How to Apply to the SLHD HREC

GUIDELINES TO APPLY TO BECOME AN AUTHORISED PRESCRIBER OF UNAPPROVED PRODUCTS FOR MULTIPLE PATIENTS AT THE ROYAL PRINCE ALFRED HOSPITAL

The Therapeutic Goods Act indicates that the TGA can authorise individual medical practitioners to prescribe unapproved products to specific patients with a particular medical condition. The medical practitioner becomes an Authorised Prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to a specific class of recipients. An Authorised Prescriber is allowed to supply the product directly to patients in their immediate care without requiring separate approval for individual patients.

1. Refer to the detailed Authorised Prescriber Information from the TGA to assist with your application. See: Unapproved products for multiple      patients (Authorised Prescriber) | Therapeutic Goods Administration (TGA)

2. Write to the Clinical Trials Sub-committee requesting endorsement to become an authorised prescriber of an unapproved product (drug or device).  Once reviewed by the Sub-committee, the application will then be reviewed by the Human Ethics Research Committee (HREC).

The following documentation should be submitted for review:

•  Cover letter – requesting to become an authorised prescriber. It should include information on each of the criteria:

o   The recipients: Indication and clinical justification

o   The product: dosage, route/method of administration, duration of treatment, any safety data (if drug)

o   Details of the prescriber(s) (name, position, department, qualifications, specialty, training and experience etc.)

•  Completed and Signed Authorised Prescriber/SAS Application Form (one must be submitted for each clinician wanting to become an authorised prescriber) See: https://www.tga.gov.au/sites/default/files/authorised-prescriber-scheme-application-form.docx
   
• Information sheet and consent form for patients (template)

• Relevant literature reference(s) supporting its use (if available)
  
  
• Any other information you intend to give patients (brochures, flyers etc. if applicable)
  

Who to contact for more information:   Sanaa Thomas: SLHD-RPAEthics@health.nsw.gov.au