EMA

MAHs and technical teams must review the revised API registration requirements and implement necessary system updates to comply by the established timelines.

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Ema update requires triage for Local Affiliate Compliance, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.