RESTRICTED
WORLD TRADE WT/ACC/ALB/19
9October 1996
ORGANIZATION(96-4104)
Original: English
ACCESSION OFALBANIA
Communication from Albania
Thefollowing information onImport Licensing Procedures, reproduced hereunder hasbeen
received from theMinistry ofIndustry, Transport andTrade oftheRepublic ofAlbania.
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Thefollowingisdesignedtoelicitinformationonimportlicensingandsimilaradministrative
procedures maintained orapplied bytheApplicant. Ifdifferent procedures ormethods oflicensing
orsimilar administrative procedures areapplied todifferent categories ofproducts, todifferent
countries ofsupply ortodifferent modes ofimportation, theyshould beexplained separately in
respect ofeachquestion asrelevant.
General Comments:
Albania doesnot,asageneral rule,maintain licensing procedures fortheimportation ofgoods,
reflecting thefactthatAlbania doesnotmaintain anyquantitative restrictions onimports. (For
information onlicensing procedures applicable totheprovision ofservices inAlbania, seethenote
accompanying Albania 'sServices Schedule).
Thefewimport licensing procedures thatdoexist, apply toproducts which aresubject to
procedural control, inorder toensure thattheydonotpresent arisktothehealth orsafety ofthe
population. Essentially these licensing procedures apply tocertain agricultural and
pharmaceutical/medicinal products.
These procedures aredescribed more fullybelow.
I. OUTLINES OFSYSTEMS
1. Give abrief description ofeachlicensing system asawhole and, withrespect toeach,
reply tothefollowing questions asrelevant, placing allofthematerial withrespect to
agiven system insequence together, andusing cross references asappropriate when
elements which have already been described arealsopresent inanother system.
Comments:
I.Ministry ofHealth andEnvironment Protection
Allimport, export, wholesale andretail saleofmedicines anddrugs iscarried outinaccordance
withtheLawNo.7815 dated 20/04/1994 "ForDrugs".
1. Themedicines anddrugs which areimported intotheRepublic ofAlbania should beregistered.WT/ACC/ALB/19
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2. Theregistration ofthemedicines anddrugs iscarried outintheNational Center ofMedicine
Verification (NCMV) bythetrading orproducing companies localorforeign which fulfilthecriteria
according tothelawonthebaseofarequest andrespective documentation.
3. Pharmaceutical entities, State orprivately owned, needalicence bytheMinistry ofHealth
andEnvironmental Protection inorder tocarry outtrade activities formedicines anddrugs.
Thelicence isvalid foraperiod ofthree years.
4. Iftheywishtoimport, theymustobtain animport licence Pharmaceutical Directorate ofthe
Ministry ofHealth against arequest presented fivedaysinadvance.
Thelicence ofimport isvalid foroneimport onlyandhasavalidity oftwomonths.
5. TheNational Centre ofMedicines Verification (NCMV) hastheright toverify imported
medicines anddrugs incustoms orintheimporter 'swarehouse. After verification, theNCMV issues
theauthorization fortheuseornotofmedicines anddrugs.
6. Formedicines ordrugs which areneeded inthepharmaceutical service andwhich arenot
registered, the"permission" forimportation (with theproposal ofthePharmaceutical Directorate) is
issued bytheMinister ofHealth andEnvironmental Protection.
7. Fordisinfectant anddisinfectant materials, theimport licence isissued bythecommission
approved forthispurpose attheMinistry ofHealth andEnvironmental Protection.
Thislicence isvalid foratwomonth period.
8. Foreachimport licence thefeeis200Lek=2USD.
TheNCMV isthecompetent authority foracceptance, and/or destruction and/orrefusal of
theimported medicines anddrugs orforcancellation oftheproduction inlocalproducers.
Important: - there arenoquotas onimports;
- thereisnodiscrimination against anycountry forimport ofmedicines
anddrugs;
- alllaws andregulations concerned arepublished intheOfficial
Magazine which includes thepublishing ofallLaws andRegulations
inside thecountry.
Anexample oftheapplication foranimport licence isattached todocument
WT/ACC/ALB/18, page8,Appendix 3.
II.Ministry ofAgriculture andFood
ThisMinistry isincharge oforganizing thelicensing procedures forimports andexports of
liveanimals andfortheimports ofseeds andseedlings.
Liveanimals
OnthebasisoftheLawNo.7626dated 21/10/1992 (Article 12,paragraph c)"Onzootechnic
services" forimport andexport ofbreeding animals and/orbiologic materials from/to other countries,
itisnecessary toobtain alicence which isissued bytheCentral Commission ofImprovement ofRaceWT/ACC/ALB/19
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(CCIR); importers/exporters, localorforeign, should make awritten request totheCCIR. Attached
totherequest should beallnecessary information fortherespective racebiologic material. TheCCIR
itselfhasameeting onceinthreemonths tocheck therequest fromtheimporters/exporters. Bydecision
oftheCCIR theapplicants aregiven therequested "permission" onthebaseofwhich theAlbanian
Veterinary Service issues thelicence forimport/export oftherequested materials.
Import ofseeds andseedlings
Onthebasis oftheLaw"Onseeds andseedlings", import seeds andseedlings inAlbania, it
isnecessary toobtain a"permission" which isissued bytheStateEntity ofSeeds andSeedlings (SESS).
Theinterested subjects should make awritten request totheSESS. They should alsohavealicence
allowing them totrade suchproducts.
After analysing therequests, theSESS issues thelicence forimportation ofthose varieties which
areregistered intheOfficial Albanian Catalogue ofSeeds andSeedling. Iftherequested varieties
forimport arenotincluded intherespective Albanian Catalogue, butfromacountry oftheEuropean
Union (EU), theimportation maybeallowed, onlyaftertheapproval oftheMinistry ofAgriculture
andfoodontherequest oftheSESS.