TGA Business services: getting started with the TGA

25 October 2016

If you are a manufacturer, sponsor or agent who wants to use our online services you will need a client identification number (Client ID) and also apply to access to our secure online TGA Business Services (TBS).

This access will allow you to manage some therapeutic good registration applications, and you will need a Client ID and access to TBS if you want to:

  • supply in Australia
  • manufacture
  • import into Australia
  • export from Australia
  • submit clinical trial notifications (CTNs)
  • notify us about adverse events or recalls.

With access to TBS you will also be able to view and cancel current Australian Register of Therapeutic Goods (ARTG) entries and generate certificates online.

Applying for your Client identification number

If you do not have a Client ID, you need to:

How to complete the organisation details form

Organisation information: Complete the form to provide the information about the company or individual who will be importing, exporting, manufacturing or supplying the therapeutic goods or sponsoring a clinical trial.

It is important that you tick the boxes for all the different interactions you will have with us.

All fields are mandatory.

TGA Business Services access request: Use this section to nominate one representative from your organisation to be the administrator. This person will be able to add, remove and update all contact details for your organisation.

Declaration: Please check and make sure a signed form is sent to the TGA.

Please refer to the Terms and Conditions for more information about your responsibilities once you have registered with the TGA.

Once you submit a completed Organisation form the TBS Helpdesk will email the nominated representative within three working days with the unique Organisation ID and an administrator guide. This will be sent to the email address you have provided.

Amending organisation details

To amend your organisation details, please see your Administrator.

Updating organisation administrator

To nominate a new representative from your organisation to be the administrator you will need to complete the Updating organisation administrator form. This person will be able to add, remove and update contact details.

Adding or removing an agent

Agents (for example a regulatory affairs consultant) will need to complete the Adding or removing an agent form to register with the TGA.

Add or remove a connection to your manufacturing organisation

Manufacturers will need to complete the Add or remove a connection to your manufacturing organisation form to authorise organisations (Agent or Sponsor) to undertake regulatory correspondence with us (TGA) in regards to Conformity Assessment certification. A manufacturer may authorise one or more organisations to be their agent relating to conformity assessment applications.

Please note: These organisations will be authorised to:

  • submit Conformity Assessment applications to TGA on your behalf
  • access your currently active conformity assessment certificates (medical devices)