Medicine or vaccine defect report



You should use the Reporting Problems webpage to report a suspected adverse event involving a medicine or vaccine.

Use this form to report defects that you think have arisen during manufacture, storage or handling of medicines. These sorts of problems are usually found in a single batch or a single pack of a product. These problems may require investigation by the Therapeutic Goods Administration (TGA) Laboratories.

When filling in this form please:

  • Use a separate form for each product reported
  • Answer each question
  • If you do not have the information requested, write 'none' or 'not applicable'

Report problems requiring urgent investigation by telephone to the Pharmacovigilance and Special Access Branch on 1800 044 144.

Your contact details

This information is used by the TGA to investigate your complaint.

Your identity will remain confidential unless you authorise the TGA to release it to another party or the disclosure of your identity is authorised or required by law.

Your postal address, including state and postcode
Your contact email address
Please include the area code if listing a landline
Can the TGA disclose your name and contact details (and any other information in this report which would assist in the investigation of the deficiency) to the company or person that is legally responsible for the medicine or vaccine's safety and quality in Australia (that is, the sponsor)?
Tags: 
medicines, reporting problems
https://www.tga.gov.au/node/5531