Novartis maintains a comprehensive process across the entire company to assess quality defects and safety issues and whether a market action（such as a product recall）would be required。Any such occurring incident is escalated through an established company-wide quality assurance process that enables a prompt investigation and assessment by committees consisting of subject-matter experts，quality management，medical safety experts and regulatory responsible persons。
Conclusions from these committees are provided，with relevant documentation，including a safety assessment，to the competent responsible health authorities in impacted markets.Market actions，e.g.，product recalls，will then be executed following an established process as agreed with and endorsed the resporth hed the reectoritial。