Information for registered users of the Australian Adverse Drug Reaction Reporting System

22 May 2015

Background

Those who are frequently reporting adverse events, can do so as a registered Australian Adverse Drug Reaction Reporting System (ADRS) user. This enables that user to:

  • access a pre-populated reporting page
  • view previous reports submitted under that log in
  • return to update existing reports with new information or attach supporting documentation.

If you do not report adverse events on a regular basis, but you still wish to report online, it may be easier for you to report as a non-registered user. Reporting as a non-registered user will mean that you do not need to maintain login and password details.

In addition to the online reporting facility, there are a number of other avenues available for reporting adverse events to the TGA. You can:

  • submit a report directly from MIMS Online
  • complete a 'Blue card' and submit it to the TGA via email, fax or mail
  • send an email to ADR.reports@tga.gov.au
  • call the TGA on 1800 044 114
  • report adverse events directly to the sponsor of the medicine or vaccine.

In line with government requirements the TGA has made improvements to the security of information provided by registered users. This means that the details of our clients are more secure and we can ensure that our log on procedures meet industry best practice. Previously, users could generate their own login details. Our new security requirement for the unique login ID is based on a numeric code to assist in protecting your information and the information you provide to the TGA.

Recent updates to the ADRS login processes

Registered user of ADRS, will have recently received correspondence from the TGA containing your unique numeric login ID and outlining the new 'password reset' requirements.

If you have previously created multiple ADRS accounts, you will have received an email containing a unique numeric login ID for each account you've created.

For example, you may have created several accounts such as:

  • JohnSmith
  • JohnTSmith
  • DrJohnSmith

If you haven't logged on yet, choose from one of the below scenarios to complete your ADRS account registration.

Adverse event reports are an essential part of ensuring the ongoing safety of medicines and vaccines in Australia - The TGA thanks all those who have reported adverse events to us.

If you have any questions or queries, don't hesitate to contact the TGA's Post-market Surveillance Branch via ADR.reports@tga.gov.au or phone us at 1800 044 114

Scenarios

Scenario 1 - I am a registered user with on ADRS account

The TGA sent all registered users of ADRS an email on 28 April which contained their unique numeric login.

Registered users should take note of your unique numeric login ID. You will need this to log into ADRS.

If you have lost or forgotten your unique numeric login ID, contact the TGA Business Services helpdesk on 1800 010 624 or via ebs@tga.gov.au to obtain it.

If you haven't yet reset your password

  1. Go to the ADRS login page at: https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf/LoginScreen?OpenForm
  2. Click on "Registered users login"
  3. You will be redirected to the new TGA Business Services login page. At the bottom of this page, click on "Reset Password"
  4. You will be redirected to the "Reset your Password" page
  5. Do not enter your email address
  6. Enter your unique numeric login ID in the box provided and click "Reset password"
  7. An email will be sent to your email address. Follow the instructions in the email to reset your password

If you have already reset your password

  1. Go to the ADRS login page at: https://www.ebs.tga.gov.au/ebs/ADRS/ADRSRepo.nsf/LoginScreen?OpenForm
  2. Click on "Registered users login"
  3. You will be redirected to the new TGA Business Services login page
  4. Do not enter your email address
  5. Enter your unique login ID and password
  6. Submit or update your adverse event reports as usual

Scenario 2 - I am a registered user with multiple ADRS accounts

If you have registered multiple times as an ADRS user, you will have received separate emails from the TGA on 28 April for each account that you have created. Your unique login ID for each account was included in each separate email.

If you have lost or forgotten your numeric unique login IDs, contact the TGA Business Services helpdesk on 1800 010 624 or via ebs@tga.gov.au to obtain them.

To view adverse event reports previously submitted via different accounts you will need to activate each account following the instructions provided in "Scenario 1 - I am a registered user with one account" above.

If you work across multiple positions or locations and wish to maintain alternative accounts for each of these, you will need to activate all of your accounts. To do this, follow the instructions provided in "Scenario 1 - I am a registered user with one account".

Scenario 3 - I am a registered user who uses both ADRS and TGA Business Services (TBS)

If you are both an ADRS and TGA Business Services (TBS) user you will have two accounts - one for ADRS and one for TBS.

You will have received a unique login ID for each account.

You will need to ensure that you enter the unique numeric login ID you were provided for the ADRS if you wish to submit adverse event reports.

If you have any questions or difficulties, please contact the TGA Business Services helpdesk on 1800 010 624 or via ebs@tga.gov.au.