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Tech alert: Green Tea Extract; Melatonin - Interim Decisions Consultation

06 Feb 2023 8:55 AM | Anonymous member (Administrator)

The TGA has published a Notice of Interim Decisions in relation to green tea extract and melatonin. The consultation on these interim decisions is open now, closing Friday 3 March 2023.

The Delegate of the Secretary has made the following interim decisions:

- not to amend the Poisons Standard in relation to green tea extract; this means that if the interim decisions is confirmed by the Delegate through this consultation in the final decision (due in several months time), there will be no change, and GTE will remain unscheduled; and

- to amend the Poisons Standard in relation to melatonin; to amend the Schedule 3 entry for melatonin to allow divided preparations containing 5 mg or less of melatonin, in packs of no more than 10 dosage units, for adults aged 18 and over to be prescribed by a pharmacist for the treatment of jetlag. This decision is to be implemented on 1 June 2023

Please read today’s full tech alert for more information on the Delegates reasons for these decisions and CMA's response to the proposal. 

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