Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Surgifrance must implement corrective actions, including the establishment of processes for handling complaints in 3 months, and a complaints register within 8 months.

Pharmacovigilance systems must be updated to monitor and report on the newly added medications.

Focus on therapeutic equivalence evaluations for generics

Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.

Affected users must identify, segregate, and quarantine the kits, add warning labels, and ensure the removal of the recalled components prior to use.

Companies must ensure compliance with the Irish language requirements and complete mandatory OMS registration before regulatory submissions to prevent delays.

Healthcare providers must utilize updated labels and ensure phosphate levels are monitored in at-risk patients and those receiving repeat therapy within three months.

Developers of NAMs are encouraged to participate in early dialogues with EMA and are now able to submit NAM-derived data for independent evaluation under a voluntary data submission pilot.