G/LIC/N/3/ALB/13  
 
27 February 2024  
(24-1789) Page: 1/19 
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 (202 4) 
ALBANIA  
The following communication, originally received on 31  January  2024, is being circulated at the 
request of the delegation of Albania.  
 
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Table of Contents  
1   PLANT PROTECTION PRODUCTS (PPP)  ................................ ................................ ........  1 
2   LIVE ANIMALS, LEATHER, FEED, BIOLOGICAL MATERIAL ON ANIMAL 
INSEMINATION,  VETERINARY DRUGS AND VACCINES  ................................ .....................  3 
3   CHEMICALS (MERCURY)  ................................ ................................ ..............................  6 
4   OZONE -DEPLETING SUBSTANCES  ................................ ................................ ................  8 
5   MILITARY GOODS  ................................ ................................ ................................ ...... 12 
6   NARCOTIC/PSYCHOTROPIC SUBSTANCES  ................................ ................................ . 17 
 
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1  PLANT PROTECTION PRODUCTS (PPP)  
Outline of System  
1. The procedure of licensing in Albania is made in accordance with Law No. 10081, dated 
23 February 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 parties.  
 
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. Approval 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 October 2016 "On the plant protection services", as 
amended, in Albania, only registered products for plant protection can be imported. The procedur es 
for the registration of PPP are performed by the Ministry of Agriculture and Rural Development.  
 
 
1 See document G/LIC/3, Annex, for the Questionnaire.  G/LIC/N/3/ALB/13  
 
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  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. All PPPs marketed or used in the territory of the Republic of Albania should undergo the 
registration procedure. Only the PPPs, registered in one of th e EU countries, can be registered in 
Albania.  
 
4. This licensing system does not intend to restrict 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.  
 
5. The Albanian legislation that regulates this licensing system includes:  
 
- Law No. 10081 dated 23 February 2009 "On Licensing, Authorizations and Permits in the 
Republic of Albania";  
- Law No. 105/2016 dated 14 October 2016 "On the plant protection services", as amended; 
and 
- Decision of the Council of the Mi nisters No. 532 dated 11 September 2018, "On the approval 
of the rules on trade, transport, preservation and storage of plant protection products".  
 
Procedures  
6.I.-XI. Not applicable.  
 
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 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, th ere is not such a system. 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 availab le to the National Food Authority for control 
effects.  G/LIC/N/3/ALB/13  
 
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  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. 19 dated 22 November 2022 "On the fees 
and secondary revenues applicable by institutions of the agriculture and food system"  
 
Documentational and other requirements for a permit application  
10. The application is done online through the government portal e -Albania. The whole set of 
documents are loaded there.  
 
11. Wholesale trading license of plant protection products is presented at the quarant ine inspectorate 
office at the cross -border points. After the control by quarantine inspectorate is carried out, the 
customs authorities accomplish customs procedures.  
 
12. Licensing fee is 2.000 ALL.  
 
13. No deposit or advance payment requirement.  
 
Condit ions 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 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.  
 
2  LIVE ANIMALS, LEATHER, 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 February 2009, as well as according to sublegal acts for law implementation. The legislation on 
licensing defines the activities according to fields (categories  and subcategories ) 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 subcategories  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 
require ments 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 NBC is published in the register and the title is delivered t o the applicant in 
the premises of the NBC.  
 
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 sanit ary-veterinary requirements are not fulfilled according to the respective law.  
 G/LIC/N/3/ALB/13  
 
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  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) veteri nary medicinal products.  
 
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 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.  10081, dated 23 February 2009 "On licenses, authorization and permission in 
Republic of Albania";  
- Law No. 10465 dated 29 September 2011 "On veterinary service in the Republic of Albania";  
- Law No. 10137, dated 11 May 2009 "On some amendments in current legislation on licenses, 
authorization and permission in Republic of Albania";  
- Law No. 9426 dated 6 October 2005 "Animal Breeding" – as amended.  
- Decision No. 538, dated 26 May 2009 "On licenses and permits treated by or through the 
National Licensing Centre (NLC) and some other common sub -legal regulations";  
- Decision No. 1295, dated 29 December 2009, "On some amendments in Decision No. 538, 
dated 26 May 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. 10081, dated 23 February 2009 "On licenses, authorization 
and permission in the Republic of Alba nia" and the system cannot be abolished without legislative 
approval. The legislation does not leave designation of products to administrative discretion.  
 
Procedures  
6.I.-XI. Not applicable.  
 
7.(a) Imports can be carried out only after issuance of the imp ort license. Goods cannot arrive at 
 the port without the license. The import is being 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 only entity where the applicant needs to apply (each importer) and present all 
the documentation. Documents are being sent online (from the NBC office), for approva l to 
the Ministry of Agriculture, and Rural Development. After this process, the NBC issues the 
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. This 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. 
Administrative complaints are analysed  by representatives of the NBC, except cases of licenses with 
preliminary inspection which are analysed  by the Ministry of Agricu lture and Rural Development.  G/LIC/N/3/ALB/13  
 
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  In the cases of preliminary inspection, the Ministry of Agriculture 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 a License  
9. There are no restrictive systems. All person s, 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 guidance of the Ministry of Finances and Economy and 
Ministry of Agriculture and Rural Development, No. 8 dated 8 May 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 sen t to the National Authority 
of Veterinary and Plant Protections and National Food Authority.  
 
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 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 tradin g 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 premises the 
administrative charge is 100 ALL.  
 
13. No advance payment or deposit is  required.  
 
Conditions of licensing  
14. All licenses are indefinite based on Article 11, Law No. 10081, dated 23 February 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 for the refusal of this license.  
 
15. No , there is no penalty for the non -utilization of a licence or a portion of a licence.  
 
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.  G/LIC/N/3/ALB/13  
 
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  19. Foreign exchange is provided automatically by banking authorities, every day.  
3  CHEMICALS (MERCURY)  
Outline of Systems  
1. Republic of Albania has ratified the Minamata Convention, by Law No. 7/2020 "On ratification of 
the Minamata Convention "On mercury "". From 26 May 2020, Albania is listed among Parties whic h 
have ratified the Minamata Convention. 
http://www.mercuryconvention.org/Countries/Parties/tabid/3428/language/en -US/Default.aspx . 
 
In the field of chemicals management, on 17 March 2016, the Republic of Albania approved Law 
No. 27/2016 "On chemicals managemen t".  
 
In article 28, point 1, of this law, specifie s 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 chemicals shall be issued by 
the Minis ter 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 proposal of the Minister responsible  for industry.  
 
Purposes and Coverage of Licensing  
2. The license foreseen in the law of chemicals No. 27/2016, cover the production, placing on the 
market, deposit and storage of hazardous chemicals.  
 
Based on point 3, Section II.2,of the DCM No. 442, dated 26 June 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", specif ies 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 
has entered into force after 1 January 2020.  
 
DCM No. 442/2019, also foreseen that the import of mercury and mercury mixtures listed in Anne x 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 co nsent 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 all 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 No. 27/2016, does not aim to restrict quantity or 
values imported, but to regulate the interior proc edures 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, including mercury, is based on:  
 
1. Law No. 27/2016  "On chemicals management";  
2. DCM No. 442, dated 26 June 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 met allic mercury Considered waste" ; G/LIC/N/3/ALB/13  
 
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  3. 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.  
 
Procedures  
6.I.-XI. No t applicable.  
 
7.(a)-(c) The documentation and procedures requested for the licence for the production, placing on 
 the market, storage and storage of hazardous chemicals, are not approved yet by the Council 
 of Ministers, on the proposal of the Minister responsible for industry.  
 
(d)  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.  
 
8. Please refer to point 7(d), above.  
 
Eligibility of Importers to Apply for License  
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)  Preve nt 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 provided to 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.  
 
Documentational and Other Requirements for Application for License  
10. Based on point 3, Section II.2,  of the DCM No. 442, dat ed 26 June 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", is specified t hat: 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 wi th 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 chemic als, will be specified in the Decision of Council 
of Ministers, on the proposal of the Minister responsible for industry.  
 
DCM No. 442/2019, in point 2, of Section II.2, also foreseen that import of mercury and the import 
of mercury mixtures listed in Anne x 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.  G/LIC/N/3/ALB/13  
 
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  The formats for the implementation of point 2, will be approved by the Minister of Environment in 
charge.  
 
11. DCM No. 442, dated 26 June 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", entered into force on 
1 January  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 No. 27/2016, also the M SDS in Albanian and English languages. Import of mercury as a 
pesticide, is not permitted in the country.  
 
12-13. The detailed documentation and procedures, including if there would be any fee for issuing 
this license for the production, placing on the mar ket, storage and storage of hazardous chemicals, 
including import of mercury, will be specified in the Decision of Council of Ministers, on the proposal 
of the Minister responsible for industry.  
 
Conditions of Licensing  
14–17. The documentation and procedures requested for the licence for the production, placing on 
the market, storage and storage of hazardous chemicals, are not approved yet by the Council of 
Ministers, on the proposal of the Minister responsible for industry.  
Other Procedural Requirements  
18. Yes, DCM No. 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 chemi cals 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 me rcury 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. No information .  
 
4  OZONE -DEPLETING SUBSTANCES  
Outline of Systems  
1. In January 2019, Council of Minister approved DCM No. 10/2019 "On Rules for the Production, 
Import, Export, placing on the Market and Use of Ozone -Depleting Substances, as well as the 
Products and Equipment that Contain these Substances", which has partiall y transposed in place 
three EU regulation Nos. 1005/2009; 291/2011; and 744/2010.  
 
Based on this DCM:  
 
(a) Import and/or export of Controlled Substances is carried out only by the Entities equipped 
with the relevant license with Code III.3, in accordance with the criteria, terms, deadlines and 
procedures set out in Law No. 10081/2009 and other applicable acts on licenses, 
authorizations and permits in the Republic of Albania. (point 1, chapter VII). Procedures and 
documentation for equipment with the impor t license code III.3, are determined, approved by 
Minister of Tourism and Environment Order  No. 166, dated 24 May 2019, amended.  
 
(b) The import of Controlled Substances included in Annex C, Group 1 of Annex I of this Decision 
is allowed only on the basis  of annual quotas, determined in Annex IV of this Decision. The  way 
for allocating the annual import quotas of the controlled substances, is determined  by Minister 
of Tourism and Environment Guideline No. 1, dated 6 May 2019, amended.  G/LIC/N/3/ALB/13  
 
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  Purposes and Coverage of Licensing  
2. The licensing system, cover the controlled substances that deplete the ozone layer, included in 
Annex C, Group 1 of Annex I.  
 
3. From all countries which are Party to the Montreal Protocol.  
 
4. DCM No. 10/2019, intend to regulate among others also import and placing in the market of 
controlled substances that deplete the ozone layer, and products, equipment's that contain such 
substances. Through the licensing system and  issuing the License "I mport of Ozone Depleting 
Substances" Code III.3, is regulated the field of activity for entities operating in this area.  
 
The import of Controlled Substances and its quantities is restricted/controlled through the 
Authorization of Minister of Tourism and Environment, in which is/are specified, issued annual import 
quotas on ozone deplete substances, for each entity. Authorization of the Minister  can be issued only 
to entities licensed with License Code III.3.  
 
5. The licensing system for the controlled sub stances that deplete the ozone layer, is based on:  
 
(1)  DCM No. 10/2019 "On Rules for the Production, Import, Export, Placing on the Market and 
Use of Ozone -Depleting Substances, as well as the Products and Equipment that Contain these 
Substances";  
(2)  Minister of Tourism and Environment Order No. 166, dated 24 May 2019 "On procedures and 
documentation for equipment with the import license code III.3, and for its 
suspension/revocation", amended;  
(3)  Minister of Tourism and Environment Guideline No. 1, da ted 6 May 2019, "On the way of 
determining the way to allocate the importation of controlled substances annual quotas", 
amended  
 
Procedures  
6.I. The controlled substances that deplete the ozone layer, and the products relying on them, are 
specified in DCM No. 10/2019, mentioned above in point 5. DCM in itself together with the 
two sub -laws which regulate procedures that need to be followed, are available for the public 
and interested stakeholders and published in the Official Journal webpag e. The annual quotas 
Diagram for Republic of Albania  are determined in Annex 4, of the DCM No. 10/2019. These 
quotas are not separated by countries or importers but  are given as a quantity in total for a 
specific year. Based in this Diagram, the annual qua ntity of such substances/products relying 
in them, which were allowed to be imported for the year 2023 was 50 T . This annual import 
quota  has been distributed among the licensed entities with code III.3, which apply to the 
Ministry responsible fo r environm ent, keeping in mind the observance of the rules for avoiding 
monopoly. In no case shall the full import quota be issued to a single entity.  For 2024, and 
according to the legislation in force the annual import quota is foreseen to be reduced in 45  T. 
 
DCM No. 10/2019, foreseen also some exceptional cases for import of controlled substances. 
In exceptional cases, for controlled substances other than hydro chlorofluorocarbons, 
exemptions may be made from the import prohibitions when protecting human life, bi ological 
diversity, national security, scientific research or to deal with natural disasters. This exemption 
is allowed when it is argued that there are no other solutions from the environmental point of 
view or other solutions are economically unaffordabl e. Any exemption  shall be made by order 
of the Minister responsible for the environment, on the basis of the reasoned request of the 
relevant national authority, specifying the type and quantity of controlled substance to be 
imported, the country from whic h it will be imported. And the time of delivery, after written 
approval from the Ozone Secretariat has been obtained in advance.  
 
II. Quotas are determined on a yearly basis. Based on the new approved legislation in this area, 
the License "Import of Ozone Depleting Substances" with Code III.3, has not a specific 
duration time but, the license issued is not valuable if it's not accompanied by the Minister 
authorization, where are specified the relevant import quotas given to the entity, on a yearly 
basis. Ap plication for the Minister Authorization for annual importing quotas, can be done only 
once a year by a n entity.  
 G/LIC/N/3/ALB/13  
 
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  III. The licensing system is Referred to the DCM 10/2019, import and/or export of the controlled 
substances can be done only by the licensed entities with code III.3. The import of controlled 
substances shall be permitted only at customs branches having trained personnel and 
equipment for the identification of ozone depleting substances. If the entity, has not been 
equipped with the relevant li cense III.3, following the Minister Authorization, the General 
Customs Directorate do not allow import. All the interested stakeholders, upon a request, can 
have all the necessary information. The Minister Guideline No. 1/2019, amended, has foreseen 
as above:  
 
- The Responsible Directorate of Ozone Depleting Policies establishes and maintains a 
register of applicant entities, import quota authorizations issued or refused and any 
other data related to this process.  
- The list of importing entities and the relevant approvals for the import of Controlled 
Substances shall be published on the website of the Ministry responsible for the 
environment.  
 
IV. There is no specific time mentioned. With the beginning of the new coming year, su bjects 
which are equipped with the License III.3, based on their needs for import, can apply to the 
Ministry responsible for environment, for annual import quotas.  
 
V. Both the license application for License III.3, also the application for Ministers Auth orization, 
has a time limit 20 days. In the case of Authorization, when the entity is required to fulfil the 
missing documents, the period of reviewing the application is postponed to maximum 25 days.   
VI. No time specified. The import procedures can be fo llowed after issuing of the Ministers 
authorization.  
 
VII. Application for License III.3, is done through the National Business Center (NBC). The next 
steps are determined and approved by the Minister order No. 166/2019, amended. The NBC  
electronically transmits to the National Environment Agency (NEA) the applications of entities 
for equipment with a license "Import of ozone depleting substances" code III.3. 
NEA downloads applications of entities for equipment under this License and send s them 
immediately to the Environmental Permitting and Licensing Monitoring Sector in the Ministry 
which review the application and prepares relevant act approval or/refuse of it.  
 
No, the importer does not have to approach more than one administrative or gan for the 
license.  
 
VIII. Procedures of issuing the License III.3, are separate from the Ministers authorization of annual 
import quotas. In the Ministers Guideline, No. 1/2019, amended, is specified that:  
 
- Where more than one entity applies to the Min istry at the same time, the available 
annual import quota shall, where possible, be distributed equally or roughly between 
interested entities. In any case, the allocation of the quota is distributed and based on 
a simple mathematical calculation that incl udes the number of entities that applied, 
what amount they applied for and how much is the total amount that can be imported 
to Albania for the year in question.  
- The annual import quota, set out in Annex 4 of the DCM No. 10/2019, is distributed 
among the  licensed entities with code III.3, applying to the Ministry, and keeping in 
mind the observance of the rules for avoiding monopoly. In no case shall the full import 
quota be issued to a single entity.  
 
IX. Referred to the DCM No. 10/2019, import of the co ntrolled substances can be done only by 
the licensed entities with code III.3, accompanied by the Minister authorization, where are 
specified the relevant import quotas given to the entity, on a yearly basis. For having the 
license in such cases, entities must follow the procedure mentioned in point VII, above.  
 
X. The import of controlled substances in Republic of Albania, is permitted only at customs 
branches having trained personnel and equipment for the identification of ozone depleting 
substances. The importing procedures of controlled substances  can only happen if the 
importing entity has the relevant license III.3, and the annual Ministers Authorization with 
detailed importing quotas given.  
 G/LIC/N/3/ALB/13  
 
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  XI. No.  
 
7.(a)-(d) The controlled substances that deplete the ozone layer, are based on quantitative limit, in 
this regard questions above are not relevant in this case.  
 
8. Any interested party subject to DCM No. 10, dated 9 January 2019, has the right to complain to 
the NBC on administrative acts, acts or omissions of the Ministry.  
 
Eligibility of Importers to Apply for License  
9.(a) and (b) No there is not such a system. The Responsible Directorate of Ozone Depleting Policies 
has the duty to establish and maintains a register of applicant entities, import  quota authorizations 
issued or refused and any other data related to this process.  
Documentation and Other Requirements for Application for License  
10. Any natural or legal person who carries out import activity of controlled substances, in order to 
obtain the license of "import of ozone depleting substances" with code III.3, apply to the windows 
of the National Business Center (NBC), by submitting the following documentation:  
(a)  Request to the Ministry responsible for environment for equipment with imp ort license for 
Ozone Depleting Substances. The application must contain in a precise and complete manner 
the points specified in the licensing device approval act set out in Schedule 1/a to Minister 
Order No. 166/2019.  
(b)  High school diploma or univers ity diploma for technical director;  
(c)  Employment contract proving the required employment relationship with the technical 
manager;  
(d)  Certificate of ownership or lease of premises;  
(e)  Self-declaration on suitability of premises and equipment.  
11. Pl ease refer to point IX, above.  
Referring to point 6 of the Ministers Guideline No. 1/2019, amended, entities licensed with code  III.3, 
to carry out the import activity of controlled substances under, for each quantity they import within 
the annual quota, must submit to the Ministry of Tourism and the Environment the following 
documents:  
(a)  The requirement to obtain an authorization for an import quota for ozone depleting 
substances. The application must contain accurately and fully the information specif ied in the 
authorization for ozone -depleting equipment for the ozone -depleting substances set out in 
Annex 1/a of the Ministers Guideline.  
(b)  Copy of the License "On the Import of Ozone Depleting Substances", code III.3;  
(c)  Completed import notificati on form for controlled substances, as set out in Annex 8 of DCM 
No. 10/2019;  
(d)  Self-declaration regarding the fulfilment  of reporting obligations according to the DCM 
No. 10/2019.  
(e)  Copies of the reporting submitted to the ministry and the National O zone Unit, in accordance 
with point 3, Chapter XI, of DCM No. 10/2019.  
12-13. Application near NBC, for obtaining the License with code III.3, has as fee of 100 lek/1 
Dollar/around 1 Euro. Meanwhile, application in the Ministry responsible for environment for 
obtaining Ministers Authorization with the annual importing quotas,  has no fee.  
Conditions of Licensing  
14. Please refer to point II, above.  
 
Based on the Guideline of the Minister No. 1/2019, the period of validity of the Minister Authorization 
for import quota of ozone depleting substances, was three months from the date of approval/issuing 
of the Authorization. Taking into consideration that the most part of the interested companies, 
applied at the beginning of the year 2020, and the lockdown situation that most countries faced at G/LIC/N/3/ALB/13  
 
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  the first months of 2020 from COVID -19, the Ministry of Tourism and Environment, evaluated to 
extent the Authoriza tions issued for the year 2020, from three months until to the end of the 
year 2020. This extension, has been made though the Minister Guideline No. 2, dated 8 July 2020 
"On some changes on the Guideline No. 1, dated 6 May 2019 "On the way of determining t he way 
to allocate the importation of controlled substances annual quotas"".  
 
15. No, but based on the Ministers Guideline No. 1/2019, amended, any importing entity within ten 
calendar days after the end of the Ministers Authorization shall formally notify  the Ministry of Tourism 
and the Environment as well as the National Ozone Unit, on the application or not by their side of 
the authorization received and if the import has occurred or not.  
 
Non fulfilment  of the reporting obligation, can be a reason for r efusal of subsequent applications for 
Ministers Authorization and import quota of Controlled Substances.  
 
16. No the legislation in force, does not foresee such thing.  
 
17.(a)  Please refer to point 10, above.  
 
(b)  Such products are not subject to licens ing or Ministers Authorization procedures.  
 
Other Procedural Requirements  
18. Please refer to point X, above.  
 
19. No, the legislation in force for import of controlled substances that deplete the ozone layer, does 
not foresee such thing.  
 
5  MILITARY GOODS  
Outline of Systems  
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 au thorizations issued by this authority after consultations if needed 
with the relevant institutions.  
 
This permission is issued based on Law No. 46/2018 "On state, international transfer control of 
military goods and dual -use items and technologies" .  
 
AKSHE's work is focused on the state 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 internat ional treaties of non -proliferation 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 Cov erage 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 products that are covered are listed in the national list according to the Council of Ministers 
Decision No. 668 on 10 November 2021: "On the approval of the updated lists of military goods and 
related technologies with dual use, which undergo the import -export state control" . 
 
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.  G/LIC/N/3/ALB/13  
 
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  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 national security.  
- 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 delivery, 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 an d other 
illegal purposes.  
- Conduct of export control over the 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 wi th international legal norms and practices.  
- Ensuring interaction 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 m ass 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";  
- Ministries Council Decision No. 31, dated 22 January 2020 "On organizing, function and status 
of State Export Control Authority"  
- The Council of Ministers Decision No. 668 on 10 November 2021 : "On the approval of the 
updated lists of military goods and related technologies with dual use, which undergo the 
import -export state c ontrol";  
- The Council of Ministers' Decision No. 604, on 28 August 2003 "On approval, in principle, of 
code of conduct of European Union on weapons exports";  
- The Council of Ministers' Decision No. 202, 10 April 2019 "On designating fees for issued lega l 
documents"; and  
- The Council of Ministers' Decision No. 76, on 30 December 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 required.  
 
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 territory 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 anaesthetic  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 secur ity 
bodies, which carry arms in accordance with the law; and  
(d) the international 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 of 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.  
 G/LIC/N/3/ALB/13  
 
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  Procedures  
6.I. The licensing procedures and formalities are published on the official website of the State 
Export Control Authority 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 as size of q uotas. 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 Authority 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 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 foll owing timescale as of 
the day of application:  
 
Fifteen 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 transf er 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/transshipment and technical assistance of controll ed 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 import certificates, end user certif icates, 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 provisions 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 Defe nce, Ministry of Foreign Affairs, Intelligence 
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 Certificate, 
they can demand for an import license. This registration is not required for the trade of dual 
use goods and technologies.  
 G/LIC/N/3/ALB/13  
 
- 15 - 
 
  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.  
 
Also, in this case the import license is not is sued automatically but the application is subject 
to controls.  
 
X. Not applicable . 
 
XI. Not applicable . 
 
7.(a)-(d) Not applicable.  
 
8. The circumstances under which the license can be refused are:  
 
- The application for obtaining licences, authorisations o r 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) there are conditions prescribed under Article 12 of this law.  
(c) the information provided in the request is intentionally incomplete or incorrect or they 
are formulated contrary to the requirements prescribed by this Law;  
(d) There are other reasons running counter to Albanian legislation in force, or the ratified 
international agreements.  
In the event 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 explanations of and reasons behind failure to 
consider it or its rejec tion. 
 
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 Importers to Apply for License  
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 registration certificate fee for military goods is US$30.  
 
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.al . 
 
Documentational and Other Requirements for App lication for Licence  
10.(1) Certificate of registration (only for military goods).  
(2)  Licence  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 licence  must submit the following documents:  
- Document that certifies expertise in the field of internat ional transfers of military goods . 
- Identification document (identity card, passport).  G/LIC/N/3/ALB/13  
 
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  - Proof that the judicial 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 licence , the illegal activities during the last ten 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 Centre.  
 
(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 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.  
 
(6) International import certificate or end -user. 
(7)  Documents that provide inform ation on the description of goods, conditions of delivery, 
quantity of goods, the value of goods, state transit transship, 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 information 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 mention ed in the previous 
question.  
 
12. The licensing fee for an import license with the validity of one year is US$30.  
 
13. There is no other deposit or advance payment except that paid for licensing fee.  
 
Conditions of Licensing  
14. The validity of the lice nse is from one -three 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 not penalty for non -utilizati on 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.  G/LIC/N/3/ALB/13  
 
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  19. All banks provide foreign exchange automatically.  
6  NARCOTIC/PSYCHOTROPIC SUBSTANCES  
Outline of Systems  
1. The Ministry of Health and Social Protection grants licenses for subjects in order to 
import/export/trade narcotic/psychotropic substances and precursors in accordance with Law 
No. 7975, dated 26  July 1995 "On Narcotics and Psychotropic Substances" as amended and 
No. 8874, dated 29 March 2002 "On the control of substances used in the illicit manufacture of 
narcotic and psychotropic substances" . 
 
Purposes and Coverage of Licensing  
2. The license is given only to the subjects that fulfil the documentation according to the 
abovementioned laws and only these companies are allowed to import/export/trade the substances 
that are included in the laws (that are in conformity with the lists  published by the International 
Narcotics Control Board (INCB) in Vienna.  
 
3. Drugs that are imported in the Republic of Albania are registered (have market authorization) and 
according to the Law No. 105/2014 "On drugs and pharmaceutical system" as amend ed the minister 
responsible for health grants marketing authorization for:  
 
(a)  drugs manufactured in our country;  
(b)  drugs that have received marketing authorization and are circulating in one of the countries 
of the European Union, the United States o f America, Canada, Turkey, Switzerland, Israel, 
Japan, Australia;  
(c)  drugs manufactured in the Balkan countries, only when they have received marketing 
authorization and circulate in their country;  
(d)  drugs equipped with marketing authorization from th e European Medicines Evaluation Agency 
(EMA) or the Food and Drug Administration (FDA) of the United States of America.  
 
4. The licensed companies authorized to import these drugs/substances are allowed to import 
restricted quantities according to the quan tities allowed to the Republic of Albania by the INCB . 
 
5. Law No.7975, dated 26 July 1995 "On narcotics and psychotropic substances" amended Law 
No. 8874, dated 29 March 2002 "On the control of substances used in the illicit manufacture of 
narcotic and ps ychotropic substances" amended Law No. 105/2014 "On drugs and pharmaceutical 
system" amended.  
 
The licenses and authorizations for import/export are given only according to the abovementioned 
laws. 
 
Procedures  
6. For products under restriction as to the quantity or value of imports (whether applicable globally 
or to a limited number of countries or whether established bilaterally or unilaterally):  
 
I. The quantities of these substances that are allowed to be imported in the Republic of Albania 
are det ermined for every calendar year. The proposal of the quantity is made by the Ministry 
of Health based on the requests of the authorized companies for each year also on the needs 
of the local hospitals needs. These requests are given to the INCB which is th e entity that 
grants and approves the quantities allowed to be imported. In the cases of the need to increase 
the quantities for the calendar year another request can be made to the INCB, request that 
has to be approved.  
 
II. Every three months the Ministr y of Health and Social Protection of Albania reports to the INCB 
the quantities imported/exported for narcotics and psychotropic substances and every year 
reports the quantities imported/exported for narcotics/psychotropics/precursors in the 
previous year and furnishes the quantities needed for the next year, quantities that must be 
approved by the Board.  
 G/LIC/N/3/ALB/13  
 
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  The licenses are given to subjects that fulfil the proper documentation according to the 
abovementioned laws and are valid as long as the subjects does n ot make any changes to the 
structure of the company (the location, the technical director etc.)  
 
The import/export authorization is given with a special permit (import/export authorization) 
by the Minister of Health and Social Protection for each import/ex port (for every specific 
amount with an expiry date and batch number) for every drug that goes through the customs.  
 
III. For every narcotic/psychotropic/precursor that goes through the customs an import/export 
authorization is given with a special permit by the Minister of Health and Social Protection. 
These authorizations are given only to authorized licensed companies for registered drugs or 
drugs that are needed for hospital/ambulatory use ore samples needed by the National Agency 
for Drugs and Medical Devices for registration purposes.  
 
IV. The companies can apply for licences and authorizations at any time.  
 
V. The Ministry grants the import/export authorization no longer than 28 days after the 
application has been made and grants or refuses the lice nce five months after the request.  
 
VI. They are not related as mentioned above.  
 
VII. For narcotic/psychotropic/precursors the companies must get an import/export authorization 
from the Ministry of Health and Social Protection and then another permit issu ed by the 
National Agency for Drugs and Medical Devices.  
 
VIII. The quantities requested by the Ministry to the INCB are based on the quantities requested 
by the companies, so each company can import the requested amount if is approved by the 
Board (INCB).  
 
IX. In cases of exports, the import permit from the exporting country is needed in order to issue 
the export authorization.  
 
X. The documents issued by the other country are furnished by the company that applies for the 
import/export authorization.  
 
XI. The export authorization can be granted for drugs that are not registered (don't have market 
authorization) in the Republic of Al bania.  
 
7.(a)-(d) Not applicable.  
 
8. The licence can be refused if not according to the proper criteria. After the licence is issued, it can 
be revoked if there is any sign that the company is not acting in compliance with the law.  
 
Eligibility of Importe rs to Apply for Licence  
9. All subjects that apply for licence are issued with license (if they meet the proper criteria) by the 
Commission of Licencing for Narcotics and Precursors with no fee. After getting the License by the 
Commission the companies can  get authorizations for import/export by the Ministry and National 
Agency with no fee for registered drugs and samples and there is a fee of 5 ,000 Albanian LEK for 
each dose for unregistered drugs.  
 
Documentational and Other Requirements for Application fo r Licence  
10. For the application is needed a letter of request with the proper information (trade name, active 
ingredients, pharmaceutical form, dose, batch number, expiry date, name of exporter and 
manufacturer), a proforma invoice, certificate of analys e/origin and packing list.  
 
11. For the application is needed a letter of request with the proper information (trade name, active 
ingredients, pharmaceutical form, dose, batch number, expiry date, name of exporter and 
manufacturer), a proforma invoice, cer tificate of analyse/origin and packing list.  
 
12. No, there is no fee for licence issuing.  G/LIC/N/3/ALB/13  
 
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  13. No, there is no fee for any deposit or advance payment requirement associated with the issue of 
licences.  
 
Conditions of Licensing  
14. The licenses issued by the  Commission of Licencing for Narcotics and Precursors are valid as 
long as the company does not make any change according to the data of the Licence issued by the 
National Center of Business Licencing.  
 
15. No, there is no penalty for the non -utilization o f a licence or a portion of a licence.  
 
16. No, licences are not transferable between importers.  
 
17. No, there are no other conditions attached to the issue of a licence.  
 
Other Procedural Requirements  
18. No, there are no other administrative procedures.  
 
19. No, foreign exchange is not automatically provided by the banking authorities for goods to be 
imported. Yes, a licence required as a condition to obtaining foreign exchange. No, foreign exchange 
is not always available to cover licences issued . 
 
__________