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A narcotic drug manufacture licence will authorise you to:
obtain a narcotic substance from a plant (undertaking extraction of the opium poppy)
obtain a narcotic from a synthetic process
transform a substance into a narcotic drug, including from one narcotic to another (for example, morphine transformed into codeine).
A permit limits the product types and quantities you can manufacture.
To manufacture cannabis products, you need a different licence and permit.
Grow, produce or manufacture cannabis in Australia
The process
Authorisation to manufacture narcotic drugs in Australia is a two-part process:
- Get a licence
- Get a permit
You can’t start activities until you have both a licence and relevant permits.
You may also need a licence from your state or territory government and the Therapeutic Goods Administration (TGA).
Find out more about licences for manufacturing therapeutic goods.
Who can apply
To get a narcotic drug manufacture licence and permit you must give evidence showing:
- business experience
- a sound and stable financial background
- good repute, connections and associations
- the sites you will operate from are appropriate and secure.
Entity types
The following can apply for a narcotic drug manufacture licence:
- individuals
- bodies corporate – companies with ‘Ltd’ in the title
- Federal, state or territory agencies.
Trusts and partnerships can’t apply. Trustees can apply.
What you must provide
You must give supporting information when you apply. This can include:
- evidence that you are a ‘fit and proper person’
- site and security details.
Fit and proper person
- identity documents
- details about your reputation and business experience
- business and other associates
- details of financial standing
Guideline: Fit and proper persons and suitable staff
Site and security details
- site and detailed floor plans
- satellite image with a security overlay of the proposed site
- details of authorised persons
- security policy or standard operating procedure
- state or territory licences or authorisations
Get a licence
You will need to sign in or create an account with Health Business Services when you apply.
Get a permit
After your licence is granted, we will send you a narcotic drug manufacture permit application.
Your permit must also be granted before starting activities.
Get help
To get help with your application email ncs@health.gov.au