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.
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.
The first is to retain the current arrangements where imported product does not have to demonstrate equivalent GMP standards.
A second option is for a condition requiring imported medicinal cannabis to be manufactured with equivalent GMP.
Under this proposal the TGA said “a notification given by the sponsor regarding GMP compliance could be assessed by the TGA prior to the release of the imported goods in accordance with the relevant notification, approval, authorisation or prescription”.
A third option is to incorporate GMP requirements for imported medicinal cannabis in TGO 93, “so that the standard may comprise a fully comprehensive medicinal cannabis quality standard with reference to specific procedures to be carried out in the manufacture of imported medicinal cannabis”.
On the issue of compounding, the TGA also presented a trio of possibilities.
The first is to retain the status quo, with medicinal cannabis products continuing to be extemporaneously compounded by pharmacists and medical practitioners.
Option two is to exclude medicinal cannabis products from the compounding exemption.
The effect, according to the regulator, would be that medicinal cannabis products would not be able to be extemporaneously compounded by pharmacists or medical practitioners “under any circumstances”.
The final suggestion is to exclude medicinal cannabis from GMP exemptions.
That would mean products could not be compounded without a GMP licence.
“The benefit of this approach would be to ensure that pharmacists and medical practitioners with a GMP licence could be lawfully supplied both domestically manufactured and imported medicinal cannabis starting material for use in extemporaneous compounding,” the TGA said.