Approvals and authorities
Medicines and poisons are regulated substances, and the Department of Health issues licenses that cover their manufacture, distribution, sale and use. We also consider applications for other regulated activities with medicines and poisons, such as research and the use of drugs and poisons in different settings, or for treatment, known as approvals. These activities are regulated under the Health (Drugs and Poisons) Regulation 1996.
The Department of Health provide forms and guidelines for certain regulated activities and sites.
Regulated activities approval forms
Approval forms for scheduled substances for therapeutic purposes
- Application for an approval to use scheduled medicines and/or poisons for therapeutic purposes (DOC 511 kB)
- Regulated restricted (Schedule 4) medicines (PDF 916 kB) use this form if you wish to use regulated restricted medicines in Queensland. Regulated restricted medicines include but are not limited to acitretin, thalidomide, clomiphene, clozapine.
- Supervision requirements (PDF 476 kB) for regulated restricted medicine approvals.
- Prescribing clozapine in the community (PDF 211 kB) fact sheet about the administrative requirements when prescribing and dispensing clozapine to Queensland patients on the Pharmaceutical Benefits Scheme (PBS) after 1 July 2015.
- Penalties for prescribing and dispensing isotretinoin without authorisation (PDF 82 kB) fact sheet about the regulatory requirements for prescribing and dispensing isotretinoin and the associated penalties.
- Treatment involving drugs of dependence (PDF 264 kB) (known as a Report to the Chief Executive) use this form for an approval for the treatment of:
- a drug dependent person, with a S8 or restricted drug of dependency
- a person with a S8, for more than 8 weeks
- any "specified condition drug" other than for attention deficit disorder in a child or for treatment of narcolepsy
- read more about regulatory requirements and opioid treatment.
Industry specific approval form
- Mine site (PDF 201 kB) use this approval form to submit an application to the Department of Health to use medicines and/or poisons at a mine site.
- Mine site guideline (PDF 289 kB) information about this type of approval and regulatory obligations.
- Island resort (PDF 176 kB) use this approval form to submit an application to the Department of Health to use medicines and/or poisons at an island resort.
- Island resort guideline (PDF 332 kB) information about this type of approval and regulatory obligations.
- Commercial paramedic services form (DOC 316 kB) use this form to submit an application to the Department of Health to use provide commercial paramedic services in Queensland.
- Animal management or welfare form (PDF 126 kB) use this form to submit an application to the Department of Health to use medicines and/or poisons for animal management and/or welfare services.
- Animal management and/or welfare guideline (PDF 257 kB) information about this type of approval and regulatory obligations.
Approval forms for scheduled substances for non-therapeutic purposes
Universities use the Application for an Approval to use scheduled substances for non-therapeutic purposes at a university (DOC 502 kB) form to submit an application to use medicines and/or poisons for research or teaching purposes.
Outside of university and other activities
There are a number of other regulated activities that may also be performed with approval from the Chief Executive, Department of Health, known as a 'Section 18 approval'. Use the Application for an approval to obtain, possess, and use scheduled substances for non-therapeutic purposes (other than at a university) (DOC 536 kB) form if you wish to apply for an approval to do an activity with scheduled substances outside of university or that is not addressed in the approvals above. If you are unsure please contact us, before completing this form.
Obligations and requirements
There are obligations to report lost or stolen scheduled substances. Find out who has to report losses or theft and what types of scheduled medicines are required to be reported to the Department of Health.
There are storage and record keeping obligations for scheduled substances that must be complied with as part of your Approval. The following document details sets out these requirements.