The following may be an explanation into the lengthy wait!...

The following may be an explanation into the lengthy wait!

Manufacturers of medicinal cannabis must obtain all necessary manufacturing licences
To manufacture medicinal cannabis in Australia, a manufacturer must obtain all of the following licences:

1. Manufacturing Licence under the ND Act

This licence pertains to the security and prevention of diversion in accordance with the Convention and is administered by the ODC. The number of licences granted will depend on the demonstrated demand.

2. Manufacturing Licence under the TG Act

This licence ensures that the products produced are of an acceptable quality and is administered by the TGA. The manufacturer must adhere to the standard prescribed by the TGA in its Manufacturing principles for medicinal products (and refer to the TGA's Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions), and the World Health Organisation's guidelines on good agricultural and collection practices (GACP) for medicinal plants.

3. Manufacturing Licence under the relevant states and territories legislation.
Key issues for medicinal cannabis production market entrants
Despite the new framework, the key issues that will continue to impact the viability of the industry include that:

• the high cost of applying for and complying with the relevant licences and permits creates a financial barrier to entrants
• the requirement to prove demand before supply provides an additional administrative hurdle which is difficult to accurately prove, and
• the high security measures required result in high production costs and may restrict the market to large pharmaceutical companies who can afford such measures

I believe that Management should at least be in a position to give an update on the license process I.e. yes our license application is progressing.  Surely they don’t just submit, hear nothing until rubber stamp put on docs??