New reporting requirements for medicine shortages in Australia

Companies supplying medicines in Australia will be required to provide additional information to the Therapeutic Goods Administration (TGA) if their products go into shortage.

The regulatory agency said that upcoming changes to reporting requirements will assist health professionals and patients in managing shortages by keeping its Medicine Shortage Reports Database as up-to-date as possible.

From September 22, 2023, companies supplying medicines (known as ‘sponsors’) will be required to specify the period of each medicine shortage in Australia. This follows changes to the Therapeutic Goods Act 1989 – external site (Act) that came into force in March 2023. A six-month grace period allowed sponsors to refine their internal shortage reporting processes to manage the change.