New Registration Procedure.docx

New Registration Procedure.docx

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NewRegistrationProcedure

D.C.G.IREGISTRATIONPROCEDURE

AspertheNotificationGSR604（E）dated24-08-2001,itisnecessaryfortheForeignmanufacturertoregisterthemanufacturingpremisesandAPI’s（ActivePharmaceuticalIngredients）manufacturedbythemforimportintoIndiaundertheDrugsandCosmeticsRules1945.

TheprocedureforRegistrationisasfollows:

（1）AnapplicationforissueofaRegistrationCertificateshallbemadetothelicensingauthority（DrugAuthoritiesatDelhi）inForm40,eitherbythemanufacturerhimselfhavingavalidwholesalelicenseforsaleordistributionofdrugsundertheserules,orbyhisauthorizedagentinIndia,eitherhavingavalidlicenseundertherulestomanufactureforsaleofadrugorhavingavalidwholesalelicenseforsaleordistributionofdrugsundertheserules,andshallbeaccompaniedbythefeespecifiedinsub-rule（3）andtheinformation’sandundertakingsspecifiedinSchedulesD-IandD-IIdulysignedbythemanufacturerorhisauthorizedIndianagentonbehalfofthemanufacturer.

（2）TheauthorizationbyamanufacturertohisagentinIndiashallbedocumentedbyapowerofattorneyexecutedandauthenticatedeitherinIndiabeforeaFirstClassMagistrate,orinthecountryoforiginbeforesuchanequivalentauthority,thecertificateofwhichisattestedbytheIndianEmbassyofthesaidcountry,andtheoriginalofthesameshallbefurnishedalongwiththeapplicationforRegistrationCertificate.

（3）AfeeofonethousandandfivehundredUSdollars（USD1500）shallbepaidalongwiththeapplicationinForm40asregistrationfeeforhispremisesmeantformanufacturingofdrugsintended-forimportintoanduseinIndia.

（4）AfeeofonethousandUSdollars（USD1000）shallbepaidalongwiththeapplicationinForm40fortheregistrationofasingledrugmeantforimportintoanduseinIndiaandanadditionalfeeattherateofonethousandUSdollars（USD1000）foreachadditionaldrug:

（5）Providedthatinthecaseofanysubsequentapplicationforregistrationofadditionaldrugsbythesamemanufacturer,thefeetoaccompanyshallbeonethousandUSdollars（USD1000）foreachdrug.

（6）ThefeesshallbepaidthroughaChallanintheBankofBaroda,KasturbaGandhiMarg.NewDelhi-110001oranyotherbranchorbranchesofBankofBaroda,oranyotherbank,asnotified,fromtimetotime,bytheCentralGovernment,tobecreditedundertheHeadofAccount“0210-MedicalandPublicHealth,04-PublicHealth;104-Fees’andFines”:

（7）Providedthatinthecaseofanydirectpaymentoffees;byamanufacturerinthecountryoforigin,thefeesshallbepaidthroughElectronicClearanceSystem（ECS）fromanybankinthecountryoforigintotheBankofBaroda,KasturbaGandhiMarg,NewDelhi,throughtheElectronicCodeofthebankintheHeadofAccount“0210-MedicalandPublicHealth,04-PublicHealth,104-FeeandFines”,andtheoriginalreceiptofthesaidtransfershallbetreatedasanequivalenttothebankChallan,subjecttotheapprovalbytheBankofBarodathattheyhavereceivedthepayment.”

（8）TheapplicantshallbeliableforthepaymentofafeeoffivethousandUSdollarsforexpenditureasmayberequiredforinspectionorvisitofthemanufacturingpremisesordrugs,bythelicensingauthority’orbyanyotherpersonstowhompowershavebeendelegatedinthisbehalfbythelicensingauthorityunderrule22

（9）TheapplicantshallbeliableforthepaymentoftestingfeesdirectlytoatestinglaboratoryapprovedbytheCentralGovernmentinIndiaorabroad,asmayberequiredforexamination,testsandanalysisofdrug.

（10）AfeeofthreehundredUSdollarsshallbepaidforaduplicatecopyoftheRegistrationCertificate,iftheoriginalisdefaced,damagedorlost.”

（11）NoRegistrationCertificateshallberequiredundertheserulesinrespectofaninactivebulksubstancetobeusedforadrugformulation,withorwithoutpharmacopoeiasconformity.”

（12）Asingleapplicationmaybemade,andasingleRegistrationCertificateinForm41maybeissuedinrespectoftheimportofmorethanonedrugorclassofdrugs,manufacturedbythesamemanufacturer:

（13）Providedthatthedrugorclassesofdrugsaremanufacturedatonefactoryormorethanonefactoryfunctioningconjointlyasasinglemanufacturingunit:

（14）Providedfurtherthatifasinglemanufacturerhastwoormorefactoriessituatedindifferentplacesmanufacturingthesameordifferentdrugs,separateRegistrationCertificatesshallberequiredinrespectofthedrugsmanufacturedbyeachsuchfactory.”

（15）OnreceiptofanapplicationforRegistrationCertificateintheFormandmannerspecifiedinrule24-A,thelicensingauthorityshall,onbeingsatisfied,that,ifgranted,theconditionsoftheRegistrationCertificatewillbeobserved,issueaRegistrationCertificateinForm41:

（16）Provided,furtherthatiftheapplicationiscomplete.inallrespectsandinformationspecifiedinSchedulesD-1andD-IIareinorder,thelicensingauthorityshall,withinninemonthsfromthedateofreceiptofanapplication,issuesuchRegistrationCertificate,andinexceptionalcircumstancesandforreasonstoberecordedinwriting,theRegistrationCertificatemaybeissuedwithinsuchextendedperiod,notexceedingthreemonthsasthelicensingauthority,maydeemfit.

（17）IftheapplicantdoesnotreceivetheRegistrationCertificatewithintheperiodasspecifiedinprovisiontosubrule

（1）,hemayappealtotheCentralGovernmentandtheCentralGovernmentmayaftersuchenquireintothematter,asitconsidersnecessary.Maypasssuchordersinrelationtheretoasitthinksfit.

（18）RegistrationCertificateissuedinForm41shallbevalidforaperiodofthreeyearsfromthedateofitsissue.

（19）IftheapplicationforafreshRegistrationCertificateismadeninemonthsbeforetheexpiryoftheexistingcertificate,thecurrentRegistrationCertificateshallbedeemedtocontinueinforceuntilordersarepassedontheapplication.

（20）Standardforcertainimporteddrugs.-Nodrugshallbeimportedunlessitcomplieswiththestandardofstrength,qualityandpurity,ifany,andthetestprescribedintherulesshallbeapplicablefordeterminingwhetheranysuchimporteddrugcomplieswiththesaidstandards:

（21）Providedthatthedrugsintendedforveterinaryuse,thestandardsofstrength,qualityandpurity,ifany,shallbethosethatarespecifiedinScheduleF

（1）andthetestprescribedinthatScheduleshallbeapplicablefordeterminingwhetheranysuchimporteddrugcompliesWiththesaidstandardsandwherenostandardsarespecifiedinScheduleF

（1）foranyveterinarydrug,thestandardsforsuchdrugshall,bethosespecifiedinthecurrentedition,forthetimebeinginforce,oftheBritishPharmacopoeiaVeterinary

（22）Providedfurtherthatthelicensingauthorityshallnotallowtheimportofanydrughavinglessthansixtypercent,residualshelf-lifeperiodasonthedateofimport:

GivenbelowistheformatofForm40tobefilledinbythemanufacturerorhisauthorizedagentinIndia

Form40

（Seerule24-A）

ApplicationforissueofRegistrationCertificateforimportofdrugsintoIndiaundertheDrugsandCosmeticsRules,1945.’

1.We,M/S________________________________________（NameandfulladdressoftheIndiancounterpart/agent）herebyapplyforthegrantofRegistrationCertificatetothemanufacturer,M/S_______________________（Nameandfulladdresswithtelephone,faxandE-mailaddressoftheforeignmanufacturer）for,hispremises,andmanufactureddrugsmeantforimportintoIndia.

2.Namesofdrugsforregistration.

（1）

（2）

（3）

3.WeencloseherewiththeinformationandundertakingsspecifiedinScheduleD（I）andScheduleD（II）dulysignedbythemanufacturerforgrantofRegistrationCertificateforthepremisesstatedbelow.

4.AfeeofUSD1500=00forregistrationofpremises,theparticularsofwhicharegivenbelow,ofthemanufacturerhasbeencreditedtotheGovernmentundertheHeadofAccount“0210-MedicalandPublicHealth,04-PublicHealth,104-FeesandFines”undertheDrugsandcosmeticsRules,1945CentralvideChallanNo.__________dated__________,（attachedinoriginal）.-

5.AfeeofUSD1000=00（PERPRODUCT）forregistrationofthedrugsforimportasspecifiedatSerialNo.2abovehasbeencreditedtotheGovernmentundertheHeadofAccount“0210-MedicalandPublicHealth,04-PublicHealth104-FeesandFines”undertheDrugsandcosmeticsRules,1945—CentralvideChallanNo.,dated__________.（attachedinoriginal）.

6.Particularsofpremisestoberegisteredwheremanufactureiscarriedon:

Address（es）:

___________________________________________

Telephone:

_________________________________

Fax:

___________________________________

E-mail:

__________________________________

Weundertaketocomplywithallthetermsandconditionsrequiredtoobtain

RegistrationCertificateandtokeepitvalidduringitsvalidityperiod.

PLACE:

DATE:

Signature_____________________________

Name______________________

Designation_________________

Seal/StampofmanufacturerorhisauthorizedagentinIndia.

（Note:

-IncaseapplicantisanauthorizedagentofthemanufacturerinIndia;themanufacturerhastogivethePowerofAttorneytohisIndianagentaspertheFormatgivenbelow）.

PowerofAttorney

Whereas,M/S.____________________________________（AuthorizedAgentsname,address,tel,fax&email）,hereinaftertobeknownasAuthorizedAgentofusintendstoapplyforaRegistrationCertificateundertheDrugsandCosmeticsRules,1945fortheimport,useandmarketingintoIndia,ofthedrugsmanufacturedbyus,we,M/S…………………………（name,address,tel,fax&emailofthemanufacturer）,hereinaftertobeknownasthe