What you need to know about TGA's new medicine shortages rules

Definition changed after feedback from stakeholders

The TGA is a step closer to introducing mandatory reporting of medicine shortages with legislative fine-tuning underway following industry feedback.

After feedback from industry stakeholders, pharmacists and doctors, a key change to the TGA's protocol is a clearer definition of a medicine shortage.

A shortage now means patient demand is unlikely to be fully met at any time in the next six months.

The protocol is expected to take effect from January.

The TGA has also moved to address concerns that some critical medicines — including metformin and EpiPen — were not explicitly included on a watchlist of important medicines subject to mandatory reporting of shortages or expected shortages.

The proposed legislation will now require sponsors to report all shortages that could lead to significant morbidity or death of one of more patients.

Here are four other key changes:

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