After helping multiple clients to successfully navigate through the Office of Drug Control (ODC) licence application process, as well as assisting a client to obtain the first successful TGA GMP manufacturing license for Medicinal Cannabis, PharmOut has earned the enviable reputation of being Australia’s leading Medicinal Cannabis Consultancy.
Leveraging off careers spent in the design, construction and operation of pharmaceutical and medical device manufacturing facilities, to offer the same for Medicinal Cannabis cultivation and manufacturing operations was simply a logical extension of our current skills. Having worked with a number of small owner-operators, like pharmacies, and the giant multinationals over the years we appreciate the unique challenges facing both small and large operations, but as a small employee-owned business, we appreciate the importance of spending money wisely. To assist Australian growers and manufacturers we are collating references to a number of partners.
The endless red tape
As Mr. Tony Abbott, the previous Prime Minister of Australia said in 2014: “I have no problem with the medical use of cannabis.” He commented further in a later correspondence to talk back host Alan Jones, that “the regulation of medicines was mired with complexity and influenced by bureaucracy, corporations as well as institutional self-interest”. Since that statement we have seen almost every Australian state and the ODC issue additional and arguably unnecessary legislation for further Medicinal Cannabis regulation which can delay the approval process by up to 8 months. This is subject to extensive public debate. Most experts in the industry agree, legislate cannabis as medicine, and then regulate it as such, no more, no less.
While working in the Medicinal Cannabis space, we realised that there is a massive education need, therefore our experts have pooled their experience and knowledge to develop a curriculum and training course to help you. Our intensive and highly engaging, 4 day Medicinal Cannabis Manufacturing Training Course is aimed at providing knowledge to all operational professionals working in the Medicinal Cannabis space and will include ODC licence applications, initial site selection, security requirements and obtaining council planning approvals all the way through to how to go about shortlisting and tendering for suitable builders. Finally, it will also include how to compile all the regulatory documentation required and how to develop your subsequent quality management system.
Our in-house, Canadian-trained, Medicinal Cannabis expert, Justin Verwoert, will take you through the entire ODC process and our ex-TGA GMP inspectors and GMP trainers will also help you navigate through the Therapeutic Goods Act and the relevant Annexes of PIC/S GMP with the objective of obtaining a Medicinal Cannabis GMP manufacturing license.
There are a number levels to this regulation, (I did say there was a lot of red tape!):
- The Good Agricultural Practice (GAP)
- State poisons licencing
- ODC licencing
- PIC/S GMPs for Pharmaceutical Active Ingredient (API) and
- PIC/S GMPs for the Final Dosage Form (FDF).
In addition, there are also the Pharmacopeial testing standards (such as the USP and EP), plus the specific Therapeutic Goods Orders to contend with!
If your head is spinning, not to worry, our inaugural Medicinal Cannabis Manufacturing Training Course starting on the 13th August 2018, will help you to navigate through all the red tape and make sense of it all.
As a plus, we will also throw in some technical writing training to help you write brilliant documents in plain English that will make your TGA Inspector beam with delight.
To make sure that our PharmOut consultants are trained and aware of international trends, we will be attending the annual LIFT conference in Toronto at the end of May, we would be delighted to meet other like minded professionals or tour other facilities.
Please note – this course is not designed to teach you how to grow cannabis!