New AP Form – ANZCCP Members

To get your application assessed by the ANZCCP HREC please register with your details below. The price to submit a new AP application is $800 and includes ANZCCP membership for 1 year plus access to the AP course. This fee must be paid on submitting registration below. Your application will not be assessed prior to completion of all requirements.

Once the Authorised Prescriber Application is formally approved, the AP is approved for a period of 2 years.

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

AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBolivia (Plurinational State of)Bonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCabo VerdeCambodiaCameroonCanadaCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCongo (Democratic Republic of the)Cook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Kingdom of)EthiopiaFalkland Islands (Malvinas)Faroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIran (Islamic Republic of)IraqIreland (Republic of)Isle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea (Democratic People's Republic of)Korea (Republic of)KosovoKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacaoMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesia (Federated States of)Moldova (Republic of)MonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth Macedonia (Republic of)Northern Mariana IslandsNorwayOmanPakistanPalauPalestine (State of)PanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussian FederationRwandaRéunionSaint BarthélemySaint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint Maarten (Dutch part)SlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwedenSwitzerlandSyrian Arab RepublicTaiwan, Republic of ChinaTajikistanTanzania (United Republic of)ThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkmenistanTurks and Caicos IslandsTuvaluTürkiyeUgandaUkraineUnited Arab EmiratesUnited Kingdom of Great Britain and Northern IrelandUnited States Minor Outlying IslandsUnited States of AmericaUruguayUzbekistanVanuatuVatican City StateVenezuela (Bolivarian Republic of)VietnamVirgin Islands (British)Virgin Islands (U.S.)Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland IslandsCountry

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

Medical Device (Name of Device -Sponsor)

• Syqe Inhaler- Syqe Medical

Indications List *

• 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 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

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?

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 (At least 2 schedule 4 and 2 schedule 8, one of which 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:

1. Please submit distinct documents as separate files, rather than merged into one file.
2. 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

Payment

New Authorised Prescriber Registration

Price: $ 800.00

New Authorised Prescriber Registration - ANZCCP MEMBER

Price: $ 700.00

Coupon

Credit Card *

Card

Name on Card

Submit