G/LIC/N/3/MNE/3  
 
27 May 2019  
(19-3668) Page: 1/14 
Committee on Import Licensing  Original: English  
 
 REPLIES TO QUESTIONN AIRE ON IMPORT LICEN SING PROCEDURES  
NOTIFICATION UNDER A RTICLE 7.3 OF THE AG REEMENT  
ON IMPORT LICENSING PRO CEDURES  (2019)  
MONTENEGRO  
The following communication, dated 17 May 2019, is being circulated at the request of the delegation  
of Montenegro1. 
 
_______________  
 
 
1   MINISTRY OF ECON OMY ................................ ................................ .............................  1 
2   MINI STRY OF HEALTH - AGENCY FOR MEDICINES AN D MEDICAL DEVICES  ................  3 
3   MINISTRY OF SUST AINABLE DEVELOPMENT AND TOURISM - ENVIRO NMENTAL 
PROTECTION AGENCY  ................................ ................................ ................................ ..... 8 
 
1  MINISTRY OF ECONOMY  
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) and the Law on Foreign Trade in Arms and Military 
Equipment (OG MNE No. 40/16). Import licenses are required for weapons and military equipment 
and other goods listed in the National Control List for export and import.  
 
Purposes and coverage of licensing  
2.  Imports of:  
 
- Weapons and military equipment  – specific tariff lines from Chapters 27, 28, 29, 31, 36, 38, 
71, 88, 89, 93 ; 
 
- Other goods from National Control List for export and import  Chapter 29 –16  tariff 
lines (polyacetals)/Chapter 30 –57 tariff lines Chapter 31 -1 tariff line, Chapter 36 -20 
tariff lines, Chapter 39 -2 tariff lines,  Chapter 40 -2 tariff lines, Chapter 63 -1 tariff 
line,  Chapter 65 -2 tariff lines,  Chapter 71 -31 tariff l ines, Chapter 83 -1 tariff line,  
Chapter 84 -4 tariff lines, Chapter 85 -5 tariff lines, Chapter 88 -6 tariff lines, Chapter 
90-1 tariff line, Chapter 93 -13 tariff lines, Chapter 95 -1 tariff line ; 
 
are subject  to licensing.  
 
3.  The import licensing system ap plies to goods originating in and coming from all countries.  
 
                                                
1 Major changes, as compared to the previous submission, have been highlighted in bold by the 
Secretariat.  G/LIC/N/3/MNE/3  
 
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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 licenses only when it is necessary to:  
- Protect human, animal or plant life or health;  
- Protect national security;  
- 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 Economy:  
 
- 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 Foreign Trade in Arms and Military Equipment  (OG MNE No. 40/16) ; 
- The Law on Optical Discs (RM OG No. 2/07 and OG MNE No. 53/11 ); 
- The Law on Administrative Procedure (RM OG No. 60/03 and OG MNE No 56/14; 20/15; 40/16 
and 37/17) ; 
- The Law on Administrative Dispute (OG MNE No. 54/16) ; 
- The National Control list for export and import ( OG MNE No. 22/19) ; and 
- The National Control List of Weapons and Military Equipment ( OG MNE No. 69/18 ). 
 
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 Economy receives opinion from the Ministry of Foreign 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 even t 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 in Arms and Military Equipment in order to be engaged in 
importation of arms and military equipment, natural and legal persons have to be r egistered within 
the Ministry of Economy. In other cases, all persons having the right to engage in import activities 
are eligible to apply for licenses which are issued by the Ministry of Economy. There is no published 
list of importers, with exception of  the register of importers of weapon kept within the Ministry of 
Economy.  
 
Documentation and other requirements for application for licence  
10.  Please see Exhibit I2. 
 
                                                
2 Available for consultation in the Secretariat (Market Access Division)(English only).  G/LIC/N/3/MNE/3  
 
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  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 
Nos. 55/03; 46/04; 81/05; 02/06 and OG MNE 22/08; 77/08; 03/09; 40/10; 20/11; 26/11; 56/13; 
45/14; 53/16; 03/17) the Ministry of E conomy charges 100€ for issuing licenses for weapons and 
military equipment  and 10€ for goods the from 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 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 
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 iss uance 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 impor ted.   
 
2  MINISTRY OF HEALTH - AGENCY FOR MEDICINE S AND MEDICAL DEVICE S 
Outline of system  
1.  Agency for Medicines and Medical Devices (hereinafter: Agency) issues authorisations 
for the import of: human and veterinary medicines, medical devices, 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 56/11 and No 06/13) ;  
• Law on Medical Devices ("Official Gazette of Montenegro", No 79/04, No 53/09 and 
No 40/11) ;  
• 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 83/0 9 and No  40/11) ;  
• Law about preventing of drug abuse ("Official Gazette of Montenegro", No 28/11 and 
No 35/13) ; 
• Decision on the control list for export and import of goods ("Official Gazette of 
Montenegro", No  22/2014, 38/2015 and 29/2016, 62/2016 and 24/2 017) ; 
• Law on administrative procedure ("Official Gazette of Montenegro", No 056/14, 
020/15, 040/16 and 037/17) . 
 
Purposes and coverage of licensing  
2.  Agency issues import licences for the following products:  
 
• Human and veterinary medicines ; 
• Drugs, precur sors and medicines containing precursors ; and G/LIC/N/3/MNE/3  
 
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  • 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, medical devices and precursors 
is not to limit the quantity or value of the import (except for drugs, the explanation is below), but 
to check the documentation on the quality, safety and ef ficacy of the products imported. Alternative 
methods for meeting the goals are not considered, because issuance of import licences is in 
accordance with the national legislation which is to a great extent harmonized with the EU legislation 
in the area.   
 
There is an annual quota for drugs in terms of quantity at the national level that cannot be exceeded. 
This quota, for each calendar year, is determined by the International Narcotics Control Board in 
Vienna (INCB), and authorisations for the import of dru gs are issued according to it.  
 
5.  Issuance of import licences is conducted in accordance with:  
 
• Law on Medicines ("Official Gazette of Montenegro", No 56/11 and No 06/13) ;  
• Law on Medical Devices ("Official Gazette of Montenegro", No 79/04, No 53/09 and No 40/11) ; 
• 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 Gaz ette 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 not to issue the licence based on 
administrative discretion.  
 
Article 5 of the Law on Medicines ("Official Gazette of Montenegro", No 56/11 and No 06/13) 
envisages that the Government of Montenegro may determine alternative procedure and conditions 
for the issuance of marketing authorisat ion 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 
that importers submit to the A gency for each drug individually on annual level. After processing 
these data, the Agency sends data to the Ministry of Health, which sends these data for the 
approval to the International Narcotics Control Board Authority in Vienna (INCB).  
 
 In the event  that there are increased needs in relation to the required annual quota, Agency 
through the Ministry of Health may, with an explanation, ask for an increase in quotas for certain 
drugs. All the information needed to obtain import authorisation for drugs ( regulations, 
instructions and forms) the importer can find on the website of the Agency http://calims.me/ . 
 
II. Amount of quotas is determined annually by the International Narcotics Control Board. 
Application for import m ay be submitted by necessity, with the condition not to exceed the 
quota, and the validity period is 6 months and it applies to a single import.  
 
III. The Agency sends one copy of the import licence for drugs to the Customs Administration, and 
after custom s clearance of the goods, Customs returns this copy of the licence to the Agency, 
which contain details of the realisation of imported products. The amount that has not been 
imported is not counted into the allowed quota. The importer receives two copies o f import 
authorisations, one of which must be sent to the competent 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 im port of drugs is up 
to 30 days but usually within 7 days.  G/LIC/N/3/MNE/3  
 
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  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 is performed only by one administrative body - 
Agency 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 dem and takes 
precedence over others for obtaining import licence for a certain drug (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 market ing of drugs, must submit annual demand 
for drugs before submitting an application for import.  
 
IX. Import licences are always needed, regardless of the fact 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 is identical regardless of whether the product will be marketed 
in Montenegro or exported to other countries (which re quires a special export licence).  
 
7.a) Products that are not subjected to the limitation in quantitative terms are medicines (for human 
and veterinary use), precursors and medical devices.  
 
 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 don e by priority (providing all necessary documentation 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 the question a) . 
 
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 - Agency 
for Medicines and Medical Devices.  
 
8.  An application for 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 applicants have the right to appeal to the ministry in charge, in accordance 
with:  
   
-  The Law on Medicines ("Official Gazette of Montenegro", No 56/11 and No 06/13) ;  
-  The Law on Medical Devices ("Official Gazette of Montenegro", No 79/04, No 53/09 
and No  40/11) ;  
-  The 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);  
-  The Law about preventing of drug abuse ("Official Gazette of Montenegro", No 28/11 
and No  35/13) ; 
-  The Law on administrative  procedure ("Official Gazette of Montenegro", No 056/14, 
020/15, 040/16 and 037/17).  
 G/LIC/N/3/MNE/3  
 
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  Eligibility of importers to apply f or 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 Agency or authority in charge of veterinary 
affairs for  veterinary medicines. Legal persons that import and market drugs and precursors 
additionally require a separate authorisation for wholesale of drugs or precursors.  
 
Wholesale of medical devices m ay be performed by legal persons seated in Montenegro, which are 
entered in the register kept by the Agency.  
 
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 authorised  to perform import and marketing on the basis of 
authorisations issued by the Agency, is published on the website of the Agency http://calims.me/   
and is regularly updated.  
 
Documentation and other requirements for application for licence  
10.  The portal Agency http://calims.me/  contains all the data that must be listed on the application 
for import all product groups.  
  
• documentation required for obtaining authorisation for import, export and transit of narcotic drugs:  
 
1)  Cover letter ;  
2)  Application for authorisation with information on imported/exported drugs ; 
3)  Statement on purpose signed by the user ; 
4)  Invoice or pro -forma invoice from a supplier ; 
5)  Import authorisation issued by  competent authority of importing country (when export 
from Montenegro is in question) and export authorisation issued by competent authority 
of exporting country (when transit through Montenegro is in question) ;  
6)  Certificate of analysis of a batch of a medicine ; 
7)  Proof of payment of prescribed fees . 
 
• documentation required for obtaining authorisation for import, export and transit of precursors 
and medicines containing precursors:  
 
1)  Cover letter ;  
2)  Application for authorisation with information on imported/exported drugs ; 
3)  Statement on purpose signed by the user ; 
4)  Invoice or pro -forma invoice from a supplier ; 
5)  Import authorisation issued by the competent authority in the importing country (in case 
of export from Montenegro) a nd export authorisation of the issued by the competent 
authority of the exporting country (in case of transit through Montenegro) – at the request 
of the Agency only ; 
6)  Certificate of analysis of a batch of a medicine ; 
7)  End user's statement on purpose  of precursors ; 
8)  Proof of payment of prescribed fees . 
 
• documentation required for obtaining authorisation for import of medicines for human and 
veterinary use:  G/LIC/N/3/MNE/3  
 
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  1)  Cover letter ;  
2)  Table containing list of medicines to be imported/exported ; 
3)  Invoice or pro -forma invoice from a supplier ; 
4)  Evidence that a medicine has been granted marketing authorization in the country of a 
manufacturer, in countries of European Union or in countries that have same standards 
for issuing marketing authorization  (marketing authorisation, or CPP certificate in English 
language, or translated in to Montenegrin) – for the first import or at the request of the 
Agency ; 
5)  Evidence from the competent authority from the European Union Member States that a 
medicine has been manufactured in accordance with Guidelines on Good Manufacturing 
Practice – GMP certificate issued by one of the EU Member States – for the first import or 
at the request of the Agency ;  
6)  Summary of Product Characteristics (SmPC) and Package Leafle t (PL) approved in one of 
the countries referred to in point 4 (in English, or translated into Montenegrin). It is also 
necessary to submit Mock -up, approved along with the SmPC and PL or developed in line 
with the approved labelling for immediate and oute r packaging – for the first import or at 
the request of the Agency ;  
7)  Certificate of analysis for each batch(es) of medicines to be imported ; 
8)  Agreement/statement of the manufacturer/MAH from the EU on the appointment of 
authorised distributors for M ontenegro – for the first import or at the request of the 
Agency ; 
9)  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 from the National laboratory of the Agency for Medicines and 
Medical Devices of Serbia (ALIMS) ; 
10)  Manufacturing and control summary protocol (for vaccines only), for batch(es) for which 
certificates are submitted ; 
11)  Justified reques t 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 of the Agency ;  
12)  Proof of payment of prescribed fees . 
 
• documentation required for obtaining autho risation 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 ap plication for entry into the register of medical devices kept 
by the Agency; in case that the application has been submitted, the date of submission 
of the documentation for entry into the register and number under which it is filed in the 
Agency has to be  stated;  
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 
Agency’s register, the reason why the medical device that has alread y been entered into 
the register cannot be used has to be given;  
5)  Supporting certificates for each product from the list:  
 -  Manufacturer'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. Upon actual importation, additional documentation is required only for the products belonging 
to the group of controlled substances i.e. drugs and precursors. Documents required are related to 
the quantity of the imported products and the date of the import. For other group of products 
(medicines and medical devices) no additional documentation upon import is not required.  
 
12.  The fees for issuing import licences are defined by Decisions adopted by the Government:  
 G/LIC/N/3/MNE/3  
 
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  -  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 
Monten egro", 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).  
 
In line with those decisions fees for import licences for medicines and medical devices are 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  
 
In line with the Decisions fees for import licences for import/export/transit for d rugs and  psychotropic 
substances in line with the international conventions are 1% of the total import /export/transit  value.  
 
In line with the Decisions fee for import/export/transit of precursors is 50 euros.  
 
13.  There is no deposit or advance payment associate d with the issue of licenses.  
 
Conditions of licensing  
14.  The period of validity of an import licence for medicines and medical devices is 3 months from 
the date of issuance and is valid for a multiple import.  
 
The period of validity of an import licence for drugs is 6 months and is valid for a single import.  
 
The period of validity of an import licence for precursors is 30 days and is valid for a single import.  
 
Licences cannot be extended, but a request for a new licence can be submitted.  
 
15.  There is no 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.  
 
(b)  No other conditions attached.  
 
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  MINISTRY OF SUSTAINA BLE DEVELOPMENT AND TOURISM - ENVI RONMENTAL 
PROTECTION AGENCY  
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 G/LIC/N/3/MNE/3  
 
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  of non -hazardous waste to remove and use as fuel or other means to generate energy is forbidde n 
as well.  
 
Permits for import/export of ozone depleted substances and alternative substances are issued in 
accordance with the Law on air protection (OG MNE, No. 25/10, 40/11, 43/15) and the Decree on 
ozone depleted 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 obligations under the Montreal protocol was to establish import/export licences 
to control consumption of ozone depleted substances. Montenegro operated under Article 5 of 
Montreal protocol and it is in compliance with the provisions of the Protocol.  
 
Permits for imp ort 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 June 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.  
 
Permits for free movement of hazardous chemicals and adding the biocide into a temporary list of 
biocide 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).  
 
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 io nizing radiation protection 
and radiation safety (OG MNE, No. 56/09, 58/09).  
 
Purposes and coverage of licensing  
2.  Import licenses are required for:  
 
- Transboundary movement of waste (import, export and transit of waste);  
- 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 and  protected  plant, animal and fungu s 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 ;  
- Ozone depleting substances and alternative substances;  
- Free movement of hazardous chemicals and adding the biocide into a temporary list of biocide; 
and 
- 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. Import is forbidden for 
countries that are not parties to the CITES Convention and Montreal protocol on ozone depleted 
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 case of CITES, ozone depleted 
substances and waste management the licensing intends to control  the quantity of imports because 
it is related to the protection of environment and fulfilling obligation in accordance with the 
international agreements: CITES Convention, Basel Convention and Montreal Protocol. 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 Transport of Dangerous Substances ("OG MNE", No. 32/14);  
- The Law on Confirmation of the Basel Convention on the Control of Tr ansboundary Movements 
of Dangerous Waste and Their Disposal ("OG FRY" -International agreements, No. 2/99);  G/LIC/N/3/MNE/3  
 
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  - The Rulebook on the content of documentation submitted in support of the application for the 
permit for import, export and transit of waste, as wel l as lists of waste classification and the 
content and manner of keeping a register of issued licenses ("OG MNE", No. 83/16, 76/16);  
- The Law on Confirmation of the CITES Convention on International Trade of Endangered 
Species of Wild Fauna and Flora ("O G 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 Law on air protection ("OG MNE", No. 25/10, 40/11, 43/15);  
- The Decree on ozone depleted substances and alternative substances ("OG MNE", No. 5/11);  
- The Law on ratification of The Vienna Convention 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 rati fication 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 Law on chemicals ("OG MNE", No. 51/17);  
- The Law on biocidal products  ("OG MNE", No. 54/16);  
- The Rulebook on detailed conditions for storage and measures for safe keeping and 
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 ch emicals 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 placing biocidal products on the market and use ("OG MNE", 
No. 059/16);  
- The Rulebook on content of the application for issuing permit for a bioc ides ("OG MNE", 
No. 017/17);  
- The Rulebook on the contents of the technical dossier and the basic data for the 
biocide ("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);  
- The Decision on Control List for Export and Import of Goods ("OG MNE", No. 22/19);  
- 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 Law on ionizing radiation protection and radiation safety ("OG RMNE", No. 56/09, 58/09).  
 
The legislation doesn’t 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 depleted substances (ODS) are under the quota system. Procedure for quota 
system for import of the ozone deplete d substances are prescribed by the Decree on ozone 
depleted substances and alternative substances ("OG MNE",  No. 5/11).  
 
 Information regarding 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 
and Environment Protection Agency (NEPA) website ( http://www.epa.org.me/ ). Information 
regarding other questions is not applicable.  
 
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 G/LIC/N/3/MNE/3  
 
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  than December 1st of the current year for the following year. The lice nces for import are issued 
for each import separately. 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. Legal person or entrepren eur performing the imports of ODS are obligated to submit 
proof to the NEPA Unified 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 al locations are not added to quotas for the next year. Also, all issued 
licences are published on the NEPA web site. The copy of the CITES licence with Customs 
Administration signature and seal.  
 
IV. Written application of importer for setting annual quota f or ODS imports, have to be submitted 
to the NEPA not later than December 1st 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 application is prescribed 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. Quotas usually satisfy demand, as they are referred to substances whose consumption is 
phasing out. All applications are examine d 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 
CITES Convention and Montreal protocol.  
 
XI. There are no such products.  
 
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 doc uments 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. Decisio n may be appealed to the Ministry of Sustainable Development and Tourism in 
accordance with the Law on Administrative 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 above, a legal person must 
meet the requirements in terms of personnel, facilities and equipment.  
 G/LIC/N/3/MNE/3  
 
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  All the persons and companies that fulfil the conditions envisage d 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.  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 agreement between importers and exporters of waste with validity period until the 
completion of delivery of waste and with financial guarantees or insurance policy or other 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 wast e 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, t he time of arrival of 
waste on border crossing point, route of waste movement from the border customs office to 
processors; and,  
- Proof of the administrative fee payment.  
 
The application for import of ozone depleted substances and alternatives substances  must contain 
the following:  
 
- Written request for permits for import/export of ozone depleted substances and alternatives 
substances which contains the following information: name and type of goods; heading tag or 
label of goods tariff; the amount of goo ds in units of measure; information about the person 
who imports and exports the goods (name, address, registration, and registration number); 
indication of the state 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 registered to carry out these activities;  
- Proof of the administrative fee payment.  
 
The appli cation for import of CITES listed species and their products and derivates 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 sustainability 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.  
 
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.  
 G/LIC/N/3/MNE/3  
 
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  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 m anufacturers 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 storage (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 
chemicals;  
- Proof of  the administr ative fee payment.  
 
For the request to adding the biocide into a temporary list of biocide, the applicant has to submit the 
basic information about the biocide:  
 
- The n ame of the biocide’s manufacturer;  
- Authorized representative 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 Rulebook on the contents of t he technical dossier and the basic data for the biocide; 
and 
- Proof of the administrative fee payment.  
 
As regards the ionizing radiation, the request has to include basic information about the goods to be 
imported; a general application form does not exi st. 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 ioni zing 
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 r adiation 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 device s producing ionizing radiation are 
secured in accordance with 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 device is required.  
 
12.  There are administrative fees as follows:  
 
- Administrative fee in the amount of 5 EUR for non -hazardous waste;  
- Administrative fee in the amount of 50 EUR for each imported consignment of CITES 
species/products/derivates (1 CITES import permit);  
- Administrative fee in the amount of 50 EUR for each imported consignment of ozone depleted 
substances;  
- Administrative fee in in the amount of 50 EUR for chemicals;  
- Administrative fee in the amount of 100 EUR for ionising radiation.  
 G/LIC/N/3/MNE/3  
 
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  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 t han 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. When it comes to ionising 
radiation, the license is va lid up to one year and cannot be extended.  
 
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 lic ense.  
 
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.  
 
__________