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ANZCCP
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AP Form (Paid)
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Are you a doctor or a sponsor submitting this form on behalf of a doctor?
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Doctor
Sponsor
Applicant Details
Email
*
Name
*
First
Last
AHPRA No
*
Address
*
Address Line 1
Address Line 2
City
State / Province / Region
Postal Code
Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia (Plurinational State of)
Bonaire, Saint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo (Democratic Republic of the)
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini (Kingdom of)
Ethiopia
Falkland Islands (Malvinas)
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran (Islamic Republic of)
Iraq
Ireland (Republic of)
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea (Democratic People's Republic of)
Korea (Republic of)
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia (Federated States of)
Moldova (Republic of)
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Macedonia (Republic of)
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine (State of)
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Martin (French part)
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten (Dutch part)
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syrian Arab Republic
Taiwan, Republic of China
Tajikistan
Tanzania (United Republic of)
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
Uganda
Ukraine
United Arab Emirates
United Kingdom of Great Britain and Northern Ireland
United States Minor Outlying Islands
United States of America
Uruguay
Uzbekistan
Vanuatu
Vatican City State
Venezuela (Bolivarian Republic of)
Vietnam
Virgin Islands (British)
Virgin Islands (U.S.)
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands
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
*
Passing the ANZCCP AP Test with a pass mark of at least 80%
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)
*
Capsule - Oral
Dried herb - Vaporisation
Inhalation - Inhalation
Pressurised Inhalation - Inhalation
Lozenge - Oral
Oral Liquid - Oral
Pastille - Oral
Patch, dermal - Topical
Spray, solution - Oral
Tablet - Oral
Tablet, chewable - Oral
Topical - Topical
Wafer - Sublingual
Meter Dosed Inhalation- Inhalation
Schedule 8 products (Dosage form - Route of administration)
*
Capsule - Oral
Dried herb - Vaporisation
Inhalation - Inhalation
Pressurised Inhalation - Inhalation
Lozenge - Oral
Oral Liquid - Oral
Pastille - Oral
Patch, dermal - Topical
Spray, solution - Oral
Tablet - Oral
Tablet, chewable - Oral
Topical - Topical
Wafer - Sublingual
Meter Dosed Inhalation- Inhalation
Indications List
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Anorexia
Anxiety disorders
Arthritis (including osteoarthritis and rheumatoid arthritis)
Attention Deficit Disorder with Hyperactivity (ADHD)
Autism Spectrum Disorder (ASD)
Behavioural issues
Cachexia
Cancer pain and symptom management
Chemotherapy Induced Nausea & Vomiting (CINV)
Chronic non cancer pain
Dementia
Depression
Endometriosis
Inflammatory Bowel Disease (IBD)
Irritable Bowel Syndrome (IBS)
Migraine
Mood Disorder
Movement Disorder
Multiple Sclerosis
Neurodegenerative Disease
Neuropathic pain
Palliative care
Post Traumatic Stress Disorder (PTSD)
Sleep Disorder (Including Insomnia)
Spasticity
Seizure management
Tourettes syndrome
Other
Other Indication
Clinical justification for the use of the unapproved goods
*
There is sufficient evidence to justify the use of the above unapproved goods for patients who suffer from symptoms secondary to the above indications, when those symptoms are serious enough to affect their function and/or quality of life, when approved treatments were unsuccessful, caused intolerable side effects or were otherwise inappropriate and where no contraindications for the use of the unapproved goods exist. In these cases, the potential benefit of using the unapproved good outweighs any potential harm.
Additional Indications (Optional)
Click to add additional indications
1
2
3
4
5
6
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?
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:
4 TGA SAS B Approval Letters (A
t least 2 schedule 4 and 2 schedule 8, one of each should be for Dried Herb (if you wish to include it in your application) OR previous HREC approval for the required schedules and dosage forms
)
Evidence of additional professional education (if available)
Patient Informed Consent Form +
Evidence of other HREC AP approval *
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_surname, Applicant_first name - title_of_document]
* 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)
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
*
Clear Signature
Submit
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