The Therapeutic Goods Administration (TGA) has released a consultation paper over proposals to raise the quality standards of imported medicinal cannabis.
The eagerly-awaited process could pave the way for major reform and require foreign-manufactured product to be held to the same GMP standards as locally-produced medicine.
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Cannabiz revealed in October that the TGA was exploring the prospect and planning to consult the industry.
The closing date for submissions is January 29.
The consultation paper says: “The TGA is looking at potential reforms principally intended to enhance the quality and safety of medicinal cannabis products by introducing equivalent GMP requirements for imported medicinal cannabis products to those that are domestically manufactured, introducing labelling requirements for imported medicinal cannabis, clarifying certain matters in the applicable standard, and requiring child-resistant closures to be used on products.
“The objective would be to provide greater assurance for medical practitioners and patients regarding the quality and safety of medicinal cannabis products that are imported and supplied in Australia, and further clarifications regarding active ingredients, labelling and packaging matters. in the interest of quality and public safety.”
The potential reforms “would include removing extemporaneously compounding exemptions for medicinal cannabis products”.
In the 23-page consultation paper, three options have been tabled over the issue of imported product and GMP.