Basic information
Outline of the 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.
Product coverage
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.
Nature of licensing
Automatic
If Automatic, administrative purpose
Non-Automatic
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
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.
Questions for products under restriction as to the quantity or value of imports
The system applies to products originating from which country?
The system has a global application.
Expected duration of licensing procedure
Legal requirements
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.
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
What persons or firms are eligible to apply for a licence?
All persons, firms and institutions are eligible to apply for an import licence.
Is there a registration fee?
Is there a published list of authorized importers?
Contact point for information on eligibility
Ministry/Authority
Address
Telephone
Fax
E-mail address
Website
Contact officer
Submission of an application
Administrative body(ies) for submission of an application
Documentation requirements
What information is required in applications?
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.
What documents is the importer required to supply with the application?
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Applications for licenses are not limited to any particular time of year.
Issuing the license
Can a licence be granted immediately on request?
Import applications must be written. The application will be handled without unnecessary
delay.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
The processing time for an application is three weeks. For urgent matters, a license can be obtained within a shorter time-limit.
Which administrative body is responsible for approving application of licences?
The Norwegian Radiation and Nuclear Safety Authority issues the license.
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
There are no other conditions attached to the issuing of licences except the above-mentioned under question 24.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
There are no charged levies or other licensing fees.
What is the amount of the fee or charge?
Is there any deposit or advance payment required associated with the issue of licences?
No deposit or advance payment is required for licensing.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
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?
The decision of the Norwegian Radiation and Nuclear Safety Authority may be appealed to the Ministry of Health and Care Services.
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.
Importation
Are there any limitations as to the period of year during which importation may be made?
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.
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.
Conditions of licensing
What is the period of validity of a licence? Can the validity 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.
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.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licenses cannot be transferred between importers.
Foreign Exchange
Is foreign exchange automatically provided by the banking authorities for goods to be imported?
N/A