Address for submitting individual case reports of suspected ARs occurring in Australia, for notifying the TGA of significant safety issues with a medicine (once the medicine is on the ARTG), or for notification to the TGA of the nominated contact person for pharmacovigilance:

Mail:

Office of Product Review
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Fax:

Office of Product Review
02 6232 8392

Email:

adr.reports@tga.gov.au

Web:

Reporting problems

Notifying the TGA of the nominated contact person for pharmacovigilance, or updating those details, can be done by completing the Client Details form (sections 1, 3 & 4) available on the eBS website under the eBS Access Forms link (see section 2.1)

Address for submitting the completed Client Details form is:

Mail:

TGA eBS Help Desk
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Fax:

TGA eBS Help Desk
02 6232 8581

If you require further assistance, please contact the eBS Help Desk.

Phone:

TGA eBS Help Desk
1800 010 624

Email:

ebs@tga.gov.au

Address for submitting information described in section 3.2 and for ARs from ongoing clinical trials conducted outside the terms of the PI or label indications (See section 2.5.1):

Mail:

The Head
Office of Medicines Authorisation
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Fax:

Office of Medicines Authorisation
02 6232 8140