澳洲TGA人用药品报批指南.pdf

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1、AccesstoUnapprovedTherapeuticGoods-AuthorisedPrescribersOctober2004INDEXTheseguidelines4Introduction6Thelegalbasisforsupplyofunapprovedtherapeuticgoods6Promotionofunapprovedtherapeuticgoods8Releaseofinformation8Basicprinciplesgoverningthesupplyofunapprovedprod

2、uctsusingtheAuthorisedPrescribermechanism10Patientrights10Responsibilitiesoftheprescriber10ResponsibilitiesoftheTGA11Rightsandresponsibilitiesofthesponsoringcompany(supplier)11ConditionsofAuthorisation12Other12TheTGA'sattitudetowardexistingSection19(5)/41HCAut

3、horisationswhenanotherproductisregisteredfortreatmentofthespecificcondition13HowtobecomeanAuthorisedPrescriber14WhocanbecomeanAuthorisedPrescriber?14RequestinganauthorisationfromTGA-theoverallapproach14ThecriteriausedbydelegatesindecidingwhethertogiveAuthorisa

4、tion14HowTGAbalancesthecriteria17Theroleoftheethicscommittee19InformationrequiredbytheethicscommitteewhenconsideringendorsementofamedicalpractitionerasanAuthorisedPrescriber19Conditionsmaybeimposedontheendorsementbyanethicscommittee19Anethicscommitteecanwithdr

5、awitsendorsement20CircumstancesunderwhichTGAmayrevokeanAuthorisation20HowtoobtainanunapprovedmedicineormedicaldeviceonceAuthorisationhasbeengranted21ProductsavailableinAustralia21ProductsnotavailableinAustralia21Reportingofadverseoutcomesassociatedwiththeuseof

6、unapprovedtherapeuticgoods23Definitions23Responsibilitiesforreporting25Whatshouldbereportedandhow25AccesstoUnapprovedTherapeuticGoods–AuthorisedPrescribers–October20042WhattodoifyourapplicationtobecomeanAuthorisedPrescriberisrejected29Informalmechanisms29Forma

7、lappealmechanisms29DecisionsundertheCustomsAct30AppendicesAppendix1GeneralconditionsofanAuthorisationunderSection19(5)/41HCAppendix2'AgreementtoTreatmentDirections'formAppendix3ConsenttoTreatmentandIndemnityforUseofProductsDerivedfromHumanBloodorPlasmaAppendix

8、4HRECLetterofendorsementforAuthorisedPrescribersAppendix5ADRAC'bluecard'forreportingadversemedicinereactionsAppendix6MedicalDeviceIncidentReportAccesstoUnapprovedTherapeuticGoods–A