Thu. 4 Feb 2021, 5:07 pm

Recent TGA announcements

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In December the Therapeutic Goods Administration (TGA) announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).  The decision allows TGA approved low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults, to be supplied over-the-counter by a pharmacist, without a prescription.

Earlier this week, the national medicine regulator also handed down an interim decision stating that the current Schedule 9 classification for MDMA and psilocybin “remains appropriate” following an application to recognise these substances as legitimate medicines to treat mental illnesses.

Additional boxed warnings are being added to the Product Information (PI) and Consumer Medicine Information (CMI) for medicines containing pregabalin and gabapentin due to the serious side effects and dependence-forming potential of these drugs, particularly when used in conjunction with other sedating medicines such as opioids.

From 1st October 2021, nicotine liquid designed for vaping will require a doctor’s prescription. This change means that the current “special access” provisions that allowed adults to import a 3 month supply of nicotine liquid will end. Further consultation will occur during 2021 to develop safety and quality standards for nicotine liquids.

For more details visit the TGA website.

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