Nature's Own Glucosamine Sulfate with Chondroitin and Nature's Own Magnesium Glycinate 1150mg Recall by Sanofi Consumer Healthcare

MAHs must categorize their proposed label and PIL updates, utilizing the self-certification route for those not requiring full assessment; submissions validated through this route will receive acceptance letters within 14 days.

MAHs must update labelling components to meet new criteria, including a minimum font size of 7 points and essential information requirements regarding the medicine's name, strength, route of administration, posology, warnings, and indications as per the guidance. New packaging must be incorporated into stocked products within six months of approval.

MAHs are advised to incorporate the updated FAQs into their compliance workflows and ensure that their submissions adhere to the updated guidance.

Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.