RESTRICTED
WORLD TRADE WT/ACC/ALB/18
9October 1996
ORGANIZATION(96-4099)
Original: English
ACCESSION OFALBANIA
Communication from Albania
Thefollowing information ontheRegulation ofPesticides inAgriculture andontheRegistration
ofPharmaceuticals, reproduced hereunder, hasbeenreceived fromtheMinistry ofIndustry, Transport
andTrade oftheRepublic ofAlbania.
_______________WT/ACC/ALB/18
Page2
Republic ofAlbania
Ministry ofAgriculture andFood
ListoftheDocument andMaterials which areNecessary to
beDeposited intheFileofRegistration
(The Regulations "OnPesticides inAgriculture" Nr.584,date6.12.1993)
1. Therequest forregistration addressed toMinistry ofAgriculture andFood (atPlantProtection
Directorate, fax003554227924, telephone 003554229309)
2. Authorization oftheproducer (when thedocuments forregistration aresubmitted bypersons
other thantheproducer).
3. Theaddress oftheproducer andtheauthorized person.
4. Thecopies ofregistration certificate intheother countries (thepreference isforUnited States,
Germany, France, United Kingdom, Japan).
5. Thedetailed dateabout physical-chemical properties:
a. oftheactive ingredient;
b. oftheformulation;
c. oftheformulation related touse(suspendibility, thestability oftheemulsion etc.).
6. Thedetailed dataabout biological-agronomical estimation:
a. ofthepests which arecontrolled andefficacy;
b. ofestimation ofphytotoxicity;
c. ofsecondary effects (about thebeneficial insects, thesuccessive crops);
d. ofproblems ofresistance.
7. Effect onenvironment (soil, water, animal, fowl, bees, fishes).
8. Thetoxicological dataofactive ingredient andtheformulation product.
9. Thedataabout acceptable maximum residue limitonplants andtheirproduct, acceptable daily
intake, pre-harvesting interval andre-entry period inthetreated area.
10. Specifications about safety conditions inwork.
11. Specifications about disposal ofpackages, spray mixtures andtheformulation products.
12. Specifications about types ofthepackages.
13. Chemical analysis methods oftheformulation andtheresidue inplants andtheirproduct.
14. Asample oftheactive ingredient (1-2g).
15. Asample oftheformulation product (ifitisrequired).
16. Theproposed label.
17. Declaration ofproducer onformulation pesticide.WT/ACC/ALB/18
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Note: Thedatemust beinfourcopies intheEnglish language
Thesamples accompaniment withcertificate (items 14,15)to:
Institute Plant Protection DURRES
(Instituti iMbrojtjes seBimeve Durres)
Telefax: 003554222182WT/ACC/ALB/18
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Republic ofAlbania
Ministry ofHealth andEnvironment Protection
National Centre ofDrug Control
OntheRegistration ofDrugs
Inconformity withLawNo.7815 of20.04.1994 "OnDrugs" alldrugs incirculation inthe
Republic ofAlbania should beregistered.
Towards theimplementation oftheLawtheMinistry ofHealth andEnvironment Protection
hasissued Ordinance No.121of05.06.1995 "Ontheprocedure oftheregistration ofdrugs inthe
Republic ofAlbania". Thisordinance rulesthatanycompany oraperson authorized bysuchacompany
wishing tocommercialize itsownproducts inAlbania should register thedrugs withtheNational Centre
forDrug Registration.
Theapplication fortheregistration ofdrugs totheNational Centre ofDrug Control should
contain thefollowing information:
I. General Data
1. Dataonthemanufacturing company (official name, postal address, phone andfaxnumbers).
2. Thename ofthedrugtoberegistered:
a. trade name (ifapplicable);
b. generic (international non-proprietary name);
c. dosage form andstrength;
d. therapeutic group (A.T.C. code).
3. Certificate fromtheappropriate institutions confirming thatthedrugisregistered andisused
inthecountry oforigin.
4. Confirmation from themanufacturing company thatthedrugismanufactured according to
Good Manufacturing Practices (GMP).
5. Dataontheregistration ofthedruginother countries (ifapplicable).
6. Shelf life.
7. Proposed salescategory (OTC, onprescription, onlyforhospital use,narcotics, psychotropics).
8. Sufficient quantity inoriginal package ofthedrugandofreference standards forquality control
accompanied bycertificate ofanalysis.
9. Sample ofpackage (inEnglish).
10. Leaflet (inEnglish).
II. Pharmaceutical Data
1. Complete composition ofdrug(names, quantities, qualities ofallingredients).WT/ACC/ALB/18
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2. Specifications onthequality ofactive ingredient, auxiliary ingredient andfinished product).
3. Methods ofanalysis foractive ingredient andauxiliary ingredient.
4. Methods ofanalysis forthefinished product andresults ofanalytical testsmade byquality
control incompliance withEuropean, British, orU.S.pharmacopoeias.
5. Stability report.
6. Conditions ofstorage.
III. Pharmacological andToxicological Data
1. Pharmacology
1.1 Pharmacodynamics
1.2 Pharmacokinetics
1.2.1 Absorption
1.2.2 Distribution
1.2.3 Metabolism andexcretion
1.2.4 Bioavilability
2. Toxicology
3. Clinical data
4. Bioequivalence study isrequested forgeneric drugs, besides alltheother data.
Foreachdosage form andstrength ofthedrugtoberegistered afeeshould bepayed tothe
National Centre forDrugRegistration. ThefeeisUS$200fordrugs included intheDrugNomenclature
Listapproved bytheMinistry ofHealth andEnvironment Protection andUS$500fordrugs outside
thatlist.
Theregistration ofadrugisvalid forfiveyears.
Allnecessary documentation should besubmitted intheEnglish language.WT/ACC/ALB/18
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REPUBLIC OFALBANIA
MINISTRY OFHEALTH AND ENVIRONMENT PROTECTION
NATIONAL CENTRE OFDRUGS CONTROL
R.eDibres, Tirana-ALBANIA Tel:(355) 4234517
APPLICATION FORM1
fortheregistration ofapharmaceutical preparation
Date Nr.
1.Pharmaceutical preparation
Trade name
Generic name
Name ofactive ingredient(s) given byINN
Dosage form
CompositionATC -code
Sale
withprescription
OTC
narcotics
psychotropic
2.Manufacturer (manufacturer forthemarketing licence):
Name
Address
Phone: Telex: Fax:
3.Authorized representative ofthemanufacturer:
Name:
Address:
Phone: Telex: Fax:
4.Indications anddosage ofthepreparation:
1English onlyWT/ACC/ALB/18
Page7
5.Information oncontainer
Period ofvalidity
6.Storage conditions
freezer (-18C) cold(+2-8C) cool(+8-15C) room temp.
Special:
7.Support oftheapplication
Compliance ofmanufacturing conditions withtheinternational requirement
Short summary about theproduct characteristics
Chemical andpharmaceutical documentation
Pharmacological andtoxicological documentation
Clinical documentation
Bioavailability
Package label
Samples ofpreparation
8.Authorized representative ofthemanufacturer
Iamfamiliar tothelegislation about theregistration ofthepharmaceutical preparation in
theRepublic ofAlbania. Iguarantee theauthenticity andcompleteness oftheinformation
given about theproduct.
(Date) (Signature) (Name)
Address:
Phone: Telex: Fax:
9.Application feepaidtoaccount ofNational Centre ofDrugs Control:
BANKA KOMBETARE TREGTARE
Tirane -ALBANIA
Dega eThesarit perQendren Kombetare teKontrollit teBarnave
Nr.Llogarise 11/131/01WT/ACC/ALB/18
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Appendix 3
REPUBLIC OFALBANIA
MINISTRY OFAGRICULTURE AND FOOD
Directorate ofPlant Protection Service
IMPORTATION LICENCE FOR PESTICIDES2
No.________ Date________
Based onArticle 30,LawNo.7662, date19.01.1993 "OnthePlant Protection Service"
Mr/Company_________________________________________________________________________
(Name, Surname /Company Name /Address, Phone)
______________________________________________________________________________________
isallowed toimport forusage purpose inRepublic ofAlbania pesticides:
1. 8.
2. 9.
3. 10.
4. 11.
5. 12.
6. 13.
7. 14.
whichwillbestoredin____________________________________________________________________
(Storekeeper 'sName, Surname)
___________ __________________________________________________________________________
(Address, Phone)
Theentrance ofpesticides inRepublic ofAlbania willbemade incustom points:
___________________________________________________________
Thislicence isvalid untildate: __________________________________
MINISTER
2English only