revised

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

Review and update data submission practices to align with the new technical specifications; ensure compliance with FDA-supported data standards.

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

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.