Restricted drug manufacturer licence - Queensland

Description

You require this licence to manufacture Schedule 4 medicines (restricted drugs), including for veterinary use. Schedule 4 medicines are prescription only medicine - medicines which must be prescribed by an authorised healthcare professional (such as a doctor).

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 a suitable person to hold the licence
  • hold the relevant experience and qualifications, as set out in the resource 'Qualifications'
  • ensure the premises to be used for manufacturing the controlled drug is suitable for the purposes.

Duration

This licence remains in effect for 12 months from the day it is granted. A renewal notice will be issued to you annually.

Fees

Fees Details for this service in table format.

Task Type Business Structure Amount
Apply Application All $691.50
Renew Renewal All $561.00

Application process

Apply

You can obtain this licence by completing the 'Medicines and poisons: manufacture and wholesale licence form' and submitting it with the appropriate fee and supporting documentation.

Before approval is granted an inspection of your business premises may be conducted to ensure that it complies with the requirements set out in the Act.

Transfer

This licence cannot be transferred.

Additional information

The following conditions apply to all licences to restricted controlled drugs. A restricted drug manufacturer must:

  • only keep or sell a restricted drug at the business premises
  • supervise all employees involved in the manufacture of restricted drugs
  • ensure a restricted drug is only handled by the licence holder or an adult employee.

Administering agency

Queensland Health

Public Health Regulation and Licensing

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Please use these contact details for help or more information:

Enquiries

Public Health Regulation and Licensing

Queensland Health

Queensland
Mailing address: PO Box 2368
Fortitude Valley
Queensland 4006
Phone: 07 3328 9310
Email: hpu_licensing@health.qld.gov.au
Contact us website: Public Health Units contact details (Opens in new window)