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Regulatory Focus™ > News Articles > 9 > Mandatory Reporting of Drug Shortages to Begin in Australia in 2019

Mandatory Reporting of Drug Shortages to Begin in Australia in 2019

Posted 25 September 2018 | By Zachary Brennan 

Mandatory Reporting of Drug Shortages to Begin in Australia in 2019

Beginning 1 January 2019, drugmakers will be required to report drug shortages in Australia, the country's Therapeutic Goods Administration (TGA) announced Tuesday.

“Medicine shortages have become an increasing problem in Australia, as the current voluntary scheme for reporting shortages has proven ineffective,” TGA said, noting that many critical shortages are not currently reported, meaning such information cannot be shared with consumers and health professionals, which causes delays to the effective management of medicine shortages.

Moving forward, shortages of critical medicines will need to be initially reported within two working days, and all relevant related information will need to be provided within five working days. All non-critical shortages will need to be reported within 10 working days. TGA tweaked the shortage timelines following industry pressure over the difficulty in responding in a short amount of time.

TGA will also have greater powers to penalize sponsors who deliberately fail to comply.

Guidance to ensure sponsors can be compliant with the new requirements is forthcoming in November, TGA said. The regulator also said it will work to enhance its current online reporting system.


Tags: shortage

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