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Medicinal cannabis manufacture

Technical guidance on the interpretation of the PIC/S Guide to GMP

10 December 2019

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Terminology in the PIC/S Guide to GMP

Finished medicinal cannabis product

The finished medicinal cannabis product is the dosage form in which the medicinal cannabis is intended to be administered to the patient, for example as an oil, tincture, extract, capsule, tablet etc.

The manufacture of the finished medicinal cannabis product is required to be in compliance with Part I of the PIC/S Guide to GMP, as well as the relevant parts of the Annexes to the Guide.

Investigational medicines

Unapproved therapeutic goods not included on the ARTG and accessed through clinical trial schemes are referred to as 'investigational medicinal products' in the PIC/S Guide to GMP.

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