TGA Business services - how to use the site

23 August 2016

Update on access to TGA Business Services for clinical trial sponsors

The TGA Business Services (TBS) system allows for different structures and relationships to be developed.

The type of access structure that sponsors set up in TBS will determine who can see Clinical Trial Notification (CTN) form information. You can control the visibility of CTN information within your organisation by choosing the appropriate access framework currently available on the TBS system.

The TGA Business Services site allows industry to manage some therapeutic good registration applications, and view and cancel their current entries on the Australian Register of Therapeutic Goods (ARTG). Sponsors are able to view, download and print ARTG Register entries for their products and generate certificates online.

Clients can also keep up to date with the latest TGA-wide and Industry specific news - directly from the site.

To apply for access to TGA Business Services please see the TGA Business services: getting started with the TGA.

For those who frequently report adverse events to the TGA, the TGA Business Services site also provides registered users with access to the Australian Adverse Drug Reaction Reporting System (ADRS). Please refer to the specific Information for registered users of the Australian Adverse Drug Reaction Reporting System for further details. If you do not report adverse events on a regular basis, but you still wish to report online, you can report via ADRS as a non-registered user. Reporting as a non-registered user will mean that you do not need to maintain login and password details.

General questions and answers

Watch our video: Welcome to the TGA Business Services site.

  • Click on the plus or minus icon next to the question to toggle the answer on or off or [Open all | Close all].
  • If you want to print all questions & answers, you need to Open all before you print.
  1. Click on Reset password on the login screen.
  2. Enter your email address or user ID and click reset. An email will be sent to the email address registered to the account.
  3. Click the link within this email and you will be sent to a new screen to enter a new password.

You have 24 hours to reset your password once you receive the email.

Passwords must:

  • Contain a minimum of 10 characters
  • Have three of the following four categories
    1. English uppercase characters (A to Z)
    2. English lowercase characters (a to z)
    3. Numbers (0 to 9)
    4. Non-alphabetic characters (for example; !, $,#,%).

Passwords must not:

  • Contain your account name or more than two consecutive characters of your full name.
  • Be the same as your last eight passwords.

You can change your password once a day.

Click on View my organisation then on View all contacts. You will be presented with a list of Active and Inactive Organisation Contacts.

Each Contact will show:

  • Name
  • Role

You can refine the list by typing in the search field.

Click on View my organisation then on View all contacts. The list of Organisation Contacts will be displayed.

Click on View my organisation then on View all connections. The list of Organisation Connections will be displayed.

Yes, the terms and conditions are available on the TGA Business Services (TBS) Terms and Conditions page.

If you are within the application section, you will need to return to your dashboard before you can sign out.

Click Back to Business Portal in the menu on the left hand side.

Back to Business Portal

Then to sign out:

  1. Click on your name on the top right hand side of the screen. A menu will be displayed. Sign out link
  2. Select Sign out
  3. Close your browser including all tabs to complete the sign out process.

Roles: what each user can do

Individuals can have multiple system roles. For example, an Administrator with Financial access can do all of the tasks for both roles.

This table shows the individual capabilities of each user role in TGA Business Services
TASK/ACCESS DRAFTER SUBMITTER FINANCIAL ADMINISTRATOR1
Dashboard Yes 1 Yes 1 Yes 1 Yes 1
News Yes 1 Yes 1 Yes 1 Yes 1
Interaction history Yes Yes Yes Yes
View organisation contact Yes Yes Yes Yes
View organisation connections Yes Yes Yes Yes
Update my contact details Yes Yes Yes Yes
Search for organisation contact Yes Yes Yes Yes
Reset my password Yes Yes Yes Yes
Also resets other users' passwords within their organisation.
View drafts and submissions Yes 2 Yes 2 No No
Create new:
  • contact
  • organisation address
No No No Yes
Activate/deactivate organisation contact No No No Yes
Update organisation details No No No Yes
Assign/modify roles No No No Yes 3
View invoices and make payments No No Yes No
  1. Customised for each role
  2. If there are multiple Drafters/Submitters for a single TBS Client ID, each of these people will be able to view the drafts/submissions of their colleagues.
  3. Administrators cannot assign the Administrator role to another contact within their organisation.

Administrator role specific information

Drafter/submitter role specific information

Financial role specific information