Medicinal Cannabis in Macedonia, recently formally renamed the Republic of North Macedonia, is booming.  Cannabis business development in the region resembles similar trends we’re noticing in the global medicinal cannabis industry across the globe.  See “Predictions for global medicinal cannabis industry growth (2020-2024)” and continue reading for information about cannabis business sectors in Macedonia/North Macedonia. As with the Medicinal Cannabis industry in the Republic of North Macedonia, it has been estimated that the Australian medicinal cannabis market is expected to be re ..read more

Medicinal Cannabis cultivation has been a hotly discussed topic in Australia ever since cultivation was made legal in October 2016. The industry has been buzzing with new ideas, initiatives and investment as well as a renewed focus on an older but crucial topic: the indoor-outdoor cultivation debate. As leading cannabis cultivation facility design architects and engineers, PharmOut are well placed to advise on cannabis facility design options. As a traditional pharmaceutical architectural, engineering and quality consultancy, PharmOut’s strengths are more complementary to an indoor cultiv ..read more

The Office of Drug Control (ODC) has recently announced changes to the cost recovery arrangements for the Medicinal Cannabis Scheme as the result of amendments to the Narcotic Drugs (Licence Charges) Regulations 2016. The changes came into effect from 15th July 2020. What is the Medicinal Cannabis Cost Recovery Framework? The Medicinal Cannabis Scheme implements a partial cost recovery scheme, in line with the Australian Government Cost Recovery Guidelines (RMG 304). The framework involves government entities charging individuals or non-government organisations some or all of the costs of a re ..read more

What is the current number of medicinal cannabis prescriptions in Australia so far? In just a few years, the number of medicinal cannabis prescriptions through the Special Access Scheme B (SAS-B) has grown substantially. It still represents a small percentage of the overall Australian population who state they rely on cannabis for medicinal purposes. Only 3 or 4 out of every 10 people who report using cannabis for medicinal purposes obtain a legal prescription for high-quality products through the scheme. Five years ago, not long after the new scheme formally began, the number of trained, re ..read more

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 (therefore is the best quality). This is a meaty topic and I am going to try and keep it as simple as possible. 1. GMP Basics There are many dodgy people out there selling snake oil and to mitigate this, governments around the world have estab ..read more

During a webinar last year, the TGA announced they were intending to introduce changes to the medicinal cannabis regulations (including supplier assurance requirements for imported medicinal cannabis products). In light of that, a TGA consultation on potential reforms to medicinal cannabis manufacturing, labelling and packaging has just closed. As a result, there are three key changes of which the medicinal cannabis industry should be aware: the introduction of child-resistant packaging the requirement of cannabis products to conform with Australian labelling requirements Good Manufacturing P ..read more

The TGA recently held a webinar to discuss the recent reforms to medicinal cannabis legislation and it included: GMP requirements for imported products to level the playing field for local manufacturers Updated labelling and packaging details in TGO 93. Updates to medicinal cannabis compounding permissions. I have discussed how to ensure GMP compliance for imported medicinal cannabis products in a previous blog. The updates to TGO 93 are also fairly straight forward – i.e. expectations from other TGOs have been included, such as the requirement for child resistant packaging (unless the produ ..read more

The TGA recently held webinars about reforms that impact the medicinal cannabis industry, including: Changes to prescribing medicinal cannabis through the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways The removal of TGO 93 Standard for Medicinal Cannabis declaration requirements Their intent to increase random and targeted quality testing of medicinal cannabis products in Australian supply. 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 ..read more

After a long wait, during what felt like an even longer year, the ODC has finally dropped a hot new legislative update (and just before we entered 2022 too). The title of this update? “Single licence and permit reforms“. Catchy, isn’t it? Because regulatory reforms aren’t as exciting for everyone as they are for me, I decided to spruce up this update into a rhyming form to make it a bit more tolerable (or intolerable) to the masses. This is what you’ll need to know:   From the McMillan review in 2019 We have eagerly waited for reform supreme; From juggling papers to holding just one, Effi ..read more

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 cannabis products. A quick background into stability and stability studies Stability studies are performed on finished pharmaceutical products (including packaging and labelling components) to evaluate how the product may be affected by exte ..read more