Cannabis in Australia – how to become a licenced manufacturer for medicinal purposes.

Licences and Permits

Before being able to manufacture narcotic drugs involving cannabis, you must hold both a licence and a permit issued under the Narcotic Drugs Act 1967 (Cth) (the Act) issued by the Office of Drug Control.

In addition, you may require a licence under the Therapeutic Goods Act 1989 (Cth). Cannabis products must be manufactured to Good Manufacturing Practice, you can obtain further information on this here.

Manufacture cannot occur until you have obtained both a licence and permit.

How do I apply?

If you are applying for a standalone licence to manufacture narcotic drugs derived from cannabis and/or cannabis resin, click here for the application form. Alternatively, if you are also applying for a cannabis licence (for example, for cultivation, production and/or research), you should access the online application form here. In this article we will only address the standalone licence to manufacture.

What information is required to complete an application?

Your application must contain certain information and the Act provides that once made, the Secretary must either grant or refuse the application. There currently is no fee associated with an application to manufacture cannabis, however, an application to obtain a licence to cultivate, for example, has a fee of $5,040 for the licence and $1,830 for the associated permit.

You will need to specify whether the basis of your application is for commercial manufacturing or for research purposes. In addition, you must nominate the activities you intend to undertake as part of the manufacturing process, as follows:

• extraction of cannabis and/or cannabis resin;
• processing, purification of cannabis extracts;
• supply of the manufactured product to another party;
• packaging of manufactured product into a final product;
• exporting the manufactured product;
• laboratory analysis of cannabis, cannabis resin, extracts and/or manufactured products;
• research (you must expand on this and summarise your intended research activities); and/or
• any other activities (you must clearly detail what these will be in your application).

The application must clearly set out the drugs and products to be manufactured. For each proposed drug, Schedule 3 to the application must be completed setting out the drug and details of proposed manufacture for various calendar years (for example, in 2020, it is proposed that cannabis extract (THC) will be manufactured at 5 mg/mL strength, in a capsule, with 70,000 units for the year, having a total volume of 100L to be extracted and 700kg of cannabis required for extraction.

Section 11J of the Act provides that the Secretary (as defined) must reject an application for a manufacture licence if the Secretary is not satisfied on reasonable grounds that the applicant and the applicant’s relevant business associates are each considered a “fit and proper person”. Accordingly, section 7 of the application requires you to list each business owner, office holder, persons with a financial interest and persons with decision making powers or influence. For each person listed, Schedule 1 to the application must be completed setting out comprehensive information about that person.

What supplemental information/documents will need to accompany an application?

The Act and Regulations require certain supplemental information to be attached. You should begin collating this required information as soon as possible so as not to delay being able to lodge your application for consideration. The material to be provided should include the following:

You must ensure that all information and supporting documentation you provide in your application is correct. It is a serious offence to make a false or misleading statement in relation to an application (for example, you can be imprisoned for up to 12 months – see Divisions 136 and 137 of the Criminal Code Act 1995 (Cth)).

Who can I supply the drugs to?

Your application for a licence to manufacture will be refused if you cannot demonstrate that supply will be in accordance with the enumerated permissible supplies under the Act which include:

• clinical trials;
• Special Access Scheme; and
• Authorised Prescribers.

State and territory governments may also have additional requirements for supply, such as patient cohorts or specific indications.

What about State/Territory licences?

Whilst you will be required to obtain any necessary State/Territory licences, it is not a prerequisite that these are obtained before an application for a manufacturing licence. However, you must provide evidence that you have obtained any such licences when applying for a manufacturing permit.

I plan to export medical cannabis, is this permissible?

You can only export medicinal cannabis (extracts and preparations) if the product is listed as ‘export-only’ or registered on the Australian Register of Therapeutic Goods (ARTG) and the exporter holds a licence and permit to export drugs from the Office of Drug Control.

Can I import cannabis material for use in manufacturing medicinal cannabis products?

If you hold a licence to manufacture and a licence and permit to import drugs, you may import cannabis, including extracts, for use in manufacture. However, the importer must hold a state/territory licence allowing possession of cannabis material before import approval may be granted and only import from countries where cannabis for medicinal use is approved at the federal level.

I’ve got my licence to manufacture now, can I purchase cannabis products from cultivators?

If you hold a licence to manufacture medicinal cannabis, you will be able to enter into contractual arrangements with cannabis cultivators/producers to produce cannabis.

It is important to note that cultivation of cannabis may not commence until both parties (cultivator and manufacturer) hold permits.

The law around medicinal cannabis, manufacturing, licensing and permits is complex. If you require assistance with any such issue, contact Zed Legal today at [email protected]