The industry surrounding plant-based treatments seems to be on a consistent rise, and many are considering entering the alternative market.
Often, what puts investors off the plant-based treatment industry is the potential red tape and governmental requirements. The regulatory environment surrounding licensing is important, and looking at the details can help prepare you.
Getting a license to grow plants used as alternative medicine requires patience, and you will need to satisfy a set of requirements. The rigorous nature of the process can be gruelling, so it’s important to review what it is you’re getting yourself into.
Without a license, it is illegal to manufacture and cultivate plant-based treatments. Doing so can lead to severe legal consequences.
The Office of Drug Control (ODC) has set out fees and charges associated with gaining access to such a license.
How to get a license to grow medicinal plant-based products
If you have any intention of cultivating or producing medicinal plant-based products, you’ll need an official license. The government has also emphasised that the cultivation of such products may only be for medicinal purposes. Before you can get going, you will need to make sure you have the relevant:
- approvals
- licences or GMP certification or clearance
- permits under each of the relevant legislative frameworks.
This includes relevant state or territory government licences or approvals.
As such, you must possess:
- a manufacturing licence under the Therapeutic Goods Act 1989 (if the manufacturer resides in Australia) or GMP certification or clearance (if the manufacturer resides overseas)
- a manufacturing and cultivation licence and associated permits under the Narcotic Drugs Act 1967
- relevant state or territory government licences or approvals
On 24 December 2021, the government implemented the Narcotic Drugs Amendment Act 2021 (Amendment Act) as an amendment to the Narcotic Drugs Act 1967 (Narcotic Drugs Act).
The new act now allows for a single license model when it comes to the production of medicinal plant-based products. The license is also perpetual and continues indefinitely, but remains subject to suspension, revocation, or surrender in accordance with the act.
There are a few eligibility requirements in place for those interested. As such, to apply for this license, you must:
- be a fit and proper person
- prove that there is a producer or manufacturer who will buy any raw materials you produce
- provide details of your business and proposed cultivation site
- complete the required form
- pay the prescribed fees
All of the above standards must be met when looking to get a plant-based treatment growers license.
Australian GMP (Good Manufacturing Practice) for plant-based treatments
The code of GMP is the relevant Australian standard when it comes to manufacturing plant-based treatments. In addition, the TGA has published specific guidance on GMP compliance for the manufacturing of unapproved products containing CBD and/or THC supplied under ‘approved access’ provisions.
The TGA has implemented internationally recognised manufacturing standards similar to those in countries such as Canada and the United States of America. By doing so, manufacturers are able to operate in an international environment when it comes to plant-based medicines.
If you are seeking to import plant-based treatments to Australia, you will need to present evidence of a GMP clearance that is equivalent to the Australian GMP standard. Plant-based treatment producers based overseas can also apply to obtain Australian GMP clearances.
Another pathway exists for importing plant-based products from Canada, the Netherlands, Israel, and Switzerland. Regulations note that these countries hold the same manufacturing regulation standards for plant-based products not on the Australian Register of Therapeutic Goods.
Oversees companies will need to comply with all the standards set out by the TGA.
The legal status of plant-based treatments in Australia
The medicinal use of plant-based products was legalised in 2016 for patients with a prescription from a qualified medical practitioner.
The Therapeutic Goods Administration (TGA) regulates the supply of plant-based treatments. Most of the existing products are unregistered.
A doctor must thus have approval from the TGA to prescribe such alternative medicines. Approval can be obtained via the Special Access Scheme-B or Authorised Prescriber Scheme.
Plant-based products are currently divided into three categories:
- Schedule 8 (controlled drugs): THC products prepared for therapeutic use fall under this category.
- Schedule 4 (prescription-only medicines): CBD where the compounds in the preparation for therapeutic use contain at least 98% cannabidiol and 2% or less of other naturally occurring compounds
- Schedule 3 (pharmacist-only medicines): Low-dose CBD products with less than 1% of THC and at least 98% of the content consisting of CBD. No products currently meet these requirements.
For now, medicinal plant-based products can only be accessed with a medical prescription. If a doctor believes that CBD or THC may prove effective in providing a patient with the desired relief, a prescription will be granted.
Summary
If you want to manufacture or produce plant-based products in Australia, you will need to apply for a special license. Doing so without such a license is illegal and holds severe consequences.
Manufacturers must meet the eligibility requirements and adhere to the guidelines set out in the Australian GMP Code in order to legally produce plant-based treatments. The relevant regulatory requirements are in line
Patients in Australia can access such plant-based treatments with a prescription from a qualified medical practitioner. Doctors need to obtain approval from the TGA before writing a prescription for CBD and/or THC.
For more information on the licensing and regulatory environment surrounding medicinal plant-based products, speak to one of our qualified experts today.