To manufacture medicinal cannabis, the manufacturer must hold both an Office of Drug Control (ODC) licence and a permit. The licence is applied for under section 11G of the Narcotic Drugs Act 1967 (Cth), which authorises the manufacture of medicinal cannabis. Evidence of the ODC licence must be provided when applying for a permit.
A person may also be required to apply for a state or territory licence. For example, in Victoria, a manufacturer may also need to apply for a licence to obtain, possess, sell or supply the medicinal cannabis products. Whether or not a manufacturer also needs a Victorian licence will depend on whether these activities are exempt by the ODC licence or completely covered. If the activities are exempt or completely covered by the conditions in the manufacturers ODC licence, then a Victorian licence is not required. If a state licence is held, the applicant will need to provide this when applying for an ODC licence.
It is also a requirement that manufacturers comply with the Good Manufacturing Practice (GMP). Therefore, in order to do so, manufacturers are required to obtain a GMP licence from the Therapeutic Goods Administration (TGA). To obtain this licence, the applicant must disclose evidence that they have complied with the relevant code of GMP. The products must be manufactured to the GMP principals which are contained in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, known as PIC/S.
As part of their obligations, manufacturers must:
- ensure the medicinal cannabis is fit for its intended use;
- comply with any requirements of the Marketing Authorisation or Clinical Trial Authorisation; and
- ensure patients are not placed at risk due to poor safety or quality.
The Forms to Manufacture Medicinal Cannabis
Medicinal cannabis can be manufactured in two forms – that is, the Active Pharmaceutical Ingredient (‘API’) and the Final Dosage Form (‘FDF’).
Medical Cannabis in API Form
The API is used as the starting material in the process to manufacture a finished product. Examples of the API are the active component of the cannabis plant, an extract of specific parts of the cannabis plant, or a powdered part of the cannabis plant. The manufacturing of an API is governed by the PIC/S Guide to Good Manufacturing Practice for Medical Products Part II and a manufacturer needs to comply with this guide.
Medicinal Cannabis in FDF Form
The FDF form of medicinal cannabis is the final form of the product which will not be changed. It is essentially the tablet, capsule or oil. To manufacture medicinal cannabis in FDF form, the manufacturer needs to obtain a licence from the ODC and another licence from the TGA. There is also a requirement to comply with Part I of PIC/S and depending on what type of final product of medicinal cannabis is being manufactured, certain PIC/S Annexures are also required to be complied with.
Next Steps
If you are interested in manufacturing cannabis and require assistance with the licensing process, feel free to contact us for a free consultation on (02) 9262 5495 or (03) 8899 7870; visit our Website; Like our Facebook Page.
This article is written by Damin Murdock. This article is not legal advice and should not be relied upon as legal advice. All articles found on this website are intended to provide informative information, nevertheless, in many instances legislation and case law has been simplified and/or paraphrased. If you would like personal legal advice based on your current circumstances, you should contact MurdockCheng Legal Practice for a free consultation.