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TGA Business Services - Drafter and submitter roles presentation

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View this presentation for information on:

  • An overview of the site
  • A client's personal view
  • The site design
  • Drafter/submitter role specific information

 

TGA Business Services - drafter and submitter overview

  • Overview
  • Client's personal view
  • Site design
  • Drafter/Submitter specific information
  • Viewing and changing your details

Overview

  • In the new TGA Business Services site each user will have a personalised unique view based on the interactions they have with the TGA.
  • Each view is based on the different interactions people have with the TGA. The TGA Business Services site is based on using roles -drafter, submitter, financial or administrator, or any combination of these.
  • This PPT gives you an overview of your role and some of the new capabilities to manage contact details.
  • For more information read the Drafters and submitters - questions and answers.

Client's personal view

Some clients will have multiple roles. This is an example of the view with all roles:

  1. The news feed is customised for each role
  2. View my organisation
  3. Drafters / Submitters see Work in Progress
  4. Financial users see Invoices
  5. All users see Interaction history

Site design for submitters and drafters

Dashboard

  • Drafts
  • Submissions
  • Account settings
    • Edit my details
  • Applications
  • Document
  • Your TGA

Drafter / Submitter dashboard

In a Submitter/Drafter role, the view will show:

  1. My Work
  2. Work in progress
  3. In the Drafts tab you can see the drafts your organisation is currently working on.

Submissions

In the Submissions tab you can see the progress of your latest submissions.

Applications

This menu gives you access to TGA applications

Documents

This menu allows you to upload documents to applications, including:

  • clearances, licences or certifications, for a medicine manufacturer
  • Consumer Medicine Information
  • Product Information

Your TGA

This menu shows your:

  • Current ARTG Entries
  • Consumer Medicine and Product Information
  • In-house IVD's
  • Manufacture Information
  • Medical Device Evidence
  • Medicines Shortage

View my details

  1. This screen can be accessed by clicking on Account settings. It allows you to:
  2. View your details
  3. Edit your profile and Change your password

Edit my profile

This screen allows you to update:

  • Title
  • Phone
  • Mobile
  • Fax
  • Address

The future

This is the first upgrade to the system - more improvements are planned.

Disclaimer

* These educational materials are provided by the TGA (a part of the Department of Health) solely for the purpose of providing general education on the TGA regulatory scheme. The materials should not be taken to be a detailed description of the scheme, or advice on the application of the therapeutic goods legislation in particular cases. Nor should they be taken to be statements of policy.

People requiring information or advice on the application of the therapeutic goods legislation in particular cases should make their own enquiries.

Whilst due care has been taken in their preparation, the Department of Health cannot guarantee, and assumes no legal liability or responsibility for the accuracy, currency or completeness of the information contained in these materials.

These materials are based on the scheme as it is in April 2015.

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