National Medicines Regulatory Authority

This is to inform all stakeholders that the NMRA will implement a new process for filing applications related to new medical devices, effective from 05^thof August 2025.

Under this updated procedure, all new applications for registration of medical devices will be accepted as consolidated dossiers.

Applicants are advised to review the updated guideline (Guideline for consolidated dossier application submission and evaluation of medical device) and relevant checklist (Checklist for document accepting of consolidated medical device application) and ensure compliance with the new requirements when preparing submissions from the effective date onward.

Submission templates,checklists and guidance documents are available on the NMRA website.

For further information or clarifications, you may contact the MDRD/NMRA Division via the following email addresses:

·      pa6@nmra.gov.lk

·      aa16@nmra.gov.lk

·      aa20@nmra.gov.lk

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Chief Executive Officer/NMRA

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This is reference to the web notice published on the NMRA website dated on 5^thMarch 2025 regarding “Current issues related to the products coming under the category of borderline products”

With reference to NMRA Act, No 5 of 2015, no person shall manufacture or import any borderline product without registering with the Authority and obtaining a license from the Authority. If any product is registered with NMRA that will be released through the ASYCUDA system.

NMRA has granted a special approval to release borderline products through the ASYCUDA system prior to the product registrations which have been submitted for product classification on or before 30th April, 2025 in order to streamline the unregistered borderline products.

However, it has been observed that there is a trend of unnecessary products are being flooded to the country due the opening this gate before granting the registration to the products and this may affect the public safety. Therefore the NMRA has decided to release the products with subject to the conditions described as below. Also the consignments could be released until 31, October 2025 and extension is not applicable after31^st October 2025.

1. For consideration of custom clearance of a product, it is mandatory to upload the acknowledgment form/s of application submission (Classification, Sample Import license and Registration Dossier) along with the following documents.

I. Purchase order to be placed on or before 31st July 2025

II. Proforma invoice to be issued on or before 31st July 2025

III. Commercial invoice to be issued on or before 31st October 2025

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2. Normal registration approval process will be effective for the applications submitted from May 1, 2025, and product release will be conducted through the ASYCUDA system only for the registered products.

3. Anyhow during the registration process (including the classification step) if any product is rejected, the consignment clearance will be discontinued(for 1 & 2).

4. The final decision will be the technical committee decision.

1.      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.

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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.
• The final decision will be the technical committee decision.

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2.    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.

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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
• The following information should be included in the Label: “This product contains vitamin K. Consult a healthcare professional prior to use if you are taking a blood thinner such as warfarin.”
• The final decision will be the technical committee decision.

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Vacancies of NMRA

1) Director (NMQAL)

2) Director (Finance)

3) Internal Auditor

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To be completed by a Medical officer. If you suspect an allergic reaction related to a pharmacological product, please complete this PINK FORM. Do not put off reporting because some details are not known. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the anaphylactic reaction. Identity of the patient and the reporter is kept strictly confidential.

Pink form

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