities, a break up of the data by State/Territory should be provided. Applications for the renewal of 12-monthly permits should be made at least one month before the expiry of the current permit.

Definition of a Medical Radioisotope

A radioisotope is considered to be for medical use when it is intended to be:

• administered to humans or used for any therapeutic procedure or purpose in any planned exposure of humans to ionizing radiation;
• used in any in vitro medical diagnosis or test;
• used in research which is either directly or indirectly related towards medical diagnosis or therapy in humans.

Please note that sealed and unsealed radioactive sources that are used to calibrate instruments in medical practices and pathology laboratories are also included as medical radioisotopes for permit applications.

Import Approval Criteria

Import approval is normally given provided that one of the following conditions is satisfied:

• The product is either for in vitro diagnostic use, or for use in experimental work not involving administration to humans.
• The product is registered on the Australian Register of Therapeutic Goods (ARTG).
• The product is a radiation therapy source.

For non ARTG registered products, that are to be administered to humans, the radiopharmaceutical conforms to one of the following:-

• Approval has been granted under Category A, B, or C of the Special Access Scheme (SAS).
• The medicine has approval under Section 19 of the Therapeutic Goods Act (TGA) and 12(B)(1) of the Regulations. or
• It has approval under the TGA, Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) Schemes for experimental use of pharmaceuticals in humans.

These Categories are listed in abbreviated form on the ARPANSA20 form. The applicant should tick the appropriate box on the form. Information regarding these Categories may be obtained from:

The information Officer
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Phone: 1800 020 653
Fax: (02) 6232 8112
Email: tga-information-officer@arpansa.gov.au

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Filling out the ARPANSA20 form

In order to obtain import approval for medical radioisotopes, the following information should be provided on the Form ARPANSA20.

Single Shipment Permits

• the Supplier's and Applicant's name, address, telephone and fax number, and the Applicant's Licence number;
• the identity , quantity and activity , including the Australian Register of Therapeutic Goods (ARTG) number (if registered), of the radioactive product;
• whether or not the product is to be administered to humans, if YES please tick the appropriate box;
• brief statement of the intended use of the radioisotopes;
• declaration by the Applicant that he/she holds an appropriate licence.
• the form must be signed by the Applicant

Single shipment permits are valid for 12 months from the date of approval.

After receipt of the import application at ARPANSA, the original will be signed and returned to the address nominated on the form (indicate in the appropriate box where the application is to be returned).

Twelve Monthly Permits

• the Applicant's name, address, telephone and fax number, and the Licence number;
• the identity, quantity and activity, including, if applicable, the ARTG number, of the radioactive products;

In completing the Form ARPANSA20, please note that:

• All questions must be answered.
• Applications for the renewal of 12-monthly permits should be made at least one month before the expiry of the current permit.

Please note, that, in order to avoid delays in the customs release process:-

• It is recommended that the Form ARPANSA20 be completed by the Applicant before the order is placed with the supplier.
• In the case of radioactive sources used for therapy or calibration (for medical purposes only), five working days should be allowed for processing of the permit.

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Processing of the ARPANSA20 Form

Copies of the Form ARPANSA20 required for the Application for Customs Prohibited Import Release for Medical Radioisotopes are provided below.

The procedure for the processing of the Form ARPANSA20 is as follows:

• A completed copy of the Form ARPANSA20 must be submitted by mail to the Australian Radiation Protection and Nuclear Safety Agency. All questions on the form must be answered.
• If the application is for a sealed radiation/therapy source, a copy of your application will be faxed to the appropriate State/Territory radiation control authority. Five working days are allowed for the State/Territory radiation control authority to raise an objection to the issue of the permit.
• Except for applications for sealed radiation/therapy sources, the approved permit will be mailed to the nominated address within two working days of receipt at ARPANSA
• Permits to import sealed radiation/therapy sources will be mailed as soon as the State/Territory radiation control authority has advised ARPANSA that there is no objection to the issue of the permit, or after five working days from the receipt of the application.
• NB:In general, all applications should be submitted to ARPANSA by mail.
• Please note, that the onus is on the applicant to ensure that the Permits are mailed to ARPANSA in time to allow for processing and approval before the goods arrive at customs. The Collector of Customs requires the original Permit, and as such faxed copies are unacceptable.

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Charges for Permits

The Payment of Invoices web page has information about how to pay fees.

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) makes a charge for the issue and processing of Application for Customs Prohibited Import Release for Medical Radioisotopes (FORM ARPANSA20).

The following conditions apply:

• No permit will be processed unless accompanied by a cheque for the required amount in full.
• Cheques are to be made payable to the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA).
• Charges are GST exempt

Single Shipment Permit: $130.00

Please note that permits for radioactive sources used for therapy or calibration will normally require 5 working days before issue, subject to notification to the relevant State Radiation Officer.

Where a genuine emergency exists that requires an urgent direct request to Customs for a permit to release, the charge will be: $215.00

The charge for a twelve monthly permit is: $1,500.00

Each twelve monthly permit is limited to a maximum of twelve (12) products. If less than twelve single shipments are anticipated in a twelve month period, the applicant may chose to apply for a single shipment permit for each shipment.

Forms

To apply print and complete one of these manual forms by hand -

Medical single shipment application form (PDF 259kb).

Medical 12 month permit application form (PDF 120kb).

OR

Complete one of these interactive forms on your computer then print -

Medical single shipment (interactive) application form (PDF 202kb).

Medical 12 month permit (interactive) application form (PDF 253kb).

Contact

Import Permits Officer
ARPANSA
619 Lower Plenty Road
Yallambie VIC 3085
Phone: 61 3 9433 2232
Fax: 61 3 9433 2210

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