WORLD TRADE  
ORGANIZATION  G/LIC/N/3/ALB/5 
24 January 2011 
 (11-0374) 
Committee on Import Licensing Original:   English 
   
REPLIES TO QUESTIONNAIRE ON IMPORT LICENSING PROCEDURES
1 
 
Notification under Article 7.3 of the Agreement on Import Licensing Procedures  
 
ALBANIA 
 
  The following notification, dated 6 December 2010, is being circulated at the request of the delegation of Albania.  
_______________ 
 
 
I. LIVE ANIMALS, LEATHER, FEED BIOLOGIC MATERIAL ON ANIMAL 
INSEMINATION AND VETERI NARY DRUGS AND VACCINES ..................................1  
II. IMPORT LICENSING PROCEDURES OF PLANT PROTECTION  
PRODUCTS (PPP)................................................................................................................. ...5 
III. IMPORT LICENSING PROCEDURES OF FAUNA AND FLORA ..................................8  
IV. WASTE IMPORT LICENSING PROCEDURES...............................................................11  
V. IMPORT LICENSING PROCEDURES FOR MEDICINAL PRODUCTS .....................14  
VI. IMPORT LICENSING PROCEDURES FOR EXPLOSIVE, PYROTECHNIC 
AND FIREWORK MATERIALS FOR CIVILIAN USE ...................................................22  
VII.  IMPORT LICENSING PROCEDURE S FOR MILITARY GOODS................................26  
 
I. LIVE ANIMALS, LEATHER, FEED BIOLOGIC MATERIAL ON ANIMAL 
INSEMINATION AND VETERINARY DRUGS AND VACCINES 
Outline of system
 
 
1.  The licensing procedure in Albania h as recently changed. Activities for production are 
licensed according to Law "On licensing", No. 10081, dated 23.02.2009 , as well as  
sub-legal acts for law implementation. The legisla tion on licensing defines the activities according to 
fields (categories and sub categories) and special criteria for licensing; required documentation and 
any other accompanying documents for each activity .  Licensing requests for activities included in 
such categories or sub categories are verified by the National Licensing Center (NLC) at the Ministry of Economy, Trade and Energy (METE).    Assessment on fulfillment of criteria for licen sing (approval) is done through an intermediate 
decision of the institution that covers the respec tive field of activity.  The decision of the Food 
Competent Authority is based on the evaluation of the submitted documents and on site inspection to 
                                                     
 
1 See document G/LIC/3. G/LIC/N/3/ALB/5 
Page 2  
 
  assess that the requirements and mandatory standards defined in the legislation have been fulfilled. 
Approval or refusal is published in the register with in the deadline, otherwise it is considered as tacit 
approval.    The final decision of the NLC is published in  the register and the title is submitted on the 
website of the NLC.  
  The CCA (MAFCP) suspends or revokes
 a licence in cases where, during verification, the 
technical-technological and sanitary-veterinary requi rements are not fulfilled according to the law.  
 Purpose and coverage of licensing
 
 
2.  The import licensing system covers these groups of products:    (a)  Live animals; 
 (b)  Biological material on animal insemination; 
 (c)  Veterinary drugs and vaccines.  3.  Imports are carried out based on bilateral trade agreements that Albania has signed with 
various countries where the products are imported fro m (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 the imports. 
There is no alternative method.  The MAFCP does not determine quotas for import licences.    5. Licensing is a legal request, and the licensing system is based on the following legal 
framework: 
 - Law No.10081, dated 23.2.2009 "On licences, au thorization and permission in Republic of 
Albania"; 
- Decision, No.538, dated 26.5.2009 "On licences and authorization that are verified through 
the NCL and the same other common sub-legal regulations";   
- Law "On Food", No. 9863, dated 28.01.2008; 
- Law, No.10 137, dated 11.5.2009  "On same amendments in current legislation on licences, 
authorization and permission in Republic of Albania"; 
- Decision, No.1295, dated 29.12.2009, "On sa me amendments in Decision", No.538, dated 
26.5.2009 "On licences and authorization that ar e verified through the NCL and the same 
other common sub-legal regulations";  
- Law No.9426 dated 06.10.2005 "Animal Breeding" - changed.   Licensing is authorized by the Law No. 10081,  dated 23.2.2009 "On licences, authorization 
and permission in the Republic of Albania" and th e system cannot be abolished without legislative 
approval. The legislation does not leave designation of products to administrative discretion. 
 
Procedures
 
  
6.I. Not applicable.  
II.  Not applicable. 
 III. For goods and import entities which meet the cr iteria and conditions defined in the relevant 
legislation, licences are without limitations.  
   G/LIC/N/3/ALB/5 
 Page 3 
 
 
  In order to ensure that licences are used for import issues, the steps are as follows: 
  - The approved list of importers is sent to  the Regional Directory of Agriculture, Food 
and Consumer Protection of each district, municipalities and Border Inspection Points 
responsible for licence control of import usage; 
 - The list of approved importers is published on the NLC's website. 
 IV. As there are no quotas for imports of such goods, the application can be submitted at any 
time.  
 
V.  The maximum time to process the application for import licences is: 
  (a) ten days for live animals;  
 (b) fifteen days for biological materials on animal insemination;  
 (c) fifteen days for veterinary drugs and vaccines.  
 
 Decision, No.1295, dated 29.12.2009, "On some amendments in  Decision" and No.538, dated 
26.5.2009 "On licences and authorization that ar e verified through the NCL and some other 
common sub-legal regulations". 
 VI.  No time limit. The importer has the right to start the import activity from the moment they 
attain the licence. 
 VII. The NLC is the only entity where the appli cant, (each importer), needs to apply and present 
all the documentation. Documents are then sen t online (from the NLC office), for approval to 
the Ministry of Agriculture Food and Consumer Protection (MAFCP). After this process, the 
NLC issues the import licence to the applicant.  
 VIII. There are no limits on licensing numbers. Ther e are no restrictions on timing and ranking of 
applications in order to get a licence. The li cence is issued based on the fulfillment of the 
conditions determined by the Albanian law.  
 
 Applications which do not meet the requirements are refused until a second period, 
determined by a competent inspection authorit y. The refusal is published on the NLC's 
website.  
  The examination of the application, from the date of the submission, takes 10 days for the 
import of live animals and within 15 days for th e trading of biological material and veterinary 
medicine.  
  There is no specific legi slation for new importers.  
 IX.  Not applicable since there are no quotas and licences are not issued automatically.  
 
X.  The import of goods is permitted based on th e legislation cited below, and in any case only 
based on export permits: 
  - Law No. 10081, dated 23.2.2009 "On li cences, authorization and permission in 
Republic of Albania"; 
 - Decision, No. 538, dated 26.5.2009 "On li cences and authorization that are checked 
over through the NCL and the same other common sub-legal regulations";   
 - Annex I: Permission and licensing categor ies which are followed by/or through the 
NLC; G/LIC/N/3/ALB/5 
Page 4  
 
   - Annex I, Section II: Food and Health. Ca tegory II.2, Code II.2, B; Category II.3: 
Breeding or animal trading with Code II.3, C; Category II.7, Code II 7B; 
 - Drugs' Trading.  XI. No, such conditions are associated with the issuance of the licence.  
 
7.(a)  No.  Imports can be carried out only after i ssuance of the import licence. Goods cannot arrive at 
the port without a licence.  Im portation can only occur after the NLC has issued the licence to 
the importer.  
 
(b)  No, because the licensing authority must examine the documentation required. The time taken 
to issue a licence is 10-15 days.  
 (c)  No limitations for the time of application.  
(d)  The NLC is the only entity where the applican t (each importer), needs to apply and present all 
the documentation. Documents are then sent onlin e (from the NLC office), for approval to the 
Ministry of Agriculture Food and Consumer Protection (MAFCP). After this process, the 
NLC issues the import licence to the applicant. 
 8.  The licence can be refused in cases where th e importer does not meet th e requirements set forth 
in the law and regulations. 
 
The applicant is officially informed by the NL C for reasons of a refusal. This information is 
automatically published on the NLC's website.   A ny interested party has the right to appeal 
on an administrative process to the NLC or the MAFCP for cases of licences with preliminary 
inspections. Administrative complaints are an alyzed by the representatives of the NLC, 
except cases of licences with preliminary inspec tion which are analyzed by the MAFCP.  
 In the cases of preliminary inspection, the MA FCP is informed by the NLC when a complaint 
is presented to their office.  In both cases, co mplaints addressed to the NLC or the MAFCP 
are published in the National Registry of Permits and Licences. For administrative issues, 
after reviewing the administrative complaint, a d ecision given may be directly appealed to the 
competent court.  The above mentioned issues are being followed by the terms specified in 
section 6, of the Code of Administrative Proce dures on administrative complaints within one 
month.  
 Eligibility of importers to apply for licence
 
 
9.(a)  There are no restrictive systems.  (b)  All persons, firms and institutions that satisfy th e criteria set forth in the current legislation have 
the right to apply for licensing.  
 
(c) No, there is not such a system.  A list of fees exists and this is based on the Order of the 
Minister of Agriculture, Food and Consumer Protection, No. 8 dated 08.05.2007 "On the fees 
and secondary revenues applicable by institu tions of the agriculture and food system". 
 
 Yes, the list of authorized importers published on the website of the NLC is sent to all central 
institutions, districts, municipalities and border inspection points.  
  G/LIC/N/3/ALB/5 
 Page 5 
 
 
  Documentation and other requireme nts for application for licence  
 
10.  The necessary information and documentation to  be filled by the applicant are provided by the 
NLC.   
11.  The required documents are those issued  by the National Licensing Centre (NLC). 
 12.  Fees depend on the type of licence.  The fee for import licences of live animals is 10.000 lek, for trading of biological material is 300 All, and 100.000 All for veterinary medicine trade. 
 
13.  No, an advance payment or a deposit is required. 
 
Conditions of licensing
 
 
14.  All licences are indefinite based on th e Article 11, Law No.10081, dated 23.2.2009 "On 
licences, authorization and permission in the Republic of  Albania".  In order to check if the conditions 
are fulfilled by the applicant, the MOAFCP frequent ly performs in site controls. If some conditions 
are not fulfilled then the MOAFCP presents the prop osal to the NLC for the re fusal of this licence.  
 15.  No.   
16.  No, licences are not transferable. 
 17.(a)  Not applicable. There are no quantity restrictions for products.  (b) No.  
 
Other procedural requirements
 
18.  No, there are not any other administrative procedures. 
 19.  Foreign exchange is provided automa tically by banking authorities, every day. 
 
II. IMPORT LICENSING PROCEDURES OF  PLANT PROTECTION PRODUCTS 
(PPP)   
Outline of system
 
 
1.  The licensing procedure in Albania has recently changed. Activities for production are 
licenced according to the Law 10081, dated 23.02.2009.  Import of products for plant protection in 
Albania is conducted through permissions issued by  the NLC, based on preliminary criteria to be 
fulfilled by the interested parties. The entities are inspected by the District Inspectorate of plant 
protection. This licence is issued through the NLC. In Albania only registered products can be imported for plant protection.    Purpose and coverage of licensing
 
 
2.  The licensing system covers plant protec tion products such as insecticides, fungicides, 
herbicides, disinfectants and similar products. Th ese products fall under code 3808 of the Combined 
Nomenclature.  
 
3.  The control system for Plant Protection Products  (PPP) is being applied to those registered in 
countries of the European Union. PPP from all countries are accepted without limitations. G/LIC/N/3/ALB/5 
Page 6  
 
  4.  This licensing system does not intend to restrict the quantity or value of imports coming into 
Albania. The purpose of issuing the import licence of  PPP is to strictly control the products. Since 
these are poisonous products, their careless utilization can affect plants, animals, human beings and 
environment. In the international legislation on plant protection there does not exist any other alternative 
known method. 
 
5. The Albanian legislation that regulates this licensing system includes:  - Law No. 10081, dated 23.02.2009 "On Licensing,  Authorizations and Permissions in the 
Republic of Albania"; 
- Law No. 9362, dated 24.03.2005 "On the plant protection services" – changed; 
- Decision of the Council of the Ministers No. 1555, dated 11.12.2008, "For the determination 
of registration rules and evaluation criteri a of Plant Protection Products (PPP)". 
  The decision of Council of Ministers No. 1555,  dated 12.11.2008, "On the determination of 
registration rules and evaluation criteria of PPP", provides that only registered Plant Protection 
Products can be imported.     
Procedures
 
 
6.I.  Not applicable. 
 
II. Not applicable.  III. Not applicable.  
IV. Not applicable. 
 V. Based on the Law No. 10081, dated 23.02.2009 "On Licensing, Authorizations and 
Permissions in the Republic of Albania" the ma ximum time for processing the applications is 
15 days.  
 
VI. No time remains. 
 VII. The applicant presents required documentation at the National Licensing Center. This is the 
only administrative organ that an importe r has to approach to get the licence. 
 
VIII. Not applicable. 
 IX. Not applicable.  X. Not applicable.  
XI. There are no such conditions associated with the licence. 
 7.(a)  The importer can import the product at the time when he judges it appropr iate.  The time limit to 
get a licence is 10-15 days and the licence ca nnot be obtained for goods arriving at the port 
without a licence.    
 
(b)  The licence is granted after the examinati on of the required documentation, within the time 
limits set forth in the legislation. Up to now, no emergency applications for licences are deposited in the National Licence Center. 
  G/LIC/N/3/ALB/5 
 Page 7 
 
 
  (c)  No limitations related to the period of the y ear during which applications for licences can be 
made. 
 (d)  Applications for import licences are affected  only by one administrative organ, which is the 
National Licensing Center. 
 
8.  The licence can be refused when the importe r fails to meet the appropriate conditions on 
storage and preservation of the plant protection product s, as required by the legislation (including the 
necessary documentation).    
 The applicant is officially informed by the NL C, for the reasons of a refusal. This information 
is automatically published on the NLC's website.   According to the legislation on plant protec tion, in the case of a refusal of a licence, the 
applicant has the right to appeal at the higher admi nistrative bodies and at the court of first instance. 
 
Eligibility of importers to apply for licence
 
 
9.(a)  There are no restrictive systems.  (b) All persons, firms and institutions that satisfy the criteria set forth in the current legislation have 
the right to apply for licensing. 
 (c) No, there is not such a system.   All persons that have import licences are e ligible to import plant protection products. All 
importers are on a published list by the Ministry of Agriculture, Food and Consumer Protection. The list 
is sent to the cross – border points where phyto-sanit ary and quarantine inspection service is established. 
According to Order No. 9 dated 12.7.2010 "On fees a nd secondary revenues applicable by agriculture 
and food institutions in the MAFCP".  
Documentation and other requireme nts for application for licence
 
 
10.  The applicant presents the required documents to the Directory of the NLC. The whole set of 
documents is available at the NLC office.   11.  The import licence of plant pr otection products is presented at the quarantine inspectorate office 
at the cross-border points. After the control by the quarantine inspectorate is carried out, the customs 
authorities accomplish customs procedures.  12.  Licensing fee is 2000 lekë.   13.  No deposit or advance payment is required.  Conditions of licensing
 
 
14.  The licence is permanent.   
15.  No penalty. 
 16.  The licence is not transferable.  17.  No conditions are attached to the issuance of the licence.  G/LIC/N/3/ALB/5 
Page 8  
 
  Other procedural requirements
 
18.  Yes, there is the procedure of the "State  Commission of PPP" for the PPP registration in the 
Republic of Albania.    19.  Foreign exchange is provided automa tically by banking authorities, every day.  
 
III. IMPORT LICENSING PROCEDURES OF FAUNA AND FLORA  
Outline of system
 
 
1.  Import permits are issued in the framew ork of the CITES Environmental Convention on 
"International Trade on Endangered Species of Wild Fl ora and Fauna" to which Albania is a Party from 
September 2003.   CITES works by subjecting international trade in specimens of selected species to certain 
controls. All import, export, re -exports and introduction from the sea of species covered by the 
Convention has to be authorized through a licens ing system. Each Party to the Convention must 
designate one or more Management Au thorities in charge of administer ing that licensing system and one 
or more Scientific Authorities to advise them on th e effects of trade on the status of the species. The 
designated management Authority for Albania is th e Biodiversity Directorate in the Ministry of 
Environment, Forests and Water Administration.  
 The species covered by CITES are listed in th ree Appendices of the Convention, according to 
the degree of protection they need. (www.cites.org/appendices).  
Purpose and coverage of licensing
 
 
2.  CITES import permit (certificate) covers all wild animal and plant species listed in the 
Appendices of the CITES Convention.    Appendix I  includes species threatened with extinction. Trade in specimens of these species is permitted only in exceptiona l circumstances.  Appendix II includes species not necessarily threatened 
with extinction, but in which trade must be controll ed in order to avoid utilization incompatible with 
their survival. 
 3.  The system applies to goods originating in  and coming from countries that are Parties to 
CITES Convention.  
4.  The licensing is intended to restrict the number  of species, wild animals and plants listed in the 
Appendices of the Convention in or der to improve their conservation and comply with the obligations 
and requirements of the Convention;  this, according to the management plans for individual species 
and/or quotas are established by Parties at the begi nning of each calendar year by Parties and notified 
to the Secretariat. Thes e quotas are published by the Secretariat through Notifications to the Parties 
and posted on the Convention's web pa ge at www.cites.org/notifications. 
 
5. The Law No. 9021, dated 06.03.2003 "On the ac cession of the Republic of Albania in the 
Convention "On the International Trade of Endange red Species of Wild Flora and Fauna" (CITES)"; 
  The Law No.9867, dated 31.1.2010 "On the rul es and procedures on international trade of 
endangered species of wild fauna and flora". This  Law sets up the required infrastructure for the 
implementation of the CITES Convention in Albania.   G/LIC/N/3/ALB/5 
 Page 9 
 
 
   Letter of the Minister of Environment for th e establishment of Scientific and Management 
Authorities for the implementation of CITES Conventi on in Albania addressed to CITES Secretariat, 
dated 30.01.2004 and revised by letter of the Mi nister of Environment, Forests and Water 
Administration of 12.04.2006 reflecting changes of organization following the re-structuring of some 
Ministries in early 2006.  Procedures
 
  
6.I.  For products under restrictions as to th e quantity, the information is published on CITES 
Convention website concerning annual quotas a nd information on national authorities in 
charge of the Convention implementation and permit issuing authorities. 
 
II.  See 4 above. 
 
III.  Licences are allotted only to species subject to the CITES Convention.  
IV.  The applications may be submitted at any time of the year. 
 V.  Processing applications may vary between one  to four weeks, depending largely on the 
consultation time with the scientific authority of  CITES for Albania, defined in the draft law 
quoted in paragraph V.  According to Article 18 of the draft law, within 5 working days from the day the application is received, the Mana gement Authority requires, in writing, the 
opinion of the Scientific Authority. This au thority must give its written opinion within 
10 days.  
 
 CITES permits or certificates are issued within  15 working days after the application is 
received. In cases when advice of the Scientific  Authority is needed, the permit or certificate 
is issued within 5 working da ys of advice being received. 
 VI.  It depends on the time available before the importation takes place. 
 
VII. The consideration of a permit or certificate application is effected by the Ministry of 
Environment, Forests and Water Administrati on as the nominated management authority of 
CITES.  However, before granting the permit, the Ministry has to consult the scientific 
authority (namely the Museum of Natural Scie nces – respectively Flora and Fauna Sections 
for wild fauna and flora species).  
 
VIII.  Not applicable. A CITES licensing system is special and the phrase "the fact that the 
application can be submitted at any time of the year" does not mean "first come first serve basis".  As from previous explanations one can understand that this is a situation in which the 
licence is issued only if the application fulfils the requirements of the Convention.  If not, the 
licence is not issued, nor allocated to someone else. 
 
IX.  Import licences are applicable only if the c ountry of intended import is an EU country, in 
compliance with the EU wildlife trade Regulation No. 338/97. 
 
X.  Management authorities of CITES are in continuous cooperation and are in constant 
communication with each other.  In the above mentioned case usually an e-mail from the 
issuing authority is sent in notification of the respective permit. 
 XI.  Yes, for species of Annex 1 of CITES, which can only be used for scientific research 
purposes. 
 G/LIC/N/3/ALB/5 
Page 10  
 
  7.(a)  Ideally one month in advance. 
 (b)  A licence cannot be granted immediately on request. 
 
(c)  No there are no limitations as to the period of the year.  
(d)  See VII above.  
 8.  An application may be refused in cases wher e the export certificate from the country of origin 
is false or if there are any doubts on the determinat ion of the species i.e. the so called "look alike" 
species. However, in any case, the Management Aut hority will first be advised by the Scientific 
Authority and later decide on the refusal of a permit or certificate.  
Eligibility of importers to apply for licence
 
 
9.  All persons, subjects and institutions are elig ible to apply for CITES permits or certificates. 
 
Documentation and other requireme nts for application for licence  
 10.  A sample form is required. The importe r is required to supply a document certifying the 
species name and origin, and the purpose he/she is ask ing for the given species to be imported, as well 
as the purpose of bringing the species into the country.  
11.  Export permit from the Management Authority of the country of origin, or from the country 
from where the species is coming. 
 
12.  No, currently there is no licensing fee or administrative charge since the by-law on these 
tariffs is not yet elaborated. 
 
13.  No for the moment. The Law quoted above fo resees that the Minister responsible for wildlife 
issues, will, by Government Decree, de termine tariffs and payment methods. 
 Conditions of licensing
 
 
14.  According to the law that will be approved by the end of the year and to the provisions of the European Council Regulation 338/97 for the impl ementation of CITES in the EU, validity of CITES 
export and re-export permits or ce rtificates is 6 months from the issuance date, whilst the import 
permits for live specimens included in Annexes I and II of the Convention is 12 months from the 
issuance date.  
 
15.  If the permit or certificate has been issued previously, for a long time, a new one might be 
required in order to reflect any changes that might ha ve occurred in the species status in respect to the 
placement in the CITES Appendices. 
 
16.  No, licences are not transferable between importers. 
 17.  Conditions attached to the issuance of a licen ce in terms of quantitative restrictions apply only 
in cases where there is a quota determined in a Notif ication to the Parties by the CITES Secretariat. 
Besides quotas given in the Notifications published by the Secretariat, other conditions are set-up only 
for live animals for which the li cence is valid, only in the cases where transportation conditions 
comply with the Regulation of the Transport for live animals or the IATA Regulation for live animals.  
 
  G/LIC/N/3/ALB/5 
 Page 11 
 
 
  Other procedural requirement  
 
18.  No. 
 
19.  All banks provide foreign exchange automatically. 
 
IV. WASTE IMPORT LICENSING PROCEDURES 
Outline of system  
 
1.  No answer was provided.  
Purpose and coverage of licensing
 
 
2.  The Ministry of Environment, Forests a nd Water Management (MEFW M) is involved in the 
process of cross-border of waste: impor tation, exportation and transition.  
 - The MEFWM issues licences for exportation and transition of waste; - The MEFWM prepares the required documents for issuing the import licence of waste, which is 
approved by the Decision of the Council of Ministers. 
 3.  The system applies to goods originating from all countries. Albania does not have any bilateral agreement with  any other country. 
 4.  The limitations for importation of waste are defined by environmental legislation and the 
conditions of the technology, laboratories a nd managing capacities which aim to protect the 
environment from pollution and damage.   5. Importation, exportation and transition of waste is administered by:  
- Law No. 8934 dated 05.09.2002 "On protection of the environment"; 
- Law No. 9010, dated 13.02.2003 "On environmental administration of solid waste"; - Decision of Council of Ministers No. 806, dated 4.12.2003 "On approval of rules and 
procedures for importation of utilizati on waste, processing and recycling"; 
- Rule No.4 dated 15.10.2003 "On checking and approval of exportation licences and transition 
of waste"; 
- Decision of Council of Ministers No.835, date d 28.12.2005 "On approval of the list of danger 
waste, other waste and other remains, that are not allowed to be imported, with the aim to 
preserve, deposit and exterminate";  
- Decision of Council of Ministers, year 1994, "On danger waste and residues"; - Law No.9537, dated 18. 5.2006 "On administration of hazardous waste". 
 
 Licensing is done according to the defined a bove-mentioned procedures and also for waste 
and residues mentioned above.  
Procedures
 
  
6.I.  The relevant legislation is published in the official gazette and on the webpage of the 
MEFWM.  
 - Importers are informed in detail at the M EFWM or the Environmental Regional Agencies.  G/LIC/N/3/ALB/5 
Page 12  
 
  - Other exporting countries can take the information from the reports which the ministry 
presents at the Secretariat of the Basel Conve ntion "On cross border of waste and danger 
waste and their extermination". 
-  Interested foreign parties can be informed directly at the MEFWM.  
- There is no definition of a maximum and mini mum limit for imported waste. The limitations 
depend only on the type of waste and the activ ity for which they are planned (processing and 
recycling). 
- There cannot be any exception or derogation from the licensing requirement.   II.  There is no application of quotas.  
 
III.  Importation is only allowed for waste which can be used for the purpose of reusing, processing 
and recycling. Similar activities ca nnot be limited. Every activity is  able to obtain a licence. The 
importers of waste are defi ned by the Decision of the Council of Ministers.   
 
IV.  Not applicable. 
 V.  The process of approval of a licence for importation of waste is made by the Decision of 
Council of Ministers. The process is long, but the ministry prepar es the required file within a 
period of 1 month.  
 
VI.  In general there are no limitations. It is defined only by the maximum deadline of the validity of 
the licence.   
 VII. For issuance of a licence of importation of waste, the following approv als should be obtained: 
 
 - A licence of exportation from the competent authority of the country of origin and the 
relevant licences from the transit countries; 
 - An environment licence issued before by the Ministry of Environment, Forestry, and 
Water Management;  
 - A licence of the exercising activity by the relevant Ministry;  - A relevant licence issued by the Ministry of Heath; 
 - An approval by the community from where the activity is taking place. 
 VIII.  The licence is examined according to the rank of application at the MEFWM. The procedures 
for preparing the draft decision of the Council of Ministers to grant an im port licence is defined 
by the environmental legislation (meaning the type  of activity for which the residue will be used 
and the type of residue that is going to be  imported). Past performance is taken into 
consideration relating to the impact on the e nvironment (meaning if there is any penalty for 
polluting the environment, or complaints by citizens etc). There is no distinction for new 
applicants. The applications are continually examined, immediately after the request is done. The information is sent to the applicant for fu rther completion of documentation necessary for 
the preparation of the draft Decision of the Council of Ministers. This draft Decision is then 
circulated for the opinion of the Ministry of Economy, Trade and Energy, Ministry of Finances, 
Ministry of Public Works and Transport, a nd Ministry of Agriculture, Food and Consumer 
Protection. The Council of Ministers decides on  granting the licence, on the conditions of 
imported waste and on the deadlines of the licence.  
 
IX.  Not applicable. 
 X.  To issue the licence, the applicant must at tach the export licence issued by the competent 
authority of the country of exportation. 
  G/LIC/N/3/ALB/5 
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  XI. No. 
 7.(a)  No.  (b)  No. 
 
(c)  No.  (d)  - Handling the documents and preparing th e file for an import licence is done at the 
Ministry of Environment, Forestry and Water Management. 
 -  The Ministry of Economy, Trade and Energy , Ministry of Finances , Ministry of Public 
Works and Transport, and Ministry of Ag riculture, Food and Consumer Protection, 
send their opinions.  
 -  The Council of Ministers approve s the import licence of waste.  
 
8.  The Ministry of Environment,  Forestry and Water Management prepares the draft Decision of 
the Council of Ministers in case of refusal of applic ations. The applicant has the right to appeal within 
30 days in the Court.  
Eligibility of importers to apply for licence
 
 9.(a)  Legislation only allows th e importation of non dangerous waste,  which should only be used for 
the purposes of processing, reusing or recycli ng, if certain conditions  are satisfied:   
  - Utilization, processing and recycling of waste is carried out with a contemporary 
technology that guarantees the protection of public health and protection of the 
environment; 
 - Stuffs or useful materials are obtained from the by-waste; expensive raw materials are 
saved; 
 - Their transportation does not negatively affect human health and environment. 
  The rules and procedures for obtaining the im port licence are defined in the Decision of the 
Council of Ministers No. 806, dated 4.12.2004 "O n approval of rules and procedures for 
importation of waste with the aim to process, use and recycle".  Only the waste which is listed in Annex I of the decision of the Council of  Ministers No. 26, date d 31.01.1994 "On dangerous 
waste and residues" can actually be imported. 
 
(b)  Not applicable. 
 (c) There is not yet any list of importers.   
 
Documentation and other requireme nts for application for licence
 
 10.  They are defined in chapter I.4 and chapte rs II.2 and 3 of the Decision of the Council of 
Ministers No. 806, dated 4.12.2004 "On approval of  rules and procedures for importation of waste 
with the aim to use process and recycle".  11.  They are defined in chapters II.2 and 3, of the Decision of the Council of Ministers No. 806, 
dated 4.12.2004 "On approval of ru les and procedures for importation of waste with the aim to use 
process and recycle".  12.  Yes, 30.000 leke, Albanian currency.  G/LIC/N/3/ALB/5 
Page 14  
 
  13.  No. 
 
Conditions of licensing
 
 
14.  The validity is defined in the Decision of th e Council of Ministers and can be different due to 
the request made by the applicant and on environmental policies in the field of waste. The maximum 
validity is 5 years.   15.  No.  
16.  This transfer is not specified for import licen ces.  In the case of changing the ownership of the 
activity, according to Article 42 of the law "On prot ection of environment", the new owner maintains 
the rights of the environmental licence and implements the conditions foreseen in it. 
 17.  Not applicable. 
 
Other procedural requirements
 
 
18.  They are mentioned in the question VII of this questionnaire. 
 19.  The exchange rate is provided automatically by banking authority, every day.   
 
V. IMPORT LICENSING PROCEDURES FOR MEDICINAL PRODUCTS 
Outline of system
 
 
1.  Due to the amendments on licensing proce dures, only some medicinal products are required 
to provide an import licence, before placing them  on the market. Medicinal products, according to 
their use and technical capacities that authorities have, are divided into groups as follows:   (a) Medicines (drugs).  (b)  Dental equipment. (c)  Medical devices (consumables). 
(d)  Disinfectants, disinsectants and deratizing substances (DDD-s).  
  Among the above-mentioned groups, the import au thorization is required only for the first 
group (medicines) and the fourth group (disinfectan ts, disinsectants and dera tizing substances). Every 
subject, before starting the activity on import/export or placing these substances on the market, has to 
be licenced by the National Licensing Center (NLC). In some of the licensing procedures, a statement 
is required by the charge d'affaires at the Ministry of Health. The decision has to be fulfilled within  
15 working days, after this it is published by the National Licensing Center in the National Licensing 
Register, as an authorized subject on these activities.  Thereafter, import authorizations are granted for 
every concrete importation according to the regulation in force:  
- The registered drugs are imported by ma rketing authorization holders (MAH) or 
manufacturing ones, based on the register of  drugs, published and updated by the National 
Center of Drugs Control.  Import procedures are performed at the entry customs offices, in the 
presence of the pharmaceutical inspector. 
 
- In case of importation of unregistered drugs (in case of an emergency such as natural 
catastrophes, epidemics, or the unique alterna tives of a drug for hospital/ambulatory service), 
the application is submitted by the Pharmaceuti cal Department (Ministry of Health). After a 
requirement evaluation for these drugs by the sp ecialized structures within the Ministry of  G/LIC/N/3/ALB/5 
 Page 15 
 
 
  Health (in rare cases an official opinion is re quired by the National Center of Drug Control), 
the Minister of Health authorizes the importation. This authorization has a 2 (two) months validity. 
 - The importation of narcotic drugs and psychotropic substanc es is separately regulated, 
because the importation process is more restricted and under control of the Albanian and 
international authorities. Licenced subjects by the National Licensing Center on wholesale trade of drugs, also need to be  authorized by the Pharmaceutical Department, related to their 
activity on importation and distribution of narco tic drugs and psychotropic substances. When 
the importer wants to import narcotics and psyc hotropic, he/she submits the request for an 
authorization import at the Pharmaceutical Department. If the required quantity doesn't 
exceed the allowed quantities, the authorization, si gned by the Minister of Health, is granted, 
with a validity of 3 (three) months from its issuance. This authorization is used as an 
international control instrument. When the aut horization has reached the destination (control 
authorities of exporting country), these authorities grant export authorization for their 
exporter. Therefore, within these three months , the Albanian importer resubmits the request 
for import authorization followed by the export- authorization of the exporting country to the 
Pharmaceutical Department. After that, th e Pharmaceutical Department grants the 
authorization, valid for a period of 2 (two) m onths. Finally, authorization is provided which 
means the allowance of narcotic or psychotropic substances into Albania. 
 
- In order to facilitate import procedures, since May 2008, according to the order of Minister 
No. 215 dated 27.05.2008, the obligation of gran ting and submitting in the custom authorities, 
the import authorization for medical equipmen ts, dental equipments and consumables has 
been avoided. If medical equipment is sources of ionizing radiation, a special permission is issued by the Commission on Radiation Protectio n in the Institute of Public Health. This 
Commission only gives permission on the specific activity that the importer will carry out. 
 - Regarding the importation of disinfectant, di sinsectant and deratizing substances (DDD), the 
applicant, after being granted a licence by the National Licensing Center on the activity of 
intercessory services hygienic-sanitarian, submits  the request for import authorization from 
the Hygienic and Epidemiologic Sector (MoH). The requirement is verified by the specialist 
of the Hygienic and Epidemiologic Sector to see if it fulfills all the requirements of the list of 
DDD substances, approved every year by the Minister of Health. Also, on the issuance of import licences related to DDD substances, an opinion of the specialists from the Public Health Institute (PHI) is required. The PHI has to express its official opinion within 10 
working days. Once the verification is comple ted, the National Sanitary Head-Inspector 
(Director of Public Health Departme nt) approves the import authorization. 
 
Purpose and coverage of licensing
 
 
2.  Importation licensing systems are:  
 
 (i) Licensing of medicines (drugs); 
 (ii) Licensing of disinfectant, disinsectant and deratizing substances;  (iii) Licensing of ionized radiation sources.   The products covered by the above mentioned licensing systems are: 
 
- Narcotic Drugs and Psychotropic Substances refe rred to in the list in accordance with Single 
Conventions of 1961 and 1971; 
- Pharmaceutical Products of chapter 30 of  the Combined Nomenclature of Goods. 
- Disinfectant, disinsectant and deratizing substances, chapters 28, 29 of the CNG. G/LIC/N/3/ALB/5 
Page 16  
 
  3.  The systems apply to all medicinal products, in spite of their origin. 
 4.  Generally, licensing systems are used to control products that will enter the country. 
Licensing is seen as a tool to control what products, in what quantity and with what quality, are entering into the market. Although health care is mainly covered by importe d products, its aim is on 
the stimulation of domestic production by incr easing the number of qualitative medicinal products 
manufactured in Albania. Normally, adoption of a pr oper legislation, setting up of structures and the 
equipping of necessary technologies,  creates the conditions and opportu nities to use other alternatives, 
which consist of controls of several stages of im ported drugs, at the border by custom authorities, 
during wholesale distribution, during dispensing by pharmacies and their use. The adoption of a new 
legislation and structures relating to the control system is under way. 
 5. Legal framework that regulates the procedures of import licensing includes:  - Council of Ministers Decision No. 325, of  14.06.1993 "On regimen of export-import and 
medicines production"; 
- Joint Guideline of Ministry of Health and Ministry of Finance No. 180 of 13.08.1993 "On 
co-operation for the regimen of import-e xport of medicines and their clearance"; 
- Law No. 7975 of 26.07.1995 "O n narcotic drugs and psychotr opic substances, amended with: 
 (a) Law No. 9271 of 9.09.2004;  (b) Law No. 9559 of 8.06.2006. 
- Decision of Council of Ministers No. 415 of  17.08.1993 "On import, export, wholesale and 
retail trade licensing of disinfectant, disinsectan t and deratizing substan ces" and related Order 
of Minister of Health No. 361 of 18.08.2000; 
- Order of Minister of Health No. 104 of 5.03. 2004, For a change in the Guideline No. 180 of 
13.08.1993 "On co-operation for the regimen of import-export of medicines and their 
clearance"; 
- Order of Minister of Health No. 245 of 29.06.2 006, For a change in the Guideline No. 180 of 
13.08.1993 "On co-operation for the regimen of import-export of medicines and their 
clearance"; 
- Law No. 9323, of 25.11.2004 "On medicines and pharmaceutical service" amended with:  (a) Law No. 9523 of 25.04.2006; 
 (b) Law No. 9644 of 20.11.2006; 
 (c) Law No. 10008 of 27.10.2008. - Law No. 9928 9.06.2008 "On dental health service in the Republic of Albania"; - Order of Minister of Health No. 162 of 16.04.2008 "On abrogation of the Order of Minister 
no. 214 of 22.04.2004"; 
- Law No. 10081 of 23.02. 2009 "On licences, authorizations and permits in the Republic of 
Albania"; 
- Law No. 10137 of 11.05.2009 "On some addenda  to the current legislation on licences, 
authorizations and permits in the Republic of Albania"; 
- Decision of Council of Ministers No. 538 of  26.05.2009 "On licences and permits handeled 
by or through the National Licensing Center (NLC) and on some sub-legal common 
regulations"; 
- Decision No. 1295 of 29.12.2009 "On some ame ndments to Decision of Council of Ministers 
No. 538 of 26.05.2009 "On licences and permits  handeled by or through the National 
Licensing Center (NLC) and on some sub-legal common regulations"; 
- Law No. 10138 of 11.05.2009 "On Public Health"; 
- Order of Minister of Health No. 102 of 22.02.2010 "On the issuing of the authorization on the 
import-export, wholesale and retail trade of the DDD substances (disinfectant, disinsectant 
and deratizing substances)";  
- Law on Protection from ionized radiation No . 8025 of 9.11.1995, amended by the Law 
No. 9973 of 28 July 2008;  G/LIC/N/3/ALB/5 
 Page 17 
 
 
  - Decision of Council of Ministers No. 158 of  13.02.2008 "On import-export of ionized 
radiation source in the Republic of Albania"; 
- Regulation No. 3918/4 of 3.11.2004 "On import,  export and transit of radioactive sources"; 
- Guidance No. 4756/1 of 21.12.2006 "On import- export of radiation materials in Albania"; 
- Categorization of Radioactiv e Sources No. 9 of 7.01.2010;  
- Regulation No. 10 of 2010 "On licensing a nd inspection of ionized  radiation sources". 
  The systems of import licensing are based on laws, government decisions or other administrative acts. None of the licensing systems ca n be abolished without an y legislative approval. 
None of the legislation leaves designation of produc t to be subjected to administrative discretion. 
 
Procedures
 
  
6.I.  The only case of implementing quantity limit ation is the importation of narcotic drugs and 
psychotropic substances. Yearly quantities are a pproved by the International Narcotic Control 
Board and are published in its special publication.  The authority does not apply the allocation of 
quotas among importers. There is an agreemen t of a yearly quota, which is divided among 
importers based on the supplying contracts that importers have signed with public or private 
health institutions, or due to medicines included in the reimbursement scheme etc. There is no 
limitation for the quantities imported from any country. Importers import the quantity they think 
is reasonable or according to the supply contracts they have signed, always within a yearly 
quota and the agreement done with other importers. Taking into consideration that this is a very 
restricted control, no request for exception or derogations from the licensing requirements is 
accepted. 
 II.  The quota size for each narcot ic drug is determined for a peri od of a year and covers all the 
country. Importation licences are granted every time the importer imports a quantity within the 
quota. As import authorizations  are valid for 3 months, only  one importation within the 
3 months can be done until the next importation from the same importer. 
  The import authorization relati ng to ionized radiation sources are for single use and valid for 
2 weeks.  
 
III.  Licences are allotted for the quan tity of a certain narcotic drug that is imported by a certain 
manufacturer and from a certain count ry (this is not defined by authority, but from the fact that 
the drug is registered and the re gistration is done by a manufactur er that is established in a 
certain country. After this, the impor ter begins his/ her procedures). 
 
 Because this is a process of reciprocal cont rol among several authoriti es, its continuity is 
supervised by these authorities. Pharmaceutical Au thorities particularly supervise licence usage, 
because no utilization would result in the lack of drugs in health institutions and the pharmaceutical market. In the case of a lice nce not being used, the importer notifies the 
responsible authority and if he does not, the authority, based on the data received in the 
pharmaceutical market, communicates with the im porter to solve any possible problems.  The 
Pharmaceutical Authorities are also able to make the importation possible from another 
importer if the first has not the possibility to do so. The primary concern of authorities is that the market does not suffer from lack of medicines. 
 
 The Radiation Protecting Commission has the ri ght to approve authorization imports, only to 
licence holders on this purpose.  Unused allocatio ns are not added to the coming periods. Every 
year begins with new quotas for su ch medicines for one year that are equal to the needs of that 
country.  
 G/LIC/N/3/ALB/5 
Page 18  
 
  IV.  There is not any defined period. 
 V.  There is not any defined pe riod, but usually the applications are processed within a working 
day. 
 
VI.  There is not any defined period. The authority  and the importer are informed that the importing 
period begins at the start of a calendar year, so they are able to begin their procedures after that date. 
  In the case of radiation sources this period is two weeks and two months. Two weeks is for the 
approval of import export and two months is for licences.  
 VII.  The only cases where the application for im port licensing is examined by two authorities are 
those of unregistered medicines, of disinfectant, disinsectant and deratizing substances and of ionized radiation sources: 
 - In some cases relating to unregistered me dicines, the official opinion of the National 
Center of Drugs Control is required.   
 - The official opinion of the Public Health Institute is required relating to disinfectant, 
disinsectant and deratizing substances, 
 - The same situation occurs with ionized radiation sources, where the importer has to 
approach more than one administrative organ.  
 
 The positive answer (approved impo rt licence) or negative one (a long with all explanations) is 
given to importers by the Ministry of Health.  
 VIII.  There are several ways to act in the case of an unsatisfied demand for a licence. If the medicine 
is for ambulatory use and is not the first alternative in the reimbursement list, then the basis is 
first come, first served. A licence will be gr anted provided that all the necessary data is 
submitted. If the drug is intended for hospital use (according to contracts the importer has with the hospitals), or is the first alternative in the reimbursement list (with the highest coverage 
level) the importer is served first so that he  fulfills these conditions; then the others are 
considered according to the ag reements among themselves, taki ng the difference of quotas. If 
the importer submits an applicati on for narcotic import authorization at the end of the year, 
knowing that the period of authorization approval obliges the importer to bring the 
cargo/shipment in the following year, which is not allowed by international control authorities, 
usually it is decided that proced ures must be done the next year when the new quotas are open. 
The importer's performance is not examined. The maximum quantities for each importer are 
determined by the agreements they reach with eac h other based on contra cts or market studies 
(it must be stressed that there is a small numbe r of narcotic drugs imported into Albania and 
there is a very small number of importers, some times even only one). There is no provision for 
new importers, they are given the same consid erations as the previous importers.  The 
applications are examined immediately. 
 
 In the case of ionized radiati on sources, new applicants have to be assessed through a licensing 
process for each import approval.  
 IX.  In the case of narcotic drugs these are ca ses of bilateral quotas. According to a regulatory 
framework, the submitted application for exporta tion grants the importation authorization from 
the importing country (granted to importer). Only the issued export authorizations for this case 
are granted immediately. 
  These are the same procedures with ionized ra diation sources, where confirmation is required 
from the importing country to provide the export approval from the exporting country.   G/LIC/N/3/ALB/5 
 Page 19 
 
 
  X.  In the case of importing narcotic drugs a nd psychotropic substances, when import and export 
authorization are grante d, the authority of the exporting country, after granting export 
authorization, based on applic ation and import authorization,  sends a copy of export 
authorization to the authorit y of the importing country. 
 
 In the case of ionized radiati on sources, the two countries are in formed by their contact points. 
 XI.  In the case of medicines:  No. The exported products, mainly of Albani an manufacturers, are the 
same that are sold in the domestic market. So far, such a limiting procedure does not exist.  
 
 In the case of ionized radiation sources:  Yes. 
  7.(a)  The import authorization validity is for 1 to 2 months, respectively, for medicines, registered or 
not; 3 months for narcotics and psychotropic and i onized radiation sources.   However relating to 
DDD the validity varies from 6 months for disinsectant and deratizing substances, to 1 year 
for disinfectants of the potable water.  
 
 The approval is valid for two weeks for ionizing radiations. 
 (b)  Yes, the licences are granted immediately on request, despite unregistere d medicines, where in 
some cases an examination fro m the Ministry of Health and the National Center of Drug 
Control is required.  The procedure for the examination is up to 3 working days. 
 (c)  No, there is no limitation.  (d)  There are cases where the application needs to be passed onto other administrative organs such 
as import of unregistered medici nes (the application passes to the NCDC); import of DDD 
substances (the applica tion passes to the PHI); and, impor t of ionized radiation sources. The 
organs cooperate with each other and the importer has to approach  only the Ministry of Health, 
when the importer receives the answer.  
 8.  The application for a licence  (import authorizati on) on medicines can be refused when the 
importer fails to meet the defined criteria and in some other cases, specifically when: 
 (a) The National Center of Drugs Control is in formed that the drug does not meet the necessary 
quality and safety standards; information is r eceived by homologue authorities or by the 
results of the NCDC's own tests (testing of samples on the market). 
 
(b) Manufacturer or control authorities inform the starting of withdrawal procedures of the 
product from the market, meanwhile the importe r submits the application for an import 
licence. 
 (c)  The registration validity of the medicine h as expired and the manufacturer has not begun the 
re-registration procedures. 
  In each case, there is an explanation for refusal. The applicants can make an appeal to the Ministry of Health, the supervising levels of the Ph armaceutical Department and to the National Center 
of Drugs Control. The other body for appeal is the Cour t, if they think that the authority has violated the 
law. 
  Related to ionized radiation s ources, the application for import authorization may be refused, 
but as mentioned above, in the case of a refusal there is an explanation. The a pplicant has the right to 
appeal.  G/LIC/N/3/ALB/5 
Page 20  
 
  Eligibility of importers to apply for licence
 
 
9.(a)  Under restrictive li censing systems, application for licences is done only by operators that fulfill 
the conditions of such systems. In health serv ices the application is submitted by a subject 
(importer or medical clinic that uses the produc ts for its own activity) who has a professional 
licence (registration) issued by the Ministry of Health. If the subject appl ies to import narcotic 
and psychotropic drugs, or medicinal products that  are source of ionizing radiation, it must have 
a second registration only for this kind of activity.  Related to ionized radi ation sources, all the 
physics or legal persons are eligible to apply fo r a licence, under the restri ctive licensing system 
too.  
 
(b)  In health services ther e are no non-restrictive systems. 
 (c) There is a system of professional licensing (registration) for importation, exportation, and 
wholesale distribution of medici nal products. Eligible firms mu st have proper facilities, 
according to criteria defined for this purpose, a nd specialized staff to pe rform the activity. This 
registration has a fee, which is published with all other requests. So far, there are importers' lists 
that can be given to the interested parties. The National Center of Drugs Control already has its online list of pharmaceutical import ers and distributors (www.qkkb.gov.al). 
 
Documentation and other requireme nts for application for licence
 
 
10.  There is not any application form, importers  receive necessary information from the authorities 
and begin the procedure.  Differen t systems are required to submit different documentation depending 
on the groups of products that will be imported.   
(a) To import registered medicines, registered importers submit an application for import 
authorization that include a) importer's data, b) a table with medicines that will be imported detailing brand name, generic name of the medi cine, quantity, manufacturing and expiry date, 
batch number, CIF price, manufacturer name a nd the country from which the import is done. 
An invoice is attached to the application. It  is submitted to the National Center of Drugs 
Control where the import licence is granted.  
(b) To import unregistered medicines, the applicati on for import authorization has the same data 
as above and is submitted to the Pharmaceutical De partment of the Ministry of Health, where 
the licence is signed and granted by the Minister of Health. 
(c) To import narcotic and psychotropic drugs, the importer has to submit the application to the 
Pharmaceutical Department in the Ministry of  Health, including the above-mentioned data, and 
full address of the manufacturer. When the importer submits to the Ministry of Health, he first 
requires the granting of an import authorization. When he/she rece ives the confirmation that the 
exporter has received the export authorization in  the originating country, the importer applies 
for the import licence when the cargo is ready. 
 (d) The import authorizati on has been abolished. If the medica l devices are sources of ionizing 
radiation the application must be accompanied by a special licence (registration) for that 
activity. 
 (e) To import disinfectant, disinsectants, derati zing substances the application shall contain the 
following information: i) importer's data, ii) Taxpayer Personal Identification Number and iii) 
certificate of origin of the goods. 
 (f) To import ionized radiation sources the licenced applicant in  this field should provide:  G/LIC/N/3/ALB/5 
 Page 21 
 
 
   - A copy of a registration to the Court; 
 - Technical data fo r radiation sources; 
 - Certification for sealed sources;  - Data on the exporting country;  - Clarification on the purpos e of the use of sources; 
 - Declaration of the source of the end use; 
 - Clarification of transport of the sources.  11.  When the cargo/shipment arrives in Albania th is must be generally s upplemented by these types 
of documents i) invoices, ii) packing list, iii) ce rtificate of analyses, iv) certificate of quality,  
v) certificate of conformity, vi) certificate of product origin. The number of documents depends on the 
type of product that is imported.   In the case of ionized radia tion sources, only an official request for approval of import and a 
copy of Proforma Invoice is required. 
 
12.  The fees are different depending on the type of licence:  - The fee to import unregistered medicines is 1000 Leks for each medicine; - The fee to import raw materials is 500 Leks for each item; - The fee to import registered medicines is 200 Leks for each authorization; 
- The fee to import narcotics and psychotropic substances is 200 Leks for each authorization; 
- The fee to import packages is 200 Leks for each authorization; - The fee to import disinfectants, disinsectant s and deratizing substances is 2000 Leks for each 
authorization; 
- The fee to import ionized radiation s ources vary from 1000 Le ks to 20.000 Leks. 
 
13.  No, it is not required. 
 
Conditions of licensing
 
 
14.  There are different validity periods for import licences: 
 
- Import authorizations for registered medicines have a 1-month validity; - Import authorizations for unregistered  medicines, have 2 months validity; 
- Import authorizations for disinfectants, disin sectants and deratizing substances have 6 months 
validity and exceptional import licences for wate r disinfectants have a 1-year validity; 
- Import authorizations for narc otic drugs and psychotropic subs tances have 3 months validity; 
- Import authorizations for ionized radiation s ources are for single use and valid for 2 weeks. 
  When the validity of a licence is over, the im porter must submit an application to extend the 
validity.  
15.  The only case of penalty for non-utilization of th e licence or the partial use of it occurs in the 
import of ionized radiation sources.   16.  Import licences are not transferable between importers.   
17.(a)  For narcotic drugs and ps ychotropic substances, the total volume of the im ported medicine, 
from all importers, shall not be more than the annual quantity approved for the country. 
  In the case of ionized radiation sources there are no other conditions. The same, for point (b) of 
this question. G/LIC/N/3/ALB/5 
Page 22  
 
  (b) There are no other conditions. 
 
Other procedural requirements
 
18.  No, there are no other proc edures prior to importations. 
 
19.  All banks provide foreign exchange automatically. 
 
VI. IMPORT LICENSING PROCEDURES FOR EXPLOSIVE, PYROTECHNIC AND 
FIREWORK MATERIALS FOR CIVILIAN USE 
Outline of system  
 
1.  To issue licences to import, export and ma nufacture explosives, fireworks and pyrotechnic 
materials to civilians, the Ministry of Defe nce has established the Commission of Granting the 
Licences for Explosives, Fireworks and Pyrotechnic Materials for Civilian Use, which is an ad hoc 
Commission established at the State Export Cont rol Authority (AKSHE).  This commission is 
composed of five persons. 
 
Purpose and coverage of licensing  
 
2.  The licensing system is a single one managed by the Ministry of Defence with the Commission 
of Granting the Licences which is in place at the State Export Control Authority. 
 
 Products subject to an import licence by this Commission are explosives, fireworks and pyrotechnic materials for civilian use.  Pyrotechnical materials, fireworks that are allowed to be imported, exported or produced in the Republic of Albania for civilian use,  whose transformation is 
done only by burning, at a rate of 1-10m/sec, that shine and blaze in different colors, are defined in 
part II, class I, groups 3 and 4,  in the commune "G", (1.3G or IAG), of the law No. 9272, dated 
16.9.2004, "For the adherence of the Republic of Alba nia in the European Agreement  "For the overland 
international transportation of dangerous ADR good s” and "the protocol of endorsement".   
  Explosive materials for civilian use are not groupe d or listed but they can be imported in the 
Republic of Albania if they meet the EU standards and have the conformity certificates attached.  
 
3.  The licensing system does not discriminate any country.  4.  The licensing system is not intended to restri ct the quantity or values of imports. There is no 
restriction in value or quantity in the Albanian legi slation to import explosive and pyrotechnic materials 
for civilian use.  
  The licensing system defines the procedures, ru les and responsibilities of the Administration for 
the production, storage, use, control, getting rid of , transfer and way of selling explosive materials for 
civilian use, to protect and secure life, human and animal health, material values and environment from risks that these materials may cause.  
 
5. Law No. 9126, dated 29.07.2003 "On the civilian use of explosive materials in the Republic of 
Albania";    Council of Ministers Decision No. 853, dated 17.12.2004 "On the procedure of issuing 
permission for importing, exporting and producing pyrotechnical material s, firecrackers, for civilian 
use";  G/LIC/N/3/ALB/5 
 Page 23 
 
 
   Council of Ministers Decision No. 597, dated 10.09.2004 "On the procedure of issuing 
permission for importing, exporti ng and producing explosive materials, for civilian use"; 
  Order of the Minister of Defence No. 315, dated 15.3.2007 "On the approval of the regulation 
on the criteria and procedures fo r issuing permits of import, expo rt and production of explosives, 
pyrotechnic substances, fireworks, for civilian use and the operating of the granting permits 
commission";   Order of the Minister of Defence No. 525, da ted 30.7.2004 "For the appl ication procedures for 
the registration of explosive substances in the state register of explosive substances for civilian us" 
 
 Common Order of the Minister of Defence No. 107 Prot, on 23.02.2005 and the Minister of 
Finance No.471/3 Prot, on 2005 "On financial rate s for permission to im port, export and produce 
explosives for civil use";  
 Order of the Minister of Defence No. 155 dated 2.03.2005 "On the financial tariffs for the 
granting of the permits of the importation, exportations  and manufacturing of the pyrotechnical 
materials, fireworks for civilian use";   Order of the Minister of Defence No 1106 date d 10.08.2009 "For registration of the explosives 
for the civil use in the state registry of the explosives, by the State exports Control Authority"; 
 
 Any import of explosive and pyrotechnic materials for civilian use need to be licenced.  An import licence is always required. An exception fr om this is made only in the following cases: 
  - For explosives, used by the Armed and Pub lic Order Forces, whose use is regulated by 
special law; 
 - The licensing system in Albania whic h cannot be abolished without legislative 
approval. 
 
Procedures
 
  6.I.  The licensing procedures and formalities are publ ished on the official website of the State 
Export Control Authority: www.akshe.gov.al. In th e Albanian legislation there is no restriction 
to the value, quantity or licence quotas.  Also a ccording to the Albanian legislation there cannot 
be derogations from the licensing requirements. 
 
II.  There is no such thing as size of quotas. A li cence can be issued with 1 year of validity.  
 III.  There is no restriction  in the Albanian legislation  related to this matter.  
 
 An import licence is issued only when there is an application for it, which fulfills the 
requirements of the Albanian le gislation. For each import perform ed by a licenced entity an 
AKSHE official is present at the customs point where the import will take place. If there is a 
request from governments and export promotion bodi es of exporting countries about the names 
of importers who deal in this area, there are no restrictions to provide them such a list. 
IV.  Not applicable.  
V.  The processing period, if the application fu lfills all the required doc umentation has a maximum 
of 30 days of processing.  
 VI.  There is no such provision in the Albanian le gislation. Once the import licence is granted, the 
importation can be done at any time during its validity period. G/LIC/N/3/ALB/5 
Page 24  
 
  VII. A licence application for an import licence is  processed by the Commission of Granting the 
Licences. However, this application must be completed before with the necessary 
documentation that is issued by the Ministry of Interior and National Licensing Center, (this document would be explained in the questions below). 
 
VIII. If the demand for licences ca nnot be fully satisfied, the licence cannot be granted. There are no 
exceptions.  Also there ar e no amounts for granting the licences to an importer.  
 IX. An import licence is always required to import explosive and pyrotechnic materials for civilian 
use, even when there is an export licence issued  by the exporting countries.  Also in this case 
the import licence is not issued automatically but the application is subject to controls. 
 X. Not applicable.  XI.  Not applicable. 
    
7.(a)  The application must be done 30 days befo re the importation of the goods. This time limit is 
the maximum to process an import licence. If the importer submits all the necessary 
documents and satisfies all the requirements, the licence can be obtained within a shorter time. But this is considered case by case.  
 
(b)  No. It has to be revised step by step. 
 (c)  No.  (d)  An application for an import licence is  processed by the Commission of Granting the 
Licences. However, the application which is issu ed by the Ministry of Interior and National 
Licensing Center, must be completed with the necessary documentation before submission.  (This document would be explained in the questions below). 
 8.   No answer was provided.  Eligibility of importers to apply for licence
 
 
9.(a-b) Yes, if the object of their activity is the import of explosive and pyrotechnic materials for 
civilian use. 
 
(c) Not applicable. 
 
Documentation and other requireme nts for application for licence  
 
10.  An importer who wants to import pyrotechnic, fireworks materials for civilian use has to submit 
an application to the Commission of Granting Lice nces at the State Export Control Authority. The 
application needs to be completed with the following documents: 
  (i)  Registration in the law-court as a physical or legal person for importation and 
firecrackers business; 
 (ii)  Registration certificate in the taxing office; 
 (iii)  Certificate of the identification number as a taxable person; 
 (iv) List composed by the firecrackers' ma nufacturer, with the code number, firecrackers 
labeling, way of packaging, quantity, weight , financial value, translated to Albanian 
and duly notarized; 
   G/LIC/N/3/ALB/5 
 Page 25 
 
 
   (v) Permission issued by the Ministry of Environment, for the safety and protection of 
the environment, (currently this is i ssued by the National Licensing Center); 
  (vi) Copy of the importer's previous permission, in the case of renovation.  
 Documents must be original or notarized  photocopies. The interested subject, before 
duty-payment, makes a bank deposit in order "To pay a draft to get the permission to import 
firecrackers", from the Ministry of Defence.   An importer wanting to import e xplosive materials for civilian use has to submit an application 
to the Commission of Granting Licences at the Stat e Export Control Authority. The application needs to 
be complete with the following documents:  
(i)  Registration in the law-court as a physical or legal person  (ii)  Necessary documentation for the type s and quantities of explosives from the 
manufacturing factory. 
(iii)  Conformity assessment document an d documentation of technical data of the 
composition of explosives, associated with pictures. 
(iv)  Permission issued by the Ministry of Environment, for the safety and protection of 
the environment. (Now issued by the National Licensing Center) 
(v)  Service contract for physical storage and tr ansportation with the third party, when there 
is no licence for these services. 
(vi)  Permission from the Ministry of Public Or der for storage and transfer of explosives, to 
be imported. 
(vii)  Copy of the previous import permit (i f any), invoices and a list of explosives, which 
have previously been used, a statement of storage conditions of the explosives and of 
the quality of these materials. 
 11.  The documents required upon importation ar e the documents mentioned in the previous 
question.  12.  The licensing fee for an import licenc e with the validity of one year is 100 US$. 
 
13.  There is no other deposit or advance paym ent except that paid for the licensing fee.  
 
Conditions of licensing
 
 14.  The validity of the import licence is 1 year. The validity of the licence cannot be extended, 
and the importer has to submit another application.  15.  There are no penalties for non-utilization of the licences.  
16.  Licences are not transferable. 
 17.  The conditions attached to the issue of th e licence are that the importer has to notify the 
Commission before importing the licensed materials. 
 
Other procedural requirements
 
18.  No, there are no other proc edures prior to importation. 
 19.  All banks provide foreign exchange automatically.  G/LIC/N/3/ALB/5 
Page 26  
 
  VII. IMPORT LICENSING PROCEDURES FOR MILITARY GOODS 
Outline of system
 
 
1.  The import of military goods and dual use goods  and technology is managed by the Albanian 
State Export Control Authority (AKSHE) under the Minister of Defence. Trade with foreign parties is 
performed based on licences and authorizations issued by this authority, after consultations with the 
relevant institutions if needed. 
 This permission is issued based on Law No . 9707 "On State Exports Control of Military 
Goods and Dual Use Goods and Technology” O fficial Journal No. 48, Page 1237; Publishing 
date: 24.04.2007). 
 The AKSHE's work is focused on the state control of expor ts, imports, transit, transfers and 
intermediary activities for military goods and dual use goods and technology, to en sure the interests of 
the Republic of Albania, to supervise its commitment  to international treaties of non-proliferation of 
weapons of mass destruction and their launching systems, the transf er of conventional weapons, as 
well as the implementation of measures aimed at pr eventing the of use of such goods for unlawful 
purposes.  
 
Purpose and coverage of licensing  
 
2.  The licensing system for military goods and dual use goods a nd technology function is a single 
one, concentrated in the State Export Control Authority. The products that are covered are listed in the 
national list according to the Decision of the Council of Ministers No.1569, of 19.11.2008, "On 
approving the list of military goods and dual use g oods and technology which undergo state control of 
import-exports", Official Gazette: Year 2008, No. 195, Page 10481; Publishi ng date: 06.01.2009.  
This list is based on the European Union publis hed 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 value of imports. There is no restriction in value or quantity in the Albanian legislation to import mili tary and dual use goods. 
 
 The state export – import control pol icy is built on the following principles: 
 
(a) Priority of national interest – political , economic and military, of  which protection is 
necessary for guaranteeing national security. 
(b) Protection of political, economic and military interest of the country. 
(c) Obligation to observe the internatio nal commitments made by the Republic of 
Albania to non-proliferation of weapons of mass destruction, the ways for their 
proliferation, and to ensure state control over international transfer of goods designed 
for military purposes, and dual-use goods, as well as to prevent these goods from being used for terrorist acts and other illegal purposes. 
(d) Legality. 
(e) The export control over military items has to be done only in line with the national 
policies mentioned in this paragraph without interfere on the free trade of this goods  
(f) Harmonisation of state export control pro cedures and regulations with international 
legal norms and practices. 
(g) Ensuring interaction with international or ganisations and foreign countries in the state 
export control area so as to reinforce international security and stability, including 
countervailing of weapons of mass destruction and the syst em for their proliferation.  G/LIC/N/3/ALB/5 
 Page 27 
 
 
  5. The Albanian legislation for the import-export military goods and technolog y of dual use is as 
follows. 
- Law No. 9707, of 05.04.2007, "On State Contro l over the import-export of military goods and 
dual use goods and technology" Official Gazet te No. 48, Page 1237; Publishing date: 
24.04.2007.  
- Decision of the Council of Ministers No. 43, of 16.01.2008, "On Organizing, functioning and 
the status of the State Export Control Authority", Official Gazette: Year 2008, No. 8, Page 240; publishing date: 30.01.2008.  
- Decision of the Council of Ministers No.1569, of 19.11.2008 , "On approving the list of 
military goods and dual use goods and tec hnology which undergo state control of 
import-exports", Official Gazette: Year 2008, No. 195, Page 10481; Publishing date: 
06.01.2009.  
- Decision of the Council of Ministers No. 305, of  25.3.2009, "On determining the procedure of 
issuing legal documents, in the framework of state control over the import-export of military 
goods and dual use  goods and  technology" , Official Gazette: Year 2009, No. 51, Page 2468; 
Publishing date: 29.04.2009. 
- Decision of the Council of Ministers  No. 304, of 25.3.2009, "On determining the procedure 
on expertise and control by the State Export Control Authority”, Official Gazette: Year 2009, No. 51, Page 2466; Publishing date: 29.04.2009. 
- Decision of the Council of Ministers No. 604, of 28.8.2003, "On approving, in principles, the 
European Union Code of Conduct regarding the export of weapons". 
- Decision of the Council of Ministers No.341, of 8.4.2009 , "On determining tariffs for the 
issuance of legal documents". 
 Any import of military and dual use goods needs to be licenced by the State Export Control 
Authority.  An import licence is always required.  An exception from this is made only in the cases 
that follow: 
 
(a)  transfer of goods in connection with even ts held by the Armed Forces, or other state 
security structures of the Republic of Albania outside its territory, or with events held by foreign military forces in the territory of the Republic of Albania, as part of international agreements laying down th e mechanism of state control over the 
movement of these goods; 
(b)  international transfers of anaesthetics (med ical anaesthetic gases), sports and hunting 
arms, gas-containing vessels, and exportation and importation of individual armament 
of military servicemen, and state law enforcement and internal security bodies, which, under law, are entitled to carry arms; 
(c)  state control procedures concerning international export transfers of goods, which aim 
at ensuring provision of military assistance in  accordance with the terms contained in 
international agreements and treaties to whic h the Republic of Albania is a party, and 
the movement of goods outside of Albani a with a view to offering emergency 
assistance to foreign countries, if this is established by law. 
 
 The licensing system in Albania cannot be  abolished without legislative approval. 
 G/LIC/N/3/ALB/5 
Page 28  
 
  Procedures
 
  
6.I.  The licensing procedures and formalities are publ ished 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 li cence quotas. There cannot be de rogations from the licensing 
requirement. 
II.  There is no size of quotas. A licence can be issued with a validity from 1-3 years with an 
extend option if there is a contract betwen the entities involved.  
 III.  There is no restriction.  An import licence is issued only when there is an application for it, 
which fulfills the requirements of  the Albanian legislation. Also the State Export Control 
Authority has the authority to do controls befo re, during, and after issuing the import licence. 
Also an end-user statement or certificate which is  filled by the importer or any other who is the 
end user is needed to obtain an import licence. 
 
IV.  Not applicable. 
 V. If issuance of licences and authorisations does require coordination among the other 
institutions concerned, the time-limit for consid ering an application shall be determined in 
accordance with the categories of goods, but sh all not exceed the following timescale as of 
the day of application: 
 
 - 15 days for importation or tran shipment of goods, and temporary 
importation/exportation of goods fo r exhibitions, fairs, adver tising, testing, and other 
similar purposes, if this does not call for transfer of ownership. 
 
 This time-limit does not include the time requi red for obtaining additional information from 
entities involved in interna tional transfer of goods. 
 VI. There are no such provisions in the Albanian  legislation. Once the import licence is granted 
the importation can take place at an y time during its validity period. 
 
VII. An application is dealt with by the Stat e Export Control Authority.  Trade activities with 
foreigners take place on the basis of licences and authorisations issued by this Authority, 
following, if required, the opinion of the ins titutions concerned.  The concerned institutions 
are the Ministry of Defence, Ministry of Foreign Affairs, Intelligence Agencies, and Ministry of Interior. 
 
VIII. If the demand for licences cannot be fully satis fied, the licence cannot be granted. There are 
no exceptions.  The new importers who want to d eal with international trade of military goods 
need to be registered by the State Export Cont rol Authority. After they get the Registration 
Certificate they can demand an import licence. This registration is not required to trade dual use goods and technologies. 
 
IX. In the Republic of Albania for the im port of military goods and dual use goods and 
technology, an import licence is always required even when there is an export licence issued 
by the exporting countries. Also in this case the import licence is not issued automatically but 
the application is subject to controls. 
 
X. Not applicable.  XI. Not applicable.  G/LIC/N/3/ALB/5 
 Page 29 
 
 
  7.(a)  The application must be done 15 days befo re importation of the goods. This time limit is the 
maximum allowed before an import licence pr ocedure.  If the importer submits all the 
necessary documents and satisfies all the requirements, the licence 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 licence application procedure is done by th e State Export Control.  Trade activities with 
foreigners take place on the basis of licences and authorisations issued by this Authority, 
following, if required, the opinion of the ins titutions concerned.  The concerned institutions 
are the Ministry of Defence, Ministry of Foreign Affairs, Intelligence Agencies, and Ministry of Interior. 
 
8.  The application to obtain licences, authorisations or international import certificates will not 
be taken into consideration if:  
(a) It is deposited by a person who does not have the judicial capacity; 
(b) Documents are missing, or they are formulated contrary to the requirements 
prescribed by the Law; 
(c)  There are other reasons running counter to Albanian legislation in force, or the 
ratified international agreements. 
 
 In the event that the application to obtain a licence, authorisation and international import 
certificate is not taken into account or rejected, th e State Export Control Authority gives notice to the 
applicant and the state body responsible, within thr ee days from the adoption of the relevant decision, 
provides the explanations of and reasons behind failu re to consider it or its rejection. The decision 
made by the State Export Control Authority to revoke a licence, authorisation and international import 
certificate, or to remove from the list the name of  an entity involved in econo mic activities with foreign 
countries for international transfers of goods, can be a ppealed to the court of appeal, in accordance with 
the general rules of appeal. An appeal against the decision suspends its execution. 
 
Eligibility of importers to apply for licence
 
 
9.  A person, firm or institution who wants to deal  with the import of military goods, has to be first 
registered by the State Export C ontrol Authority. This provision is  not required to import dual use 
goods.  The regi stration certificate fee for military goods is 30 US$.  All pers ons or firms that are 
registered by the State Export Control Authority are in a list published on the website: www.akshe.gov.mod.al.   
Documentation and other requireme nts for application of licence
 
 
10.(a) Certificate of registration (only for military goods). 
 (b) Licence application form completed by type, acco rding to the guidelines set forth in this form, 
signed by the legal representative of the entity (notarized photocopy of the passport). 
 
(c) Brief summary of the current commercial activity, which reflects the entity's ability to 
perform activities in the area of transfer of military goods (only private commercial entities) 
  (d) A natural person who seeks to obtain a li cence must submit the following documents: 
 G/LIC/N/3/ALB/5 
Page 30  
 
   - Document that certifies expertise in the field of international transfers of military 
goods; 
 - Identification document (identity card, passport,);  - 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 offence that constitutes grounds for 
denial of licence, 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); 
 - The historical Extract document issued by the National Registration Center regarding 
the changes that has been made during the years on the data mentioned above, in the 
simple extract. 
 (e) A legal person who seeks to obtain a licence must submit the following documents:   - Confirmation that the company is not on a trial neither in Civil or Criminal Section. 
This document is issued by the judicial  district in which the company has the 
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);  - Act of establishment (notarized copy);  - Decision of the court to establish the company;   - Taxpayer Personal Identification Number; 
 - The historical extract mentioned above. 
 (f) International import certificate or end-user.  (g) Documents that provide information on the description of goods, c onditions of delivery, 
quantity of goods, the value of goods, state trans it transship, destination country and the last 
user, and country of origin of goods. 
 (h) Notarized copy of the contract or order, certified by the legal representative of the subject. 
 (i) Bill of goods. 
 
(j) Documents that provide information on the d escription of goods, conditions of delivery, place 
of destination or origin of goods. 
 (k) Documents that provide information on the pa rtner firm address, financial credibility, the 
bank account. 
 (l) Other valid documents to be considered as such by the State Export Control Authority.  (m) Warrant payment of the appropriate fee.  G/LIC/N/3/ALB/5 
 Page 31 
 
 
  11.  The documents required upon importation ar e the documents mentioned in the previous 
question .  
 12.  The licensing fee for an import licence with a va lidity of one year is 30 US$.  The licensing fee 
for an import licence with a validity of three years is 60 US$. 
 
13.  There is no other deposit or advance paym ent except that paid for the licensing fee.  
 
Conditions of licensing
 
 14.  The validity of the licence is 1-3 years, acco rding to the type of the licence required. The 
validity of the licence can be extended, but not up on the term of validity of  the economic agreement, 
which refers to the licence.  
15.  There are no penalties for non-utilization of the licences. 
 16.  Licences are not transferable.  17.  There are no other conditions attach ed to the issue of the licence.  
 
Other procedural requirements
 
18.  No, there are no other proc edures prior to importations. 
 19.  All banks provide foreign exchange automatically. 
 
 
__________