Ionizing radiation generators and radioactive sources for spare parts for devices that produce ionizing radiation
- Document symbol
- G/LIC/N/3/MNE/8/Rev.1
- Original language
- English
- Published on
- 19/11/2024
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.
Permits for importing ionizing radiation generators, for radioactive sources for spare parts for devices that produce ionizing radiation are issue in accordance with the Law on Ionizing Radiation Protection and Radiation Safety and the Law on Nature Protection.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Import licenses are required for:
- Generators of ionizing radiation, radioactive sources and spare parts for devices that produce ionizing radiation.
Q3. The system applies to goods originating in and coming from which countries?
The system applies to goods originating and coming 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 issue of licenses is not intended to limit the quantities or value of imports, but exclusively with the purpose of adequate monitoring of the imported goods. No alternative methods were considered.
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 licensing is maintained in accordance with:
- The Law on ionizing radiation protection and radiation safety ("OG RMNE", No. 56/09, 58/09, 40/11, 15/16).
- The Foreign Trade Law ("Official Gazette of Republic Montenegro (OG RMNE)", No. 28/04, 37/07 and "Official Gazette of MNE", No. 57/14);
- Decision to amend National Control list for export and import ("Official Gazette of Montenegro” No. 55/23);
- The Decree on the implementation of the Foreign Trade Law ("OG RMNE", No. 52/04, 44/07 and ("Official Gazette of Montenegro", No. 78/2017);
- The Law on Administrative Procedure ("Official Gazette of Montenegro ", No. 56/14, 20/15, 40/16, 37/17);
- Law on Nature Protection ("Official Gazette of Montenegro" No. 54/16).
The legislation does not leave designation of products to be subjected to licensing to administrative discretion.
It is possible for the government (or the executive branch) to abolish the system without legislative approval.
NOTE: In order to improve the legal framework, on May 17, 2024, the Parliament of Montenegro adopted the Law on Ionizing Radiation Protection, Radiation and Nuclear Safety and Security ("Official Gazette of Montenegro", No. 049/24 of May 29, 2024), with delayed application starting from July 1, 2027. Aware of the complexity of the obligations regulated by the new Law, which are only the minimum conditions to which we are bound by the transposed Directives, international standards and the shortcomings of the existing Law observed during its implementation, a period of three years is necessary, not only for the adoption of by-laws and strategic acts that will enable its implementation, but it is also the period that business entities need to prepare in such a way as to fulfill all the obligations that this Law prescribes for them.
In order to create market competitiveness and trade facilitation, the recommendations given in the final report of the project "Solving obstacles to market access in selected supply chains in CEFTA" in six CEFTA Parties were considered during the drafting process of the new Law on Ionizing Radiation Protection, Radiation and Nuclear Safety and Security. The project was implemented by UNICTAD and the International Trade Center (ITC) in cooperation with the German Federal Ministry for Economic Cooperation and Development. On that occasion, analyzes of various trade obstacles identified by the private sector were made, and recommendations were proposed, which also related to the control of radioactivity. In this regard, the new 2024 Law recognizes the recognition of certificates/evidence on the performed control of radioactivity in water and construction materials during importation, which reduces the business barrier.
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)?
There is no fixed time-limit for submitting an application before importation. In accordance with the Law on Administrative Procedure length of time for processing application is 30 days from the day of receipt of the official request. License could be obtained in a shorter period than 30 days if all required documents are submitted.
Q7.b. Can a licence be granted immediately on request?
There is no such possibility.
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.
There are no such limitations.
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?
EPA is a Single administrative body in charge of consideration of licence applications.
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?
In addition to non-fulfilling of the criteria prescribed by relevant legislation, application could be rejected in the case when applicant submits application for the goods that are not allowed for import. Reasons for rejection of any form are given by EPA to the applicant in a separate administrative act. Decision may be appealed to the Ministry of Economic Development in accordance with the Law on Administrative Procedure.
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 legal persons or entrepreneurs registered in the Central Registry of the Commercial Court are eligible to apply for licenses. Regarding permits for chemical, besides above, a legal person must meet the requirements in terms of personnel, facilities and equipment.
All persons and companies that fulfil the conditions envisaged by the Law are eligible to apply for licenses.
- There is no registration fee;
- There is no published list of authorized operators.
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?
As regards the ionizing radiation, the request has to include basic information about the goods to be imported; a general application form does not exist. The importer must submit the following:
- Proof that the facilities and rooms where trading in ionizing radiation sources or radioactive material is performed in comply with technical, secure, safe, sanitary and other prescribed requirements ensuring health and protection of people and the environment against ionizing radiation;
- Proof that there is an employee in charge for protection against ionizing radiation;
- Proof that persons operating ionizing radiation sources are provided with adequate ionizing radiation protection equipment, as well as equipment for radiation measurements;
- Proof that all persons operating ionizing radiation sources have professional qualification required and satisfy prescribed health requirements for work with ionizing radiation sources;
- Certificate on technical/technological integrity of ionizing radiation source, obtained by the competent authority;
- Instruction for action in case of radiation accident;
- Proof that radioactive materials x-ray devices or other devices producing ionizing radiation are secured in accordance with prescribed requirements for their trading.
Q11. What documents are required upon actual importation?
Importer must present valid license issued by NEPA along with standard customs documentation. When it comes to ionising radiation, in addition to above mentioned, complete technical documentation of the device is required.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There are administrative fees as follows:
- Administrative fee in the amount 2€ for Request for licence
- Administrative fee in the amount of 70€ - Licence for applicant who are going to perform importing ionising radiation
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 associated with the issue of licenses.
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 valid for the period specified in the license, but not longer than one year. When it comes to ionising radiation, the license is valid up to one year and cannot be extended.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization of a license or a portion of a license.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The licenses are not transferable 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 issue of a license.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
There are no other administrative procedures, apart from import licensing required prior to importation.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
Foreign exchange is automatically provided by the banking authorities for goods to be imported.