‍01.  Notice on Products which contained Overages

The National Medicines Regulatory Authority, Sri Lanka has decided to implement certain requirements for the products which contained overages of Active Ingredients.  

The requirements are as follows:

• If a product contains Active Ingredients with overage, the overage must be clearly specified in the Master Formula.
• An Active Ingredient overage is acceptable only if it is less than or equal 50% (≤ 50%).
• If the overage exceeds 50% (> 50%), it must be scientifically justified with appropriate evidence. The acceptance of such overage will be based on the adequacy and reliability of the submitted scientific justification.

02. Notice on Labeling Requirement for Vitamin K containing products

The National Medicines Regulatory Authority has decided to implement certain changes to the labeling requirements of Borderline Products that contained vitamin K to enhance safety measures for the general public.

The requirements are as follows:

• Restricted to oral dosage forms of products which are coming under Borderline Product category with maximum limit of 60mcg per day for general public
• A cautionary label or similar wording is required: "This product contains vitamin K. Consult a healthcare professional prior to use if you are taking a blood thinner such as warfarin."