National Medicines Regulatory Authority

Sri Lanka

Welcome to the official website of the National Medicine Regulatory Authority of Sri Lanka. We are dedicated to ensuring the safety and efficacy of medicines for the people of Sri Lanka.

Providing Quality Medicine Regulation in Sri Lanka

The National Medicine Regulatory Authority of Sri Lanka is committed to ensuring the safety, efficacy, and quality of medicines in the country. We strive to protect public health by regulating the manufacturing, importation, distribution, and sale of medicines.

Functions of the NMRA

Regulatory

NMRA regulates medicines, medical devices, borderline products imported to and manufactured in Sri Lanka. We also regulate pharmacies. Clinical trials conducted in Sri Lanka are also regulated by us.

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Laboratory

National Medicines Quality Assuarance of the NMRA is responsible for the analyzing of the quality of any medicine, medical device or borderline product forwarded by the Authority. It functions as an additional approved analyst when the circumstance so requires.

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Pharmacovigilance

Pharmacovigilance Division is responsible for monitoring and dealing with adverse drug reaction, quality failure and counterfeit medicines.

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Enforcement

Inspectorate and Enforcement Division is responsible for inspecting and investigating issues pertaining to proper implementation of the provision of the NMRA Act.

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Latest Announcements

NMRA Updates

Updated Import / Consignment Data Submission Format

June 13, 2025
Regulatory Updates

To All Marketing Authorization Holders of Borderline Products

June 12, 2025
NMRA Updates

Notice on updated labeling requirement

June 6, 2025
Regulatory Updates

Notice Regarding the Medical Device Dossier submission on 10th of June 2025

June 6, 2025
NMRA Updates

Customer Satisfaction Survey and Survey for Reliance Application

June 4, 2025
View All Announcements
NMRA Updates

Updated Import / Consignment Data Submission Format

June 13, 2025

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.)

Regulatory Updates

To All Marketing Authorization Holders of Borderline Products

June 12, 2025

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 Updates

Notice on updated labeling requirement

June 6, 2025

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.

Regulatory Updates

Notice Regarding the Medical Device Dossier submission on 10th of June 2025

June 6, 2025

To All Marketing Authorization Holders of Medical Devices, are hereby informed that Medical Device Dossiers will be accepted on 11th of June 2025 instead of 10th of June 2025 due to the public holiday (Poya Day). Sorry for the inconveniences caused

NMRA Updates

Customer Satisfaction Survey and Survey for Reliance Application

June 4, 2025
Complaints QR Code
Scan the QR code below to submit your complaints.
Reporting falsified / Counterfeit Products
Scan the QR code below to report falsified or counterfeit products.