Guideline

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.