National Medicines Regulatory Authority

The National Medicines Regulatory Authority (NMRA) of Sri Lanka hereby informs all stakeholders that Certificate of Registration will no longer be issued for the following product categories,

• Sanitary Napkins
• Feeding bottles (Childcare Product)
• Toothbrushes
• Toothpaste (which are not having medicinal claims)

These will be regulated under mandatory SLSI standards and Consumer Affairs Authority oversight. This decision has been approved by NMRA board, Medical Device Evaluation Committee and Cosmetic Evaluation Sub-Committee.

This will be effective from 23rd of June 2025.

For further inquiries, Please contact the Medical Device Regulatory Division at NMRA.

Notice: Interagency Collaboration and Regulatory Waivers

To all Local Medical Device Manufacturers,
As per the instructions given by Chairman/NMRA and the concern of the Board of Directors/NMRA hereby withdraw the web notice published on 08.05.2025 under the title of “GMP inspection waiver for Listed and Class I Medical Devices”.

CEO/NMRA

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Important Notice: Updated Import/Consignment Data Submission Format

The National Medicines Regulatory Authority(NMRA) has introduced a new standardized format for submitting import / manufacturing consignment data. This updated format is now applicable to the following product categories:

·       Medicines

·       Medical Devices

·       Borderline Products

·       Cosmetics

All importers and local manufacturers required to use the new format for submitting their import/ manufacturing data.

 What’s New?

·       Updated table structure

·       More detailed product information fields

·       Applicable to a wider range of regulated products

 Effective Immediately:

·       The new format must be used for submissions covering the January–March, April-June, July–September and October-December quarters.

·       Submissions using the old format will no longer be accepted.

 Access the New Format:
 Click here to download the new data submission format:

For any queries or clarifications, please contact: mcimport@nmra.gov.lk

(Previously submitted import/ manufacturing data in the old format can be accepted, but new submissions must follow the new format.)

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‍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."

NMRA has extended the grace period for the implementation of product-specific QR codes or barcodes on all commercial packing from 31st May 2025 to 31 December 2025.

• Notice on updated labeling requirement