Regulation & Licensing

Medical Import Permit Details

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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) must be made to ARPANSA on the appropriated form.

Download Form ARPANSA20:

Single Shipment Permits

The importer may seek approval from ARPANSA for the importation of sealed and unsealed radiation sources used in medical applications.

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 twelve 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/territory licence (approval) and also, at twelve monthly intervals, the importing company must provide to ARPANSA a list of all recipients of the imported materials and the quantities supplied (distribution list). 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.

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.

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 ionising 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/biological laboratories are also included as medical radioisotopes for permit application purposes.

Import Approval Criteria

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

  • it is recommended that the Form ARPANSA20 be completed by the applicant/'end user' before the order is placed with the supplier
  • the onus is on the applicant/'end user' to ensure that the permits are emailed or posted to ARPANSA in time to allow for processing and approval before the goods arrive at customs
  • in the case of sealed radioactive sources used for therapy or calibration (for medical purposes only), five working days should be allowed for processing of the permit.

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 with Therapeutic Goods Administration (TGA) on the Australian Register of Therapeutic Goods (ARTG).
  • The product is a sealed 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). For Category B or C, TGA SAS number (documentation provided by TGA) is required prior the import permit application.
  • 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 check 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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Completing the ARPANSA20 form

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

Single Shipment Permits
  • the supplier's and applicant's name, address, telephone and email address, and the applicant's licence number and the state of 'port of entry'
  • if the applicant is NOT the 'end user' please check the box and provide an additional page with the following information:
    • the 'end user's' name
    • practice address, telephone number, email address (optional)
    • practice licence number
  • 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 check the appropriate box
  • brief statement of the intended use of the radioisotopes
  • the form must be signed by the applicant or the 'end user'
  • if the applicant is not the 'end user', an additional page for each 'end user' must be provided listing:
    • the product code (if applicable)
    • product description
    • quantity (how many)
    • activity (MBq)
    • total activity (MBq) of shipment
    • radioisotope and license no.

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

Twelve Monthly Permits
  • the applicant's name, address, telephone number, email address and the applicant's licence number and the state of 'port of entry'
  • product code (if applicable), product description, quantity (no limit) and total activity(MBq) of shipment, and the ARTG number of the radioactive products.

When completing the Form ARPANSA20, please note:

  • Applications for the renewal of 12 monthly permits should be made at least one month before the expiry of the current permit.
  • A break-up of the data by state/territory of all recipients of the imported materials and the quantities supplied (distribution list) is to be provided to ARPANSA on a yearly basis prior to renewal.
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Processing of the ARPANSA20 Form

Download Form ARPANSA20 required for the application for Customs Prohibited Import Release for Medical Radioisotopes.

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

  • A completed copy of the Form ARPANSA20 must be submitted by email or post:

    medicalpermits@arpansa.gov.au

    or

    the Australian Radiation Protection and Nuclear Safety Agency
    619 Lower Plenty Rd
    Yallambie VIC 3085

  • If the application is for a sealed radiation/therapy source, a copy of your application will be emailed to the appropriate state/territory regulator. Five working days are allowed for the state/territory regulators to raise an objection to the issue of the permit on the basis of insufficient authorisation to deal with the radioactive source.
  • Except for applications for sealed radiation/therapy sources, a copy of the approved permit will be emailed to the Australian Customs office in the state of 'port of entry' and an 'Information only' copy of the approved permit will be emailed to the nominated email address of the applicant and/or customs agent.
  • All permits to import sealed radiation/therapy sources will be processed as above in five working days providing the state/territory regulator has advised ARPANSA that there is no objection to the issue of the permit.
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Charges (FEES) for Permits

See Import and Export Permit Applications for the current fee sturcture for import permit applications.

Payment Methods and Enquiries has information about how to pay fees.

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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  • Phone Number(02) 9541 8333
  • Fax Number(02) 9541 8348
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