One of the four approved pathways to supply Medicinal Cannabis in Australia is via Medicinal Cannabis Clinical Trails under the CTN scheme. This blog discusses this route in greater detail. Medicinal Cannabis in the treatment and relief of symptoms of chronic conditions The use of Medicinal Cannabis in the treatment and relief of symptoms of…
For large Medicinal Cannabis greenhouses, you typically need a large flat area with a fall of less than 1 in 400 (making all airports prime Medicinal Cannabis cultivation sites). Recently, there was an article about a medicinal cannabis “farm” which had been approved to be built in Brisbane, but had provoked a degree of “public…
Finally, that minor typo in Chapter 9 has been fixed; it has been a frustrating 10 years! Now that’s off my chest, we can look at the main changes between PIC/S GMP PE 009 version 13 and 14. Usually, version changes have been restricted solely to chapters or annexes that are under review, however, given…
In a recent press release, the PIC/S Committee recently announced the revision of the PIC/S GMP Guide (PE 009) to PIC/S version 14, with updates to: Chapter 3 – Premises and Equipment Chapter 5 – Production Chapter 8 – Complaints and Product Recall According to PIC/S, these chapters have been revised based on the equivalent…
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…
In January 2018 the federal health minister announced that, after industry consultation, the export of Medicinal Cannabis from Australia would now be permitted.Subsequently, the export of Medicinal Cannabis products was legalised in February 2018 through the Narcotic Drugs Amendment (Cannabis) Regulations 2018. The ODC Export of Medicinal Cannabis, Guidance for Cultivators and Manufacturers of Medicinal…
When good drugs turn bad and how Good Distribution Practice can help I’m currently involved in the implementation of the regulatory controls around medicinal cannabis in Australia and eventually, we will need to work out the good distribution practice for medicinal cannabis. The Australian Government’s drug regulator, the Therapeutic Goods Administration (TGA) and the Office…
The final part of the blog series looks at Chapter 10 (Quality Control) and the glossary. In addition, we say goodbye to small number of clauses which have been removed between the 2007 and 2017 versions of Annex 1. Readers may also wish to view the Initial Blog, Part 1, Part 2,Part 3, Part 4, Part…
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