Inform the TGA promptly once you have determined that you need to conduct a recall (Step 6).

Submitting all necessary information

If you have not already done so, complete the online Notifying recall actions of therapeutic goods form or email the TGA with all the information that you currently have. For biologicals, human blood and blood components, complete the Human blood and tissues recall report form.

Submit the following to us:

• distribution details and stock status (Step 4)
• the risk analysis (Step 5)
• the proposed type, class and level of recall (Step 6)
• your recall strategy (Step 7)
• your communication strategy and draft communications (Step 8).

Once you have submitted this form you will receive a TGA recall reference number. Please use this reference number in all correspondence about this recall.

The TGA can help you determine the appropriate information to submit if you ask for help.