WORLD TRADE  
ORGANIZATION   
G/LIC/N/3/ALB/6 
5 November 2012 
 (12-6063) 
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 communication, dated 30 October 2012, is being circulated at the request of the delegation of Albania.  
_______________ 
 
 
I.  IMPORT LICENSING PROCEDURE S ON MILITARY GOODS .................................... 1  
II.  IMPORT LICENSING PROCEDURES ON HEALTH ....................................................... 7  
III. IMPORT LICENSING PROCEDURES OF PLANT PROTECTION 
PRODUCTS (PPP)................................................................................................................. . 15 
IV.  LIVE ANIMALS, BIOLOGIC MATERIAL ON ANIMAL INSEMINATION 
AND VETERINARY DRUGS AND VACCINES ................................................................ 17  
V.  IMPORT LICENSING PROCEDURES FOR WASTE ..................................................... 21  
 
 
I. IMPORT LICENSING PROCEDURES ON MILITARY GOODS  
Outline of system 
 
1.  The import of the military goods and dua l 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 . 9707 "On State Exports Control of Military 
Goods and Dual Use Goods and Technology" O fficial Journal No. 48, Page 1237; Publishing 
date: 24 April 2007. 
  AKSHE's work is focused on the state contro l of exports, imports, transits, transfers and 
intermediary activities for military goods and dual use goods and technology, to 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 aiming prevention of use of such goods for unlawful 
purposes.  
                                                      
1 See document G/LIC/3. G/LIC/N/3/ALB/6 
Page 2  
 
  Purpose and coverage of licensing 
 
2.  The licensing system for military goods and dual use goods and technology function as one, 
concentrated in the State Export Control Aut hority mentioned in the previous question. 
 
The products that are covered are listed in the national list according to the Decision of the 
Council of Ministers No. 106 of 9 February 2011,  "On approving the updated list of military goods 
and dual use goods and technology which unde rgo state control of import-exports". 
This list is based on Europ ean Union published list on military goods and dual-use 
goods and technology.  
3.  The system does not discriminate any country.  
 4.   The licensing system is not intended to restrict the quantity or values of imports. In the 
Albanian legislation for the import of military and dual use goods there is no restriction in value or 
quantity.   The state export – import control policy is built on the following principles:  
- Priority of national interest – political, economi c and military, of which protection is necessary 
for guaranteeing national security; 
- Protection of political, economic and military interest of the country; - Obligation to observe the international comm itments made by the Re public of Albania to 
non-proliferation of weapons of mass destruction, the ways for their prolif eration, and to ensure 
state control over international transfer of goods designed for mi litary purposes, and dual-use 
goods, as well as to prevent these goods from bein g used for terrorist ac ts and other illegal 
purposes; 
- Legality; - Conduct of export control to the extent  required to achieve its purpose only; 
- Harmonisation of state export c ontrol procedures and regulations with international legal norms 
and practices; 
- Ensuring interaction with intern ational organisations and forei gn countries in the state export 
control area so as to reinforc e international security and stability, including countervailing of 
weapons of mass destruction and th e system for their proliferation. 
 
5. The Albanian legislation for the import-export military goods and technolog y of dual use is as 
follows:  - Law No. 9707, of 5 April 2007, "On State Cont rol over the import-expor t of military goods 
and dual use goods and technology" Official Gazette No. 48, Page 1237; Publishing date: 
24 April 2007; 
- Decision of the Council of Ministers No. 43, of 16 January 2008, "On Organizing, 
functioning and the status of the State Export Control Authority", Official Gazette: Year 2008, No. 8, Page 240; publishing date: 30 January 2008; 
- Decision of the Council of Ministers No. 106, of 9 February 2011, "O n approving the updated 
list of military goods and dual use goods and technology which undergo state control of 
import-exports"; 
- Decision of the Council of Ministers  No. 305, of 25 March 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 April 2009;  G/LIC/N/3/ALB/6 
 Page 3 
 
 
  - Decision of the Council of Ministers  No. 304, of 25 March 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 April 2009; 
- Decision of the Council of Ministers No. 604, of 28 August 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 April 2009, "On determining tariffs for the 
issuance of legal documents". 
 
Any import of military and dual use goods need 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)  transfer of goods in connection with events he ld by the Armed Forces, or other state security 
structures of the Republic of Albania outside of its territory, or with events held by foreign 
military forces in the territory of the Republic of  Albania, as part of international agreements 
laying down the mechanism of state co ntrol over the movement of these goods; 
(b)  international transfers of anaesthetics (medi cal anaesthetic gases), sports and hunting arms, 
gas-containing vessels, and exportation and impor tation of individual armament of  military 
servicemen, and state law enforcement and inte rnal security bodies, which, under law, are 
entitled to carry arms; 
(c)  state control procedures concerning interna tional export transfers of goods, which aim at 
ensuring provision of military assistance in accordance with the terms contained in 
international agreements and treaties to which the Republic of Albania is a party, and the 
movement of goods outside of Albania with a view to offering emergency assistance to 
foreign countries, if this is established by law. 
 
 The licensing system in Albania cannot be  abolished without legislative approval. 
 
Procedures 
  
6.I. The licensing procedures a nd formalities are publis hed on the official website of the State 
Export Control Authority. www.akshe.gov.al.  In th e Albanian legislation there is no restriction 
in the value, quantity or license quotas.  Also  according to the Alba nian legislation there 
cannot be derogations from  the licensing requirement. 
 II.  There are no such as size of quotas. A license can be issued with the validity from 1-3 year 
with the extend option if there is a contract betwen the entities envolved.  
 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, whic h fulfills the requirements of the Albanian 
legislation. Also the State Export Control Auth ority has the authority to do controls before, 
during, and after issuing the import license. Al so 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 c onsidering an application shall be determined 
in accordance with the categories of goods, but  shall not exceed the following timescale as of 
the day of application: 
 G/LIC/N/3/ALB/6 
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   - 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 international transfers of goods. 
 VI.  There is no such provisions in the Albanian  legislation. After that the import license is 
granted it the importation can be done at  any time during is validity period. 
 
VII. A license application is proceeded by the State Export Control Authority. Trade activities 
with foreigners take place on the basis of licences and authorisations issued by this Authority, 
following if required the consulting of opinion of the institutions concerned. 
  The concerned institutions are the Ministry of Defence, Ministry of Foreign Affairs, 
Intelligence Agencies, and Ministry of Interior.  
 VIII. If the demand for licenses cannot be fully satisfi ed, the license cannot be granted. There is no 
exeptions. 
  The new importers  that want to deal with in ternational trade of military goods need to be 
registred by the State Export Control Authority. After they get the Registration Certificate 
they can demand for an import license. This regi stration is not required for the trade of dual 
use goods and technologies. 
 IX.  In the Republic of Albania for the im port of military goods and dual use goods and 
technology, always is required an import licen se even when there is an export license issued 
by the exporting countries.  
  Also in this case the import license is not issued automatically but the app lication is subject to 
controls. 
 
X.  Not applicable. 
 XI. Not applicable.   7.(a)  The application must be done 15 days befo re to import the goods.  This time-limit is the 
maximum to proceed an import license. If the importer submit all the necessary documents 
and satisfy all the requirements, the license can be  obtained within a shorter time.  But this is 
to be considered case by case.  
 (b)  No.  It has to be revised step-by-step.  
(c)  No. 
 (d) A licence application is procceded by the State Export Control.  Trade activities with 
foreigners take place on the basis of licences a nd authorizations issued by the Authority, 
following if required the consulting of opinion of  the institutions concerned.  The concerned 
institutions are the Ministry of Defence, Mini stry of Foreign Affairs, Intelligence Agencies, 
and Ministry of Interior. 
   G/LIC/N/3/ALB/6 
 Page 5 
 
 
  8.  The circumstances under which the license can be refused are: 
 - The application for obtaining licences, authorisations or international import certificates will 
not be taken into consideration if: 
 
 (a) It is deposited by a person w ho does not have the judicial capacity; 
 (b) Documents are missing, or they are formulated contrary to the requirements 
prescribed by the Law; 
 (c)  There are other reasons running counter to Albanian legislation in force, or the 
ratified international agreements. 
 
 In the event that the application for obtaining  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 taking of the relevant decision, 
laying down the explanations of and reasons be hind failure to consider it or its rejection. 
 
 The decision made by the State Export Control Authority to revoke licence, authorisation and 
international import certific ate, or to remove from th e rolls the name of an en tity 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 agains t decision does suspend its 
execution. 
 
Eligibility of importers to apply for licence 
 
9. A person or a firm or institution that wants to  deal with the import of military goods has first to 
be registered by the State Export Control Authority.  This provision is not requir ed for the import of dual 
use goods.  The regi stration certificate fee for military goods is 30 USD. 
  All the persons or firms that are registered by the State Export Control Authority are in a list published on the website: www.akshe.gov.mod.al. 
 
Documentation and other requireme nts for application for licence 
 
10.   (1)  Certificate of registration (only for military goods). (2) License 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). 
(3)  Brief summary of current commercial activity, which reflects the entity's ability to perform 
activities in the area of transfer of militar y goods (only private commercial entities). 
(4)  A natural person who seeks to obtain a license must submit the following documents: 
 - Document that certifies expertise in the field of international transfers of military 
goods; 
 - Identification document (identity card, passport); 
 - Proof that the 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 license, the illegal activities during the last 10 years from the date of the 
application for license; 
 - Certificate of tax authorities and the bank where the money transfer will be 
performed; G/LIC/N/3/ALB/6 
Page 6  
 
   - Taxpayer Personal Identification Number (allowed for import-export); 
 - Extract the simple and historical taken by the National Registration Center. 
(5)  Legal person who seeks to obtain a li cense must submit the following documents: 
 - Confirmation that the company is trial (C ivil 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 ta xes 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 Center. 
(6) International import certificate or end-user. 
(7)  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. 
(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 ar e the documents mentioned in the previous 
question .  
 12.  The licensing fee for an import license with th e validity of one year is 30 USD.  The licensing 
fee for an import license with the validity of three years is 60 USD. 
 13.  There is not other deposit or advance payment except that paid for licensing fee.   
Conditions of licensing 
 
14.  The validity of the license is from 1-3 year, A ccording to the type of the license required. The 
validity of the license can be extended, but not afte r the term of validity of the economic agreement, 
which refers to this license.  15.  There are not penalty for non-utilization of the licenses. 
 
16.  Licenses are not transferable.  17. There are not other c onditions attached to the issue of the license.  
  Other procedural requirements 
 
18.  No, there are not other procedures prior importations. 
 19.  All banks provide foreign exchange automatically.  G/LIC/N/3/ALB/6 
 Page 7 
 
 
  II. IMPORT LICENSING PROCEDURES ON HEALTH 
Outline of system 
 
1.  Due to the amendments on licensing procedures, only for some of medicinal products is required to provide an import license, before placing them on the market. Medicinal products, 
according to their use and technical  capacities that authorities have , are divided in groups as per 
below:   (a)  Medicines (drugs); (b)  Dental equipments;  
(c)  Medical devices (consumables); 
(d)  Disinfectants, disinsectants and deratizing substances (DDD-s).    Among the above mentioned groups, the import authorization is required for medicines, 
DDD-s (disinfectants, disinsectants and deratizing subs tances) and dental equipments in case they are 
source of ionized radiation.  Every subject, before starting the activity on import/export or place on 
the market of these substances, has to be licensed  nearby the National Licensing Center (NLC).  In 
some of licensing procedures, is needed the statement of the charge d'affaires structure at the Ministry 
of Health.  The decision need to be fulfill within 15 days of work, after that it come published by the 
National Licensing Center in the National Licensing Register, as a authorized subject on these activities.   There after, import authorizations ar e granted for every concrete importation according to 
regulation in force: 
 (1) All the pharmaceutical products circulating in the Albania market should be registered, except 
certain case (such as pharmaceuticals prepared in pharmacy or facing the emergency cases). The registered drugs are imported by juridi cal subjects licensed on this activity by the 
National Licensing Center (NLC), under the written statement of the Ministry of Health, prior 
to the licensing approval by the NLC.  Only for the medicines under patent protection, the 
importers need to be assigned by the Representative Offices established in Albania or by regional ones; in case of generics there's no n eed for such assignment.  Licensed subjects on 
the import of medicines carry out their imports , based on the published 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. 
(2) In case of import of unregistered drugs (in case of emergency such as natural catastrophes, 
epidemics, or drug's unique alternatives for hos pital/ambulatory service), the application is to 
be submitted near by the Pharmaceutical Depart ment (Ministry of Health).  After evaluation 
on needs for these drugs by the specialized stru ctures within the Ministry of Health, the 
Minister of Health authorizes the importation. This authorization has validation for 2 (two) 
months. 
(3) The import of narcotic drugs and psychotropi c substances is regulated separately, because 
importation process is more restricted and u nder control of Albanian and international 
authorities.  Licensed subjects by the National Licensing Center on wholesale trade of drugs also need to be authorized by the Pharmace utical Department, related to their activity on 
importation and distribution of narcotic drugs and psychotrop ic substances.  When the 
importer wants to import narcotics and psychotro pic, he/she submits at the Pharmaceutical 
Department the request on authorization impor t.  If the required quantity doesn't exceed the 
allowed quantities, the authorization signed by the Minister of Health is granted, with validation for 3 (three) months from its issuing date.  This authorization is used as an 
international control instrument.  When the au thorization has reached the destination (control 
authorities of exporting country), these authorities grant export authorization for their exporter.  Therefore, within these three mont hs, the Albanian importer resubmits near the 
Pharmaceutical Department, the request for import authorization followed by the G/LIC/N/3/ALB/6 
Page 8  
 
  export-authorization of the exporting country.  After that, the Pharma ceutical Department 
proceeds with procedure of granting of the author ization, valid for a period of 2 (two) months.  
Finally, provision of this authorization means allowing entry into Albania of narcotic or psychotropic substances. 
(4) In order to facilitate the import procedures, after the month of May of 2008, according to the 
order of Minister No. 215 dated 27 May 2008, has been avoid the obligation of granting and 
submitting in the custom authorities, the import authorization for medical equipments, dental equipments and consumables. If medical equipm ents are sources of ionizing radiation, an 
approval is issued by the Commission on Radiation Protection in the Institute of Public Health.  This approval takes into account the quality certificate, data on the device 
model/batch No.; maximal tension, manufacturing date and the quality certificate of the two 
last years from the importing date, invoice No.; the approximate date to be imported.   
(5) Related to importation of disinfectant, di sinsectant and deratizing substances (DDD), the 
subject after being licensed by the National Licen sing Center on the activity of intercessory 
services hygienic-sanitarian, he/she submits the request for import authorization near by the 
Hygienic and Epidemiologic Sector (MoH).  Th e requirement comes verified by the charged 
specialist of the Hygienic and Epidemiologic Sect or if it fulfills all the requirements of the list 
of DDD substances, approved every year by the Minister of Health.  Also, on the issuing of the import authorization related to DDD substa nces, is required the opinion of specialists 
from Public Health Institute (PHI), regarding the samples for the concrete import to be first 
tested.  PHI has to express its official opi nion within 10 days of work.  Based on all 
effectuated verification, the National Sanitary  Head-Inspector (Director of Public Health 
Department) 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 product covered by the above mentioned licensing systems are: 
 
- Narcotic Drugs and Psychotropic Substances referred to the list in accordance of Single 
Conventions of 1961 and 1971; 
- Pharmaceutical Products of the chapter 30 of the Combined Nomenclature of Goods; 
- Disinfectant, disinsectant and deratizing substances, chapters 28, 29 of CNG. 
 
3.  Pharmaceuticals to be registered in Alba nia and later imported, should be registered and 
circulate in one of the European countries, Swit zerland, USA, Canada, Japan and Australia.  With 
regard to the pharmaceuticals manufactured within the Balkan area, they can be registered and later 
imported, only if these goods circulate in their country at least since 2 years.    
4.  Licensing system generally is used to contro l 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 to the 
market.  Even though, health care is mainly covered by imported products, is aiming on the stimulation of the domestic production by incr easing the number of qualitative medicinal products 
manufactured in Albania.  Normally, adoption of proper legislation, setting up of structures and 
equipping with necessary technology, creates the c ondition and opportunities to use other alternatives, 
which consist on control of importe d drugs at several stages, at the border by custom authorities, 
during wholesale distribution, during dispensing by pharmacies and their use.  The adoption of new legislation and structures relating to the control system is under way.   G/LIC/N/3/ALB/6 
 Page 9 
 
 
  5. Legal framework that regulates the procedures of import licensing includes: 
 - Council of Ministers Decision No. 325 of 14 June 1993 "On regimen of export-import and 
medicines production"; 
- Joint Guideline of Ministry of Health a nd Ministry of Finance No. 180 of 13 August 1993 
"On co-operation for the regimen of import-export of medicines and their clearance"; 
- Law No. 7975 of 26 July 1995 "On narcotic dr ugs and psychotropic substances, amended 
with: 
 (a) Law No. 9271 of 9 September 2004;  (b) Law No. 9559 of 8 June 2006. 
- Decision of Council of Ministers No. 415 of 17 August 1993 "On import, export, wholesale 
and retail trade licensing of disinfectant, disi nsectant and deratizing substances" and related 
Order of Minister of Health No. 361 of 18 August 2000; 
- Order of Minister of Health No. 104 of 5 Marc h 2004, "For a change in the Guideline No. 180 
of 13 August 1993 on co-operation for the regime n of import-export of medicines and their 
clearance"; 
- Order of Minister of Health No. 245 of 29 June 2006 "For a change in the Guideline No. 180 
of 13 August 1993 on co-operation for the regime n of import-export of medicines and their 
clearance"; 
- Law No. 9323, of 25 November 2004 "On me dicines and pharmaceutical service" amended 
with: 
 (a) Law No. 9523 of 25 April 2006; 
 (b) Law No. 9644 of 20 November 2006;  (c) Law No. 10008 of 27 October 2008. - Law No. 9928 9 June 2008 "On dental hea lth service in the Republic of Albania"; 
- Order of Minister of Health No. 162 of 16 Apr il 2008 "On abrogation of the Order of Minister 
No. 214 of 22 April 2004"; 
- Law No. 10081 of 23 February 2009 "On licenses, authorizations and permits in the Republic 
of Albania"; 
- Law No. 10137 of 11 May 2009  "On some addenda to the current legislation on licenses, 
authorizations and permits in the Republic of Albania"; 
- Decision of Council of Ministers No. 538 of  26 May 2009 "On licenses and permits handeled 
by or through the National Licensing Cent er (NLC) and on some sublegal common 
regulations"; 
- Decision No. 1295 of 9 December 2009 "On some amendments to Decision of Council of 
Ministers No. 538 of 26 May 2009 On licenses and permits handeled by or through the National Licensing Center (NLC) and on some sublegal common regulations"; 
- Law No. 10138 of 11 May 2009 "On Public Health"; 
- Order of Minister of Health No. 102 of 22 Fe bruary 2010 "On the issuing of the authorization 
on the import-export, wholesale and retail trad e of the DDD substances (disinfectant, 
disinsectant and deratizing substances)";  
- Order of Minister of Health No. 365 of 3 A ugust 2012 "On the approval of the List and usage 
of the DDD substances (disinfectant, disinsectan t and deratizing substances) in the Public 
Health"; 
- Law on Protection from ionized radiation No. 8025 of 9 November 1995, amended by the 
Law No. 9973 of 28 July 2008; 
- Decision of Council of Ministers No. 158 of 13 February 2008 "On import-export of ionized 
radiation source in the Republic of Albania"; 
- Regulation No. 3918/4 of 3 November 2004 "On Import, export and trasit of radioactive 
sources"; 
- Guidance No. 4756/1 of 21 December 2006 "On import-export of radi ation materials in 
Albania"; 
- Categorization of Radioactive Sources No. 9 of 7 January 2010;  G/LIC/N/3/ALB/6 
Page 10  
 
  - Regulation No. 10 of 7 January 2010 "On li censing and inspection of ionized radiation 
sources"; 
- Approval No. 494/6 of 7 February 2011 "Approva l on import-export for X-rays generators"; 
- Guidance No. 134 of 12 April 2011 "On import – export and transit of radioactive sources of 
first and second category in the Republic of Albania". 
 
 The systems of import licensing are based on laws, government decisions or other administrative acts.  None of the licensing systems ca n be abolished without a ny legislative approval.  
None of the legislation leaves designation of produc t to be subjected of administrative discretion. 
 Procedures 
 6.I.  The only case of implementing quantity limita tion is the importation of  narcotic drugs and 
psychotropic substances.  Yearly quantities are approved by International Narcotic Control 
Board and are published in its special publication.   Practically the authority does not apply the 
allocation of quotas among importers.  There is a yearly quota, which is divided among 
importers by agreement based on the supplying contracts that importers have signed with 
public or private health institutions, or due to medicines inclusion in the reimbursement 
scheme etc.  There is not any limitation for the quantities imported from any country. 
Importers import the quantity they think it is r easonable or according to the supply contracts, 
they have signed, always within yearly quot a and the agreement done with other importers. 
As we are taking into consideration a very r estricted control, no request for exception or 
derogations from the licensing requirement is accepted. 
  With regard to DDD substances, each year come  approve by the Minster the list of substances 
according to the WHO recommendations and Di rective 98/8/EC rega rding the biocide 
products to be used in the public health.  Only  these substances specified in this list can be 
import.   
 II. The quota size for each narcotic drug is dete rmined for a year period and covering all the 
country.  Importation licenses ar e granted every time that impor ter will import a quantity within 
the quota.  Because of, the import authorizations  are valid for 3 months, after one importation 
within 3 months can be done the next importation from the same importer. 
  Related to ionized radiation sources the import  authorization are for single use and valid for 
2 weeks.  
 
III. Licenses are allotted for the quan tity of a certain narcotic drug that is imported by a certain 
manufacturer and a certain country (this is not de fined by authority, but from the fact that drug 
is registered and the registration is done by a manufacturer that is established in a certain 
country.  After this, the importer begins his/ her procedures). 
  Because this is a process of reciprocal cont rol among several authorities, its continuity is 
supervised by these authorities.  Pharmaceu tical Authorities supervises especially license 
usage, because no utilization would result in the lack of drugs in health institutions and 
pharmaceutical market.  In the case of no utiliza tion of the license, the importer notifies the 
responsible authority and if he does not, the authority based on the data received in the 
pharmaceutical market, communicates with impor ter to solve any possible problems or to 
make possible the importation from another importer if the first has not possibility to do it. 
The primary concern of authorities is that the market not to suffer the lack of medicines. 
    G/LIC/N/3/ALB/6 
 Page 11 
 
 
  The Radiation Protecting Commission has the right  to approve authorization imports, only to 
license holders on this purpose.  Unused allo cations are not added to the coming periods. 
Every year begins with new quotas that are e qual with need that country has for such 
medicines for one year. 
 
IV. There is not any defined period. 
 V. There is not any defined period, but usually the applications are pr ocessed within a working 
day. 
 
VI. There is not any defined period.  The author ity and the importer are informed that with the 
start of a calendar year begins even the impor ting periods, so they begins their procedures 
after that date. 
  Related to radiation sources this period is two weeks and two months. 
 
VII. The only cases where the application for import licensing is examined by two authorities are 
those, of disinfectant, disinsectant and deratiz ing substances and of ionized radiation sources: 
 - Related to disinfectant, disinsectant and deratizing substances, is required the official 
opinion of Public Health Institute; 
 - The same situation occurs with the ioni zed radiation sources, where the importer has 
to approach more than one administrative organ.  
  The positive answer (approved import license) or negative one (along with all explanations) is 
given to importer in the Ministry of Health.  
 
VIII. There are several ways to act in the case of not satisfied license demand. If the medicine is for 
ambulatory use and it is not the first alternative in  the reimbursement list, it is served the first 
to come.  It is enough to submit the applicati on with all necessary data and the license will be 
granted to him.  If the drug is intended for hospital use (according to  contracts importer has 
with hospitals), or is first alternative in th e reimbursement list (with the highest coverage 
level) it is served first the importer that fulf ill these conditions and then  the others according 
to the agreements among themselves, take the di fference of quotas.  If the importer submits an 
application for narcotic import authorization in the end of the year, knowing that the period of 
authorization approval obliges importer to bring the cargo/shipment in the following year, which is not allowed by international control au thorities, usually is decided that procedures 
must be done the next year when the new quotas are open.  It is not examined the importer 
performance.  The maximal quantities for each im porter are determined by the agreements 
they reach with each other based on contracts or market studies (it must be stressed that there 
is a small number of narcotic drugs imported in Albania and ther e is a very small number of 
importers, sometimes even only one).  There is not any provision for new importer, they are 
considered in the same way like the old ones.  The applications are examined immediately. 
 
 Related to ionized radiation sources, new a pplicants have to be assessed through licensing 
process for each approval import.  
 IX. In the case of narcotic drugs we have the case of bilateral quotas.  According to regulatory 
framework and practically together with the a pplication for exportation it is submitted even 
the importation authorization from the importing country (granted to importer).  The export 
authorizations the only issued for this case are granted immediately. 
  Nearly the same happens with the ionized ra diation sources, where, to provide the export 
approval from the exporting country, is need ed the confirmation from importing country.  G/LIC/N/3/ALB/6 
Page 12  
 
  X. In the case of importing of narcotic drugs and psychotropic substances, when import and 
export authorization are granted, the authority of exporting country after granting export authorization, based on application and import authorization, sends to the authority of 
importing country a copy of export authorization. 
 
 Related to ionized radiation sources, two coun ties are informed between them through their 
contact points. 
 XI. Related to medicines:   No.  The exported products, mainly of Albanian manufacturers, are 
the same that are sold in the domestic market. So  far, such a limiting procedure does not exist.  
 
 Related to ionized radiation source:  Yes. 
 7.(a)  The import authorization validity is of 1, 2 months respectively for medicines, registered or 
not; of 3 months for narcotics and psychotr opic and ionized radiation sources; meanwhile 
related to DDD the validity vary from 6 months for disinsectant and deratizing substances, to 
1 year for disinfectants of the potable water.  
 (b)  Yes, the licenses are granted immediately on request, despite unregistered medicines, where 
in some cases is required the examination of Mi nistry of Health and the National Center of 
Drug Control.  The procedure for the examination is up to 3 working days. 
 
(c)  No, there is not any limitation.  (d)  There are cases where the application needs to  be passed on other administrative organs such 
as, import of DDD substances (the application passes to PHI) and import of ionized radiation 
sources.  The organs cooperate with each othe r and the importer has to approach to only one, 
Ministry of Health, when importer receives the answer.  
 8.  The application for license (import authori zation) on medicines can be refused when the 
importer fails to meet the defined criteria and in some other cases, specifically when:  
- National Center of Drugs Control is inform ed that the drug does not meet the necessary 
quality, safety standards; information is received by homologues authorities or by the results of NCDC own tests (testing of samples in the market); 
- Manufacturer or control authorities informs for the starting of withdrawal procedures of the 
product from market, meanwhile the importer submits the application for import licence; 
- The registration validity of the medicine has expired and the manufacturer has not begun the 
re-registration procedures. 
  On each case, there is an explanation for refusa l.  The applicants can make the appeal to the 
Ministry of Health, the supervisi ng levels of Pharmaceut ical Department and of National Center of 
Drugs Control.  The other body for appeal is the court,  if they think that the authority has violated the 
law. 
  Related to ionized radiation s ources, the application for import authorization may be refused, 
but as mentioned above, in ca se of refusal there is an explanation.  The applicant has the right to appeal.  
 Eligibility of importers to apply for licence 
 9.(a)  Under restrictive licensing systems, appli cation for licenses is done only by operators that 
fulfill the conditions of such systems.  In h ealth services the application is submitted by a 
subject (importer or medical clinic that u ses the products for its own activity) which has a  G/LIC/N/3/ALB/6 
 Page 13 
 
 
  professional license (registration) issued by the Mi nistry of Health.  If the subject applies to 
import narcotic and psychotropic drugs, or me dicinal products that are source of ionizing 
radiation, it must have e second regist ration only for this kind of activity. 
 Related to ionized radiation sources, all the phys ics or legal persons are eligible to apply for 
license, under restrictive licensing system too.  
 
(b) In health services there are not non-restrictive systems. 
 (c) There is a system of professional licensing (registration) for importa tion, exportation, and 
wholesale distribution of medicinal products.  Eligible are those firms that have proper 
facilities, according to criteria defined for this  purpose and specialized staff to perform this 
activity.  This registration has a fee, which is pu blished with all other requests.  So far, there 
are importers' lists that can be given to the in terested parties.  National Center of Drugs 
Control already has its online list of pharmaceutical importers and distributors 
(www.qkkb.gov.al). 
 
Documentation and other requireme nts for application for licence 
 
10.  There is not any application form, importers re ceive necessary information to the authorities and 
begin the procedure.  In the different systems is submitted different documentation depending on groups 
of products that will be imported.  
 
(a) To import registered medicines, registered importer submits an application for import 
authorization that include a) importer's data, b) a table with medicines that will be imported where is detailed brand name, generic name of the medicine, quantity, manufacturing and 
expiry date, batch number, CIF price, manufact urer name and the country from which the 
import is done.  An invoice is attached to the application.  Submission is done to the National 
Center of Drugs Control where the import license is granted.  
(b) To import unregistered medicines, the applica tion for import authorization has the same data 
as above is submitted to the Pharmaceutical Depart ment of the Ministry of Health, where the 
import authorization signed by Minister of Health is granted. 
(c) To import narcotic and psychotropic drugs, the importer has to submit the application to the 
Pharmaceutical Department in the Ministry of Health, including a bovementioned data, and 
full address of manufacturer.  When the importer submits the Ministry of Health, first he requires the granting of import authorization.  When he/she receives even the confirmation 
that exporter has received the export authori zation in the originating country the importer 
applies for the import license when the cargo is ready. 
(d) To import medical devices, de ntal equipments and consumables, has been avoid the obligation 
of granting and submitting in the custom authorities, the import authorization for medical equipments, dental equipments and consumables.  If the medical devices are sources of ionizing radiation the application must be ac companied by an approval for that activity. 
(e) To import disinfectant, disinsectants, deratizing substances the applicant submits an 
application that contains the following informa tion: i) importer's data , ii) Taxpayer Personal 
Identification Number and iii) certificate of orig in of the goods iv) custom office v) storage 
address of these products. 
(f) To import ionized radiation source the licensed applicant on this field should be provided by: 
 - a copy of registration to the court;  - technical data for radiation sources; 
 - certification for sealed sources; 
 - data on exporter country;  - clarification on the purpose of the use of sources;  - declaration for the source in the end of the use;  - clarification of transport of the sources. G/LIC/N/3/ALB/6 
Page 14  
 
  11.  When the cargo/shipment arrives in Albani a this must be supplemented generally by these 
types of documents i) invoices, ii) packing list, iii)  certificate of analyses, iv) certificate of quality, 
v) certificate of conformity, vi) certificate of pr oduct origin.  The number of documents depends on 
type of the product that is imported.  
 Related to ionized radiation sources, for upon actual importation is required an official request 
for approval of import, quality certificate, data on the device model/batch No.; maximal tension, 
manufacturing date and the quality certificate of the two last years from the importing date, invoice, the approximate  date to be imported.  
12.  The fees are different depending on type of license: 
- The fee for import of un registered medicines is 1000 Leks for each medicine; 
- The fee for import of raw materials is 500 Leks for each item; - The fee for import of regi stered medicines is 200 Leks  for each authorization; 
- The fee for import of narcotics and psychotropic substances is 200 Leks for each authorization; 
- The fee for import for packages is  200 Leks for each authorization; 
- The fee for import of disinfecta nts, disinsectants a nd deratising substances the fee is 2000 Leks 
for each authorization; 
- The fee for import of ionized radiation s ources vary from 1000 Leks to 20.000 Leks. 
 13.  No, it is not required.  Conditions of licensing 
 14.  There are different validity periods for import licenses:  
- Import authorization for the registered medicines have 1 month validity; 
- Import authorization for unregistered  medicines have 2 months validity; 
- Import authorization for disinfectants, disinsect ants and deratizing subs tances have 6 months 
validity and exceptionally the import licenses for water disinfectants have 1 year validity; 
- Import authorizations for narc otic drugs and psychotropic subs tances have 3 months validity; 
- Import authorization for ionized radiation source are for single use and valid for 2 weeks. 
 
15.  The only case of penalty for non-utilization of the lice nse or the partial use of it occurs in the 
import of ionized radiation sources.   16.  Import licenses are not transferable between importers.  
 
17 (a) For narcotic drugs and psychotropic substances , there is condition that the total quantity of the 
imported medicine, from each im porter, will not be more than  the annual quantity approved for 
the country. 
  Related to ionized radiation source there's any other condition.  The same for the point (b) of 
this question. 
 (b)  There are not other conditions.  
Other procedural requirements 
18.  With regard to narcotics prior to the importation, the Minister of Health issues an 
authorization on import, based on requirement of th e licensed company (taking into account that the 
required quantity doesn't exceed the yearly allowed quantities).  This authorization is used as an  G/LIC/N/3/ALB/6 
 Page 15 
 
 
  international control instrument .  When the authorization has reached the destination (control 
authorities of exporting country), these authorities grant export authorization for their exporter.  19.  All banks provide foreign exchange automatically.  III. IMPORT LICENSING PROCEDURES OF  PLANT PROTECTION PRODUCTS 
(PPP) 
Outline of system 
 
1.  The procedure of licensing in Albania has recently changed. Activities for production are 
licensed according to the Law 10081, dated 23 February 2009 – Import of products for plant 
protection in Albania is conducted through permissi ons issued by NLC, based on some preliminary 
criteria to be fulfilled by the interested parties.   The entities are being inspected from the District 
Inspectorate of the plant protection. This license is issued through NLC.  In Albania could be 
imported only registered products 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.  These products fall under code 3808 of the Combined 
Nomenclature.  
 
3.  The control system for Plant Protection Products  is being applied to those that are registered 
in countries of European Union.  PPP are accepted without limitations coming from all countries.   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 
environment.  In the international legislation on plant protection does not ex ist other alternative known 
method  5. The Albanian legislation that regulates this licensing system includes: 
 
- Law No. 10081, dated 23 February 2009 "On Licensing, Authorizations and Permissions in 
the Republic of Albania"; 
- Law No. 9362, dated 24 March 2005 "On th e plant protection services" – changed; 
- Decision of the Council of the Ministers No. 1555, dated 11 December 2008, "For the 
determination of registration ru les and evaluation criteria of Pl ant Protection Products (PPP)". 
  The decision of Council of Ministers No. 1555, dated 12 November 2008, "On the determination of registration rules and evaluation cr iteria of PPP", provides that only registered Plant 
Protection Products could be imported.     Procedures 
 6.I.-IV  Not applicable.  
V.  Based on the Law No. 10081, dated 23 Febr uary 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. G/LIC/N/3/ALB/6 
Page 16  
 
  VII. The applicant presents required documentation at the National Licensing Center. This is the 
only administrative organ that importer has to approach to get the licence. 
 VIII.  Not applicable.   
IX.  Not applicable. 
 
X.  Not applicable. 
 XI.  There are not such conditions  associated with the license. 
 
7.(a)  The importer can import the product at the time  when he judges is appr opriate. The time limit to 
get a license is 10 – 15 days and the license cannot be obtained for goods arriving at the port 
without license.    
 
(b)  The license is granted after the examination of required documentation, within the time limits 
set forth in the legislation.  Up to now, no emer gency applications for license are deposited in 
National License Center. 
 
(c)  No limitations related to the period of the year during which applications for license can be 
made. 
 (d)  Application for import licenses are affected onl y by one administrative organ, which is National 
Licensing Center.  
 
8.  The license can be refused when the importer failure to meet the a ppropriate conditions on 
storage and preservation of the plan t protection products as required by  the legislation (including the 
necessary documentation).     The applicant is informed officially by NL C, for the reasons of licence's refusal.  This 
information is published automatically on the NLC's website. 
  According to the legislation on plant protection in the case of the refusal of the license, the 
applicant has the right to appeal at the higher admi nistrative bodies and at the court of first instance. 
 Eligibility of importers to apply for licence 
 9.(a) There are not 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 license are elig ible to import plant protection products.  All 
importers are listed in the Ministry of Agricultu re, Food and Consumer Pr otection and the list is 
published.  The list is sent to the cross – border point where phyto-sanitary and quarantine inspection 
service is established.    According to the Order No. 9 dated 12 July 2010 "On fees and secondary revenues applicable 
by agriculture and food institutions in the MAFCP". 
  G/LIC/N/3/ALB/6 
 Page 17 
 
 
  Documentation and other requireme nts for application for licence 
 
10.  The applicant presents required documents at the Directory of the NLC. The whole set of documents is available at NLC office.   
11.  Import license of plant protection products is presented at the quarantine inspectorate office at 
the cross - border points. After the control by qua rantine inspectorate is carried out, the customs 
authorities accomplish customs procedures.  
12.  Licensing fee is 2000 lekë.  
 13.  No deposit or advance payment requirement. 
 
Conditions of licensing 
 
14.  The license is permanent.    
15.  No penalty. 
 16.  The license is not transferable.  
17.  No conditions are attached to  the issuing of the license.  
 
Other procedural requirement 
 
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.  
 IV. LIVE ANIMALS, BIOLOGIC MATERIAL ON ANIMAL INSEMINATION AND 
VETERINARY DRUGS AND VACCINES 
Outline of system 
 
1.  The procedure of licensing in Albania has recently changed. Activities for production are 
licensed according to Law "On licensing", No. 10081, dated 23 February 2009 , as well as according 
to sublegal acts for Law implementation. The legi slation on licensing defines the activities according 
to fields (categories and sub categories) and speci al criteria for licensing; evincive documentation and 
any other accompanying documents for each activity.   
 Requests for licensing of activities included in such categories or sub categories are checked 
over by the National Licensing 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 respective field of activity. 
  The decision of Food Competent Authority is based on the evaluation of submitted documents and on site inspection to assess fulfillment of requi rements and mandatory standards defined in the 
legislation. Approval or refusal is published in the re gister within deadline, ot herwise it is considered 
as approval in silence.  
 G/LIC/N/3/ALB/6 
Page 18  
 
   The final decision of NLC is published in the re gister and the title is submitted at the wickets 
of NLC.    CCA (MAFCP) suspends or revokes the license in cases when during checking it results that 
technical-technological and sanitary-veterinary requi rements are not fulfilled according to the Law.  
 
Purpose and coverage of licensing 
 
2.  Import licensing system is covering these groups of products:  
(a)  live animal; 
(b)  biologic material on animal insemination; 
(c)  veterinary drugs and vaccines. 
 3.  Import is carried out based on bilateral trade agreements that Albania has signed with various 
countries where the products are imported from (or even from other countries that meet the 
requirements of the legislation in force). 
 4.  The licensing  system does not intend to restrict the qua ntity and the value of imports. There is 
not any alternative method. MAFCP does not determine quotes for import licenses.    5. Licensing is a legal request, and the licensing system is based on the following legal framework: 
 
- Law No. 10 081, dated 23 February 2009 "On licenses, authorization and permission in 
Republic of Albania"; 
- Decision, No. 538, dated 26 May 2009 "On licen ses and authorization that are checked over 
through NCL and same other comm on sub-legal regulations";   
- Law "On Food", No. 9863, dated 28 January 2008; 
- Law, No. 10 137, dated 11 May 2009 "On same amendments in current legislation  on 
licenses, authorization and permission in Republic of Albania"; 
- Decision, No. 1295, dated 29 December 2009, "On same amendments in  Decision, No. 538, 
dated 26 May 2009 On licenses and authoriza tion that are checked over through NCL and 
same other common sub-legal regulations";  
- Law No. 9426 dated 6 October 2005 "Animal Breeding"  changed. 
  Licensing is authorized by the Law No. 10 081, dated 23 February 2009 "On licenses, authorization and permission in the Republic of Albania"  and the system can not be abolished without 
legislative approval.  The legislation does not leave designation of products to administrative discretion. 
Additional legal requirements on licensing is Law No. 10465 dated 29 September 2011 "On 
veterinary service in the Republic of Albania", Article 137.  
Procedures 
  
6.I.-II Not applicable.   
 
III.  For goods and import entities which meet the criteria and conditions defined in the relevant 
legislation, licenses are without limitations.  
  The steps in order to ensure that license s are used for import issues 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 body for control of license of import usage; 
 - List of approved importers is published on the NLC's website.  G/LIC/N/3/ALB/6 
 Page 19 
 
 
  IV.  As there are not quotas for imports of such goods , the application can be submitted at any time.  
 V.  The maximum time to process the application for license to import to:  - Live animals  is 10 days;  
 - Biologic material on animal insemination is 15 days;  
 - Veterinary drugs and vaccines is 15 days.  
 Decision, No. 1295, dated 29 Dece mber 2009, "On some amendments in  Decision No.538, 
dated 26 May 2009 On licenses and authoriza tion that are checked over through NCL and 
some other common sub-legal regulations". 
 
VI.  No time limit. The importer has the right to  start the import activity, since the moment they 
get the license.  
 VII. NLC is the only entity where the applicant needs to apply (each importer) and present all the 
documentation.  Documents are being sent online (from NLC office), for approval to the 
Ministry of Agriculture Food and Consumer Protection (MAFCP).  After this process, NLC 
issues the import license to the applicant.  
 VIII.  There are no limits on licensing numbers.  There are no restrictions on timing and ranking of 
the applications in order to get a license.  The license is issued based on the fulfillment of the 
conditions determined by the Albanian law.  
 In cases that the applicant does not meet the re quirements, the application is refused until a 
second period, determined in the act of competent inspection authority.  The act of refusal is published on the NLC's website.  
 The examination of the applicant's request, from the date that has deposited the application, is 
performed within 10 days for the import of live animals and within 15 days for the trading of 
racial material and veterinary medicine.  
 IX.  Not applicable since we do not have quotas and we do not issue licenses automatically.   X.  The import is not  permitted only based on  export perm issions.  
 - The import of goods is made only based on: 
 - Law No.10081, dated 23 February 2009 "On licenses, authorization and permission in 
Republic of Albania"; 
 - Decision, No.538, dated 26 May 2009 "On licenses and authorization that are 
checked over through NCL and same othe r common sub-legal regulations";   
 - Annex I: Permission and licensing categories which are followed by/or through NLC; 
 - 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 issuing of the license.   
 
7.(a)  No. 
 (b)  No, because the licensing authority must ex amine the documentation required. The timing to 
issue a license is 10-15 days.  
 
(c)  No limitations for the time of application. 
 G/LIC/N/3/ALB/6 
Page 20  
 
  (d)  NLC is the only entity where the applicant needs to apply (each importer) and present all the 
documentation. Documents are being sent onlin e (from NLC office), for approval to the 
Ministry of Agriculture Food and Consumer Protection (MAFCP). After this process, NLC issues the import license to the applicant. 
 
8.  The license can be refused in case when the importer does not meet the requirements set forth 
in the law and regulations.   The applicant is informed officially by NL C, for the reasons of licence's refusal. This 
information is published automatically on the NLC's website.  
 
 Any interested party has the right to appeal  on an administrative way to the NLC or MAFCP 
for cases of licenses with preliminary inspections. Administrative complains are being analyzed by 
the representatives of NLC, except cases of licenses with preliminary inspection which are analyzed 
by the MAFCP.  
 
 In the cases of preliminary inspection, MAFC P is informed by NLC when a complaint is 
presented to their office.    In both cases, complaints addressed to NLC or MAFCP, it is published in the National Registry of Permits and Licenses.  
 
 For administrative issues, a decision given after reviewing the administrative complaint maybe appealed directly to the competent court.    Regarding the above mentioned issues, are being followed the terms specified in section 6, of 
the Code of Administrative Procedures on administrative complaints within one month.  
 
Eligibility of importers to apply for licence 
 9.(a)  There are not 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.   
 A list of fees exists and that is based on th e Order of the Minister of Agriculture, Food and 
Consumer Protection, No. 8 dated 8 May 2007 "O n the fees and secondary revenues applicable by 
institutions of the agriculture and food system".  
  Yes, the list of the authorized importers pub lished on the website NLC is sent to all central 
institutions, districts, municipalities and border inspection points.   Documentation and other requireme nts for application for licence 
 
10.  The necessary information and the documentati on to be filled by the applicant are provided 
by NLC.  
 
11.  The required documents are those issued by National Licensing Centre (NLC).   G/LIC/N/3/ALB/6 
 Page 21 
 
 
  12.  Depends on the type of license, there is diffe rent fee for different license. The fee for import 
license of live animals is 10.000 lek, for trading of  racial material is 300 All, and 100.000 All for 
veterinary medicine trade.  
 13.  No, advance payment or deposit is required. 
 
Conditions of licensing 
 
14.  All licenses are indefinite based on the ar ticle 11, Law No. 10 081,  dated 23 February 2009 
"On licenses, authorization and permis sion in the Republic of Albania". 
 
 In order to check if the conditions are fu lfilled by the applicant, the MOAFCP performs 
frequent in site controls. If some conditions are not fulfilled than the MOAFCP presents the proposal 
to the NLC for the refusal of this license.   
15.  No. 
 16.  No, licenses are not transferable.  
 17.  Not applicable. We don't have  quantity restriction for products. 
 Other procedural requirements 
 
18.  No, there are not any other administrative procedures. 
 19.  Foreign exchange is provided automati cally by banking authorities, every day. 
 
V. IMPORT LICENSING PROCEDURES FOR WASTE 
Outline of system 
 
1.  The system is maintained to protect the life and health of the population, and to protect the 
environment.  Importation is allowed only for that ty pe of waste which can be used for the purpose of 
reusing, processing and recycling them.  The Ministry of Environment, Forestry and Water 
Administration (MoEFWA) is the responsible instit ution for the process of cross-border of waste: 
importation, exportation and their transition.  Mo EFWA issues exportation license and the permission 
for transition of the wastes.  MoEFWA is responsib le for preparation of the necessary documents to 
be presented to the Council of Ministers which approves the Decision on the import license of the 
wastes. 
 
Purpose and coverage of licensing 
 
2.  The products covered are waste from social and economic activities and physically consumed 
products that are not included in th e definition of non-dangerous waste. 
 
3.  The system applies to all wastes coming  from all countries, regardless of their origin. 
 4.  The limitations for importation of waste are defined by the environmental legislation 
establishing the conditions for technology, laboratori es and managing capacities; its aim is to protect 
the environment. 
 G/LIC/N/3/ALB/6 
Page 22  
 
  5. Importation, exportation and transition of waste is administered by: 
 (1) Law No. 8934 dated 5 September 2002 "On protection of environment"; 
(2) Law No. 10463, dated 22 September 2011 "On integrated waste management"; 
(3) Decision of Council of Ministers No. 806, da ted 4 December 2003 "On approval of rules and 
procedures for importation of utilizati on waste, processing and recycling"; 
(4) Rule No. 4 dated 15 October 2003 "On check ing and approval of exportation licenses and 
transition of waste"; 
(5) Decision of Council of Ministers No. 835, da ted 28 December 2005 "On approval of the list 
of danger waste, other waste and other remains, that are not allowed to be imported, with the 
aim to preserve, to deposit and to exterminate";  
(6) Decision of Council of Ministers, year  1994, "On danger waste and remains". 
  The system cannot be abolishe d without legislative approval. 
 Procedures 
  6.I.  The relevant legislation is published in th e official gazette and on the webpage of MoEFWA.  
  - Importers are informed in details in MoEFWA;  - Other exporting countries can take the in formation by the reports  which the Ministry 
presents to the Secretariat of the Basel Convention "On cross border of waste and 
danger waste and their extermination"; 
 - No exception or derogation from the licensing requirement.   II.-IV. Not applicable. 
 
V.  The MoEFWA prepares the necessary documentations  for government approval within one      
month.  
 VI.  Not applicable.  
VII.  The following institutions must be approached for prior approval: 
  - The Ministry of Environment, Forestry and Water Administration, which issue the 
environmental permit;  
 - The relevant Ministry which issue the lice nse for exercising the activity in the relevant 
field; 
 - The Ministry of Health;  - The community of the district where the activity will be placed.   VIII.  Not applicable.  
 - First come first served; 
 - Past performance is taken into considerat ion relating to the impact on the environment 
(existence of any penalty for polluting th e environment during previous activities, 
complains by citizens, etc.);  
 - No; 
 - No distinction between new applicants and experienced one.  
 IX.  Not applicable.   G/LIC/N/3/ALB/6 
 Page 23 
 
 
  X.  The export license from the competent authority of country of origin is a prior condition to 
issuing the import license. 
 XI.  No.  
7.(a)  No. 
 (b)  No.  (c)  No. 
 
(d)  See 6.VII.  8.  When an application is refused, MoEFWA prepares the Draft Decision of the Council of Ministers that refused the application.  The applicant has the right to appeal within 30 days in Court.  
 
Eligibility of importers to apply for licence 
 
9.(a)  The legislation allows only the importation of non dangerous waste, which should be used 
only for the purposes of processing, reusing or re cycling if the followi ng conditions are met:   
  
- Utilization, processing and recycling of the waste are carried out by a contemporary 
technology that guarantees the protection of pub lic health and protection of the environment; 
- Through waste processing are obtained stuffs or useful materials; and to save raw material 
which are expensive; 
- Their transportation does not negatively affect human health and environment. 
 
 Rules and procedures to obtain the import licen se are defined in the Decision of the Council 
of Ministers No. 806 dated 4 December 2004 "On appr oval of rules and procedures for importation of 
waste with the aim to process, to us e and to recycle".  Only the type of wastes listed in Annex I of the 
Decision of the Council of Ministers No. 26, dated 31 January 1994 "O n dangerous waste and 
remains" can be imported. 
 
Documentation and other requireme nts for application for licence 
 
10.  The documents are defined in Chapter I, point 4 and chapter II points 2 and 3 of the decision of 
the Council of Ministers No. 806, dated 4 Decembe r 2004 "On approval of rules and procedures for 
importation of waste with the aim to use, to process and to recycle". 
 11.  They are defined in Chapte r II, points 2 and 3, of the Deci sion of the Council of Ministers 
No. 806, dated 4 December 2004 "On approval of rules a nd procedures for importa tion of waste with the 
aim to use, to process and to recycle".  
12.  Yes, 30.000 leks, Albanian currency. 
 13.  No. 
 
Conditions of licensing 
 14.  The maximal validity is 1 year.  15.  No.  G/LIC/N/3/ALB/6 
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  16.  This transfer is not specified for an import license.  In the case of changing the ownership of the 
activity according to Article 42 of the law "On protec tion of environment", the new owner has the rights 
of the environmental license, and impl ements the conditions foreseen in it. 
 17. Not applicable. 
 
Other procedural requirements 
18.  They are mentioned in question VII of this questionnaire. 
 19.  The exchange rate is provided automatically by banking authority, every day.   
 
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