CONTENTS Abbreviations iv Acknowledgements vi …...medical devices, diagnostics and other health...

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY - TMDAClients’ Service Charter

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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

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY - TMDA Clients’ Service Charter

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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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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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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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i. Registrationofdomesticmanufacturedantisepticsanddisinfectants Within30days

ii. Registrationofimportedantisepticsanddisinfectants Within60days

2.5 Registration of Herbal Medicinesi. Registrationofdomesticmanufacturedherbal

medicines Within90days

ii. Registrationofimportedherbalmedicines Within180days


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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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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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5. Approval of Alterations and Variationsi. Majorvariationofaregisteredmedicine 45 daysii. Minorvariationofaregisteredmedicine Within30daysiii.Variationofregisteredmedicaldevicesand

diagnostics 10daysiv.Majoramendmentforapprovedclinicaltrial 30daysv. Minoramendmentforapprovedclinicaltrial 10days


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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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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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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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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-


32

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


33

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


Eastern ZonePSSFBuilding,Victoria

AliHassanMwinyiRoad,

P.O.Box31356,DaresSalaam

Tel:+255737226328/788470312

Fax:+255222450793


Southern Highlands ZoneNHIFBuilding3rdfloor,

P.O.Box6171,Mbeya

Tel:+255252504425

Fax:+255252504425


Central ZonePSSFBuilding,

P.O.Box1253,Dodoma

Tel:+255262320156

Fax:+255262320156


Our Zone Offices can also be reached through the following addresses:


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Southern ZonePSSSFBuilding,

P.O.Box1447,Mtwara

Tel:+255232334655


Western ZoneTUWASABuilding,

P.O.Box520,Tabora

Tel:+255262600082/654817849

Cell:+255654817849

Fax:+255262600081



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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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Date post:	14-Jul-2020
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CONTENTS Abbreviations iv Acknowledgements vi …...medical devices, diagnostics and other health...

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