contents abbreviations iv acknowledgements vi …...medical devices, diagnostics and other health...
TRANSCRIPT
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CONTENTS
Abbreviations iv
Acknowledgements vi
Foreword viii1.0 Introduction 1
2.0 Application 3
3.0 Definition Of Terms 3
4.0 TMDA Profile 4
4.1 Vision 54.2 Mission 54.3 Philosophy 54.4 Core Values 54.5 Quality Policy Statement 6
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5.0 Purpose Of The Clients’ Service Charter 8
6.0 Benefits Of The Client’s Service Charter 8
6.1 BenefitsToClients 96.2 BenefitsToTMDA 9
7.0 Service Guidelines And Commitment 10
8.0 Service Standards And Promises To Clients 11
8.1 Service Standards 118.2 PromisesToClients 21
9.0 Client’s Rights And Responsibilities 24
9.1 ClientsRights 249.2 Client’sResponsibilities 26
10. Stakeholder Rights 26
11.0 Monitoring, Evaluation And Reporting Performance Against Standards 29
11.1 MonitoringAndEvaluation 29
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11.2 ReportingPerformanceAgainstStandards 31
12. Review And Maintenance Of The Charter 31
13. Business Hours 32
14. Client’s Feedback And Complaints Handling 32
15. How To Contact Tmda 33
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ABBREVIATIONS
ADR - AdverseDrugReactionAIDS - AcquiredImmune-DeficiencySyndromeCap - ChapterCHAI - ClintonHealthAccessInitiativeCRS - CatholicReliefServicesCSC - Clients’ServiceCharterCSSC - Christian Social Services CommissionEAC - EastAfricanCommunityGMP - GoodManufacturingPracticesHIV - HumanImmunodeficiencyVirusIEC - Information,EducationandCommunicationISO - InternationalOrganizationforStandardizationMAB - MinisterialAdvisoryBoardNCDs - NonCommunicableDiseases
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PO-PSMGG- President’sOffice-PublicServiceManagementandGoodGovernanceQMS - QualityManagementSystemSADC - SouthernAfricaDevelopmentCommunitySOPs - StandardOperatingProceduresTBS - TanzaniaBureauofStandardsTFDA - TanzaniaFoodandDrugsAuthorityTMDA - TanzaniaMedicinesandMedicalDevicesAuthorityWHO - WorldHealthOrganizationWLA - WHOListedAuthorities
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ACKNOWLEDGEMENTS
ThisfourtheditionoftheClientsServiceCharterhasbeencompiledbyateamofstafffromtheCommunicationandPublicEducationunit incollaborationwithstafffromothersectionsandunitswithintheTMDA
IwouldliketosincerelythankMs.GaudensiaSimwanza,Mr.DamasMatiku,Dr. Henry Irunde, Mrs. Agnes Mneney, Mrs. Roberta Feruzi, Mr. JamesNdege,Mr. SigfridMtey,Mrs.NjuuKapwera andMr.RuttaKahamba fortheirtirelesseffortsinreviewingthepreviousversionsoftheClientsService
CharterincludingincorporatingvariousviewsofTMDAstakeholdersduringthepreparationandfinalizationofthisCharter.
Similarly,IwishtocongratulateMr.JohnMwingira,Mrs.DeborahWami,Mrs.PriscaMatagi,Mr.HusseinMakame,Mr.MartinMalima,Mr.SuleimanKichawele,Dr.ElirehemaMfinanga,Mr.Daniel FrancisMsilamgunda,Mrs.MarcelinaMtalo,Mrs.MarthaMalle,Mrs.DorosellaKahwaandMrs.MariamMirambowhoalsoparticipatedinvariousstagesofthepreparationofthis Charter.
Iwould also like to thank allTMDAManagerswhomet from23rd to 27th March, 2020 for a
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comprehensivereviewofthedraftCharterandagreedonappropriateservicedeliverystandardsbasedonthecurrentresourcesoftheAuthorityandtheuseofsystemsinservicedelivery.
Special gratitude is owed to theCatholicRelief Services (CRS)with its affiliated institutionsnamely Clinton Health Access Initiative (CHAI) and Christian Social Services Commission(CSSC)workinginTanzaniaundertheproject‘FASTER’fortheirfinancialassistancetosupportconveningofdraftingmeetings,validationworkshopsandstakeholderconsultations.
Inaddition,variousstakeholders,whosubmittedtheircommentsthroughtheTMDAwebsiteand a series ofmeetings organized, are likewise acknowledged as their inputs have greatlybolsteredthisCharterincludingadjustingthetimelinesoutlined.
Lastly,IwouldliketothanktheManagementandtheMinisterialAdvisoryBoard(MAB)oftheMinistryofHealth,CommunityDevelopment,Gender,ElderlyandChildrenforTMDAfortheguidance,commentsandthefinalendorsementoftheCharter.
Chrispin Mesiaki SevereDIRECTOR OF BUSINESS SUPPORT
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FOREWORD
TheNational Industrialization EconomicAgenda compels both publicand private institutions to create a conducive and enabling businessenvironment inTanzania. In tandemwith this,public institutionsare
required to set standards of service to customers tomeet their needs andexpectations.Importantlyandinlinewiththeprinciplesofgoodgovernance,suchstandardsshouldbemutuallyagreedwithclientsandstakeholderstobeserved.
TheGovernmentofTanzaniathroughthePresident’sOffice,PublicServiceManagementandGoodGovernance(POPSMGG)adoptedtheconceptofsettingservicestandardsthroughmutualagreementbetweenserviceprovidersandcustomers.SincethenthishasbeenfundamentalinlayingdownprinciplesandguidelinesfordevelopmentandimplementationofClientsServiceCharters(CSCs).Thesameneedstobereviewedfromtimetotimetoexceedcustomerneedsand expectations.
ThecurrentTMDA’sCSCwhichsupersedesthe2016editionhasbeendraftedinlinewiththeagreementofAfricanPublicServiceMinisterswhosignedanAfricanPublicServiceCharterinWindhoek,Namibiain2001.ThesigningofthePan-Africancharterhasshiftedtheparadigm
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of public institutions on theway they observe, handle and serve customers inmost publicinstitutions.Tanzania Medicines and Medical Devices Authority (TMDA) is serving different types ofcustomers toembrace thosewhoaredealingwithmanufacturing,distributionandsellingofmedicines,medical devices anddiagnostics, differentMinistries, public entities, private andnon-governmental organizations, media and the general public. Review for the CSC 2016hasbeenconductedwiththeaimofimprovingcustomerservicedeliveryinlinewithvarioustechnological, systemic and legislative changes. These include the implementation of theManagementInformationSystem(MIS),theavailableresourcesaswellastheadoptionoftheFinanceActNo. 8 of 2019whichmade changes to the functions of the thenTanzania FoodandDrugsAuthority(TFDA)wherebythecontroloffoodandcosmeticswastransferredtotheTanzaniaBureauofStandards(TBS).
IwouldliketocallonallcustomersandstakeholderstoreadthisCharterandnotifyusincasewedonotmeetthetimelineshighlightedinthisdocument.OnbehalfoftheManagementandstaffofTMDA,Iwouldliketopromisetoallocatesufficientresourcestoincludehuman,financialandmaterials,toofferservicesthatwouldmeetandexceedtheanticipationsofourcustomers.
Anycommentsorsuggestionsthatwouldimprovethisdocumentarealsowelcomedandthesamemay be submitted by email, letter or any othermeans of communication through the
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TMDAHeadquartersand/orZoneOfficeslocatedinMwanza,Arusha,DaresSalaam,Mbeya,Dodoma,Tabora,MtwaraandSimiyuRegions. Inaddition, theTMDAwill always strive toensurethatitsdocumentsincludingthisCharter,complywiththeQualityMnagementSystem(QMS)inaccordancewiththeInternationalstandardISO9001:2015.
Adam Mitangu FimboACTING DIRECTOR GENERAL
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1.0 INTRODUCTIONTheTanzaniaMedicinesandMedicalDevicesAuthority(TMDA)hadbeenimplementingtheQualityManagementSystem(QMS)andaccreditedtoISO9001:2015standardsince2011.TheQMSobservestwoprinciplesnamelyeffectivequalityservicedeliveryandcustomersatisfaction.Aspartof thissystem, theTMDAfirstapprovedtheCSC in2006and lateronreviewedthesupersedededitionsin2012and2016respectively.ThisisthefourtheditionoftheCSCtoberevisedbyTMDA.
The TMDAhad also conducted systematic customer satisfaction surveys between 2004 and2014.Accordingtothesurveysdone,in2004,theexternalcustomersatisfactionindexwas42%and72%forinternalcustomers.In2008,theexternalcustomersatisfactionindexwas66%and63%forinternalcustomers.Whilein2014,thecomparisonwas67.6%and74.4%forexternalandinternal customers respectively.
Assessmentoftheindicesobserveddelineatesthattherewasanupwardtrendinsatisfactionfor external customers between 2004 and 2014. This is a good sign and signals out that thetrendneedstobemaintainedbyTMDA.ThecurrentCSChasconsideredtheoutcomesofthesurveyandtheTMDAcommitstoofferservicesthatwillexceedinglysurpasstheneedsandexpectationsofourcustomers.
Thisrevisededitionhighlightsamongstothers,theTMDAprofile,vision,mission,corevalues,
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quality policy statement, roles and functions of TMDA.Other items articulated include thepurposeofthisCSC,itsbenefits,servicestandards,promisestoourclients,customerfeedbackandcomplaintshandlingaswellasmonitoringandevaluationofsetstandards.Therightsandresponsibilitiesofourclientshavealsobeenarticulated.
This2020editionhasalsotakenintoaccountthebelowlistedTMDA’sstrategicobjectiveswhichhavealsobeenunderlinedintherevisedStrategicPlan:
HIV/AIDS infectionsandNonCommunicableDiseases (NCDs)reducedandServicesimproved;
NationalAnti-CorruptionStrategyeffectivelyimplementedandsustained; Gender and environmental issues improved; Quality,effectivenessandSafetyofmedicines,medicaldevicesanddiagnosticsassured; Laboratoryservicesimproved; Publiceducationstrengthenedandcustomerservicesimproved;and Institutionalcapacitytodeliverregulatoryservicesstrengthened.
This Charter will serve as an important tool in enhancing and monitoring these strategicobjectives.
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2.0 APPLICATION ThisCharterappliestoexternalclientsandstakeholderswhoutilizeTMDAservices.TheCharterprovidesforstandardsofservicedeliveryexpectedbyclientsandwhattheAuthorityanticipatesfromitsclientsincludingwhatcanbedoneifthespecifiedstandardsarenotmet.
3.0 DEFINITION OF TERMS InaccordancewiththisCharter,thefollowingtermsandphrasesaredefinedasfollows:
Client(s)Means product manufacturers, healthcare providers, researchers, distributors, processors,wholesalers,retailers,agrouporanyindividual interestedoraffectedbyservicesofferedbyTMDA.Theyalso includegovernmentandprivate institutionsaswellasconsumersandthegeneralpublic;
DaysMeansdaysfromMondaytoFridayexceptpublicholidays.Thedayshighlightedinthedeliveryofservicesdonotmeancalendardaysbutworkingdays;
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Regulated productsMeansmedicines (includes human and veterinarymedicines),medical devices, diagnostics,laboratory equipment, blood and blood products, biocidals, radiopharmaceuticals, medicalgasesandherbalmedicines,regulatedandasdefinedundertheTanzaniaMedicinesandMedicalDevicesActCap,219;
Stakeholder Meansanindividual,institutionororganizationwhichinonewayoranotherisrelatedtooraffectedbyTMDAservicesand/orfunctions.
4.0 TMDA PROFILE TanzaniaMedicinesandMedicalDevicesAuthority(TMDA)isasemi-autonomousregulatorybodyundertheMinistryofHealth,CommunityDevelopment,Gender,ElderlyandChildrenwhichisresponsibleforprotectingandpromotingpublichealthbyensuringquality,safetyandeffectivenessofmedicines,medicaldevicesanddiagnostics.
TMDAformerlyTanzaniaFoodandDrugsAuthority(TFDA)becameoperationalon1stofJuly,2003.HoweverthenameTFDAwasstaturilychangedintoTMDAonthe1stofJuly2019aftertheamendmentoftheTanzaniaFood,DrugsandCosmeticsAct,Cap219bytheFinanceNo.8of2019whoseeffectwastoseparatetheregulationofmedicinalproductsfromfoodproducts.
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4.1 VISION To be the leading Regulatory Authority in ensuring safe, quality and effective, medicines,medicaldevices,diagnosticsandotherhealthrelatedproductsforall.
4.2 MISSION Toprotectandpromotepublichealthbyensuringquality,safetyandeffectivenessofmedicines,medicaldevices,diagnosticsandotherhealthrelatedproducts.
4.3 PHILOSOPHY TMDAstrivestoofferqualityregulatoryservicesinthepursuitofprotectingpublichealthandtheenvironmentbyusingcompetentanddedicatedstaff.
4.4 CORE VALUESWealways embrace and institutionalizevalues thatguarantee customer satisfaction.Weareexpectedtobecommittedtoupholdingthefollowingvaluestodefineourcharacterandpersonalattributes:
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Integrity Toupholdhigheststandardsofconductandcommitmentwhileactinginthebestinterestofthecountry
Customerfocus Alwaystreatcustomersandcolleagueswithcourtesyandberesponsive timely and proactive to meet their needs
Quality Strivetodeliverthebestservicestocustomerswithutmostprofessionalism
Teamwork Supportoneanother,workcooperativelyandrespectoneanother’sviews
Accountability Beingaccountableforactionsandoutcomes
Transparency Operateinafullytransparentmannerandcommunicateopenlyandtimelytotherelevantstakeholders
4.5 QUALITY POLICY STATEMENT TMDAiscommittedtoprovidequalityservicesinresponsetocustomerneedsandexpectations.TMDAshallstrivetobalancetheinterestsofourstakeholderswithoutcompromisingquality,safety and effectiveness of medicines, medical devices and diagnostics by managing theAuthoritywithutmostprofessionalism.
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TMDAiscommittedtocomplywiththerequirementsofISO9001:2015Standardandcontinuallyimprove the effectiveness of theQualityManagement System. It shallmanage and provideresourcesforcontinuousimprovementofservicestoensurecustomersatisfaction.Pursuant to the Tanzania Medicines and Medical Devices Act, Cap 219, TMDA discharges thefollowingfunctions:-
a. Regulatingthemanufacturing,importation,distributionandsellingofmedicines,medicaldevicesanddiagnostics;
b. Inspecting manufacturing industries and business premises dealing with regulatedproductsandmakesurethestandardsrequiredareattained;
c. Evaluatingandregisteringmedicines,medicaldevicesanddiagnosticssoastoreachtherequiredstandardsbeforemarketingauthorization;
d.Issuanceofbusinesspermitsforpremisesdealingwithregulatedproducts;e. Assessingthequality,safetyandefficacyofcontrolleddrugs;f. Conducting laboratory investigations for regulated products to ascertain their quality
specifications;g.Conductingpharmacovigilanceofmedicalproductsandvigilanceofmedicaldevicesand
diagnosticscirculatingonthemarket;h.Promotingrationaluseofmedicines,medicaldevicesanddiagnostics;and
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i. Educatingandsharingaccurateandreliableinformationtostakeholdersandthegeneralpubliconregulatorymatters.
5.0 PURPOSE OF THE CLIENTS’ SERVICE CHARTERThisCharterintendstoimperativelyunderscoretheaccountabilityofTMDAtocomplywithpre-determinedstandardsofservicedeliverytoitsclients.Moreover,theCharteraimstostrengthenrelationshipsbetweentheAuthorityanditsclientsbysharinginformationonTMDAservicesinthefollowingareas:
(a)Whatitdoes;(b)Standardsofserviceclientscanexpect;(c) Client’srightsandresponsibilities;(d)Howtocommunicate;and(e) How to submit complaints, comments, remarks and suggestions regarding service
delivery.
6.0 BENEFITS OF THE CLIENT’S SERVICE CHARTERThebenefitsofthisCSCtoTMDAanditsclientsareasfollows:
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6.1 Benefits to Clients TounderstandthetypesofservicesofferedbyTMDA; TomeasurethelevelofsatisfactionafterservicedeliverybyTMDA; ToevaluatethequalityofservicesofferedbyTMDAandprovidefeedbackforthepurposeofimprovingtheservices;
TorealizecustomercontributioninprovisionofservicesofferedbyTMDA; To compare services offered by TMDA with other government institutions and givesuggestionsonhowtoimprovewherenecessary;
Torealizevalueformoneyoftherenderedservices; TodeterminethetimeitwouldtakeforTMDAtoofferservices;and To plan in advance and allocate appropriate resources depending on services to be
delivered.
6.2 Benefits to TMDA Torealizeitsvisionandmission; Toimprovetransparencyonservicedeliverytoclients; Toimproveworkdisciplineandresponsibilitytocustomers;
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TostrengthenrelationshipandcommunicationbetweenTMDAanditsclients; TomaintaingoodreputationandimageoftheAuthoritytoclientsandother stakeholders;and
Toevaluatethelevelofservicedeliveryand makeeffortstoimprovewherenecessary.
7.0 SERVICE GUIDELINES AND COMMITMENT InTMDA’sdesiretoprovidehighqualityservicestoourclients,thefollowingservicevaluesandcommitmentswillbeadheredto:
Engagingcompetentanddedicatedstaffinservicedelivery; Beinghonesttoclientsandinstitution; Beingfair; Beingrespectfulandvalueremarksofclientsandstakeholders; Showingintegrity; Demonstratingopennessandtransparency; Beingflexibleinfacingchallenges; Avoidingconflictsofinterest;and
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Consideringethicsandcodesofconduct.
8.0 SERVICE STANDARDS AND PROMISES TO CLIENTS
8.1 SERVICE STANDARDS TheAuthorityaimsatprovidingqualityservicestoourclients.Wewillfulfillthisbymeetingtheservicestandardsasshowninthetablebelow:
S/N TypeofService StandardsofServiceDelivery
1. 1.1 Registration of Premises and Issuance of Business Permits (Domestic)i. Inspectionofnewpremisesformanufacturingof
medicines,medicaldevices,diagnosticsandotherregulatedproducts
Within 5 days
ii.SendingofinspectionreportafterGMPinspection Within 5 days
iii.Inspectionofnewpremisesforstorageanddistributionofmedicines,medicaldevicesdiagnosticsandotherregulatedproducts
Within 7 days
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S/N TypeofService StandardsofServiceDelivery
iv.Issuanceofpremisesregistrationcertificateandbusinesspermits Within 3 days
v. IssuanceofGMPcompliancecertificate Within 3 daysvi. Renewalofbusinesspermitsformanufacturing,
storageanddistributionofmedicines,medicaldevices,diagnosticsandotherregulatedproducts
Within 3 days
vii.Followupinspectionfornewpremisesuponnotificationbyapplicant Within 5 days
1.2 GMP Inspection reports and certificates (Overseas)i. SendingofinspectionreportafterGMPinspection
forimportedproducts Within 45 days
ii. IssuanceofGMPcompliancecertificate Within 45 days2. Product Marketing Authorization
2.1 Registration of medicinal products including vaccines from domestic manufacturers
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S/N TypeofService StandardsofServiceDelivery
i. Evaluationofmedicinalproductsincludingvaccinesuponreceiptofcompletedapplication Within60days
ii. Evaluationofqueryresponses Within30days
2.2 Registration of imported medicinal products including vaccinesi. Evaluationofmedicinalproductsincludingvaccines
uponreceiptofcompletedapplicationfromforeignmanufacturers
Within180days
ii. Evaluationofqueryresponses Within80days2.3 Registration of medicines under priority procedures
i. ProductsunderWHOcollaborativeprocedure Within90days
ii. Orphanmedicines Within90daysiii.MedicinesapprovedbyWLAcountries Within90daysiv. ProductsfromEACandSADC Within90days2.4 Registration of antiseptics and disinfectants
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S/N TypeofService StandardsofServiceDelivery
i. Registrationofdomesticmanufacturedantisepticsanddisinfectants Within30days
ii. Registrationofimportedantisepticsanddisinfectants Within60days
2.5 Registration of Herbal Medicinesi. Registrationofdomesticmanufacturedherbal
medicines Within90days
ii. Registrationofimportedherbalmedicines Within180days
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S/N TypeofService StandardsofServiceDelivery
2.6 Registration of Medical Devices and Diagnosticsi. NotificationofclassAmedicaldevices Within 5 daysii. RegistrationofdomesticmanufacturedClassA&B
medical devices. Within20days
iii.RegistrationofimportedClassA&Bmedicaldevices Within 45 days
iv.RegistrationofdomesticClassC&Dmedicaldevicesanddiagnostics Within 45 days
v. RegistrationofimportedClassC&Dmedicaldevicesanddiagnostics
Within90days
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S/N TypeofService StandardsofServiceDelivery
3. Renewal of Product Marketing Authorizationi. Medicinalproducts(includingVaccines)from
domesticmanufacturers Within20days
ii. Importedmedicinalproducts Within30daysiii.Domesticmanufacturedherbalmedicines,antiseptics
anddisinfectants Within20days
iv. Importedherbalmedicines,antisepticsanddisinfectants Within30days
v. Medicaldevicesanddiagnostics Within20days4. Issuance of Clinical Trial Certificates
i. Issuanceofclinicaltrialcertificatesforanewapplication Within30days
ii. Issuanceofclinicaltrialcertificatesunderemergencysituation Within 14 days
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S/N TypeofService StandardsofServiceDelivery
5. Approval of Alterations and Variationsi. Majorvariationofaregisteredmedicine 45 daysii. Minorvariationofaregisteredmedicine Within30daysiii.Variationofregisteredmedicaldevicesand
diagnostics 10daysiv.Majoramendmentforapprovedclinicaltrial 30daysv. Minoramendmentforapprovedclinicaltrial 10days
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S/N TypeofService StandardsofServiceDelivery
6. Issuance of Import/Export Permitsi. Importandexportpermitsofregisteredmedicines,
medicaldevices,diagnostics,antiseptics,disinfectantsandotherregulatedproducts
Within 1 day
ii. Specialimportandexportpermitofmedicines,medicaldevices,diagnostics,antiseptics,disinfectantsandotherregulatedproducts
Within 7 days
iii. Issuanceofcertificateforimportationofcontrolleddrugs Within 5 days
iv. Issuanceofpermitsforprocurementanduseofnarcoticdrugs Within 3 days
7. Evaluation and Approval of Promotional MaterialsEvaluationandapprovalofpromotionalmaterialsformedicines,herbalmedicines,medicaldevice,diagnostics,antisepticsanddisinfectants
Within10days
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S/N TypeofService StandardsofServiceDelivery
8. IssuanceofDisposalCertificateforunfitmedicines,herbalmedicines,medicaldevices,antiseptics,disinfectantsandotherhealthrelatedproducts.
Within3daysafterdisposal
9. Issuance of Laboratory Results for Samples of TMDA regulated productsi. Issuanceoflaboratoryresultsformedicines,
antiseptics,disinfectantsandotherregulatedproductsamples
Within20days
ii. Issuanceoflaboratoryresultsformedicaldevicesanddiagnosticsamples
Within30days
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S/N TypeofService StandardsofServiceDelivery
10. Feedback to Customers and whistleblowersi. Acknowledgementafterreceivingcustomer
complaints/comments/suggestionsorinquiries Within 3 days
ii. Providingfeedbackafterreceivingcustomer/complaints/comments/suggestionsorinquiries Within30days
iii.Acknowledgementafterreceivingemailssentthroughinfo@tmda.go.tz Within 2 days
iv.Providingfeedbackafterreceivingemails Within 5 daysv. Acknowledgementafterreceivinginformationfrom
whistleblowers Within 3 days
vi.Providingfeedbackafterreceivinginformationfromwhistleblowers
Within20days
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S/N TypeofService StandardsofServiceDelivery
11. Response to ADR Reportsi. AcknowledgementafterreceivingAdverseDrug
Reaction(ADR)reportsWithin 3 days
ii. AcknowledgementafterreceivingSAEreports Within 3 daysiii.ProvidingfeedbackafterevaluationofADRreports Within90days
8.2 PROMISES TO CLIENTS TheAuthoritypromises the following to its clients in accordancewith thisCharter, existingqualitypolicystatementandstaffcodeofconduct:
(i) Equality when dealing with clientsTMDA will treat all clients fairly and professionally. Any sort of discrimination based onplace of origin, race, gender, religion, ethnicity, philosophical or political views or personalconsiderationswillnotbeallowedandentertained. (ii) Staff conduct TMDAstaffwillidentifythemselvestoclientsbywearingidentitycardsandnametagsduring
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workinghoursandintroducethemselvesbytheirnameswhenevernecessary.Staffwillalwaysbepolite,courteous,friendly,empathic,considerate,helpful,cooperativeandcaringtoclientsall the time.
(iii) Responsiveness TMDAcommitstoadheretothesetservicestandardsandprovidecorrectandtimelyinformationtoourclientsandthepublicatlargeonregulatedproducts.
(iv) Appropriateness TMDAwillworktoensurethatthequalityofservicedeliverymeetsandexceedsourcustomerneedsandexpectationsinlinewithexistinglaws,regulations,guidelinesandstandardoperatingprocedures(SOPs)whileatthesametimepreservingtheenvironment.
(v) Confidentiality TMDA will treat information accessed from clients with the highest and utmost level ofconfidentialityandusethesameonlyfortheintendedpurposeandasrequiredbyexistinglawsorregulationsandnototherwise.
(vi) Decision- making processTMDAaimsatafairbalancebetweenspeedofdecisionmakingandassessmentofthematterat
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stakeandwillgivereasonsfordecisionsthatwillbemade.
(vii) Accessibility TMDAserviceswillbeaccessiblephysicallyatitsHeadquarterandZoneofficesbyphone,fax,mobilephoneandemailaddressbetweenMondaystoFridays,from8:00.amto5:00pmexcludingpublicholidays.Thetollfreenumber0800110084willalsobeavailableduringworkinghourstorespondtocustomerenquiries.Moreover,TMDAservicesatportsofentryandonlineportalserviceswillbeaccessible24hoursforsevendaysaweek(24/7).Additionally,allinformationaboutTMDAregulatoryactivitiesandguidelineswillbedirectlyaccessiblethroughthewebsitewww.tmda.go.tzatalltimes.
(viii) Dissemination of information TMDAwilldisseminate informationto itsclients throughwebsite,massmedia, Information,Education and Communication (IEC) materials such as brochures, pamphlets, billboards,stickersandfliers.Otherpromotionalmaterialsnamelycaps,‘T-shirts’andwheelcoverswillalsobeused.Furthermore,informationaboutTMDAanditsfunctionswillalsobedisseminatedthroughpubliceducationprogrammestoincluderadio,TV,printmediaandexhibitions.
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9.0 CLIENT’S RIGHTS AND RESPONSIBILITIES
9.1 CLIENTS RIGHTS InconnectiontotheservicesTMDAoffersandinaccordancewiththesetstandards,ourclientshavearighttoexpecthighqualityservicesfromTMDA.Theseexpectationsmaydifferdependingoncategoriesofclientsasdelineatedbelow:-(a) Product manufacturers, processors, distributors and retailersThesecategoriesofclientshavethefollowingrights:
TounderstandthestandardsofservicesofferedbyTMDA; ToreceivetimelyfeedbackfromTMDAontheoutcomeoftheirapplicationsforapproval; Toaccessinformationandreceiveeducationonregulatedproducts; Toparticipate in thedevelopmentandamendmentof laws,regulationsandguidelinespertainingtoTMDAservices;
Toreceiveassuranceonprivacyandconfidentialityofinformationrelatedtotheirproducts,premisesandanyothersubmittedinformationinthecourseofsecuringTMDAservices;
Tobetreatedequally,fairlyandwithoutanybias; Tobegivenqualityservices,withcourteousness,professionalism,valueandrespectfromTMDAstaff;
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ToappealagainstanydecisionmadebyTMDAonservicesdeliveredonceaggrieved;and To lodgecomplaints,concerns,compliments, remarksorsuggestionsregardingTMDA
services.
(b) Consumers and general public (i) Assuranceonquality,safetyandeffectivenessofTMDAregulatedproducts;(ii) Timelygettingofinformationonfalsifiedandsubstandardproducts,adversehealtheffects
andotherunfitproducts;(iii)Continuous education on TMDA regulated products, requirements of the Tanzania
MedicinesandMedicalDevicesAct,Cap219andtheirrightstotakepartinenforcingtheexistinglaws;
(iv)Timelyresponsetocomments,complaintsandenquiriesregardingTMDAservices;
(c) Health Care Professionals and ResearchersTherightsoftheseclientsinclude;
AssuranceofqualityandsafetyofproductsregulatedbyTMDA; Timelyinformationregardingregisteredandwithdrawnproductsfromthemarketwhen
needed;
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Thehighestpositivecooperationinadministeringresearchtodetermineefficacyofhumanandveterinarymedicines,herbalandlocalmedicinesaswellasmedicaldevices;
Timelyapprovalofapplicationsofclinicaltrialsandmedicaldevices;and Timelyandaccurateinformationregardingtheachievementsmaderegulatoryactivitiesandonrationaluseofregulatedproducts
9.2 CLIENT’S RESPONSIBILITIES TMDAexpectsclosecooperationwiththeclients,thusourclientsareobligedto:i. VoluntarycompliancetoTanzaniaMedicinesandMedicalDevicesAct,Cap219;ii. BehonesttoTMDAandgeneralpublic;iii. RespectTMDAstaffandnotusingabusivelanguagewhendoingbusinesswithTMDA;iv. Toadheretoinstitutionalprocedurespertainingtoservicesprovision;v. Toreadandunderstandthischarterandgovernedlaws,regulations,guidelinesandother
relevantdocumentsrelatedtoservicesprovidedbyTMDA;vi. TimelyandaccuratelyrespondtoTMDArequestsregardingregulatedproducts;and;vii. TimelypaymentsoffeesandchargesforregulatoryservicesprovidedbyTMDA.
10. STAKEHOLDER RIGHTSIn the context of this charter stakeholders include Government Institutions, Development
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Partners, lawenforcers,CivilSocietyOrganizations (CSOs),MediaandLibrariesandserviceproviders.Theirrightsareindicatedasfollows;
(a) Government Institutions and other Law enforcers PositivecooperationandcollaborationinenforcingtheTanzaniaMedicinesandMedical
DevicesAct,Cap219; Timelyprovisionoftechnicalinputsandtoolsrequiredindealingwithmattersrelated
tolawenforcementoftheTanzaniaMedicinesandMedicalDevicesAct,Cap219; Timelyandaccurateinformationandeducationonanyprogressmadeine x e c u t i n g
activitiesrelatedtoregulatedproducts; BeinginvolvedinthereviewofLaw,regulationsandguidelinesofregulatedproducts
whereapplicable;
(b) Development Partners To getting information from TMDA regarding regulated products, services and
Implementationstatusoffundedprojects;andTomakefollowupandadviceaccordingtoimplementationofcontractsofferedby
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(c) Civil Society Organizations (CSOs)i) Positive cooperation and support in executing projects and businesses related to
regulatedproductsii)Timelyandaccurateinformationandeducationonthequalityandsafetyofproducts
(d) Media and Libraries Timely dissemination of information and education materials regarding regulated
productsandotherservicesofferedbyTMDAusingappropriatechannelsandwithintheinternalQualitypolicy,lawsandproceduresoftheAuthority;
To be involved in various stakeholders` meetings regarding operational activitiesincluding reviewing of regulations and different guidelines under the TanzaniaMedicinesandMedicalDevicesAct,Cap219.
(e) Service providers Givenfairopportunityintheprocessesofobtaining servicesproviders; TimelypaymentsforservicesofferedtoTMDA;and Timely informationon the status of applications to become a serviceproviderwhen
participatinginpre-qualification Toparticipateinthebiddingprocessofgettingacontractforprovisionofgoods/services
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inaccordancewiththeexistinglaws.
11.0 MONITORING, EVALUATION AND REPORTING PERFORMANCE AGAINST STANDARDS
11.1 MONITORING AND EVALUATIONTMDA shall conduct periodic monitoring and annual performance evaluation of the setstandardsinthisCharter.Wewillpromptlyimplementmeasurestoimproveourserviceswhenopportunitiestoimproveareidentified.M&EoftheseCharterwillbedonedirectlybyusingthefollowingmechanism:
(a) Inspection of Operating systems Inspection of TMDAQualityManagement Systemswill continuously be done according toapproved schedules. Theinspectionwillgaugeperformanceofservicesbystudyingperformancereportsfromeverydirectorateanddepartment,StandardOperatingProcedures(SOPs)andkeepingofdocuments.
AuditingofTMDAresourcesincludingfinancialissueswillbedonebytheinternalAuditunitthroughfinancialandprocurementprocesseswhichwillbedoneaccordingtoproceduresandtherespectivereportsubmittedtothemanagementfordecisionmaking.
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(b) Efficient response of client’s complaintsClients’expectationschangefromtimetotime.Inthisregard,differentchannelswillbeusedtoprovidefeedbackandfacilitateclientsexpresstheiropinionsandcommentsonthelevelsofservicesstandardsdeliveredbyTMDA.
Thefollowingapproacheswillbeusedinobtainingcommentsandfeedbackfromourclients:(i) Usingspecific forms for the submissionofvariouscustomercomplaintsandcomments
availableatthecustomerservicedeskandontheAuthority’swebsite(www.tmda.go.tz).(ii) [email protected].(iii) UsingcustomersuggestionboxesatallTMDAoffices.(iv) Usingmobileservices thatareopendailyduringworkingdays togetherwithTollFree
number0800110084.(v) ConductsurveysoncustomersatisfactionlevelsandservicesprovidedbyTMDA.(vi) Conductingdirectordirectdiscussionswithclients.(vii) Receiving information from whistleblowers as part of the implementation of the
whistleblowingPolicy.(viii)Obtaining information through a specific customer feedback questionnaire on the
availabilityofTMDAservices(ExitInterviewQuestionaireForm)
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(ix) Using a specific questionnaire to obtain information from the public if various TMDAinformationisaccessedthroughvariousmeansofcommunication.
11.2 REPORTING PERFORMANCE AGAINST STANDARDS WewillpubliclyaccountforourperformancebypublishingAnnualProgressReportswherebyissuesofcompliancetoTMDAservicestandardswillbefeatured.
Thereportingmechanismwillbeasfollows:
(i) EnsuretheAnnualProgressReportincludesthesectionforclientscommentsreceivedinayearsoastomakeeasethefollowupofthischarterandensurethatstaffandgeneralpublicreceivethereportsaccordingly;
(ii) Discussthecharters’implementationwithstaffduringstaffmeetingwhicharescheduledtwiceayear;and
(iii) Provide charter performance information annually to the Ministerial Advisory Board(MAB).
12. REVIEW AND MAINTENANCE OF THE CHARTER ThisCharterisalivingdocumentandgoesintandemwithchangesthatmightoccurinsocietyandthatmayaffectourservicedelivery.ReviewofthisCharterispivotaltoensurethatitisup-
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to-date.Reviewwillbedonebyengagingwithclientsandotherstakeholdersaftereverythreeyearsorastheneedarises.Thereviewwilltakeintoconsiderationthefollowing:-
a.MonitoringandevaluationofthisChatter;b.Feedbackfromclientsandstakeholders;c.Changesintheorganizationalstructure;d.Changesinclient’sprofile,needsandpriorities;ande.Changesinservicedeliverysystems.
13. BUSINESS HOURSTMDAofficeswillbeopenforourclientsandstakeholdersfrom08:30am-05:00pm,MondaytoFridayexceptweekendsandpublicholidays.
14. CLIENT’S FEEDBACK AND COMPLAINTS HANDLING TMDAiscommittedtoimprovingthestandardsofservicedeliveryfromtimetotime.Feedbackincludingcomplaintsfromourclientswillfosterandforgerelationshipsandensurethatservicesofferedareofgoodquality,efficient,effectiveandup-todate.
We welcome feedback on this Charter including complaints, compliments and suggestionsrelated to the servicesweoffer.Thesecanbegiven throughpostaladdresses, emails,verbal
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conversations, letters, hotline number (toll free), telephones or faxes. Filling of the specialcomplaint/complimentformsthatareavailableonthewebsiteandCustomerCareDeskwillalsobeacceptedandattendedto.Allcomplaintsandsuggestionswillbetakenseriouslyanddealtwithasquicklyaspossible.
15. HOW TO CONTACT TMDAAllTMDAcustomersareentitledtotheservicesthatweoffer.Clientsareurgedtosubmittheircomments,opinions,suggestions,complaints,concernsoradviceontheservicesweoffer.Bydoingso,weasagovernmentinstitutionwillbeinformed,takenecessaryactionsneededandcontributetowardsprotectionofpublichealthwhichisfundamentallytheresponsibilityofbothofus.
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Clients can contact TMDA by letter, phone, fax or email through the following addresses:
Director General
TanzaniaMedicinesandMedicalDevicesAuthority(TMDA),Headquaters,
P.O.Box1253Dodoma
Sub-head office
P.O.Box77150,DaresSalaamPhone:+255222450512/2450751/2452108
Fax:+255222450793Tollfree:0800110084
Email:[email protected],Website:www.tmda.go.tz
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Lake ZoneNyasakaRoad,Nyakato
Buzuruga,
P.O.Box543,Ilemela-Mwanza
Tel:+255282981224/5
Fax:+25528282981205
Email:[email protected]
Northern ZoneSakinaStreet,
P.O.Box16609,Arusha
Tel:+255272970333/73782442
Fax:+255272547098
Email:[email protected]
Eastern ZonePSSFBuilding,Victoria
AliHassanMwinyiRoad,
P.O.Box31356,DaresSalaam
Tel:+255737226328/788470312
Fax:+255222450793
Email:[email protected]
Southern Highlands ZoneNHIFBuilding3rdfloor,
P.O.Box6171,Mbeya
Tel:+255252504425
Fax:+255252504425
Email:[email protected]
Central ZonePSSFBuilding,
P.O.Box1253,Dodoma
Tel:+255262320156
Fax:+255262320156
Email:[email protected]
Our Zone Offices can also be reached through the following addresses:
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Southern ZonePSSSFBuilding,
P.O.Box1447,Mtwara
Tel:+255232334655
Email:[email protected]
Western ZoneTUWASABuilding,
P.O.Box520,Tabora
Tel:+255262600082/654817849
Cell:+255654817849
Fax:+255262600081
Email:[email protected]
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CUSTOMER COMPLAINT/COMPLEMENT
FORM
TMDA/DG/CPE/F/001 Rev #:03
Part I: Customer Particulars Name: …………………………………….. Title: …………………………………………..
Company:…………………………………. Address:……………………………………….
Phone No:………………………………… E-mail:…………………………………………
Signature:……………………………….. Date:……………………………………………
Part II: Description of complaint/ complement
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………..
…………………………………………………………………………………………………………
………………………………………………………………………………………………………… ………………………………………………………………………………………………………… ………………………………………………………………………………………………………….
Received by: ………………..….. Signature: ………………… Date: …..……………
Part III: Review of complaint/complement by Manager, Communication and Public Education/Zone Manager and action taken.
…………………………………………………………………………..…………………………
………………………………………………………………………………………………………
………………………………………………………………………………………………………
………………………………………………………………………………………………………
………………………………………………………………………………………………………
Signature: ………………………… Date: ……………………………….
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