Medicinal Cannabis

Many heralded the TGA’s proposal to downschedule low-dose cannabidiol (CBD) to S3 as groundbreaking, however, as I’ve covered in a previous blog, there are additional complications that need to be addressed. The TGA’s initial safety review made recommendations for the dose of S3 CBD to be limited to 60mg/day, which received a fair amount of…

In one of my old blogs, Cultivation of Medicinal Cannabis vs Hemp, I highlighted the differences between the industrial hemp and medicinal cannabis industries – in particular, the fact that there was little-to-no crossover between the two (other than industrial hemp businesses being able to supply seeds to the medicinal cannabis industry). However, Professor John…

This year due to COVID, the Australian Medicinal Cannabis Conference 2020 is being hosted virtually, and we have had many generous presenters come on board to share valuable information and experience. For those who are mainly concerned about the ODC regulatory updates (doctors and patient access topics excluded) I’ve summarised the main points from Adj…

The TGA recently released their Notice of interim decisions to amend (or not amend) the current Poisons Standard, and those in the medicinal cannabis industry were waiting with bated breath for the decisions relating to low-dose CBD. Two proposals were submitted and have different results: Proposal Result Remove CBD from scheduled materials list altogether Rejected…

In August 2016, PharmOut tendered and won a contract to assist a client to obtain a Therapeutic Goods Administration (TGA) Good Manufacturing Practice (GMP) Licence for a manufacturing facility, and in April 2017 they received their licence. This was not an unusual assignment as we routinely assist manufacturers with GMP licensing around the world. However,…