listed medicines application and submission user guide · therapeutic goods administration listed...

Listed medicines application and submission user guide TGA Business Services (TBS)

Version 3.0, June 2018

TherapeuticGoodsAdministration

ListedmedicinesapplicationandsubmissionuserguideV3.0June2018

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Copyright©CommonwealthofAustralia2018Thisworkiscopyright.Youmayreproducethewholeorpartofthisworkinunalteredformforyourownpersonaluseor,ifyouarepartofanorganisation,forinternalusewithinyourorganisation,butonlyifyouoryourorganisationdonotusethereproductionforanycommercialpurposeandretainthiscopyrightnoticeandalldisclaimernoticesaspartofthatreproduction.ApartfromrightstouseaspermittedbytheCopyrightAct1968orallowedbythiscopyrightnotice,allotherrightsarereservedandyouarenotallowedtoreproducethewholeoranypartofthisworkinanyway(electronicorotherwise)withoutfirstbeinggivenspecificwrittenpermissionfromtheCommonwealthtodoso.RequestsandinquiriesconcerningreproductionandrightsaretobesenttotheTGACopyrightOfficer,TherapeuticGoodsAdministration,POBox100,WodenACT2606oremailedto<[email protected]>.



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Contents

Introduction ___________________________________ 5

TGABusinessServicesportalforlistedmedicines _______________________5

Assumedknowledge___________________________________________________________5

Accessinghelp__________________________________________________________________5

Email‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐5

Phone‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐5

Getting started _________________________________ 6

AccessingtheTGABusinessService_________________________________________6

ToaccesstheTBSsystem:‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐6

Toenterthesponsorportal:‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐6

Usertypes‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐7

Homepage‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐7

Creatingnewapplications____________________________________________________8

Accessingdraftapplications‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐8

Navigatingthroughanapplication‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐9

Requiredfields‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐11

Add,removeandeditdatainfields‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐11

Applicationtabs‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐11

Completinganapplication‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐12

Applicationtab‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐12

Registrationtab‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐13

Manufacturerstab‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐13

Productstab‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐14

Ingredients‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐14

Proprietaryingredients‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐16

Indications‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐18

Howtoaddapermittedindication‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐19

Howtolinkindications‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐22

Warnings‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐28

Subsection26B(1)Notification____________________________________________28

Otherregulatoryrequirementstab_______________________________________29

Other application types _________________________ 29

Varyingorchanginganexistingproduct‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐29

Codestockapplications‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐30



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Medicinekitapplications___________________________________________________31

Productstab‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐31

Compositepack______________________________________________________________32

Products‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐33

Changemultiplecurrentlistingsapplication____________________________33

Applicationtab‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐33

Registrationtab‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐34

Manufacturerstab___________________________________________________________34

Validatinganapplication___________________________________________________35

Submission____________________________________________________________________36

TroubleshootingintheTGABusinessServicesPortal_________________38

CommonITissues‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐38



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Introduction

TGA Business Services portal for listed medicines Listedmedicinesareconsideredlowriskbasedontheiringredientsandtheindicationsmadeforthem.Mostlistedmedicinesarecomplementarymedicines,suchas:vitaminandmineralformulations,herbalpreparations,homeopathicpreparations,andessentialoils.

TheTGABusinessservices(TBS)portalprovidesanelectronicfacilityforthelistingofmedicinesontheAustralianRegisterofTherapeuticGoods(ARTG).AmedicineislistedontheARTGonthebasisofinformationprovidedbytheapplicantandacertificationbytheapplicantthatthegoods(thatarethesubjectoftheapplication)meettherequirementsofSection26AoftheTherapeuticGoodsAct1989(theAct).TheActallowsforcancellationofaproductfromtheARTGifasponsor’scertificationisincorrect.

AccesstotheTBSsystemisviaasecureloginontheTBShomepageandrequiresausernameandpassword.InordertogetaccesstoTBS,applicantsmustfirstsubmitanorganisationdetailsformtoobtaina‘clientidentificationnumber’TheTGAwillestablishaccessfortheapplicanttobecomethe‘E‐BusinessAdministrator’fortheircompanyandthenapplicationsforuseraccountscanbemade.

Allnecessarytoolsrequiredtolodge,changeandmaintainanapplicationforalistedmedicineareaccessibleviaTBS.Thisguideisintendedtobeusedasastep‐by‐stepdescriptionofeachprocessoftheapplicationandsubmissionprocess.Eachsectionwilloutlinethefunctionalityanddescribehoweachsectionshouldbecompleted.

Assumed knowledge ItisassumedthatuserswillhaveanunderstandingoftheregulationofcomplementarymedicinesinAustraliaandthelegalobligationsofasponsorofalistedmedicine.Formoreinformation,refertotheAustralianRegulatoryGuidelinesforComplementaryMedicines.

ItisalsoassumedthatuserswillhavereadandunderstoodtherequirementsrelatingtoPermittedIndications.Formoreinformation,refertothePermittedindicationsforlistedmedicinesguidance.

Accessing help HelpisavailablefromwithintheTBSportalandcanbeaccessedbyclickingthe‘Help’linkinthetopleftcorneroneachpageoftheapplication.Thiswillopenhelpinanewwindow.

Email

Forlistedmedicineapplicationandsubmissionenquiries,pleaseemailcomplementary.medicines@health.gov.auwithasmuchinformationaspossible,suchasacopyofyourproblemapplicationorscreenshotsoferrormessagesyouhavereceived.

ForquestionsaboutTBSrelatedissuesandaccessyoucancontacttheTBShelpdeskonebs@health.gov.au.

Phone

YoucanphoneComplementarymedicineson1800020653or0262328634:



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YoucanphonetheTBShelpdeskon1800010624.

Getting started

Accessing the TGA Business Service TheTGABusinessservices(TBS)isaccessedthroughyourwebbrowser.ThisiscommonlyInternetExplorerbutmayalsobeChrome,FirefoxorSafari.

To access the TBS system:

1. Openyourinternetbrowser

2. Gotowww.ebs.tga.gov.au

Thehomepagewillappearasshownbelow.Thispageisaccessiblebyall;however,secureloginisrequiredtoaccesstheapplicationsystemviathesponsorportal.

To enter the sponsor portal:

1. EnsureyouhavethepasswordprovidedtoyoubytheTBShelpdesk.

2. SelectLogintoBusinessServicesfromthelefthandsideoftheTBShomepage.

3. Theloginscreenwilldisplay.Enteryourusernameandpassword.



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Note:Usernameandpasswordarecasesensitive.

Yourpasswordwillnotbereadableonscreen,appearingasarowof⦁⦁⦁⦁⦁⦁⦁⦁⦁⦁.

User types

SecurityfortheTBSishandledatanorganisationallevel.Therearethreeusertypes:

1. Administrator:isabletosetupnewusersbutcannotdraftorsubmitapplications.

2. Drafter:isabletocarryoutallfunctionsneededtocompleteapplicationsbutcannotsubmitapplications.

3. Submitter:canperformthesametasksasadrafterandisalsoabletosubmitacompletedapplicationtotheTGA.

Eachsponsorisallocatedausernameandpasswordfortheir‘‘Administrator’account.Theycanthencreatetheirownusersforthe‘Drafter’and‘Submitter’roles.Onceloggedin,allusersareabletoseethecurrentapplicationsforthesponsor.

Home page

Onceloggedin,youwillseetheportalhomepage,asshownbelow.

Fromthisscreenyoucan:

Viewdrafts:alldraftapplicationscompletedinTBScanbeviewed.

Viewlodgedsubmissions:viewandtracktheprogressofallsubmittedapplicationsunderallTBSsystems.

News:viewthelatestnews.

Createapplicationsandsubmissions:openthevariousapplicationtypesandsubmitvalidatedapplications.

Maintainuseraccount:editportaloptions,userdetailsandviewaccountactivity.

YourTGAinformation:viewcurrentARTGentriesandproductinformation.



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Creating new applications Tocreatealistedmedicineapplication:

1. Selecttheapplicationsdropdownarrow.

2. SelectListedmedicine.Thiswillresultinthefollowingoptionsbecomingavailable:

Generallisting:themostcommonapplicationtype,containingasinglemedicine.

Compositepack:allowsfortwoormoremedicineformulationstobeincluded,formingapack.

Codestock:createsanapplicationbasedonacodestockproduct.

Medicinekit:previouslylistedmedicineswhichwillbesoldtogetherinapurposebuiltpack.

Changemultiplecurrentlistings:allowsforminorchangestobemadetomultiplelistings.

3. Selecttheappropriateapplicationtypefromthelist.Thiswillopentheassociatedform.Theprocessoffillingouteachapplicationtypevariesslightly.Thefollowingsectionsofthedocumentwillguideyouthroughtheprocess.

Accessing draft applications

PreviouslycompleteddraftapplicationswhichhavenotbeensubmittedcanbeaccessedviatheTBSPortal,asshownbelow:



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SelectingWorkondraftswillopenalistofcurrentdraftapplications.Clickonthedraftapplicationyouwishtocontinueediting.

Toaccessotherfunctionssuchas‘copy’,‘delete’or‘printpreview’,pressonthearrowtotheleftoftheapplicationyouwishtoaccess.

NOTE:Draftapplicationsareautomaticallydeletedfromthesystemiftheyhavenotbeenupdatedinthelasttwelvemonths.Oncedeleted,recordsarenotretrievable.

Navigating through an application

Onceanewapplicationtypeordrafthasbeenselected,theapplicationwillopenasshownbelow:



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Thevariousaspectsoftheformareexplainedasfollows:

1. Applicationmenu:allowsyouto‘save’or‘close’anapplication.Italsoallowsforvalidationonceallnecessaryinformationhasbeenentered.

2. Helpmenu:providesdefinitionsandinformationregardingeachstepoftheapplicationprocess.

3. Applicationtype:referstothetypeofapplicationbeingcreated,forexample:‘Generallisting’,‘Medicinekit’,‘Codestock’.

4. Status:indicatesthestateoftheapplication,thatis:‘draft’(applicationhasnotyetbeenvalidated)or‘passed’(applicationhasvalidatedsuccessfully).

5. ApplicationID:beginswith‘LM’andistheidentificationnumberoftheapplicationyouareworkingon.Thisnumbercanbeusedtotroubleshoottechnicalissues.

6. Username:thenameofthecurrentuser.

7. Clientreference:anamethatcanbeenteredbytheapplicantinordertoidentifythecurrentapplication.ThisnameisnotseenorusedbytheTGA.

8. Lastupdated:thedateandtimetheapplicationwaslastupdated.

9. Previous/Next:navigatesthroughthetabsoftheapplication.



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10. Save:savecurrentapplication.

11. Validate:validatecurrentapplication.

NOTE:‘Validation’isnotpossibleuntilallrequiredfieldshavebeencompleted.

12. Printpreview:viewtheapplicationbeforeprinting.

13. Close:closecurrentapplication,returningtotheTBSportal.

Required fields

Fieldsintheapplicationare‘required’or‘conditionallyrequired’dependingonanumberofdifferentfactors.Requiredfieldsaremarkedbyaredasteriskandconditionallyrequiredfieldsaremarkedbyagreyasterisk.

Add, remove and edit data in fields

Whereappropriate:

Add:toaddanentry,pressthe‘Add’buttonandinserttherequiredinformation.

Remove:selectthecheckboxinfrontoftheentrywhichyouwishtoremoveandpressthe‘Remove’button.

Application tabs

Theapplicationhasbeendividedintoanumberoftabs,asshownbelow.

Clickoneachtabinordertonavigatethroughtheapplication.

Application:generalinformationregardingthelisting,includingapplicantcontactdetails,iftheapplicationisasection30responseandwhethertheapplicationisforanewlistingorchangetocurrentlisting.

Registration:productname,productcode,exportnamesandcodestocknotification.

Manufacturers:manufacturerdetailsandstepsperformed.

Products:informationrelatingtotheproductincludingrouteofadministration,dosage,



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containerspecifications,ingredients,indicationsandwarnings.Alsoincludessubsection26B(1)Notification.

Otherregulatoryrequirements:regulatoryinformationrelatingtothespecificproduct.

Completing an application

Thefollowingwilldescribetheprocessofcompletingagenerallisting.Mostsectionsareapplicabletoallapplicationtypes;howevermorespecificguidanceforeachapplicationtypecanbeobtainedfromtherelevantsectionofthisguide.

Application tab

Field Description

Applicantname DisplaysyourclientnamebasedonyourloginID.

Sponsorname Selectthesponsornamefromthedropdownlist.

Sponsoraddresses

Iftherequiredaddressisnotavailable,pleasecontacttheTBSHelpDesk.

Billingaddress:Selectthepreferredbillingaddressforthisproduct

Regulatorycorrespondenceaddress:Selectthesponsoraddressfromthedropdownlistprovided.

IsthisapplicationinresponsetoaSection30

Select‘Yes’ifthisapplicationisbeingsubmittedasaresponsetoaSection30request.

EntertheAUSTLbeingrespondedtoif‘Yes’hasbeenselected.

Thisapplicationisto NominatewhetherthisapplicationistochangeanexistingARTGlistingortocreateanewARTGlisting.

AUSTL Therearetwosituationswherethisfieldisused:

EnteracurrentAUSTLtoupdatethelisting.

EnteracurrentAUSTLtocreateanewlistingbasedonanexistinglisting.

Submissioncost Displaysthesubmissioncostwhenthedraftapplicationhasbeencompletedandvalidated.

Paymentexemptionnumber

Enterapaymentexemptionnumber,ifapplicable,tonotifyTGAthatpaymentisnotrequired.



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Registration tab

Field Description

Productname Enterthenameoftheproduct.ThisisthefinalproductnamethatwillbeusediftheproductislistedontheARTG.Auniquenameassignedtothegoodsbythesponsortoappearonthelabel.

Productcode Selectthecodethatbestdescribesthetypeofproductbeingsubmittedfromthedropdownlist.Mostlistedmedicinesaregenerally‘Otherproducts’,unlesstheycontainhomeopathicingredients.

Exportnames Multipleexportnamescanbeaddedtoaproduct.

Pressthe‘Add’buttontoaddexportnames.Toremoveexportnames,selecttheboxbesidethenameyouwishtoremoveandpressthe‘Remove’button.

Canthisproductbeusedasacodestock

Indicatesiftheproductcanbeusedasacodestock.

Note:Selecting‘codestock’doesnotmeantheformulationwillbeconfidential.

Iftheapplicationisforaproductmadefromacodestocksource,thecodestocksourcedetailswillbedisplayedhere.

Manufacturers tab

Toaddamanufacturer:

1. Pressthe‘Add’buttonbesidethe‘Manufacturerssection’toopenthe‘ManufacturerDetails’form.

2. Selectthelocationofthemanufacturer;either‘Australian’or‘Overseas’.

3. Selectwhattermthesearchwillbeconductedusing;the‘Name’,‘ManufacturerID’or‘LicenceID’forthemanufacturer.

4. Enterall,orpartoftheinformation,thenpressthe‘Search’button.



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NOTE:Ifnotenoughinformationisentered,anerrormessagestating“Toomanyentriesfound.Pleaserefineyoursearch”willappear.

5. Selecttherequired‘Manufacturername’fromthedropdownlist

6. Selectthe‘Manufacturerlocation’fromthedropdownlist

7. Selectthestepsperformedbythemanufacturer.Eachstepcanbeundertakenbymorethanonemanufacturer.

8. Whencomplete,pressthe‘Save’buttontoreturntothemanufacturingtab.

Products tab

Pleasenotethatsomeofthesectionslistedbelowareonlyconditionallyrequired,dependingonanumberoffactorsrelatingtoyourproduct.

Field Description

Routeofadministration Pressthe‘Add’buttontoentertheroute(s)ofadministration.Multipleroutesofadministrationcanbeaddedtoaformulationbypressing‘Save’betweeneachaddition.

DosageForm Selectthedosageformfortheformulationfromthedropdownlist.

ContainertypeContainervolumeContainerclosureContainercondition

Onlyrequiredwhentheformulationcontainsingredientswhichhavebeenrestrictedtoa‘containertype’,‘closure’or‘sizelimit’.

Informationcanbeenteredintothecorrectfieldorselectedfromadropdownlist.

MaximumsingledoseMaximumdailydose

Onlyrequiredwhenrestrictionsapply.Fieldstoselectunitsfromwilldisplayifusinganon‐divideddosageform,forexample:powder.

Minimumweightofdivideddosageform

Onlyrequiredwhenusingadivideddosageform(forexample:tablet)andtheformulationcontainsrestrictedingredients.

Ingredients

Australianapprovedterminologyshouldbeusedwhensubmittinganapplication.Approvednamesfallintothefollowingcategories:

AAN–AustralianApproved(ChemicalSubstance)Name



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ABN–AustralianBiologicalName

AFN–AustralianFoodName

AHN–AustralianHerbalName

AHS–AustralianHerbalSubstance

AIN–AustralianIngredientName

HCN–HerbalComponentName

Toaddaningredient:

1. Pressthe‘Add’buttonnexttothe‘Ingredients’sectiontoopenthe‘Ingredientdetails’form.

2. Theingredientdetailsformisdisplayedasshownbelow.Selecttheingredienttype,ingredientrole,andentertheingredientname.‘ProprietaryIngredients’canbesearchedforusingtheirIDnumber.

3. Pressthe‘Search’buttonorusethe‘Enter’keytobeginasearch.

4. Selectthecorrectingredientnamefromthedropdownlist.

5. Entertheingredientquantityandselecttheunitsfromthedropdownlist.



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Proprietary ingredients

Formulationdetailsof‘ProprietaryIngredients’arenotreleasedandusuallycontaineithermultipleexcipientingredientsorasingleactivepreparationwhichmayalsoincludeexcipientingredients.

‘ActiveProprietaryIngredients’requireingredientquantitiestobeentered.Someexcipient‘ProprietaryIngredients’suchasflavours,fragrancesandprintinginksalsorequirequantitiestobeentered,asthefollowinglimitsapplytothefinalformulation:

Flavour–5%

Fragrance–1%

PrintingInk–0.1%

Thefollowingoptionsareavailableintheingredientbox.Notethatonlythosefieldsapplicabletotheparticularingredientwillbedisplayed.

Field Description

Ingredientname Selecttheingredientfromthedropdownlist.

FormulationtypeIngredientroleIngredienttypeProprietaryingredientID

Thesefieldsareautomaticallypopulatedbasedontheingredientsselected.

Ingredientquantity Ingredientquantitiesarerequiredforallactiveingredients.

ExcipientingredientquantitiesarecurrentlynotrequiredunlesstheyareAHNsorhaverestrictions.

Entertheingredientquantityandselecttheappropriateunit.

Equivalent Therearetwoinstanceswhereequivalentsareused:

Equivalentdryorfreshherbwherethepreparationisanextract.

Whereacomponentofasubstanceisdeclaredonthelabelormandatedduetoregulatoryrequirements.

HomeopathicIngredients

Ingredientname Selecttheingredientfromthedropdownlist.

Potency Enterthepotencyofahomeopathicingredient

Labelname&potency Enterthelabelnameandpotencyvaluesofahomeopathicingredient



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HomeopathicIngredients

Diluent Pressthe‘Add’buttontoaddadiluenttotheingredient.Selectappropriatediluentsfromthedropdownlistandenterthepercentage.Multiplediluentscanbeadded.

Selectthe‘Diluentsarenotpresentinthefinalproduct’boxifapplicable.

Reference Selectthehomeopathicreferencefromthedropdownlist.

EssenceIngredients

Concentrationofmothersubstance

Applicablewhentheingredientroleis‘Essence’.Enterthequantityandselecttheunitfromthedropdownlist.

Manufacturermethod Applicablewhentheingredientroleis‘Essence’.Selectthemanufacturingmethodsfromthedropdownlist.

IngredientsofHumanorAnimalOrigin

Ingredientofhumanoranimalorigin

ApplicabletoAANorABNingredients.

Note:ApreclearancecertificateissuedbytheTGA’sScientificEvaluationBranchmayberequired.

Animalorigin Selectthecountry,orcountries,oforiginfortheingredientfromthedropdownlist.

Animaltype Selecttheanimaltheingredientisderivedfromthedropdownlist.

Animalpart Selectthepartoftheanimalfromwhichtheingredientisderivedfromthedropdownlist.

AustralianHerbalName(AHN)Ingredientsonly

Plantpart Selecttheplantpartfromthedropdownlist.

Plantpreparation Selecttheplantpreparationfromthedropdownlist.Notethatselectingadifferentplantpreparationmaycausevaluesinotherfieldstobeautomaticallyupdated.

Equivalentpreparation Selecttheappropriateequivalentpreparationfromthetogglebuttonsifrequired.

Equivalentquantity Entertheamountofequivalentpreparationtobeusedintheingredient.Selecttheunitfromthedropdownlist.



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AustralianHerbalName(AHN)Ingredientsonly

Finalpreparationratio Enterthefinalpreparationratio.Theratiowillreversedependingonthepreparationtypeselected.

Newratio Applicablewhentheingredientratiorequiresupdating.Enterthenewratiovaluethenpressthe‘Update’buttontotherightoftheratiofield.

Preparationsteps Pressthe‘Add’buttontoaddapreparationtotheingredient.Multiplepreparationstepscanbeadded.

Plantpreparation:Selecttheplantpreparationfromthedropdownlist.Thiswillautomaticallydefaulttotheplantpreparationvaluepreviouslyselectedontheparentingredientpage.

Preparationratio:Entertheratiovaluesifdifferenttotheoriginalratioenteredontheparentingredient.

Plantpreparationstep:Thisisautomaticallygeneratedbythesystem.

Solvents:Pressthe‘Add’buttontoaddasolvent.Multiplesolventscanbeadded.Selectappropriatesolventsfromthedropdownlistandenterthepercentage.

Note:Totalpercentagemustequal100%Selectthe‘Remainderwater’boxifapplicable.

Remainingrestrictedsolvent

Requiredifsolventsarerestricted.Thesolventtobeaddedmustbethesameasthoseusedinpreparationstepspreviouslycompleted.

Clickthe‘Add’buttontoadda‘Remainingrestrictedsolvent’totheingredient.Multiplesolventscanbeadded.

ResidueQuantity:Theupperlimit(maximumamount)ofsolventallowedinthespecificationsfortheingredient.

Carrier Acarrierisanexcipientingredientwhichmaybeincludedinaherbalingredient.Pressthe‘Add’buttontoaddacarriertotheingredient.Multiplecarrierscanbeadded.

Indications

Whencreatinganewgenerallisting,compositepackorcodestockyoumustselectyourindicationsfromthe‘listofpermittedindications’whichiscontainedintheTherapeuticGoods(PermissibleIndications)Determination.Formoreinformation,pleaseseethePermittedindicationsinlistedmedicineguidance.

Whencreatingamedicinekitlisting,youcanusespecificindications.



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Asasponsorofalistedmedicine,itisyourresponsibilitytoensurethatyourproductmeetsalltherequirementsforlisting,including(butnotlimitedto)thatyouholdevidenceforallindicationsmadeforyourmedicine.Similarly,youmustholdevidenceforalladvertisingclaimsyoumake,includingthepermittedindicationsforyouradvertisedmedicine.

How to remove standard and specific indications

Attheendofthe3yeartransitionforPermittedindications(6March2021),allstandardandspecificindicationsmustberemovedfromallARTGentriesforlistedmedicines,exceptmedicalkits.

Toremovea‘Standardorspecificindication’:

1. Selecttheindicationsthatyouwishtoremovefromeitherstandardorspecificindicationslist.

2. Selectthe‘Remove’button.

3. Select‘OK’andtheindicationswillberemoved.

How to add a permitted indication

FormoreinformationonPermittedIndicationsandthetermsusedinthissection,pleaseseethePermittedindicationsinlistedmedicinesguidance.

Toadda‘Permittedindication’:

1. Pressthe‘Add’button.

2. Selectthe‘Evidencetype’youholdtosupportyourindicationsusingtheradiobuttons.Theresultsreturnedwillbedifferentdependingonwhichevidencetypeyouselect.

a. For‘Scientificevidence’selectthe‘Scientific’radiobuttonandclick‘Search’.



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When‘Scientificevidence’isselected,onlyindicationswhichcanbesupportedby‘Scientific’and‘ScientificorTraditional’evidencewillbereturnedinyoursearch.

b. For‘Traditionalevidence’selectthe‘Traditional’radiobutton.A‘Contextqualifier’boxwillappear.

Youneedtoentera‘Contextqualifier’thatspecifiesthetraditionalparadigmfortheindication.Clickthedropdownarrowontherighthandsideandmakeaselectionfromthedropdownlistand‘Save’.

Thesearchresultsaredependentonyour‘ContextQualifier’selection:

Foralltraditionalindicationcontexts,noindicationswhichmustbesupportedby‘Scientific’evidencewillbedisplayed.

IfyouselecttheAyurvedicmedicineContextqualifier,onlyindicationswhichcanbesupportedby‘Ayurvedic’,‘Traditional’or‘ScientificorTraditional’evidencewillbereturned.

IfyouselecttheTraditionalChinesemedicineContextqualifier,onlyindicationswhichcanbesupportedby‘TraditionalChineseMedicine’,‘Traditional’or‘ScientificorTraditional’evidencewillbereturned.

SelectingtheTraditionalChinesemedicineContextQualifierwillalsoallowyoutoaddaTCMPatternqualifier.ThisisexplainedatStep7.

ForallothertraditionalContextqualifiers,onlyindicationswhichcanbesupportedby‘Traditional’or‘ScientificorTraditional’evidencewillbereturned.



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3. Clickthe‘Search’buttonandyouwillbetakentoanewscreentosearchforpermittedindications.

Notethepermittedindicationssearchfieldincludesanoptionto‘Showonly‘parentindications’thatrefertoadiseaseorcondition’.Thisisforusewhenyouwanttolinksymptomindicationstoadisease/condition.RefertoHowtoLinkIndications.

YoucansearchforPermittedindicationsby:

• Keywordorphrasee.g.‘health’

• Bodypart/systeme.g.‘heart’

• Codee.g.CVHEHE‐G‐MS

SelectaSearchcategory,enteryoursearchcriteriainthesecondboxandclick‘Search’.

4. Clickthedropdownarrowbesidethe‘PermittedIndication’boxtodisplaythepermittedindicationsthatmeetyoursearchcriteria.ChooseaPermittedindicationfromthedropdownmenuandclickSelect.

5. Thepermittedindicationandrelevantrequirementswillbedisplayedbelowthesearchbar.

IftheindicationhasRequirements,anacknowledgementwillalsoappear.



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At night

6. Toaddtheindication,selectOKandyouwillbetakenbacktothepreviousscreen.

NotethatbyselectingOK,youareacknowledgingthatyouhavereadandareawareoftherequirementsrelatingtotheuseoftheselectedindications.

7. Youcanchoosetoaddoptionalqualifiersfromdropdownliststoalignwiththeevidenceyouhold.Thethreeoptionalqualifiersaredescribedinthetablebelow.Notethattheoptionalqualifierscanbeselectedbeforeoraftertheindicationhasbeenchosen.

Optionalqualifiers Description

TCMpattern ThiswillonlybeavailableforselectionifaTraditionalChinesemedicineContextqualifierwasselected.

Timeofuse Specifiesthetargetpopulationforthemedicine,e.g.‘inhealthyindividuals’.

Population Indicatesthetimeoftherapeuticbenefitforthemedicine,e.g.‘afterexercise’.

Whenyouhaveselectedyouroptionalqualifiersfromthedropdownlists,select‘Save&Close’.

How to link indications

Youhavetheoptiontolinkcertainindicationstospecifythesymptomsofacondition/disease,toalignwiththeevidenceyouhold.

Parentindications(thatcanhaveotherindicationslinkedtothem)areusuallythosethatincludetheterm‘symptomsof’.Theindicationcodeofaparentindicationendsin‘‐PR’.WhenyouselectaparentindicationinELF,youwillbegiventheoptiontolinksymptomindicationstoit.Ifanindicationisselectedthatdoesnothaveacodethatendswith‘PR’thereisnotanoptiontolinkittoanotherindication.

NotethatparentindicationsandsymptomindicationscanbeincludedinyourARTGentryasstandaloneoraslinkedindications.

at night

in adults



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1. Followsteps1to2underHowtoaddapermittedindication.AtStep3yoursearchcanbefilteredtoshowonlythoseindicationsthatcanbeusedasparentindications.Checktheboxnexttothewords‘Showonly‘parentindications’thatrefertoadiseaseorcondition’.

2. SearchthelistofparentindicationsbyselectingaSearchcategory,enteringyoursearchcriteriaandclicking‘Search’.

Onlyindicationswiththeletters‘PR’attheendofthecodeappearinthelist

Choosetheindicationyouwantfromthedropdownlistandclick‘Select’.

3. Whenaparentindicationisselected,amessagewillappearundertheindicationadvisingthatifyoucanlinkasymptomindication.



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4. Tosearchforanindicationtolinktotheparentindication,selectaSearchcategory,entersearchcriteriaandclick‘Search’.Afterselectinganindicationfromthedropdownlist,click‘Select’.

Notethatthelistofindicationswillnotincludeanythathaveacodeendingin‘PR’becauseaparentindicationcannotbelinkedtoanotherparentindication.

5. Thelinkedindicationwillappearbeneaththeparentindication.Ifalinkedindicationhasarequirementthatisdifferenttotherequirementsalreadylistedfortheotherindicationschosen,itisincludedinthe‘Requirement(s)’section.Ifarequirementisthesameasonealreadylisted,itwillnotberepeatedinthelist.



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6. Youcanrepeattheabovestepstocontinueselectingindicationstolinktotheparentindicationuntilthelistiscompleted.

7. Toremovealinkedindicationfromthelist,selectthecheckboxbesidetheindicationandselect‘Remove’.Anyuniquerequirementsforthatindicationwilldisappearfromthe‘Requirement(s)’list.

Select‘OK’tofinishandyouwillreturntothepreviouswindow.

8. Theparentindicationisdisplayedinthewindow.Youmaychoosetoaddoptionalindicationqualifierstoyourparentindication.



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Notethatthesamequalifiersapplytothecompletesetofindications(i.e.theparentandlinkedindications).

9. Select‘Save&Close’tofinalisetheselection

Thesetofindicationsselectedaredisplayedintheapplicationform.TheparentindicationwillappearwithanyqualifiersselectedinStep8.Thelinkedindicationsareslightlyindented.

Removinganindicationfromyourapplication

Oneormorelinkedindicationscanberemovedfromtheapplicationbycheckingtheboxnexttothemandselecting‘Remove’.

Note:ifyouremoveaparentindicationthathasindicationslinkedtoit,thecompletesetisremoved.

Editingaparentindicationtolinkmoreindicationstoitortochangethequalifiers

Ifyouwishtoeditasetofindications,clickontheparentindication.



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Youcanchangethequalifiersforthesetinthiswindow,oryoucanselect‘Edit’tolinkmoreindicationstotheparentindication.

Linkedindicationshavethesamequalifiersastheparentindication.Ifyouclickonalinkedindicationthesamewindowopensasfortheparentindication,buttheabilitytoeditthequalifiersisdisabled.

Useofindicationsmultipletimesintheapplication

Anindicationcanbeusedmultipletimesinanapplication:

Aparentindicationcanbeaddedtotheapplicationasastand‐aloneindication,i.e.withoutlinkingotherindicationstoit.

Anindicationthatcannotbeusedasaparentindicationcouldbelinkedtomultipleparentindicationsand/orusedasastand‐aloneindication.



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Warnings

NOTE:Previouslysponsorswererequiredtomanuallyenterthewarningstatementsapplicabletoindicationsselectedandbeawareofanyotherregulatoryrequirementsassociatewithitsuse.

Allrequirements(includingrequiredlabelandwarningstatements)forpermittedindicationswillnowbepre‐populatedintotheListedMedicineApplicationFormforsponsors.SponsorsarerequiredtoacknowledgetheserequirementsbeforebeingabletovalidatetheirApplicationForm.

Toaddawarning:

1. Pressthe‘Add’buttonnextto‘Warnings’toopentheform:

2. Typeinkeywordsfromthewarningandpressthe‘Search’buttonorthe‘Enter’keytobeginthesearch

3. Selecttherequiredwarningsandpressthe‘Saveandclose’button.

NOTE:Toaddmultiplewarnings,youmaypress‘Save’andkeepthewarningboxopen,allowingtheselectedwarningtobeaddedandanewwarningsearchtobeconducted.

Subsection 26B(1) Notification Acertificateisrequiredinrelationtopatentstotheeffectthattheapplicantisnotmarketing(doesnotproposetomarket)thetherapeuticgoods,inamannerthatwouldinfringeavalidclaimofapatentinrelationtothegoods.However,patentcertificationrequirementsonlyapplywherethereisarequirementtosubmitsafetyorefficacydataofthegoodsaspartoftheprocessforapplyingforregistrationorlisting.Aslistedmedicinesdonotrequiresubmissionofsuchdata,sponsorsmustcertifythatapatentcertificateisnotrequiredatthetimeoflisting.TheSubsection26B(1)NotificationenablessponsorstonotifytheSecretarythatthecertificationrequirementsofSubsection26B(1)oftheActhavebeenmet.

Subsection28B(1)Notificationismandatoryandmustbecompletedbeforeanapplicationcanbevalidatedandsubmitted.

ToaddaSubsection26B(1)Notification:

1. Pressthe‘Add’buttonnexttotheSubsection26B(1)Notificationheading



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Answerthequestionsbyselectingeither‘Yes’or‘No’radiobuttonsforthefollowingquestions:

2. Areyourequiredtosubmitevidenceorinformationtoestablishthesafetyorefficacyofthislistingapplication?

Usually,theanswertothisquestionis‘No’.

3. Forthepurposeofsubsection26B(1)youarenotifyingtheSecretarythatacertificateundersubsection26B(1)isnotrequiredforthisapplication.

Usually,theanswertothisquestionis‘Yes’.

4. Pressthe‘SaveandClose’buttontoreturntotheApplicationform.

Other regulatory requirements tab Thissectioncontainsothergeneralinformationandregulatoryrequirementsapplicabletotheapplication.Informationcontainedunderthistabisgeneratedaftersuccessfulvalidation.

Thistabmaycontainimportantregulatoryrequirementsthatneedtobeconsideredpriortosubmission.

Other application types

Varying or changing an existing product

AllchangescanbemadetoyourproductthroughtheTGABusinessServicesPortal.Changesmadetoanexistingentrymayresultinanumberofvalidationoutcomeswithvariousfeesdependingonthesignificanceofchanges,whicharecommunicatedattimeofsuccessfulvalidationinapop‐upbox.Thesetypesofchangesare:

ARTGCorrection

Variation

Grouping

New(withanewAUSTLnumber).

Forfurtherinformationonproductchangestolistedmedicines,pleaseconsulttheGuidanceonproductchangesinELF3.

Onceyouhaveloggedin,selecttherelevantapplicationtype,forexample‘GeneralListing’fromthedropdownmenuwithin‘Applications’.



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Onthe‘Application’tabwithinthedraftapplication,pleaseselect‘ChangeaCurrentARTGentry’,andentertheAUSTLnumber.Thenclick‘Search’.Thiswillpopulateyourapplicationwithallinformationwithinthislisting.Oncethisoccurs,changesmaybemadetotheapplication.

Oncethenecessarychangeswithintheapplicationhavebeenmade,theapplicationmustbevalidated.Thiswillcomparetheinformationintheentireapplicationagainstthepreviousentry,andthesystemrulesthatreflectsregulatoryrequirements.Forexample,ingredientrequirementsoutlinedintheTherapeuticGoods(PermissibleIngredients)Determination.Thismayresultinunexpectedvalidationerrorswhichneedtobeaddressedpriortosubmittingtheapplication.

Code stock applications

Codestockapplications’arepreparedfromanexistingmedicinethathasbeenmadeavailableforuseasacodestockbythesponsor.Acodestockformulationcanbesoldtoanumberofsponsors,whothenselltheproductundertheirownbrandname.Thestockformulationisthesameineveryinstance.Theonlydifferenceisthebrand/productnameitissoldunderandtheindicationsfortherapeuticuse.Aproductcreatedfromacodestockformulationcannotbealteredapartfromtheproductname,indicationsandwarnings.



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Tocompleteanewmedicinepreparedfromacodestock:

1. FromtheTBSportal,select‘Createapplicationsandsubmissions,’thenselect‘Listedmedicines’,thenselect‘Codestock’.

2. Inthesectiontitled‘Codestocksource’onthe‘Registration’tabentertheAUSTLnumberofthecodestocksourcetobeusedandpressthe‘Search’button.IftheenteredAUSTLcanbeusedasacodestock,thefollowingmessagewillappear:

3. Pressthe‘Ok’button.Toloadthedetailsofthecodestockintotheformpressthe‘Save’buttonfromthebottommenu.

4. Completethe‘Applicationtab’asexplainedonpage13ofthisguide.

5. Completethe‘Registrationtab’,explainedonpage14,takingnoteofthe‘Codestocksource’section.

Detailsrelatingtotheformulationofthecodestockcannotbechanged.Theonlydetailswhichcanbechangedrelatetotheproductname(includingexportnames),warningsandindications.

Medicine kit applications A‘Medicinekitapplication’isusedwhenexistingmedicinesaretobesoldtogetherasapurposebuiltkit.Forthefulldefinitionofmedicinekit,refertoSection7BoftheAct.

TocompleteanewMedicineKitapplication:

1. FromtheTBSportal,select‘Createapplicationsandsubmissions,’thenselect‘Listedmedicines’,thenselect‘Medicinekit’.

2. Completethe‘Applicationtab’.

3. Entertheproductnameandexportnames,ifrequired,inthe‘Registrationtab’.Notethatthe‘Productcode’selectedwillbe‘Drugkits’.

4. Completethe‘Manufacturerstab’.Notethatyoucannotselect‘Manufactureofdosageform’withinamedicinekitapplication.

Products tab

Threetypesofmedicinescanbeaddedtoamedicinekit:exempt,listedandregisteredmedicines.



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Toaddedalistedorregisteredmedicine:

1. Pressthe‘Add’buttonfromthe‘Exempt/Listed/Registeredmedicine’section.

2. Select‘AddListed/Registeredmedicine’toopenthe‘Medicinedetails’search.

3. EntertheAUSTLorAUSTRnumberandpressthe‘Search’buttonor‘Enter’key.Ensurethatthecorrectmedicinehasappearedandclick‘Save.’

Toaddanexemptmedicine(suchasabandage):

1. Pressthe‘Add’buttonfromthe‘Exempt/Listed/Registeredmedicine’section.

2. Select‘Exemptmedicine’.

3. Enterthenameoftheexemptmedicineandpress‘Enter’orselect‘SaveandClose’toreturntotheapplication.

Toaddmultipleexemptmedicines,youmayselect‘Save’andkeepthemedicineExemptDetailsboxopen,allowingtheselectedmedicinetobeaddedandanewmedicinetobeentered.

Composite pack A‘Compositepackapplication’isusedformedicinesthataretobesoldtogetherinonepackage,wherethemedicinesareeithercombinedbeforeuseoradministeredinaparticularsequence,



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forasingletreatmentorcourseoftreatment.Forthefulldefinitionofcompositepack,refertoSection7BoftheAct.

‘Compositepackapplications’differfrom‘Generallistingapplicationsonlyinthattheyrequiretheadditionofmultipleformulationsinthesameapplicationwhereas‘Generallistingapplications’haveasingleformulation.

Tocompletea‘Compositepackapplication’:

1. FromtheTBSportal,select‘Createapplicationsandsubmissions,’thenselect‘Listedmedicines’,thenselect‘Compositepack’.

2. Completethe‘Application’,‘Registration’and‘Manufacturers’tabsasexplainedpreviously.

Products

Thistabwillallowyoutoaddmultipleformulationswhichwillmakeupthecompositepack.Aminimumoftwoformulationsarerequired.Thissectioncanbecompletedaspreviouslydescribed.Theonlydifferenceisinthe‘Componentname’,whichwillbethenameusedtodistinguisheachportionofthecompositepack.

Change multiple current listings application The‘Changemultiplelistingsapplication’allowsforthesamechangetobemadeacrossanumberofcurrentlylistedmedicines.Therefore,theinformationrequiredundereachtabvariesfromthe‘Generallistingapplication’.

Application tab

Theapplicationtabinthe‘Changemultiplelistingsapplication’requiresa‘Changemultilistingname’tobeincluded.



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Registration tab

TomakeachangetoseveralARTGlistings,entertheAUSTLnumbersoftheproductstobechanged,asshownbelow.

ToaddanAUSTL:

1. Press‘Add’,toopenthesearchfunction

2. EntertheAUSTLnumberrequiredandpress‘Search’.

3. ConfirmthatthedetailsoftherequiredAUSTLarecorrectandpress‘Save.’

Manufacturers tab Thistaballowsthefollowingchangestobemade:

Commonmanufacturingsteps.

– BasedoninformationgeneratedfromtheselectedAUSTLs,commonmanufacturingstepswillbedisplayedandcanbechanged.

Newmanufacturerscanalsobeaddedbypressingthe‘Add’buttonintheNewManufacturerssectionoftheformshownbelow.



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Validating an application Onceanapplicationhasbeencompleted,itmustbevalidatedpriortosubmissionforprocessing.Tovalidateanapplication:

1. Pressthe‘Validate’buttonwhichappearsinthelowerright‐handcorneroftheapplication.

Duringvalidation,theapplicationandallrelatedsub‐documentsarecheckedagainstthelistedmedicinebusinessrules.Ifissuesarefound,validationresultswillbedisplayedinasidebar,asshownbelow:

Hoveringthemouseoveramessagehighlightstheselectedmessage.Double‐clickthehighlightedvalidationmessagetoopenthesectionoftheformthevalidationmessagerelatestoandmaketherequiredcorrections.

Onceissueshavebeencorrected,pressthe‘Validate’buttonagain.Ifnomoreissuesarise,asuccessfulvalidationmessagewillbedisplayedasshownbelow:

Thismessageincludesthe‘Applicationtype’andassociated‘Submissioncost’.Pressthe‘Ok’buttontoreviewthe‘Otherregulatoryrequirements’.



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Oncethe‘Otherregulatoryrequirements’havebeenreviewed,pressthe‘Proceedtosubmission’button.Ifyoudonotwishtosubmittheapplicationstraightawaypress‘Save’andtheapplicationwillremaininthe‘drafts’areaoftheTBSBusinessportal.

Note:Iftheapplicationevervalidatesinanunexpectedmanner,pleasecontactComplementaryMedicinesimmediately,anddonotsubmittheapplication.Pleasecarefullyreviewallinformationwithintheapplication,includingpop‐upboxes,priortoproceeding.

NOTE:ApplicationsareNOTsubmittedautomaticallyaftersuccessfulvalidation.

Submission Pressingthe‘Proceedtosubmission’buttonfromtheapplicationformwilltakeyoutothesubmissionsareaoftheportal,asshownbelow:

Eligibleapplicationsmusthavesuccessfullypassedvalidationinordertobeavailableforsubmission.Applicationsavailableforsubmissionaredisplayedincludingtheirproductname,applicationID,date/timeofvalidation,applicationtypeandassociatedfee.

SubmissionscanalsobemadefromtheTBSportalunderthe‘Listedmedicines>Createapplicationsandsubmissions>Submissionslink.



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Tosubmityourapplications:

1. Selectthecheckboxnexttotheapplicationyouwishtosubmit.Thiswillopenthe‘StatutoryDeclaration’asshownbelow:

2. ReadtheStatutoryDeclaration.Thenpressthe‘Agree’or‘Disagree’button.

Note:byclickingon‘Agree’,youdeclarethattheinformationgivenintheapplicationthestatementsmadeinthedeclarationarecurrentandcorrect.

3. Onceyouhaveagreed,theselectedapplicationwillbehighlighted.Repeatsteps1and2toaddsubsequentapplicationstoyoursubmission.Allselectedapplicationswillbesubmittedinasinglesubmission.

4. Eachoftheapplicationsselectedforsubmissionwilldisplay‘Yes’inthesubmitcolumnunder‘Eligibleapplications’asshownbelow:

5. Pressthe‘Submit’buttoninthebottomrighthandcorner.Successfulsubmissionwilltakethesubmittertothe‘Notificationpage’.



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6. Pressthe‘Printinvoice’buttoninthebottomrighthandcornertoprintaninvoiceforthissubmissionasshownbelow.

Trouble shooting in the TGA Business Services Portal Theonlinelistedmedicineapplicationandsubmissionportalsuccessfullyprocessesalargenumberofapplicationseachyear,however,occasionallytherearesystemerrorsthatmayoccurfromtimetotime.

Ifanapplicationisnotbehavinginamanneryouexpect(forexample,avariationapplicationgeneratesanewAUSTL),pleaseDONOTsubmittheapplication.Instead,usethistroubleshootingguidebelowtoinvestigatetheissues.

Ifyouareunabletorectifytheissue,contactcomplementary.medicines@health.gov.au.Inyourcorrespondencepleaseincludethefollowing:

applicationID

screenshotofthevalidationmessages

detailsofthechange(s)required.

Common IT issues

Issue Suggestion

Whenvalidating,thereisaninstantvalidationerror.

Stopthevalidationprocessandre‐validate



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Issue Suggestion

Thesystemisrespondingslowlyorajumbledscreenhasappeared.

Clearthecomputercache.

InternetExplorer:PressCTRL‐SHIFTandclickontherefreshbuttonintheaddressbaratthesametime

Firefox:PressShiftandclickontherefreshbuttonintheaddressbaratthesametime

Yourapplicationfailsvalidation. ReadValidationerrormessagecarefullyandcorrecttheapplicationasperinstructionsintheValidationmessage.

Doubleclickonthevalidationerrortobedirectedtothefieldthatisaffected.

Youmayneedtochecktherequirementsiftheerrorisunexpected,forexamplethePermissibleIngredientsDetermination.

Thefollowingsystemerrormessageappears–‘www.ebs.tga.gov.ausays:Anerroroccurredwhileupdatingsomeofthepage...’

Tryre‐validatingtheapplicationuntilthemessagedisappears.IfnotcontacttheTGAviatheaboveemail.

Whenvalidatinganapplicationthefollowingerrormessageappearsstating‘WarningX’required,eventhoughithasbeenaddedtotheapplication.

Delete‘WarningX’,saveandvalidatetheapplication.Re‐add‘WarningX’,saveandvalidatetheapplication

YoureceiveanautomatedemailwithanewAUSTLbuttheAUSTLdoesnotappearontheRegister.

Wait24‐48hoursfornewAUSTLnumbertoappearontheRegister.Afterthistime,[email protected]

Thevalidationmessageappears–ManufacturerXnotvalidfordosageform.

TheproductdosageformmustbeanexactmatchwiththeManufacturer’slicenceorclearanceorbecoveredbyadosageformgroup.

Forexample,tabletfilm‐coatediscoveredbythedosageformgroupSolidUnitDosageForms–Tablets.

ForadditionalinformationrefertoTBScodetables



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Issue Suggestion

YourvariationapplicationgeneratedanewAUSTLnumber.

IntheApplicationtabcheckthattheradiobutton‘ChangeacurrentARTGEntry’beenselected&theAUSTLnumberentered.Selectthe‘Search’buttontopre‐populatetheapplication.

Ifyouhavenotchangedanythingitwillautomaticallyvalidateasa‘New’application.

ChecktheGuidanceonproductchangestoensurethechangesyouhavemadedonotwarranta‘New’AUSTL.

IfyoumaketwoormoreGroupingtypechangesintheoneapplicationitislikelythata‘New’AUSTLwillbegenerated.

ForadditionalinformationrefertoGuidanceonProductChanges

Yourapplicationhasvalidatedsuccessfullybutwhenyouclickon‘ProceedtoSubmission’–the‘eligibleapplication’fieldisblank.

Ensurethatthecorrectbillingaddressandsponsornamehasbeenselected

Youareunabletovarya‘CodeStock’listing. TherearerestrictionsregardingvariationstoCodeStockparentsandchildren.ContactComplementary.medicines@health.gov.au.

Yourapplicationdoesnotappearinthesubmissionwindow.

AfterproceedingtoSubmission,ifawindowdoesnotappearadvisingyouofthecostandtypeofapplication,yourapplicationhasnotbeensubmittedcorrectly.Youshouldattempttore‐submit.

Yourdraftapplicationhasdisappearedfromthesystem.

Unediteddraftapplicationwillremaininthesystemfor365days.Thesystemwillautomaticallydeleteitafterthistime.

Topreventthis,openthedraftandselectsave.



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Versionhistory

Version Descriptionofchange Author Effectivedate

V1.0 Originalpublication Section/Office XX/XX/XXXX

V2.0 Updatedpublication ComplementaryandOTCMedicinesBranch

March2018

V3. Updatedtoincludeguidanceonlinkingpermittedindications

ComplementaryandOTCMedicinesBranch

June2018

Therapeutic Goods Administration

POBox100WodenACT2606AustraliaEmail:[email protected]:1800020653Fax:0262031605

https://www.tga.gov.au

Reference/Publication#

listed medicines application and submission user guide · therapeutic goods administration listed...

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