effective

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.

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.