Overseas recalls

The TGA receives information about overseas recall actions as part of its ongoing working relationship with many international agencies and overseas regulators of therapeutic goods. If the therapeutic good which has undergone a recall action overseas is included in the Australian Register of Therapeutic Goods (the Register) and/or has been commercially imported and distributed in Australia, then the TGA will assess whether the importer will be required to conduct a recall action for the good in Australia. Such recall actions will appear in the SARA database after two days (excluding weekends) of the recall action commencing in Australia.

Therapeutic goods that have not been supplied in compliance with local regulatory requirements, or have been imported from overseas by consumers for personal use, for example via the internet, will not appear in this system. Consumers should be aware of the risks of importing therapeutic products for personal use that are not in compliance with local regulatory requirements. For more information see Buying medicines and medical devices over the Internet.

Information about therapeutic good recalls occurring overseas is made available online by other agencies. This includes information from the United States Food and Drug Administration (US FDA), Health Canada, the European Medicines Agency (EMA), the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) and others.