Report a medicine or vaccine defect

Use this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.

Deficiencies or defects of medicines or vaccines thought to have arisen during manufacture, storage or handling can be reported to the TGA. Problems of this nature are usually found in a single batch of a product and may require laboratory investigation by the TGA laboratories.

Report problems requiring urgent investigation by telephone to the Pharmacovigilance and Special Access Branch on 1800 020 653.

Form

Current Contact details
About the product (General)
About the product (specific)
About the defect
Complete

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 020 653.

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 name (mandatory)

Your address (mandatory)

Your postal address, including state and postcode

Your email (mandatory)

Your contact email address

Your telephone or mobile number (mandatory)

Please include the area code if listing a landline

Your fax number

Can the TGA disclose your name and contact details? (mandatory)

Yes

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)?

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Report a medicine or vaccine defect

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