effective

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.

Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.

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.