WORLD TRADE  
ORGANIZATION  G/LIC/N/3/ALB/4 
23 October 2009 
 (09-5254) 
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 2008  
 
ALBANIA 
 
  The following communication, dated 19 October 2009, is being circulated at the request of the delegation of Albania.  
_______________ 
 
  Albania's import licensing regime, as notified in document G/LIC/N/3/ALB/3 has not been 
modified and still remains valid for 2009, except fo r the change introduced in the Questionnaire on 
import licensing procedures for medical products  attached hereto2. 
 
                                                      
1 See G/LIC/3, Annex, for the Questionnaire. 
2 In English only. G/LIC/N/3/ALB/4 
Page 2  
 
  LAW No. 10 008 Dated 27.10.2008 
 
RELATED TO SOME ADDENDA AND AMENDMENTS TO LAW NO. 9223, DATED 
25.11.2004 “FOR MEDICAMENTS AND PHARMACEUTICAL SERVICE”, 
AMENDED 
 
Pursuant to articles 78 and 83, item 1 of Constitu tion, upon the proposal of Council of Ministers, 
 
ASSEMBLY 
OF REPUBLIC OF ALBANIA 
DECIDED: 
 
 To add the following addenda and amendments  to law no. 9223 dated 25.11.2004 “For 
medicaments and pharmaceutical service”, amended.  
Article 1 
 
 Items 28 and 29, with the following content, sh all be added to article 3 titled “Definitions”: 
 28.  ‘Regional Public Health Directorate’ (herei nafter Regional PHD) shall remain the authority 
which coordinates, governs, and supervises all he alth service on national level through pharmaceutical 
structures comprised of pharmacists. 
 29.  ‘Pharmacist’ shall mean a professional who has been conferred a degree as pharmacist after a unique 5-year period of studies (Second Level In tegrated Degree). All the degrees awarded by 
University of Tirana, pharmacy branch, pursuant to former program as approved by Ministry of 
Health and Science and foreign degrees in pharmacy, recognized by such ministry, and shall be bear 
equal recognition.  
Article 2 
 
 Article 17 shall be amended as follows:  
‘Article 17 
Accelerated registration procedures 
  Medicaments registered under European Medicaments Evaluation Agency (EMEA), 
American Administration for Food and Medicament s (FDA), medicaments registered in Switzerland, 
Canada, and Australia as well as medicaments regist ered pursuant to communitarian procedures of 
EU, shall automatically be registered within 30 working days after proving the authenticity of the 
documentation submitted”. 
 
Article 3 
 
 Article 18 shall be amended as follows: 
 
“Article 18 
Publication of medicaments register 
 
1) National Centre for Medicaments Control (NCMC) shall publish pe riodically and annually 
the register containing relevant prices and names of importers authorized by license holding firms or manufacturing ones and updates it on monthly basis.   G/LIC/N/3/ALB/4 
 Page 3 
 
 
  2) National Centre for Medicaments Contro l (NCMC) shall be responsible to submit 
medicaments register and its updates to Customs General Directorate.  3) National Centre for Medicaments Control (NCM C) shall be responsible to notify immediately 
pharmaceutical bodies and Customs General Director ate with regard to each new medicament 
registered or disqualified/excluded and for each me dicament imported under special authorization”.   
 
Article 4 
 
Article 20 shall be amended as follows: 
“Article 20 
Control stamp 
 
1) All medicaments traded in the market shall necessarily bear the control stamped provided by 
National Centre for Medicaments Control (NCMC). 
 
2) The control stamp shall be duplicate and at least contain the following elements: 
 a) medicaments name and dosage;  b) retail price;  c) authorized importer’s name.  
3) The other elements of control stamp and stamping or manufacturing procedures shall be 
determined by a decision of Council of Ministers.       
Article 5 
 
Article 24 shall be amended as follows: 
 
“Article 24 
Medicaments wholesale 
 
1) The activity of medicaments wholesale shall be exercised by legal subjects, domestic or 
foreigners, equipped by a license provi ded only by Ministry of Health. 
 2) To launch the afore-mentioned activity, the in terested subject shall declare, upon his/her own 
responsibility, that he/she meets all the requirements provided for by the existing relevant legislation. 
 
3) Regional Public Health Directorate shall veri fy the statements submitted by the legal subject 
within 20 working days.  4) If such an authority fails to provide a reply,  the pharmaceutical directorate at Ministry of 
Health, within 5 working days, shall forward such  procedures to National Centre for Medicaments 
Control, which shall provide an answer with 10 working days. 
 
5) After the receipt of inspection report issued by the relevant Public Health Directorate or 
National Centre for Medicaments Control, Minist ry of Health shall issue the license within 10 
working days. The license shall be distributed to legal subject by regional offices of Public Health 
Directorate. 
 
6) Pharmaceutical distributor shall have cont racted as employee a technical manager who is a 
pharmacist by profession.  G/LIC/N/3/ALB/4 
Page 4  
 
  7) The technical manager and pharmacists sha ll be registered to regional Public Health 
Directorate.  8) The subject licensed for medicament wholesal e may trade on wholesale basis even treating 
materials, accessories such as hygienic, cosmetic or diet related items. 
 
9) Criteria and approval procedures of such activ ity as well as the type of self-declaration shall 
be determined by a decision of Council of Ministers”.                
Article 6 
 
 Article 25 shall be amended as follows: 
 
“Article 25 
Technical manager of pharmaceutical distributor 
 
 Importer, exporter, and pharmaceutical dist ributor’s technical manager shall mean a 
pharmacist, member of Pharmacist Order of Albania, with a 2-year working experience in pharmaceutical sector, responsible for all the technical  and professional activity of the relevant legal 
subject. 
 
Article 7 
 
 Letter “b” of article 31 shall be amended as  follows: “b) shall posses s a two-year working 
experience”. 
 
Article 8 
 
 Article 32 shall be amended as follows: 
 
“Article 32 
Pharmacy 
 
1) The activity of pharmacy may be exercised by all physical or legal subjects, domestic or foreigner, licensed by regional Public Health Directorate.  2) To launch the afore-mentioned activity, the in terested subject shall declare, upon his/her own 
responsibility, that he/she meets all the requirements provided for by the existing relevant legislation. 
 3) A false statement shall result in a five-year license banning.   4) Regional Public Health Directorate shall veri fy the statements submitted by the legal subject 
within 20 working days. 
 
5) If such an authority fails to provide a reply w ithin this deadline, the ac tivity shall be regarded 
as approved.  6) Regional Public Health Directorate shall notify periodically to National Centre for 
Medicaments Control, within 10 working days, w ith regard to each new pharmacy established in its 
territory.  7) National Centre for Medicaments Control shall carry out an inspection of the activity within 5 
working days from such a notification.  G/LIC/N/3/ALB/4 
 Page 5 
 
 
  8) Pharmacy shall be permitted to exercise the activity at the presence of technical manager and 
employed pharmacist.  9) Technical manager shall be li censed for only a single pharmacy. 
 
10) Technical manager and pharmac ists employed at a pharmacy shall be registered to regional 
Public Health Directorate.     11) Criteria and approval procedures of such activ ity as well as the type of self-declaration shall 
be determined by a decision of Council of Ministers”.         
          
Article 9 
 
 Articles 33 and 34 shall be repealed. 
 
Article 10 
 
 Article 35 shall be amended as follows: 
 
“Article 35 
Pharmaceutical agency 
 
1) In rural areas, where no pharmacy operates, the establishment of pharmaceutical pharmacies with an assistant pharmacist as a technical manager sh all be approved on the basis self declaration to 
meet the required criteria.  
2) To initiate the activity of medicament trad ing by means of pharmaceutical agency, the 
procedures provided for by article 32 of  the current law shall be followed. 
 3) Pharmaceutical agency shall exercise retail tr ading of medicaments as provided for in the list 
approved by Minister of Health”.   
Article 11 
Article 46 shall be amended as follows: 
 
“Article 46 
The activity of medicaments import – export 
 
1) The activity of medicaments import – export sha ll be exercised by legal subjects, domestic or 
foreigner, after the receipt of professional license regarding the technical manager as a pharmacist with a two-year professional working experience.  2) To secure such a license, the subject shall fo llow the procedures provided for by article 24 of 
the current law”.  
 G/LIC/N/3/ALB/4 
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  Article 12 
Article 47 shall be amended as follows: 
 
“Article 47 
Import of registered medicaments 
 
1) Medicaments registered in the Republic of Al bania shall be imported by subjects authorized 
by license holding firms or manufacturing ones pur suant to medicaments published register as 
provided for by article 18 of the actual law.  
2) Import procedures shall be performed in  entry customs offices at the presence of 
pharmaceutical inspector”.   
 
Article 13 
 
 Article 58 shall be amended as follows: 
 
“Article 58 
Annulment of approved activities, license withdraw al and medicament seizure and confiscation. 
 1) When pharmaceutical inspectors observe admini strative violations pursuant to article 57 of 
the actual law, they shall submit a proposal to releva nt Public Health Directorate and notify Ministry 
of Health with regard to:   a) suspension of activity;  b) license withdrawal 
 
2) Pharmaceutical inspectors shall seize and confiscate medicaments in cases of violations 
provided for by the actual law.    
Article 14 
 
 Article 59 shall be amended as follows:  
“Article 59 
Administration and elimination/destruction of confiscated medicaments 
 1) Confiscated medicaments, which happen to be usable and properly documented, shall fall 
under the administration of Ministry of Health. 
 2) Seized or confiscated medicaments, which happe n to be not usable, shall be destroyed at the 
presence of pharmaceutical inspectors and properly documented pursuant to the manner provided for 
by legislation for protection of environment at th e expense of the subject which has performed such 
violation”.      
 
Article 15 
 
 The actual law shall enter into force 15 days after its publication in the Official Bulletin. 
 
      S P E A K E R  
     JOZEFINA TOPALLI (ÇOBA)  
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