The PIC/S Guide to GMP applies unless not applicable or replaced by alternatives based on quality risk management principles and the principles under Annex 13 (for manufacture of investigational medicinal products) and demonstrated to be effective.
These technical guidance documents have been originally developed for complementary medicines, they contain relevant guidance however, on risk management in manufacture, subject to the principles of Annex 20 of the PIC/S Guide to GMP.
Once medicinal cannabis products are registered in the ARTG, access pathways will no longer apply and therefore these technical guidance documents may no longer be relevant.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.