G/LIC/N/3/ALB/8  
 
20 November 2019  
(19-7885) Page: 1/23 
Committee on Import Licensing  Original: English  
 
 REPLIES TO QUESTIONN AIRE ON IMPORT LICEN SING PROCEDURES1 
NOTIFICATION UNDER A RTICLE 7.3 OF THE AG REEMENT  
ON IMPORT LICENSING PRO CEDURES  (2019)  
ALBANIA  
The following communication, dated 28 October 2019, is being circulated at the request of the 
delegation of Albania.  
 
_______________  
 
1   LIVE ANIMALS, LE ATHER, FEED, BIOLOGI CAL MATERIAL ON ANIM AL 
INSEMINATION, VETERI NARY DRUGS AND VACCI NES ................................ ....................  1 
2   PLANT PROTECTION  PRODUCTS (PPP)  ................................ ................................ ....... 5 
3   WASTE  ................................ ................................ ................................ .......................  7 
4   MEDICAL PRODUCTS  ................................ ................................ ................................  10 
5   MILITARY GOODS  ................................ ................................ ................................ ..... 18 
 
1  LIVE ANIMALS, LEATHE R, FEED, BIOLOGICAL MATERIAL ON ANIMAL INSEMINATION, 
VETERINARY DRUGS AND  VACCINES  
Outline of System  
1.  The procedure of licensing is performed according to Law “On licensing”, No. 10081, 
dated  23.02.2009 , as well as according to sublegal acts for law implementation. The legislation on 
licensi ng 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 categori es or sub categories are checked over by 
the National Business Centre (NBC) at the Ministry of Finances and Economy.  
 
Assessment on fulfilment of criteria for licensing (approval) is done by the institution that covers the 
respective field of activity.  
 
The decision of the competent Directory in the Ministry of Agriculture and Rural Development is 
based on the evaluation of submitted documents and on -site inspection to assess fulfilment of 
requirements and mandatory standards defined in the legislation. App roval or refusal is published in 
the register within the deadline, otherwise it is considered as approved.  
 
The final decision of the NBC is published in the register and the title is delivered to the applicant in 
the wickets of the NBC.  
 
                                                
1 See document G/LIC/3, Annex, for the Questionnaire.  G/LIC/N/3/ALB/8  
 
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  The competent Directory in the Ministry of Agriculture and Rural Development can suspend or revoke 
the license in cases where, during controls and verifications results that the technical -technological 
and sanitary -veterinary requirements are not fulfilled acc ording to the respective law.  
 
Purposes 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 medicinal products.  
 
3.  Import is carried out based o n 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 th e quantity and the value of imports. There is 
not any alternative method. The Ministry of Agriculture and Rural Development 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”;  
•  Law No. 10465 dated 29.09.2011 "On veterinary service in the Republic of Albania";  
•  Law, No. 10 137, dated 11.5.2009 “On some amendment s in current legislation on 
 licenses, authorization and permission in Republic of Albania”;  
•  Law No. 9426 dated 06.10.2005 “Animal Breeding” – as amended ; 
•  Decision, No. 538, dated 26.5.2009 “On licenses and permits treated by or through the 
 National Lic ensing Centre (NLC) and some other common sub -legal regulations”;  
•  Decision, No. 1295, dated 29.12.2009, “On some amendments in Decision, No. 538, 
dated 26.5.2009 “On licenses and authorization that are checked over through NBC and 
some other common sub-legal regulations” . 
 
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.  
 
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 lice nses are used for import issues, the steps are as follows:  
- The approved list of importers is sent to the Regional Agencies of the Service of 
Veterinary and Plant Protections in regions, National Food Authority and border 
inspection points or responsible body for control of license;  
- List of approved licenses is published on the NBC’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 application for a license  to import is:  
(a) live animals      10 days;  
(b) biological material on animal insemination  15 days;  
(c)  veteri nary medicinal products    15 days.  
 
These terms for processing the applications are based on the decision, No. 1295, dated 
29.12.2009, “On some amendments in Decision No. 538, dated 26.05.2009 “On licenses and G/LIC/N/3/ALB/8  
 
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  authorization that are checked over through the NCL and some other common sub -legal 
regulations”.  
 
VI.  After issuing the license there are no limitations in realizing the importation activity.  
  
VII. The NBC is the only entity where the applicant needs to apply and present all the 
documentation. Documents are being sent online (from the NBC office), for approval to the 
Ministry of Agriculture and Rural Development. After this process, the NBC issues the import 
license to the applicant.  
 
VIII. There are no limits on licensing numbers. There are no restrictions on timing and ranki ng 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 the requirements, the application is refused until 
a second period, de termined in the act of the competent inspection authority. The act of refusal 
is published on the NBC’s website.  
 
The examination of the applicant's request, from 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 medicinal products.  
 
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 the 
Republic of Albania”;  
- Law No. 10465 dated 29.09.2011 "On veterinary service in the 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”;  
- Annex I: Permission and licensing categories which are fo llowed by/or through NBC;  
- Annex I, Section II: Food and Health. Category II.2, Code II.2, B; Category II. 3 ; 
- Breeding or animal trading with Code II.3, C; Category II.7, Code II 7B . 
 
XI. No, such conditions are associated with the issuing of the licens e. 
 
7. Where there is no quantitative limit on importation of a product or on imports from a particular 
country:  
 
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 NBC issues the license 
to the importer.  
b) No, because the licensing authority must examine the documentation required. The timing to 
issue a license is 10 -15 days.  
c) No limitations for the time of application.  
d) The NBC is the on ly entity where the applicant needs to apply (each importer) and present all 
the documentation. Documents are being sent online (from the NBC office), for approval to 
the Ministry of Agriculture, and Rural Development. After this process, the NBC issues th e 
import license to the applicant . 
 
8.  The license can be refused in cases when the importer does not meet the requirements set forth 
in the law and regulations.  
 
The applicant is informed officially by the NBC, for the reasons of a license’s refusal. Thi s information 
is published automatically on the NBC’s website.  
 
Any interested party has the right to appeal on an administrative procedure to the NBC or Ministry 
of Agriculture and Rural Development for cases of licenses with preliminary inspections. G/LIC/N/3/ALB/8  
 
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  Administrative complaints are analysed by representatives of the NBC, except cases of licenses with 
preliminary inspection which are analysed by the Ministry of Agriculture and Rural Development.  
 
In the cases of preliminary inspection, the Ministry of Agricul ture and Rural Development is informed 
by the NBC when a complaint is presented to their office.  
 
In both cases, complaints addressed to the NBC or Ministry of Agriculture and Rural Development, 
are published in the National 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 licence  
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 common guidance of the Ministry of Finances and Economy 
and Ministry of Agriculture and Rural Development, No. 8 dated 08.05.2007 “On the fees and 
secondary revenues applicable by institutions of the agriculture and food system”, as amended.  
 
The list of approved licenses is published on the NBC’s website and is sent to the Regional Agencies 
of the Service of Veterinary and Plant Protections in r egions, National Food Authority and border 
inspection points or responsible bodies for control of license.  
 
Documentation and other requirements for application for licence  
10. The necessary information and the documentation to be filled by the applicant a re provided by 
the NBC.  
  
11. The required documents are those issued by the National Business Centre (NBC).  
 
12.  Depends on the type of license, there is a different fee for different licenses. The fee for a license 
is: 
(a) for live animals - 10.000 ALL;   
(b) for trading of racial material – 10.00 ALL; and  
(c) for veterinary medicinal products - 100.000 ALL.  
 
If made online, the application is free of charge otherwise if made at the NBC’s wickets the 
administrative charge is 100 ALL.  
 
13.  No, advance pay ment 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 and Rural Development performs frequent 
on-site controls. If some conditions are not fulfilled then the Ministry of Agriculture and Rural 
Development presents the proposal to the NBC fo r 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. 
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  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 PRO DUCTS (PPP)  
Outline of System  
1. The procedure of licensing in Albania is made in accordance with Law No. 10081, dated 
23.02.2009 “On Licensing, Authorizations and Permits in the Republic of Albania”, as amended. 
Import of products for plant protection in Albania is conducted through permissions issued by the 
NBC, based on some preliminary criteria to be fulfilled by the interested parti es. 
 
The entities are inspected from the National Food Authority. The decision of the NFA is based on the 
evaluation of submitted documents and on -site inspection to assess fulfilment of requirements and 
mandatory standards defined in the legislation. Appr oval or refusal is published in the register within 
the deadline, otherwise it is considered as approved. This license is issued through the NBC.  
 
According to Law No. 105/2016 dated 14.10.2016 "On the plant protection services” in Albania, only 
registered  products for plant protection can be imported. The procedures for the registration of PPP 
are performed by the Ministry of Agriculture and Rural Development.  
 
Purposes 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.  All PPPs marketed or used in the territory of the Republic of Albania should undergo the 
registration procedure. There are registered in the Republic of Albania only PPPs, which are 
registered in one from the European Union countries.  
 
4.  This licensing system does not intend to restrict the quantity or value of imports coming into 
Albania. T he 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 protecti on in international legislation.  
 
5.  The Albanian legislation that regulates this licensing system includes:  
• Law No. 10081 dated 23.02.2009 “On Licensing, Authorizations and Permits in the Republic 
of Albania”;  
• Law No. 105/2016 dated 14.10.2016 "On the pl ant protection services “;  
• Decision of the Council of the Ministers No.532 dated 11.09.2018, “On the approval of the 
rules on trade, transport, preservation and storage of plant protection products”.  
 
Procedures  
6.I.-IV. Not applicable.   
 
V. Based on Law N o. 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 Business Centre. This is 
the only administrative organ that issues the license.  
 
VIII.-X. Not applicable .  
 
XI. There are no such conditions associated with the license.  
 G/LIC/N/3/ALB/8  
 
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  7. Where there is no quantitative limit on importation of a product or on imports from a particular 
country:  
 
a) The importer can import the product at the time when he judges is appropriate. The time limit 
to obtain a license is 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 Business Centre.  
 
c) No limitations related to the period of the year during which applications for license can be 
made.  
 
d) Application for trading licenses are affected only by one administrative organ, which is the 
National Business Centre.  
 
8.  The license can be refused when the importer fails to meet the appropriate conditions on storage 
and preservation of the plant protection products as required by the legislation (including the 
necessary documentation). The applicant is informed officially by the NBC, for the reasons of the 
license’s refusal. This information is published automatically on the NBC’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 in stance.  
 
Eligibility of importers to apply for licence  
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 s ystem. All persons who have wholesale trading licenses are eligible to import 
plant protection products that are registered in Albania. The list of approved licenses by subjects is 
published on the website of the NBC. The list is available to the National Food Authority for control 
effects.  
 
A list of fees exists which is based on the common guidance of the Ministry of Finances and Economy 
and Ministry of Agriculture and Rural Development, No. 8 dated 08.05.2007 “On the fees and 
secondary revenues applicable by institutions of the agriculture and food system”, as amended.  
 
Documentation and other requirements for application for licence  
10. The applicant presents the required documents to the Directory of the NBC. The whole set of 
documents is avail able at the NBC office.  
 
11. Wholesale trading license of plant protection products is presented at the quarantine inspectorate 
office at the cross -border points. After the control by quarantine inspectorate is carried out, the 
customs authorities accompli sh customs procedures.  
 
12.  Licensing fee is 2000 ALL.  
 
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 th e issuing of the license.  
 G/LIC/N/3/ALB/8  
 
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  Other procedural requirements  
18.  Yes, there is the procedure of the PPP registration in the Republic of Albania. This procedure is 
performed by the Ministry of Agriculture and Rural Development.  
 
19. Foreign exchange is provided automatically by banking authorities, every day.  
 
3  WASTE  
Outline of System  
1.  In the field of chemicals management, on 17.03.2016, in Republic of Albania has been approved 
the new Law no. 27/2016 "On chemicals management". In article 28, point 1, of this law, is specified 
that the production, placing on the market, deposit and storage of hazardous chemicals are 
performed by licensed legal entities. The license for the production, placing on the market, deposit 
and storage of hazardous chem icals shall be issued by the Minister responsible for industry. 
Documentation and procedures for issuing licenses for the production, placing on the market, storage 
and storage of hazardous chemicals shall be approved by the Council of Ministers, on the pr oposal 
of the Minister responsible for industry.  
 
Purposes and coverage of licensing  
2.  The license foreseen in the law of chemicals 27/2016, cover the production, placing on the 
market, deposit and storage of hazardous chemicals.  
 
Based on point 3, Sect ion II.2,of the DCM no. 442, dated 26.6.2019 "On approval of the Rules for 
the Prohibition of Export of Metal Mercury, Mercury Compounds and  Mercury Mixtures, Safe storage 
of metallic mercury and Specific Criterias for Safe storage of metallic mercury Con sidered waste", is 
specified that: In any case, placing on the market, deposit and storage of wastes (mercury wastes) 
shall be carried out in accordance with the requirements laid down in the applicable legislation on 
the management of chemicals by natural  or legal persons, provided with a relevant license for the 
production, placing on the market, and the storage of hazardous chemicals. This DCM will enter into 
force after 1 January  2020.  
 
DCM 442/2019, also foreseen that import of mercury and the import o f mercury mixtures listed in 
Annex I to that Decision for a particular use in accordance with the legislation on chemicals 
management is allowed only when the ministry responsible for the environment/Chemicals Office, 
in frame of the obligations of Mercury  Convention, has given written consent for that import. Consent 
in writing is given when:  
 
(a)  the exporting State is a Party to the Convention and the mercury to be exported shall not be 
considered as the primary extract of the mineral wool, prohibited under the Convention ; or 
(b) the exporting State not party to the Convention provides the document that the mercury is 
not considered to be the primary extract of the mercury mineral.  
 
3.  The system applies to hazardous chemicals, coming from a ll countries, and which intend to be 
produced, placed on the market (including import), deposit and storage hazardous chemicals in 
Republic of Albania.  
 
4.  The license foreseen in the law of chemicals 27/2016, does not aim to restrict quantity or values 
imported, but to regulate the interior procedures for hazardous chemicals with purpose protection 
of human health and the environment.  
 
5.  The licensing system for the production, placing on the market, deposit and storage of hazardous 
chemicals, includin g mercury , is based on:  
 
(a) Law no. 27/2016 "On chemicals management "; 
(b) DCM no. 442, dated 26.6.2019 "On approval of the Rules for the Prohibition of Export of Metal 
Mercury, Mercury Compounds and Mercury Mixtures, Safe storage of metallic mercury and 
Specific Criterias for Safe storage of metallic mercury Considered waste" ; G/LIC/N/3/ALB/8  
 
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  (c)  Documentation and procedures for issuing licenses for the production, placing on the market, 
storage and storage of hazardous chemicals shall be approved by the Council of Mini sters, on 
the proposal of the Minister responsible for industry.  
 
Procedures  
6. The license foreseen on the law on chemicals management, is not based on quotas. In this regard, 
point I to IV, above, are not relevant in this case.   
 
I. Based on the Law no. 27/2016 "On chemicals management ", documentation and procedures 
for issuing licenses for the production, placing on the market, storage and storage of 
hazardous chemicals shall be approved by the Council of Ministers, on the proposal of the 
Minister responsible for industry. In this regard, the above questions will be properly 
addressed after preparation, approval of that DCM . 
 
II. Please refer to point IV, above.  
 
III. Please refer to point 2, above.  
 
IV. We do not have such information.  
 
V.  
 
VI.  
 
VII.  
 
VIII.  
 
IX.  
 
X.  
 
XI.  
 
7. Please refer to point 2 and VIII, above.  
 
8.  Please refer to point VIII, above.  
 
Eligibility of importers to apply for licence  
9. Based on the Law no. 27/2016 "On chemicals management ", the license for the production, 
placing on the market, deposit and storage of hazardous chemicals, shall be issued to legal entities 
if they meet the essential requirements for the storage of hazardous chemicals:  
 
(a)  have a system for maintenance and storage of special hazardous chemicals;  
(b)  prevent the access / entry of unauthorized persons who may use chemicals for inappropriate 
purposes;  
(c)  take preventive measures to avoid the risk of dangerous chemicals.  
 
With this license can also be provide s natural persons who use hazardous chemicals for such 
activities as: artistic activities, scientific research activities and other specific activities.  
 
The detailed documentation and procedures for issuing this license for the production, placing on 
the market, storage and storage of hazardous chemicals, with be specified in the Decision of Council 
of Ministers, on the proposal of the Minister responsible for industry.  
 
Documentation and other requirements for application for licence  
10.  Based on point 3, Section II.2,of the DCM no. 442, dated 26.6.2019 "On approval of the Rules 
for the Prohibition of Export of Metal Mercury, Mercury Compounds and  Mercury Mixtures, Safe 
storage of metallic mercury and Specific Criterias for Safe storage o f metallic mercury Considered G/LIC/N/3/ALB/8  
 
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  waste", is specified that: In any case, placing on the market, deposit and storage of wastes (mercury 
wastes) shall be carried out in accordance with the requirements laid down in the applicable 
legislation on the management o f chemicals by natural or legal persons, provided with a relevant 
license for the production, placing on the market, and the storage of hazardous chemicals.  
 
The detailed documentation and procedures for issuing this license for the production, placing on  
the market, storage and storage of hazardous chemicals, with be specified in the Decision of Council 
of Ministers, on the proposal of the Minister responsible for industry.  
 
DCM 442/2019, in point 2, of Section II.2, also foreseen that import of mercury and the import of 
mercury mixtures listed in Annex I to that Decision for a particular use in accordance with the 
legislation on chemicals management is allowed only when the ministry responsible for the 
environment/Chemicals Office, in frame of th e obligations of Mercury Convention, has given written 
consent for that import. Consent in writing is given when:  
 
(a)  the exporting State is a Party to the Convention and the mercury to be exported shall not be 
considered as the primary extract of the mi neral wool, prohibited under the Convention ; or 
(b)  the exporting State not party to the Convention provides the document that the mercury is 
not considered to be the primary extract of the mercury mineral.  
 
The formats for the implementation of point 2, will be approved by the Minister of Environment in 
charge.  
 
11. DCM no. 442, dated 26.6.2019 "On approval of the Rules for the Prohibition of Export of Metal 
Mercury, Mercury Compounds and  Mercury Mixtures, Safe storage of metallic mercury and Specific  
Criterias for Safe storage of metallic mercury Considered waste", will enter into force on 
1 Januar y 2020. In this  context for import of the actual mercury, the entity must have the license 
for the production, placing on the market, storage and storage of hazardous chemicals, based on 
the law 27/2016, also the MSDS in Albanian  and English  language. Import of mercury a s a pesticide, 
is not permitted in the country.  
 
12.  The detailed documentation and procedures,  including if there would be any fee for issuing this 
license for the production, placing on the market, storage and storage of hazardous chemicals, 
including i mport of mercury, will be specified in the Decision of Council of Ministers, on the proposal 
of the Minister responsible for industry.  
 
13.    
 
Conditions of licensing  
14.-17.  Please refer to point 12, above . 
 
Other procedural requirements  
18.  Yes, DCM 4 42/2019, in point 2, of Section II.2, also foreseen that import of mercury and the 
import of mercury mixtures listed in Annex I to that Decision for a particular use in accordance with 
the legislation on chemicals management is allowed only when the minist ry responsible for the 
environment/Chemicals Office, in frame of the obligations of Mercury Convention, has given written 
consent for that import. Consent in writing is given when:  
 
(a)  the exporting State is a Party to the Convention and the mercury to b e exported shall not be 
considered as the primary extract of the mineral wool, prohibited under the Convention ; or 
(b)  the exporting State not party to the Convention provides the document that the mercury is 
not considered to be the primary extract of the mercury mineral.  
 
The formats for the implementation of point 2, will be approved by the Minister of Environment in 
charge.  
 
19.    Foreign exchange is provided automatically by banking authorities, every day.    
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  4  MEDICAL PRODUCTS  
Outline of System  
1.  Due to the amendments on licensing procedures, only for some of medicinal products is required 
to provide an import license, before placing them on the market. Medicinal products, according to 
their use and technical capacities that a uthorities have, are divided in groups as per below:  
(a)  Pharmaceutical products (Human medicines);   
(b)  Dental equipment;  
(c)  Medical devices (consumables);  
(d)  Disinfectants, disinsectants and deratizing substances (DDD -s).  
 
Among the above -mentio ned groups, the import authorization is required for human medicines, 
DDD-s (disinfectants, disinsectants and deratizing substances) and dental equipments in case they 
are source of ionized radiation. Every subject, before starting the activity on import/e xport or place 
on the market of these substances, has to be licensed nearby the National Business Center (in the 
following NBC). In some of licensing procedures, is needed the statement of the charge d’affaires 
structure  at the Ministry of Health and Socia l Protection. The decision needs  to be fulfilled  within 
15 days of work, after that, it come published by the NBC in the Trade Register, as an authorized 
subject on these activities. After that, import authorizations are granted for every specific 
importation according to regulation in force:  
 
(i) All pharmaceutical products (human medicines) circulating in the Albanian market should be 
granted a marketing authorization, except certain cases such as due to  health service’s needs 
(for hospital/ambula tory treatment), to human medicines that do not have a similar authorized 
alternative by the Agency, are granted an import authorization by the responsible minister on 
health issues.  
 
The authorized pharmaceutical products are imported by legal subjects li censed on this activity 
by the NBC, under written statement of the Ministry of Health and Social Protection, prior to 
the licensing approval by the NBC. Only for pharmaceutical products (human medicines) under 
patent protection, the importers come assigned  by the Representative Offices established in 
Albania or by regional ones; in case of generics there’s no need for such assignment. Licensed 
subjects on import of human medicines carry out their imports, based on the updated register 
of pharmaceuticals, pu blished by the National Agency of Medicines and Medical Devices (in 
the following Agency). Import procedures are performed at the entry customs offices, in the 
presence of pharmaceutical inspectors.  
 
(ii)  In case of health service’s needs (for hospital/am bulatory treatment), to pharmaceutical 
products (human medicines) that do not have a similar authorized alternative by the Agency, 
are granted an import authorization by the responsible minister on health issues. Such 
application needs  to be submitted near  by the Regulation Sector of Pharmaceutical Market 
and Medical Devices (Ministry of Health and Social Protection). After documents’ evaluation 
by the above -mentioned  unit, the Minister of Health and Social Protection issues the import 
authorization, which is valid for 2 (two) months.  
 
(iii)  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 NBC,  on wholesale trade of human medicines, also need 
to be authorized by the Interinstitutional Commission on Narcotic Drugs and Psychotropic 
Substances, related to their activity on importation and distribution of narcotic drugs and 
psychotropic substances . In case of the importer is interested in import of narcotics and 
psychotropic, he/she submits its request on import authorization at the Regulation Sector of 
Pharmaceutical Market and Medical Devices . If the required quantity doesn’t exceed the 
allowed qua ntities, the Minister of Health and Social Protection issues the import authorization, 
which is valid for 3 (three) months, from its issuing date. This authorization is used as an 
international control tool. When the authorization has reached the destinati on (control 
authorities of exporting country), these authorities grant an export authorization for their 
exporter. Therefore, within these 3 (three) months, the Albanian importer resubmits near the 
Regulation Sector of Pharmaceutical Market and Medical Dev ices, the request for import 
authorization, followed by the export - authorization of the exporting country. After that, the 
Regulation Sector of Pharmaceutical Market and Medical Devices proceeds with procedure of G/LIC/N/3/ALB/8  
 
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  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.  
 
(iv) In order to facilitate the import procedures, after May 2008, according to the order of Minister 
no. 215, of 27 June 2008, has been avoid the obligation of granting and submitting in the 
custom authorities, the import authorization for medical equipments, dental equipments and 
consumables. If medical equipments are sources 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 th e device model/batch no.; maximal tension, 
manufacturing date and the quality certificate of the two last years from the importing date, 
invoice no. the approximate date to be imported.   
 
(v) Related to importation of disinfectant, disinsectant and derati zing substances (DDD), the 
subject after being licensed by the NBC on the activity of hygienic -sanitarian intercessory 
services, he/she submits the request for import authorization nearby Secretariat of 
authorization of biocides in the Ministry of Health a nd Social Protection. The requirement 
comes verified by the Secretariat, if the substance to be authorized is part of the updated list 
of DDD substances, approved by the Minister of Health and Social Protection; also, if the 
substance fulfills all the requ irements specified in the mentioned Order of the Minister of 
Health. Furthermore, on the issuing of the import authorization related to DDD substances, is 
required the opinion of specialists from Public Health Institute (PHI), 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. Based on 
all effectuated verification, the Authorization Committee for biocidal produ cts recommends for 
the issue of the import authorization.  
 
Purposes and coverage of licensing  
2.  Importation licensing systems are:  
 
(i) Licensing of pharmaceutical products (human medicines);  
(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 (Human medicines) of the chapter 30 of the Combined 
Nomenclature of Goods;  
• Disinfectant, disinsectant and deratizing substances, chapters 28, 29 of CNG . 
 
3.  Pharmaceutical products (human medicines) to be granted a marketing authorization in Albania 
and later imported in order to be placed on the domestic market, should be authorized and circulate 
in one of the European countries, USA, Switzerland, Israel, Tur key, Canada, Japan and Australia 
and/or those produced in Balkan countries, unless they have an marketing authorization and also 
circulate in their country.  
 
4.  Licensing system generally is used to control products that will enter in our country. Licens ing is 
seen as a control tool to identify such products, intended to be placed on the domestic market, in 
terms of active ingredient, quantity and quality. Even though, health care is mainly covered by 
imported products, is aiming on stimulation of domesti c production, by increasing the number of 
qualitative human medicines manufactured in Albania. Normally, adoption of proper legislation, 
setting up of structures and equipping with necessary technology, creates the condition and 
opportunities to use other alternatives, which consist on control of imported pharmaceutical products  
at several stages, at the border by custom authorities, during wholesale distribution, during 
dispensing by pharmacies and their use. Adoption of new legislation and structures rela ting to the 
control system is an ongoing process.  
 
5.  Legal framework that regulates the procedures of import licensing includes:  
• Law No. 105/2014 of 31 July 2014 “On human medicines and pharmaceutical service” 
amended by the Law No. 109/2015 of 15 October 2015;  G/LIC/N/3/ALB/8  
 
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  • Council of Ministers Decision No. 142, of 18 February 2015 “On designation of the rules for 
issuing of the Minister of Health’s authorization on import of unauthorized human 
medicines”;   
• Joint Guideline between the Ministry of Health and Soci al Protection and Ministry of Finance 
and Economy No. 126 of 02 February 2018 ”On fee desigantion for granting the import 
authorization”;  
• Council of Ministers Decision No. 325, of 14 June 1993 “On regimen of export -import and 
pharmaceutical products produ ction”;  
• Joint Guideline of Ministry of Health and Ministry of Finance No. 180 of 13 August  1993 “On 
co-operation for the regimen of import -export of pharmaceutical products and their 
clearance”, amended by;  
o Minister of Health Order No. 104 of 5 March 2004 , “For a change in the Guideline 
No. 180 of 13 August 1993 “On co -operation for the regimen of import -export of 
pharmaceutical products and their clearance”;  
o Minister of Health Order No. 245 of 29 June 2006 “For a change in the Guideline No. 
180 of 13 Augu st 1993 “On co -operation for the regimen of import -export of 
pharmaceutical products and their clearance”;  
o Minister of Health Order No. 81 of 06 June 2008 “For a change in the Guideline No. 
180 of 13 August 1993 “On co -operation for the regimen of import -export of 
pharmaceutical products and their clearance”;  
• Law No. 7975 of 26 July 1995 “On narcotic drugs and psychotropic substances, amended 
by: 
o Law No. 9271 of 9 September 2004;  
o Law No. 9559 of 8 June 2006;  
o Law No. 10137 of 11 May 2009;  
• Law No. 89/2014 of 17 April 2014 “On medical devices”;  
• Minister of Health Order No. 86 of 17 February 2015 “On issuance of marketing authorization 
for medical devices”;  
• Law No. 10081 of 23 February 2009 “On licenses, authorizations and permits in the Republic 
of Albania”;  
• Law No. 10137 of 11 May 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 May 2009 "On licenses and permits handeled by 
or through the  National Licensing Center (NLC) and on some sublegal common regulations”;  
• Council of Ministers Decision No. 1295 of 29 December 2009 “On some amendments to 
Decision of Council of Ministers No. 538 of 26 May 2009 “On licenses and permits handeled 
by or thr ough the National Licensing Center (NLC) and on some sublegal common 
regulations "; 
• Law No. 9928 of 9 June 2008 “On dental health service in the Republic of Albania” amended 
by:  
o Law No. 10137  of 11 May 2009;  
o Law No. 50/2013  of 14 February 2013;  
• Minister o f Health Order No. 162 of 16 April 2008 “On abrogation of the Order of Minister 
No. 214 of 22 April 2004”;  
• Law No. 10138 of 11 May 2009 “On Public Health” amended by Law No. 52/2013 , of 
14 February 2013;  
• Council of Ministers Decision No. 415 of 17 August 1 993 “On import, export, wholesale and 
retail trade licensing of disinfectant, disinsectant and deratizing substances”;  
• Minister of Health Order No. 202 of 23 May 2014 ”On the autorizathion of import of  biocidal 
products and the approval of the list of bio cidal products for disinfection, desinsection and 
deratization in the public health”;  
• Law on Protection from ionized radiation No. 8025 of 9 November 1995, amended by:  
o Law No. 9973 of 28  July 2008;  
o Law No. 26/2013 o f 14 March 2013:  
• Decision of Council of Ministers No. 158 of 13 February 2008 “On import -export of ionized 
radiation source in the Republic of Albania”;  
• Regulation No. 3918/4 of 3 November “On Import, export and trasit of radioactive sources”;  
• Guidance No. 4756/1 of 21 December 2006 “ On import -export of radiation materials in 
Albania” ; 
• Categorization of Radioactive Sources No. 9 of 7 January 2010;  
• Regulation No. 10 of 7 January  2010 “On licensing and inspection of ionized radiation 
sources”;  G/LIC/N/3/ALB/8  
 
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  • Approval no. 494/6 of 7 February 2011 ”Approval on import -export for X -rays generators”;  
• Guidance No. 134 of 12 April 2011 ”On import - export 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 of administrative discretion.  
 
Procedures  
6.I. The only case o f implementing quantity limitation is importation of narcotic drugs and 
psychotropic substances. Annual quantities are approved by the International Narcotic Control 
Board (INCB) and are published on its official web page: https://www.incb.org. Practically  the 
authority does not apply the allocation of quotas among importers. There is an annual 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 t o pharmaceutical 
products’ inclusion in the reimbursement scheme etc. There is not any limitation for the 
quantities imported from any country. Importers could import the quantity they think it is 
reasonable or according to the supply contracts, they have signed, always within annual quota 
and the 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 substance s, exist an updated list of substances, drafted upon the WHO 
recommendations and Directive 98/8/EC, of the European Parliament and of the Council, of 
16 February 1998, concerning 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 or psychotropic substance is determined for a calendar 
year period and covering all the country. Importation authorizations are granted every time 
that importer will import a quantity within the quota. Because of the import authorizations are 
valid for 3 months, after one importation within 3 (three) months can be done the next 
importation from the same importer.  
 
Related to ionized radiation sources the import authorization s are for single use and valid for 
2 (two) weeks.  
 
III. Licenses are allotted for the quantity of a certain narcotic drugs or psychotropic substances 
that are imported by a certain manufacturer and a certain country (this is not defined by 
authority, but from the fact that the drug is authorized and such authorization 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 s everal authorities, its continuity is 
supervised by these authorities. Pharmaceutical Authorities supervise especially license usage, 
because no utilization would result in the lack of drugs in health institutions and 
pharmaceutical market. In case of no u tilization 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 importer to solve any possible problems or to 
make possible the importat ion from another importer if the first has not possibility to do it. 
The primary concern of authorities is that the market not to suffer the lack of pharmaceutical 
products.  
 
The Radiation Protecting Commission has the right to approve authorization import s, 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 need that country has for such pharmaceutical 
products for one year.  
 
IV.  There is not any defined pe riod.  
 
V. There is not any defined period, but usually applications are processed within a working day.  G/LIC/N/3/ALB/8  
 
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  VI. There is not any defined period. The authority and importer are informed that with the start 
of a calendar year begins even 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 case where the application for import licensing is examined by two authorities is that 
of disinfectant, disinsectant and deratizing substances and of ionized radiation sources:  
- Related to disinfectant, disinsectant and deratizing substances, is required the official 
opinion of Public Health Institute ; 
- The same situation occurs with the ionized radiation sources, where the importer has 
to approach  more than one administrative organ.  
 
VIII. There are several ways to act in case of not satisfied license demand. If the pharmaceutical 
product is for ambulatory use and it is not the first alternative in the reimbursement list, it is 
served the first to come. It is enough to submit the application with all necessary data and 
the license will  be granted to him. If the drug is intended for hospital use (according to 
contracts importer has with hospitals), or is first alternative in the reimbursement list (with 
the highest coverage level) it is served first the importer that fulfill these condit ions and then 
the others according to the agreements among themselves, take the difference of quotas. If 
the importer submits an application for narcotic import authorization in 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 is 
decided that procedures must be done the next year when the new quotas are open. It is not 
examined the importer performance.  The maximal quantities for each importer 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 in Albania and there is a 
very small num ber of importers, sometimes even only one). There is not any provision for 
new importer, they are considered in the same way like 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. Narcotic drugs and psychotropic substances are the case of bilateral quotas. According to 
regulatory framework and practicall y together with the application 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 the ionized radiation sources, where, to provide the export 
approval from the exporting country, is needed the confirmation from importing country.  
 
X. In case of importing of narcotic drugs and psychotropic substances, when import and export  
authorization are granted, the authority of exporting country after granting export 
authorization, based on application and import authorization, sends to the authority of 
importing country an export authorization copy.  
 
Related to ionized radiation sourc es, two counties are informed between them through their 
contact points.  
 
XI. Related 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 pro cedure does not exist.  
 
Related to ionized radiation source:  Yes.  
 
7.a) The import authorization validity is of 1 (one) and 2 (two) months: respectively 1 (one) month 
for authorized pharmaceutical products and 2 (two) months for unauthorized ones; of 
3 (three) months for narcotics and psychotropic and ionized radiation sources; meanwhile 
related to DDD substances, the validity is of 6 (six) months.  
 G/LIC/N/3/ALB/8  
 
- 15 - 
 
  b) Yes, licenses (authorization) are granted immediately on request, despite unauthorized 
pharmaceutical p roducts, where in some cases is required the examination of Ministry of 
Health and Social Protection. The procedure for the examination is up to 3 (three) working 
days.  
 
c) No, there is not any limitation.  
 
d) There are cases where application needs to be passed on other administrative organs such as, 
import of DDD substances (the application passes to Public Health Institute) and import of 
ionized radiation sources. The organs cooperate with each other and the importer has to 
approach to only one, Minis try of Health and Social Protection, when 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, specifi cally when:  
• Agency is informed that the drug does not meet the necessary quality, safety standards; 
information is received by homologues authorities or by the results of the Agency itself 
(testing of samples in the market);  
• Manufacturer or control authori ties informs for the starting of withdrawal procedures of the 
product from market, meanwhile the importer submits the application for import license 
(authorization) ; 
• The marketing authorization validity of the pharmaceutical product has expired and the 
manufacturer has not begun the renewal procedures.  
 
Eligibility of importers to apply for licence  
9.(a) Under restrictive licensing systems, application for licenses is done only by operators that 
fulfill the conditions of such systems. In health services 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 and Social Protection. If the 
subject applies to import narcoti c and psychotropic drugs, or medicinal products that are 
source of ionizing radiation, it must have e second registration only for this kind of activity.  
 
Related to ionized radiation sources, all the physics or legal persons are eligible to apply for 
license, under restrictive licensing system too.  
 
(b) In health services there are not non -restrictive systems.  
 
If not, is there a system of registration of persons or firms permitted to engage in importation?  
What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized 
importers?  
 
There is a system of professional licensing for importation, exportation, and wholesale distribution 
of medicinal products. Eligible are those firms that have proper facilities, 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. According to the legislation into force on pharmaceutical products, 
the Agency prepares and publishes annually the register of authorized human medicines, declared 
CIF prices and the importers’ list authorized from Marketing Authorization Holders. 
(http://akbpm.gov.al/ ) 
 
Documentation and other requirement s for application for licence  
10.  There is not any application form, importers receive necessary information to the authorities 
and begin the procedure. In the different systems is submitted different documentation depending 
on groups of products that wil l be imported.  
 
(a) To import authorized pharmaceutical products, authorized importer submits an application for 
import authorization, that includes:  
 - importer’s data;  
- list of pharmaceutical products to be imported where is detailed: trade name, generic 
name, quantity;  
- manufacturing and expiry date;  G/LIC/N/3/ALB/8  
 
- 16 - 
 
  - batch number;  
- approved CIF price;  
- manufacturer name;  
- the country from which the import is done.  
 
An invoice is attached to the application. Submission is done to the Agency, where the import  
authorization is granted.  
 
(b) To import unauthorized 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 being submitted to the Regulation Sector of Pharmaceutical Market and 
Medical Devices (Ministry of Health and Social Protection), where the import authorization 
signed by Minister of Health and Social Protection, is granted to the respe ctive applicant.  
 
(c) To import narcotic drugs and psychotropic substances, the importer has to submit the 
application to the Regulation Sector of Pharmaceutical Market and Medical Devices (Ministry 
of Health and Social Protection), including abovemention ed data, and full address of 
manufacturer. When the importer submits the Ministry of Health and Social Protection, first 
he requires the granting of import authorization. When he/she receives even the confirmation 
that exporter has received the export auth orization in the originating country, the importer 
applies for the import authorization when the cargo is ready.  
 
(d) To import medical devices are applied the requirements stipulated in the Minister’s Order into 
force, for this purpose. If the medical dev ices 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 near the 
Secretariat:  
 
 (i) An application that contains the following information:  
 - Importer’s data such as: legal/natural person’s name and the administrator’s 
name, address;  
- Trade name of the product to be imported;  
- Active subst ance;  
- Package;  
- Quantity;  
- Custom office and storage address of these products.  
 
The applicant declares on his responsibility, to be 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 Business Center, 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” . 
 G/LIC/N/3/ALB/8  
 
- 17 - 
 
   (iii)  Registration Certificate of the biocide product in one of the EU countries, Switzerland, 
United Kingdom, Canada, Australia and United States of America (translated and 
notarized in Albanian language) . 
  
 (iv) Copy of the label in Albanian language, where are being specified, as provided in the 
Guideline for labeling, packaging and storage conditions of DDD substances in public 
health.  
 
 (v)  The issued document by the Public Health Institute on analyzing and effectiveness 
evaluation of the DDD substances in public health.  
 
 (vi)  Material s for Safety Data Sheet, in Albanian and English language (compulsory since 
1 January 2013);  
 
(f) To import ionized radiation source the licensed applicant on this field should be provided by:  
 
- A copy of registration to the court;  
- Technical data for ra diation 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 of the use;  
- Clarification of transport of the sources.  
 
11. When the cargo/ship ment arrives in Albania this must be supplemented generally 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 
type of the product that is imported.  
 
The aforementioned documents are also required concerning pharmaceutical products, as foreseen 
by the legislation into force on human medicines and pharmaceutical service.  
 
Related to ionized radiation sources, for upon actual importation is required an o fficial request 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 type of license:  
• The fee for import of unauthorized pharmaceutical products is 5000 Leks for each 
dosage -form; 
• The fee for import of raw materials is 500 Leks for each item;  
• The fee for import of authorized human me dicines 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, disinsectan ts and deratising substances the fee is 
2000 Leks for each authorization ; 
• The fee for import of ionized radiation sources vary from 1000 Leks to 20.000 Leks.  
 
13.  No, it is not required.  
 
Conditions of licensing  
14.  There are different validity periods f or import licenses (import authorizations):  
 
- Validity of import authorization for the authorized pharmaceutical products is of 1 (one) 
month;  
- Validity of import authorization for unauthorized  pharmaceutical products, is of 2 (two) 
months;  
- Validity o f import authorization for disinfectants, disinsectants and deratizing substances, is 
of 6 (six) months;  G/LIC/N/3/ALB/8  
 
- 18 - 
 
  - Validity of import authorization for narcotic drugs and psychotropic substances is of 3 (three) 
months;  
- Validity of import authorization for ionized radiation source (single use) is of 2 weeks.  
 
When the validity of authorization is over, the importer must submit a new application to respective 
departments.  
 
15. The only case of penalty for non -utilization of the license or th e partial use of it, 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 condition that the total quantity of 
the imported p harmaceutical product, from each importer, will not be more than the annual 
quantity approved for the country.  
 
 Related to ionized radiation source there’s any other condition. The same, for the point (b) of 
this question.  
 
(b) There are  no other conditio ns. 
 
Other procedural requirements  
18.  With regard to narcotics drugs and psychotropic substances prior to the importation, the Minister 
of Health and Social Protection issues an authorization on import, based on requirement of the 
licensed company (taking into account that the required quantity doesn’t exceed the annual allowed 
quantities). This authorization is used as an international control tool. When the authorization has 
reached the destination (control authorities of exporting country), these  authorities grant export 
authorization for their exporter.  
 
19.   All banks provide foreign exchange automatically.  
 
5  MILITARY GOODS  
Outline of System  
1.  The import of the military goods and dual use goods and technology is managed by the Albanian 
State Export Control Authority (AKSHE) under the Minister of Defense. Trade with foreign parties is 
performed based on licenses and authorizations issued by this authority after consultations if needed 
with the relevant institutions.  
 
This permission is issued based on Law 46/2018  “ On state, international transfer control of military 
goods and dual -use items and technologies ”. 
 
AKSHE’s work is focused on the stat e control 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 -proliferat ion of 
weapons of mass destruction and their launching systems, the transfer of conventional weapons, as 
well as the implementation of measures aiming prevention of use of such goods for unlawful 
purposes.  
 
Purposes and coverage of licensing  
2.  The licen sing 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 products that are covered are listed in the national list according to the Council  of Ministers 
Decision 91, on 27.02.2019: “ On the approval of the updated lists of military goods and related 
technologies with dual use, which undergo the import -export state control ”. G/LIC/N/3/ALB/8  
 
- 19 - 
 
  This list is based on 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 for the import of military and dual use goods there is no restriction in value or quantity.  
 
The state export – import control policy is built on the following principles:  
• Priority of national interest – political, economic and military, the protection of which is 
necessary for guaranteeing . 
• Protection of the political, economic and military interest of the country.  
• Obligation to observe the international commitments undertaken by the Republic of Albania 
about the non -proliferation of weapons of mass destruction, their means of d elivery, and to 
ensure state control over international transfer of goods designed for military purposes, and 
dual-use items, as well as to prevent these goods from being used for terrorist acts and other 
illegal purposes.  
• Conduct of export control over th e international transfers of these goods to the extent required 
to only achieve its purpose.  
• Harmonization of state control procedures and regulations, international transfers of these 
goods with international legal norms and practices.  
• Ensuring interactio n with international organizations and foreign countries in the state export 
control area, so as to reinforce international security and stability, including non -proliferation 
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 : 
• The Law No. 46/2018, “On state, international transfer control of military goods and dual -
use items and technologies”.  
• The Law No 74/2014 “On Arms” . 
• Ministr ies Council Decision No.43, date 16.01.2008 “On organizing, function and status of 
State Export Control Authority” . 
•  The Council of Ministers Decision 91, on 27.02.20 19: “O n the approval of the updated lists 
of military goods and related technologies with dual use, which undergo the import -export 
state control”.   
• The Council of Ministers’ Decision 305, on 25.3.2009  “On the designating procedure, 
regarding the issuing of ass ured legal documents in the field of state control activities of 
import -export, military goods, and related technologies of dual use”.   
• The Council of Ministers’ Decision 304, on 25.3.2009 “On the designating procedures 
regarding expertise’s fulfilment  and the control by the State Control Authority of Exports”.  
• The Council of Ministers’ Decision 604, on 28.8.2003 “On approval, in principle, of code of 
conduct of European Union on weapons exports”.   
• The Council of Ministers’ Decision 341, 8.4.2009 “On desi gnating fees for issued legal 
documents”.   
• The Council of Ministers’ Decision 76, on 30.12.2008 “On designated format, schedules and 
presentation time of reports”.   
 
Any import of military and dual use goods needs  to be licensed by the State Export Control Authority.  
An import license is always r equired.  An exception from this is made only in the cases that follow:  
 
(a) the transfer of controlled goods in connection with the activities of Armed Forces, or other 
state security structures of the Republic of Albania outside of its territory, carried out as part 
of international agreements ensuring the mechanism of state control over the movement of 
these goods;  
b) the international transfer of controlled goods in connection with the activities of foreign 
military forces in the terri tory of the Republic of Albania, carried out in the framework of 
international agreements ensuring the mechanism of state control over the movement of these 
goods;  
c) the international transfers of anaesthetics  (medical aesthetic  gases), sports and hunting  arms 
excluded from the military list, gas transport vessels, and exportation and importation of 
personal armament of military servicemen, and state law enforcement and internal security 
bodies, which carry arms in accordance with the law;  G/LIC/N/3/ALB/8  
 
- 20 - 
 
  d) the internati onal transfer of controlled goods, which aim at ensuring provision of state 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 o f the country 
with a view to offering emergency assistance to foreign countries, when this is established by 
law. 
 
The licensing system in Albania cannot be abolished without legislative approval.  
 
Procedures  
6.I. The licensing procedures and formalities a re published on the official website of the State 
Export Control Authority. http://akbpm.gov.al/ . In the Albanian legislation there is no 
restriction in the value, quantity or license quotas.  
 
Also, according to the Al banian legislation there cannot be derogations from the licensing 
requirement.  
 
II. There are no such 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 this matter. An import license is issued 
only when there is an application for it, which fulfils the requirements of the Albanian legislation. 
Also, the State Export Control Author ity has the authority to do controls before, during, and 
after issuing the import license. Also, to obtain an import license is needed an end -user 
statement or certificate which is filled by the importer or any other who is the end user.  
 
IV. Not applicabl e. 
 
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.  
 
 (a) 30 days for import of military goods and for registration to conduct transfers of 
military  goods.  
 (b) 20 days for the import of dual use items and technologies . 
 (c)  15 days for transit/transhipment and technical assistance of controlled goods, 
and temporary importation/exportation of controlled goods for exhibitions, fairs, 
advertising, testing, and other similar purposes, if these do not call for transfer 
of ownership.  
 (d) 15 days for international imp ort certificates, end user certificates, delivery 
verification certificates.  
 
 This time -limit does not include the time required for obtaining additional information from 
entities involved in international transfers of goods.  
 
VI. There are no such provis ions in the Albanian legislation. After that 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 if required the consulting of opinion of the institutions concerned.  The concerned 
institutions are the Ministry of Defence, Ministry of Foreign Affairs, Intelligenc e Agencies, and 
Ministry of Interior.  
 
VIII. If the demand for licenses cannot be fully satisfied, the license cannot be granted. There are 
no exceptions. The new importers that want to deal with international trade of military goods 
need to be registered by the State Export Control Authority. After they get the Registration G/LIC/N/3/ALB/8  
 
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  Certificate they can demand for an import license. This registration  is not required for the 
trade of dual use goods and technologies.  
 
IX. In the Republic of Albania for the import of military goods and dual use goods and technology, 
always is required an import license even when there is an export license issued by the 
exporting countries.  
 
X. Not applicable . 
 
XI. Not applicable . 
 
7.a) The application must be done 15 days before to import the goods. This time limit is the 
maximum to proceed an import license. If the importer submits all the necessary documents 
and satisfy 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 authorisati ons issued by this  
Authority, following if required the consulting of opinion of the institutions concerned.  
 
The concerned institutions are the Ministry of Defence, Ministry of Foreign Affairs, Intelligence  
Agencies, and Ministry of Interior.  
 
8.  The ci rcumstances 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:  
 
- The application for obtaining licences, will be rejected by the State Export Control Authority  
if: 
 (a) During the assessment, the institutions or other governmental bodies which have 
powers over international transfer controls did not give their  consent . 
 (b) The information provided in the request is intentionally incomplete or incorrect or they 
are formulated contrary to the requirements prescribed by this Law . 
 (c) There are other reasons running counter to Albanian legislation in force, or the ratified 
international agreements.  
 
In the ev ent that the application for obtaining licenses, or certificate is 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, laying down the explana tions of and reasons behind failure to 
consider it or its  rejection.  
 
The decision made by the State Export Control Authority  to revoke licence, authorisation and 
international import certificate, or to remove from the rolls the name of an entity involved in 
economic activities with foreign countries for international transfers of goods, may be appealed 
against to the court of appeal, in accordance with the general rules of appeal. Appeal against decision 
does not suspend its execution.  
 
Eligibility of impo rters to apply for licence  
9. A person or a firm or institution that wants to deal with the import of military goods has first to 
be registered by the State Export Control Authority. This provision is not required for the import of 
dual use goods.  The regi stration certificate fee for military goods is 30 USD.  
 
All the persons or firms that are registered by the State Export Control Authority are in a list 
published on the website: www.akshe.gov.mod.al .   
 G/LIC/N/3/ALB/8  
 
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  Document ation and other requirements for application for licence  
10.   
 
(1) Certificate of registration (only for military goods).  
(2)  License application form completed by type, according to the guidelines set forth in this 
form, signed by the legal representative of the entity (notarized photocopy of the 
passport).  
(3)  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) . 
(4)  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 ); 
- Proof that the ju dicial process is not (Section Civil and Criminal) 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 where the money transfer will be 
performed ; 
- Taxpayer Personal Identification Number (allowed for import -export) ; 
- Extract the simple and historical taken by the National Registration Center . 
(5)  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 a ct of establishment. (notarized copy) ; 
- Decision of the court to establish the company ; 
- Taxpayer Perso nal Identification Number ; 
- Extract the simple and historical taken by the National Registration Center.  
(6)  International import certificate or end -user. 
(7)  Documents that provide information on the description of goods, conditions of delivery, 
quantity of goods, the value of goo ds, state transit tranship , destination country and 
the last user, and country of origin of goods.  
(8)  Notarized copy of the contract or order, certified by the legal representative of the 
subject.  
(9)  Bill of goods.  
(10)  Documents that provide informat ion on the description of goods, conditions of delivery, 
place of destination or origin of goods.  
(11)  Documents that provide information on the partner firm address, financial credibility, 
the bank account.  
(12)  Other valid documents to be considered as  such by the State Export Control Authority.  
(13)  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 .   
 
13. There is no other deposit or advance payment except that paid for licensing fee.  
 G/LIC/N/3/ALB/8  
 
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  Conditions of licensing  
14. The validity of the license is from 1 -3 year, according to the type of the license required. The 
validity o f the license can be extended, but not after the term of validity of the economic agreement, 
which refers to this license.  
 
15. There is not 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.  
 
Other procedural requirements  
18. No, there are no other procedures prior importations.  
 
19. All banks provide foreign exchange automatically.   
 
 
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