G/LIC/N/3/MNE/5  
 
26 November  2021 
(21-8962) Page: 1/24 
Committee on Import Licensing  Original: English  
 
 REPLIES TO QUESTIONNAIRE ON IMPORT LICENSING PROCEDURES  
NOTIFICATION UNDER ARTICLE 7.3 OF THE AGREEMENT  
ON IMPORT LICENSING PROCEDURES  (2021) 
MONTENEGRO  
The following communication, of which the first draft was received on 29 July 2021, is being 
circulated at the request of the delegation of Montenegro1. 
_______________  
 
1   MINISTRY OF ECONOMIC DEVELOPMENT  ................................ ................................ ... 1 
1.1   Arms and military equipment  ................................ ................................ .......................  1 
1.2   Other goods  ................................ ................................ ................................ ...............  3 
1.3 Goods which may be used for the execution of a death penalty and whose application  
may be subject to tortur e. ................................ ................................ ................................ .. 5 
2   INSTITUTE FOR MEDICINES AND MEDICAL DEVICES  ................................ .................  7 
2.1   Human and veterinary medicines, and medical devices  ................................ ...................  7 
2.2   Controlled substances (drugs, precursors and medicines containing precursors)  ...............  10 
3   NATURE AND ENVIRONMENTAL PROTECTION AGENCY  ................................ ............  13 
3.1   Waste  ................................ ................................ ................................ .....................  13 
3.2   Ozone depleting substances and alternative substances  ................................ ................  15 
3.3   Endangered and protected species of flora and fauna  ................................ ....................  18 
3.4   Hazardous chemicals ................................ ................................ ................................ . 20 
3.5   Ionizing radiation generators and radioactive sources for spare parts for devices that 
produce ionizing radiation  ................................ ................................ ................................ . 23 
 
 
1  MINISTRY OF ECONO MIC DEVELOPMENT2 
1.1  Arms and military equipment  
Outline of system      
1.  Import licensing system is regulated by the Law on Foreign Trade in Arms and Military Equipment 
(OG MNE No. 40/16).  Import licenses are required for weapons and military equipment  listed in the 
National Control List for export and import.   
 
1 Any changes, as compared to the previous submission, have been highlighted in bold by the 
Secretariat." . 
2 Since 7 December 2020, the Ministry of Economy is now named the Ministry of Economic 
Development . 
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  Purposes and coverage of licensing  
2.  Imports of:  
 
- Weapons an d military equipment  – specific tariff lines from Chapters 27, 28, 29, 31, 36, 38, 
71, 88, 89, 93  
 
are subject  to licensing.  
 
3.  The import licensing system applies to goods originating in and coming from all countries.  
 
4.  Licenses are not intended to restrict the quantity or value of imports. In accordance with the Foreign 
Trade Law the Government may require import licenses only when it is necessary to:   
 
- Protect national security . 
 
5.  The following laws and legal acts regulate issuance of licenses by the Ministry of Econom ic 
Development : 
 
- The Law on Foreign Trade in Arms and Military Equipment (OG MNE No. 40/16) ; 
- The National Control List of Weapons and Military Equipment (OG MNE No. 69/18).  
-        The Law on Admi nistrative Procedure (RM OG No. 60/03 and OG MNE No . 56/14; 20/15; 40/16 
and 37/17) . 
 
Procedures  
6. Not applicable.  
 
7.a) Licenses are issued in a period not exceeding 15 days, except for weapons and military 
equipment where licenses are issued in a period not exceeding  30 days, provided that all 
required documents are submitted. Licenses could be obtained in a shorter period.  
 
b) Yes. 
 
c) There are no limitations as to the period of the year during which application for licence and/or 
importation may be made.  
 
d) An importer has to approach only one administrative organ as regards the application.  
Ministry of Econom ic Development  has to obtain  positive opinion from the Ministry of Fo reign 
Affairs, the Ministry of Defence and the Ministry of Internal Affairs in accordance with the Law 
on Foreign Trade in Arms and Military Equipment  (OG MNE No. 40/16).   
 
8.  None, except in cases prescribed by international regulations including international sanctions, 
recommendations of OEBS, etc.  
 
The reasons for any refusal are given to the applicant in writing.  In the event of refusal to issue a 
licence, the applicant h as a right of appeal to the Administrative Court of Montenegro, as prescribed 
by the Law on Administrative Procedure ( RM OG No. 60/03 and OG MNE No . 56/14; 20/15; 40/16 
and 37/17) and the Law on Administrative Dispute (OG MNE No. 54/16).  
 
Eligibility of im porters to apply for licence  
9. According to the Law on Foreign Trade in Arms and Military Equipment in order to be engaged in 
importation of arms and military equipment, natural and legal persons have to be registered within 
the Ministry of Econom ic Devel opment . There is no published list of importers, with exception of the 
register of importers of weapon kept within the Ministry of Econo mic Development . 
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  Documentation and other requirements for application for licence  
10.  Please see Exhibit I3. 
 
11. The importer must only provide a copy of a license or approval upon actual importation along 
with other required customs documents (declaration, invoice, bill of lading, certificates and, where 
required, other certificates - origin, conformity, veterinary,  health , quality, phytosanitary).  
 
12.  Yes, there is a license fee. In accordance with the Law on Administrative Fees (RM OG No.  18/19) 
the Ministry of Econom ic Development  charges 100 € for issuing licenses for weapons and military 
equipment  from the National Control List for export and import . 
 
13. There is no deposit or advance payment requirement associated with the issue of licenses.  
 
Conditions of licensing  
14. Licenses are valid for one year from the date of issuance. If the realization of th e activities related 
to foreign trade lasts longer than a year, the Ministry may determine the validity of the license until 
the deadline for completion of the work specified in the contract, but not longer than three years.  
 
15. There is no penalty for no n-utilization of a license or a portion of a license.  
 
16. Licences are not transferable between importers . 
 
17. There are no conditions attached to the issuance of a licence.  
 
Other procedural requirements  
18. There are no other administrative procedures,  apart from import licensing required prior to 
importation.  
 
19. Foreign exchange is automatically provided by the banking authorities for goods to be imported.   
 
1.2  Other goods  
Outline of system  
1.  Import licensing system is regulated by the Foreign Trade Law (RM OG No. 28/04; 37/07 and 
OG MNE No. 73/10; 01/14; 14/14 and 57/14) . Import  licenses are required for other goods listed in 
the National Control List for export and import.   
 
Purposes and cover age of licensing  
2.  Imports of:  
 
- Other goods from National Control List for export and import  Chapter 29 –  19    tariff lines 
(polyacetals)/ Chapter 30 – 60 tariff lines Chapter 31 - 1 tariff line, Chapter 33 -1 tariff line, 
Chapter 34 -1 tariff line, Chapter 36 - 20 tariff lines, Chapter 37 -1 tariff line, Chapter 38 -
2 tariff lines, Chapter 39 - 3  tariff lines,  Chapter 40 - 2 tariff lines, Chapter 48 -1 tariff line, 
Chapter 50 -1 tariff line, Chapter 61 -1 tariff line Chapter 63 -  4 tariff line,  Chapter 65 – 
2 tariff lines,  Chapter 70 -1 tariff line Chapter 71 -  5  tariff lines, Chapter 83  - 1 tariff line,  
Chapter 84 -  9 tariff lines, Chapter 85 - 5 tariff lines, Chapter 88 -  6 tariff lines, Chapter 90 
-  53  tariff lines, Chapter 93 -  24  tariff lines,  Chapter 95 - 2 tariff lines,  Chapter 96 – 1 tariff 
line 
 
are subject  to licensing.  
 
3.  The import licensing system applies to goods originating in and coming from all countries.  
 
 
3  Available for consultation on the Import Licensing website "https://www.importlicensing.wto.org"  
(English  only).  G/LIC/N/3/MNE/5  
 
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  4.  Licenses are not intended to restrict the quantity or value of imports. In accordance with the Foreign 
Trade Law the Government may require import license s only when it is necessary to:   
 
- Protect human, animal or plant life or health;  
- Protect environment or exhaustible natural resources;  
- Protect public morals;  
- Protect intellectual property rights; or  
- Enforce any special rules related to gold and silver.   
 
5.  The following laws and legal acts regulate issuance of licenses by the Ministry of Econom ic 
Development : 
 
- The Foreign Trade Law (RM OG No. 28/04; 37/07 and OG MNE No. 73/10; 01/14; 14/14 
and 57/14);  
- The Law on Optical Discs (RM OG No. 2/07 and OG MNE No. 53/11 ); 
- The National Control list for export and import ( OG MNE No. 40/20 );  
- Decision  to amend National Control list for export and import (OG MNE No.40/20) . 
- The Law on Administrative Procedure (RM OG No. 60/03 and OG MNE No 56/14; 20/15; 40/16 
and 37/17) . 
 
Procedures  
6. Not applicable.  
 
7.a) Licenses are issued in a period not exceeding 15 days, provided that all required documents 
are submitted. Licenses could be obtained in a shorter period.  
 
b) Yes. 
 
c) There are no limitations as to the period of the year during which application for licence and/or 
importation may be made.  
 
d) An importer has to approach only one administrative organ as regards the application. The 
Ministry of Econom ic Development  has to obtain positive opinion from the Ministry of Internal 
Affairs (explosives, civil a ircrafts,  arms for sport and hunting etc.) Civil aircraft agency (civil 
aircraft s, drones) in accordance with The Foreign Trade Law (RM OG No. 28/04; 37/07 and 
OG MNE No. 73/10; 01/14; 14/14 and 57/14) .  
 
8.  None, except in cases prescribed by internation al regulations including international sanctions, 
recommendations of OEBS, etc.  
 
The reasons for any refusal are given to the applicant in writing.  In the event of refusal to issue a 
licence, the applicant has a right of appeal to the Administrative Court of Montenegro, as prescribed 
by the Law on Administrative Procedure ( RM OG No. 60/03  and OG MNE No 56/14; 20/15; 40/16 
and 37/17) and the Law on Administrative Dispute (OG MNE No. 54/16).  
 
Eligibility of importers to apply for licence  
9. All persons having the right to engage in import activities are eligible to apply for licenses which 
are issued by the Ministry of Econom ic Development.  There is no published list of importers . 
 
Documentation and other requirements for application for licence  
10.  Please see Exhibit I3. 
 
11. The importer must only provide a copy of a license or approval upon actual importation along 
with other required customs documents (declaration, invoice, bill of lading, certificates and, where 
required, other certificates - origin, conformity, veterinary, health, quality, phytosanitary).  
 
12.  Yes, there is a license fee. In accordance with the Law on Administrative Fees (RM OG No.  18/19) 
the Ministry of Econom ic Development  charges 10 € for goods from the National Control List for 
export and import . G/LIC/N/3/MNE/5  
 
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  13. There is no deposit or advance payment requirement associated with the issue of licenses.  
 
Conditions of licensing  
14. Licenses are valid for one year from the date of issuance. If the realization of the activities related 
to foreign trade lasts longer tha n a year, the Ministry may determine the validity of the license until 
the deadline for completion of the work specified in the contract, but not longer than three years.  
 
15. There is no penalty for non -utilization of a license or a portion of a license.  
 
16. Licences are not transferable between importers . 
 
17. There are no conditions attached to the issuance of a licence.  
 
Other procedural requirements  
18. There are no other administrative procedures, apart from import licensing required prior to 
importa tion. 
 
19. Foreign exchange is automatically provided by the banking authorities for goods to be imported.   
 
1.3 Goods which may be used for the execution of a death penalty and whose application 
may be subject to torture.  
Outline of system  
1. Import licensing system is regulated by the Law on foreign trade of goods and services  which may 
be used for the execution of a death penalty,  torture or other cruel, inhuman or humiliating treatment 
or punishment (OG MNE No.  2/18). 
 
Purposes and coverage of licensing  
2.  Imports of:  
 
- goods which may be used for the execution of a death penalty,  torture or other cruel, inhuman 
or humiliating treatment or punishment  – specific tariff lines from Chapters 29, 30, 33, 38, 
39, 42, 62, 84, 93 
 
are subject  to licensing.  
 
3.  The import licensing system applies to goods originating in and coming from all countries.  
 
4.  Licenses are not intended to restrict the quantity or value of imports. In accordance with the Foreign 
Trade Law the Government may r equire import licenses only when it is necessary to:   
 
- Protect national security.  
 
5.  The following laws and legal acts regulate issuance of licenses by the Ministry of Econom ic 
Development : 
 
- Law on foreign  trade of goods and services which may be used for the execution of a death 
penalty,  torture or other cruel, inhuman or humiliating treatment or punishment (OG MNE 
No. 2/18);  
- The Law on Administrative Procedure (RM OG No. 60/03 and OG MNE No . 56/14; 20/ 15; 40/16 
and 37/17) . 
 
Procedures  
6. Not applicable.  
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  7.a) Licenses are issued in a period not exceeding 30 days, except in case the additional checks 
are to be performed  in a period not exceeding  45 days, provided that all required documents 
are submitted. Licenses could be obtained in a shorter period.  
 
b) Yes. 
 
c) There are no limitations as to the period of the year during which application for licence and/or 
importation may be made.  
 
d) An importer has to approach only one administrative organ as regards the application . The 
Ministry of Econom ic Development  has to obtain positive opinion from the Ministry of Foreign 
Affairs, the Ministry of Internal Affairs Ministry of Culture in cases where  these goods will be 
used for  exposure to museums in accordance with the Law on foreign trade of goods and 
services which  may be used for the execution of a death penalty,  torture or other cruel, 
inhuman or humiliating treatment or punishment (OG MNE No.  2/18).  
 
8.  None, except in cases prescribed by international regulations including international sanctions, 
recommendations of OEBS, etc.  
 
The reasons for any refusal are given to the applicant in writing.  In the event of refusal to issue a 
licence, the applicant has a right of appeal to the Administrative Court of Montenegro, as prescribed 
by the Law on Administrative Procedure ( RM OG No. 60/03  and OG MNE No . 56/14; 20/15; 40/16 
and 37/17) and the Law on Administrative Dispute (OG MNE No. 54/16).  
 
Eligibility of importers to apply for licence  
9. According to the Law on foreign trade of goods and services which may be used for the execution 
of a death penalty,  torture or other cruel, inhuman or humiliating treatment or punishment (OG MNE 
No. 2/18), natural and legal persons . There is no published list of importers . 
 
Documentation and other requirements for application for licence  
10.  Please see Exhibit I3. 
 
11. The importer must only provide a copy of a license or approval upon actual importation along 
with other required customs documents (declaration, invoice, bill of lading, certificates and, where 
required, other certificates - origin, conformity, veterinary, health, quality, phytosanitary).  
 
12.  Yes, there is a license fee. In accordance with the Law on Administrative Fees (RM OG No.  18/19) 
the Ministry of Econom ic Development  charges 100 € for issuing licenses  goods which may be used 
for the execution of a deat h penalty,  torture or other cruel, inhuman or humiliating treatment or 
punishment . 
 
13. There is no deposit or advance payment requirement associated with the issue of licenses.  
 
Conditions of licensing  
14. Licenses are valid for one year from the date of issuance. If the realization of the activities related 
to foreign trade lasts longer than a year, the Ministry may determine the validity of the license until 
the deadline for completion of the work specified in the contract, but not longer than one year. 
 
15. There is no penalty for non -utilization of a license or a portion of a license.  
 
16. Licences are not transferable between importers . 
 
17. There are no conditions attached to the issuance of a licence.  
 
Other pr ocedural requirements  
18. There are no other administrative procedures, apart from import licensing required prior to 
importation.  G/LIC/N/3/MNE/5  
 
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  19. Foreign exchange is automatically provided by the banking authorities for goods to be imported.   
 
2  INSTITUTE FOR MEDICINE S AND MEDICAL DEVICES  
2.1  Human and veterinary medicines, and medical devices  
Outline of System  
1. Institute for Medicines and Medical Devices (hereinafter: Institute) issues authorisations for the 
import of: human and veterinary medicines, and medical devices. Authorisations are issued in 
accordance with the following legislation:  
 
- Law on Medicines ("Official Gazette of Montenegro", No . 080/20 );  
- Law on Medical Devices ("Official Gazette of Montenegro", No . 024/19) ;  
- Law on administrative procedure ("Official Gazette of Montenegro", No . 056/14, 020/15, 
040/16 and 037/17) . 
 
Purposes and Coverage of Licensing  
2. The Institute issues import licences for the following products:  
 
- human and veterinary medicines ; and 
- medical devices.  
 
3. The system is related to the goods originating/coming from any country.  
 
4. The purpose of issuing authorisations for the import of medicines and  medical devices is not to limit 
the quantity or value of the import, but to check the documentation on the quality, safety and efficacy 
of the products imported. Alternative methods for meeting the goals are not considered, because the 
issuance of import l icences is in accordance with the national legislation which is to a great extent 
harmonized with the EU legislation in the area.   
 
5. The issuance of import licences is conducted in accordance with:  
 
- Law on Medicines ("Official Gazette of Montenegro", No. 080/20) ;  
- Law on Medical Devices ("Official Gazette of Montenegro", No . 024/19) ; 
- Law on administrative procedure ("Official Gazette of Montenegro", No . 056/14, 020/15, 
040/16 and  037/17).  
 
The issuance of import licences is obligatory and there is no possibility to issue the licence based on 
administrative discretion.  
 
The Article 8 of Law on Medicines ("Official Gazette of Montenegro", No 080/20) envisages that 
Government of Montenegro may dete rmine alternative procedure s and conditions for the issuance of 
marketing authorisation for a medicine.  
 
Procedures  
6.I-XI. Not applicable.   
 
7.(a) The application for import for these products may be submitted at any time according to the 
opinion of the importer. The time -limit for issuing licence is 30 days. This term is most often 
7 days, or if the goods have already arrived at the customs and at the request of the importer, 
it may be even shorter, i.e. be done by priority (providing all necessary d ocumentation is still 
obligatory).  
 
(b) In case of emergency, if the documentation is correct, the licence may be issued in less than 
30 days or shorter than the average period (see answer to question a) . 
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  (c) There are no limitations regarding the period of the year during which the application may be 
submitted and / or import be done.  
 
(d) Processing of applications for import is performed only by one administrative body - Institute 
for Medicines and Medical Devices.  
 
8. An application for a licence may be rejected due to inadequate documentation on the product or the 
applicant and in other cases in accordance with relevant laws. Reasons for rejection of any kind are 
given to the applicant in the form of an appropriate leg al act.  
 
In case of rejection, the applicants have the right to appeal to the Administrative Court , in accordance 
with:  
 
-  Law on Medicines ("Official Gazette of Montenegro", No . 080/20) ;  
-  Law on Medical Devices ("Official Gazette of Montenegro", No . 024/19) ;  
-  Law on administrative procedure ("Official Gazette of Montenegro", No . 056/14, 020/15, 
040/16 and 037/17).  
 
Eligibility of Importers to Apply for Licence  
9. There is a system of registration of legal persons that may perform import and marketing.  
 
Import or marketing of medicines may be performed by legal persons seated in Montenegro, which 
possess wholesale authorisation (wholesalers), issued by the Institut e or authority in charge of 
veterinary affairs for veterinary medicines.  
 
Wholesale of medical devices may be performed by legal persons seated in Montenegro, which are 
registered in accordance with decision on wholesale registration by the Institute.  
 
Fees for issuance of licences for the import and wholesale of all these products are defined by:  
  
-  Decision on the manner of payment and amount of fees for issuance of authorisations, 
certificates and approvals for manufacture and marketing of medicines ("Official Gazette of 
Montenegro", No . 22/13 from 17 May 2013) ; and   
-  Decision on the mode of payment and amount of fees for entering and removing medical 
devices, manufacturers and legal persons that market and import medical devices into and 
from the Register, as well as keeping the Register (Official Gazette of Montenegro  
No. 78/2009).  
 
A list of all legal persons that are au thorised to perform import and marketing on the basis of 
authorisations issued by the Institute, is published on the website of  the Institute 
https://www.cinmed.me/  and is regularly updated.  
 
Documentational and Other Requirements for Application for Licence  
10. The Institute ’s portal https://www.cinmed.me/  contains all the data that must be listed on the 
application for import all product groups.  
  
• Documentation required for obtaining authorisation for import of medicines for human 
and veterinary u se: 
 
1)  Cover letter ;  
2)  Table containing list of medicines to be imported/exported ; 
3)  Invoice or pro -forma invoice from a supplier ; 
4)  Batch release certificate in accordance with Internationally harmonised requirements for batch 
certification for each batch the import of which is applied for ; 
5)  In case of import/export of blood products and immunological products a certificate of analysis 
for every batch is required, from a manufacturer and from one of the laboratories that are OMCL 
members, or countries that have signed agreements with European Union on recognition of G/LIC/N/3/MNE/5  
 
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  batch certification, or from the National laboratory of the Institute for Medicines and Medical 
Devices of Serbia (ALIMS) ; 
6)  Manufacturing and control summary pr otocol (for vaccines only), for batch(es) for which 
certificates are submitted ; 
7)  Justified request of the health institution, i.e. opinion of medical specialist on the need for import 
of the particular medicine – for the first import or at the request o f the Institute ; 
8)  Proof of payment of prescribed fees . 
 
• Documentation required for obtaining authorisation for import of medical devices:  
 
1)  Cover letter ; 
2)  Application for authorisation with information on imported medical devices ; 
3)  Letterheaded statement of the applicant for import of medical devices justifying the reason for 
not submitting application for entry into the register of medical devices kept by the Institute; in 
case that the application has been submitted, please state th e date of submission of the 
documentation for entry into the register and number under which it is filed in the Institute ; 
4) Letterheaded statement of the healthcare institution (healthcare professional) justifying the 
import of specific medical devices. If a similar medical device is entered in the Institute’s register, 
the reason why the medical device that has already been entered into the register cannot be 
used shall be given;  
5)  Supporting certificates for each product from the list:  
 -  Manufacture r's Declaration of Conformity (DoC) ; 
 -  EC certificates, except for medical devices of Class I and In Vitro – Others ; 
6)  Invoice or pro -forma invoice from a supplier ; 
7)  Proof of payment of prescribed fees . 
 
11. Documents required are related to the quantity of the imported products and the date of the 
import.   For medicines and medical devices additional documentation upon import is not required.  
 
12. The fees for issuing import licences are defined by Decisions adopted by the Government:  
 
-  Decis ion on the manner of payment and amount of fees for issuance of authorisations, 
certificates and approvals for manufacture and marketing of medicines ( "Official Gazette of 
Montenegro", No . 22/13 from 17 May 2013) ; and   
-  Decision on the mode of payment a nd amount of fees for entering and removing medical 
devices, manufacturers and legal persons that market and import medical devices into and 
from the Register, as well as keeping the Register. (Official Gazette of Montenegro 
No 78/2009).  
 
In line with thos e decisions , fees for import licences for medicines and medical devices is determined 
based on the total value of the requested import:  
 
Import value     Fees (EUR)  
up to 5 000 EUR      60  
from 5 000 up to 50 000 EUR   125  
from 50 000 up to 250 000 EUR  250  
from 250 000 up to 500 000 EUR  500  
from 500 000 up to 1.000 000 EUR  1.000  
 
13.  No.  
 
Conditions of Licensing  
14. Period of validity of an import licence for medicines is until the end of the import of the quantities 
indicated in the import licence and it is valid for a multiple import.  
 
Period of validity of an import licence for medical devices is 3 months from the  date of issuance and 
is valid for a multiple import.  
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  Licences could not be extended but request for a new licence can be submitted.  
 
15. No, there is not a penalty for the non -utilization of a licence or a portion of a licence.  
 
16. Licences are not transferable between importers.  
 
17.(b) No other conditions attached.   
 
Other Procedural Requirements  
18. No. 
 
19. N/A. 
 
2.2  Controlled substances (drugs, precursors and medicines containing precursors)  
Outline of System  
1. Institute for Medicines and Medical Devices (hereinafter: Institute) issues authorisations for the 
import of: medicines classified as drugs (hereinafter: drugs), precursors and medicines containing 
precursors. Authorisations are issued in accordance with the following legislation:  
 
- Law on Medicines ("Official Gazette of Montenegro", No . 080/20) ;  
- Law on control of manufacture and trade of substances that can be used in the manufacture 
of narcotic drugs and psychotropic substances ("Official Gazette of Montenegro", No . 83/09 
and No . 40/11) ;  
- Law about preventing of drug abuse ("Official Gazette of Montenegro", No . 28/11 and 
No. 35/13) ; 
- Law on administrative procedure ("Official Gazette of Montenegro", No . 056/14, 020/15, 
040/16 and 037/17) . 
 
Purposes and Coverage of Licensing  
2. Institute issues import licences for the following products:  
 
- controlled substances (drugs, precursors and medicines containing precursors) . 
 
3. The system is related to the goods originating/coming from any country.  
 
4. There is an annual q uota for drugs, precursors and medicines containing precursors, such as 
pseudoephedrine, ephedrine and norephedrine in terms of quantity at the national level that cannot 
be exceeded. This quota, for each calendar year, is determined by the International N arcotics Control 
Board in Vienna (INCB), and authorisations for the import of mentioned controlled substances are 
issued according to it.  
 
5. Issuance of import licences is conducted in accordance with:  
 
- Law on Medicines ("Official Gazette of Montenegro" , No. 080/20);  
- Law on control of manufacture and trade of substances that can be used in the manufacture 
of narcotic drugs and psychotropic substances ("Official Gazette of Montenegro", No . 83/09 
and No . 40/11);  
- Law about preventing of drug abuse ("Official Gazette of Montenegro", No . 28/11 and 
No. 35/13);  
- Law on administrative procedure ("Official Gazette of Montenegro", No . 056/14, 020/15, 
040/16 and  037/17).  
 
Issuance of import licences is obligatory and there is no possibility to issue the licence based on 
administrative discretion.  
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  The Article 8 of Law on Medicines ("Official Gazette of Montenegro", No 080/20) envisages that 
Government of Montenegro may determine alternative procedure and conditions for the issuance of 
marketing autho risation for a medicine.  
 
Procedures  
6.I. Information on permitted annual quotas for import of drugs are published on the website of 
the International Narcotics Control Board (www.incb.com). Quotas are formed on the basis of 
needs for drugs, precursors and  medicines containing precursors, such as pseudoephedrine, 
ephedrine and norephedrine individually on annual level that importers submit to the Institute. 
After processing these data, the Institute sends data to the Ministry of Health, which forward  
these data for the approval to the International Narcotics Control Board (INCB).   
 
 In cases  where  needs for controlled substances are increased in relation to the required annual 
quota,  the Institute , through the Ministry of Health may, with an explanation, ask for an 
increase in quotas for certain drug, precursor and medicine containing precursors, such as 
pseudoephedrine, ephedrine and norephedrine.  
 
All the information needed to obtain import autho risation for drugs (regulations, instructions 
and forms) the importer can find on the website of the Institute https://www.cinmed.me/ . 
 
II. The a mount of quotas is determined annually by the International Narcotics Co ntrol Board. 
Application for an import may be submitted by necessity, with the condition not to exceed the 
quota, and the validity period of import authorisation for drugs is 6 months and for precursors 
and medicines containing precursors is 30 days, which  are intended for single import.  
 
III. The Institute sends one copy of the import licence for drugs, precursors and medicines 
containing precursors to the Customs Administration, and after customs clearance of the 
goods, Customs returns this copy of the li cence to the Institute, which contain details of the 
realisation of imported products. The amount that has not been imported is not counted into 
the allowed quota. One copy of import authorisations for drugs  is intended for importer, and 
one for the  compet ent authority of the exporting country.  
 
IV.  Applications may be submitted immediately after publishing quotas.  
 
V. The period needed for processing applications and issuing licence for the import of drugs is up 
to 30 days but usually within 7 days.  
 
VI. Import can be done immediately after obtaining import licence (date of issuance of the licence 
is stated on the licence).  
 
VII.  Processing of applications for import of drugs, precursors and medicines containing precursors 
is performed only by one admini strative body – Institute for Medicines and Medical Devices.  
 
VIII. If the demand for licences cannot be completely fulfilled i.e. if a small amount is missing for 
fulfilling an annual quota, the applicant which did not import his stated year demand takes 
precedence over others for obtaining import licence for a certain drug, precursor or medicines 
containing precursors such as pseudoephedrine, ephedrine and norephedrine (see answer to 
question I). Applications for import are processed according to the date  of receipt, 
chronologically. The new importer who obtained wholesale licence for marketing of drugs and 
precursors must submit annual demand for drugs before submitting an application for import.  
 
IX. Import licences are always needed, regardless of the f act that exporting countries issues 
export licences. Import licences are not issued automatically.  
 
X. Not applicable.  
 
XI. There have been no such cases so far. Legal provisions provide that the procedure for 
approving the import of drugs, precursor or me dicines containing precursors is identical 
regardless of whether the product will be marketed in Montenegro or exported to other 
countries (which requires a special export licence).  G/LIC/N/3/MNE/5  
 
- 12 - 
 
  7.(a) - (d) Not applicable.  
 
8.  An application for a licence may be rejected due to inadequate documentation on the product 
or the applicant and in other cases in accordance with relevant laws. Reasons for rejection of 
any kind are given to the applicant in the form of an appropriate legal act.  
 
In case of rejection, the a pplicants have the right to appeal to the Administrative Court , in accordance 
with:  
 
-  Law on Medicines ("Official Gazette of Montenegro", No . 080/20) ;  
-  Law on control of manufacture and trade of substances that can be used in the manufacture of 
narco tic drugs and psychotropic substances ("Official Gazette of Montenegro", No . 83/09 and 
No. 40/11) ;  
-  Law about preventing of drug abuse ("Official Gazette of Montenegro", No . 28/11 and  
 No. 35/13) ; 
-  Law on administrative procedure ("Official Gazette o f Montenegro", No . 056/14, 020/15, 
040/16 and 037/17).  
 
Eligibility of Importers to Apply for Licence  
9. There is a system of registration of legal persons that may perform import and marketing. Legal 
persons that import and market drugs and precursors add itionally require a separate authorisation 
for wholesale of drugs or precursors.  
 
Fees for issuance of licences for the import and wholesale of all these products are defined by:  
  
-  Decision on the manner of payment and amount of fees for issuance of au thorisations, 
certificates and approvals for manufacture and marketing of medicines ("Official Gazette of 
Montenegro", No . 22/13 from 17 May 2013) ; and   
 
- A list of all legal persons that are au thorised to perform import and marketing on the basis of 
authorisations issued by the Institute, is published on the website of the Institute 
https://www.cinmed.me/  and is regularly updated.  
 
Documentational and Other Requirements for Application for Licence  
10. The portal Institute https://www.cinmed.me/  contains all the data that must be listed on the 
application for import all product groups.  
  
• Documentation required for obtain ing authorisation for import of narcotic drugs is 
consisted of the following:  
 
1) The application cover letter;  
2) Completed  Application form for issuance of the import, export and transit authorisation for 
drugs  (available on the CInMED web portal) ; 
3) User's (applicant's) statement of the purpose;  
4) Pro forma or forma invoice;  
5) Batch release certificate in accordance with Internationally harmonised requirements for batch 
certification  for each batch of the medicin e whose import is required.  
 
• Documentation required for obtaining authorisation for import of precursors and 
medicines containing precursors is consisted of the following:  
 
1) The application cover letter;   
2) Completed Application form for issuance of the import, export and transit authorisation for 
precursors and medicines containing precursors  (available on the CInMED web portal) ; 
3) User's (applicant's) statement of purpose;   
4) Pro-forma invoice or forma invoice;  G/LIC/N/3/MNE/5  
 
- 13 - 
 
  5) End user's statement of purpose of precursors, in accordance with  the Rulebook on the form 
and content of statement of end user on the purpose of precursors  ("Official Gazette of 
Montenegro", No . 4/2015) (applies only to precursors) ; 
6) Batch release cert ificate in accordance with Internationally harmonised requirements for batch 
certification  for each batch of the medicine whose import is required.  
 
11. Upon actual importation, additional documentation is required only for the products belonging 
to the group of controlled substances i.e. drugs and precursors and medicines containing precursors. 
Documents required are related to the quantit y of the imported products and the date of the import.  
 
12. The fees for issuing import licences are defined by Decisions adopted by the Government:  
 
-  Decision on the manner of payment and amount of fees for issuance of authorisations, 
certificates and approvals for manufacture and marketing of medicines ( "Official Gazette of 
Montenegro", No . 22/13 from 17 May 2013) . 
 
In line with this Decision, fees for import licences for import/export/transit for drugs and 
psychotropic substances in line with the inte rnational conventions is 1% of the total 
import/export/transit value.  
 
In line with this Decision, fees for import/export/transit of precursors are 50 euros.  
 
13.  No.  
 
Conditions of Licensing  
14. Period of validity of an import licence for drugs is 6 months and is valid for a single import.  
 
Period of validity of an import licence for precursors and medicines containing precursors  is 30 days 
and is valid for a single import.  
 
Licences could not be extended but request for a new licence can be submitted . 
 
15. No, there is not a penalty for the non -utilization of a licence or a portion of a licence.  
 
16. Licences are not transferable between importers.  
 
17.(a) No other conditions attached.  
 
Other Procedural Requirements  
18. No. 
 
19. N/A. 
 
3  NATURE AND ENVIRONMENTAL PROTECTION AGENCY  
3.1  Waste  
Outline of System  
1.  Licenses for the transboundary movement of waste (import, export and transit) are issued in 
accordance with the Law on waste management (OG MNE, No. 64/11, 39/16) and Basel Convention 
on the Control of Transboundary movements of hazardous waste and their disposal 
(OG FRY-International agreements, No. 2/99). The import of hazardous waste is forbidden. The import 
of non -hazardous waste to remove and use as fuel or other means t o generate energy is forbidden as 
well. 
 G/LIC/N/3/MNE/5  
 
- 14 - 
 
  Purposes and coverage of licensing  
2.  Import licenses are required for:  
 
- Transboundary movement of waste (import, export and transit of waste);  
 
3.  The system applies to goods originating and coming from all countries.  
 
4.  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. For waste management the licensing 
intends to control the quantity of imports because it is related to the protection of  the environment 
and fulfilling the obligation in accordance with the international agreement: Basel Convention.   
No alternative methods were considered.  
 
5.  The licensing is maintained in accordance with:  
 
-      The Law on waste management ("OG MNE", No. 64/11, 39/16);  
- The Law on Confirmation of the Basel Convention on the Control of Transboundary Movements 
of Dangerous Waste and Their Disposal ("OG FRY "-International agreements, No. 2/99);  
- The Rulebook on the content of documentation submitted in support of the application for the 
permit for import, export and transit of waste, as well as lists of waste classification and the 
content and manner of kee ping a register of issued licenses ("OG MNE", No. 83/16, 76/16);   
 
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.  
 
Procedures  
6. Not applicable.  
 
7.a) 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 day 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.  
 
b) There is no such possibility.  
 
c) There are no such limitations.  
 
d) NEPA is a Single administrative body in charge of consideration of licence applications.  
 
8.  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 NEPA to the applicant in a separate administrative act. 
Decision may be appealed to the Ministry of Sustainable Development and Tourism in accordance with 
the Law on Administr ative Procedure.  
 
Eligibility of importers to apply for licence  
9. All legal persons or entrepreneurs registered in the Central Registry of the Commercial Court are 
eligible to apply for licences. Regarding permits for chemical, beside s 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.  G/LIC/N/3/MNE/5  
 
- 15 - 
 
  -  There i s no published list of authorized operators.  
 
Documentation and other requirements for application for licence  
10.  The application for permit for import of non -hazardous waste, only for the purpose of its 
processing, must contain the following:  
 
- Documentation of signs and types of waste from the list of non -hazardous waste;  
- An ag reement between importers and exporters of waste with validity period until the 
completion of delivery of waste and with financial guarantees or insurance policy or othe r form 
of insurance in the case of return in the country of export;  
- An agreement between importers and processors of waste, in case that the importer is not 
the waste processor;  
- Proof that the importer of waste is registered for import activities;  
- Information on methods for transport and shipment of waste (at once or in several 
shipments);  
- Information on the border crossing point on which imports will be made, the time of arrival of 
waste on border crossing point, route of waste movement from the bo rder customs office to 
processors; and,  
- Proof of the administrative fee payment.  
 
11. Importer must present valid license issued by NEPA along with standard customs documentation.  
 
12.  There are administrative fees as follows:  
 
- Administrative fee in the amount of 2 EUR for non -hazardous waste;  
 
13.  There is no deposit or advance payment associated with the issue of licenses.  
 
Conditions of licensing  
14.  The license is valid for the period specified in the license, but not longer than one year.  
 
15.  There is no penalty for non -utilization of a license or a portion of a license.  
 
16.  The licenses are not transferable between importers.  
 
17.  There are no other conditions attached to the issue of a license.  
 
Other procedural requirements  
18.  There are no other administrative procedures, apart from import licensing required prior to 
importation.  
 
19.  Foreign exchange is automatically provided by the bankin g authorities for goods to be imported.  
 
3.2  Ozone deplet ing substances and alternative substances  
Outline of System  
1.  Permits for import/export of ozone deplet ing substances and alternative substances are issued in 
accordance with the Law on the Protection against Adverse Impacts of Climate Change (Official Gazette 
of MNE, No. 073/19, date d 27.12.2019). and the Decree on ozone deplet ing substances and alternative 
substances (OG MNE, No. 5/11). Also, on 23 October 2006 Montenegro ratified by means of succession 
the Vienna Convention on ozone layer protection, the Montreal Protocol on ozone depleted substances 
and the Amendments to the Montreal Protocol. One of the ob ligations under the Montreal protocol was 
to establish import/export licences to control consumption of ozone deplet ing substances. Montenegro 
operated under Article 5 of Montreal protocol and it is in compliance with the provisions of the Protocol.  
 G/LIC/N/3/MNE/5  
 
- 16 - 
 
  Purp oses and coverage of licensing  
2.  Import licenses are required for:  
 
- Ozone depleting substances and alternative substances;  
 
3.  The system applies to goods originating and coming from all countries. Import is forbidden for 
countries that are not parties to the Montreal protocol on ozone deplet ing substances.  
 
4.  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. In the case of o zone depl eting 
substances , the licensing intends to control the quantity of imports because it is related to the 
protection of the environment and fulfilling the obligation in accordance with the international 
agreements: the Vienna Convention and the Montreal Prot ocol. No alternative methods were 
considered.  
 
5.  The licensing is maintained in accordance with:  
 
- Law on the Protection against Adverse Impacts of Climate Change (Official Gazette of MNE, 
No. 073/19, date d 27.12.2019) ; 
- The Decree on ozone deplet ing substances and alternative substances ("OG MNE", No. 5/11);  
- The Law on ratification of The Vienna Con vention for the Protection of the Ozone Layer with 
Annexes I and II ( "Official Gazette of SFRJ " – International agreements, No. 1/90);  
- The Law on ratification of The Montreal Protocol on Substances that Deplete the Ozone Layer 
("Official Gazette of SFRJ " – International agreements, No. 16/90);  
- The Law on ratification of the Amendments to The Montreal Protocol on Substances that Deplete  
 the Ozone Layer ("Official Gazette of Serbia and Montenegro"  - International agreements, 
No. 24/04) .  
 
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.  
 
Procedures  
6.I. Imports of ozone deplet ing substances (ODS) are under the quota system. Procedure for quota 
system for import of the ozone deplet ing substances are prescribed by the Decree on ozone 
deplet ing substances and alternative substances ("OG MNE",  No. 5/11).  
 
II. A quota for import of ozone depleting substances is determined on an annual basis and written 
application of importer for setting annual quota have to be submitted to the NEPA not later 
than 1 December  of the current year for the following year. The licences for impor t are issued 
for each import separately.  
 
III. The licenses are not allotted for certain goods partly or only to domestic procedures of like 
goods. Legal person or entrepreneur performing the imports of ODS are obligated to submit 
proof to the NEPA Unifie d Customs Document of imported or exported amounts of ODS for each 
issued permit, not later than three days after the performed import or export of such substances. 
Unused allocations are not added to quotas for the next year. Also, all issued licences are  
published on the NEPA web site.  
 
IV. Written application of importer for setting annual quota for ODS imports, have to be submitted 
to the NEPA not later than 1st December of the current year for the following year. An application 
for obtaining import permit for import of ODS could be submitted as soon as quotas are allocated 
for the year for which the quota is allocated.  
 
V. Length of time for processing applicati on is prescribed by the Law on Administrative Procedure.  
Processing time is up to 30 days.  G/LIC/N/3/MNE/5  
 
- 17 - 
 
  VI. Import can be done immediately after obtaining import licence (date of issuance of the licence 
is stated on the licence).  
 
VII. NEPA is a Single administrative body for consideration of licence applications.  
 
VIII. Quotas usually satisfy demand, as they are referred to substances whose consumption is 
phasing out. All applications are examined simultaneously and allocation of quota is made on 
the past performance.  In the case of new importers of ODS, they will be given 10% from total 
annual quota. This is in accordance with the recommendation and experience from EU and 
region countries.  
 
IX. Not applicable.  
 
X. Through the communication between country authorities in charge of the implementation of 
the Montreal Protocol.  
 
XI. There are no such products.  
 
7.a)-d) Not applicable.  
 
Eligibility of importers to apply for licence  
9. All legal persons or entrepreneurs registered in the Central Registry of the Commercial Court are 
eligible to apply for licences. Regarding permits for chemical, beside s above, a legal person must meet 
the requirements in terms of personnel, facilities and equipment.  
 
All pers ons 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.  
 
Documentation and other requirements for application for licen ce 
10.  The application for import of ozone deplet ing substances and alternatives substances must 
contain the following:  
 
- Written request for permits for import/export of ozone deplet ing substances and alternatives 
substances which contains the following  information: name and type of goods; heading tag or 
label of goods tariff; the amount of goods in units of measure; information about the person 
who imports and exports the goods (name, address, registration, and registration number); 
indication of the st ate of origin of goods; the name of the company that supplied the goods and 
the country from which goods are supplied; border crossing;  
- A copy of the invoice or pro -invoice companies that supplied goods; and,  
- Evidence that the importer / exporter is re gistered to carry out these activities;  
- Proof of the administrative fee payment.  
 
11. Importer must present valid license issued by NEPA along with standard customs documentation.  
 
12.  There are administrative fees as follows:  
 
- Administrative fee in the amount of 40 EUR for each imported consignment of ozone deplet ing 
substances;  
 
13.  There is no deposit or advance payment associated with the issue of licenses.  
 
Conditions of licensing  
14.  The license is valid for the period specified in the license, but not longer than one year. In case 
of import of chemicals and ozone deplet ing substances and alternative substances the license is valid 
for the period specified in the license, or until the end  of the current year.  G/LIC/N/3/MNE/5  
 
- 18 - 
 
  15.  There is no penalty for non -utilization of a license or a portion of a license.  
 
16.  The licenses are not transferable between importers.  
 
17.  There are no other conditions attached to the issue of a license.  
 
Other procedural requirements  
18.  There are no other administrative procedures, apart from import licensing required prior to 
importation.  
 
19.  Foreign exchange is automatically provided by the banking authorities for goods to be imported.  
 
3.3  Endangered and pro tected species of flora and fauna  
Outline of System  
1.  Permits for import of species and their products and derivates are issued in accordance with the 
Law on nature protection (OG MNE, No. 054/16) and the CITES Convention. By means of succession, 
on 3 Ju ne 2007, Montenegro ratified the CITES Convention. Montenegro operates under Articles 1 to 
25 of the CITES Convention and it is in compliance with the CITES provisions.  
 
Purposes and coverage of licensing  
2.  Import licenses are required for:  
 
- Endangered  and protected species of wild flora and fauna their products and derivates;  
- Endangered and protected species of wild flora and fauna their products and derivates  in 
accordance with the CITES Convention an d protected  plant, animal and fungus species 
(examples of wild plants, fungi and animals from free and their cultivated specimens; their 
development forms -eggs, seeds, fruits, mycelium, etc.; their parts and derivatives; therefrom 
easily recognizable products) in accordance with the Law of  Nature Protection . 
 
3.  The system applies to goods originating and coming from all countries. Import is forbidden for 
countries that are not parties to the CITES Convention . 
 
4.  The issue of licenses is not intended to limit the quantities or value of imp orts, but exclusively 
with the purpose of adequate monitoring of the imported goods. In case of CITES, the licensing 
intends to control the quantity of imports because it is related to the protection of  the environment 
and fulfilling the obligation in acco rdance with the international agreements: CITES Convention . 
No alternative methods were considered.  
 
5.  The licensing is maintained in accordance with:  
 
- The Law on Confirmation of the CITES Convention on International Trade of Endangered Species 
of Wild Fauna and Flora ( "OG FRY ", International agreements, No. 11/01);  
- The Nature Protection Act ("OG MNE", No. 054/16);  
- The Ordinance on closer conditions for the trade in protected wild species of plants, animals and 
fungi ("OG MNE", No. 109/17) . 
 
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.  
 
Procedures  
6.I Information r egarding CITES species quotas can be found at CITES website 
(http://www.cites.org/ ) and formalities of filing applications for licences can be found at Nature G/LIC/N/3/MNE/5  
 
- 19 - 
 
  and Environment Protection Agency (NEPA) website ( http://www.epa.org.me/ ). Information 
regarding other questions is not applicable.  
 
II. System of quotas for CITES permits is not established in Montenegro.  
 
III. The licenses are not allotted for certain goods partly or only to domestic procedures of like 
goods. Also, all issued licences are published on the NEPA web site. The copy of the CITES 
licence with Customs Administration signature and seal.  
 
IV. Not applicable.  
 
V. Length of time for processing application is pre scribed by the Law on Administrative Procedure.  
Processing time is up to 30 days.  
 
VI. Import can be done immediately after obtaining import licence (date of issuance of the licence 
is stated on the licence).  
 
VII. NEPA is a Single administrative body for consideration of licence applications.  
 
VIII. Not applicable.  
 
IX. Not applicable.  
 
X. Through the communication between country authorities in charge of the implementation of 
the CITES Convention.  
 
XI. There are no such products.  
 
7.a)-d) Not applicable.  
 
8.  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 NEPA to the applicant in a separate administrative act. 
Decision may be appealed to the Ministry of Sustainable Development and Tourism in accordance with 
the Law on Administrative Procedure.  
 
Eligibility of i mporters to apply for licence  
9. All legal persons or entrepreneurs registered in the Central Registry of the Commercial Court are 
eligible to apply for licences.  
 
All persons and companies that fulfil the conditions envisaged by the Law are eligible to ap ply for 
licenses.  
 
-  There is no registration fee ;  
-  There is no published list of authorized operators.  
 
Documentation and other requirements for application for licence  
10.  The application for import of CITES listed species and their products and de rivates has to contain 
the following:  
 
- Application f or issuance of CITES import permit;  
- Copy of CITES export permit;  
- Positive opinion of Montenegrin scientific authorities that import of species will not jeopardize 
survival of that species and sustai nability of biodiversity in Montenegro;  
- Positive opinion of Montenegrin scientific authorities that imported species will be properly 
accommodated;  
- Statement by the importer regarding the mode of species transport and using purposes;  
- Proof of administrative fee payment;  
- Additional documents according to Law on nature protection and Law on foreign trade.  
 G/LIC/N/3/MNE/5  
 
- 20 - 
 
  Written request for permits for plant, animal and fungus species has to contain the following 
information:  
 
- Name and seat, or the name and address of the importer;  
- The name of the input border crossing;  
- Day and start time of importation;  
- Quantity;  
- Provider/supplier (quantity);  
- A court certificate; and  
- Proof of the administrative fee payment.  
 
11. Importer must present valid li cense issued by NEPA along with standard customs documentation.  
 
12.  There are administrative fees as follows:  
- Administrative fee in the amount of 50 EUR for each imported consignment of CITES 
species/products/derivates (1 CITES import permit) . 
 
13.  There is no deposit or advance payment associated with the issue of licenses.  
 
Conditions of licensing  
14.  The license is valid for the period specified in the license, but not longer than one year.  
 
15.  There is no penalty for non -utilization of a license or a portion of a license.  
 
16.  The licenses are not transferable between importers.  
 
17.  There are no other conditions attached to the issue of a license.  
 
Other procedural requirements  
18.  There are no other administrative procedures, apart from import licensing required prior to 
importation.  
 
19.  Foreign exchange is automatically provided by the banking authorities for goods to be imported.  
 
3.4  Hazardous chemicals  
Outline of System  
1.  Permits for free movement of hazardous chemicals and adding biocide into a temporary list of 
biocide s are issued in accordance with the Law on chemicals (OG MNE, No. 51/17) and the Law on 
biocidal products ( "OG MNE ", No. 54/16).  
 
Purposes and coverage of licen sing 
2.  Import licenses are required for:  
 
- Free movement of hazardous chemicals and adding biocide into a temporary list of biocide s. 
 
3.  The system applies to goods originating and coming from all countries.  
 
4.  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 method s were 
considered.  
 
5.  The licensing is maintained in accordance with:  
 
- The Law on chemicals ("OG MNE", No. 51/17);  
- The Law on biocidal products ("OG MNE", No. 54/16);  G/LIC/N/3/MNE/5  
 
- 21 - 
 
  - The Rulebook on detailed conditions for storage and measures for safe keeping an d use of 
hazardous chemicals ("OG MNE", No. 61/18);  
- The Decree on prohibition and restriction of the use, placing on the market and production of 
chemicals that presenting an unacceptable risk to human health and the environment ("OG 
MNE", No. 70/18);  
- The Rulebook on detailed contents of prior notification for export of chemicals ("OG of MNE", 
No. 061/17);  
- The Rulebook on list of dangerous chemicals and products which export is prohibited ("OG of 
MNE", No. 071/18);  
- The Rulebook on conditions for pla cing biocidal products on the market and use ("OG MNE",  
No. 059/16);  
- The Rulebook on content of the application for issuing permit for biocides ("OG MNE",  
No. 017/17);  
- The Rulebook on the contents of the technical dossier and the basic data for biocides ("OG MNE", 
No. 005/17, 9/18);  
- The Foreign Trade Law ("Official Gazette of Republic Montenegro (OG RMNE)", No. 28/04, 37/07 
and "OG MNE", No. 57/14);  
- Decision to amend  National Control list for export and import (OG MNE No.40/20);  
- The Law on Administrative Procedure ("OG MNE", No. 56/14, 20/15, 40/16, 37/17);  
- The Decree on the implementation of the Foreign Trade Law ("OG RMNE", No. 52/04, 44/07 and 
("OG MNE", No. 78 /2017) . 
 
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.  
 
Procedures  
6. Not applicable.  
 
7.a) 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 day from 
the day of receipt of the off icial request.  License could be obtained in a shorter period than 30 
days if all required documents are submitted.  
 
b) There is no such possibility.  
 
c) There are no such limitations.  
 
d) NEPA is a Single administrative body in charge of consideration of licence applications.  
 
8.  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. 
Reason s for rejection of any form are given by NEPA to the applicant in a separate administrative act. 
Decision may be appealed to the Ministry of Sustainable Development and Tourism in accordance with 
the Law on Administrative Procedure.  
 
Eligibility of importe rs to apply for licence  
9. All legal persons or entrepreneurs registered in the Central Registry of the Commercial Court are 
eligible to apply for licences. Regarding permits for chemical, beside s above, a legal person must meet 
the requirements in terms o f personnel, facilities and equipment.  
 
All persons and companies that fulfil the conditions envisaged by the Law are eligible to apply for 
licenses.  
 G/LIC/N/3/MNE/5  
 
- 22 - 
 
  -  There is no registration fee.  
-  There is no published list of authorized operators.  
 
Documentation and other requirements for application for licence  
10.  Written request for permits for free movement of hazardous chemicals has to contain the 
following information:  
 
- Name and seat, or the name and address of the supplier, trade name and chemical name and 
address of the manufacturers of chemicals;  
- Information on the method of packaging and labelling of chemicals;  
- Information on the purpose and use of chemicals;  
- Data on the quantity of chemicals;  
- Information on the method of sto rage (location, description of facilities);  
- Measures to be implemented for the safe keeping and storage of chemicals;  
- Other information requested by the NEPA;  
- Contract of insurance against liability for any damage that may result from the use of 
chem icals; 
- Proof of  the administrative fee payment.  
 
For the request to adding the biocide into a temporary list of biocide s, the applicant has to submit the 
basic information about the biocide:  
 
- The n ame of the biocide’s manufacturer;  
- Authorized represe ntative of the biocide’s manufacturer;  
- Identity of biocides and active substances in the biocide;  
- Effectiveness of biocides;  
- The content of the declaration;  
- The method of use;  
- Classification, packaging and labelling of biocides;  
- Annex 4 of Rule book on the contents of the technical dossier and the basic data for the biocide; 
and 
- Proof of the administrative fee payment.  
 
11. Importer must present valid license issued by NEPA along with standard customs documentation.  
 
12.  There are administrative fees as follows:  
 
- Administrative fee in in the amount of 40 EUR for chemicals . 
 
13.  There is no deposit or advance payment associated with the issue of licenses.  
 
Conditions of licensing  
14.  The license is valid for the period specified in the license, but not longer than one year. In case 
of import of chemicals and ozone depleted substances and alternative substances  the license is valid 
for the period specified in the license, or until the end of the current year.  
 
15.  There is no penalty for non -utilization of a license or a portion of a license.  
 
16.  The licenses are not transferable between importers.  
 
17.  There are no other conditions attached to the issue of a license.  
 
Other procedural requirements  
18.  There are no other administrative procedures, apart from import licensing required prior to 
importation.  
 
19.  Foreign exchange is automatically provided by the banking authorities for goods to be imported.  
 G/LIC/N/3/MNE/5  
 
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  3.5  Ionizing radiation generators and radioactive sources for spare parts for devices that 
produce ionizing radiation  
Outline of System  
1.  Permits for importing  ionizing radiation generators, for radioactive sources for spare parts for 
devices that produce ionizing radiation are issued in accordance with the Law on ionizing radiation 
protection and radiation safety (OG MNE, No. 56/09, 58/09).  
 
Purposes and covera ge of licensing  
2.  Import licenses are required for:  
 
- Generators of ionizing radiation, radioactive sources and spare parts for devices that produce 
ionizing radiation.  
 
3.  The system applies to goods originating and coming from all countries.  
 
4.  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.  
 
5.  The licensing is maintained in accordance with:   
-        The Law on ionizing radiation protection and radiation safety ("OG RMNE", No. 56/09, 58/09).  
- The Foreign Trade Law ("Official Gazette of Republic Montenegro (OG RMNE)", No. 28/04, 37/07 
and "OG MNE", No. 57/14);  
- Decision to amend National Cont rol list for export and import (OG MNE No.40/20);  
- The Decree on the implementation of the Foreign Trade Law ("OG RMNE", No. 52/04, 44/07 and 
("OG MNE", No. 78/2017);  
-        The Law on Administrative Procedure ("OG MNE", No. 56/14, 20/15, 40/16, 37/17) . 
  
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.  
 
Procedures  
6. Not applicable.  
 
7.a) 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 day 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.  
 
b) There is no such possibility.  
 
c) There are no such limitations.  
 
d) NEPA is a Single administrative body in charge of consideration of licenc e applications.  
 
8.  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 NEPA to the applicant in a separate administrative act. 
Decision may be appealed to the Ministry of Sustainable Development and Tourism in accordance with 
the Law on Administrative Procedure.  
 G/LIC/N/3/MNE/5  
 
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  Eligibility of importers to apply for licence  
9. All legal persons or entrepreneurs registered in the Central Registry of the Commercial Court are 
eligible to apply for licences. Regarding permits for chemical, beside s 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.  
 
Documentation and other requirements for application for licence  
10.  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 t he 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 f or 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 wi th prescribed requirements for their trading.  
 
11. 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 de vice is required.  
 
12.  There are administrative fees as follows:  
 
- Administrative fee in the amount of 100 EUR for ionising radiation.  
 
13.  There is no deposit or advance payment associated with the issue of licenses.  
 
Conditions of licensing  
14.  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.  
 
15.  There is no penalty for non -utilization of a license or a por tion of a license.  
 
16.  The licenses are not transferable between importers.  
 
17.  There are no other conditions attached to the issue of a license.  
 
Other procedural requirements  
18.  There are no other administrative procedures, apart from import licensing required prior to 
importation.  
 
19.  Foreign exchange is automatically provided by the banking authorities for goods to be imported.  
 
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