Radioactive sources
- Document symbol
- G/LIC/N/3/NOR/10
- Original language
- English
- Published on
- 27/04/2021
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 Norwegian Radiation and Nuclear Safety Authority is the competent authority for radioactive sources. The Norwegian Regulations on Radiation Protection and Use of Radiation give exemption levels for different radioactive isotopes. To import radioactive sources (including radiopharmaceuticals) with activities above these exemption levels you need an authorization; either by licensing or registration. Authorization by registration is a simplified authorization which involves registering the source in an electronic national source registry before import. Authorization by licensing involves an application process with review and assessment of relevant information. The license has an expiry date.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
A license is required either based on the area of use of the radioactive source or based on how strong the source is. Examples of areas of use which require license are industrial radiography, logging operations, comprehensive research, administration of radiopharmaceuticals in humans and radiotherapy on humans. A license is required for all importers of strong radioactive sources, i.e. with activities greater than 2x106 of the exemption levels, and all radiopharmaceuticals above exemption level.
Q3. The system applies to goods originating in and coming from which countries?
The system has a global application.
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 objective of the licensing system is to prevent harmful and potentially dangerous use of radioactive sources and to ensure the safe handling of disused radioactive sources. The overall purpose is to ensure the proper use of radiation, prevent harmful effects of radiation on human health and contribute to the protection of the environment.
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?
Is the licensing statutorily required?
The authorization system is mandated in the Norwegian Act on Radiation Protection section 6, and further elaborated in the Norwegian Regulations on Radiation Protection sections 9 (license) and 13 (registration).
Act on Radiation Protection and Use of Radiation (No. 36 of 12 May 2000):
In Norwegian: https://lovdata.no/dokument/NL/lov/2000-05-12-36?q=str%C3%A5levern; and
In English: https://dsa.no/en/legislation.
Regulations on Radiation Protection and Use of Radiation (No. 1659 of 16 December 2016):
In Norwegian: https://lovdata.no/dokument/SF/forskrift/2016-12-16-1659?q=str%C3%A5levern;
In English: https://dsa.no/en/legislation.The authorization system is thus statutorily required
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
The designation of products to be subjected to authorization is not left to administrative discretion.
Is it possible for the government to abolish the system without legislative approval?
It is possible for the government to abolish the system 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)?
The processing time for an application is three weeks. For urgent matters, a license can be obtained within a shorter time-limit.
Q7.b. Can a licence be granted immediately on request?
Import applications must be written. The application will be handled without unnecessary delay.
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.
Applications for licenses are not limited to any particular time of 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?
The Norwegian Radiation and Nuclear Safety Authority issues the license.
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?
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
A license can be refused if the applicant fails to demonstrate that the source will be used in a justified, optimized and safe manner.
Are the reasons for any refusal given to applicants?
Reasons for any refusal are given to the applicant in the decision.
Have applicants a right of appeal in the event of refusal to issue a licence? If so, to what bodies and under what procedures?
The decision of the Norwegian Radiation and Nuclear Safety Authority may be appealed to the Ministry of Health and Care Services.
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 an import licence.
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?
The applicant must document that the planned use of radiation is justified and optimized. What information that is required is dependent on the area of use of the source. We do not have English translations of the application forms. In any case the company name, organization number and address must be submitted, and the applicant must provide information on their competence, instructions, procedures, safety and security assessments, safety equipment, source registry, emergency preparedness plan and system for management of disused sources.
In the license, the Norwegian Radiation and Nuclear Safety Authority may set further conditions to assure justified use of radiation and prevent against harmful effects of radiation on human health. This may include further conditions for the radiation use, registration, reporting, competence, training, security, use of measuring equipment, maintenance routines, quality control of apparatus and equipment for radiation use, return schemes, financial guarantees, import, export, emergency preparedness and design of premises.
The Norwegian Radiation and Nuclear Safety Authority may cancel, change or set new conditions in an authorization, and if necessary, withdraw an authorization if:
(a) the disadvantage of the radiation use proves to be significantly greater or different from what was expected when the authorization was granted;
(b) the disadvantage of the radiation use can be reduced without unreasonable costs for the undertaking;
(c) the radiation use can be significantly reduced or substituted; cf. Section 23;
(d) conditions set, or orders made pursuant to the Radiation Protection Act are materially or repeatedly ignored; or
(e) it follows from an authorization issued under Sections 9 or 10 or the Public Administration Act Section 35.
Q11. What documents are required upon actual importation?
At the actual time of importation, the documentation of the registration and/or license should be presented to customs.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There are no charged levies or other licensing fees.
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.
No deposit or advance payment is required for licensing.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The license is usually valid for a period of one to ten years, depending on the activity of the source and the area of use. The license can be extended/renewed by application.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty on licenses which have not been used or on licenses which have only been used partially.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licenses cannot be transferred between importers.
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?
There are no other conditions attached to the issuing of licences except the above-mentioned under question 24.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
An authorization is required, not only for importing radioactive sources, but also for using the sources.
For the import and sale of radiopharmaceuticals, wholesale traders need a permission from the Norwegian Medicines Agency.