Law of Georgia on Drugs and Pharmaceutical Activityascentcrs.com/images/documents/Law of Georgia on...
Transcript of Law of Georgia on Drugs and Pharmaceutical Activityascentcrs.com/images/documents/Law of Georgia on...
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
(10.08.2009#1586beeffectivefromOctober15,2009)
Developmentofnewpharmaceuticalproductandfinancingofpharmacologicalstudyshallbefree.
Article6.RepealedfromDecember15,2009
Article7.RepealedfromDecember15,2009
Article8.RepealedfromDecember15,2009
ChapterIV.Statecontrolofthepharmaceuticalproductsafety
(10.08.2009#1586beeffectivefromOctober15,2009)
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
(10.08.2009#1586beeffectivefromOctober15,2009)
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
(10.08.2009#1586beeffectivefromOctober15,2009)
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
effectivefromOctober15,2009)
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
effectivefromOctober15,2009)
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
(10.08.2009#1586beeffectivefromOctober15,2009)
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
non-activesubstance(s)(specificationandmethodsofanalysis);
b.f)Monographsaboutmethodsofanalysisofpharmaceuticalproductincludingspecification;
b.g)Pharmaceuticalproductmanufacturingflowdiagram;
b.h)Sampleofpharmaceuticalproduct–2standardspackingplusamount,requiredfor2analysis,with
relevantqualitycertificate;
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
activesubstance(s)(specificationandmethodsofanalysis);
c.d)Nameandaddressofmanufacturer(s)ofactivesubstance(s);
c.e)Monographsorreferencestothemonographsrepresentedinsetsofinternationalstandardsabout
non-activesubstance(s)(specificationandmethodsofanalysis);
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
activesubstance(s)(specificationandmethodsofanalysis);
d.d)Monographsonmethodsofanalysisofimmunobiologicaldrug,includingspecification;
d.e)Immunobiologicaldrugmanufacturingflowdiagram;
d.f)Sampleofimmunobiologicaldrug–2standardpackingplusamount,requiredforanalysis,with
relevantqualitycertificate;
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
non-activesubstance(s)(specificationandmethodsofanalysis);
e.e)Monographsaboutmethodsofanalysisofparatherapeuticagent,includingspecification;
e.f)Paratherapeuticagentmanufacturingflowdiagram;
e.g)Dataonstabilityofparatherapeuticagent;
e.h)Sampleofparatherapeuticagent–2standardspackingplusamount,requiredforanalysis,with
relevantqualitycertificate;
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
non-activesubstance(s)(specificationandmethodsofanalysis);
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
Requirements–Analysisofdataonpreparationstabilityshallindicatethattheshelflifeofpreparationhas
notbeenreducedinaccordancewiththeapprovedspecification;
b.q)Changingofstorageconditions
Requirements–Analysisofdataonpreparationstabilityshallindicatethattheshelflifeofpreparationhas
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
Requirements–Resultsofmethodvalidationshallindicatethatthenewtestmethodisequaltoprevious
one;
b.w)Changingoftestmethodforinductiondevice
Requirements–Resultsofmethodvalidationshallindicatethatthenewtestmethodisequaltoprevious
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