Medicines; PHARMACEUTICAL PRODUCTS (HS 30)

Proposed update to the standard - Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017

The Therapeutic Goods Administration (TGA) is proposing to update the regulation of medicinal cannabis labelling and packaging. The proposal reform seeks to:

·         provide clarity to the stated content of active ingredients and establish new labelling requirements

·         introduce a requirement for child-resistant closures in the interest of public safety

The update to the standard is not intended to impose significant regulatory burden or create barriers to supply cannabis goods in Australia.

A public consultation on the draft changes to the standard is currently open and closed on 29th January 2021. The consultation documents are available via the link provided below.

The TGA will review all the submissions received and will make changes to the draft standard and associated guidance in consideration of this feedback. It is planned that there will be a transition period to allow sufficient time for suppliers of medicinal cannabis products to comply with any updates to the standard.