reporting_requirement

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

Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.

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.