Radioactive substances
- Document symbol
- G/LIC/N/3/AUS/16
- Original language
- English
- Published on
- 27/11/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
The importation of radioactive substances and goods containing radioactive substances is prohibited under the provisions of the Customs Act 1901 (Customs Act) 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 that permission is presented to the Australian Border Force (ABF) 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.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The goods covered include any radioactive material or substance including radium, any radioactive isotope or any article containing any radioactive material or substance.
Q3. The system applies to goods originating in and coming from which countries?
The PI regulations apply to the importation of radioactive substances from all countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
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.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The control on importation of the specified goods is a statutory requirement under Regulation 4R of the PI Regulations made under the Customs Act. The system cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
Application should be made in advance of the arrival of the goods.
Q7.b. 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.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Permits may be issued at any period of the year.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
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. Application forms, and instructions for completing the forms, are available on the ARPANSA website (https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-export-permits).
Before submitting an application for permission to import, the recipient/s taking possession of the radioactive substance must hold a valid radiation 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.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
Application for permission to import can be refused on the discretion of the Minister for Health. 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.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
All persons, firms and institutions are eligible to apply for permission to import.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
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/. 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 radiation licence.
Application forms are available on the ARPANSA Website (https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-export-permits).
Q11. What documents are required upon actual importation?
The written permission from the Minister for Health, or an authorised officer, an approved signed import permit, is required to be produced on import.
Q12. Is there any licensing fee or administrative charge? If so, 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-export-permits.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
There is no deposit or advance payment requirement associated with the issue of permits.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence 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 Twelve-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.
Q15. 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.
Q16. 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.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
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-export-permits.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No.