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Tech Alert: TGA Interim decision Hemp seed oil

21 Jul 2021 1:29 PM | Anonymous member (Administrator)

The TGA have published a Notice of interim decisions on proposed amendments to the Poisons Standard on their website, which includes the Delegate's INTERIM decision on hemp seed oil. Consultation is now open on this interim decision until 17 August 2021 so that the Delegate may make a FINAL decision, leading to a planned implementation date of 1 October 2021.

This interim decision would allow hemp seed oil complying with certain conditions on lower limits for cannabidiol and tetrahydrocannabidiols to no longer be scheduled and be sold for internal use in therapeutic goods.

Please note that if the down-scheduling proceeds as proposed, this does not automatically permit use in listed medicines until a successful application is made for the Permissible Ingredients Determination - more information on this is in today’s alert. Please also note that this interim decision includes a limit for cannabidiol in hemp seed oil, however it does not amend the decision for cannabidiol in Schedule 3.

Today’s technical alert includes more details, including the proposed scheduling requirements, the reasons for the decision and potential implications for industry.

The same round of Delegate interim decisions intends to add a new entry for Kambo, a traditional folk preparation derived from tree frogs that has recently attracted media attention in Australia, as a Schedule 10 substance (Substances of such danger to health as to warrant prohibition of sale, supply and use). This substance is not discussed in this technical alert as it is not used in the commercial context, however more information on the substance and the Delegate’s reasons on this interim decision is available on the TGA website.

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