The Therapeutic Goods Administration has laid out its case for medicinal cannabis reform in a consultation paper, as groups like medicinal cannabis telehealth giant Montu claim to welcome regulation. Announced last week and opened on Monday, the TGA consultation is exploring three key issues; the appropriateness of the unapproved goods pathway for medicinal cannabis access, safety and quality concerns and the impact of direct-to-consumer telehealth models.
There are two pathways by which patients in Australia can access an unapproved product legally: the Approved Provider (AP) pathway and the Special Access Scheme (SAS).
Initially, the TGA said, it had anticipated that allowing access via the AP and SAS scheme would support products to be registered on the Australian Register of Therapeutic Goods (ARTG).
It had also expected that a relatively small number of prescribers would be prescribing medicinal cannabis, that only patients with very specific clinical needs would be receiving those prescriptions and that there would only be a small number of products supplied as a result of those prescriptions.
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