reporting_requirement

MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.

MAHs must update their application submission procedures to utilize the SUGAM portal for all relevant post-approval changes from June 24, 2026.

MAHs must implement safety monitoring protocols and ensure compliance with reporting obligations associated with the newly classified prescription drugs.

Review the guidance to ensure compliance with post-marketing safety reporting timelines and annual report submissions; update SOPs for ICSR processing and periodic report generation.

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.