Licence to Manufacture or Supply Drugs of Addiction - NSW - Australian Business Licence and Information Service

Description

You will need this licence if you intend to manufacture or supply addictive drugs.

Addictive drugs are classified as Schedule 8 substances in the Poisons List. You must keep detailed records of the production and all transactions involving these substances.

Service type

Licence

A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

To be eligible for this licence, you must:

be considered fit and proper for the purposes of the licence (including not having a criminal record)
provide adequate security for the premises where the drugs are held
provide or be willing to undertake a National Criminal Record Check
only manufacture or supply addictive drugs from the premises nominated on the licence.

Expiry

30 September each year

Fees

Task	Type	Business Structure	Amount	Description
Apply	Licence	All	$765.00	Annual fee for other organisation to manufacture drugs of addiction. Fees for 2024-25
Apply	Licence	All	$86.00	Annual fee for public institution to supply drugs of addiction. Fees for 2024-25
Apply	Licence	All	$19.00	Annual fee for charitable organisation to supply drugs of addiction. Fees for 2024-25
Apply	Licence	All	$383.00	Annual fee for other organisation to supply drugs of addiction. Fees for 2024-25

Forms

Task	Business Structure	Resources
Apply	All	Application for a Licence to Manufacture or Supply Drugs of Addiction - PDF (Opens in new window)
Apply	All	Application for a Licence to Supply by Wholesale Drugs of Addiction - PDF (Opens in new window)
Apply	All	Application for a Licence to Supply Drugs of Addiction - PDF (Opens in new window)
Apply	All	Statutory Declaration - PDF (Opens in new window)

Act(s) name

Poisons and Therapeutic Goods Act 1966 New South Wales

Regulation(s) name

Poisons and Therapeutic Goods Regulation 2008 New South Wales

Approval time

4 to 6 weeks

Transfer

This licence cannot be transferred.

Administering agency

NSW Ministry of Health

People, Culture and Governance

Legal and Regulatory Services

Contact details

**Please use these contact details for help or more information:**

Enquiries

Legal and Regulatory Services

People, Culture and Governance

NSW Ministry of Health
New South Wales
Operating address:	1 Reserve Road St Leonards, New South Wales 2065
Mailing address:	LOCKED BAG 2030 St Leonards, New South Wales 1590
Phone:	02 9391 9000
Website:	NSW Ministry of Health (Opens in new window)

**Please use these contact details for help or more information:**

Pharmaceutical Services

Legal and Regulatory Services

People, Culture and Governance

NSW Ministry of Health
New South Wales
Operating address:	1 Reserve Road St Leonards, New South Wales 2065
Mailing address:	LOCKED BAG 2030 St Leonards, New South Wales 1590
Phone:	02 9391 9944
Fax:	02 9424 5860
Email:	MOH-PharmaceuticalServices@health.nsw.gov.au
Website:	About Us (Opens in new window)

Supporting information

Licences and Authorisations (Opens in new window)

Licence to Manufacture or Supply Drugs of Addiction - New South Wales