Mandatory reporting of shortages from January 1 in Australia

Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), says that mandatory reporting of medicines shortages in Australia will commence on January 1, 2019. These changes will facilitate more proactive, timely and transparent management and communication about medicine shortages for the benefit of Australian consumers and health professionals.

From the beginning of next year, sponsors of prescription and some over-the-counter (OTC) medicines will be required to report all medicine shortages (including those arising from discontinuations or recall actions) within specified timeframes.

To assist stakeholders to prepare for these changes and ensure that medicine sponsors are able to easily and effectively comply with the new reporting requirements, the TGA is now releasing Management and communication of medicine shortages and discontinuations in Australia - Guidance for sponsors and other stakeholder bodies