AP Form (Paid)

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

Doctor
Sponsor

Applicant Details

Email *

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 Test certificate

Click or drag a file to this area to upload.

(NOTE: We will not start reviewing your application until the applicant has completed the AP test 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 *

Scheduled Products & Indications To Apply For

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

Schedule 4 products (Dosage form - Route of administration) *

Schedule 8 products (Dosage form - Route of administration) *

Medical Device (Name of Device -Sponsor)

Syqe Inhaler- Syqe Medical

Indications List *

Other Indication

Clinical justification for the use of the unapproved goods *

Additional Indications (Optional)

Click to add additional indications

Patient population

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

Additional Indication 1

1) Indication Name

1) Seriousness of the medical condition(s) for which the good will be used

1) Clinical justification for using the unapproved good. This should address expected benefits of the proposed medicine versus its potential risks, including evidence1 of: * the unapproved good’s suitability for the intended indication * the unapproved good’s efficacy and expected benefits * any unknown or expected adverse effects, risks and safety issues * related toxicology

1) Is there an approved good for the same indication as what you applying to use the unapproved good for?

1) Have you already or will you attempt to use the approved good prior to supplying the unapproved good?

1) Why is the approved good inappropriate or unsuitable for use? Why is the proposed unapproved good a more appropriate option than an approved available alternative?

Additional Indication 2

2) Indication Name

2) Seriousness of the medical condition(s) for which the good will be used

2) Clinical justification for using the unapproved good. This should address expected benefits of the proposed medicine versus its potential risks, including evidence1 of: * the unapproved good’s suitability for the intended indication * the unapproved good’s efficacy and expected benefits * any unknown or expected adverse effects, risks and safety issues * related toxicology

2) Is there an approved good for the same indication as what you applying to use the unapproved good for?

2) Have you already or will you attempt to use the approved good prior to supplying the unapproved good?

2) Why is the approved good inappropriate or unsuitable for use? Why is the proposed unapproved good a more appropriate option than an approved available alternative?

Additional Indication 3

3) Indication Name

3) Seriousness of the medical condition(s) for which the good will be used

3) Clinical justification for using the unapproved good. This should address expected benefits of the proposed medicine versus its potential risks, including evidence1 of: * the unapproved good’s suitability for the intended indication * the unapproved good’s efficacy and expected benefits * any unknown or expected adverse effects, risks and safety issues * related toxicology

3) Is there an approved good for the same indication as what you applying to use the unapproved good for?

3) Have you already or will you attempt to use the approved good prior to supplying the unapproved good?

3) Why is the approved good inappropriate or unsuitable for use? Why is the proposed unapproved good a more appropriate option than an approved available alternative?

Additional Indication 4

4) Indication Name

4) Seriousness of the medical condition(s) for which the good will be used

4) Clinical justification for using the unapproved good. This should address expected benefits of the proposed medicine versus its potential risks, including evidence1 of: * the unapproved good’s suitability for the intended indication * the unapproved good’s efficacy and expected benefits * any unknown or expected adverse effects, risks and safety issues * related toxicology

4) Is there an approved good for the same indication as what you applying to use the unapproved good for?

4) Have you already or will you attempt to use the approved good prior to supplying the unapproved good?

4) Why is the approved good inappropriate or unsuitable for use? Why is the proposed unapproved good a more appropriate option than an approved available alternative?

Additional Indication 5

5) Indication Name

5) Seriousness of the medical condition(s) for which the good will be used

5) Clinical justification for using the unapproved good. This should address expected benefits of the proposed medicine versus its potential risks, including evidence1 of: * the unapproved good’s suitability for the intended indication * the unapproved good’s efficacy and expected benefits * any unknown or expected adverse effects, risks and safety issues * related toxicology

5) Is there an approved good for the same indication as what you applying to use the unapproved good for?

5) Have you already or will you attempt to use the approved good prior to supplying the unapproved good?

5) Why is the approved good inappropriate or unsuitable for use? Why is the proposed unapproved good a more appropriate option than an approved available alternative?

Additional Indication 6

6) Indication Name

6) Seriousness of the medical condition(s) for which the good will be used

6) Clinical justification for using the unapproved good. This should address expected benefits of the proposed medicine versus its potential risks, including evidence1 of: * the unapproved good’s suitability for the intended indication * the unapproved good’s efficacy and expected benefits * any unknown or expected adverse effects, risks and safety issues * related toxicology

6) Is there an approved good for the same indication as what you applying to use the unapproved good for?

6) Have you already or will you attempt to use the approved good prior to supplying the unapproved good?

6) Why is the approved good inappropriate or unsuitable for use? Why is the proposed unapproved good a more appropriate option than an approved available alternative?

Additional Required Documents

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 +
Evidence of additional professional education (if available)

* if applicable

+ template available on the RACGP website (you may use your own form, but it MUST state emphatically that driving under the influence of THC is ILLEGAL and there is NO medical defence at law)

To assist with our processing of your application:

Please submit distinct documents as separate files, rather than merged into one file.
Please name each file clearly, using the following formatting:
[Applicant_first name_Applicant_surname_Title_of_document]
e.g.
John_Smith_S4_Oral
John_Smith_S8_Herb
John_Smith_Consent_Form

Upload Documents *

Click or drag files to this area to upload. You can upload up to 10 files.

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

Details of my commercial interests are as follows: *

Signature *