Radioactive substances

Member: 

Basic information

1

Outline of the system

The importation of radioactive substances and goods containing radioactive substances is prohibited under the provisions of the Customs Act 1901 and Customs (Prohibited Imports) Regulations 1956 (PI Regulations) unless the permission in writing is granted by the Australian Minister for Health, the CEO of the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) appointed in writing by the Minister, or an Australian Public Service employee assisting the CEO appointed in writing by the Minister as an authorised officer, and presented to the Australian Border Force at the time of importation. In order for a permit to be considered, the entity taking possession of the sources, including the recipient/s, must hold a valid and current radiation licence to possess, sell or store radioactive substance, where required. The Radiation Licence is obtained from the relevant Commonwealth, state or territory radiation regulatory control authority where required.

2

Product coverage

The goods covered include any radioactive material or substance including radium, any radioactive isotope or any article containing any radioactive material or substance.

Nature of licensing

Automatic

3

If Automatic, administrative purpose

Non-Automatic

4

If Non-Automatic, description of the notified Non-Automatic Licensing regime

5

Products under restriction as to the quantity or value of imports

The importation of radioactive substances is regulated as a community protection measure and to comply with Australia's international obligations under the Basel Convention on the Control of trans-boundary Movements of Hazardous Wastes. The PI Regulations are not intended to restrict the quantity or volume of imports.

6

Questions for products under restriction as to the quantity or value of imports

Not applicable.

7

The system applies to products originating from which country?

The PI regulations apply to the importation of radioactive substances from all countries.

8

Expected duration of licensing procedure

Eligibility of applicants

12

Is there a system of registration of persons or firms permitted to engage in importation?

13

What persons or firms are eligible to apply for a licence?

All persons, firms and institutions are eligible to apply for permission to import.

14

Is there a registration fee?

15

Is there a published list of authorized importers?

Contact point for information on eligibility

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Ministry/Authority

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Address

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Telephone

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Fax

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E-mail address

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Website

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Contact officer

Submission of an application

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Administrative body(ies) for submission of an application

Documentation requirements

24

What information is required in applications?

For permission to import, applications must be made in writing to ARPANSA on the appropriate form available on the ARPANSA website: https://www.arpansa.gov.au/.

25

What documents is the importer required to supply with the application?

The application should include the following information on the permit application form:

• Applicant's name and address;
• end users name and address;
• storage premises details;
• details of the radioactive substance;
• details of the goods to be imported; and
• details of the Radioactive Substance Licence.

Application forms are available on the ARPANSA Website (https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-exp...).

Window of submission of an application

26

How far in advance of importation must application for a licence be made?

Application should be made in advance of the arrival of the goods.

27

Are there any limitations as to the period of the year during which application for licence can be made? If so, explain

Permits may be issued at any period of the year.

Issuing the license

28

Can a licence be granted immediately on request?

Permits to import are granted when it is established that the recipient/s taking possession of the radioactive substances have obtained the required radiation Licence, where required, from the relevant Commonwealth, State or Territory radiation control authority. For the import of radioactive substances, the relevant Commonwealth, State or Territory radiation control authority is advised of the application for permission to import.

29

Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence

30

Which administrative body is responsible for approving application of licences?

A permit is issued by the Minister for Health, the CEO of ARPANSA or an Australian Public Service employee assisting the CEO appointed in writing by the Minister as an authorised officer. Applications to import radioactive materials or articles containing radioactive materials must be made to ARPANSA on Form ARPANSA 20, "Application for Customs Prohibited Import Release for Medical Radioisotopes", or on ARPANSA-FORM-1704, "Application for Permission to Import Non-Medical Radioactive Substances" or on ARPANSA-FORM-1705, "Application for permission to import non-medical radioactive substances - Twelve month permit". These forms, and instructions for completing the forms, are available on the ARPANSA website (https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-exp...).

31

Must the applications be passed on to other organs for visa, note or approval?

Before submitting an application for permission to import, the recipient/s taking possession of the radioactive substance must hold a valid Radioactive Substances Licence, where required, from the relevant Commonwealth, State or Territory radiation control authority. The licence number and licence details must be stated on the application form.

32

Are there any other conditions attached to the issue of a licence?

Permission granted under Regulation 4R of the PI Regulations may specify conditions or requirements to be complied with by the holder of the permission.

All forms and requirements for import of radioactive substances can be found on the ARPANSA website at https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-exp...

Fees and other administrative charges

33

Is there any licensing fee or administrative charge?

ARPANSA has an administrative charge for the granting of a single shipment permit, and for the granting of a Twelve-Month Permit as per the charge fee structure on the ARPANSA website: https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-exp....

34

What is the amount of the fee or charge?

ARPANSA has an administrative charge for the granting of a single shipment permit, and for the granting of a Twelve-Month Permit as per the charge fee structure on the ARPANSA website: https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-exp....

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Is there any deposit or advance payment required associated with the issue of licences?

There is no deposit or advance payment requirement associated with the issue of permits.

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Amount or rate?

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Is it refundable?

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What is the period of retention?

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What is the purpose of this requirement?

Refusal of an application

40

Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?

Application for permission to import can be refused on the discretion of the Minister for Health

41

Are the reasons for any refusal given to applicants?

42

Have applicants a right of appeal in the event of refusal to issue a licence?

There is no right of appeal against the Minister's decision. However, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.

43

If so, to what bodies and under what procedures?

There is no right of appeal against the Minister's decision. However, an appeal may be made on the decision-making process itself under the Administrative Decisions (Judicial Review) Act 1977.

Importation

44

Are there any limitations as to the period of year during which importation may be made?

45

What documents are required upon actual importation?

The written permission from the Minister of Health, or an authorised officer, an approved signed import permit, is required to be produced on import.

46

Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?

No.

Conditions of licensing

47

What is the period of validity of a licence? Can the validity be extended? How?

Permits for the importation of medical or non-medical radioisotopes may apply to one consignment only, or may apply for a number of importations for a specified twelve-month period (Twelve Month Permit). Twelve-Month Permits are issued for the importation of radiopharmaceutical drugs registered on the Australian Register for Therapeutic Goods (ARTG) and for low hazard radioactive materials. The holder of a 12 Month Permit is required to confirm that the distributor requesting the product(s) holds an appropriate radiation licence or is exempt from radiation licensing. A single shipment permit is valid for six months.

48

Is there any penalty for the non-utilization of a licence or a portion of a licence?

There is no penalty for the non-utilisation of a permit or a portion of a permit.

49

Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?

Permits are not transferable between importers or permit applicants.

Foreign Exchange

50

Is foreign exchange automatically provided by the banking authorities for goods to be imported?

Not applicable.

51

Is a licence required as a condition to obtaining foreign exchange?

Not applicable.

52

Is foreign exchange always available to cover licences issued?

Not applicable.

53

What formalities must be fulfilled for obtaining the foreign exchange?

Not applicable.