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Manufacture of medicinal cannabis for supply under 'approved access' provisions

Guidance on GMP compliance

2 January 2018

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Introduction

This guidance is for sponsors and manufacturers considering manufacturing non sterile medicinal cannabis products for supply under provisions of access to medicines that have not been approved for general use, including medicinal cannabis for clinical trials.

This guidance does not apply to medicinal cannabis products that are listed or registered on the ARTG (Australian Register of Therapeutic Goods).

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