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LawofGeorgiaonDrugsandPharmaceuticalActivityThis Law creates legal basis for stateprovisionof lawful practice regarding circulationof pharmaceutical

products(10.08.2009#1586beeffectivefromOctober15,2009)

ChapterI.GeneralProvisions

Article 1.The regulation subject of the Law and its scope of use (10.08.2009 #1586 be effective from

October15,2009)

1. LegislationofGeorgiaondrugs andpharmaceutical activity includes theConstitutionofGeorgia,

InternationalcontractsandagreementsofGeorgia,thisLawandotherlegislativeactsandby-laws

ofGeorgia.

2. ThepurposeofthisLawistopromotethegrowthofpopulation’saccesstoreliablepharmaceutical

products forwhich the Law establishes legal framework governing circulation of pharmaceutical

productsandtherightsandobligationsofindividualsandlegalentitiesinthisfield.

3. State regulation mechanisms specified under this Law shall be applied to the

complementarymedicinal agent, biologically active supplement and paratherapeutical agent if a

person concernedonhis/herown initiative carriesout their voluntary registration in accordance

withthenationalmodeofstateregistrationofpharmaceuticalproduct.

4. Noninvasivecontraceptivemechanicalagentshallbeexemptedfromthestateregulation,specified

underthisLaw

Article11.Definitionofterms(10.08.2009#1586beeffectivefromOctober15,2009)

1. Genericpharmaceuticalproduct–Internationalunpatentedreproducedpharmaceuticalproduct.

2. Bulkpharmaceuticalproduct–pharmaceuticalproduct,whichpassedallmanufacturingstagesexcept

forfinalpacking.

3. Immunobiological drug – medicinal agent used for immunobiological prophylaxis and therapy

(vaccines,serums,testsystems).

4. Instruction – Information accompanied to pharmaceutical product and designed for personnel with

medicalandpharmaceuticaleducationand/oruser.

5. Prescription–Written applicationof a doctor to apharmacist about rules of preparation, dispensing

andadministrationofpharmaceuticalproduct.

6. Pharmaceutical product prepared by magistral prescription– pharmaceutical product prepared for

particularpatient.

7. Marking–information,representedonoriginaland/orsecondarypacking.

8. Secondarypacking–theformofpackinginwhichapharmaceuticalproductwithitsoriginalpackingis

placed.

9. Pharmaceutical product prepared by officinal prescription – pharmaceutical product, prepared in

drugstoreinaccordancewiththepharmacopeia.

10. Originalpacking–theformofpacking,whichisindirectcontactwithpharmaceuticalproduct.

11. Radioactiveanddiagnosticmedicinalagent–ionizingand/orchemicalagentusedinmedicalpractice.

12. Medical-purpose goods–medical goods, used inmedical practice for disease prevention, treatment,

diagnosis and patient care: tools, equipment, devices, medical apparatus, bandaging material,

prostheticsandorthopedicitemsetc.

13. Pharmaceutical product(medicinal agent)–drug or physiologically active, natural or synthesized

substanceortheircombination,permittedformedicalapplicationincludingcomplementarymedicinal

agent,biologicallyactivesupplementandparatherapeuticalagent,registeredvoluntarilyinaccordance

withthenationalmodeofstateregistrationofpharmaceuticalproduct.

14. Complementary(homeopathic, anthroposophical, homotoxic)medicinal agent – an agentmade from

naturalorigin (mineral,herbaloranimal) substanceor thecombinationof substances theactionand

normalityofwhichisnotprovedbyjustifiedevidences.

15. Biologicallyactivesupplement(BAD)–agentformaintenanceofphysiologicalstate.

16. Paramedicinalagent–mineral,herbaloranimaloriginagentwithcertaintherapeuticeffectcontaining

specificsubstanceofadruginsuchformandamountthatmaybeconsideredasadrugform.

17. Effectivenessofapharmaceuticalproduct–levelofpositiveinfluenceofapharmaceuticalproducton

pathologicalprocess,establishedbyscientificmethods.

18. Circulation of pharmaceutical product – activity which includes preparation, production,

standardization, quality control, packing, purchasing, shipping and transportation, storing of

pharmaceutical product, delivering of information about it to population and specialists, its

advertisement,marketing,export,import,re-export,usage,destructionandotheractivities,relatingto

thepharmaceuticalproduct.

19. Rawmaterial–rawmaterialsofanyorigin,usedforpreparationofdrugdirectlyorafteritsprocessing.

20. Authorization of pharmaceutical product for Georgianmarket– the procedure for establishment of

conformityofpharmaceuticalproductwiththerequirementsspecifiedundertheGeorgianlegislation,

on the basis of which circulation of pharmaceutical product in Georgian market is permitted in

accordancewiththeexistinglegislation.

21. Wholesale trade (wholesale distribution) of pharmaceutical product – transactions relating to the

purchase, storage, supply, export, import and re-export of a pharmaceutical product except for its

directsaletothecustomer.

22. Traceability–Possibility to establish origin of pharmaceutical product and/or its ingredients at

productionanddistributionstages.

23. Safety of pharmaceutical product –characteristic obtained based on comparative analysis of

effectivenessandharm-causingriskevaluationofpharmaceuticalproduct.

24. Agency–competentserviceundercontroloftheMinistryofLabor,HealthandSocialAffairsofGeorgia.

25. Qualityofpharmaceuticalproduct– indexofconformityof identity,quantitativecomposition,purity,

chemicalandbiologicalcomponentstothepharmacopeiastandard.

26. Controlofpharmaceuticalmarket–setofphysical,organizationalandlegalmeasuresfortheprovision

of conformity to the regulations established regarding circulation of pharmaceutical product in the

market.

27. OfficialregisterofpharmaceuticalproductsofGeorgia(hereinafterreferredtoastheRegister)–listof

pharmaceuticalproductsauthorizedforGeorgianmarket,whichismaintainedbytheAgency.

28. Minister–MinisterofLabor,HealthandSocialAffairsofGeorgia.

29. Ministry–MinistryofLabor,HealthandSocialAffairsofGeorgia.

30. Batch–specifiedamountof initialsubstanceandrelevantadjuvantagentssubjectedtoprocessing in

oneormorefurthertechnologicalprocessinsuchawaytoobtaintheirhomogeneity.

31. Batch registration–obligatory indicationof thebatchnumberandamountof sale-purchaseobject in

documents certifying transactions made in each interim link following distribution after relevant

administrativeprocedureofregistrationofpharmaceuticalproductinRevenueService,alegalentityof

publiclawoftheMinistryofFinanceofGeorgiaanditscorrespondingregistrationinadjacentzone.

32. Tradelicenseholder–holderofpharmaceuticalproductwhichproducespharmaceuticalproductsitself

ormakesanorderforitsproduction.

33. Adulteratedpharmaceuticalproduct–pharmaceuticalproductdeliberatelymislabeledwithrespectto

identityand/oritsorigin.

34. Randominspection–administrativeactionmadebytheAgency,thefrequencyandusedmethodof

whichcorrespondtotheevaluationofviolationrisk.

35. Pharmaceuticalagent–substanceorcombinationofsubstanceswithestablishedpharmacological

activityandsafety,whichisthesubjectofclinicaltrial.

36. Preclinical trial of pharmaceutical agent – pharmacological, toxicological and other scientific non-

human study of a pharmaceutical agent for the purpose of determination of its specific activity and

impactlevelonphysiologicalsystem.

37. Pharmacopeia–Setofstandardsandprovisions,specifyingqualityofpharmaceuticalproduct.

38. Pharmacopoeial standard (specification, item, monograph, temporary pharmacopeial

monograph,standard specification)–the document, describing qualitative characteristics of

pharmaceuticalproductandmethodsoftheiranalysis,whichisthebasisforqualityevaluation.

39. Distributorofpharmaceuticalproduct–wholesaleorretaildistributorofpharmaceuticalproduct.

40. Pharmaceutical –metered, finished pharmaceutical product(including, pill, tablet, capsule, ampoule,

suppository,capletetc.).

41. Pharmaceutical activity –activity of natural persons and legal entities involved in the field of

pharmaceuticalproductcirculationinaccordancewiththeregulationsestablishedundertheGeorgian

legislation.

42. Pharmaceuticalsubstance–substanceofanyorigin,withrelevantqualityandpharmacologicalactivity

usedforpreparationand/ormanufacturingofpharmaceuticalproduct.

43. Referencestandard–agentorsubstanceindicatedinpharmacopeia,withoneormoreexactlyspecified

properties, used for evaluation of instrument calibration, measurement method or quality of

substance.

44. Active substance – agent or substance received from the manufacturer, with one or more exactly

specifiedproperties,usedforevaluationofinstrumentcalibration,measurementmethodorqualityof

substance.

45. Clinicaltrial(examination,study)ofpharmaceuticalproduct–studyofimpactofpharmaceuticalagent

onhumanorganismfor thepurposeofdeterminationofsideeffects,evaluationofeffectivenessand

safetylevel.

46. Preparation of pharmaceutical product –preparation of pharmaceutical product in authorized

drugstoreinaccordancewiththemagistralorofficinalprescription.

47. Manufacturingofpharmaceuticalproduct–serialproductionofpharmaceuticalproductinenterprisein

strictcompliancewiththerequirementsofrelevantstandard.

48. Pharmaceutical product under special control –narcotic drug, psychotropic agent and/or precursor

permittedundertheGeorgianlegislation.

481 Medicinal agent equated to the pharmaceutical product under special control – pharmaceutical

product not included into the list of pharmaceutical products under special control but illegal

circulation and abuse of which creates threat to public health, aggravates narcological situation

existinginthecountryandisincludedinthelistapprovedbytheorderoftheMinister.

482 Substandard pharmaceutical product – medicinal agent, qualitative indicator(s) of which does not

correspond to thequality standardsandspecification requirements,examinedandevaluatedby the

Agencyduringregistrationprocess,and/ortotheinternationalstandards

49. Person concerned–manufacturer, trade license holder or any other natural person or legal entity

interestedinauthorizationofpharmaceuticalproductformarket,willingregistrationofpharmaceutical

product in accordancewith the recognitionor nationalmodeof state registrationof pharmaceutical

product.

50. Recognition of standards and guidelines of preclinical and clinical trials of pharmaceutical agent –

approvalofinternationalstandards,technicalregulationsandguidelinesforapplicationbytheMinistry

on the basis of Georgian legislation, including international treaties and agreements, in accordance

withwhichpreclinicalandclinicaltrialsofpharmaceuticalagentshallbeconductedinGeorgia.

51. Qualitycertificateofpharmaceuticalproduct–document,certifyingcorrespondenceofpharmaceutical

productwithpharmacopeiastandards.

52. Certificate of pharmaceutical product (CPP) – document, issued by the relevant country’s or

intergovernmental regulatory state agency of pharmaceutical products, certifying the right of a

pharmaceuticalproducttobeintroducedinitsownmarket.

53. Voluntary registration –non-obligatory registration, permitted only for complementary therapeutic

agent,biologicallyactivesupplementandparatherapeuticagent,registrationofwhichismadebythe

Personconcernedonitsowninitiative.

54. Introductionofpharmaceuticalproductauthorized forGeorgianmarketwithdifferentpackagingand

markingforthefirsttime - introductiononGeorgianmarketofpharmaceuticalproductwithoriginal

and/or secondary packaging and marking other than the packaging and marking of pharmaceutical

productauthorizedby recognitionornationalmodeof state registration, aswell as those registered

beforeOctober15,2009,whichareauthorizedforthemarketunderitscontrol,byothercountry’sor

intergovernmental regulatory state agency of pharmaceutical products, specified by the Georgian

government

Article2.Statepolicyforpharmaceuticalproductcirculation(10.08.2009#1586beeffectivefromOctober

15,2009)

Statepolicyforpharmaceuticalproductcirculationshallenvisageavailabilityofeffective,safeandhigh-

qualitypharmaceuticalproductinGeorgianmarket.

Article3.Roleofthestateinthefieldofcirculationofpharmaceuticalproduct(10.08.2009#1586be

effectivefromOctober15,2009)

1. ExecutiveauthoritiesshallprovideimplementationofGeorgianlegislationandrelevantstatepolicy

inthefieldofcirculationofpharmaceuticalproduct.

2. ThefollowingshallbethefunctionsoftheMinistry:

a) Developmentofstatepolicyinthefieldofcirculationofpharmaceuticalproduct;

b) Establishmentofregulationsandconditionsforverificationofvalidityofauthorizationbyother

country’sorintergovernmentalregulatorystateagencyofpharmaceuticalproductsofpharmaceutical

productauthorizedbyrecognitionornationalmodeofstateregistrationofapharmaceuticalproduct

forGeorgianmarket,formarketsundertheircontrol.

c) Approvalofregulationsandformatformaintainingoftheofficialregister;

d) Establishmentofrulesforwithdrawal/disposalofpharmaceuticalproductwithoutmarket

authorization,aswellasadulterated,rejected,unfitted,expiredpharmaceuticalproduct,orprovision

ofrecognitionoftechnicalregulationsofothercountry;

e) Developmentofotherrelevantlegislativeactsforthepurposeofprovisionoffulfillmentofobligations

specifiedunderthisLaw,andtheirpublicationwithinthescopeofitsowncompetence

3. ThefollowingshallbethefunctionsoftheAgency:

a) AuthorizationofpharmaceuticalproductfortheGeorgianmarket;

b) Randominspectionofapharmaceuticalproduct;

c) MaintainingofOfficialregisterandprovisionofitspublicity;

d) Granting of permissions for pharmaceutical production (except for the narcotic drug),

clinical trial of pharmaceutical agent, authorized drugstore, export or import of

pharmaceutical product subjected to special control, and monitoring of permission

conditions;

e) Carryingoutofmeasuresdirectedagainstadulterationofpharmaceuticalproduct;

f) In special cases, specified under the Georgian legislation, monitoring of withdrawal of

pharmaceuticalproductfrommarketingnetworkoritsdisposal,maintainingofregisterof

pharmaceuticalproductdistributorsandtheirrandominspection;

g) IssuanceofdocumentcertifyingauthorizationfortheGeorgianmarket;

h) Fulfillmentofotherfunctions,specifiedundertheGeorgianlegislation.

ChapterIII.Developmentofpharmaceuticalproductandpharmacologicalstudy

(10.08.2009#1586beeffectivefromOctober15,2009)

Article 4.Obligation of keeping of confidentiality and exclusivity of information about pharmaceutical

product(10.08.2009#1586beeffectivefromOctober15,2009)

1. The Agency or other body, carrying out administrative procedures shall be obliged to keep

confidentiality regarding information, delivered by the Person concerned,which on the basis of the

Georgianlegislationisconsideredasatradesecret.

2. TheAgencyshallbeobligedtokeepexclusivityregardinginformationaboutpharmaceuticalproduct,

whichmeansthat:

a) thescientific-technicalpartofregistrationdocumentationsubmittedfortheregistrationof

pharmaceuticalproductshallbeconfidentialandshallnotbedistributedasthepublic

information;

b) anyuseofscientific-technicalinformationaboutalreadyregisteredpharmaceuticalproductforthe

purposeofmakingofdecisionrelatingtotheregistrationofsimilarpharmaceuticalproductshall

notbepermitted.

3. CopyrightandpatentrightofthepharmaceuticalproductmanufacturerisprotectedunderGeorgian

legislation.

4. Non-fulfillmentbytheAgencyofobligationsspecifiedunderthisArticleshallinvolveresponsibilityin

accordancewiththeGeorgianlegislation.

Article 5.Development of new pharmaceutical product and financing of pharmacological study


Developmentofnewpharmaceuticalproductandfinancingofpharmacologicalstudyshallbefree.

Article6.RepealedfromDecember15,2009



ChapterIV.Statecontrolofthepharmaceuticalproductsafety


Article9.Theobjectiveofstatecontrolofthepharmaceuticalproductsafety

TheobjectiveofstatecontrolofthepharmaceuticalproductsafetyshallbetheprotectionofGeorgian

marketagainstadulterated,rejected,unfitted,expiredpharmaceuticalproductwithoutauthorizationfor

Georgianmarket,involvingthreattothecustomers.

Article10.Repealed(13.08.2004#377)

Article 101. Measures to be taken by the state for the provision ofpharmaceutical product safety


FortheprovisionofpharmaceuticalproductsafetytheStateshalltakethefollowingmeasures:

a)AuthorizationofpharmaceuticalproductfortheGeorgianmarket;

b)Grantingofpermissionforpharmaceuticalproduction;

c)Grantingofpermissionforclinicaltrialofpharmaceuticalagent;

d)Grantingofpermissionforauthorizeddrugstore;

e)Grantingofexportorimportpermissionforpharmaceuticalproductunderspecialcontrol;

f)Provisionofpossibilitiesforsystemmonitoringofregistrationofpharmaceuticalproductbatch;

g)Registrationofpharmaceuticalproductdistributors;

h)Randominspectionofpharmaceuticalproductdistributors.

Article11.Randominspection(10.08.2009#1586beeffectivefromOctober15,2009)

1. TheAgencyshallbeobligedtoconductrandominspectionofpharmaceuticalproductdistributors

basedonriskevaluations.

2. DuringrandominspectiontheAgencyshallbeentitledtoinspectthestateofobservationofrules

establishedforpharmaceuticalproducttraceabilityandstorageconditions.

3. Incases,specifiedundertheGeorgianlegislation,theAgencyshallbeentitledtopurchase

pharmaceuticalproductfrompharmaceuticalproductdistributorsforthepurposeofconductionof

furtherrandominspection.

4. TheAgencyshallapprovethemanualforrandominspection(technicalregulations,guidelinesinwhich

therulesandconditionsforconductionofrandominspection,includingsamplepurchasingare

represented),basedonriskevaluationorprovideitsrecognition.

Article111.Marketcontrolandmonitoring(10.08.2009#1586beeffectivefromOctober15,2009)

1. ForrandominspectionofpharmaceuticalproductbasedonriskevaluationtheAgencyshallusethe

laboratoryinspectionanddistributionchainadministrativecontrolmechanisms.

2. ForthepurposeofcontrolandmonitoringofpharmaceuticalproductsinGeorgianmarkettheAgency

shallmainlyusethedistributionchainadministrativecontrolmechanism.

3. Laboratoryinspectionmechanismshallbeusedincaseofhighriskofadulterationorunfitnessof

pharmaceuticalproductauthorizedinaccordancewiththerecognitionornationalmodeofstate

registrationofpharmaceuticalproduct,thecriteriaofwhichshallbeapprovedbytheMinister.

4. InexceptionalcasestheAgencyshallhavediscretionarypowertonotconsiderformalcriteriaforrisk

determinationanduselaboratoryinspectionmechanismsbutduringayearthefrequencyofinspection

shallnotexceed10%

Article112.Divisionofpharmaceuticalproductintogroupsforthepurposeofadvertisementandretailsale


1. Forthepurposeadvertisementandretailsalepharmaceuticalproductshallbedividedintothree

groups:

a) Firstgroupincludespharmaceuticalproductunderspecialcontrol,aswellasmedicalagent

equatedtoitintermsoflegalcirculationmode(thelistoftherapeuticagentsequatedtoa

pharmaceuticalproductunderspecialcontrol,aswellastheregulationsfortheirlegalcirculation

shallbespecifiedbytheMinister);

b) Secondgroupincludespharmaceuticalproduct,undueadministrationofwhichmaybedetrimental

tohumanhealthandlifeand/oradministrationofwhichisnotallowedonlyinaccordancewiththe

instruction,withoutdoctor'sorder,andwhichisputonprescription(rulesforwritingof

prescriptionforpharmaceuticalproductincludedintosecondgroupshallbespecifiedbythe

Minister);

c) Thirdgroupincludespharmaceuticalproduct,administrationofwhichinaccordancewiththe

instructionispermittedwithoutdoctor'sorder,andwhichisputwithoutprescription.

2. Itshallnotbeallowedtoincludepharmaceuticalproductwiththesamegenericname,formand

dosage,differenttradenameintomorethanonegroup.

3. Thelistofpharmaceuticalproducts,includedintofirstandthirdgroupsunderthisArticleshallbe

specifiedbytheMinister.

4. Pharmaceuticalproduct,includedintothirdgroupshallbespecifiedonthebasisofinternational

practice.AllotherpharmaceuticalproductsauthorizedforGeorgianmarketshallbeautomatically

includedintothesecondgroup.

Article113.Advertisementofpharmaceuticalproduct(10.08.2009#1586beeffectivefromOctober15,

2009)

1. Advertisementofpharmaceuticalproductshallmeanthematerialdistributedthroughmassmedia,as

wellasinanyformandmeansand/oractsthepurposeofwhichisthepromotionofpharmaceutical

productusage.

2. Advertisementofpharmaceuticalproductunderspecialcontrol(includedintofirstgroup),includedinto

secondgroupandapharmaceuticalproductwithoutauthorizationforGeorgianmarketshallnotbe

allowed.

3. Advertisementofpharmaceuticalproductofthirdgroupshallbeallowedonthebasisofprevious

agreementofadvertisementtextwiththeAgencyandwithfulfillmentofthefollowingconditions:

a)Ifanadvertisementofpharmaceuticalproductisdistributedasaprintedmaterial,itshallinclude

warningindication:“Priortoadministration,pleasereadtheinstruction;fordetailedinformation

aboutsideeffects,contactyourdoctor”;

b)Ifanadvertisementofpharmaceuticalproductisdistributednotasprintedmaterial,thewarning

indicationshallbeaudible;

c)IfanadvertisementofpharmaceuticalproductisdistributedviaTV,anditisperceivedvisually,as

wellasaudibly,thewarningindicationshallbevisible(readable)duringnolessthanthreeseconds

anditshallbeaudibleaswell.

4. AgreementofadvertisementtextwiththeAgencymeanstheagreementthattheadvertisementtextis

inconformitywiththeinformationindicatedininstruction.

5. Itshallnotbeallowedthattheadvertisementtextcontentofpharmaceuticalproductbedifferentfrom

theindicationsgiveninuserinstruction.

6. It shall not be allowed to indicate disease in the advertisement text of complementary therapeutic

agent, biologically active supplement and paratherapeutic agent that are not registered as a

pharmaceuticalproduct,aswellasnotregisteredvoluntarilyundernationalmodeofstateregistration

ofpharmaceuticalproduct,andtheirrepresentationasapharmaceuticalproduct.

7. Advertisement of pharmaceutical product, voluntarily registered under national mode of state

registrationofpharmaceuticalproduct is exemptedand the regulation referred to in thisArticle shall

notbeapplied,exceptforsubparagraph5thereof.

8. TheAgencyshall carryoutmonitoringofpharmaceuticalproductadvertisementwith theprovisionof

fulfillmentofconditions,establishedunderthisLaw.

9. Thefollowingshallnotbeconsideredasanadvertisement:

a) Marking,instructionofpharmaceuticalproduct;

b) Businesscorrespondence;

c) Bookletandreferencematerialsoffactualorinformationalnatureiftheinformationcontained

refersonlytothechangesofpharmaceuticalproductand/orsafetymeasures;

d) Informationrelatingtohealthand/ordiseaseifitdirectlyorindirectlydoesnotcontainany

referencetotreatmentbyapharmaceuticalproduct;

e) Deliveryofinformationaboutpharmaceuticalproducttohealthcarepractitionersandpharmacists.

10.Distributionoffirstandsecondgrouppharmaceuticalproducts,aswellaspharmaceuticalproducts

withoutmarketauthorizationforGeorgianmarkettothepopulationshallnotbeallowed.

Article114.ModesofAuthorizationofpharmaceuticalproductforGeorgianmarket

1. AuthorizationofpharmaceuticalproductforGeorgianmarketshallbecarriedoutinaccordancewith

thefollowingmodes:

a)Recognitionmodeofstateregistrationofpharmaceuticalproduct;

b)Nationalmodeofstateregistrationofpharmaceuticalproduct.

2. Thebasisforapplicationofrecognitionmodeofstateregistrationofpharmaceuticalproductshallbe

thedifferentiationofothercountry’sor intergovernmentalregulatorystateagencyofpharmaceutical

products according to reliability, authorizationof only high-quality pharmaceutical products for their

ownmarkets.

3. Requirements of safety, effectiveness and quality specified by other country’s or intergovernmental

regulatory state agency of pharmaceutical products regarding authorization of pharmaceutical

products for markets under its control shall be unilaterally acknowledged by Georgia and repeated

examinationfortheestablishmentofconformityofthesafety,qualityandtherapeuticaleffectiveness

ofpharmaceuticalproductwiththesameorsimilarrequirementsshallnotbeconducted.

Article115.TermofauthorizationofpharmaceuticalproductforGeorgianmarket(10.08.2009#1586be


1. ThetermofauthorizationofpharmaceuticalproductforGeorgianmarketshallbeestablishedin

accordancewiththerecognitionandnationalmodesofstateregistrationofpharmaceuticalproduct.

2. AfterexpirationofthetermofauthorizationofpharmaceuticalproductforGeorgianmarket,

circulationofpharmaceuticalproductexceptforitsimportshallbepermitteduptotheexpirationof

shelflifeofpharmaceuticalproductalreadyincirculationattheterritoryofGeorgia.

Article116.Officialregister(10.08.2009#1586beeffectivefromOctober15,2009)

1. Including of pharmaceutical product into official register shall mean its authorization for Georgian

market.

2. Registrationnumberofapharmaceuticalproduct,apersonconcerned,manufacturingcountry, trade

name,internationalunpatentedname(ifany),form,dosage,ifandwhennecessary,theconcentration,

registrationdateande-versionofpacking-markingsampleshallbeindicatedintheOfficialregister.

3. Official register is a public document and for free availability of information it shall be obligatory to

maintainitine-formandprovideitsavailabilityviaInternet.

4. EntryofpharmaceuticalproductintoOfficialregisterinaccordancewiththerecognitionmodeofstate

registrationofpharmaceuticalproductmaybemadeasfollows:

a) Proactively by theAgency, on thebasis of informationonpharmaceutical product authorizedby

other country’s or intergovernmental regulatory state agency of pharmaceutical products for

relevantmarket;

b) After administrative examination of homological identification document specified under Article

1110ofthisLaw,submittedbyaPersonconcerned;

c) By a Person concerned after passing of procedure of notification about introduction of

pharmaceuticalproductauthorizedforGeorgianmarketwithdifferentpackagingandmarkingfor

thefirsttime.

5. EntryofpharmaceuticalproductintoOfficialregisterinaccordancewiththenationalmodeofstate

registrationofpharmaceuticalproductshallbemadeonlyaftertheprocedurespecifiedunderArticle

1111ofthisLaw.

Article117.Recognitionmodeofstateregistrationofpharmaceuticalproduct(10.08.2009#1586be


1. Recognition mode of state registration of pharmaceutical product shall be applied to the

pharmaceuticalproduct,whichisauthorizedbyothercountry’sorintergovernmentalregulatorystate

agencyofpharmaceuticalproductsforrelevantmarket.

2. Georgian government shall specify the list of other country’s or intergovernmental regulatory state

agencies of pharmaceutical products for the purpose of recognition of pharmaceutical product

registeredbythem.

3. APersonconcerned,duringrecognitionmodeofstateregistrationofpharmaceuticalproductmaybe

anyperson.

4. A Person concerned may carry out procedure for authorization of pharmaceutical product for

Georgian market in accordance with the recognition mode of state registration of pharmaceutical

productunderthisLaw,notwithstandingtheimportpurpose.

5. In caseof introductionofpharmaceuticalproduct inaccordancewith the recognitionmodeof state

registrationofpharmaceuticalproductforthefirsttime,aPersonconcernedshallsubmitthefollowing

homologicalidentificationdocuments:

a) Certified translation of instruction in Georgian and instruction original in accordance with the

regulations,establishedbytheMinistry;

b) Pharmaceuticalproduct:

b.a.)form;

b.b.)dosage

b.c.)marking sample,whichmaybeanoriginalor representedasane-version.TheAgency shall

havediscretionauthorityregardingrequestformofmarkingsample;moreover,ifapharmaceutical

productisnotputintoproduction,theAgencyisobligedtoaccepte-versionofmarkingsampleand

afterputtingofpharmaceuticalproduct intoproduction, theAgencymayrequest replacementof

e-versionofmarkingsamplewithmaterialform;

b.d.)reference-standardinsufficientamountforconductionof2analysis(aPersonconcernedshall

beentitledtorepresentactiveagentofpharmaceuticalproduct);

c) Term of authorization of pharmaceutical product for relevant market by other country’s or

intergovernmentalregulatorystateagencyofpharmaceuticalproducts;

d) Uniquenumberofauthorizationofpharmaceuticalproductforrelevantmarket;

e) Certificate of pharmaceutical product issued by other country’s or intergovernmental regulatory

state agency of pharmaceutical products, whichmay be issued for anymarket under control of

other country’s or intergovernmental regulatory state agency of pharmaceutical products,

acknowledgedbyGeorgiangovernment;

f) Instead of the certificate of pharmaceutical product referred to in sub-paragraph “e” of this

paragraphitshallbepermittedtosubmitthedocumentequivalenttothiscertificate,whichmaybe

issued for any market under control of other country’s or intergovernmental regulatory state

agency of pharmaceutical products, acknowledged by Georgian government. Instead of the

certificate of pharmaceutical product and document equivalent thereto it shall be permitted to

submittheircertifiedcopies;

g) Methodsofanalysisthatmaybeprintedoutfrompubliclyavailablesource(pharmacopeia)orwith

indicationofsuchsource;

h) Sampleofpharmaceuticalproduct–2standardpackingortheamount,requiredfor2analyses.

6. If any document referred to in paragraph 5 of this Article includes any other information required

under homological identification documents, it shall not be necessary to submit it as a separate

document.

7. The Agency shall conduct administrative examination of homological identification document and

entertheinformationaboutpharmaceuticalproductintoOfficialregisterwithin7businessdays.

Article 118. Notification obligation of a Person concerned in case of first-time introduction of

pharmaceutical product already authorized for Georgian market with different packing-marking


1. Forthefirst-timeintroductionofpharmaceuticalproductalreadyauthorizedforGeorgianmarketwith

differentpacking-marking,re-registrationshallnotberequired.Suchpharmaceuticalproductshallbe

authorizedforGeorgianmarketonthebasisofregulations,specifiedunderthisArticlefornotification.

2. Thenotificationshallincludethefollowinginformation:

a)certified translation of instruction in Georgian and instruction original in accordance with the

regulations,establishedbytheMinistry;

b)e-versionofpackingandmarkingofthepharmaceuticalproductsample;

c)certificate issued by a person having authorization for the distribution of pharmaceutical product in

relevant country, which certifies authorization by other country’s or intergovernmental regulatory state

agency of pharmaceutical products, of medical product with such packing and marking for the market

under its control. The certificate shall be accompaniedwith the identification information about person

havingauthorizationforthedistributionofpharmaceuticalproduct;

d)Uniquenumberofauthorizationofpharmaceuticalproductforrelevantmarket.

3.Afterreceiptofnotification:

a)theAgencyshallbeobligedtoverifyinformationsubmittedbyaPersonconcerned;

b)theAgency,onlytakingintoaccountoffactualsituationshallbeentitledtoreasonablyrejectfirst-time

introduction of pharmaceutical product already authorized for Georgian market with different packing-

markingandnotifyaPersonconcernedaboutitinwriting;

c)failure to respond automatically means the consent of the Agency to first-time introduction of

pharmaceuticalproductalreadyauthorizedforGeorgianmarketwithdifferentpacking-marking.

4.IncaseofconsenttheAgencyshallbeobligedtoenterinformationintoOfficialregisterwithin5business

daysaboutpharmaceuticalproductauthorizedwithdifferentmarkingandpackingforGeorgianmarket.

Article 119.Obligationof a Person concernedduring circulationof a pharmaceutical product inGeorgian

market

1. Person concerned shall be obliged to keep the following during the period of circulation of

pharmaceuticalproductinGeorgianmarket:

a)Batchqualitycertificate;

b)Serialnumberofpharmaceuticalproduct.

2. Documentationreferredto in firstparagraphof thisArticleshallbekeptwith thePersonconcerned

duringtheperiodofpossessingofpharmaceuticalproductbyit.

3. After transferringofpharmaceuticalproducttootherperson, theresponsibility for thefulfillmentof

obligationsunderthisArticleshallberestedtoapersondirectlypossessingapharmaceuticalproduct

beforeitsrealization.

Article1110.Verificationofhomologicalidentificationdocuments

1. AfterreceiptofhomologicalidentificationdocumentsfromaPersonconcernedtheAgencyshallbe

entitledtoverifysubmitteddocumentationandtransferitscopieswithoutindicationoftradesecret

containinginformationtothepersonauthorizedfortherepresentationofthebranchofficeofrelevant

foreigncountry,registeredinaccordancewithGeorgianlegislation.

2. TheAgencyshallbeobliged to transfer thecopies referred to in firstparagraphof thisArticle to the

person authorized for the representation of the branch office of foreign country (permanent office)

uponrequest.

3. Thepersonauthorizedfortherepresentationofthebranchofficeofforeigncountry(permanentoffice)

may verify obtained documentation and in case of any doubt regarding origin and quality of

pharmaceuticalproductnotifytheAgency.

4. Incaseofnotificationfromthepersonauthorizedfortherepresentationofthebranchofficeofforeign

country (permanent office), the Agency shall be obliged to verify such information and take all

measuresspecifiedunderGeorgianlegislationincaseofjustifieddoubt.

5. After verification of homological identification documents the Agency shall enter information about

pharmaceuticalproductintotheOfficialregister.

6. IncaseofexpirationofauthorizationtermofpharmaceuticalproductforGeorgianmarkettheAgency

shallbeobligedtocancelregistrationandwithdrawitfromtheOfficialregister.

Article1111.Nationalmodeofstateregistrationofpharmaceuticalproduct(10.08.2009#1586beeffective

fromOctober15,2009)

1. Stateregistrationofpharmaceuticalproductbynationalmodeshallbecarriedoutasfollows::

a) A person interested in state registration of pharmaceutical product by nationalmodemay be a

pharmaceuticalproductmanufacturerortradelicenseholder.Personconcernedshallsubmittothe

Agency the application and attached documents. The application shall met the requirements of

Article78ofGeneralAdministrativeCodeofGeorgia;

b) Registrationdocumentsincludeadministrativeandscientific-technicalparts;theAgencyshallcarry

outtheiradministrativeandscientific-technicalexamination;

c) Administrative part of registration documents shall be submitted in Georgian and scientific-

technicalpart–inGeorgian,RussianorEnglishinthreecopies;moreover,scientific-technicalpart

maybesubmittedine-versionform;

d) The Agency no later than within 14 days shall inspect conformity of submitted registration

documentswiththerequirementsofthisArticle,i.e.carryouttheiradministrativeexamination;

e) Onthebasisofaffirmativeconclusionofadministrativeexamination,registrationdocumentsshall

be subjected to further scientific-technical examination for the purpose of determination of

standardization,quality,safetyandtherapeuticeffectivenessofapharmaceuticalproduct;

f) For elimination of defects revealed at administrative or scientific-technical examination stage, a

Personconcernedshallbegiven the termup to2months. In caseof failure toeliminatedefects

withinthisperiod,theregistrationdocumentsshallnotbeexamined;

g) IncaseofnecessitytheAgencyshallbeentitledtoadditionally involveexperts inexaminationof

registrationdocumentswhoshallberesponsiblefortheobjectivenessoftheirownconclusions.

2. Changes relating to the active agent, form, activity strength (dosage, concentration), administration

method(way)andproductionofpharmaceuticalproductshallbeconsideredasIIcategory(withspecial

significance)changesandrequireregistration.

3. Changesreferredtoinparagraph21ofthisArticleshallbeconsideredasIcategory(withrelativelyless

significance)changesandrequiredeliveryofinformationaboutchangetotheAgency.

4.In caseofnon-fulfillmentof conditions referred to inparagraph3of thisArticle, such change shallbe

movedtoIIcategorychangesandrequireregistration.

5.IncaseofchangesofIandIIcategory:

a)thefollowingshallbesubmitted:

a.a)reasoningofchange;

a.b)documentationcertifyingsuchchange;

a.c)relevantupdatedregistrationdocumentation;

b)Registrationofchangeshallnotinvolvechangingofregistrationterm.

6. Forre-registrationofpharmaceuticalproduct,registrationdocumentationshallbesubmittednolater

than2monthsbeforeexpirationofregistrationterm,otherwise,registrationofpharmaceutical

productshallbecarriedoutbyinitialregistrationmode.

7. Duringre-registrationofpharmaceuticalproductaPersonconcernedshallbeobligedtosubmit

documentationreferredtoinparagraph19ofthisArticleanddata,publicationsandreferencesonside

effectsofapharmaceuticalproductforrecent5yearsandattachthedocumentcertifyingpaymentof

registrationfee.

8. Counting of the term of registration procedure, including re-registration, registration of change and

registration-listingshallbestartedfromthemomentofsubmissionofregistrationdocumentsinfull.

9. During registration procedure the Agency shall make a decision about registration, or rejection or

approvalofregistrationofchange,includingforregistrationofIIcategorychange-within3months,re-

registrationand registration-listingofpharmaceuticalproduct–within2months, for registrationof I

category,“a”typechange–within10daysandforregistrationofIIcategory,“b”typechange-within

1monthsandthisshallbedocumentedthroughadministrativeact.

10. Incaseofrejectionofpharmaceuticalproductregistration,theAgencyshallbeobligedtoimmediately

deliverjustifiedrefusalinwritingtothePersonconcern.IfcaseoffailuretonotifythePersonconcern

about decision on rejection of registration within the terms specified in subparagraph “d” of first

paragraphandparagraph9ofthisArticle,apharmaceuticalproductshallbeconsideredregisteredand

theAgency shall beobliged to issue thedocument certifyingauthorization forGeorgianmarket. The

document certifying authorization for market shall be executed within 10 days after issuance of

administrative act on registration. Administrative act and the document certifying authorization for

Georgianmarketareequallyvaliddocuments.

11. Ifapharmaceuticalproductisnotputintoproduction,theAgencyshallbeobligedtoaccepte-version

of marking sample and after putting of pharmaceutical product into production the Agency may

requestreplacementofthee-versionofmarkingsamplebymaterialform.

12. TheAgencyshallcancelregistrationofpharmaceuticalproductinGeorgia:

a)uponrequestofthePersonconcerned;

b)iftherewasrevealedthatpharmaceuticalproducthaspropertiescausingharmtohumansandtheir

descendants.

13. Theagency, temporarily,untileliminationof registrationsuspensioncause,shall suspendregistration

ofpharmaceuticalproductinGeorgia:

a)uponrequestofthePersonconcerned;

b)incaseofchangingofanypartofregistrationdocuments,whicharenotregisteredand/orlistedin

accordancewiththeestablishedregulationsandform.

14. TheAgencyshallcancelthedocumentcertifyingauthorizationforGeorgianmarket:

a)incaseofcancellationofpharmaceuticalproductregistration;

b)incaseofnecessityof issuanceofanewdocumentcertifyingauthorizationofpharmaceuticalproduct

forGeorgianmarket.

15. Expirationof registration termshall involve cancellationof thedocument certifyingauthorization for

Georgianmarket.

16. CirculationofpharmaceuticalproductattheterritoryofGeorgiashallbepermittedduring5yearsafter

itsregistrationandafterexpirationofregistrationterm–uptoexpirationofitsshelflife.

17. Incaseofchange,circulationattheterritoryofGeorgiaofpharmaceuticalproductexistingbeforesuch

changeispermitteduptotheexpirationofitsshelflife.

18. Pharmaceutical substance, bulk and intermediate pharmaceutical products, pharmaceutical products

prepared inaccordancewith themagistral andofficinalprescriptions, allergendesigned for specific

naturalpersonshallnotrequireregistration.

19. Inadministrativepartofregistrationdocumentsthefollowingshallbesubmitted:

a. Applicationcontainingtableofcontentforattacheddocuments(withtheindicationofpages);

b. Original application about registration of pharmaceutical product to be represented in Georgia

undernationalmodeofstateregistrationofpharmaceuticalproduct;

c. Original document certifying granting of representation authority by the Person concerned to

naturalpersonorlegalentity;

d. Pharmaceutical product certificate in the form, recommended by World Health Organization

(original) or in its absence–the document certifyingmanufacturing of pharmaceutical product in

accordance with GMP standards or manufacturing license of pharmaceutical product, issued by

authorizedagencyofmanufacturingcountry;

e. Standard packing of pharmaceutical product to be registered with standard marking (or in e-

version);

f. IncaseofregistrationofpharmaceuticalproductmanufacturedinGeorgia-instructioninGeorgian,

andincaseofregistrationofimportedpharmaceuticalproduct–certifiedtranslationofinstruction

inGeorgianandoriginalinstructioninaccordanceregulationsestablishedbytheMinistry.

20. Inscientific-technicalpartofregistrationdocumentsthefollowingshallbesubmitted:

a)Fortheregistrationofaninnovative(new)pharmaceuticalproduct:

a.a)Document,certifyingregistrationofpharmaceuticalproductinmanufacturingcountry,aswellasin

othercountries(ifany);

a.b)Chemicalcompositionofpharmaceuticalproduct,withtheindicationofallingredientsandtheir

amountsperunitdose;

a.c)Monographsaboutactivesubstance(s)(specificationandmethodsofanalysis);

a.d)Nameandaddressofmanufacturer(s)ofactivesubstance(s),bulkpharmaceuticalproduct;

a.e)Monographs or references to themonographs represented in sets of international standards about

non-activesubstance(s)(specificationandmethodsofanalysis);

a.f)Monographsaboutmethodsofanalysisofpharmaceuticalproductincludingspecification;

a.g)Pharmaceuticalproductmanufacturingflowdiagram;

a.h) Sample of pharmaceutical product – 2 standard packing plus amount, required for 2 analyses,with

relevantqualitycertificate;

a.i) Reference standard(s) in the amount, sufficient for conduction of 2 analysis with relevant quality

certificate;

a.j)Dataonstabilityofpharmaceuticalproduct;

a.k)Dataformpreclinicaltrialaboutspecificpharmacologicalactivityofpharmaceuticalproduct,namely:

a.k.a)pharmacodynamicaction;

a.k.b)mechanismofaction

a.l)Dateofpharmacokineticstudy;

a.m)Dataoftoxicologicalstudyaboutacute,subacuteandchronictoxicity;

a.n)Informationonteratogenicity,embryotoxicity,mutagenicity,carcinogenicityandallergenicity;

a.o)Clinicaldataonpharmacokinetic,pharmacodynamicsandsideeffects;

a.p)Clinicaltrialreportofpharmaceuticalproduct;

a.q)Summarizeddataonsideeffects;

a.r)Experienceinclinicalapplicationofpharmaceuticalproduct:

a.r.a)Interactionwithotherpharmaceuticalproduct;

a.r.b)publicationsandreferences;

b)Fortheregistrationofgenericandreproducedpharmaceuticalproduct:

b.a)Chemical composition of pharmaceutical product, with the indication of all ingredients and their

amountsperunitdose;

b.b)Relevantdocumentcertifyingauthorizationofreproductionofpharmaceuticalproductonthebasisof

license(ifany);

b.c.)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout

activesubstance(s)(specificationandmethodsofanalysis);

b.d)Nameandaddressofmanufacturer(s)ofactivesubstance(s);

b.e)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout


b.f)Monographsaboutmethodsofanalysisofpharmaceuticalproductincludingspecification;

b.g)Pharmaceuticalproductmanufacturingflowdiagram;

b.h)Sampleofpharmaceuticalproduct–2standardspackingplusamount,requiredfor2analysis,with


b.i)Referencestandard(s)intheamount,sufficientforconductionof2analysiswithrelevantquality

certificate;

b.j)Dataonstabilityofpharmaceuticalproduct;

b.k)Informationonbioequivalenceortherapeuticequivalence,takingintoaccountofaformand

introductionwayofpharmaceuticalproduct(inaccordancewiththerecommendationsofWorldHealth

Organization);

b.l)Publicationsandreferences;

c)Fortheregistrationofbloodpreparation:

c.a)document,certifyingregistrationofbloodpreparationinmanufacturingcountry,aswellasinother

countries(ifany);

c.b)Chemicalcompositionofbloodpreparationwiththeindicationofallingredientsandtheiramountsper

unitdose;

c.c)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout


c.d)Nameandaddressofmanufacturer(s)ofactivesubstance(s);

c.e)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout


c.f)Monographsaboutmethodsofanalysisofbloodpreparationincludingspecification;

c.g)Bloodpreparationmanufacturingflowdiagram;

c.h)Sampleofpharmaceuticalproduct–2standardpackingplusamount,requiredforanalysis,with

relevantqualitycertificateapprovedbyauthorizedagency;

c.i)Referencestandard(s)intheamount,sufficientforconductionof2analysiswithrelevantquality

certificate;

c.j)Dataonstabilityofbloodpreparation;

c.k)Descriptionofclosedcontainersystem;

c.l)Informationabouteffectivenessandsafetyofbloodpreparation(intheformat,recommendedby

WorldHealthOrganization)withthedescriptionofmethodsusedforinactivationofviruses;

c.m)publicationsandreferences;

d)Forregistrationofimmunobiologicaldrug:

d.a)document,certifyingregistrationofimmunobiologicaldruginmanufacturingcountry,aswellasin

othercountries(ifany);

d.b)Methodandmaterialofproductionofimmunobiologicaldrug;nameandaddressofmanufacturer(s);

d.c)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout


d.d)Monographsonmethodsofanalysisofimmunobiologicaldrug,includingspecification;

d.e)Immunobiologicaldrugmanufacturingflowdiagram;

d.f)Sampleofimmunobiologicaldrug–2standardpackingplusamount,requiredforanalysis,with


d.g)Dataonstabilityofimmunobiologicaldrug;

d.h)Clinicaldataoneffectiveness,safetyandsideeffectsofimmunobiologicaldrug;

d.i)Interactionwithotherpharmaceuticalproduct;

d.j)Publicationsandreferences;

e)Forregistrationofparatherapeuticagent:

e.a)Chemicalcompositionofparatherapeuticagent,withtheindicationofallingredientsandtheir

amountsperunitdose;

e.b)Monographsaboutactivesubstance(s)(specificationandmethodsofanalysis);

e.c)Nameandaddressofmanufacturer(s)ofactivesubstance(s);

e.d)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout


e.e)Monographsaboutmethodsofanalysisofparatherapeuticagent,includingspecification;

e.f)Paratherapeuticagentmanufacturingflowdiagram;

e.g)Dataonstabilityofparatherapeuticagent;

e.h)Sampleofparatherapeuticagent–2standardspackingplusamount,requiredforanalysis,with


e.i)Referencestandard(s)(ifrequired)intheamount,sufficientforconductionof2analysiswithrelevant

qualitycertificate;

e.j)Dataonstabilityandeffectivenessofparatherapeuticagent;

f)Fortheregistrationofradiopharmaceuticals:

f.a)Document,certifyingregistrationofradiopharmaceuticalinmanufacturingcountry,aswellasinother

countries(ifany);

f.b)Compositionofradiopharmaceutical,withtheindicationofallingredientsandtheiramountsperunit

dose,specificorrelativeactivity;

f.c)Monographsaboutactivesubstance(s)(specificationandmethodsofanalysis);

f.d)Methodsofproductionofactivesubstance(s);nameandaddressofmanufacturer(s);

f.e)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout


f.f)Monographsaboutmethodsofanalysisofradiopharmaceutical,includingspecification;

f.g)Radiopharmaceuticalmanufacturingflowdiagram;

f.h)Qualitycertificateofradiopharmaceutical,approvedbyauthorizedagency;

f.i)Dataonstabilityofradiopharmaceutical;

f.j)Dataineffectivenessandsafetyofradiopharmaceutical(incaseoftherapeuticradiopharmaceutical);

f.k)Dataonsafetyofradiopharmaceutical(incaseofdiagnosticradiopharmaceutical);

g)Forregistration–listingofbiologicallyactivesupplement(BAD)designedforphysiologicalstate:

g.a)CompositionofBAD;

g.b)MethodofanalysisofBAD;

g.c)SampleofBAD–2standardpackingplusamount,requiredfor2analysis,withrelevantquality

certificate;

g.d)Freesalecertificate(ifany);

h)Forregistration–listingofcomplementarytherapeuticagent:

h.a)Fullcompositionofcomplementarytherapeuticagent;

h.b)Methodofanalysisofcomplementarytherapeuticagent;

h.c)Sampleofcomplementarytherapeuticagent–2standardpackingplusamount,requiredfor2analysis,

withrelevantqualitycertificate;

h.d)Monographsaboutexperienceinusageofcomplementarytherapeuticagentinmedicalpractice,as

wellasaboutitseffectivenessandsafetywithrelevantreferences;

h.e)Justificationofactionandpurposeofcomplementarytherapeuticagentonthebasisofmedicinal

principles;

i)Fortheregistrationofcontraceptivemechanicalagent(exceptfornoninvasivecontraceptivemechanical

agent):

i.a)Nameandaddressofmanufacturer(s)ofcontraceptivemechanicalagent;

i.b)Standard,specifyingqualityassessmentcriteria;

i.c)2samplesofcontraceptivemechanicalagentwithrelevantqualitycertificate;

j)Forregistration-listingofdentalproducts:

j.a)Name,compositionofdentalproduct,informationaboutitscomponentsandpurpose;

j.b)Standard,specifyingqualityassessmentcriteria;

j.c)Qualitycertificateofdentalproduct;

j.d)Informationondentalproductsafety;

j.e)Sampleofdentalproduct;

k)Forregistration-listingofdiagnosticagents:testsystems(accordingtonosologies),allergens(exceptfor

allergensdesignedforspecificnaturalperson),reagents(forclinicalbiochemistryandclinical

chemistry)andserums:

k.a)Purposeofdiagnosticagentandapplicationmethod(thelistwiththeindicationofcataloguenumber

ofmanufacturercompanyand/orcatalogue(ifany);

k.b)Informationonsafetyandeffectivenessofdiagnosticagent–incaseofINVIVOapplication;

k.c)Qualityassessmentcriteriaandinformationonstabilityofdiagnosticagent(ifrequired).

21.Icategory(withrelativelylesssignificance)changes:

a)Icategory„a“typechanges:

a.a.)Changesinmanufacturinglicense

Requirements–updatedmanufacturinglicenseshallbesubmitted;

a.b)Changingofpharmaceuticalproductname

Requirements:

a.b.a)Newnameshallnotcauseanymisleadingwithrespecttointernationalunpatentednameand/or

registeredpharmaceuticalproductname;

a.b.b)Incaseofgeneralrecognizedname,thechangeismadewithrespecttopharmacopeialnameor

internationalunpatentedname;

a.c)Changingofnameand/orlegaladdressoftradelicenseholder–anentitywithregistrationauthority

Requirements–manufacturershallnotbechanged;

a.d)Changingofactivesubstancemanufacturer

Requirement–Specificationandqualitycontrolmethodsofsubstanceshallcorrespondtothe

internationallyrecognizedpharmacopeia;

a.e)Changingofinscription,coatingorothermarkings,imprintsontabletsandinscriptiononcapsules

Requirements–newinscriptionshallnotcauseanymisleadingwithrespecttoothertabletsandcapsules;

a.f)Changingofinitialpackagemarking,secondarypackagemarkinganddesign

Requirements–2newsamplesshallberepresented;

a.g)Changingofamountofpharmaceuticalproductinpackage

Requirements–packingmaterialshallnotbechanged;

b)Icategory„b“typechanges:

b.a)Changingofnon-activesubstance

Requirements–shallnotbechanged:

b.a.a)similarfunctionalproperties;

b.a.b)forsolidtherapeuticforms–solubilitylevel;

b.b)removalofpaintorreplacementofonepaintwithother;

b.c)addition,removalorchangingofflavoringagents

Requirements–shallnotbechanged:

b.c.a)similarfunctionalproperties;

b.c.b)forsolidtherapeuticforms–solubilitylevel;

b.d)changingoftabletcovermassorcapsulecovermass

Requirements–solubilitylevelshallnotbechanged;

b.e)qualitativechangingofinitialpackingcontent

Requirements–offeredpackingmaterialshallbeequivalenttopreviousone,withrelevant

properties;changesshallnotaffectsterileproducts;

b.f)removalofanyindicationofapplicationorofoneofintroductionways

Requirements–safetyofapplicationandqualityofpreparationshallbemaintainedandjustifiedbythe

retrospectivepreclinicaltrialdata;

b.g)Insignificantchangesinproductionofactivesubstance

Requirements–Undesirablechangesshallnotbemadeinthespecificationofsubstance,aswellas,

physicalpropertiesofsubstanceshallnotbechanged,nonewadditivesshallbeaddedorlevelofadditives

shallnotbechangedthatrequiresconductionofstudyforestablishmentoffinishedproductsafety;

b.h)Changingofseries/batchamountofactivesubstance

Requirements–Dataanalysisoncontrolofsubstanceshallindicatethatmanufacturingprocessuniformity

hasnotbeendisturbedand/orphysicalpropertiesofsubstancehavenotbeenchanged;

b.i)Insignificantchangesinpharmaceuticalproductmanufacturing

Requirements–Specificationofpreparationshallnotbechanged;newtechnicalprocessshallprovide

manufacturingofidenticalpreparationintermsofquality,effectivenessandsafety;

b.j)Changingoffinishedproductproductionbatchvolume

Requirements–manufacturingprocessuniformityshallnotbedisturbed;

b.k)Changingofpharmaceuticalproductspecification

Requirements–Specificationshallbeimprovedornewtestsforthepreparationqualitycontrolshallbe

addedandrangeofvariationofparametersshallbespecified;

b.l)Synthesisorrecoveryofsupplements,whicharedescribedininitialregistrationdocumentationandare

notindicatedinpharmacopeia

Requirements–Specification,compositionofadditivesortheirlevelshallnotbechangedthatrequires

conductionofstudyforestablishmentoffinishedproductsafety;aswellas,physical-chemicalpropertiesof

finishedproductshallnotbechanged;

b.m)Changingofspecificationofpharmaceuticalproductsupplement(exceptforvaccinesadjuvant)

Requirements–Specificationshallbeimprovedornewtestsforthepreparationqualitycontrolshallbe

addedandrangeofvariationofparametersshallbespecified;

b.n)Prolongationofshelflifeofpharmaceuticalproductindicatedduringlicensing

Requirements–Dataonstabilityofpreparationshallbesubmittedaccordingtoprotocolapprovedduring

obtainmentoftradelicense;thedatashallindicatethattheshelflifehasnotbeenchanged;itshallnot

exceed5years;

b.o)Changingofshelflifeafteropeningofpackingforthefirsttime

Requirements–Analysisofdataonpreparationstabilityshallindicatethattheshelflifeofpreparationhas

notbeenreducedinaccordancewiththespecificationapprovedduringobtainingoftradelicense;

b.p)Changingofshelflifeofpharmaceuticalproductafteritsrecovery


notbeenreducedinaccordancewiththeapprovedspecification;

b.q)Changingofstorageconditions


notbeenreducedinaccordancewiththespecificationapprovedduringobtainingoftradelicense.Dataon

stabilityinaccordancewiththespecificationapprovedduringobtainingoftradelicenseshallbesubmitted;

b.r)Changingoftestmethodofactivesubstance

Requirements–Resultsofmethodvalidation(inspectionofreliability)shallindicatethatthenewtest

methodisequaltopreviousone;

b.s)Changingofqualitycontrolmethodofpharmaceuticalproduct

Requirements–Preparationspecificationshallnotbechanged;resultsofmethodvalidationshallindicate

thatthenewmethodofqualitycontrolisequaltopreviousone;

b.t)Relevantchangingofamendmentmadetopharmacopeia

Requirements–Changeshallbemadeonlyforthepurposeofimplementingofnewamendmentto

pharmacopeia;

b.u)Changingoftestmethodfornon-pharmacopeialsupplement

Requirements–Resultsofmethodvalidationshallindicatethatthenewtestmethodisequaltoprevious

one;

b.v)Changingoftestmethodforinitialpacking


one;

b.w)Changingoftestmethodforinductiondevice


one;

b.x)Changingofinitialpackingform

Requirements–Qualityandstabilityoffinishedproductplacedintopacking,aswellas,interactionof

packingmaterialandpreparationshallnotbechanged;

b.y)Changingofsizeandaverageweightoftablets,capsulesandsuppositorieswithoutqualitativechanging

oftheircontent

Requirements–solubilitylevelshallnotbechanged.

22.IIcategorychangesrequiringregistration:

a)Changingofpharmaceuticalproductform,strengthandadministrationmethod:

a.a)Changingofbiopenetration;

a.b)Changingofpharmacokinetics;

a.c)Changingofpharmaceuticalproductefficiency;

a.d)Changingoftherapeuticformoradditionofnewtherapeuticform;

a.e)Additionofnewapplicationmethod;

b)Changingofactivesubstances:

b.a)Additionofoneormoreactivesubstances,includingantigeniccomponentofvaccine;

b.b)Removalofoneormoreactivesubstances,includingantigeniccomponentofvaccine;

b.c)Changingofamountofactivesubstance;

b.d)Replacementofactivesubstancewithothersalt(etherealcomplex)derivative(bycomponentswith

thesametherapeuticproperties),otherisomer,isomermixorisolatedisomermix;

b.e)Replacementofbiologicalsubstanceorbiotechnologicalproductwithothersubstanceorproduct

havingdifferentmolecularstructure;carriermodification,whichisusedforproductionofantigenmaterial;

c)Changingoftherapeuticindications:

c.a)Additionofindicationofadministrationinotherfieldoftherapy(treatment,prophylaxis,diagnostics);

c.b)Removalofindicationofadministrationinotherfieldoftherapy(treatment,prophylaxis,diagnostics);

d)Changingofmanufacturingplace.

23.Amountoffeeforstateregistrationofpharmaceuticalproductundernationalmodeshallbespecified

inaccordancewiththisLaw.

Article1112.Sampleofpharmaceuticalproduct(10.08.2009#1586beeffectivefromOctober15,2009)

1. Sampleofpharmaceuticalproductisthepossibilityofcomparisonwithpharmaceuticalproductexisting

indistributionchainforthepurposeofconductionofrandominspectionbytheAgency.

2. TheAgencyshallusesampleofpharmaceuticalproductforvisualcomparisonofpharmaceutical

productmarkingandduringlaboratoryinspection.

3. Rulesforreplacementofpharmaceuticalproductsamples,keptbytheAgencyshallbespecifiedbythe

Minister.

Article1113.Exceptionalcasesofimportofpharmaceuticalproductwithevasionofauthorizationmodes

forGeorgianmarket(10.08.2009#1586beeffectivefromOctober15,2009)

PharmaceuticalproductwithevasionofauthorizationmodesforGeorgianmarketmaybeimportedfor

non-commercialpurposesinthefollowingcases:

a) Forpreclinicalandclinicaltrials;

b) Forregistration,intheformofsample;

c) Forindividualneedsofnaturalperson;

d) Forexhibition,symposium,conference,forumandcongress-intheformofsample,without

distributionauthority;

e) Forre-export;

f) Forthepurposeofstorageincustomswarehouse/customsterminaland/orforincludingin

transitcommoditytransaction;(27.03.2012.#5961)

g) Asanbulkpharmaceuticalproductdesignedforlocalproduction;

h) Inspecialcases(ActsofGod,massinjuryofpopulation,epidemic,raredisease)for

humanitarianaidpurposes,aswellasincaseofspecialpublicinterestsunderconsentof

theMinistry.(17.12.2010.#4125)

ChapterV.Manufacturingofpharmaceuticalproduct

Article12.Manufacturingofpharmaceuticalproduct

1. Manufacturingofpharmaceuticalproductshallbesubjectedtoauthorizationmode.

2. Manufacturing of pharmaceutical product, which is not registered in Georgia, shall be permitted for its

registration,itspreclinicalandclinicaltrials,export.

3. ManufacturingpermissionforpharmaceuticalproductshallbeissuedbytheAgency.

4. Georgiaselectivelyacknowledgesthelistofinternational,regionalandnationalGMP(goodmanufacturing

practice)standards,whichshallbeacknowledgedbytheGeorgiangovernment.

5. Authorization conditions for pharmaceutical product shall be specified in accordancewith the Georgian

legislation.

6. ForthepurposeofthisLaw,theauthorizeddrugstore,whichpreparespharmaceuticalproductonthebasis

magistral or officinal formula, as well as the drugstore of such medical institution, which carries out

prepackagingofpharmaceuticalproductinrequiredamountsforitsusageinhealth-careinstitutions,shall

notbeconsideredasapharmaceuticalproductmanufacturingandnopermissionshallberequired.

7. Thepersonmanufacturingpharmaceuticalproductbatchesshallberesponsibleforthesafety,qualityand

effectivenessofmanufacturedpharmaceuticalproduct.

8. IntroductionofnationalGMPstandardformanufacturingshallbecarriedoutbytheGeorgiangovernment

instages,inaccordancewiththeriskmanagementprinciple

Article13.Repealed.(18.12.2001.#1119.SakanonmdebloMatsne#36)

Article14.Repealed(10.08.2009#1586beeffectivefromOctober15,2009)

Article15.Repealed(18.12.2001.#1119.SakanonmdebloMatsne#36)

ChapterVI.Saleofpharmaceuticalproduct(10.08.2009#1586beeffectivefromOctober15,2009)

Article16.Wholesaleandretailsaleofpharmaceuticalproduct

1. Retailsaleofpharmaceuticalproductshallbemadebyauthorizeddrugstore,drugstore(specializedtrade

object), and retail facility, and in cases, specified under the Georgian legislation – personnel with

pharmaceuticaleducationoranaturalperson,theentityofindependentmedicalactivity.

2. Authorized drug store shall be subjected to authorization control and it shall be entitled to sell

pharmaceuticalproducts,includedintofirst,secondandthirdgroups,aswellastopreparepharmaceutical

productinaccordancewiththeofficinalormagistralprescription.

3. Drugstore(specializedtradeobject)shallbeentitledtosellpharmaceuticalproducts,includedintosecond

andthirdgroups,andretailfacility–onlythepharmaceuticalproductsincludedintothirdgroup;moreover,

theremaybeseparated,isolateddrugstore(specializedtradeobject)withindependententrance,aswell

asadrugstore,locatedintoretailfacility(specializedtradeobject)intheformofisolatedarea.

4. For the purpose of improvement of population access to the pharmaceutical products, personnel with

pharmaceuticaleducationoranaturalperson,theentityofindependentmedicalactivityshallbeentitled

to carryout retail saleof pharmaceutical product (except for thepharmaceutical productsunder special

control)invillagesandsettlements.

5. Commencementandfinishingofpharmaceuticalproductwholesaleandretailsaleshallbesubjectedto

obligatorynotificationoftheAgency;theformandrulesofnotificationshallbeapprovedbytheMinister.

6. Applicationofsuchpharmaceuticalproductunderspecialcontrolbyamedicalserviceprovider,whichis

thepartofmedicalservice,shallnotrequireauthorization.

7. Authorizationconditionsofauthorizeddrugstoreforsaleofpharmaceuticalproductunderspecialcontrol

andtheruleofsellingofsuchproductshallbespecifiedinaccordancewiththeGeorgianlegislation.

8. Itshallnotbepermittedtosellpharmaceuticalproductatmarketandfair,aswellasfromopen-typeretail

facilityandnon-stationaryretailplace.

9. Itshallnotbepermittedtosellpharmaceuticalproductsoffirstandsecondgroupsinaccordancewith

Article112ofthisLawtojuveniles.(30.07.2013#907).

10. Sellingofthefollowingmedicalagentswithoutprescriptionshallnotbepermitted:

a)Pharmaceuticalproducts,includedintofirstgroup;

b)Pharmaceuticalproducts,includedintosecondgroup.

Article17.Requirementsforpharmaceuticalproductdistributor(10.08.2009#1586beeffectivefrom

October15,2009)

1. Principle of regulation of pharmaceutical product distribution shall be the provision of storage and

dispensing conditions and due maintaining of documentation required for registration of batch of sold

product.

2. Pharmaceuticalproductdistributorshallbeobligedtoregisterpharmaceuticalproductbatchdesignedfor

salebyit.

3. Pharmaceutical product distributor shall be obliged to introduce modern technologies for storage of

pharmaceuticalproductandprovidestorageofpharmaceuticalproductanditsfurtherrealization insuch

conditionsthatprotecttheproductagainstnegativeimpactofambientfactors(temperature,humidity).

4. Pharmaceutical product distributor shall be obliged to store pharmaceutical product in accordancewith

sanitary-hygienic/technicalconditions,specifiedintheinstructionofrelevantpharmaceuticalproduct.

5. Sanitary-hygienic/technical conditions for drug store (specialized trade object) and retail facility shall be

specifiedbytheMinistryinaccordancewiththisArticle.

6. Inretailfacilitysellingofpharmaceuticalproductshallbepermittedif:

a) pharmaceuticalproductisdisplayedinplacespeciallydesignedforitbyspecialindicationinsuchawaythat

it is separated from other products and it is possible to clearly distinguish such pharmaceutical product

fromotherproducts;

b) for drug store (specialized trade object) located in retail facility there is allocated independent, isolated

area for pharmaceutical product distribution, andmoreover if distribution of pharmaceutical product in

such drug store (specialized trade object) is carried out by the responsible personnel with medical or

pharmaceuticaleducation(hereinafterreferredtoastheResponsiblepersonnel),whoarenotallowedto

makesimultaneoussupervisionoverotherproductsand/orexecutionofotherwork;

c) inaccordancewiththestorageconditionsindicatedintheinstruction,pharmaceuticalproductisprotected

againstnegativeimpactofambientfactors(includingdirectsunlight,humidity,temperatureetc.).

d) distribution, storage and placement of pharmaceutical product is carried out with full observance of

sanitary-hygienicconditions.

7. PharmaceuticalproductincludedinsecondgroupshallnotbeavailableforcustomerswithoutResponsible

personnel, and pharmaceutical product included in third group shall be available for customers in

accordancewiththerequirements,referredtointhisLawwithoutResponsiblepersonnel.

8. Expiredandunfittedpharmaceuticalproduct,beforeitsdisposalshallbekeptindependently,isolatedfrom

otherpharmaceuticalproducts.

9. If pharmaceutical product distributor has justified doubts that pharmaceutical product does not have

authorizationforGeorgianmarket,itisadulterated,rejected,unfitted,expired:

a) theDistributorshallbeobligedto:

a.a)suspenddistributionofsuspiciouspharmaceuticalproduct;

a.b)immediatelynotifytheAgencyaboutit.

b) TheAgencyshallbeobligedto:

b.a)verifyinformationfromtheDistributor;

b.b)notifytheDistributorwithinreasonableperiodoftimeifthedoubtisnotproved;

b.c)providesupervisionofwithdrawalofpharmaceuticalproductfromwholesaleandretailsalenetworkif

it is identified that the pharmaceutical product batch is unauthorized for Georgianmarket, adulterated,

rejected,unfitted,expired.

Article171.Forfeitureanddisposalofpharmaceuticalproduct(10.08.2009#1586beeffectivefrom

October15,2009)

PharmaceuticalproductshallbesubjectedtoforfeiturebytheAgencyanddisposalatthecostofproduct

owner in accordance with the regulations, approved by the Ministry or on the basis of acknowledged

guidelines,if:

a) itisunauthorizedforGeorgianmarket,adulterated,rejected,unfitted,expired;

b) it is found out that as result of unforeseen mistake made at manufacturing stage, it is unduly marked

and/ormaycreatethreattocustomer’slifeorhealth.

ChapterVII.Repealed(10.08.2009#1586beeffectivefromOctober15,2009)

ChapterVIII.Substances,agentsunderspecialcontrolandtheirpharmaceuticalforms

Article20.Substances,agentsunderspecialcontrolandtheirpharmaceuticalforms

1. Inthefieldofpublichealthandinaccordancewiththestatepolicyfortheprovisionofpublicorder,

narcoticdrugsandtheircontainingagents,poisonsandpoison-containingagents,separatepsychotropic

andpotentagentsshallbesubjectedtospecialstatecontrol.

2. Listofsubstances,agentsunderspecialcontrolandtheirpharmaceuticalformsshallbeinaccordancewith

theinternationalconventionsinthisfield.

3. TheMinistryofLabor,HealthandSocialAffairsofGeorgiawhenrequiredshallsupplementtheselists

takingintoaccountlocalnarcologicalsituationandpracticeoflawenforcementandinvestigationagencies.

Article21.Controloflegalcirculationofsubstances,agentsunderspecialcontrolandtheirpharmaceutical

forms

1. Manufacturingandlegalcirculationofsubstances,agentsunderspecialcontrolandtheirpharmaceutical

formsshallbegovernedinaccordancewiththeGeorgianlegislation.

2. Annualdemandonnarcoticdrugs,relevantquotas,includingexportandimportofsuchsubstancesshallbe

specifiedbytheMinistryofLabor,HealthandSocialAffairsofGeorgia.

3. Allpersonsinvolvedinlegalcirculationofsubtances,agentsunderspecialcontrolandtheirpharmaceutical

formsshalldeliverinformationtotheMinistryofLabor,HealthandSocialAffairsofGeorgiainaccordance

withestablishedrule.(12.02.2010#2560)

Article22.Circulationofradioactivetherapeuticagents

Rulesforpacking,storage,import,shippingandtransportation,dispensing,applicationanddisposalof

radioactivepreparationsusedinmedicalpracticeshallbespecifiedinaccordancewiththeGeorgian

legislation.

ChapterIX.Repealed(10.08.2009#1586beeffectivefromOctober15,2009)

ChapterX.Monitoringofsideeffectsofmedication

Article26.Monitoringofsideeffectsofmedication

1. Attending doctors of therapeutic- prophylaxis network, therapeutic service specialist of patient care

institutionsandstructuresoftheMinistryofLabor,HealthandSocialAffairsofGeorgiashallparticipatein

unifiedsystemofmonitoringofsideeffectsofmedication.Repealed(18.12.2001#1191)

2. Integrated coordination of monitoring system and analysis of obtained informational material shall be

madebytheStateRegulationAgencyforMedicalActivities,whichshall:

a) collectinformationaboutsideeffectsofmedication,analyzeandsummarizeit;

b) exchangesuchinformationwithmedicalservicesofothercountriesandWorldHealthOrganization.

c) organizeexaminationofobtaineddataandpreparerecommendationsaboutmanufacturingofmedication,

itswithdrawalfromcirculationandcancelationofitsregistrationcertificate;

d) studyincompatibilityandinteractionofmedicationsinstages,summarizeinformationonpharmaceutical

products,prepareinformationalmaterial.(13.08.2004#337)

3. Theruleandorderofformationofinformationflowfromtherapeuticnetworkaboutsideeffectsof

medicationshallbedevelopedandapprovedbytheMinistryofLabor,HealthandSocialAffairsofGeorgia.

(13.08.2004#337)

4. EntitiesofpharmaceuticalproductcirculationandapplicationshallbeobligedtodelivertotheState

RegulationAgencyforMedicalActivitiestheinformationaboutallcasesregardingsideeffectsof

medicationandpeculiaritiesofotherinteractionofpharmaceuticalproduct,whicharenotindicatedin

patientinformationleaflet.(13.08.2004#337)

ChapterXI.Repealed(24.09.2009#1703beeffectivefromOctober16,2009)

ChapterXII.Repealed(10.08.2009#1586beeffectivefromOctober15,2009)

ChapterXII1.Responsibilityinthefieldofpharmaceuticalproductcirculation

Article371.Basisofresponsibilityrelatingtothequalityandsafetyofpharmaceuticalproduct(10.08.2009

#1586beeffectivefromOctober15,2009)

1. Responsibilityofpersonsinvolvedinpharmaceuticalproductcirculationshallbeclassifiedinaccordance

withthefollowingbasis:

a) Marketauthorizationholderandthestateshallberesponsibleforthesafety,qualityandeffectivenessof

pharmaceuticalproductauthorizedforGeorgianmarketundernationalmodeofstateregistrationof

pharmaceuticalproduct;

b) Thestateshallberesponsibleforthesafety,qualityandeffectivenessofpharmaceuticalproduct

authorizedforGeorgianmarketunderrecognitionmodeofstateregistrationofpharmaceuticalproduct;

c) Pharmaceuticalproductbatchmanufacturershallberesponsibleforcorrespondenceofpharmaceutical

productauthorizedforGeorgianmarketundernationalmodeofstateregistrationofpharmaceutical

product,withthedocumentationsubmittedduringregistration;

d) IfafterputtingofimportedpharmaceuticalproductauthorizedforGeorgianmarketinmarketingnetwork,

propertiesofpharmaceuticalproductarechangedduetowhichitdoesnotmetthesafetyandquality

standards,Importerand/orrepresentativeofrelevantunitofmarketingnetworkshallberesponsible.

Guiltinessshallbeestablishedinaccordancewiththeregulations,specifiedunderGeorgianlegislation;

e) Forviolationofpharmaceuticalproductwholesaleandretailsaleconditions,whichincludesalltransactions

relatingtopurchase,storage,supplyandsaleofpharmaceuticalproductresponsibilityshallbeimposedto

pharmaceuticalproductdistributor.

2. Responsibilityofapersonforviolationsrevealedduringpharmaceuticalactivityshallbespecifiedin

accordancewiththisLawandtheGeorgianlegislation.

3. TheprotocolforadministrationviolationsspecifiedunderthisLawshallbedrawnupbytheagency

(official)authorizedbytheMinistry(24.09.2009#1703beeffectivefromOctober16,2009)

Article372.Illegalpharmaceuticalactivity

1. Activitywithoutpermissionofpharmaceuticalmanufacturing,exportorimportofpharmaceuticalproduct

underspecialcontrol,authorizeddrugstore,clinicaltrialofpharmaceuticalproductshallinvolveimposing

offineintheamountof8000GEL.

2. Forthesame,repeatedactthefineintheamountof16000GELshallbeimposed.

Article373.Violationofauthorizationconditionsofpharmaceuticalmanufacturing,exportorimportof

pharmaceuticalproductunderspecialcontrol,authorizeddrugstore,clinicaltrialofpharmaceutical

product(30.07.2013#907)

Violationofauthorizationconditionsofpharmaceuticalmanufacturing,exportorimportofpharmaceutical

productunderspecialcontrol,authorizeddrugstore,clinicaltrialofpharmaceuticalproductshallinvolve

imposingoffineintheamountof2000GEL.

Article374.Violationofrulesofpharmaceuticalactivity

1. Preparation and distribution of pharmaceutical product by unauthorized personnel (personnel without

pharmaceuticaleducation/entitywithoutauthorityofindependentmedicalactivity)shallinvolveimposing

offineintheamountof4000GELwiththeseizureoflaw-violationobject.

2. Violation of pharmaceutical product preparation rules, violation of storage conditions, specified under

instructionshallinvolveimposingoffineintheamountof2000GELwiththeseizureoflaw-violationobject.

3. Violationofrulesofpharmaceuticalproductdistribution(exceptforpharmaceuticalproductsincludedinto

firstgroupunderArticle112ofthisLaw)shallinvolveimposingoffineintheamountof500GEL.

4. Theactspecifiedunderparagraph3ofthisArticle,committedrepeatedlyshallinvolveimposingoffinein

theamountof1000GEL.

5. ViolationofdistributionrulesofpharmaceuticalproductincludedintofirstgroupunderArticle112ofthis

Lawshallinvolveimposingoffineintheamountof6000GEL.

6. Theactspecifiedunderparagraph5ofthisArticle,committedrepeatedlyshallinvolveimposingoffinein

theamountof12000GEL.

7. Distributionofsubstandard,expired,unfittedpharmaceuticalproductshallinvolveimposingoffineinthe

amountof6000GELwiththeseizureoflaw-violationobject.

8. CirculationofadulteratedpharmaceuticalproductinGeorgianmarketshallinvolveimposingoffineinthe

amountof20000GEL,withtheseizureoflaw-violationobject.

9. Violation of rules of registration, manufacturing, standardization, marking, shipping and transportation,

importandexport,re-export,batchregistrationanddisposalhallinvolveimposingoffineintheamountof

1600GEL,withtheseizureoflaw-violationobject.

10. Thesameactspecifiedunderparagraph9of thisArticle,committedrepeatedlyshall involve imposingof

fineintheamountof4000GEL,withtheseizureoflaw-violationobject.

Article 375.Circulation of pharmaceutical product with evasion of authorization modes for Georgian

marketand/orwithoutauthorizationforGeorgianmarket(30.07.2013#907)

1. Circulation of pharmaceutical product with evasion of authorizationmodes for Georgianmarket and/or

without authorization for Georgianmarket pharmaceutical product shall involve imposing of fine in the

amountof6000GEL,withtheseizureoflaw-violationobject.

2. Thesameactcommitted repeatedly shall involve imposingof fine in theamountof12000GEL,with the

seizureoflaw-violationobject.

Article376.Violationofrulesofpharmaceuticalproductadvertisement(30.07.2013#907)

Violationofrulesofpharmaceuticalproductadvertisement(withrespecttoadvertiser,aswellasexecutor)

shallinvolveimposingoffineintheamountof2000GEL.

Article377.Commencementandfinishingofpharmaceuticalproductdistributionwithoutdeliveryof

obligatorynotificationtotheAgency

1. Inaccordancewithparagraph5,Article16ofthisLawcommencementandfinishingofpharmaceutical

productdistributionwithoutdeliveryofobligatorynotificationtotheAgencyshallinvolveimposingoffine

intheamountof2000GEL.

2. Thesameactcommittedrepeatedlyshallinvolveimposingoffineintheamountof4000GEL.

Article378.Changingofpharmaceuticalproductpacking-markingwithoutregistrationotdeliveryof

obligatorynotificationtotheAgency

Changingofpharmaceuticalproductpacking-markingwithoutregistrationordeliveryofobligatory

notificationtotheAgencyshallinvolveimposingoffineintheamountof2000GEL,withsuspensionof

distributionuptotheeliminationoflaw-violation.

Article379.SellingofpharmaceuticalproductincludedintofirstorsecondgroupinaccordancewithArticle

112ofthisLawtojuvenile

SellingofpharmaceuticalproductincludedintofirstorsecondgroupinaccordancewithArticle112ofthis

Lawtojuvenileshallinvolveimposingoffineintheamountof500GEL.

ChapterXIII.Transitionalandfinalprovisions(title30.07.2013#907)

Article38.Transitionalandfinalprovisions(title30.07.2013#907)

1. Paragraph6ofArticle14ofthisLawbeeffectiveformedicationtobeputintoretailcirculation,whichshall

beregisteredorre-registeredinaccordancewithrulesestablishedattheterritoryofGeorgiafromJanuary

1,2003(25.12.2002#1848).

2. Repealed(10.04.2002#1356)

21.Paragraph9ofArticle16ofthisLawbeeffectivefromJanuary1,2014andsubparagraph“b”of

paragraph10–fromSeptember1,2014(25.12.2013#1862)

3. Paragraph11ofArticle11ofthisLawbeeffectivefromJanuary1,2006.(11.10.2005#1918)

4. WithinthreemonthsafterenteringintoforceofthisLaw,theMinistryofAgricultureofGeorgiashall

provide:(18.06.2008#23)

a) Developmentofrulesforcontrolofstateregistration,re-registrationorcancellationofregistrationand

quality/safetyforGeorgia-manufacturedorimportedveterinarypreparations(agents);

b) Approvalofformsofregistrationcertificatesforveterinarypreparations;

4. Articles6,7and8ofthisLawbeinvalidatedfromDecember15,2009.(10.08.2009#1586beeffectivefrom

October15,2009)

EduardShevardnadze

ThePresidentofGeorgia

Tbilisi

April17,1997

#659-IIs

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