G/LIC/N/3/MNE/2  
 
20 June 2018  
(18-3862) 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  (2018)  
MONTENEGRO  
The following communication, dated 25 May 2018, is being circulated at the request of the 
delegation of Montenegro . 
 
_______________  
 
1   MINISTRY OF ECONOMY  ................................ ................................ ..............................  1 
2   MINISTRY OF HEALTH - AGENCY FOR MEDICINES  AND MEDICAL DEVICES  .................  3 
3   MINISTRY OF SUSTAINA BLE DEVELOPMENT AND TOURISM - 
ENVIRONMENTAL PROTEC TION AGENCY  ................................ ................................ ..........  9 
 
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 
Equip ment (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.  Import s 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 31 -1 tariff line 
(ammonite)/ Chapter 39  – 1 tariff line (polyacetals)/ Chapter 71 – 26 tariff lines (pre cious 
metals)/ Chapter 84 – 1 tariff line (machines for processing rubber).  
 
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 human, animal or plant life or health;  
- Protect national security;  
- Protect environment or exhaustible natural resources;  
- Protect public morals;  
- Protect intellectual property rights; or  G/LIC/N/3/MNE/2  
 
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  - 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. 24/17) ; and 
- The National Control List of Weapons and Military Equipment (OG MNE No. 33/17).  
 
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 Economy receives opinion from the Ministry of Foreign Affairs, the Ministry of 
Defence and the Ministry of Intern al 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 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 ar ms and military equipment, natural and legal persons have to be registered 
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 Ec onomy. 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 I1.  
 
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 Economy charges 10 0€ for issuing licenses for 
                                                
1 Available for consultation in the Secretariat (Market Access Division)(English only).  G/LIC/N/3/MNE/2  
 
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  weapons and military equipment  and 10€ for goods 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 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 specifie d 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 lic ence.  
 
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.   
 
2  MINI STRY OF HEALTH - AGENCY FOR MEDICINES  AND MEDICAL DEVICES  
Outline of System  
1.  Agency for Medicines and Medical Devices (hereinafter: Agency) issues licenses for the import 
of: human and veterinary medicines, medical devices, medicines classified as drugs  (hereinafter: 
drugs), precursors and medicines containing precursors. The licenses are issued in accordance with 
the following legislation: the Law on Medicines, the Law on Medical Devices, the Law on the control 
of manufacture and marketing of substances  that can be used in the manufacture of narcotic drugs 
and psychotropic substances, the Law on the Prevention of Drug Abuse , the Decision on the control 
list for export and import of goods , the Law on general administrative procedure , and the Law on 
admini strative procedure.  
 
Purposes and coverage of licensing  
2.  Agency issues import licences for the following products: human and veterinary medicines, 
drugs, precursors and medicines containing precursors, 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, medical devices and 
precursors is not to limit the quantity or value of the import (except for drugs, the explanation is 
below), but to c heck the documentation on the quality, safety and efficacy of the products 
imported. Alternative methods for meeting the goals are not considered, because issuance of 
import licenses 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 drugs 
are issued according to it.  
 
5.  Issuance of import licences is conducted in accordance with:  
 
- The Law on Medicines ("Official Gazette of Monte negro", No 56/11 and No 06/13);  
- The Law on Medical Devices ("Official Gazette of Montene gro", No 79/04, No 53/09 and 
No 40/11);  G/LIC/N/3/MNE/2  
 
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  - The Law on the Control of Manufacture and Marketing 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 on the Prevention of Drug Abuse ("Official Gazette of Montenegro", No 28/11 and 
No 35/13) ;  
-  The Law on G eneral Administrative Procedure ("Official Gazette of Montenegro", No 60/03, 
No 73/10 and No 32/11) ; 
-  The Law on Administrative Procedure ("Official Gazette of Montenegro", No 056/14, 020/15, 
040/16 and 037/17) ; and 
-  The 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  24/2017).  
 
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 procedures and 
conditions for the issuance of marketing authorisation for a medicine.  
 
Procedures  
6.I. Information on permitted annual quotas for import of drugs are published on the website of 
the Interna tional Narcotics Control Board (www.incb.com). Quotas are formed on the basis 
of needs submitted to the Agency by importers for each drug individually on annual level. 
After processing these data, the Agency submits the data to the Ministry of Health, and the 
Ministry submits these data for the approval to the International Narcotics Control Board 
Authority in Vienna (INCB).  
 
In the event of increased needs in relation to the annual quota approved by the INCB, the 
Agency may ask for increase in quotas for certain drugs through the Ministry of Health and 
with an explanation. All the information needed to obtain import authorisat ion for drugs 
(regulations, instructions and forms) are available on the website of the Agency 
http://calims.me/ . 
 
II. Amount of quotas is determined annually by the INCB. Application for import may be 
submitted as necessa ry, under the condition not to exceed the quota, while the validity 
period of a license is 6 months and it applies to a single import.  
 
III. The Agency sends one copy of the import license for drugs to the Customs Administration, 
and after customs clearanc e of the goods the Customs Administration returns the copy of 
the license containing details of the realisation of imported products to the Agency. The 
amount that has not been imported is not counted into the allowed quota. The importer 
receives two copie s of import authorisations, one of which must be sent to the competent 
authority of the exporting country.  
 
IV. Applications for licenses may be submitted as soon as the quotas are published.  
 
V.  The period needed for processing the application and issuin g the license for the import of 
drugs doesn’t exceed 30 days, but licenses are usually issued within 7 days.  
 
VI.  Import can be done as soon as the import license is obtained (date of issuance of the licence is 
stated on the licence).  
 
VII. Processing of applications for import of drugs is performed by one administrative organ - the 
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 the annual quota, the applicant which did not import his stated annual request takes 
precedence over others for obtaining import licence for a certa in drug (see answer to 
question  I). Applications for import are processed according to the date of receipt, 
chronologically. T he new importer, who obtained wholesale licence for marketing of drugs, G/LIC/N/3/MNE/2  
 
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  must submit annual request for drugs to the Agency before submitting an application for 
import.  
 
IX. Import licences are always required, regardless of the fact that exporting countrie s issues 
export licences. Import licences are not issued automatically.  
 
X. Not applicable.  
 
XI. There have been no such cases so far.  The procedure for approving the import of drugs is 
identical regardless of whether the product is marketed in Montenegro  or exported to other 
countries (which require a special export licence).  
 
7. (a) Products that are not subjected to quantitative limitations are medicines (for human and 
veterinary use), precursors and medical devices.  
 
 The application for import for the se products may be submitted at any time. The period 
needed for processing the application and issuing the license for import  doesn’t exceed 30 
days. However, in practice the period needed for a license to be issued is 7 days, or if the 
goods have already arrived at the customs and at the request of the importer, the period may 
be even shorter, i.e. be done by priority (provision of all necessary documentation is still 
obligatory).  
 
(b) In the case of emergency provided that the required documentation is co rrect, the licence may 
be issued in less than 30 days or shorter than the average period (see answer to 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 by one administrative body – the Agency for 
Medicines and Medical Devices . 
 
8.  An application for license 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 appropriate legal act.  
 
In case of rejection, the applicants have the right to appeal to the  Ministry in charge (the Ministry of 
Health), in acc ordance with:  
 
- The Law on Medicines ("Official Gazette of Mont enegro", No 56/11 and No 06/13);   
-  The Law on Medical Devices ("Official Gazette of Montene gro", No 79/04, No 53/09 and 
No 40/11);  
-  The Law on the C ontrol of Manufacture and Marketing of Substances that can be used in the 
manufacture of narcotic drugs and psychotropic substances ("Official Gazette of 
Monte negro", No 83/09 and No 40/11);  
-  The Law on the Prevention of Drug Abuse ("Official Gazette of Montenegro", No 28/11 and 
No 35/13);  
- The Law on General Administrative Procedure ("Official Gazette of the Republic of 
Montenegro” No 60/03) ; 
-  The Law on General Administrative Procedure ("Official Gazette of Montenegro", No 60/03, 
No 73/10 and No 32/11) ; 
-  The Law on A dministrative Proced ure ("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 placed in Montenegro, which possess 
the 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 precurso rs are 
additionally required to possess a separate authorisation for wholesale of drugs or precursors.  
 G/LIC/N/3/MNE/2  
 
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  Wholesale of medical devices may be performed by legal persons seated in Montenegro, which are 
entered in the register kept by the Agency.  
 
Fees for is suance of licences for the import and wholesale of all these products are defined by:  
 
-  The 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   
-  The 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 t he 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 t he Agency http://calims.me/  
and is regularly updated.  
 
Documentation and other requirements for application for licence  
10.  The portal Agency http://calims.me/  contains 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:  
 
- cover letter ; 
- application for authorisation with information on imported/exported drugs ; 
- statement on purpose signed by the user ; 
- invoice or pro -forma invoice from a supplier ; 
- 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) ;   
- certificate of analysis of a batch of a medicine ; 
- proof of payment of prescribed fees . 
 
 documentation required for obtaining authorisation for import, export and transit of 
precursors and medicines containing precursors:  
 
- cover letter ;   
- application for authorisation with information on imported/exported drugs ; 
- statement on purpose signed by the user ; 
- invoice or pro -forma invoice from a supplier ; 
- import authorisation issued by the competent authority in the importing country (in case 
of export from Montenegro) and 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 ; 
- certificate of analysis of a batch of a medicine ; 
- end user's statement on purpose of precursors ; 
- proof of payment of prescribed fees . 
 
  G/LIC/N/3/MNE/2  
 
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   documentation required for obtaining authorisation for import of medicines for human and 
veterinary use:  
 
- cover letter ;   
- table containing list of medicines to be imported/exported ; 
- invoice or pro -forma invoice from a supplier ; 
- evidence that a medicine has been granted marketing authorization in the country of a 
manufacturer, in countries of the European Union or in countr ies 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 ; 
- evidence from the competent authorit y from the European Union Member States that a 
medicine has been manufactured in accordance with the 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 ;   
- summary of Product Characteristics (SmPC) and Package Leaflet (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 develop ed in line 
with the approved labelling for immediate and outer packaging – for the first import or at 
the request of the Agency ;   
- certificate of analysis for each batch(es) of medicines to be imported ; 
- agreement/statement of the manufacturer/MAH from the EU on the appointment of 
authorised distributors for Montenegro – for the first import or at the request of the 
Agency ; 
- in case of import/export of blood products and immunological products a certificate of 
analysis for every batch is required, from a manu facturer 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) ; 
- manufacturing and control summary protocol (for vaccines only), for batch(es) for which 
certificates are submitted ; 
- 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 of the Agency ;   
- proof of payment of prescribed fees . 
 
 documentation required for obtaining authorisation for import of medical devices:  
 
- cover letter ; 
- application for authorisation with information on imported medical devices ; 
- letter-headed statement of the applicant for import of medical devices justifying t he 
reason for not submitting application 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 i s filed in the 
Agency has to be stated;  
- letter-headed 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 m edical device that has already been entered into 
the register cannot be used has to be given;  
- supporting certificates for each product from the list:  
- Manufacturer's Declaration of Conformity (DoC)  ; 
- EC certificates, except for medical devices of Class I an d In Vitro – Others ; 
- invoice or pro -forma invoice from a supplier ; 
- proof of payment of prescribed fees . 
 
  G/LIC/N/3/MNE/2  
 
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  11.  Upon actual importation, additional documentation is required only for the products belonging to 
the group of controlled substances i.e. drugs a nd precursors. Documents required are related to the 
quantity of the imported products and the date of the import. For the 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:  
 
- The 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   
- The 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 (Of ficial Gazette of Montenegro 
No 78/2009).  
 
In line with the decisions fees for import licences for medicines and medical devices are de termined 
based on the total value of the requested import as follows:  
 
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 and international conventions fees for import licences for 
import/export/transit for drugs and psychotropic substances are 1% of the total 
import/export/transit value.  
 
In line with the Decisions fees for  import/export/transit of precursors is 50 euros.  
 
13.  There is no deposit or advance payment associated with the issue of licenses.  
 
Conditions of licensing  
14.  The period of validity of an import license for medicines and medical devices is 3 months from 
the date of issuance and the license is valid for a multiple import.  
 
The period of validity of an import license for drugs is 6 months and the license is valid  for a single 
import.  
 
The period of validity of an import license for precursors is 30 days and the license is valid for a 
single import.  
 
The validity of licences cannot be extended, but a request for a new license can be submitted.  
 
15.  There is not a penalty for the non -utilization of a license or a portion of a license.  
 
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.  
 G/LIC/N/3/MNE/2  
 
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  3  MINISTRY OF SUSTAINA BLE DEVELOPMENT AND TOURISM - ENVIRONMENTAL 
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 mov ements of hazardous w aste 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 to generate energy is forbidden 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 Mon treal 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 import of specie s 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 Article s 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. 5 1/17) 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 ionizing 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 theirs products and derivates;      
Endangered and protected species of wild flora and fauna   theirs products and derivates  in 
accordance with the CITES convention and   protected  plant, animal and fungus species 
(examples of wild plant s, 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 dep leting 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 radi ation. 
 
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 G/LIC/N/3/MNE/2  
 
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  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 W aste 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 Transboundary 
Movements of Dangero us 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 classificati on 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 ("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 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 B iocidal 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. 28/13);  
- The Rulebook 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. 049/13, 012/16);  
- 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 biocides ("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);  
- The Foreign Trade Law ("Official G azette 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 for 2017("OG MNE", No. 24/17);  
- The Law on Administrative Procedure ("OG MNE", No. 56/14, 20/15, 40/16, 37/1 7); 
- 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 designat ion 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.   
 G/LIC/N/3/MNE/2  
 
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  Procedures  
6.I. Imports of ozone depleted substances (ODS) are under the quota system. Procedure for quota 
system for import of the ozone depleted substances are prescribed by the Decree on ozone 
depleted substances and alternative substances ("OG MNE",  No. 5/11).  
 
Inform ation 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 and alternative substances is determined on 
an annual basis and written applicatio n of importer for setting annual quota have to be 
submitted to the NEPA not later than December 1st of the current year for the following year. 
The licences for import are issued for each import separately. System of quotas for CITES 
permits is not establi shed in Montenegro.  
 
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 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 allocations 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 for 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 Admini strative 
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 examined simultaneously and allocation of quota is m ade 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 Ad ministrative 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 possibili ty. 
 
(c) There are no such limitations . 
 
(d) NEPA is a Single administrative body in charge of consideration of licence applications.  G/LIC/N/3/MNE/2  
 
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  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 NEP A 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 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.  
 
All the 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 applica tion 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 betwee n 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 
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 border customs office to 
processors; and,  
- Proof of the administrative fee payment.  
 
The applic ation 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 a nd 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 state of origin of goo ds; 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 application for import of CITES listed species and their products and derivates has to contain 
the following:  
 
- Application for issuance of CITES import permit;  
- Copy of CITES export p ermit;  
- 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 sp ecies will be properly 
accommodated;  
- Statement by the importer regarding the mode of species transport and using purposes;  
- Proof of administrative fee payment;  G/LIC/N/3/MNE/2  
 
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  - 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.  
 
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;  
- Inform ation 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 administrative 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 name of the biocide’s manufact urer; 
- 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 the 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 exist.  The importer must submit the following:  
 
- Proof that the facilities and rooms where trading in ionizing radiation sources or radioactive 
material is performed in comply with technical, secure, safe, sanitary and other prescribed 
requirements ensuring health and protection of people and the environment against ionizing 
radiation;  
- Proof that there is an employee in charge for protection against ionizing radiation;  
- Proof that persons operating ionizi ng radiation sources are provided with adequate ionizing 
radiation protection equipment, as well as equipment for radiation measurements;  
- Proof that all persons operating ionizing radiation sources have professional qualification 
required and satisfy pre scribed health requirements for work with ionizing radiation sources;  
- Certificate on technical/technological integrity of ionizing radiation source, obtained by the 
competent authority;  
- Instruction for action in case of radiation accident;  
- Proof that  radioactive materials x -ray devices or other devices producing ionizing radiation 
are secured in accordance with prescribed requirements for their trading.  
 
 G/LIC/N/3/MNE/2  
 
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  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.  
 
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. 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 portion of a license.  
 
16.  The licenses are not transferable between importers.  
 
17.  There a re no other conditions attached to the issue 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 ba nking authorities for goods to be imported.  
 
 
 
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