Cannabiz editor-at-large Rhys Cohen takes a look at the small print in the Department of Health’s consultation paper on reforms to medicinal cannabis manufacturing, labelling and packaging.
The Department of Health has commenced a consultation process addressing several significant regulatory challenges facing Australia’s medicinal cannabis industry. At a very general level, these issues are:
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- An uneven playing field where imported products and ingredients are held to a lower quality standard than those locally made.
- Concerns regarding the extent, oversight, and quality of extemporaneously compounded cannabis preparations.
In addition to these headline issues, the consultation paper includes some interesting discussion around:
- Packaging, labelling and specifying ingredients.
- Additional guidance for analytical testing.
The consultation paper itself does a good job of explaining the regulatory minutia and I encourage you to read it for yourself. So instead of just re-stating the document in its entirety, I’m going to give a brief overview and then focus on the parts I think are the most relevant and interesting.
Quality standards for imports
The problem goes something like this: unapproved medicines (which include almost all cannabis medicines), that are manufactured overseas, are exempt from the requirement that they be manufactured according to Good Manufacturing Practice (GMP) quality standards.
So unapproved medicinal cannabis ingredients and products that are imported don’t need to meet GMP. But locally made ones do. That puts local companies at a disadvantage.
Both imported and locally made products, as well as their active ingredients, have to conform with Therapeutic Goods Order 93 (TGO93) which sets out minimum quality standards and requires products to be consistent and free of contaminants.
The Department of Health wants to ensure a level playing field for everyone by imposing similar quality standards on both imports and local products. They have proposed two possible solutions (other than ‘doing nothing’).