WORLD TRADE  
ORGANIZATION  G/LIC/N/3/ALB/2 
2 January 2008 
 (08-0015) 
Committee on Import Licensing Original:   English 
  
 
REPLIES TO QUESTIONNAIRE ON IMPORT LICENSING PROCEDURES
1 
 
Notification under Article 7.3 of the Ag reement on Import Licensing Procedures for 2007  
 
ALBANIA 
  The following communication, dated 19 December  2007, 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 ..................................2  
 
II. IMPORT LICENSING PROCEDURES OF PLANT PROTECTION  
PRODUCTS (PPP)................................................................................................................. ...5 
 
III. IMPORT LICENSING PROCEDURES OF FAUNA AND FLORA ..................................7  
 
IV. IMPORT LICENSING PROCEDURES OF FISH AND FISH PRODUCTS...................10  
 
V. WASTE IMPORT LICENSING PROCEDURES...............................................................12  
 VI.
 IMPORT LICENSING PROCEDURES FOR MEDICINAL PRODUCTS .....................15  
 
VII. IMPORT LICENSING PROCEDURE S FOR MILITARY GOODS................................20  
 
 
                                                      
1 See G/LIC/3, Annex, for the Questionnaire. G/LIC/N/3/ALB/2 
Page 2  
 
  I. LIVE ANIMALS, LEATHER, FEED BIOLOGIC MATERIAL ON ANIMAL 
INSEMINATION AND VETERINARY DRUGS AND VACCINES 
Outline of systems
 
 
1. Applications have to be submitted to the Regi onal Directory of Agricu lture, Food and Consumer 
Protection of each district who are in charge of issuing the veterinary – sanitary certificate.  The Regional 
Directory sends a request to the General Director y of Food Safety and Consumer Protection in the 
Ministry of Agriculture Food and Consumer Protection,  where the experts visit the establishment dealing 
with the live animals, feed, and leather activity so as to inspect the establishment and check the veterinary 
– sanitary certificate and protocol of the control.   The General Directory approves the activity of the 
establishment, issues the import license and compiles a list of the establishments that can import.  This list 
is sent to the Border Inspection Point.  
Purposes and coverage of licensing
 
 2. The Import licensing system covers the following groups of products: 
 
(a) live animals 
(b) leather 
(c) feed 
(d) biologic material on animal insemination 
(e) veterinary drugs and vaccines 
 3. Imports are carried out based on bilateral agreements that Alba nia has signed with different 
countries.  
4. The system does not intend to restri ct the quantity and the value of imports. 
 5. Licensing systems are maintained  based on this legal framework: 
 
• Law No. 9308 dated 04.11.2004  “On veterinary inspection service”;  
• Order No. 203 dated 19.04.06 of the Mini ster of Agriculture, Food and Consumer 
Protection “On Licensing procedures of imports’ entities”; 
• Regulation of the Ministry of Agriculture, Food and Consumer Protection “On 
Establishment, opening and functio ning of veterinary pharmacies”; 
• Regulation of the Ministry of Agriculture , Food and Consumer Protection “On import 
and sale of veterinary medicines”. 
  Licensing is authorized by Law No. 9308 date d 04.11.2004 "On veterinary inspection service" 
and the system cannot be abolished without legisl ative approval.  The legislation does not leave 
designation of products to administrative discretion. 
 
Procedures
 
 
6. Not applicable.  
I. The legislation is published on the website of the Ministry of Agriculture, Food and Consumer 
 Protection and is sent to the Regional Direct ory of Agriculture, Food and Consumer Protection 
 of each district.  II. Not applicable.   G/LIC/N/3/ALB/2 
 Page 3 
 
 
   
III. The approved list of importers is sent to the Regional Directory of Agriculture, Food and 
Consumer Protection of each district, m unicipalities and Border Inspection Points. 
 IV. Not applicable. 
 
V. The maximum length of time for processing applic ations is 10 days, for importing each group of 
products, mentioned in Question II. 
 VI. There is no limitation.  
 
VII. The importer's establishment is  first inspected by the Regional Directory of Agriculture, Food and 
Consumer Protection of each distri ct, which grants the veterinary – sanitary certificate.  Final 
approval is issued by General Directory of Food Safety and Consum er Protection in the Ministry 
of Agriculture Food and Consumer Pr otection. (Or, See paragraph 1). 
 
VIII. Once the applicant has completed all the require d documentation, the licence is issued.  The date 
of application is taken into consideration.  The ex amination of an applicant file is made within 10 
days from the date the a pplication is deposited. 
 IX. Not applicable. 
 
X. Imports are based on bilateral agreements  that Albania has with other countries. 
 XI. No such conditions are associated with issuing of the license.  
7. (a) Imports can be carried out only after issuing the import license.  Goods can not arrive at the port 
without a license. 
 (b) No, the licensing authority must examine the documentations required.  (c) No limitations. 
 
(d) The establishment of the importer is inspecte d by the Regional Directory of Agriculture, Food 
and Consumer Protection of each district, which gi ve the veterinary – sanitary certificate.  The 
final approval is issued by the General Director y of Food Safety and Consumer Protection in the 
Ministry of Agriculture Food and Consumer Protection. (or See paragraph 1 and 6.VII.) 
 
8. Refusals can take place if an importer does not meet the requirements set forth in the law and 
regulations. 
 
In the veterinary field, claims are presented within 5 days to the Examination Commission of 
Violations. 
 Eligibility of Importers to Apply for License
 
 
9. All persons who satisfy the criteria set forth in the veterinary legislation compiled by the Ministry 
of Agriculture, Food and Consumer Protection. 
 
(a) (b) There are no restrictive systems.  
There is a fee based on the Order of the Mini ster of Agriculture and Food and Consumer 
Protection No. 8 dated 08.05.2007 "O n the fees and secondary revenu es applicable by institutions G/LIC/N/3/ALB/2 
Page 4  
 
  of the agriculture and food system".  A list of authorized importers is sent to all central 
institutions, districts, municipalit ies and border Inspection points. 
 
Documentational and other requiremen ts for application for a licence
 
 10. For veterinary medicines the following documents are required: 
 
- A request by the applicant 
- The NIPT (Identification Nu mber as Taxable Person) 
- A Veterinary sanitary certificate 
- A Plan of the establishment 
- The Rent contract for the building of the establishment 
- Diploma on veterinary services. 
 
 The documentation required upon application to ha ve a license for the im portation refers to:  
 
- A request by the applicant 
- NIPT (Identification Numb er as Taxable Person) 
- Plan of the establishment 
- Rent contract for the building of the establishment 
- Veterinary sanita ry certificate 
 
11. The list of authorized importers issued by th e General Directory of Food Safety and Consumer 
Protection in the Ministry of Agricu lture Food and Consumer Protection. 
 12. See 9.  The license is 10.000 leks. 
 
13. No.  
Conditions of licensing
 
 
14. The validity of a license to import veterinary me dicines and vaccines is 5 years.  The validity of a 
license to import live animals, feed, animal leather and biological materials on an imal insemination is one 
year.  After the expiry, importers have to re-apply to extend the license. 
 15. No.  
16. No, licenses are non transferable. 
 17.(a) Not applicable.  (b) No.  Other procedural requirements
 
 
18. There are no other administrative procedures.  19. Foreign exchange is provided automa tically by banking authorities, every day. 
  G/LIC/N/3/ALB/2 
 Page 5 
 
 
  II. IMPORT LICENSING PROCEDURES OF PL ANT PROTECTION PRODUCTS (PPP) 
Outline of systems  
 
1. Importing of plant protection products (PPP) in to Albania is covered by “Import Licensing of 
plant protection products”.  Licenses are issued by the Director of the Directory of Health of Animals 
and Plant Protection in the Ministry of Agriculture , Food and Consumer Protection.  Only registered 
plant protection products can be imported into Albani a.  Before applying for an import license, the 
importer must apply for permission to market the PPP.  
Purposes and coverage of licensing
 
 
2. The licensing system covers PPP  such as insecticides, fungicide s, herbicides, disinfectants and 
similar products.  These products fall unde r code 3808 of the Combined Nomenclature. 
 3. The system applies to all PPP coming from  all countries, regardless of their origin. 
 
4. The licensing system does not intend to restrict  the quantity or value of imports.  The purpose of 
issuing import licensing of PPP is to  strictly control these products.  Given that these are poisonous 
products, their careless u tilization can affect plants, animals,  human beings and the environment. 
  There exists no other alternative known method s according to the international legislation on 
PPP. 
 5. The Albanian legislation that regul ates the licensing system includes: 
 
- Law No. 9362 dated 24 March 2005 “On Plant Protection Services”  
- Decision of the Council of Ministers No. 72, dated 15 February 2001 “On the approval of 
the regulation on Plant Protection Products” 
  The licensing is statutorily required, but the legislation does not leave any space for 
administrative discretion.  The decision of the Council of Ministers No. 72 dated 15.02.2001 “On the 
approval of the regulation on Plant Protection Products” provides that only the registered products can 
be imported.  
 
The licensing system cannot be abolished wit hout legislative approval; it is the law which 
authorizes the issuing of a license.  Procedures
 
 
6. I. Not applicable.  II. Not applicable.  
III. The import license is valid for all registered PPP in Albania. 
The list of the importers engaged in the importation of PPP is not yet available to the governments 
and export promotion bodies of the exporting count ries, given that  up to  now there has been no 
request from them related to this issue.  The list of approved PPP is ma de known to all importers.  
 
IV. Not applicable. 
 G/LIC/N/3/ALB/2 
Page 6  
 
  V. The period of time for processing the applica tions is 10 days from the date of depositing the 
request for a license.  
 VI. Not applicable.  
VII. The required documentation has to be presented to the Department of Animal Health and Plant 
Protection, at the Ministry of  Agriculture, Food and Consumer Protection.  This is the only 
administrative organisation that  importers have to approach. 
 VIII. Not applicable. 
 
IX. Not applicable.  X. Not applicable. 
 
XI. There are no such conditions associated with the license. 
 7.(a) The license is permanent, so the importer can import the product at the time when he judges it  appropriate.  A license cannot be obtained fo r goods arriving at the port without a license.  
 (b) The license is granted after examination of the re quired documentation, within the time limits set 
forth in the legislation.  Up to now, no emergency applications for licenses have been deposited in 
the Directory of Animal Health and Plant Protection .   
 (c) No limitations related to the period of the year dur ing which applications for license can be made.    
 
(d) Application for import licenses are affected only by one administrative or ganisation, the Directory 
of Animal Health and Plant Protection.   
 
8. An application for a license can be refused when the importer fails to meet the appropriate 
conditions on storage and preservation of the PPP as requi red by the legislation.  In the case of a refusal 
of a license, the applicant has the right to appeal at the higher administrative 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 who have import licenses are eligible  to import PPP.  All importers are listed in the 
public list at the Ministry of Agriculture, Food a nd Consumer Protection.  The list is sent to the 
cross-border point where the phytosanitary and qu arantine inspection service is established.  
 According to Order No. 98 dated 26.02.2004 “On fees and secondary reve nues applicable by 
agriculture and food institutions” th e registration fe e is 5000 leks.  
 
Documentational and Other Requirem ents for Application for License
 
 
10. The following documentation has to be presente d to the Directory of An imal Health and Plant 
Protection:  (i) a request applying for an import license; (ii) marke ting permission for plant protection 
products issued by the Directory of Agriculture an d Food of the District ( iii) diploma on agronomy 
studies.  
  G/LIC/N/3/ALB/2 
 Page 7 
 
 
  11. Import licenses of PPP  are presented to the Qu arantine Inspectorate Office at the cross-border 
points.  After the control by the Quarantine Inspectorate has been ca rried out, the customs authorities 
accomplish customs procedures.   12. Licensing fee is 2000 leks.  
  
13. No deposit or advance payment requirement.  
Conditions of Licensing
 
 14. The license is permanent.  
 15. No penalty.  16. The license is not transferable. 
 
17. No conditions are attached to  the issuing of the license.  
 
Other Procedural Requirements
 
 
18. No other administrative procedures. 
 
19. Foreign exchange is provided automati cally by banking authorities, every day.  
  
III. IMPORT LICENSING PROCEDURES OF FAUNA AND FLORA 
Outline of Systems
 
 
1. Import permits  are issued in the context of CITES Envi ronmental Convention on “International 
Trade on Endangered Species of Wild Flora and Faun a” to which Albania is a Party since September 
2003.    
 CITES subjects international trade of selected species specimens to certain controls.  All 
import, export, re-exports and introduction of sea species covered by the Convention has to be 
authorized through a licensing system.  Each Party to the Convention must designate one or more Management Authorities in charge of administering that licensing system and one or more Scientific 
Authorities to advise them on the effects of trade on the status of the species. 
 
 The species covered by CITES are listed in three Appendices
, according to the degree of 
protection they need.  
 
Purposes and Coverage of Licensing  
 
2. CITES import permit (certificate) covers all an imal and plant species listed in the Appendixes 
of the CITES Convention.   Appendix I include species threaten ed with extinction.  Trade in  specimens of these species is 
permitted only in exceptional circumstances. 
 
 Appendix II includes species not necessarily thr eatened with extinction, but in which trade 
must be controlled in order to avoid utili zation incompatible with their survival. 
 G/LIC/N/3/ALB/2 
Page 8  
 
  3. The system applies to goods originating in a nd coming from countries that are Parties to CITES 
Convention. 
 
4. The licensing is intended to restrict the num ber of species and number of wild animals and 
plants listed in the Appendixes of the convention in order to improve their conservation status and, at 
the same time, to comply w ith the obligations and requirements of the Convention. 
 5. - Law No. 9021, dated 06.03.2003 “On the accession of the Republic of Albania in the 
Convention “On the International Trade of Endangered Species of Wild Flora and Fauna” 
(CITES)”; 
 
- Letter of the Minister of Environment for th e establishment of Scientific and Management 
Authorities for the implementation of CITES C onvention in Albania addressed to CITES 
Secretariat, dated 30 January 2004 and its revision dated 12
 April 2006; 
 
- A draft law “On the protection of the enda ngered species of wild fauna and flora on 
international trade” is being completed.  Th e law sets up the required infrastructure for the 
implementation of the CITES Convention in Albania.  
 
Procedures  
 
6. I. For products under restrictions as to the quantity, the information is published on CITES 
 Convention website concerning annual quotas. 
 
II. The size of the quotas is determined by the Convention Secretariat after consultation and 
proposals received by CITES Parties.  The quotas are published in the CITES. 
 
III. Licenses are allotted only to species subject of CITES Convention.  IV. The applications may be submitted at any time of the year.  V. According to the law actually in force, the application processing time may vary between 
1-4 weeks. 
 In the new draft law: CITES permits or certificat es are issued within 15 working days from the 
date of receiving the application.  In cases when  advice of the Scientific Authority is needed, 
the permit or certificate is issued within 5 working days of advice being received. 
 
VI. Not applicable.  VII. The Ministry of Environment, Forests and Water Administration is the institution that issues the 
permit or certificate.  Before granting the permit, the Ministry has to sent the application to the 
scientific authority (i.e. Museum of Natural Sciences for fauna species and Institute of 
Biological Research for flora species) for approval.  
 
VIII Not applicable. 
 IX. No. 
 
X. Not applicable.  XI. Not applicable.   G/LIC/N/3/ALB/2 
 Page 9 
 
 
  7.(a) Ideally one month in advance. 
 
(b) No.  (c) No limitations. 
 
(d) See VII.  
 8. The application may be refused when:  
- The export certificate from the country of origin is false; 
- If there are any doubts on the species determination, the so called “look alike” species.  
 
Eligibility of Importers to Apply for License
 
 
9. All persons, firms and institutions are eligib le to apply for CITES permits or certificates. 
 (a) N/A.  (b) N/A.  Documentation and Other requiremen ts for Application for License
 
 
10. Sample form attached in Annex 1 of this document (in English and Al banian language).  The 
documents to be supplied attached to the application are as follows:  
 
 - A document certifying the species’ name and origin; 
 - The purpose why the given species is to be imported into the country.  11. The export permit issued by the Management Auth ority of the country of origin, or issued by 
the country the species are coming from. 
 
12. No. 
 
13. No. 
 
Conditions of licensing
 
 
14. 12 months from the date of issue.  
 15. No  16. No. 
 
17. In case of importation of live animals, tran sportation conditions should be complied to in 
accordance with the Regulation of the Transpor t of Live Animals or IATA Regulation.  
 
Other Procedural Requirements
 
 
18. No. 
 19. All banks provide foreign exchange automatically. 
 G/LIC/N/3/ALB/2 
Page 10  
 
  IV. IMPORT LICENSING PROCEDURES OF FISH AND FISH PRODUCTS 
Outline of Systems
 
 
1. The import license regulates the introduction of  aquatic species other than aquaculture.  No 
license is required for importing aquatic species ot her than aquaculture.  Any person requiring 
introducing aquatic species into wa ters of the Republic of Albania, falling under this category must 
acquire a special authorization from the Ministry of Environment, Forest and Water Administration (MEFWA).  The applicant completes a request form describing the purpose of its activity.  A health 
certificate issued by the Directory of Veterinary is re quested to be attached to the application form.  The 
Directorate of Fisheries Policies in the MEFWA prepar es the authorization to be signed by the Minister 
of EFWA. 
  
Purposes and Coverage of Licensing
 
 
2. All products included in Chapter 3 of the Cust om Code as live fish, not for aquatic purposes.  
All the enterprises licensed in a quaculture can import, without quantitative limitations.  The licence 
holder has the right to import aquatic species for aquaculture.   3. The system applies to all goods which are in conformity with sanitary and phytosanitary 
measures, regardless of their origin.  
 
4. The licensing is intended to regulate the introduction of the species with no purposes of 
aquaculture.  There are no quantity limitations.  The scope of Authorization is to protect Albanian 
waters from introducing aquatic species fro m an environmental point of view.  
 5. The Albanian legislation that regul ates the licensing system includes: 
- Law No. 7908 dated 05. 04. 1995 "On fish ery and aquaculture” Article 26 “The 
Authorization for Introducing Aquatic Sp ecies and Exporting/importing of Juveniles”; 
- Regulation No 2 “On licensing of fisher ies and aquaculture” dated 17/05/2007. 
Procedures
 
 
6. No limitation on quantity or value of imports: 
I. Not applicable. II. No quota. III. Licenses or authorization are allotted for all species. IV. Not applicable. 
V. The application processing time is 15 days.  
VI. Not applicable. 
VII. The consideration of license application is eff ected by the MEFWA.  In  this Ministry licenses 
are analyzed from the Board of License.  After receiving of environmental license, entity those 
intents to import can be automatically licensed on aquaculture purposes.  A health certificate 
must be received from Directorate of Veterinary.  
  G/LIC/N/3/ALB/2 
 Page 11 
 
 
  VIII. The licenses are issued when the Ministry of  Environment, Forests and Water Administration 
evaluate that the species are not dangerous for bi odiversity and there is sufficient guaranties to 
prevent the introduction of non endemic species in natural waters.   
 IX. Not applicable. 
 
X. Not applicable.  XI. Not applicable.  
7.(a) One month in advance.  No.  The products must undergo quarantine and all costs are charged to 
the importer. 
 (b) No. The licensing board is convened on the firs t week of the month.  After approval it takes 
some time to prepare the documents and the license to be signed by the Minister. 
 
(c) No.  (d) Consideration taken by MEFWA, Directorate of Fisheries Policies.  
 8. An application may be refused only in cases where the MEFWA evaluates that the species are 
dangerous for biodiversity and there is not suffi cient guaranty to prevent the introduction of non 
endemic species in natural waters.  
Eligibility of Importers to Apply for Licence
 
 9. All persons, firms and institutions are eligible to apply for licenses. 
 (a) (b) Not applicable.  
Documentational and Other Requirem ents for Application for Licence
 
 10. The importer is required to supply a document  certifying the species name and origin, and the 
purpose he/she is asking 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.  13. No.  Conditions of Licensing
 
 
14. I. The validity of the license:  
- For marine aquaculture, the lic ense is valid for 10 years; 
- For traditional, earthy pond aquaculture , the license is valid for 20 years. 
 
II. The validity of aquaculture licence depends on facts such as: the owner document, the terms of 
rental contracts of  the area where the applicant intendeds to develop the aquaculture activity and the investment capability. G/LIC/N/3/ALB/2 
Page 12  
 
   
15. No penalty.  16. As a general rule licenses are not transferable  between importers. In case of any alteration, the 
applicant has to present a written request, dully suppor ted, to, but proposed by the Director of Fishery 
Policies Directorate, or by the License Board, or the Commission of Contraventions Examination on 
Fisheries and Aquaculture.  The request has to be supported by documents and data. 
 17. Not applicable.  
(a) Not applicable. 
 (b)  Prior to issuing the license, the MEFWA has to obtain the opinion from the Commission for 
Coordination of Scientific  Research and Technology. 
 
Other Procedural Requirements
 
 
18. No.  19. All banks provide exchange rate automatically, every day.  
 
V. WASTE IMPORT LICENSING PROCEDURES 
Outline of Systems
 
 
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 type of waste which can be  used for the purpose of 
reusing, processing and recycling them.  The Minist ry of Environment, Forests and Water Management 
(MEFWM) is the responsible institution for the process of cross-border of waste: importation, exportation and their transition.  MEFWM issues exportation license and the permission for transition 
of the wastes.  MEFWM is responsible for preparat ion of the necessary documents to be presented to 
the Council of Ministers which approves the Decision on the import license of the wastes.  Purposes and Coverage of Licensing
 
 
2. The products covered are waste from social a nd 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.  
 
5. Importation, exportation and transition of waste is administered by:  
1. Law No. 8934 dated 05.09.2002 “On protection of environment”; 
2. Law No. 9010, dated 13.02.2003 “On environment administration of solid waste”; 
3. 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”; 
4. Rule No.4 date 15.10.2003 “On checking and approval of exportation licenses and 
transition of waste”;  G/LIC/N/3/ALB/2 
 Page 13 
 
 
  5. 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, th at 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”; 
7. Law no. Nr.9537, dated 18.5.2006 “On administration of hazardous waste”. 
 
  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 MEFWM.  
 
- Importers are informed in details in MEFWM or in the Regional Agencies of Environment; 
- Other exporting countries can take the inform ation by the reports which the Ministry 
presents to the Secretariat of the Basel C onvention “On cross border of waste and danger 
waste and their extermination”; 
- Interested foreign parties can be  informed directly in MEFWM; 
- No exception or derogation fro m the licensing requirement.  
 II. Not applicable.   
III. Not applicable. 
 IV. Not applicable. 
 
V. The MEFWM 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 Management, which issue the 
environmental permit;  
- The relevant Ministry which issue the license fo r exercising the activity in the relevant field; 
- The Ministry of Health; 
- The community of the district where the activity will be placed.  
 
 VIII. - Not applicable. 
- First come first served; 
- Past performance is taken into consideration relating to the impact on the environment 
(existence of any penalty for polluting the envi ronment during previous activities, complains 
by citizens, etc).  
- No.  
- No distinction between new applicants and experienced one.  
 
IX. Not applicable. 
 
X. The export license from the competent authority of country of origin is a prior condition to 
issuing the import license.  
 XI. No. G/LIC/N/3/ALB/2 
Page 14  
 
   
7.(a) No. 
 
(b) No. 
 
(c) No. 
 
(d) See 6. VII. 
 
8. When an application is refused, MEFWM 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 recy cling if the following conditions are met:   
 
- Utilization, processing and recycling of the waste are carried out by a contemporary 
technology that guarantees the protection of  public 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 4.12.2004 “On approval of ru les and procedures for importation of waste with 
the aim to process, to use and to re cycle”.  Only the type of wastes lis ted in Annex I of the Decision of 
the Council of Ministers no.26, date31.01.1994 “On dangerous waste and remains” can be imported. 
   
Documentation and Other Requiremen ts 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 4.12.2004 “On approval of rule s and procedures for importation 
of waste with the aim to use, to process and to recycle”.  
11. They are defined in Chapter II, points 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 th e aim to use, 
to process and to recycle”.  12. Yes, 30.000 leks, Albanian currency.  
13. No. 
 
Conditions of Licensing
 
 
14. The validity is defined in the Decision of the C ouncil of Ministers and can be different due to the 
request made by the applicant and on environmental po licies in the field of waste.  The maximal validity 
is 5 years.   15. No.   G/LIC/N/3/ALB/2 
 Page 15 
 
 
  16. This transfer is not specified for an import license.  In the ca se of changing the ownership of the 
activity according to Article 42 of the law “On prot ection of environment”, the new owner has the rights 
of the environmental license, and implem ents the conditions foreseen in it.  
 17.(a)(b) Not applicable. 
 
Other Procedural Requirements
 
 
18. They are mentioned in ques tion VII of this questionnaire. 
 
19. The exchange rate is provided automatically by banking authority, every day.   
 
 
VI. IMPORT LICENSING PROCEDURES FOR MEDICINAL PRODUCTS 
Outline of Systems  
 
1. The importation of medicinal products in Al bania, is carried out through import licensing. 
Products are divided into several groups, according to  the use and technical ca pacities that authorities 
have.  As a first step, all importers should receive  a professional license on the activity that is called 
“importer registration”.  Only companies register ed by the Ministry of Health for importing and 
distribution of these products, or registered clinics fr om the Ministry of Health that use the products 
themselves, can import these products.  Import licens es are granted for every importation according to 
the regulation in force:  (a) To import registered medicines, the register ed importer submits the application for import 
licensing to the National Centre of Drugs Control.  The license is granted immediately after the 
examination of the application and the documents provided. 
 (b) In the case of unregistered medicines, the applica tion is to be submitted to the Pharmaceutical 
Department at the Ministry of Health, which i ssues the license after the evaluation of the needs 
by specialized structures. 
 
(c) To import consumables and medical equipments, the application is submitted to the Hospital 
Planning Department at the Ministry of Health  which issues the license.  If medical equipment 
is a source of ionizing radiation, prior to issuing the import license by the Ministry of Health, a special permission is issued by the Commission on Radiation Protection at the Institute of Public Health.  This Commission gives only the permission on the specific activity that 
importer will carry out.  Importa tion of equipment is done by importers or medical clinics 
which use the equipments for themselves.  As  a first step, all importers should receive a 
professional license on the activity that is called “importer registration”. 
 (d) In the case of importation of dental equipment a nd consumables, a declaration is required by 
the registered importer (the trader or the clinic that submits the application at the Public Health 
Department of the Ministry of Health.  The license is granted immediately.  A declaration is 
required to the clinic that the imported equipment are for their own use. 
 (e) The importation of narcotic drugs  and psychotropic substances is more restricted and under the 
control of Albanian and International Author ities.  After fulfilling security conditions and a 
verification process, the registered importer is registered for the second time.  The importer will 
receive an authorization for the activity of importation and distribution of narcotic and 
psychotropic substances; then the importer w ill apply for an import authorization of the 
substances which will be sent to the exporting co untry.  This authorization is used as an G/LIC/N/3/ALB/2 
Page 16  
 
  international control instrument.  The control authority of the exporting country issues an 
exportation authorization for their exporter.  Th e Albanian importer submits the application for 
an import license to the Pharmaceutical Department at the Ministry of Health.  
 (f) The importer of disinfectant, disinsectants, deratizing substances (DDD) submits the 
application for the importation to the Public H ealth Department of the MOH where the license 
is granted immediately. 
 
Purposes and Coverage of Licensing
 
 2. Importation licensing systems are: (i) licensing of medicines, (ii) licensing of dental equipment 
and consumables, (iii) licensing of medical devices and consumables (iv) and the licensing of DDD 
substances.   The products covered by the above mentioned licensing systems are: 
 
- Narcotic Drugs and Psychotropic Substances re ferred to the list in accordance with Single 
Conventions of 1961 and 1971; 
- Pharmaceutical Products in chapter 30 of  the Combined Nomenclature of Goods; 
- Dental materials, chapters 33, 34, 37 of CNG; 
- Medical and dental equipment and devices,  chapters 37, 70, 90 and 94 of CNG; 
- DDD substances, chapters 28, 29 of CNG. 
 3. The systems apply to all medicinal products, regardless of their origin.  4. Generally, a licensing system is used to contro l imported drugs that will enter into the country 
at several stages: at the border by customs authoriti es, at wholesale distribution, at retail by pharmacies 
to the end user.  The systems were developed due to th e lack of or insufficiency of domestic legislation, 
control and inspecting structures and control technol ogy. Licensing systems are not used as a tool to 
limit quantities or value of importations.   5. Legal framework that regulates the procedures of import licensing includes: 
 
- Law No. 9323, dated 25.11. 2004 “On medicines and pharmaceutical services” amended 
with Law No. 9523 dated  25.04, 2006; 
- Law No. 7975 dated 26.07.1995 “On narcotic dr ugs and psychotropic substances, amended 
with Law No. 9271 dated 9.11. 2004; 
- Council of Ministers Decision No. 325, date d 14.06.1993 “On regime of exportation-
importation and medicines production”; 
- Joint Guideline of Ministry of Health and Ministry of Finance No. 180 dateed 13.08.1993 
“On co-operation for the regime of import-export of medicines and their clearance”; 
- Order of Minister of Health No. 104 dated 5.03 2004, “On a change in the Guideline nr. 
180 dated 13.08.1993 “On co-operation for the re gime of import-export of medicines and 
their clearance”; 
- Order of Minister of Health No. 214 dated 22.04. 2004; 
- Law No. 9153 dated 6.11. 2003, ”On some am endments in the Law No. 8167 21.11.1996 
”On dental health service”, changed by the Law No. 8414 dated 1.10. 1998”; 
- Regulation No. 279 dated 31.05. 2004 ”On impor tation licences of dental equipments and 
consumables; 
- Decision of Council of Ministers No. 415 dated 17.08.1993 ”On licensing of import, 
export, wholesale and retail of DDD substances”  and related Minister of Health Order 
No.°361 dated 18.08.2000. 
  G/LIC/N/3/ALB/2 
 Page 17 
 
 
   None of the licensing systems can be abolished without any legislative aproval.  None of the 
systems leave designation of products subject to administrative discretion.  
Procedures
 
 
6. I. Quantity limitations are applied on importati on of narcotic drugs and psychotropic substances, 
only.  Annual quantities are approved by th e International Narcotic Control Board and are 
published in its special publication.  The amount of quotas to each importer is  not allocated by the 
licensing authority.  The allocation of quot as is made by importers themselves.  
 No limitations for the quantities imported from any country. 
 No request for exception or derogations fr om the licensing requirement is accepted. 
 
II.  Quotas are determined on a y early basis covering all the country. Authorization for import is valid 
up to 3 months.  The importer has to  re-apply to renew the license. 
 
III. Licenses are granted to any importer who imports into Albania the registered narcotic drug and 
psychotropic substances.  Pharmaceutical Authorities supervises in partic ular license usage, be cause the non utilization 
would result in a lack of drugs in health institu tions and the pharmaceutical market. In the case of 
non utilization of the license, the importer notifie s the responsible authority.  If he does not, the 
authority, based on the data received in the pharmaceutical market, communicates with the 
importer to solve any possible problems, or to  make possible the importation from another 
importer, if the first one has not possibility to do it.  Unused allocations are not added to  quotas for succeeding periods.  
 IV. There is not any defined period. 
 
V. The applications are proces sed within one working day. 
 
VI. The authority and the importer are both info rmed of the date of opening of the period of 
importation. The licensing proc edures begin after this date. 
 
VII. The issuing of an import li cense for unregistered drugs is considered by two authorities:  
   - The Ministry of Health; and    - The National Centre of Drugs Control.  
 
VIII. The method used is fi rst come first served.  
 The quotas are allotted by ag reement between importers.  
 There are no provisions for new importers.   The applications are examined immediately.  IX. Yes, in the case of importation of na rcotic drugs and psyc hotropic substances.  
 
X. In the case of importation of narcotic drugs and psychotropic substances , after granting the export 
authorization, the exporting count ry authority sends to the importin g country authority a copy of 
the export authorization. 
 
XI. No.  
 7. (a) The application for a license should be done:   - 1 month before the impor tation of registered and non – registered medicines; 
 - 2 months before the importation of dental materials and medical devices;  G/LIC/N/3/ALB/2 
Page 18  
 
   - 6 months before the importation of DDD.  
 
(b) Yes. 
 (c) No. 
 
(d) The application for a license is examined only by  the Ministry of Health.  An exemption is 
applied only for unregistered medici nes, when the application is examined by the Ministry of 
Health and the National Centre of Drugs Control.  Both organisations c ooperate with each other 
and the importer has to approach  only the Ministry of Health.  
 
8. The application for a license can be refused when  the importer fails to meet the defined criteria 
and in some other cases, specifically when:  
(1) The National Centre of Dr ugs Control finds that the drug does not meet the necessary 
quality and safety standards; information is receiv ed by homologue authorities or by the results of 
NCDC's own tests.  (2) The manufacturer or control authorities inform for the starting of withdrawal procedures from the market of the product, meanwhile the importer has submitted the application for import 
license. 
 
(3) The registration validity of the medicine has 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 
Pharmaceutical Department at the Ministry of Health  and at the National Centre of Drugs Control.  The 
importer can also appeal to the Court. 
 
Eligibility of Importers to Apply for Licence
 
 
9.(a) Under restrictive licensing sy stems, application for a license is  done only by operators that fulfil 
the conditions of such systems.  In health serv ices, the application is submitted by a subject 
(importer or medical clinic that  uses the products for its own ac tivity) which has a professional 
license (registration) issued by the Ministry of Health.  If the importer applies to import narcotic 
and psychotropic drugs, or medicinal products that are a source of ionizing radiation, it must have 
a second registration for this kind of activity. 
 
(b) In health services there are no non-restrictive systems. 
 
 All importers should receive a professional license on the activity that is called “importer 
registration”.  There is a registration fee which is published.  There is an online list of pharmaceutical 
importers and distributors at www.qkkb.gov.al   
 Documentational and Other Requirem ents for Application for Licence
 
 
10. There is no application form . Different types of licenses require different documents.  
 
 To import registered and unregistered medicines,  the registered importer submits an application 
that includes:    (1) The importer’s data;   G/LIC/N/3/ALB/2 
 Page 19 
 
 
   (2) A list of medicines to be imported. For each medicine the importer must give the 
following data:   - Brand name,   - Generic name of the medicine,   - Quantity,  
 - Date of manufacturing and expiration,  
 - Batch number,   - CIF price,   - Manufacturer's name and the country of origin. 
 
 (3) An invoice attached to the application.  
  To import narcotic and psychotropic drugs, the registered importer submit s the applicable above 
mentioned data, with full address of the manufacturer. 
 
 For the importation of medical material, the a pplication submitted must include the following 
information:  - Importers data  - The list of imported goods  - The quantity to be imported  -  The date of expiry 
 - Batch number 
 - CIF price  - The name of manufacturer and   - The country from which the im port is to be carried out.  
 
To import dental consumables and equipment, the following documents must be submitted:  
- The application with the importer’s data 
- A translated and certified invoice 
- A quality certification  
- If the applicant is a dental clinic, it has also to submit a self-declaration that consumables 
or equipments will be for it s own use and not for trade.  
 
To import medical devices, the following documents must be submitted:  
- The importer’s data 
- Medical devices destination 
- The imported quantity 
- A packing list 
- The invoice 
- In case of importation of medical devices of a sources ionizing radiation, the application 
must be accompanied by a special license. 
 
To import DDD substances the following documents must be submitted:  
- The importer’s data 
- The Taxpayer Personal Identification Number and  
- The certificate of origin of the goods. 
 
11. The number of documents depends on the ty pe of product that is imported but the main 
documents required upon actual im portation are as follows:  
- The invoice,  
- The packing list,  
- The certificate of analyses,  
- The certificate of quality,  G/LIC/N/3/ALB/2 
Page 20  
 
  - The certificate of conformity,  
- The certificate of origin.   
 
12. There are different fees for different types of licenses: 
- For unregistered medicines the fee is 1000 leks for each medicine; 
- For raw materials the fee is  500 leks for each item; 
- For registered medicines, me dical materials, medical devi ces and DDD substances, the 
fee is 200 leks for each license; 
- For dental consumables and equipments the fee is 1000 leks for each license. 
 
13. No. 
 
Conditions of Licensing
 
 
14. There are different validity  periods for import licenses: 
 
- The validity of import licenses for re gistered medicines is one month; 
- The validity of import licenses for unregistere d medicines, consumables, dental consumables 
and equipments, medical devices is two months; 
- The validity of import licenses for DDD substa nces is six months. Exceptionally the import 
licenses for water disinfectants is one year ; 
- The validity of import authorizations for narcot ic drugs and psychotropi c substances is three 
months. 
 
 When the validity of the license has expired, the importer must submit an application to extend 
the validity.  
15. No penalty. 
 
16. Import licenses are not transferable between importers.  
 
17. (a) For narcotic drugs and psychot ropic substances, there is a conditi on that the total quantity of the 
imported medicine, from each importer, will not  be more than the annual quantity approved for 
the country. 
 (b) No.  
 
Other Procedural Requirements
 
 
18. No, there are no other proce dures prior to importation. 
 
19. All banks provide foreign exchange automatically. 
 
 
VII. IMPORT LICENSING PROCEDURES FOR MILITARY GOODS 
Outline of Systems  
 
1. Import – export permission of military goods for private entities is issued by the Export State 
Control Authority at the Ministry of Defence.  This permission is issued based on the Law No. 9707, 
dated 05.04.2007 “On state control of the activ ity of import and export of dual use goods”. 
  G/LIC/N/3/ALB/2 
 Page 21 
 
 
   Import permission of radioactive materials in the territory of the Republic of Albania is issued 
by the Ministry of Foreign Affairs, based on the Decision of the Council of the Ministers No. 357 date 
13.06. 2007 “On the procedures for issuing the diplomatic clearance for entrance, lending and transit of the navy military vehicles, military aviation, and arm oured vehicles, in the territory of the Republic of 
Albania”. 
 
Purposes and Coverage of Licensing
 
 
2. Groups of products covered are:  arms and munitions, fireworks,  explosives for civil use, and 
other dual use goods. 
 
3. The system does not discriminate any country.   4. The system does not intend to restrict the quantity or value of imports.  The purpose of the system is to control the activity of the traders due to dangerousness of the goods.  Up to now, no other 
alternative methods are considered to control these activities.  
 5. The law under which the licensing system is  maintained is Law No. 9707, dated 05.04.2007 
“On state control of import and export activity of dual use goods”.  This licensing system can not be eliminated because it involves dangerous goods that ri sk human life and to protect the national security 
of the Republic.   
 
 Licensing is statutorily required and cannot be abolished without legislative approval.  The 
legislation does not leave designation of products to  be subjected to admi nistrative discretion. 
 
Procedures
 
 
6. I. Not applicable.  II. The license is valid for one year.  III. Not applicable. 
 
IV. Not applicable.  V. The time of processing the application is 30 days.  
VI. Not applicable. 
 VII. These licences are issued by the Ministry of  Defence only.  Before presenting the application 
the applicant must get environmental and police clearance. 
 VIII. All applicants can obtain an import licence if they fully comply with the requirements.  
 
IX. Not applicable.  X. Not applicable.  
XI. Not applicable. 
 7.(a) - 45 days on to export and re-export military materials; 
- 30 days on to export and re-export dual use goods and temporary export and import of 
each goods; G/LIC/N/3/ALB/2 
Page 22  
 
  - 15 days to import and transit the dual use goods and temporary export and import of each 
goods.  
 (b) If the documentation has no any discrepancy, yes. 
 
(c) No. 
(d) These licences are issued by  the Ministry of Defence only. Before submission of the 
application, the applicant must get environmental clearance from the Ministry of Environment, Forest and Water Administration, and police clearance. 
 
8. Circumstances under which th e license can be refused are: 
 
- When the applicant has executed a penal activity  that is related to the importation activity 
of the explosives, fireworks a nd pyrotechnics for civil use; 
 
- When, during the import of the goods, the le gal person does not meet the technical 
requirements related to the production, use, or  conformity, by exercising risks to human 
and animals life, and the environment.   
 
 The reasons for refusal are given to the appli cant. The applicant can appeal the Minister of 
Defence, according to the Law No. 8485 dated 12.5.1999. 
 
Eligibility of Importers to Apply for License
 
 
9. The applicant must be registered by the Court of First Degree for the importation of the fireworks or explosives for civil use. All entiti es that fully satisfy the criteria are eligible. 
 
Documentational and Other Requirem ents for Application for Licence
 
 
10. Juridical persons applying for import licen se of explosives have to present the following 
documents:  
 
- The court decision of the registration as the legal person for the importation of explosives; 
- The documentation from the manufacturer on the types and quantities of the explosives; 
- The conformity assessment certificate of the explosives, accompanied by a photo;  
- The permission issued by the Regional Agency of the Environment on protection of 
environment and safety; 
- The contract on the service of transportation and physical maintenance, with the entity that 
will carry this type of service, when the entity is not licensed; 
- The permission on storage and transfer of the explosives, issued by the Ministry of Public 
Order; 
- A copy of the previous import license, invoices and list of explosives used. A declaration 
on the quantity of explosives currently stocked and their quality. 
 
 The juridical or physical person applying fo r an import license for fireworks and pyrotechnic 
goods for civil use has to present to the Ministry of Defense a written request, in the form of an 
autobiography, the full address, followed by these documents: 
 
- The court decision of the registration as the legal person for the importation of fireworks 
and pyrotechnic goods; 
- The certificate of registration from the fiscal authorities; 
- The Taxpayer Personal Identification Number;  G/LIC/N/3/ALB/2 
 Page 23 
 
 
  - The list of fireworks and pyrotechnic goods, compiled by the producer accompanied with 
the code number, type, weight, quantity, and the value, translated into the Albanian 
language; 
- The permission issued by the Regional Agen cy of the Environment on protection of 
environment and safety; 
- The permission on the storage of fireworks a nd pyrotechnic goods, issued by the Police on 
Fire Protection and Salvation; 
- A copy of the previous import license, in the case of renewal.  
  Import licensing of military materials for the Ministry of Defence, is issued only to MEICO 
enterprise.  This enterprise (MEI CO) has the exclusivity on the import and export activity on military 
materials, on behalf of the Ministry of Defence,  based on the Decision of the Government No. 366, 
dated 05.10.1991 “On establishment of the import – e xport entity depending on Ministry of Defence”. 
The Commission on Approval of Prices, in the Ministry of Defence, prepares the list of the goods to be imported by MEICO, associated with the approved prices of the imported goods.  
11. The documents required on importation are mentioned in question 10. 
 12. The licensing fee for the importation of expl osives for civil use, fireworks and pyrotechnic 
substances is 6% of the value of the invoice of the imported goods.   
13. There is no other deposit or advance payment other than that paid for the licensing fee.  
 
Conditions of Licensing
 
 
14. The validity of the license is one year. Th e validity of the license can not be extended. 
 
15. There are no penalties for non-utilization of the licenses.  16. Licenses are not transferable.  17. There are no other conditions attach ed to the issue of the license.  
 Other Procedural Requirements
 
 
18. No, there are no other proce dures prior to importation. 
 
19. All banks provide foreign exchange automatically. 
  
__________