G/LIC/N/3/ALB/7  
 
14 April 2014  
(14-2316)  Page: 1/22  
Committee on Import Licensing  Original: English  
 
REPLIES TO QUESTIONNAIRE ON IMPORT LICENSING PROCEDURES1 
NOTIFICATION UNDER ARTICLE 7.3 OF THE AGREEMENT  
ON IMPORT LICENSING PROCEDURES 
ALBANIA  
 
The following communication, dated 27 March 2014, is being circulated at the request of the 
delegation of Albania. 
 
_______________ 
 
 
In accordance with Article 7.3 of the Agreement on  Import Licensing, the Government of Albania is 
presenting answers to the Questionnaire on Im port Licensing Procedures, for the year 2013, 
relating to these groups of products:  
 
 Import licensing procedures on live animals, leather, feed, biological material on animal 
insemination, veterinary drugs and vaccines; 
 
 Import licensing procedures on plant protection products (PPP); 
 
 Import licensing procedures on waste; 
 
 Import licensing procedures on medicinal products; 
 
 Import licensing procedures on military goods; 
 
 
The Government of Albania is requesting the Committee on Import Licensing to circulate this 
notification to the WTO Members. 
                                               
1 See document G/LIC/3. G/LIC/N/3/ALB/7 
 
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  1  LIVE ANIMALS, LEATHER, FEED, BIOLOGICAL MATERIAL ON ANIMAL INSEMINATION, 
VETERINARY DRUGS AND VACCINES 
Outline of system 1.  The procedure of licensing in Albania has recently been changed. Activities for production are 
licensed according to Law “On licensing”, No. 10081, dated 23.02.2009 , as well as according to 
sublegal acts for law implementation. The legislation on licensing defines the activities according to fields (categories and sub categories) and special criteria for licensing; evincive documentation and 
any other accompanying documents for each activity.  
 Requests for licensing of activities included in such categories or sub categories are checked over by the National Licensing Centre (NLC) at the Ministry of Economic Development, Trade and 
Entrepreneurships.  
 Assessment on fulfilment of criteria for licensing (approval) is done through an intermediate 
decision of the institution that covers the respective field of activity. 
 The decision of the Food Competent Authority is based on the evaluation of submitted documents 
and on-site inspection to assess fulfilment of requirements and mandatory standards defined in the 
legislation. Approval or refusal is published in the register within the deadline, otherwise it is considered as approved.   
The final decision of the NLC is published in the register and the title is submitted at the wickets of 
the NLC.   
The CCA can suspend or revoke the license in cases where, during checking the results, 
technical-technological and sanitary-veterinary requirements are not fulfilled according to law.   
Purpose and coverage of licensing 
2.  Import licensing system is covering these groups of products:  
 (a)  live animals; 
(b)  biological material on animal insemination; 
(c)  veterinary drugs and vaccines.  
3.  Import is carried out based on bilateral trade agreements that Albania has signed with various 
countries where the products are imported from (or even from other countries that meet the requirements of the legislation in force). 
 
4.  The licensing  system does not intend to restrict the qu antity and the value of imports. There is 
not any alternative method. The Ministry of Agriculture, Rural Development and Water Administration does not determine quotas for import licenses.   
 
5. Licensing is a legal request, and the licensing system is based on the following legal framework:  
 Law No. 10 081, dated 23.2.2009 “On licenses, authorization and permission in 
Republic of Albania”; 
 Decision, No. 538, dated 26.5.2009 “On licenses and authorization that are checked 
over through NCL and some other common sub-legal regulations”;   
 Law “On Food”, No. 9863, dated 28.01.2008; 
 Law, No. 10 137, dated 11.5.2009 “On same amendments in current legislation  on 
licenses, authorization and permission in Republic of Albania”; 
 Decision, No. 1295, dated 29.12.2009, “On same amendments in  Decision, No. 538, 
dated 26.5.2009 On licenses and authorizatio n that are checked over through NCL and 
some other common sub-legal regulations”;  
 Law No. 9426 dated 06.10.2005 “Animal Breeding” - changed. 
 Licensing is authorized by the Law No. 10 081, dated 23.02.2009 “On licenses, authorization and 
permission in the Republic of Albania”  and the system cannot be abolished without legislative 
approval. The legislation does not leave designation of products to administrative discretion. G/LIC/N/3/ALB/7 
 
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  Additional legal requirements on licensing is Law No. 10465 dated 29.09.2011 "On veterinary 
service in the Republic of Albania", Article 137.  Procedures 
6.I-II. N.A. 
III. For goods and import entities which meet the criteria and conditions defined in the relevant 
legislation, licenses are without limitations.  
 
In order to ensure that licenses are used for import issues, the steps are as follows:  - The approved list of importers is sent to the Regional Directory of Agriculture, Food 
and Consumer Protection of each district, mu nicipalities and border inspection points 
or responsible body for control of license of import usage; 
- List of approved importers is published on the NLC’s website. 
 
IV. As there are no quotas for imports of such goods, the application can be submitted at any 
time.  
 
V. The maximum time to process the ap plication for a license to import is: 
(a) live animals 10 days;  (b) biological material on animal insemination 15 days; 
(c)  veterinary drugs and vaccines 15 days. 
 Decision, No. 1295, dated 29.12.2009, “On some amendments in  Decision No. 538, dated 
26.05.2009 “On licenses and authorization that are checked over through the NCL and some 
other common sub-legal regulations”. 
 
VI. Decision, No. 1295, dated 29.12.2009, “On some amendments in  Decision No. 538, dated 
26.05.2009 “On licenses and authorization that are checked over through the NCL and some 
other common sub-legal regulations”. 
 
VII. The NLC is the only entity where the app licant needs to apply (each importer) and present 
all the documentation. Documents are being sent online (from the NLC office), for approval to the Ministry of Agriculture, Rural Development and Water Administration. After this 
process, the NLC issues the import license to the applicant.  
 VIII. There are no limits on licensing numbers. There are no restrictions on timing and ranking of 
applications in order to get a license. The license is issued based on the fulfilment of the 
conditions determined by the Albanian law.  
 
In cases where the applicant does not meet th e requirements, the application is refused until 
a second period, determined in the act of th e competent inspection authority. The act of 
refusal is published on the NLC’s website.  
 
The examination of the applicant's request, fr om the date when the application has been 
deposited, is performed within 10 days for the import of live animals and within 15 days for 
the trading of racial material and veterinary medicine.  
 
There is no specific legislation for new importers.    
IX. Not applicable since we do not have quotas and we do not issue licenses automatically.  
 
X. The import is not permitted only based on export permissions.   
The import of goods is made only based on: 
 - Law No. 10081, dated 23.02.2009 “On licenses, authorization and permission in 
Republic of Albania”; 
- Decision, No. 538, dated 26.05.2009 “On licenses and authorization that are checked 
over through NCL and some other common sub-legal regulations”;   G/LIC/N/3/ALB/7 
 
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  - Annex I: Permission and licensing categories which are followed by/or through NLC; 
- Annex I, Section II: Food and Health. Cate g o r y  I I . 2 ,  C o d e  I I . 2 ,  B ;  C a t e g o r y  I I .  3 :  
Breeding or animal trading with Code II.3, C; Category II.7, Code II 7B;  
- Drugs’ Trading. 
 
XI. No, such conditions are associated with the issuing of the license.  
7.(a) Imports can be carried out only after issuance of the import license. Goods cannot arrive at 
the port without the license. The import is be ing made only after the NLC issues the license 
to the importer.  
 
(b) No, because the licensing authority must ex amine the documentation required. The timing 
to issue a license is 10-15 days.  
 
(c) No limitations for the time of application. 
 (d) The NLC is the only entity where the applic ant needs to apply (each importer) and present 
all the documentation. Documents are being sent online (from the NLC office), for approval 
to the Ministry of Agriculture, Rural Development and Water Administration. After this process, the NLC issues the import license to the applicant 
 
8.  The license can be refused in cases when th e importer does not meet the requirements set 
forth in the law and regulations.  
The applicant is informed officially by the NLC, for the reasons of a license’s refusal. This 
information is published automatically on the NLC’s website.   
Any interested party has the right to appeal on an administrative procedure to the NLC or Ministry 
of Agriculture, Rural Development and Water Administration for cases of licenses with preliminary inspections. Administrative complaints are analysed  by representatives of the NLC, except cases of 
licenses with preliminary inspection which are analysed by the Ministry of Agriculture, Rural 
Development and Water Administration.  
 In the cases of preliminary inspection, the Ministry of Agriculture, Rural Development and Water 
Administration is informed by the NLC when a complaint is presented to their office.  
 In both cases, complaints addressed to the NLC or Ministry of Agriculture, Rural Development and 
Water Administration, are published in the Na tional Registry of Permits and Licenses.  
 For administrative issues, a decision given after reviewing the administrative complaint may be directly appealed to the competent court.  
 
The above mentioned issues are followed by the terms specified in section 6 of the Code of Administrative Procedures on administrative complaints within one month.  
 
Eligibility of Importers to Apply for a License 
9.   There are no restrictive systems. All persons,  firms and institutions that satisfy the criteria 
set forth in the current legislation have the right to apply for a license. No, there is no such 
system.   A list of fees exists which is based on the Order of the Minister of the Ministry of Agriculture, Rural 
Development and Water Administration, No. 8 dated 08.05.2007 “On the fees and secondary 
revenues applicable by institutions of the agriculture and food system”.  
 
Yes, the list of the authorized importers published on the NLC website is sent to all central 
institutions, districts, municipalities and border inspection points.   
 
 G/LIC/N/3/ALB/7 
 
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  Documentational and other requirements for a permit application  
10.  The necessary information and the documentation to be filled by the applicant are provided by 
the NLC.   
11.  The required documents are those issued by the National Licensing Centre (NLC). 
 12.  Depends on the type of license, there is a different fee for different licenses. The fee for an 
import license on live animals is 10.000 lekë; for trading of racial material 300 All; and 100.000 All 
for veterinary medicine trade.  
 13.  No, advance payment or deposit is required. 
 
Conditions of licensing 
14.  All licenses are indefinite based on Article 11, Law No. 10 081, dated 23.02.2009 “On licenses, 
authorization and permission in the Republic of Albania”.  In order to check if the conditions are 
fulfilled by the applicant, the Ministry of Agriculture, Rural Development and Water Administration performs frequent in-site controls. If some conditions are not fulfilled then the Ministry of 
Agriculture, Rural Development and Water Administration presents the proposal to the NLC for the 
refusal of this license.   15.  No. 
 
16.  No, licenses are not transferable.  
 
17.(a) Not applicable. We do not have quantity restrictions for products. 
(b) No. Other Procedural requirements 
18.   No, there are not any other administrative procedures.  
 19.   Foreign exchange is provided automatically by banking authorities, every day.   
2  PLANT PROTECTION PRODUCTS (PPP) 
Outline of system 1.  The procedure of licensing in Albania has recently been changed. Activities for production are 
licensed according to Law No. 10081, dated 23.02.2009 – Import of products for plant protection 
in Albania is conducted through permissions issued by the NLC, based on some preliminary criteria to be fulfilled by the interested parties. The entities are inspected from the District Inspectorate of 
plant protection. This license is issued through the NLC.  In Albania, only registered products for 
plant protection can be imported.  Purpose and coverage of licensing 
2.  The licensing system covers plant protection products such as insecticides, fungicides, 
herbicides, disinfectants and similar products. These products fall under code 3808 of the Combined Nomenclature.  
 
3.  The control system for plant protection products  is being applied to those who are registered in 
countries of the European Union. PPP are accepted without limitations coming from all countries.  
 
4.  This licensing system does not intend to rest rict the quantity or value of imports coming into 
Albania. The purpose of issuing the import license of PPP is to strictly control the products. Since these are poisonous products, their careless utilization can affect plants, animals, human beings 
and the environment.  It is the only known method for plant protection in international legislation. 
 G/LIC/N/3/ALB/7 
 
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  5.  The Albanian legislation that regulates this licensing system includes: 
 
 Law No. 10081 dated 23.02.2009 “On Licensing, Authorizations and Permissions in the 
Republic of Albania”; 
 Law No. 9362 dated 24.03.2005 "On the plant protection services “ – changed; 
 Decision of the Council of the Ministers No. 1555 dated 11.12.2008, “For the determination 
of registration rules and evaluation criteria of Plant Protection Products (PPP)”. 
 
The decision of the Council of Ministers No. 1555 dated 12.11.2008, “On the determination of 
registration rules and evaluation criteria of PPP”, provides that only registered plant protection 
products could be imported.    
 
Procedures 
6.I-IV.Not applicable. 
 
V. Based on Law No. 10081 dated 23.02.2009 “On Licensing, Authorizations and Permissions in 
the Republic of Albania” the maximum time for processing the applications is 15 days.  
 
VI. No time remains.   VII. The applicant presents the required documentation to the National Licensing Centre. This is 
the only administrative organ that the importer has to approach to get the licence. 
 VIII-X .Not applicable. 
 
XI. There are no such conditions associated with the license.     
7.(a)  The importer can import the product at the time when he judges is appropriate. The time 
limit to obtain a license is 10–15 days and the license cannot be obtained for goods arriving at the port without a license.    
 
(b) The license is granted after the examination of the required documentation, within the time 
limits set forth in the legislation. Up to now, no emergency applications for licenses are deposited in the National License Centre. 
 
(c) No limitations related to the period of the year during which applications for license can be 
made. 
 
(d) Application for import licenses are affected only by one administrative organ, which is the 
National Licensing Centre. 
 
8.  The license can be refused when the importer fails to meet the appropriate conditions on 
storage and preservation of the plant protection pr oducts as required by the legislation (including 
the necessary documentation).  The applicant is informed officially by the NLC, for the reasons of the license’s refusal. This information is published automatically on the NLC’s website.  According 
to the legislation on plant protection in the case of the refusal of the license, the applicant has the 
right to appeal at higher administrative bodies and at the court of first instance. 
 
Eligibility of Importers to Apply for License 
9.  There are no restrictive systems.  All persons, firms and institutions that satisfy the criteria set 
forth in the current legislation have the right to apply for a license. 
 
No, there is not such a system.  All persons who have import licenses are eligible to import plant protection products. All importers are listed in th e Ministry of Agriculture, Rural Development and 
Water Administration where the list is published. The list is sent to the cross–border point where 
phyto-sanitary and quarantine inspection service is established.   
According to Order No. 9 dated 12.07.2010 “On fees and secondary revenues applicable by 
agriculture and food institutions in the Ministry of Agriculture, Rural Development and Water Administration”. G/LIC/N/3/ALB/7 
 
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  Documentational and other requirements for a permit application  
10.  The applicant presents the required documents to the Directory of the NLC. The whole set of 
documents is available at the NLC office.   
11.  Import license of plant protection products is presented at the quarantine inspectorate office 
at the cross-border points. After the control by qu arantine inspectorate is carried out, the customs 
authorities accomplish customs procedures. 
 
12.  Licensing fee is 2000 lekë.   13.  No deposit or advance payment requirement. 
 
Conditions of licensing 
14.  The license is permanent.  
 
15.  No penalty. 
 16.  The license is not transferable. 
 
17.  No conditions are attached to the issuing of the license. 
 
Other Procedural requirements 
18.  Yes, there is the procedure of the ”State Commission of PPP” for the PPP registration in the 
Republic of Albania.   
 19.  Foreign exchange is provided automatically by banking authorities, every day.  
 
3  WASTE 
Outline of system 
1.  The system is maintained to protect the life and health of the population, and to protect the 
environment.  Based on Law No. 156, dated 10.10.2013 “On some amendments in the law 
No. 10463, dated 22.09.2011 ”On integrated waste management”, amended in which importation is not allowed in Albania.  The Ministry of Environment, (MoE) is the responsible institution for the 
process of cross-border of waste: exportation and their transition.  The MoE issues exportation 
licenses and the permission for transition of waste.    
Purpose and coverage of licensing 
2.  The products covered are waste from social and economic activities and physically consumed 
products that are not included in the definition of non-dangerous waste. 
 
3.  The system does not apply to all waste coming  from all countries, because of the prohibition of 
waste import to the Republic of Albania.  
4.  The prohibition on importation of waste is defined by the Law No. 156/2013 which is 
aforementioned.  
5.  Exportation and transition of waste is administered by: 
 - Law No. 10431 dated 09.06.2011 “On protection of environment”; 
- Law No. 10463 dated 22.09.2011 “On integrated waste management”; 
- Rule No. 4 dated 15.10.2003 “On checking and approval of exportation licenses and 
transition of waste”; 
- The Decision of the Council of Ministers No. 835 dated 28.12.2005 “On approval of the list of 
danger waste, other waste and other remains, that are not allowed to be imported, with the 
aim to preserve, to deposit and to exterminate”;  G/LIC/N/3/ALB/7 
 
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  The system cannot be abolished without legislative approval. 
 Procedures 
6.I. The relevant legislation is published in the official gazette and on the webpage of the MoE.  
 
- Other exporting countries can take the information by the reports which the Ministry 
presents to the Secretariat of the Basel Convention “On cross border of waste and 
danger waste and their extermination”; 
- Interested foreign parties can be informed directly in the MoE; - No exception or derogation from the licensing requirement.  
 
II.-IV.   Not applicable. 
 V. The MEFWM prepares the necessary documentation for government approval within one 
month. 
VI. Not applicable. 
 
VII. The following institutions must be approached for prior approval: 
 - The Ministry of Environment which issues the environmental permit;  
- The relevant Ministry which issues the license for exercising the activity in the relevant 
field; 
- The Ministry of Health; - The community of the district where the activity will be placed.  
 
VIII.  - Not applicable. 
- First come first served; 
- Past performance is taken into consideration relating to the impact on the 
environment (existence of any penalty for polluting the environment during previous activities, complains by citizens, etc.).  
- No.  
- No distinction between new applicants and experienced ones.  
 
IX. Not applicable. 
 
X. The export license from the competent authority of country of origin is a prior condition to 
issuing the import license.  
 
XI. No.  7.(a) No. 
 
(b) No.  
(c) No. 
 (d) See 6. VII. 
 
8.    Not applicable.  Eligibility of Importers to Apply for License 
9.    Not applicable. 
 Documentational and other requirements for a permit application  
10. Not applicable. 
   11. Not applicable. 
 G/LIC/N/3/ALB/7 
 
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  12. Not applicable. 
 13. Not applicable.  
Conditions of licensing 
14.  The validity is defined in the Decision of th e Council of Ministers and can be different due to 
the request made by the applicant and on enviro nmental policies in the field of waste.  The 
maximum validity is 5 years. 
 15.  No.  
16.  This transfer is not specified for an import license.  In the case of changing the ownership of the 
activity according to Article 42 of the law “On protection of environment”, the new owner has the rights of the environmental license, and implements the conditions foreseen in it. 
 
17.  Not applicable.  
Other Procedural requirements 
18.  They are mentioned in question VII of this questionnaire. 
 19.  The exchange rate is provided automati cally by banking authority, every day.   
 
4  MEDICINAL PRODUCTS 
Outline of system 
1.  Due to amendments on licensing procedures, only some medicinal products are required to 
provide an import license, before placing them on the market. Medicinal products, according to 
their use and technical capacities that authorities have, are divided in groups as per below:  
 
(a)  Pharmaceutical products (drugs);  (b)  Dental equipment; (c)  Medical devices (consumables); 
(d)  Disinfectants, disinsectants and deratizing substances (DDD-s).  
 Among the above mentioned groups, import authorization is required for pharmaceutical products, 
DDD-s (disinfectants, disinsectants and deratizing substances) and dental equipment in case they 
are the source of ionized radiation. Every subject, before starting the activity on import/export or 
placing these substances on the market, has to be licensed by the National Licensing Centre 
(NLC). In some licensing procedures, the statem ent of the Chargé d’Affaires Structure at the 
Ministry of Health is needed. The decision needs to  be fulfilled within 15 working days, after that it 
is published by the National Licensing Centre in the National Licensing Register, as an authorized 
subject on these activities. After that, import authorizations are granted for every concrete 
importation according to regulation in force: 
 (a) All pharmaceutical products circulating in the Albania market should be registered, except 
for certain cases (such as pharmaceutical products prepared in pharmacy or facing 
emergency cases). Registered pharmaceutical products are imported by legal subjects licensed on this activity by the National Licensing Centre (NLC), under the written statement 
of the Ministry of Health, prior to the licensin g approval by the NLC. Importers need to be 
assigned by the Representative Offices establis hed in Albania or by regional ones only for 
pharmaceutical products under patent protection; in cases of generics there is no need for such assignment. Licensed subjects on the impo rt of pharmaceutical products carry out their 
imports, based on the updated register of pharmaceutical products, published by the 
National Centre of Drugs Control. Import procedures are performed at the entry customs offices, in the presence of the pharmaceutical inspector. 
(b) In case of import of unregistered pharmaceutical products (in case of emergency such as 
natural catastrophes, epidemics, or drug’s unique alternatives for hospital/ambulatory service), the application needs to be submitted near by the Pharmaceutical Department 
(Ministry of Health). After evaluation on needs for these drugs by the above mentioned G/LIC/N/3/ALB/7 
 
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  Department, the Minister of Health authorizes the importation. This authorization has a 
validity of 2 (two) months. 
(c) The import of narcotic drugs and psychotropic substances is regulated separately, because 
importation process is more restricted and under control of Albanian and international 
authorities. Licensed subjects by the Nation al Licensing Centre, on wholesale trade of 
pharmaceutical products, also need to be authorized by the Pharmaceutical Department, related to their activity on importation and distribution of narcotic drugs and psychotropic 
substances. When the importer wants to import narcotics and psychotropic, he/she submits 
at the Pharmaceutical Department the request on authorization import. If the required quantity does not exceed the allowed quantities , the authorization signed by the Minister of 
Health is granted, with a validity of 3 (three) months, from its issuing date. This 
authorization is used as an international control instrument. When the authorization has 
reached the destination (control authorities of exporting country), these authorities grant export authorization for their exporter. Ther efore, within these 3 (three) months, the 
Albanian importer resubmits to  the Pharmaceutical Department, the request for import 
authorization followed by the export-authorization of the exporting country. After that, the Pharmaceutical Department proceeds with proced ure of granting of the authorization, valid 
for a period of 2 (two) months. Finally, providing of this authorization means allowing the 
entry in Albania of narcotic or psychotropic substances. 
(d) In order to facilitate the import procedures, after May 2008, according to the order of 
Minister No. 215, of 27.06.2008, has been avoid the obligation of granting and submitting in 
the custom authorities, the import authorization for medical equipment, dental equipment 
and consumables. If medical equipment is sour ces of ionizing radiation, an approval is 
issued by the Commission on Radiation Protection in the Public Health Institute. This 
approval takes into account the quality certificate, data on the device model/batch no.; 
maximal tension, manufacturing date and the quality certificate of the two last years from the importing date, invoice no. and the approximate date to be imported.   
(e) Related to importation of disinfectant, disi nsectant and deratizing substances (DDD), the 
subject after being licensed by the National Licensing Centre on the activity of hygienic-sanitarian intercessory services, he/she submits the request for import authorization by the Public Health and Primary Care Sector (Health Care Department) 
Ministry of Health. The requirement is verified by the charged specialist of the Public Health 
and Primary Care Sector, if the substance to be authorized is part of the updated list of DDD substances, approved by the Minister of Health; also if the substance fulfils all the 
requirements specified in the mentioned Order of  the Minister of Health. Furthermore, on the 
issuing of the import authorization related to DDD substances, the opinion of specialists from 
the Public Health Institute (PHI) is required regarding the samples of each concrete import. 
These samples need to be analyzed and evaluated with regard to the DDD substance 
contained. Public Health Institute has to express its official opinion within 10 days of work. Based on all effectuated verification, the Director of Health Care Department, issues the import authorization.  
 
Purpose and coverage of licensing 
2.  Importation licensing systems are:  
(i) Licensing of pharmaceutical products (drugs); 
(ii) Licensing of disinfectant, disinsectant and deratizing substances; 
(iii) Licensing of ionized radiation sources. 
 
The product covered by the above mentioned licensing systems are: 
 Narcotic Drugs and Psychotropic Substances referred to the list in accordance of Single 
Conventions of 1961 and 1971; 
 Pharmaceutical Products of the chapter 30 of the Combined Nomenclature of Goods; 
 Disinfectant, disinsectant and deratizing substances, Chapters 28, 29 of CNG. 
 
3.  Pharmaceuticals to be registered in Albania and later imported, should be registered and 
circulated in one of the European countries, Switzerland, USA, Canada, Japan and Australia. With regard to pharmaceuticals manufactured within the Balkan area, they can be registered and later 
imported, only if these goods have been circulated  in their country for at least 2 (two) years.   
 4.  The Licensing system is generally used to control products that will enter in our country. Licensing is seen as a control tool to identify the products, the quantity and quality of these G/LIC/N/3/ALB/7 
 
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  products, which are intended to be entered on the domestic market. Even though health care is 
mainly covered by imported products, its aim is on the stimulation of the domestic production by increasing the number of qualitative medicinal products manufactured in Albania. Normally, 
adoption of proper legislation, setting up of st ructures and equipping with necessary technology, 
creates the condition and opportunities to use other alternatives, which consist on control of 
imported drugs at several stages, at the border by custom authorities, during wholesale distribution, during dispensing by pharmacies an d their use. The adoption of new legislation and 
structures relating to the control system is under way. 
 5.  The Legal framework that regulates the procedures of import licensing includes: 
 Council of Ministers Decision No. 325 of 14.06.1993 “On regimen of export-import and 
pharmaceutical products production”; 
 Joint Guideline of Ministry of Health and Ministry of Finance No. 180 of 13.08.1993 “On 
co-operation for the regimen of import-export of pharmaceutical products and their 
clearance”; 
 Law No. 7975 of 26.07.1995 “On narcotic drugs and psychotropic substances, amended 
by: 
o Law No. 9271 of 9.09.2004; 
o Law No. 9559 of 8.06.2006; 
 Minister of Health Order No. 104 of 5.03.2004, “For a change in the Guideline No. 180 of 
13.08.1993 “On co-operation for the regimen of import-export of pharmaceutical products 
and their clearance”; 
 Minister of Health Order No. 245 of 29.06.200 6 “For a change in the Guideline No. 180 of 
13.08.1993 “On co-operation for the regimen of import-export of pharmaceutical products 
and their clearance”; 
 Law No. 9323 of 25.11.2004 “On pharmaceutical products and pharmaceutical service” 
amended by: 
o Law No. 9523 of 25.04.2006; 
o Law No. 9644 of 20.11.2006; 
o Law No. 10008 of 27.10.2008. 
 Council of Ministers Decision No. 24 of 22.01.2014 ”On designation of the rules for issuing 
of the Minister of Health’s authorization on import of unregistered pharmaceutical 
products”; 
 Law No. 9928 of 9.06.2008 “On dental health  service in the Republic of Albania”; 
 Minister of Health Order No. 162 of 16.04.200 8 “On abrogation of the Order of Minister 
No. 214 of 22.04.2004”; 
 Law No. 10081 of 23.02.2009 “On licenses, authoriz ations and permits in the Republic of 
Albania”; 
 Law No. 10137 of 11.05.2009 “On some addenda to the current legislation on licenses, 
authorizations and permits in the Republic of Albania”; 
 Council of Ministers Decision No. 538 of 26.05.2009 “On licenses and permits handled by 
or through the National Licensing Centre (NLC) and on some sublegal common 
regulations”; 
 Council of Ministers Decision No. 1295 of 29.12.2009 “On some amendments to Decision 
of Council of Ministers No. 538 of 26.05.2009 “On licenses and permits handled by or 
through the National Licensing Centre (NLC) and on some sublegal common regulations”; 
 Council of Ministers Decision No. 415 of 17.08.1993 “On import, export, wholesale and 
retail trade licensing of disinfectant, disinsectant and deratizing substances”; 
 Law No. 10138 of 11.05.2009 “On Public Health”; 
 Minister of Health Order No. 102 of 22.02.2010 “On the issuing of the authorization on the 
import-export, wholesale and retail trade of the DDD substances (disinfectant, disinsectant 
and deratizing substances);  
 Minister of Health Order No. 365 of 3.08.2012 ”On the approval of the List and usage of 
the DDD substances (disinfectant, disinsectant  and deratizing substances) in the Public 
Health”; 
 Law on Protection from ionized radiatio n No. 8025 of 9.11.1995, amended by the Law 
No. 9973 of 28.07.2008; 
 Decision of Council of Ministers No. 158 of 13.02.2008 “On import-export of ionized 
radiation source in the Republic of Albania”; 
 Regulation No. 3918/4 of 3.11.2004 “On Impo rt, export and transit of radioactive 
sources”; 
 Guidance No. 4756/1 of 21.12.2006 “On import-export of radiation materials in Albania”. G/LIC/N/3/ALB/7 
 
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   Categorization of Radioactive Sources No. 9 of 7.01.2010;  
 Regulation No. 10 of 7.01.2010 “On licensing and inspection of ionized radiation sources”; 
 Approval No. 494/6 of 7.02.2011 ”Approval on import-export for X-rays generators”; 
 Guidance No. 134 of 12.04.2011 ”On import – expo rt and transit of radioactive sources of  
1st and 2nd category in the Republic of Albania”. 
 
The systems of import licensing are based on laws, government decisions or other administrative acts. None of the licensing systems can be abolished without any legislative approval.  None of the 
legislation leaves designation of product to be subjected to administrative discretion. 
 Procedures 
6.I. The only case of implementing quantity limi tation is the importation of narcotic drugs and 
psychotropic substances. Yearly quantities are approved by the International Narcotic 
Control Board and are published in its special publication. Practically the authority does not apply the allocation of quotas among importers.  There is a yearly quota, which is divided 
among importers by agreement based on the supplying contracts that importers have signed 
with public or private health institutions, or due to pharmaceutical products inclusion in the reimbursement scheme etc. There is not any limitation for the quantities imported from any 
country. Importers import the quantity they think is reasonable or according to the supply 
contracts they have signed, always within yearly quota and agreement done with other importers. As we are taking into consideration a very restricted control, no request for exception or derogations from the licensing requirement is accepted. 
 
 With regard to DDD substances, an updated list of substances is in force, which has been 
drafted on the WHO recommendations and Dire ctive 98/8/EC, of the European Parliament 
and of the Council, of 16 February 1998, concerni ng the placing of biocidal products on the 
market. Only substances, specified in this updated list, can be imported.   
 
II. The quota size for each narcotic drug is determined for a year period and covering all the 
country. Importation licenses are granted every time the importer will import a quantity within the quota. Because import authorizations are valid for 3 months, only one importation 
within 3 months can be done until the next importation from the same importer. 
 
 Related to ionized radiation sources the import authorization are for single use and valid for 
2 weeks.  
 
III. Licenses are allotted for the quantity of a certain narcotic drug that is imported by a certain 
manufacturer and a certain country (this is not defined by the authority, but from the fact that the drug is registered and the registration  is done by a manufacturer that is established 
in a certain country. After this, the importer begins his/ her procedures). 
 
 Because this is a process of reciprocal control among several authorities, its continuity is 
supervised by these authorities. Pharmaceutical Authorities especially supervises license usage, because no utilization would result in the lack of drugs in health institutions and 
pharmaceutical market. In case of no utilizati on of the license, the importer notifies the 
responsible authority and if he does not, the authority based on the data received in the pharmaceutical market, communicates with the importer to solve any possible problems or 
to make the importation possible from another importer if the first has no possibility to do it. 
The primary concern of authorities is that the market does not suffer the lack of pharmaceutical products. 
 
 The Radiation Protecting Commission has the right to approve authorization imports, only to 
license holders on this purpose. Unused allocations are not added to the coming periods. Every 
year begins with new quotas that are equal with the need that the country has for such pharmaceutical products for one year. 
 
IV. There is not any defined period.  G/LIC/N/3/ALB/7 
 
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  V.  There is not any defined period, but usually the applications are processed within a working 
day. 
 
VI. There is no defined period. The authority and the importer are informed that with the start 
of a calendar year begins the importing periods, so they begin their procedures after that date. 
 
Related to radiation sources this period is two weeks and two months. 
 
VII.  The only cases where the application for import licensing is examined by two authorities are 
those, of disinfectant, disinsectant and dera tizing substances and of ionized radiation 
sources: 
 
 The official opinion of Public Health Institute is required relating to disinfectant, 
disinsectant and deratizing substances. 
 The same situation occurs with the ionized radiation sources, where the importer has to 
approach more than one administrative organ.  
 
 The positive answer (approved import license) or negative one (along with all explanations) 
is given to the importer, in the Ministry of Health.  
 
VIII. There are several ways to act in case of an unsatisfactory license demand. If the 
pharmaceutical product is for ambulatory use and it is not the first alternative in the reimbursement list, it is first served first come. It is enough to submit the application with 
all the necessary data and the license will be granted to him. If the drug is intended for 
hospital use (according to contracts the importer has with hospitals), or is the first alternative in the reimbursement list (with the highest coverage level) it is first served to the importer that fulfils these conditions and th en the others according to the agreements 
among themselves, take the difference of quotas . If the importer submits an application for 
narcotic import authorization at the end of the year, knowing that the period of authorization approval obliges importer to bring the cargo/shipment in the following year, which is not 
allowed by international control authorities, usually it is decided that procedures must be 
done the next year when the new quotas are open. The importer's performance is not examined. The maximum quantities for each im porter are determined by the agreements 
they reach with each other based on contracts or market studies (it must be stressed that 
there is a small number of narcotic drugs imported into Albania and there is a very small number of importers, sometimes even only one) . There is no provision for new importers, 
they are considered in the same way as the old ones. The applications are examined 
immediately. 
 
Related to ionized radiation sources, new applicants have to be assessed through licensing process for each approval import.  
 
IX. In case of narcotic drugs we have the case of bilateral quotas. According to the regulatory 
framework and practically together with the app lication for exportation it is submitted even 
the importation authorization from the importing country (granted to importer). The export 
authorizations the only issued for this case are granted immediately. 
 
 Nearly the same happens with ionized radiat ion sources, where, to provide the export 
approval from the exporting country, confirmati on is needed from the importing country.  
 
X. In case of the importation of narcotic drugs and psychotropic substances, when import and 
export authorization is granted, the authority of the exporting country after granting export 
authorization, based on application and import authorization, sends the authority of the 
importing country a copy of the export authorization. 
 
Relating to ionized radiation sources, both counties are informed through their contact points. 
 
XI. Relating to pharmaceutical products:  No. The exported products, mainly of Albanian 
manufacturers, are the same that are sold in the domestic market. So far, such a limiting procedure does not exist.  G/LIC/N/3/ALB/7 
 
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   Relating to ionized radiation source:  Yes. 
 7.(a) The import authorization validity is for 1 and 2 months: respectively 1 (one) month for 
registered pharmaceutical products and 2 (two) months for unregistered ones; 3 months for narcotics and psychotropic and ionized radiation sources; meanwhile the validity is for 6 
months for DDD substances.  
 (b) Yes, the licenses are granted immediately on request, despite unregistered pharmaceutical 
products, where in some cases the examination of the Ministry of Health is required. The 
procedure for the examination is up to 3 working days. 
 
(c) No, there is no limitation. 
 
(d) There are cases where the application needs to be passed on to other administrative organs 
such as the import of DDD substances (the ap plication passes to PHI) and the import of 
ionized radiation sources. The organs cooperate with each other and the importer has to 
approach only one, the Ministry of Health, when the importer receives the answer.  
 8.  The application for license (import authorization) of a pharmaceutical product can be refused 
when the importer fails to meet the defined criteria and in some other cases, specifically when: 
 
 The National Centre of Drugs Control is informed that the drug does not meet the 
necessary quality, safety standards; information is received by homologue authorities or by the results of the NCDC's own tests (testing of samples in the market); 
 Manufacturer or control authorities inform for the starting of withdrawal procedures of the 
product from market, meanwhile the importer submits the application for an import license. 
 The registration validity of the pharmaceut ical product has expired and the manufacturer 
has not begun the re-registration procedures. 
 
On each case, there is an explanation for refusal. Applicants can make an appeal to the Ministry of 
Health, the supervising levels of the Pharmaceutic al Department and of the National Centre of 
Drugs Control. The other body for appeal is the court, if they think that the authority has violated the law.  
Related to ionized radiation sources, the application for import authorization may be refused, but 
as mentioned above, in case of refusal there is  an explanation. The applicant has the right to 
appeal.  
 
Eligibility of Importers to Apply for License 
9.  Under restrictive licensing systems, application fo r licenses is done only by operators that fulfil 
the conditions of such systems. In health serv ices the application is submitted by a subject 
(importer or medical clinic that uses the products for its own activity) which has a professional license (registration) issued by the Ministry of Health. If the subject applies to import narcotic and psychotropic drugs, or medicinal products that are a source of ionizing radiation, it must only have 
a second registration for this kind of activity. 
 
Relating to ionized radiation sources, all the physics or legal persons are eligible to apply for a license, also under the restrictive licensing system.  
 
In health services there are no non-restrictive systems. There is a system of professional licensing (registration) for importation, exportation, and wholesale distribution of medicinal products. Firms that have proper facilities are eligible according to criteria defined for this purpose and specialized staff to perform this activity. This registration has a fee, which is published with all other requests. So far, there are importers’ lists that can be given to the interested parties. The National Centre of Drugs Control already has its online list of pharmaceutical importers and distributors (http://www.qkkb.gov.al). 
 G/LIC/N/3/ALB/7 
 
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  Documentational and other requirements for a permit application  
10.  There is no application form, importers receive necessary information from the authorities and 
begin the procedure. Different documentation is submitted in the different systems, depending on the groups of products that will be imported.   a. To import registered pharmaceutical products, registered importers submit an application for 
import authorization, that include: 
 importer’s data; 
 list of pharmaceutical products to be imported where it is detailed: trade name, generic 
name of the pharmaceutical product, quantity; 
 manufacturing and expiry date; 
 batch number; 
 CIF price; 
 manufacturer name; 
 country from which the import is done.  
 
An invoice is attached to the application. Submission is made to the National Centre of Drugs Control, where the import authorization is granted.   b. To import unregistered pharmaceutical products, the application for import authorization 
includes:  
 Name of pharmaceutical product; 
 Active substance; 
 Dosage – form; 
 Quantity; 
 Unit price; 
 Name and the address of the marketing authorization holder and/or of the manufacture 
company; 
 A brief prescription of the usage of the pharmaceutical products to be imported.  
 This application is submitted to the Pharmaceutical Department (Ministry of Health), where the import authorization signed by the Minister of He alth is granted to the respective applicant.  
 c. To import narcotic and psychotropic drugs, the importer has to submit the application to the 
Pharmaceutical Department in the Ministry of Health, including the above-mentioned data, and full address of the manufacturer. When the importer first submits to the Ministry of 
Health, he requires the granting of the import authorization. When he/she receives the confirmation that the exporter has received the export authorization in the originating country, the importer applies for import authorization when the cargo is ready. 
 
d. To import medical devices, dental equipment and consumables, the obligation of granting and 
submitting the import authorization in the custom authorities has been avoided. If the medical devices are sources of ionizing radiation, the application must be accompanied by an approval for that activity, issued by the Commission on Radiation Protection (Public Health Institute). 
 
e. To import disinfectant, disinsectants, deratizing substances the applicant submits to the Health 
Care Department (M inistry of Health): 
 
(i)  An application that contains the following information: 
 Importer’s data such as: legal/natural person’s name and the administrator’s name, 
address;  
 Taxpayer Personal Id entification Number; 
 Trade name of the product to be imported; 
 Active substance; 
 Package;  
 Quantity; 

 Custom office and storage address of these products. G/LIC/N/3/ALB/7 
 
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 The applicant declares on his responsibility that he is aware of the legislation and other 
respective rules into force, on importing, transporting, storage, trading and usage of DDD substances, protection of human beings, flora, fauna and the environment from these products and the responsibilities deriving from this activity.   
 
(ii)  The license, issued by the National Licensing Centre, with regard to the II8B “Other health 
services and/or hygienic- sanitarian ones”, with the respective nomination of the activity “Hygienic – sanitarian intercessory services such as: disinfection, disinsection and deratization”; 
(iii)  Registration Certificate of the biocide product in one of the EU countries, Switzerland, 
United Kingdom, Canada, Australia and the United States of America (translated and notarized in Albanian language); 
(iv)  Copy of the label in Albanian language, where they are being specified, as provided in the 
Guidelines for labelling, packaging and storage conditions of DDD substances in public health; 
(v)  The issued document by the Public Health Institute on analysing and effectiveness 
evaluation of the DDD substa nces in public health; 
(vi)  Materials for Safety Data Sheet, in Alba nian and English language (compulsory since 
1
st January 2013); 
 
f. To import ionized radiation sources, the licensed applicant on this field should provide: 
 A copy of the registration to the court; 
 Technical data for the radiation sources; 
 Certification for sealed sources; 
 Data on exporter country; 
 Clarification on the purpose of the use of sources; 
 Declaration for the source in the end use; 
 Clarification of transport of the sources. 
 11.  When the cargo/shipment arrives in Albania this must generally be supplemented by these 
types of documents i) invoices, ii) packing list, iii) certificate of analyses, iv) certificate of quality, 
v) certificate of conformity, vi) certificate of product origin. The number of documents depends on the type of product that is imported. 
 
Relating to unregistered drugs, the inspector of the National Centre of Drugs Control, before starting the clearance process, also requires from the importer, except the authorization of the Minister of Health on import of unregistered drug, the following documents: 
 Invoice, according to which is prepared the requirement, along with all data regarding the 
quantities; 
 Quality Certificate for each batch number; 
 Origin Certificate of the pharmaceutical product. 
 Relating to ionized radiation sources, upon actual importation an official request is required for approval of import, quality certificate, data on the device model/batch no.; maximal tension, 
manufacturing date and the quality certificate of  the two last years from the importing date, 
invoice, the approximate  date to be imported.  
12.  The fees are different depending on the type of license: 
 The fee for import of unregistered pharmaceutical products is 5000 Leks for each 
pharmaceutical product; 
 The fee for import of raw materials is 500 Leks for each item; 
 The fee for import of registered pharmaceutical products is 200 Leks for each 
authorization; 
 The fee for import of narcotics and psychotropic substances is 200 Leks for each 
authorization; 
 The fee for import for packages is 200 Leks for each authorization; 
 The fee for import of disinfectants, disinsectants and deratising substances is 2000 Leks 
for each authorization. 
 The fee for import of ionized radiation sources vary from 1000 Leks to 20.000 Leks. G/LIC/N/3/ALB/7 
 
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  13.  No, it is not required. 
 Conditions of licensing 
14.  There are different validity periods for import licenses: 
 Validity of import authorization for the registered pharmaceutical products is 1 month; 
 Validity of import authorization for unregistered pharmaceutical products, is 2 months; 
 Validity of import authorization for disinfectants, disinsectants and deratizing substances, 
is 6 months; 
 Validity of import authorization for narcot ic drugs and psychotropic substances is 
3 months; 
 Validity of import authorization for ionized radiation source (single use) is 2 weeks. 
 
When the validity of authorization is over, the importer must submit a new application to respective departments. 
 
15.  The only case of a penalty for non-utilization or the partial use of a license occurs in the import of ionized radiation sources.  
 
16.  Import licenses are not transferable between importers.  
 17.(a) For narcotic drugs and psychotropic substances, there is a condition that the total quantity of 
the imported pharmaceutical product, from each importer, will not be more than the annual 
quantity approved for the country.  Relating to ionized radiation sources there is no other 
condition. The same for point (b) of this question. 
 
(b)  There are no other conditions. 
 Other Procedural requirements 
1 8 .   W i t h  r e g a r d  t o  n a r c o t i c s  p r i o r  t o  i m p o r t a t i o n ,  t h e  M i n i s t e r  o f  H e a l t h  i s s u e s  a n  i m p o r t  
authorization based on the requirement of the licensed company (taking into account that the 
required quantity does not exceed the yearly allowe d quantities). This authorization is used as an 
international control instrument. When the authorization has reached the destination (control 
authorities of the exporting country), these authorit ies grant export authorization to their exporter. 
 19.  All banks provide foreign exchange automatically. 
 
5  MILITARY GOODS 
Outline of system 1.  The import of military goods and dual use goods and technology is managed by the Albanian 
State Export Control Authority (AKSHE) under the Minister of Defence. Trade with foreign parties is 
performed based on licenses and authorizations i ssued by this authority after consultations if 
needed with the relevant institutions.  
 
This permission is issued based on Law No. 9707 "On State Exports Control of Military Goods and Dual Use Goods and Technology” Official Journal No. 48, Page 1237; Publishing date: 24.04.2007). 
The AKSHE’s work is focused on the state contro l of exports, imports, transits, transfers and 
intermediary activities for military goods and dual use goods and technology, to ensure the 
interests of the Republic of Albania, to supervise its commitment to international treaties of non-proliferation of weapons of mass destructio n and their launching systems, the transfer of 
conventional weapons, as well as the implementati on of measures aimed at prevention of use of 
such goods for unlawful purposes.   
Purpose and coverage of licensing 
2.  The licensing system for military goods and dual use goods and technology function as one, 
concentrated in the State Export Control Authority mentioned in the previous question. The G/LIC/N/3/ALB/7 
 
- 18 - 
 
  products that are covered are listed in the national list according to the Decision of the Council of 
Ministers No. 106 of 9.02.2011  "On approving the updated list of military goods and dual use 
goods and technology which undergo state control of import-exports". This list is based on the European Union published list on military goods and dual-use goods and technology.  
 
3.  The system does not discriminate any country.  
4.  The licensing system is not intended to restrict the quantity or values of imports. In the Albanian 
legislation there is no restriction in value or quantity for the import of military and dual use goods.  The state export – import control policy is built on the following principles: 
- Priority of national interest – political, economic and military, of which protection is 
necessary for guaranteeing national security. 
- Protection of political, economic and military interest of the country. - Obligation to observe the international commitments made by the Republic of Albania to 
non-proliferation of weapons of mass destruction, the ways for their proliferation, and to 
ensure state control over international transfer  of goods designed for military purposes, and 
dual-use goods, as well as to prevent these goods from being used for terrorist acts and 
other illegal purposes. 
- Legality. - Conduct of export control to the extent required to achieve its purpose only. 
- Harmonisation of state export control procedures and regulations with international legal 
norms and practices. 
- Ensuring interaction with international organisations and foreign countries in the state 
export control area so as to reinforce international security and stability, including 
countervailing of weapons of mass destruction and the system for their proliferation. 
 5.  The Albanian legislation for the import-export military goods and technology of dual use is as 
follows: 
- Law No. 9707 of 05.04.2007, "On State Control over  the import-export of military goods and 
dual use goods and technology" Official Gazette No. 48, Page 1237; Publishing date: 
24.04.2007;  
- Decision of the Council of Ministers No. 43 of 16.01.2008, "On Organizing, functioning and 
the status of the State Export Control Authority", Official Gazette: Year 2008, No. 8, Page 240; publishing date: 30.01.2008;  
 
- Decision of the Council of Ministers No. 106 of 9.02.2011,  "On approving the updated list of 
military goods and dual use goods and te chnology which undergo state control of 
import-exports"; 
- Decision of the Council of Ministers  No. 305 of 25.03.2009, "On determining the procedure 
of issuing legal documents, in the framework of state control over the import-export of 
military goods and dual use  goods and  technology",  Official Gazette: Year 2009, No. 51, 
Page 2468; Publishing date: 29.04.2009;  
- Decision of the Council of Ministers  No. 304 of 25.03.2009, " On determining the procedure 
on expertise and control by the State Export Co ntrol Authority”, Official Gazette: Year 2009, 
No. 51, Page 2466; Publishing date: 29.04.2009;  
- Decision of the Council of Ministers No. 604 of 28.08.2003, "On approving, in principles, the 
European Union Code of Conduct regarding the export of weapons”; 
- Decision of the Council of Ministers No. 341 of 8.04.2009, “On determining tariffs for the 
issuance of legal documents”. 
Any import of military and dual use goods need s to be licensed by the State Export Control 
Authority.  
 An import license is always required.  G/LIC/N/3/ALB/7 
 
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  An exception for this is made only in the cases that follow: 
(a)  transfer of goods in connection with events held by the Armed Forces, or other state security 
structures of the Republic of Albania outside of its territory, or with events held by foreign military forces in the territory of the Republic of Albania, as part of international agreements 
laying down the mechanism of state control over the movement of these goods; 
(b)  international transfers of anaesthetics (med ical anaesthetic gases), sports and hunting arms, 
gas-containing vessels, and exportation and importation of individual armament of  military 
servicemen, and state law enforcement and internal security bodies, which, under law, are 
entitled to carry arms; 
(c)  state control procedures concerning international export transfers of goods, which aim at 
ensuring provision of military assistance in accordance with the terms contained in 
international agreements and treaties to which the Republic of Albania is a party, and the 
movement of goods outside of Albania with a view  to offering emergency assistance to foreign 
countries, if this is established by law. 
 
The licensing system in Albania cannot be abolished without legislative approval.  
Procedures 
6.I. The licensing procedures and formalities are published on the official website of the State 
Export Control Authority http://www.akshe.gov.al. In the Albanian legislation there is no 
restriction in the value, quantity or license quotas. Also according to the Albanian legislation 
there cannot be derogations from the licensing requirement. 
 II. There are no such things as size of quotas. A license can be issued with the validity from 1-3 
year with the extend option if there is a contract between the entities involved.  
 
III. There is no restriction  in the Albanian legislation  related to this matter. An import license is 
issued only when there is an application for it, which fulfils the requirements of the Albanian 
legislation. The State Export Control Authority also has the authority to do controls before, 
during, and after issuing the import license. Also to obtain an import licence, an end-user statement or certificate which is filled by the importer or any other who is the end user is needed. 
 
IV. Not applicable.  
V. If issuance of licences and authorisations does not call for coordination of work among the 
other institutions concerned, the time-limit for considering an application shall be determined in accordance with the categories of goods, but shall not exceed the following 
timescale as of the day of application: 
 
- 15 days for importation or transhipment of goods, and temporary 
importation/exportation of goods for exhibitions, fairs, advertising, testing, and other 
similar purposes, if this does not call for transfer of ownership. 
 
 This time-limit does not include the time required for obtaining additional information from 
entities involved in international transfers of goods. 
 
VI. There is no such provision in the Albanian legislation. After the import license is granted, the 
importation can be done at any time during its validity period. 
 
VII. A license application is proceeded by the State Export Control Authority. Trade activities with 
foreigners take place on the basis of licences and authorisations issued by this Authority, following the opinion of the institutions concerned, if required.  The concerned institutions 
are the Ministry of Defence, Ministry of Foreign Affairs, Intelligence Agencies, and Ministry of 
Interior.  
VIII. If the demand for licenses cannot be fully sa tisfied, the license cannot be granted. There is 
no exception. The new importers who want to deal with international trade of military goods 
need to be registered by the State Export Cont rol Authority. After they get the Registration 
Certificate they can demand an import license. This registration is not required for the trade of dual use goods and technologies. G/LIC/N/3/ALB/7 
 
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  IX. In the Republic of Albania for the import  of military goods and dual use goods and 
technology, an import license is always required  even when there is an export license issued 
by the exporting countries. Also in this case the import license is not issued automatically but the application is subject to controls. 
 
X-XI. Not applicable.  
7.(a) The application to import the goods must be done 15 days before. This time limit is the 
maximum prior to an import license. If the importer submits all the necessary documents 
and satisfies all the requirements, the license can be obtained within a shorter time. But this is to be considered case by case.  
 
(b) No. It has to be revised step by step. 
 (c) No. 
(d) A license application is proceeded by the State Export Control. Trade activities with 
foreigners take place on the basis of licences and authorisations issued by this Authority, following the opinion of the institutions concerned, if required. The concerned institutions are 
the Ministry of Defence, Ministry of Foreign Affairs, Intelligence Agencies, and Ministry of 
Interior.  
 8.  The circumstances under which the license can be refused are: 
 
The application for obtaining licences, authorisations or international import certificates will not be taken into consideration if: 
(a) It is deposited by a person who does not have the judicial capacity; 
(b) Documents are missing, or they are formulated contrary to the requirements 
prescribed by the law; 
 (c)  There are other reasons running counter to Albanian legislation in force, or the ratified 
international agreements. 
 In the event that the application for obtaining a licence, authorisation and international import certificate is not taken into account or rejected, the State Export Control Authority gives notice to 
the applicant and the state body responsible within  three days from the taking of the relevant 
decision, providing explanations of and reasons behind the failure to consider it or its rejection.  
The decision made by the State Export Control Au thority to revoke a licence, authorisation and 
international import certificate, or to remove the name of an entity involved in economic activities with foreign countries for international transfers of goods from the rolls, may be appealed to the 
court of appeal, in accordance with the general rules of appeal. An appeal against a decision 
suspends its execution.  Eligibility of Importers to Apply for License 
9.  A person, firm or institution that wants to deal with the import of military goods has to first be 
registered by the State Export Control Authority. This provision is not required for the import of 
dual use goods. The registration certificate fee for military goods is 30 USD. All the persons or 
firms that are registered by the State Export Co ntrol Authority are in a list published on the 
website: http://www.akshe.gov.mod.al.  
 
Documentational and other requirements for a permit application  
10. 
(a)   Certificate of registration (only for military goods); (b)   License application form completed by type, according to the guidelines set forth in this 
form, signed by the legal representative of th e entity (notarized photocopy of the passport); 
(c)   Brief summary of current commercial activity, which reflects the entity's ability to perform 
activities in the area of transfer of military goods (only private commercial entities); 
(d)  A natural person who seeks to obtain a license must submit the following documents: 
 Document that certifies expertise in the field of international transfers of military goods 
 Identification document (identity card, passport); G/LIC/N/3/ALB/7 
 
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   Proof that no judicial process, (Section Civi l and Criminal), is issued by the judicial 
district in which the person resides; 
 Certificate of prosecution that is not a criminal proceeding; 
 Certificate of execution that no obligations to individuals or legal entities, private or 
state; 
 Document that proves he is not convicted of any offense that constitutes grounds for 
denial of license, the illegal activities during the last 10 years from the date of the 
application for licence; 
 Certificate of tax authorities and the bank wh ere the money transfer will be performed; 
 Taxpayer Personal Identification Number (allowed for import-export); 
 Extract the simple and historical taken by the National Registration Centre. 
(e)  Legal person who seeks to obtain a license must submit the following documents: 
 Confirmation that the company is trial (Civil and Criminal Section) issued by the judicial 
district in which the company is headquartered; 
 Certificate of prosecution that is not a criminal proceeding; 
 Certificate of execution that no obligations to individuals or legal entities, private or 
state; 
 Proof of payment of taxes by the tax department; 
 Certificate from the bank where the money transfer will be performed; 
 Statute of the company (notarized copy); 
 The act of establishment (notarized copy); 
 Decision of the court to establish the company; 
 Taxpayer Personal Identification Number; 
 Extract the simple and historical taken by the National Registration Centre. 
(f)  International import certificate or end-user; 
(g)  Documents that provide information on the description of goods, conditions of delivery, 
quantity of goods, the value of goods, state tr ansit tranship, destination country and the last 
user, and country of origin of goods; 
(h)  Notarized copy of the contract or order, cert ified by the legal representative of the subject; 
(i)  Bill of goods; 
(j)  Documents that provide information on the description of goods, conditions of delivery, 
place of destination or origin of goods; 
(k)  Documents that provide information on the partner firm address, financial credibility, the 
bank account; 
(l)  Other valid documents to be considered as such by the State Export Control Authority; 
(m)  Warrant payment of the appropriate fee.  
11.  The documents required upon importation are the documents mentioned in the previous 
question.  
 12.  The licensing fee for an import license with the validity of one year is 30 USD. The licensing 
fee for an import license with the validity of three years is 60 USD. 
 
13.  There is no other deposit or advance paym ent except that paid for a licensing fee.  
 
Conditions of licensing 
14.  The validity of the license is from 1-3 years,  according to the type of the license required. The 
validity of the license can be extended, but not after the term of validity of the economic 
agreement, which refers to this license. 
 15.  There is no penalty for non-utilization of the licenses.  
16.  Licenses are not transferable. 
 17.  There are no other conditions attached to the issue of the license. G/LIC/N/3/ALB/7 
 
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  Other Procedural requirements 
18.  No, there are no other procedures prior to importation. 
 19.  All banks provide foreign exchange automatically.  
 
 
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