effective

Sponsors must prepare for increased costs tied to the submission and maintenance of products on the ARTG which will impact their regulatory budget planning and compliance processes.

Review and implement the TGA checklist for all psychiatrist prescribers of MDMA/psilocybine; update ICSR workflows to capture adverse events as per checklist requirements.

MAHs should review the updated DRGD to understand new processing timelines for variation submissions and assess how the reliance mechanism can be leveraged for faster safety updates. Adjust internal timelines and processes for post-marketing variation submissions accordingly.