Authorised Prescriber New Application & Renewal Form

Please ensure you have made payment prior to the next HREC submission cut off date.

Non-payment will result in your application not being reviewed at the next HREC meeting.

Are you a doctor or a sponsor submitting this form on behalf of a doctor?

Doctor
Sponsor

Do you wish to create an account on this site

Yes. I have not registered before.
No. I am already registered with the site.

New or Renewal of Application?

New Application
Renewal of Application

Applicant (Doctor) Details

Name

First

Last

AHPRA No

Address

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Application Details

Site(s) at which the unapproved good will be prescribed (list all addresses)

Qualifications, expertise and experience required to manage the medical condition(s) for which the good will be used

Upload ANZCCP AP Exam certificate

Drag & Drop Files, Choose Files to Upload

(NOTE: We will not start reviewing your application until the applicant has completed the AP Exam with a passing mark of 80% and sent their certificate to [email protected])

How will risks associated with the use of the unapproved good by managed? This should address: A. Process of obtaining informed consent from patients B. Monitoring and reporting that will be undertaken (include details of interval and duration of monitoring) C. Process of investigating and reporting adverse events

You must address all 3 criteria:
A. Process of obtaining informed consent from patients
B. Monitoring and reporting that will be undertaken include details of interval and duration of monitoring
C. Process of investigating and reporting adverse events

Scheduled Products & Indications To Apply For

Approval is being sought for the following scheduled medicinal cannabis products & indications.

Clinical justification for the use of the unapproved goods

Additional Indications (Optional)

How many additional indications do you wish to apply for?

Selected Value: 0

Patient population

Adults
Paediatric – under 18y/o (paediatricians only)

New AP appplication

4 x TGA SAS B Approval Letters (At least 2 Schedule 4 (Category 1) and 2 Schedule 8 (Category 2-5), two of which should be for Dried Herb (if you wish to include it in your application)
Patient Informed Consent Form – Using the ANZCCP Consent form template
ANZCCP AP Course Test Certificate
Evidence of additional professional education – if applicable

For Renewal of Application.

Please ensure you upload with your application:

Previous HREC AP approval letter
Previous HREC AP amendment letter(s) *
TGA 6 monthly reports for previous HREC approval period
Patient Informed Consent Form – Using the ANZCCP Consent form template
Evidence of additional professional education (if available)

Additional Required Documents

Patient Consent Form

Patient Informed Consent Form

Drag & Drop Files, Choose Files to Upload

TGA Documents

TGA Approval # 1

Drag & Drop Files, Choose Files to Upload

TGA Approval # 2

Drag & Drop Files, Choose Files to Upload

TGA Approval # 3

Drag & Drop Files, Choose Files to Upload

TGA Approval # 4

Drag & Drop Files, Choose Files to Upload

TGA Approval # 5

Drag & Drop Files, Choose Files to Upload

TGA Approval # 6

Drag & Drop Files, Choose Files to Upload

TGA 6 Monthly Report # 1

Drag & Drop Files, Choose Files to Upload

TGA 6 Monthly Report # 2

Drag & Drop Files, Choose Files to Upload

TGA 6 Monthly Report # 3

Drag & Drop Files, Choose Files to Upload

TGA 6 Monthly Report # 4

Drag & Drop Files, Choose Files to Upload

HREC Documents

HREC Approval Document # 1

Drag & Drop Files, Choose Files to Upload

HREC Approval Document # 2

Drag & Drop Files, Choose Files to Upload

HREC Amendment Letter # 1

Drag & Drop Files, Choose Files to Upload

HREC Amendment Letter # 2

Drag & Drop Files, Choose Files to Upload

Other Evidence

Evidence of Other Professional Development

Drag & Drop Files, Choose Files to Upload

Disclosure

I certify that I

Do not have a commercial interest in any of the products for which I am applying
Do have a commercial interest in one or more of the products for which I am applying