Schedule 9 permits for each individual participant in clinical trials
A registered medical practitioner is required to hold a Schedule 9 permit for each individual participant in the clinical trial before administering, supplying or prescribing the Schedule 9 substance in the clinical trial.
If it is not known which participants will be prescribed the Schedule 9 substance (i.e. if it is a double-blind trial), then a Schedule 9 permit is required for every participant in the clinical trial.
Schedule 9 permits are only issued for a participant in a clinical trial which has received approval from a Human Research Ethics Committee (HREC) registered by the National Health and Medical Research Council.
This is a 2-step process.
Step 1 - Pre-application assessment
Pre-application assessment can take up to 4 weeks from when we receive all of the required information and documentation.
The following information and documentation is required to be submitted:
- A copy of the document issued by the HREC approving the clinical trial and relevant details.
- A copy of the Site Specific Assessment (SSA) authorisation for Victorian site(s).
- A copy of the clinical trial protocol (i.e. HREC approved version) and relevant details.
- Schedule 9 substance details including dose form, dose per unit, expected maximum daily dose (if applicable) and duration of treatment.
- Handling, storage and administration details.
- Principal investigator(s) and health practitioner(s) details.
Pre-application assessment cannot take place if any of the above information and documentation is not supplied or is incomplete.
Pre-application assessment information and documentation should be submitted via the Pre-application assessment of a Schedule 9 clinical form.
You will be advised if further information or clarification is required and the outcome of the pre-application assessment via email.
Once the pre-application assessment is complete, we will provide the prescribed form for the Schedule 9 treatment permit application.
Step 2 - Schedule 9 permit applications for individual participants
The Schedule 9 permit application for each individual participant in the clinical trial must be in the prescribed form.
Each Schedule 9 treatment permit application for each individual participant can take up to 7 days to process. Applicants are advised to submit permit applications 2 weeks in advance of first dosing for each individual participant.
Each permit application must be accompanied by a copy of a signed consent form in respect of the participant for whom the application is made.
The latest copy of the clinical trial protocol with its accompanying HREC approval must also be provided if the protocol has been updated since the pre-application assessment.
Permits for an organisation to lawfully possess a Schedule 9 substance
In addition to Schedule 9 permits required by medical practitioners for individual participants (described above), the organisation that carries out a clinical trial involving a Schedule 9 substance in Victoria may require an additional permit to be in lawful possession of the Schedule 9 substance.
However, a separate permit for possession would not be needed if the organisation carrying out the clinical trial in Victoria only ever obtains Schedule 9 substances that are dispensed from a pharmacist working in a pharmacy.
In this case, the organisation is authorised to be in possession of a Schedule 9 substance under Sub-regulation 7(1) (Item 8) of the Drugs, Poisons and Controlled Substances Regulations 2017.
When pharmacists dispense a Schedule 9 substance, they must do so on a lawful prescription from a prescriber for a specific person. They must also place a dispensing label on the container holding the Schedule 9 substance which states the specific person’s name.
If an organisation carrying out a clinical trial in Victoria intends to obtain a Schedule 9 substance that is not dispensed as described above, then it may need to hold a relevant permit to be in lawful possession of the substance. A new application fee would need to be paid (Permit code 8,9 in the Medicines and Poisons Regulation permit fee schedule).
Reviewed 05 September 2023