Exceptional release of a biological

A copy of the form, accompanied by the required documentation, must be forwarded to TGA within 28 days of the date of release of the non-conforming biological.

This form is to notify the TGA of the Exceptional Release of a non-conforming biological. Non-conforming biologicals may only be released for use in patients with serious medical conditions in specific circumstances.

A guidance document is provided below to assist in completing the form, including details of the specific circumstances when exceptional release of a biological can be used.

The sponsor must provide this form to the TGA within 28 days of the date of release of the non-conforming biological.

For all instances of exceptional release, the sponsor of the non-conforming biological must provide the TGA with a report including details of the release and any adverse events relating to the use of the nonconforming biological within 6 months after its release. The information required in this report is specified in the guidance document below.

Guidance for the exceptional release notification form

Notification form for the exceptional release of a biological

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Contact details for enquiries about exceptional release

If your enquiry is not about exceptional release, see: Contact the TGA

Email bloodandtissues@tga.gov.au
Phone 1800 678 799
Fax +61 2 6202 1731
Postal address The Medical Officer, Exceptional Release
Scientific Evaluation and Special Product Access Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Street address
(for deliveries)
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia