Approvals and authorities
Medicines and poisons are substances regulated under the Health (Drugs and Poisons) Regulation 1996. Queensland Health issues licenses that cover their manufacture, distribution and sale. We also issue approvals to use scheduled substances for other purposes, such as therapeutic treatment or for research and analysis, where a person is not already authorised to use the substance in that location or for that purpose.
Queensland Health provides guidelines and application forms for prospective applicants, as well as templates and other resources for those persons and entities granted approvals.
Use of scheduled substances for therapeutic purposes
- Procedures and protocols for medicines management (PDF 283 kB) this guideline provides information to assist applicants to develop and implement documented processes and procedures relevant to scheduled medicines.
Treatment with regulated restricted drugs or drugs of dependence
- Prescribing and dispensing regulated restricted drugs, such as clozapine, isotretinoin and thalidomide:
- Fact sheet for prescribers and dispensers (PDF 154 kB), including your obligations and penalties under the HDPR
- Application form to use regulated restricted drugs (PDF 2041 kB)
- Treatment involving drugs of dependence (PDF 420 kB) (known as a Report for Chief Executive Approval) use this form for an approval for the treatment of:
- a drug dependent person, with a S8 or restricted drug of dependency
- any "specified condition drug" other than for attention deficit disorder in a child between the ages of 4-18 or for treatment of narcolepsy.
- read more about regulatory requirements and opioid treatment.
Emergency first aid
- Emergency first aid approvals (PDF 194 kB) this guideline provides information about this type of approval and regulatory obligations.
- Emergency first aid approval application form (PDF 251 kB) use this form to submit an initial or amendment application to Queensland Health to use scheduled medicines for emergency first aid.
- Relevant person - The relevant person application is used to support an Application for approval to use scheduled medicines for emergency first aid. Persons relevant to an application are directors of the applicant organisation, nominated persons, and doctors nominated to provide clinical oversight.
- Relevant person for a licence or approval application (PDF 156 kB) use this form to accompany an application for an emergency first aid approval.
- For approved entities:
- Notification of intended operations (PDF 191 kB) use this form to provide Queensland Health with advance notification of intended provision of short-term first aid services.
- Post event evaluation record (PDF 162 kB) use this form to report to Queensland Health details of medicines usage for each specific location/event where services have been provided.
Treatment of acute health conditions at isolated locations
- Isolated location approvals (PDF 181 kB) this guideline provides information about this type of approvals and regulatory obligations.
- Isolated location approval application form (PDF 1771 kB) use this form to submit an initial or amendment application to Queensland Health to use scheduled medicines for treatment of acute health conditions at isolated locations.
- Medicines usage report (XLSX 24 kB) use this form to report to Queensland Health details of medicines usage for each location where services have been provided.
Immunisation program certification
- Guideline - Applying for certification of an immunisation program (PDF 93 kB) provides information about the application process.
- Application for certification of an immunisation program (Immunisation Program Nurses) (PDF 155 kB) use this form to apply for certification of an immunisation program. Applications must meet the requirements of the Drug Therapy Protocol – Immunisation Program Nurse (PDF 76 kB)
- Relevant person for a licence or approval application (PDF 156 kB) use this form to accompany an application for certification of an immunisation program.
NOTE – Immunisation programs are not for the provision of COVID-19 vaccines, see information about COVID-19 vaccines
Animal management or welfare
- Animal management or welfare form (PDF 645 kB) use this form to submit an application to Queensland Health to use medicines and/or poisons for animal management and/or welfare services.
- Animal management and/or welfare guideline (PDF 119 kB) information about this type of approval and regulatory obligations.
Other approvals to use scheduled substances for therapeutic purposes
To seek approval to use a scheduled substance for a therapeutic purpose not covered by one of the above categories, please use the following non-specific application form.
- Application for an approval to use scheduled medicines and/or poisons for therapeutic purposes (DOCX 1295 kB)
Use of scheduled substances for non-therapeutic purposes
Research and teaching at universities
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.