Authorised Prescriber Pathway Services

Comprehensive support for medical practitioners navigating the TGA Authorised Prescriber scheme for medicinal cannabis and other therapeutic products.

Navigating the TGA Authorised Prescriber Pathway

The Therapeutic Goods Administration (TGA) administers the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and various Orders and Determinations that regulate the quality, safety, and efficacy of therapeutic goods in Australia. The TGA also regulates access to "unapproved" therapeutic goods that have not yet received general approval.

Similar to our Regulatory Framework Analysis service, our Authorised Prescriber Pathway service provides expert guidance through complex regulatory requirements. We help medical practitioners efficiently navigate the process of becoming an Authorised Prescriber, allowing them to prescribe unapproved therapeutic products like medicinal cannabis to patients under their care.

Our comprehensive support services guide practitioners through each stage of the process, from eligibility assessment and training to application support and ongoing compliance management.

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A roadmap or arrow to signify personalized eligibility reports and recommendations.
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Eligibility Assessment

We assist medical practitioners in determining their eligibility to become Authorised Prescribers based on their qualifications, training, and expertise in specific therapeutic areas.

Evaluation of qualifications and clinical experience
Assessment of therapeutic knowledge in specific areas
Identification of additional training requirements
Personalized eligibility reports with recommendations

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Training and Education

We source training on the endocannabinoid system and cannabis pharmacology to meet TGA requirements for Authorised Prescribers.

Comprehensive training on the endocannabinoid system
Education on medicinal cannabis products and formulations
Dosing considerations and therapeutic applications
Adverse effects, drug interactions, and contraindications
Regular updates on regulatory changes and research findings

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HREC Endorsement Support

We provide comprehensive assistance in preparing and submitting applications for Human Research Ethics Committee (HREC) endorsement, a critical step in the Authorised Prescriber process.

Preparation of HREC application documentation
Development of clinical protocols and treatment plans
Supporting evidence compilation
Application submission and follow-up assistance
Typical processing time: 3 weeks

TGA Application Support

We guide medical practitioners through the Standard Pathway application process for Authorised Prescriber status using the TGA's SAS and AP Online System.

Step-by-step guidance through the online application system
Preparation of supporting documentation
Application review before submission
Follow-up communication with TGA
Typical approval time: 10 business days

Compliance and Reporting

We assist practitioners in meeting their ongoing compliance and reporting obligations to maintain Authorised Prescriber status with both the TGA and HREC.

Preparation and submission of six-monthly reports
Tracking of patient numbers by medicine category
Monitoring of federal and state legislation changes
Compliance guidance for prescription and supply requirements
Renewal application support

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Ongoing Advisory Services

We provide continuous guidance on regulatory developments, clinical best practices, and therapeutic advances to support practitioners in their prescribing activities.

Updates on regulatory changes affecting prescribing
Clinical guidance on product selection and dosing
Information on new therapeutic applications
Advisory support for complex patient cases
Access to our network of specialists and resources

Our Services

The Authorised Prescriber Pathway Process

Initial Assessment

We begin with a thorough assessment of the practitioner's eligibility, identifying any additional training or expertise needed to meet TGA requirements.

HREC Application

We prepare and submit the application for HREC endorsement, including all required documentation, treatment protocols, and supporting evidence.

Ongoing Compliance Support

After approval (typically within 10 business days), we provide ongoing support with compliance requirements, including six-monthly reports to TGA and HREC.

Training Completion

Practitioners complete our HREC-endorsed training on the endocannabinoid system, pharmacology of cannabinoids, and therapeutic applications of medicinal cannabis.

TGA Application Submission

Once HREC endorsement is obtained (typically within 3 weeks), we guide practitioners through the TGA online application process for Authorised Prescriber status.

Benefits for Medical Practitioners

Continuing Professional Development

We source CPD approved education provider by the RACGP (Activity ID: 651070), for comprehensive training provides practitioners with specialized knowledge about emerging therapeutic options, enhancing clinical expertise and expanding professional capabilities.

Expanded Patient Options

Becoming an Authorised Prescriber allows practitioners to offer patients access to promising treatments that aren't yet fully approved, enhancing treatment options for conditions with limited alternatives.

Streamlined Patient Access

Unlike per-patient SAS applications, Authorised Prescriber status allows immediate prescription to appropriate patients without individual TGA approvals, improving treatment timing and accessibility.

Ongoing Support

Our service doesn't end with approval; we provide continuous guidance on regulatory changes, emerging research, and best practices to support your prescribing activities and ensure ongoing compliance.