Announcements

For the information of all marketing authorization holders;

The Pricing Division will hold a Public Day for local agents to discuss matters related to pending applications on Monday, 27th August 2025 at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.

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This is a reminder regarding the earlier notice issued on 5th of March 2025, concerning the labeling requirement for registered borderline products.

As stated in the earlier notice, it will be mandatory for all registered borderline products to carry a sticker or label on the commercial pack, effective from 31st of August 2025.We kindly urge all relevant stakeholders to ensure full compliance with this requirement by the stated deadline.

Model label:

All local manufacturers are hereby requested to submit data related to second brand/generic applications for pharmaceutical products that are already registered with the National Medicines Regulatory Authority.

This information is being collected to support regulatory evaluation and database updates.

Kindly fill in the Google Form using the link below and attached the mandatory documents listed.

Click here to access the Google Form :

https://forms.gle/4t9PJwBErcN2ZgPY9

Mandatory Documents (to be uploaded for each product and each strength):

1.   Copy of the previous Registration Certificate

2.  Copy of the last Evaluation Report

3.  Duly filled Declaration Format declaring the sameness of the product (separate declaration required for each product an each strength)

Instructions:

• Submit separate entries for product/strength.
• Ensure that all attached documents are clear, complete and legible.

Your timely cooperation in this matter is highly appreciated.

This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 5th March 2025 . Relevant classification reports will be issued as early as possible.

(This publication has been initiated from 80th Subcommittee of BPEC)

Click Here: Rejected Borderline Classification Applications

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All Market Authorization Holders of medicines are hereby informed that, with effect from 01^stAugust 2025 applications for the renewal and re-registration will not be considered for registration unless the following documentation is submitted at the time of application submission, in accordance with the provisions of Section 65(d) of the National Medicines Regulatory Authority Act, No.5 of 2015.

1.    Imported Medicines:

Application must be included;

•   Evidence of Importation during the past two (02) years,

•   Proof of participation in tenders, or

•   A written clarification for the absence of importation or non-participation in tenders during the specific period.

2.    Locally Manufactured Medicines:

Application must be included;

·     Evidence of production within the past two (02) years,

·     Proof of participation in tenders,or

·     A written explanation if the product has not been manufactured or has not participated in tenders during the specific period.

Important:

Applications submitted without the above mandatory information will not be accepted for evaluation. This requirement is enforced under the authority of Section 65(d) of the NMRA Act, which empowers the Authority to ensure the continuous availability of registered medicinal products in the market.

Additionally, for applications already submitted without the required documentation, evaluators are instructed to request the necessary information via email prior to granting registration.

Your strict compliance with this directive is expected.

This is to inform all Marketing Authorization Holders and Importers of Medicines that the National Medicines Regulatory Authority (NMRA) will restart the procedure of including the Maximum Retail Price (MRP) on import licenses and the submission of pricing information for import license renewals. This procedure is in line with the provisions of the NMRA Act and relevant regulations.

Accordingly, the approved MRP will be included in import licenses at the time of renewal for all import licenses expiring on or after 1st of November 2025. Therefore, all import license renewal applications for licenses expiring on or after 1st of November 2025 must be submitted ten (10)weeks prior to the license expiry date.

Applicants are required to commence document submission immediately, from today on wards, to ensure timely processing of renewal applications for licenses expiring on or after 1st of November 2025.

In addition, the NMRA Pricing Division will send an email request for price details as part of this process. Marketing Authorization Holders and importers are requested to respond and submit the price details in the standard pricing format within two weeks to ensure timely processing.

Failure to comply with the specified timeline may result in delays in license renewal and potential disruption to product availability.

We urge all import license holders to strictly adhere to the above requirements and ensure the timely submission of all necessary documentation.

CEO
National Medicines Regulatory Authority(NMRA)

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Notice to All Marketing Authorization Holders

Please be informed that due to a technical error in the medicine registration database, the website currently displays data updated only up to 2nd July 2025. The database will be updated promptly once the issue is resolved.

We apologize for any inconvenience caused.

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All market authorization holders of medicine are hereby inform that any sample import license applications submitted in 2024 that have not yet required a response should be filled in the following google form before the August 20th, 2025.

‍Google Form : Medicine Sample Import License Applications (2024)

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The National Medicines Regulatory Authority (NMRA) wishes to inform all pharmacy owners and relevant stakeholders that online inspections of pharmacies will be conducted only through the official phone number:

070 585 0498

Please be advised that no other number will be used for this purpose. If you receive inspection-related calls from any other number, kindly report it immediately to NMRA with evidences

Click Here : Notice to all retail and wholesale pharmacy owners

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Notice to All Authorized Local Agents,
This is to kindly inform all authorized local agents that the USD rate considered for the month of August 2025 for processing price details of medicines / medical devices is 303.86
Please ensure that all price submission for MRP approvals are prepared accordingly.‍

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This is to inform all stakeholders of the following:
A list of Renewal/RR and list of new applications which the price details have not yet been submitted is attached below for your information. Price request emails have already been sent to the respective local agents. the required price information has not been received.

Click here to view the list:

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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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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If you suspect an adverse event to medicines / borderline products, please complete this 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 adverse reaction. Identity of the patient and/or the reporter is kept strictly confidential.

Suspected Adverse Reaction to Medicines / Borderline Products - Case Reporting form

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This form is intended to collect details of companies involved in the importation and / or local manufacturing of medicine / medical devices, cosmetics and borderline products.

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Form Link : https://forms.gle/3Sbsf7LMfeZQw2xZ9

All marketing authorization holders of medicines are hereby informed that the NMRA has decided not to register new products or renew existing products of Bisoprolol Hemifumarate Tablets.

All marketing authorization holders of medicine are hereby informed that NMRA decide not to register new products or not to renew existing products of Chloramphenicol Eye Ointment.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Cloxacillin oral dosage forms.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Deflazacort Tablets 30mg.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Ethambutol Tablets 800mg.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Ketorolac Tablets.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Orciprenaline Tablet.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Paracetamol Effervescent Tablets.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Ramipril Modified Release dosage forms as Ramipril has a long half-life which anyway allows for once daily dosing and there is no particular advantage of having a modified release dosage form.

All marketing authorization holders of medicine are hereby informed that NMRA decided not to register new products or not to renew existing products of Timolol Maleate Long Acting Ophthalmic Solution.

For the information of all marketing authorization holders,

The Pricing Division will hold a Public Day for local agents to discuss matters related to pending applications on Monday, 14^th July 2025 at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2^nd Floor.

Notice to All Authorized Local Agents,

This is to kindly inform all authorized local agents that the USD rate considered for the month of July 2025 for processing price details of medicines / medical devices is 302.67

Please ensure that all price submission for MRP approvals are prepared accordingly.‍

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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."

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

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Notice to All Authorized Local Agents

This is to kindly inform all authorized local agents that the USD rate considered for the month of June 2025 for processing price details of medicines / medical devices is 301.36

Please ensure that all price submission for MRP approvals are prepared accordingly.

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Please be informed that board approval has been granted to implement a Single File Submission with up to ten colour variants with in the same cosmetic product series, for new and re-registration application. The charge for one file will be the charge of ten different files.

Notice to All Clinical Trial Document Submission Personnel

The National Medicines Regulatory Authority (NMRA) wishes to inform to allrelevant personnel regarding the following submission requirements for clinicaltrial applications:

• ‍Submission Deadline: All newclinical trial applications must be submitted at least 14 days priorto the Clinical Trial Evaluation Committee (CTEC) meeting, which is held on thesecond Friday of each month.
•  Document Submission Time: Allclinical trial documents must be submitted before 3:00 PM on workingdays at the NMRA’s accepting counter.

Timely submission is essential to ensure that applications are reviewedwithout delay.

Submissions received after the deadline will be considered for inclusion inthe following month's CTEC meeting agenda.

Thank you for your cooperation.

CEO/NMRA

For the information of all marketing authorization holders,

The Pricing Division will hold a Public Day for local agents to discuss matters related to pending applications on Friday, 30th May 2025 at 10.00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd floor.

Please be informed that the checklist for submitting documents for new cosmetic registration applications has been revised. Please refer to Annexure 01 for the updated version. The updated checklist will be effective from 01 June 2025.

The forms related to Borderline Products Regulatory Division have been updated and you are requested to use the revised and new formats where necessary for application submission.

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To all Local Medical Device Manufacturers

Notice Regarding GMP Inspection Waiver for Listed and Class 1 Medical Device Manufacturing Sites

The National Medicines Regulatory Authority (NMRA) has decided to waive the GMP inspection requirement for manufacturing sites involved in the production of Listed and Class 1 medical devices (refer to the attached list & Annexed 1). 

Manufacturers may now apply for product registration without prior GMP approval, provided the following criteria are met:

Submission Requirements:

Manufacturers must submit the following documents to the Manufacturing Regulatory Division (MFRD) on Thursday: 

Site Master File with, 

• Business Registration Information 
• Site Layout 
• Brief Description of Manufacturing Activities 
• List of Products intended to be manufactured at the facility

GMP Waiver Process: 

Upon review of the submitted documents, the MFRD will issue a GMP Waiver Document. This document must then be submitted along with the product registration application in place of GMP approval.

NMRA has granted two years blanket GMP approval to allow the relevant manufacturers to obtain ISO 9001 for the above category of products with effect from 10/05/2025 to 09/05/2027 

After 09/05/2027 NMRA will only accept ISO 9001 in lieu of GMP inspection for the above categories.

For any inquiries, please contact the Manufacturing Regulatory Division

CEO/NMRA

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To all Market Authorization Holders of Medicines, 

You are hereby informed that NMRA will initiate a renewal process for overseas manufacturing sites with effect from 1st August 2025. Initially, manufacturing sites approved on or before 31st December 2005 will be required to submit applications for renewal. NMRA will carry out an onsite GMP inspection if the site has not been inspected by NMRA reference authority. 

The following conditions will be applied for the renewal process: 

• The local agent would require submitting an application for renewal of the manufacturing premises foreign, with the required documents. 
• NMRA will publish the format of the application and the list of required documents, in due course. A deadline to submit renewal applications will also be announced.
• A renewal application fee as prescribed in the fees regulations will be charged. 
• A fee for GMP inspection - Foreign, as prescribed in the fees regulations will be charged, if decided to carry out an onsite inspection. 
• Manufacturing sites for which renewal applications are not submitted within the announced deadline will be discontinued. 
• The renewed approvals will be valid for a period of five years. 

You may contact Manufacturing Regulatory Division, NMRA for further clarifications. 

Note that, If the renewal of manufacturing site is not completed, the product registration will not be renewed and new product applications (Sample import license and product registration) will not be accepted. 

CEO/NMRA

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For the information of all marketing authorization holders,

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The Pricing Division will hold a public day for local agents to discuss matters related to pending applications on Tuesday, 29th April 2025, at 10.00 AM. To participate, please schedule an appointment by entering your details in the book available with the security officer on the 2nd floor.

Notice to All Authorized Local Agents

This is to kindly inform all authorized local agents that the USD rate considered for the month of May 2025 for processing price details of medicines / medical devices is 300.77

Please ensure that all price submission for MRP approvals are prepared accordingly.

The final date of accepting Borderline Product Classification applications will be on 29th April 2025 as per the web notice published on NMRA website dated on 5th March 2025

Warning letter issued to local pharmaceutical manufacturer, Newgen Lanka Healthcare (Pvt) Ltd. due to repeated deviations from GMP practices.

Notice to all Authorized Local Agents

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of April 2025, the United States Dollar (USD) rate is considered as 299.58 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submission for MRP approvals are prepared accordingly.

The National Medicines Regulatory Authority (NMRA) announces a final grace period for the registration of all currently operating unlicensed pharmacies.

Final Grace Period Announcement

Grace Period: From April 1, 2025, to July 1, 2025

1. The valid period of Classification Report is one year and the valid period is counted from approval date of the Classification Report ("Classified as a Borderline Product").

Only two additional data submissions are allowed for one Classification Application.

If a Classification Report is issued as a "awaiting additional data" for a new application;

• First additional data submission to be done within the three months from the date of first Classification Report issued.
• Second additional data submission to be done within three months from the date of second Classification Report issued

2. Sample Import Licence/ Formulation Approval

Sample Import Licence/ Formulation Approval requesting application to be submitted to NMRA within one year period from the date of approval of the Classification Report classified as a Borderline Product.

The valid period of Sample Import licence/ Formulation approval application is one year

3. Registration Dossier Submission.

Registration dossier to be submitted within the valid period of the Sample Import Licence/Formulation Approval.

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Notes:

If any applicant is failed to submit any of the above applications (1,2 & 3) within the valid period is subjected to reject the consignment clearance approval.

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Notice to all Authorized Local Agents,

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of March 2025, the corrected United States Dollar (USD) rate considered for pricing calculation is 298.01 for reviewing price details of medicines. All the prices recommended by using prevously published exchange rate, shall be recalculated and corrected.

We are apologizing for the inconvenience occurred on this.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate. Please ensure that all price submissions for MRP approvals are prepared accordingly.

The National Medicines Regulatory Authority hereby announces the temporary withhold of accepting new retail pharmacy applications, with effective from 1st April 2025.

For the information of all marketing authorization holders;

The Pricing Division will hold a Public Day for local agents to discuss matters related to pending Applications on Thursday, 20th March 2025, at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.

Current issues related to the products coming under the category of borderline products;

A. Classification application submission and customs release for the products which may come under the borderline product category

As per the NMRA Act, since 2016, the Borderline Product Regulatory Division has being continuously involved in the product registration. Majority of importers have brought such products to the country without obtaining the product registration from NMRA and recently Sri Lanka Customs introduced an online platform called as ASYCUDA SYSTEM to release the products linking with other relevant government regulatory bodies.

Once introducing this ASYCUDA SYSTEM, many importers were unable to release their products through the system due to unavailability of product registration. As a result of, it creates a gap between a regulatory perspectives and continuation of market field causing an accumulation of goods at Sri Lanka Customs.

For this matter following solutions were proposed:

1. Products release through the ASYCUDA SYSTEM only;

Products that fall under the borderline category will be released only through the ASYCUDA system, and registration is a mandatory requirement. However, a deadline was proposed for the classification applications submission: April 30, 2025 to release the product through the ASYCUDA system without the product registration (Classification application submission is mandatory ) and the consignments could be released until 31, October 2025

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.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) 3. Offence against the misleading/incorrect information found in a product:

5.Offence against the misleading/incorrect products;

Any misleading/incorrect information (related to a product) in an advertisement, on the label, PIL, packaging materials or in any other manner will be punishable offence under the requirements of the NMRA Act, No. 5 of 2015.

B. Publication of new guideline related in borderline products

A guideline will be published in due course for the following list of products, including TUL(Tolerable Upper Levels), Minimum, and Maximum levels. Once the guideline is published, adherence to the guideline will be required for the continuation of product registration

List of ingredients :Fluoride, Probiotics, Chondroitin, D-Mannose, Alpha-lipoic acid (ALA),Choline, Glucosamine, Co-enzyme Q10, Inositol, Omega 3 (EPA +DHA), Omega 6 (gamma Linoleic acid), Taurine, N-Acetyl cysteine, Methyl Sulphonyl Methane (MSM), N-Acetyl L-tyrosine, Vitamin K2, Phosphatidycholine (Lecithin), Carnitine and Boron

C. Export only products;

Export only products will not be considered for product registration under the category of borderline products.

Exceptions: product registration in reference NRAs

D. Model label for registered borderline products

A sticker or label on the commercial pack will be mandatory for all registered borderline products, with effective from August 31, 2025.

Model label:

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Notice to all Authorized Local Agents

Subject : Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of March 2025, the United States Dollar (USD) rate is considered as 297.27 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

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Please be informed that all pharmacies-related regulatory activities done by the NMRA, including applications accepting, responsible pharmacists' interviews and issuing payment vouchers will be carried out only on Mondays, Wednesdays and Fridays from 8.30 am to 2.00 pm with effect from 2025/03/01.

Notice to all Authorized Local Agents

Subject : Consideration of Average Dollar Rate for Price Approvals of MRP’s by NMRA

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of February 2025, the United States Dollar (USD) rate is considered as 296.74 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

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The colour code for Prednisolone Tablets 1 mg is Yellow.

No new products are registered and no existing products are renewed for Lomefloxacin Eye Drops as there is no advantage due to this is a second generation antibiotic.

All marketing authorization holders having valid registrations for Lomefloxacin Eye Drops are informed to submit the registration certificate along with the import license / manufacturing license for the product on or before 28th February 2025.

Download - From: F-MC-002

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Download - From: F-MC-001

For the information of all marketing authorization holders;

The pricing Division will hold a public Day for local agents to discuss matters tp pending Applications on Friday 17^th January 2025,at 9.30 A.M. To participate, please schedule an appointment by entering your details in the available with the Security Officer on the 2^nd Floor.

Applying Sample Import License of Medicines 

All marketing authorization holders of medicine are here by informed that NMRA  has decided to accept sample import license applications only for the medicines  which have less than 5 valid registrations until further notice. 

All marketing authorization holders are required to provide a copy of the medicine  database from the NMRA website as evidence for the 5 valid registrations. 

Categories of Sample Import License Applications 

1. Sample Import Licenses – Normal 

This category applies to sample Import License applications received along with the  purpose of “examination”. 

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2. Sample Import Licenses – Other 

 Applications submitted with following purposes 

- Test/Analysis ( Based on medicine evaluation sheet / *Acknowledgment  of medicine dossier) 

- Distribution as physician samples 

- Tender samples ( Requested by government institutes) 

*Acknowledgment of medicine dossier submission for medicine which are  mandatory to tested.(Merophenam, Thyroxine and Erythromycin)  

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3. Sample Import Licenses - Agency Transfer 

- This category applies only to sample import license applications with an agency  transfer.(Only change of the market authorization holder of Sri Lanka without changing  generic name, brand name and manufacturing facility of the product) 

- The product must have been registered by the previous market authorization holder, with  valid registration or registration expired within the last two years from the submission  date of SIL application.

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Sample Import License Application Requirements: 

Mandatory Documents: 

1. Part A of Form MR001 Revision 01 

2. Sample License Application Form (Form XI) 

Should comply with the Regulation 59(1) of the gazette No. 2145/1 and following should be  included) 

∙ Actual manufacturing site address 

∙ Importer with the address 

∙ Correct generic name dosage from and strength 

∙ Brand name (if any) 

∙ Requested quantity 

∙ Pack size & Pack type 

(Purpose of applying SIL should be correctly selected and originally signed by the applicant.) 

3. Copy of Manufacturing Site Approval Letter 

4. Letter of Authorization from the Manufacturer 

5. Price Details 

6. Other Supporting Documents (if applicable): 

• Previous Registration Certificate (Mandatory for SIL Agency Transfer and existing product). 
• Agency Transfer (Mandatory for SIL Agency Transfer). 
• MEC Approval Letter for New Molecular Entities. 
• Declaration Letter for import samples from other category (Mandatory for SIL - Other). 

*Other Regulatory Compliance Documents as applicable

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Only 7's, 14's and 21's pack sizes are allowed to be registered for Ribociclib Tablets.

No new products are registered and no existing products are renewed for Aceclofenac Sustained Release Capsule 200 mg.

No new products are registered and no existing products are renewed for pharmaceutical products except topical pharmaceutical preparations containing Bronopol as an excipient.

No new products are registered and no existing products are renewed for combination skin pharmaceutical preparations containing Corticosteroid + Zinc Sulphate.

Notice to All Authorized Local Agents

This is to kindly inform all authorized local agents that, as discussed with the members of the SLCPI and the Pricing Committee, the NMRA will consider the average dollar rate of the previous three months for price approvals of Maximum Retail Prices (MRPs) of medicines from January 2025 onwards.

Accordingly for the month of January 2025, the United States Dollar (USD) rate is considered as 298.58 for reviewing price details of medicines.

This decision aims to ensure fair and consistent pricing of medicines while considering the fluctuations in the exchange rate.

Please ensure that all price submissions for MRP approvals are prepared accordingly.

For the information of all marketing authorization holders and local manufacturers,

From 1st January 2025 onward, all import data for pharmaceuticals and manufacturing data from all local manufacturers must be submitted in the specified "Pharmaceutical import / consignment data submission format", along with the soft copies, to Market Control Division of the NMRA.

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Web Notice of the changes of Foreign Manufacturing Plant Approval Process from 01/01/2025

Please be informed that National Medicines Regulatory Authority will accept applications for registration of foreign manufacturing sites with following GMP approvals until further notice.

1. PIC/s Approved (Pharmaceutical Inspection Co-operation Scheme)
2. EU GMP Approved (European Union Good Manufacturing Practices)
3. WHO Prequalified or WHO approved. (Inspection should be done by WHO team)

This decision will be implemented with the effect from 01/01/2025

This temporary measure is implemented to maintain a high standard of quality and safety of medicines imported to Sri Lanka and to apply reliance regulatory approach recommended by WHO.

Please note that any manufacturing site with unregistered products and without above GMP approvals will be considered case by case. The requests should be submitted to CEO, NMRA in this regard. All such requests will be subjected to manufacturing peer review committee for consideration.

This decision is only applicable for medicines manufacturing sites applications.

Although all skin preparations containing a combination of a potent steroid and an antifungal are not allowed to be registered in Sri Lanka , the NMRA deiced allowing to market only the remaining stock of such products in the market . New consignments will strictly not be allowed .

Note : The potency of the steroid is considered as per the Topical corticosteroid preparation potencies classification in the BNF .

For the information of all marketing authorization holders;

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Borderline files accepting date will be held on 26th November (Tuesday) 2024 due to an unavoidable reason. [Only for this week]

From December onwards borderline file accepting date will be held on Thursday as usual.

The pricing Division will hold a Public Day for local agents to discuss matters related to pending application on Friday, 22nd October 2024,at 10:00 AM. To participate, please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor.

Consignment clearance approval for the products that may come under the category of borderline will not be granted with the effect from 30th November 2024.

(Date: 08 November 2024)

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To all MAH of Medicines,

In our ongoing efforts to ensure transparency within the National Medicines Regulatory Authority (NMRA), we are implementing a new procedure for accessing the Google sheet titled "Reviewing Status of New Medicinal Products" available on the NMRA website.

To facilitate this, we kindly request each company to provide one email address that will be used to access the aforementioned Google sheet by scanning and filling the below QR code on or before 20th of November 2024. This step is crucial for maintaining a streamlined and secure review process.

Your cooperation in this matter is highly appreciated.

https://docs.google.com/forms/d/e/1FAIpQLSdJfGjk9NJ-qkW-OD-lXgh1KwHoqVXpTJp-TWj1oGM1jbV9gQ/viewform?usp=sf_link

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CEO 
NMRA

Cefuroxime injection 1000 mg is not accepted for registration under "Need" clause.

All skin preparations containing a combination of a potent steroid and an antifungal are not allowed to be registered in Sri Lanka. All the certificates of such combinations should be returned to the NMRA before 04th of November 2024 and all available products in the market should be recalled by the relevant marketing authorization holders within 30 days from 28th October 2024.

Multivitamin & Multimineral products having amount more then or equal to therapeutic level as per the BNF for at least one are considered for registration under Medicines.

Apply wording "NMRA approved" for registered borderline products

To inform all marketing authorization holders of bordering products to print or place a non-peelable sticker on each commercial pack indicating the wording ' NMRA approved' and the details of market authorization holder with effect from 1st November 2024.

• Notice on Labeling Requirement

(Date: if applicable)

All marketing authorization holders of borderline products are here by informed that NMRA has decided to change the accepting date for borderline products from Tuesday to Thursday. (Effective from 24/10/2024)

(Date: 11^th June 2024)

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This applies for local manufacturers only

For initial registration

Comparative Dissolution study data should be submitted according to the WHO guidelines for Comparative Dissolution or Biowaiver. The comparator for the dissolution study should be decided in consultation with the NMRA.

At the end of the Provisional Registration period, for conversion from provisional Registration to Full Registration.

1. BCS Class I & III excluding narrow therapeutic index and modified release a Biowaiver study report should be submitted according to the WHO Biowaiver guideline.
2. BCS Class II & IV, narrow therapeutic index and modified release drug products a bioequivalence study should be submitted for Full Registration.
3. If a Bioequivalence study is not available for products in point 2, a commitment letter with evidence will be accepted for continuation of Provisional Registration.

Rolling Provisional Registration is granted for a maximum of four year within which a Bioequivalence study data should be submitted.

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All Market Authorization Holders of Medicines,

You are hereby informed that, effective from 27 September 2024, all market authorization holders are required to submit their eCTD dossiers using the following Google Form. This submission is in addition to the hard copy dossier submission.

https://docs.google.com/forms/d/e/1FAIpQLSe6lDBDbVbT7AiDKWXJrSt_NbhmP6xAYV96bEX2Z9MRrNFerg/viewform?usp=sf_link

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Important Instructions :

Rename the eCTD dossier : Before submitting, please rename your eCTD dossier according to the dossier number received from the accepting counter.

Submission Deadline : Ensure that both the eCTD and hard copy dossiers are submitted by the specified deadlines.

Declaration letter for verifying the sameness of the submitted manual and eCTD dossier

Soft copy should be renamed only with the dossier number

Please note that eCTD dossier should be submitted within 24 hours after submission of the manual dossier

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We appreciate your corporation in this matter.

( Amended on : 2024.11.12 )

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Warfarin Tablets 2 mg accepted for registering in Sri Lanka and the colour code is Lavender

NMRA has decided to implement colour codes for Warfarin tablets in order to prevent the confusion in identifying different strengths by the patients.

0.5 mg - White

1 mg - Brown

2 mg - Lavender

3 mg - Blue

5 mg - Pink

Failing to abide this will create unnecessary problem when clearing at custom

To All Marketing Authorization Holders of Cosmetics

Regulatory strengthening of controls on falsified products

The board of the national medicine regulatory authority decided to implement certain changes to the labeling requirements of cosmetics in order to enhance protection against falsified products coming into the market.

The requirements as follows:

• Printed or non-peelable stickers should be placed on each commercial pack indicating the wordings “NMRA approved” and the details of market authorization holder. The sticker indicating the retail price of the product shall be used. A specimen is given below as an example.

The sticker is recommended to be implemented immediately for all batches released to the market with effect from 1^st September 2024. The batches already released to market are not affected by this decision.

The requirements will be made compulsory for imported and local manufacturing products after a grace period of three months from 1^st September 2024.we expect your fullest corporation to implement these controls and help prevention of falsified products getting into the market.

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To all Market Authorization Holders, Importers and Local Manufactures of Medicines, Medical Device, Borderline Products, and Cosmetics.

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Hereby inform you all that the custom clearance of all Medicines, Medical Devices, Borderline Products, Cosmetics and Raw Materials for manufacturing will be facilitated through ASYCUDA system after 19.09.2024.

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On 19.09.2024 onwards all consignees need to upload their documents to the ASYCUDA system according to the following format,

* Mandatory documents

NM4 - This becomes mandatory when requested by NMRA or product is unregistered.

NM5 - This becomes mandatory in sample importations.

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CEO / NMRA

To all Market Authorization Holders and Manufactures of Medicines, Medical Devices, Borderline products, and Cosmetics. 

Hereby inform you all that the processing and file accepting date of Manufacturing Regulatory Division will be changed from Wednesday to Thursday. This will be effective from 05. 09. 2024 onwards. 

Hereafter the official file accepting date of the Manufacturing Regulatory Division will be Thursday of every week. 

CEO/NMRA 

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To all manufacturers of cosmetics products in Sri Lanka, 

This is to inform you that you are requested to obtain the ISO 22716 /2007 certification for the cosmetics manufacturing plant from the SLSI or anybody accredited by the SLAB for the standard ISO 22716/2007 with effective from 01st of May 2024. 

NMRA has decided, not to conduct a Good Manufacturing Practice (GMP) Inspections for cosmetics manufacturing plants further and NMRA will rely on the ISO 22716 GMP certification provided by accredited body SLSI or anybody accredited by the SLAB for the standard ISO 22716/2007. 

Already approved sites will be granted two years grace period until 31st May 2026 to adhere to the process. For the site already applied, NMRA will conduct GMP inspection and those will be required to obtain ISO 22716 within two years from 1st May 2024. 

For the new applications, applicant should submit a site master file with basic information about the site and the products which are planning to manufacture in the site. 

New applications to be submitted to the Manufacturing Regulatory Division NMRA and NMRA will issue an acknowledgement. Applicant should apply for ISO 22716 GMP certification along with the acknowledgement given by NMRA. 

CEO/NMRA 

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Updated labeling requirements for medicines (NMRA approved sticker and Bar/QR code)

‍Web publication of drafted guideline for safe dispose of expired & unusable pharmaceuticals to the purpose having public comments.

Send your comments to pa24@nmra.gov.lk on or before, 30.08.2024

To all Local manufacturers of Medicines and Medical Devices,

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NMRA decided to grant an approval for the 6 months requirement of raw materials, packaging materials, testing materials and excipients for the local manufacturers to avoid delays of the approval process.

Local manufacturers should submit following documents for the approval.

1. Request Letter
2. GMP Certificate / Preliminary approval ( for new sites)
3. Performa Invoice / List of the Products

Separate request needs to be submitted for an individual supplier. For subsequent approvals, the local manufacturer should submit details of "Imports in the preceding 6 months".

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CEO / NMRA

To all Marketing Authorization Holders of Medical Devices,

All Medical Device Marketing Authorizations Holders are hereby informed that NMRA has decided to undertake an action plan to publish the information of all registered manufacturers through an online platform. Therefore, medical device marketing authorization holders whose details are not available in the below list of manufacturing site registration details must enter their information into the link provided.

You must attach a scanned copy of Manufacturing site approval letter or any evidence of manufacturing site registration as an authentication of your registration.

Please provide the required details on or before 31st December 2024.

List of Manufacturing site registration details

Click on the link below to submit the details into the Google form.

https://docs.google.com/forms/d/e/1FAIpQLSewxXglorCe90U1NvjUh8kMtXSUrpz5-IahmNsFAsYwBAolvQ/viewform?usp=sf_link

Chief Executive Officer

NMRA

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(Date: 03 June 2024)

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Renewal of Licenses for Retail pharmacies and wholesale Establishments due to change of the pharmacist

please note that the following will be implemented with effect from 01^st March 2024.

1. Pharmacist interview will be  conducted on the same day that the application for the change of pharmacist is submitted to the NMRA.
2. The owner of the pharmacy is responsible to arrange a video conference to demonstrate the arrangement and operations of the pharmacy as required by the interview officer during the interview ( please find the internal arrangement checklist below )
3. The pharmacist should be present in person to the NMRA for the interview on the same day that the application for the change of pharmacist is submitted to the NMRA.

Upon successful completion of the interview, the applicant is required to make the necessary payment on the day of interview to obtain the renewal license.

Checklist for internal arrangement

For Retail Pharmacies

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For Wholesale Establishment.

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( Date: 07 February 2024 )

NOTICE TO ALL RETAIL PHARMACISE AND WHOLESALE ESTTABLISHMENTS

Group A

It is mandatory to submit an inspection report issued by the area food and drug inspector / authorized officer along with

1. Duly filled renewal application with the updated supportive documents (please refer web link - https://www.nmra.gov.lk/index.php?option=com_content&view=article&id=662 )
2. Duly filled acknowledgement from
3. check list marked with available documents

on Monday, Wednesday or Friday to pharmacy Regulatory Division, NMRA

Group B

It is mandatory to submit following documents without inspection report directly on Monday, Wednesday and Friday to Pharmacy Regulatory Division NMRA

1. Duly filled renewal application with the updated supportive documents (please refer web link - https://www.nmra.gov.lk/index.php?option=com_content&view=article&id=662 )
2. Duly filled acknowledgement from
3. check list marked with available documents

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( Date: 07 February 2024 )

To all Market Authorization Holders of Medicines,

NMRA is publishing herewith a link to obtrain multisource generic product dossier details having reference country registration pending at NMRA

Please provide required details on or before 30th June 2024.

Please note that the lists of reference countries were published on the NMRA website.

Click on the link below to submit the details into the Google form.

https://docs.google.com/forms/d/e/1FAIpQLSffLbLw18DJPtPzD_m3_Q4a2NKdadwYhN5rAfh1g_bVlgZqvQ/viewform?usp=sf_link

CEO / NMRA

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( Date: 11 June 2024)

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