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Changes to documentation requirements for Authorised Prescriber applications

5 July 2021

The TGA will accept endorsement for Authorised Prescriber applications for unapproved products for a duration of up to 5 years, and endorsement for medicinal cannabis products may be provided by category of SUSMP Schedule.

Endorsement duration

The TGA is able to accept approval/endorsement durations of up to 5 years for all unapproved goods, where deemed appropriate by the endorsing body. Commonwealth approval durations for Authorised Prescriber applications will generally be aligned with that of the HREC approval in order to standardise access.

Medicinal cannabis products

The TGA is able to accept approvals from Human Research Ethics Committees or endorsement from specialist colleges reviewing Authorised Prescriber applications for unapproved medicinal cannabis products on the basis of the SUSMP Schedule of the product as set out below:

  • Schedule 4 medicinal cannabis products
  • Schedule 8 medicinal cannabis products

The approving or endorsing body must specify the dosage form, route of administration, indication and class of patient for endorsement.

Previously, HREC endorsement has been requested on a per product (trade name) basis to reflect TGA Authorised Prescriber approval letters. TGA approval is provided on a per product (trade name) basis to provide assurance that medicinal cannabis products supplied in Australia comply with the TGA's minimum quality standard order for medicinal cannabis products, the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.

Medical practitioners must still apply for Authorised Prescriber approval on the basis of specific products to provide this assurance.