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644 result(s) found, displaying 1 to 25
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FormsSponsors must report every six months in relation to unapproved therapeutic goods supplied under the SAS and Authorised Prescriber (AP) schemes.
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User guideLearn how to access the AusUDID Production and Pre-Production environments.
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User guideLearn how to prepare and submit up to 200 UDI records at once using the Australian UDI Bulk Upload Template.
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User guideLearn how to search, view and download UDI records in the AusUDID.
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User guideLearn how to create and manage UDI records in the AusUDID online portal.
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User guideLearn how to manage UDI records when a device is supplied by more than one sponsor.
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FormsInformation on when a manufacturer's statutory declaration should be provided.
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User guideAuthorised Prescribers must submit a report every 6 months for each AP authorisation they hold.
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User guideLearn how to respond to TGA medical device post‑market review notifications with step‑by‑step instructions using the PMR compliance dashboard.
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FormsForms for notifying the TGA of a change in sponsorship.
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FormsOrganisation details form for TGA Business Services, used by sponsors, manufacturers and agents to provide information required under the Therapeutic Goods Act 1989.
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
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FormsComplete this form to authorise or remove an agent (e.g. a regulatory affairs consultant) or people external to your company to undertake regulatory correspondence with us.
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FormsThis form is used to nominate a new representative from your organisation to be the administrator
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FormsWe are redeveloping the Conformity Assessment application form to enable applicants to provide all the required information at the time of submitting their application.
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FormsThis form is to be completed by the ingredient owner to authorise sponsors to use a protected ingredient that is the subject of an exclusivity period to list a medicine in the Register
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 final
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/239/95 Rev. 1, Corr.1*
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FormsSuspected adverse events that occur after having a vaccination can be reported to the TGA
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FormsUse this form to report suspected adverse reactions to vaccines and prescription, over the counter and complementary medicines.
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User guideHow to install the ADR reporting template in the Best Practice software.
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User guideHow to use the ADR reporting template in the Best Practice software
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User guideInstalling the ADR reporting template in the Medical Director software.
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User guideUsing the ADR reporting template in the Medical Director software