ODC Medicinal Cannabis Manufacturing License Info

OCD medicinal cannabis manufacturing license options; what should you expect?

If you’re new to the world of cannabis in Australia and you’re already a licensed cannabis producer in Canada, you’re probably wondering about The Office of Drug Control (ODC) medicinal cannabis manufacturing license.

In this post, we cover the ins and outs of the ODC, including:

– ODC Guidelines

– ODC Permit Information

– Who Needs an ODC Medicinal Cannabis Manufacturing License

– Narcotics License Application Information

– And more!

Keep reading to learn more about the ODC and what’s involved with getting an ODC Medicinal Cannabis Manufacturing License now.

ODC Guidelines

The Office of Drug Control (ODC) is the Australian federal government office responsible for issuing medicinal cannabis manufacturing licenses. This government entity also provides guidance on the manufacture of medicinal cannabis products and sets out requirements that must be met in order to obtain a license.

In order to get a license from the ODC, applicants must first apply for a medical cannabis license authorizing the manufacture of medicinal cannabis products. This is available on the ODC’s website.

Keep in mind that the Therapeutic Goods Administration (TGA) has been granted the task of licensing GMP (Good Manufacturing Practice).

The supply is also controlled. Since medicinal cannabis product supplies are only allowed for a specific number of supply categories that the ND Act and Narcotic Drugs Regulations 2016 have put in place, it’s important to understand that these are controlled products. Clinical trials, Special Access Schemes, and Authorized Prescribers are the categories that allow supplies of medicinal cannabis products. Additional requirements regarding supply, including but not limited to patient cohorts or specific indications, can be put in place by state and territory governments.

If you’ve applied for a medicinal cannabis license to manufacture cannabis products, you’ll need to demonstrate that the supply will be created while adhering to all prerequisites.

Loving this post? Make sure to check out our other article on Canada Cannabis Manufacturing License Types and Canada Cannabis Manufacturing Regulations before you leave!

Other OCD Permit Info

There isn’t a prerequisite for operators to hold a state or territory license that authorizes activities that relate to Schedule 8 (Controlled Drugs) before submitting an application to obtain a Commonwealth Manufacturing License. But, applicants need to give evidence that they have already obtained all necessary licenses and approvals that the State or Territory where their manufacturing site is located if they’re submitting an application to get a manufacturing permit.

For those interested in exporting medicinal cannabis, this activity comes with limitations. This is not allowed unless it’s a product that’s labelled export-only or registered on the Australian Register of Therapeutic Goods (ARTG). The exporter also must hold a permit and license from the ODC to export drugs.

Anyone who holds a Commonwealth license for manufacturing narcotic drugs including cannabis and a Commonwealth permit and license to import drugs is allowed to import cannabis material for manufacturing purposes. This includes extracts.

But keep in mind that as an importer, you’ll need to have a state/territory license that lets you possess cannabis material prior to being approved for imports You’re also limited to importing from countries that have medicinal use cannabis legal federally.

Who Needs an ODC Medicinal Cannabis Manufacturing License?

Anyone who obtains a license under the ND Act for manufacturing cannabis drugs is allowed to enter contractual arrangements with cannabis producers/cultivators producing cannabis. The cultivators and manufacturers need to have applicable permits under this act.

Furthermore, permits may not be issued if the manufacturer isn’t holding the right state/territory licenses and authorizations. All applicants are subject to testing, and this testing could be in addition to any tests a state or territory government might require. The license is issued under the ND Act isn’t always enough for a state or territory or state to issue the necessary licenses for manufacturing, wholesale, or supply,

ODC Contact Info

For those looking to inquire about licensing and permitting for medicinal cannabis cultivation or production, medicine manufacturing, or importing or exporting medicines, you can contact the ODC using this information:

The phone number is +61 2 6289 4618. However, if you need to get in touch with the Therapeutic Goods Administration, you can call them at 1800 020 653 or email them at medicinal.cannabis@health.gov.au.

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