The TGA recently held webinars about reforms that impact the medicinal cannabis industry, including: Summary of Changes to SAS and AP applications Volatility in the cannabis industry has led to stock shortages, product name changes, and discontinuations. To make life easier, the TGA has determined that SAS and AP applications for unapproved medicinal cannabis products…
The TGA recently held a webinar called ‘Meeting Your Obligations – Supplying medicinal cannabis in Australia,’ and while it was useful as an overview of the therapeutic good development lifecycle, it did not delve too much into the main supply pathways that are actively being used for unapproved medicinal cannabis products. Considering the new Schedule…
10 Questions to Ask About Cannabis Insurance Policy Coverage | Reviews Today we interviewed a new cannabis insurance brokerage firm, based in the USA, which is now providing Open Air Crop Insurance for cannabis and hemp. Here is their list of answers to the cannabis industry’s FAQ’s regarding insurance coverage for medicinal cannabis and hemp…
As the medical cannabis industry matures, a question has started popping up more frequently regarding medicinal cannabis stability, namely: “What do I put down for shelf life/expiry for a new medicinal cannabis product?” In this blog we provide a brief overview into stability, stability studies, and how to apply minimum shelf life requirements to medicinal…
I’m often asked to clarify the difference between TGA Medicinal Cannabis and EU GMP Medicinal Cannabis, i.e. who is that has the highest “Gold Standard” for Medicinal Cannabis? I suspect this has come about because many are trying to claim that their cannabis is cultivated, harvested and processed in accordance with the strictest pharmaceutical standards…
Given the TGA’s strict supply pathways it would be easy to assume that medicinal cannabis is reserved solely for humans, however, this is not the case. In fact, veterinarians are also able to use certain cannabinoids to treat pets and livestock. While the TGA handles human medicines, the control of veterinary medicines is managed through…
As many in the pharmaceutical industry know, the TGA has strict rules on advertising therapeutic goods. These rules are outlined via the Therapeutics Goods Advertising Code as well as guidance provided in Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) During the Australian Medicinal Cannabis Conference, the TGA were questioned on their approach to illegal…
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…
Please complete the form on the PharmOut contact us page. We will get back to you within one business day.
Phone: +61 3 9887 6412
Email: info@pharmout.net
