Australia Amended its Cannabis Regulation regarding GMP Requirements

Australia´s Therapeutic Goods Administration (TGA), which regulates Medicinal Cannabis in Australia, has put out its latest Compilation regarding the production and import regulations (TGO 93).

Manufacturing Quality

Besides specific requirements for active ingredients and cannabinoids, microbiological quality, contaminants (e.g. heavy metals, pesticides, mycotoxins, including Ochratoxin A), and labelling the document contains a section 13 on manufacturing quality.

As of July 2023, all imported medicinal cannabis products released for supply in Australia will have to present evidence to be produced under GMP (Good Manufacturing Practice). This means that each step of manufacture that occurs outside Australia must be in accordance with GMP. The only exemptions that exist for non-GMP use of medicinal cannabis are for when it is used as starting material (i.e. plant material or oil extracted directly from the cannabis plant) in the manufacture of another medicinal cannabis product manufactured in accordance with GMP. All other uses of medicinal cannabis will have to be GMP compliant.

For more information please see Australia´s Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order Compilation No. 3.

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