Compounding Medicinal Cannabis vs GMP Manufacture

Compounding Medicinal Cannabis vs GMP Manufacture

The TGA recently held a webinar to discuss the recent reforms to medicinal cannabis legislation and it included: GMP requirements for imported products to level the playing field for local manufacturers Updated labelling and packaging details in TGO 93. Updates to medicinal cannabis compounding permissions. I have discussed how to ensure GMP compliance for imported…

Supplier assurance requirements for imported medicinal cannabis products
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Supplier assurance requirements for imported medicinal cannabis products

During a webinar last year, the TGA announced they were intending to introduce changes to the medicinal cannabis regulations (including supplier assurance requirements for imported medicinal cannabis products). In light of that, a TGA consultation on potential reforms to medicinal cannabis manufacturing, labelling and packaging has just closed. As a result, there are three key…

An ode to the ODC single licence and permit reforms

An ode to the ODC single licence and permit reforms

After a long wait, during what felt like an even longer year, the ODC has finally dropped a hot new legislative update (and just before we entered 2022 too). The title of this update? “Single licence and permit reforms“. Catchy, isn’t it? Because regulatory reforms aren’t as exciting for everyone as they are for me,…

TGA Updates for Medicinal Cannabis

TGA Updates for Medicinal Cannabis

The TGA recently held webinars about reforms that impact the medicinal cannabis industry, including: Changes to prescribing medicinal cannabis through the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways The removal of TGO 93 Standard for Medicinal Cannabis declaration requirements Their intent to increase random and targeted quality testing of medicinal cannabis products in…

Supplying Medicinal Cannabis in Australia

Supplying Medicinal Cannabis in Australia

The TGA recently held a webinar called ‘Meeting Your Obligations – Supplying medicinal cannabis in Australia,’ and while it was useful as an overview of the therapeutic good development lifecycle, it did not delve too much into the main supply pathways that are actively being used for unapproved medicinal cannabis products. Considering the new Schedule…