TGA operations over the holiday period 2022-23

Urgent contact information

We have phone lines which are operational for urgent contact during the holiday period.

National Coronavirus Helpline

The National Coronavirus Helpline operates 24 hours a day, 7 days a week with additional options for priority groups.

• calls from Australia (free call) 1800 020 080

Recalls of therapeutic goods

If you have experienced an adverse event with one of the products listed for recall action, seek advice from a health professional as soon as possible.

Product sponsors should continue to notify the TGA of new, routine recalls using the online recall notification form via the TBS portal.

If you are a sponsor needing to notify the TGA of an urgent recall, please contact our out-of-hours recalls line which operates 7 days a week.

• calls from Australia 0412 205 568
• calls from overseas +61 412 205 568

Routine recall matters will be attended to from 3 January 2023.

Export of human blood and tissue

If you are a health service provider seeking a permit for the urgent export of human blood or tissue, please contact our urgent exports line via phone call or text message. A response will be provided within 24 hours. This line operates 7 days a week.

• calls from Australia 0466 925 878 or 0428 916 562
• calls from overseas +61 466 925 878 or +61 428 916 562

Report problems with a therapeutic good

If you are experiencing an adverse event or think you may be experiencing one, seek advice from a health professional as soon as possible.

To report a problem with a medicine or medical device, please use our online reporting forms.

Consumers can call the Healthdirect Australia line to speak to a registered nurse. Healthdirect provide 24/7 health information, advice and referral for all Australians. The Healthdirect line is not for emergencies.

Special Access Scheme (SAS) arrangements

Health care practitioners can supply unapproved goods to seriously ill patients without the approval of the TGA as long as the medical practitioner notifies the TGA within 28 days, using a Category A SAS form.

Prescribers can:

• Use the TGA SAS online system
• Email notifications to sas@health.gov.au

Routine SAS matters will be attended to from 3 January 2023.

Medicine shortages

Information about current medicine shortages, as provided by sponsors, is available on our Medicine Shortage Reports Database.

If you are experiencing issues obtaining your medicine, you should speak to your doctor or pharmacist. Even if there is a shortage, another brand of your medicine may still be available from your pharmacy. In some situations, your doctor or pharmacist may be able to recommend an alternative medicine or treatment.

If you are a sponsor of a reportable medicine, you can report a shortage or discontinuation to the TGA using the online medicine shortages notification form via the TBS portal.