Announcements

The Pharmacies regulatory divisions of National medicines regulatory authority has introduced an online application portal for all pharmacy licenses related applications. With effect from today (21/04/2026), all applications for retail pharmacy and wholesale establishment will be accepted only through this online portal.

The link to access the portal is available on the NMRA official website under the pharmacy regulatory division. Details instructions for application submission also are provided on the portal.

All applicants are kindly requested to submit their applications accordingly.

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Expiry within two years from date of application.

Renewal applications will be considered if the existing license has expired within two years from the date of submission of the application to NMRA with penalty and appropriate fee for the period.

Expiry more than two years from date of application.

Renewal applications submitted after two years from the date of expiry of the existing license will be considered as a new application. Existing rules and regulations for a new pharmacy will be applicable.

The above provisions will be applicable only up to 31 December 2026.

Click Here : Renewal of Expired Pharmacy Licenses

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The National Medicines Regulatory Authority (NMRA) requires all local manufacturers to submit comprehensive production and supply chain data for the calendar years2023, 2024, and 2025.Please refer the attachment.

Submission Method: Please email your data to mc@nmra.gov.lk.

Format: Submissions must be in a digital format(Excel preferred) to ensure accuracy.

For any technical clarifications or inquiries, please contact the Market Surveillance and Control Division through mc@nmra.gov.lk

• Click here : Notice
• Click here : Excel Format

PUBLIC NOTICE

‍Closure of the National Medicines Regulatory Authority (NMRA) on 15th April 2026

The general public is hereby informed that the National Medicines Regulatory Authority (NMRA) will be closed on 15th April 2026 in observance of the Sinhala and Hindu New Year.

Accordingly, all operations of the Authority will be suspended on this day.

The public is kindly requested to make necessary arrangements in advance to avoid any inconvenience.

We kindly seek your understanding and cooperation in this matter.

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Chief Executive Officer

National Medicines Regulatory Authority

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The National Medicines Regulatory Authority (NMRA) invites Expressions of Interest (EOI) from qualified legal professionals to provide Legal Consultation Services for a period of three (03) months, commencing from 01st May 2026.

• Click here : Notice
• Click Here : Application

To: All Market Authorization Holders

Please be informed that the Pricing Division of the National Medicines Regulatory Authority (NMRA) will implement a revised schedule for public days related to pricing regulation matters, effective from 1st April 2026.

The designated public days will be as follows:

• Second Monday of each month (1.00 pm to 4.00 pm)
• Fourth Monday of each month (1.00 pm to 4.00 pm)

Please note that the online appointment system will no longer be in effect. All interested parties may visit on the above-mentioned days and are required to mark their presence at the registry with the security officers at NMRA.

All stakeholders are kindly requested to plan their visits accordingly.

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Chief Executive Officer

National Medicines Regulatory Authority (NMRA)

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Calling for public hearing for Medicine Regulation.

The National Medicines Regulatory Authority (NMRA) will conduct a public hearing to obtain views, comments and recommendations from stockholders and the general public regarding the proposed Medicine Regulation.This hearing aims to promote transparency, inclusiveness, and stockholder participation in the policy-making process related to the regulation, safety,quality, and accessibility of medicines in Sri Lanka.

Healthcare professionals, industry represtatives, civil society organizations, academics and members of the public are invited to share their views and suggestions to improve the proposed policy. The feedback received during this consultation will be taken into consideration in the finalization of the Regulation.

As per the request of the above parties the authority decided to extend the time period. Therefore, the final date for the submission of feedback is 2026.04.21.

Written comments or feedback should be submitted to the following email. lo@nmra.gov.lk

Registered Post: Chief Executive Officer, National Medicines Regulatory Authority, State Engineering Corporation Building (2nd Floor), No. 130,W.A.D.Ramanayaka Mawatha, Colombo 02.

All references should be clearly stated as 'Public Comments regarding Medicine Regulation' the subject or in the top left corner of the envelope.

Please contact below for further information:

Telephone: 0112698896/7  email: lo@nmra.gov.lk

Click Here : Public hearing on the proposed Medicine Regulation

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Average US Dollar Rate April-2026 for Price Approvals of MRP’s by NMRA

Notice to all Authorized Local Agents,

This is to kindly inform all authorized local agents that the USD rate considered for the month of April -2026  for processing price details of medicines/ medical devices is 313.36.

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

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All applicants submitting Re-Registration (RR) dossiers to the National Medicines Regulatory Authority are hereby informed that a Declaration of the Product must be submitted along with the application, with effect from 1st April 2026.

Applicants are required to confirm that:

• There are no changes to the product as per the existing registration approved by NMRA;

           or

• Where applicable, provide details of any changes made in accordance with the relevant variation guidelines.

A standard declaration format is attached to this notice. Applicants are required to duly complete and sign the declaration by the authorized signatory of the Marketing Authorization Holder (MAH) and submit it together with the RR dossier.

Click Here : standard declaration format

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The Medical Devices Regulatory Division of the NMRA has recommenced issuing Product Clarification Letters (PCLs) effective from 31st of March 2026.

Detailed instructions and the relevant application forms will be published on the NMRA website in due course.

Stakeholders are kindly advised to refer to the NMRA website for further updates.

Click Here : Public Notice

To all owners of Retail and Wholesale Pharmacies and Responsible Pharmacists in Sri Lanka,

Please be informed that the Pharmacies Regulatory Division of the NMRA will implement a new schedule for public days for document submissions, effective from April 1^st, 2026.

The public days are as follows.

• Monday - License Renewals (With or without changes/amendments)
• Friday - New Pharmacy Applications

To ensure a smooth process, please adhere to the following:

Step 1: All visitors must schedule an appointment before visiting pharmacies' regulatory division through the official NMRA portal.
Click Here : official NMRA portal link

Step2: Appointment Confirmation Email will be sent by NMRA with a specific appointment date and instructions.

Step3: You must present to NMRA with a printed or digital copy of the Appointment Confirmation Email sent by the NMRA.

Individuals without a valid appointment for the specific service day will not be accepted.

We appreciate your cooperation in helping us enhance the efficiency of our regulatory functions.

Chief Executive Officer

National Medicines Regulatory Authority (NMRA)

Click Here: Notice

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In view of the prevailing crisis situation in the Middle East region, and with the objective of minimizing fuel consumption, the Government has declared every Wednesday as a public holiday with effect from 18.03.2026.

However, the public is hereby informed that the functions of the National Medicines Regulatory Authority will continue to be carried out on Wednesdays by calling in a limited number of officers.

Accordingly, although the Government has declared Wednesdays as public holidays, the functions of the National Medicines Regulatory Authority will continue as usual without closing the office.

Click Here : Public Notice

Chief Executive Officer

National Medicines Regulatory Authority

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Calling for public hearing for Medicine Regulation.

The National Medicines Regulatory Authority (NMRA) will conduct a public hearing to obtain views, comments and recommendations from stockholders and the general public regarding the proposed Medicine Regulation.This hearing aims to promote transparency, inclusiveness, and stockholder participation in the policy-making process related to the regulation, safety,quality, and accessibility of medicines in Sri Lanka.

Healthcare professionals, industry represtatives, civil society organizations, academics and members of the public are invited to share their views and suggestions to improve the proposed policy. The feedback received during this consultation will be taken into consideration in the finalization of the Regulation.

The final date for the submission of feedback and for the public hearing is 05.04.2026

Written comments or feedback should be submitted to the following email. lo@nmra.gov.lk

Registered Post: Chief Executive Officer, National Medicines Regulatory Authority, State Engineering Corporation Building (2nd Floor), No. 130,W.A.D.Ramanayaka Mawatha, Colombo 02.

All references should be clearly stated as 'Public Comments regarding Medicine Regulation' the subject or in the top left corner of the envelope.

Please contact below for further information:

Telephone: 0112698896/7  email: lo@nmra.gov.lk

Click Here : Public hearing on the proposed Medicine Regulation

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All Local Manufacturers of Medicines, Medical Devices, Cosmetics and Borderline Products are kindly requested to submit their manufacturing data using the provided Excel template, effective from 1^st of April 2026

Click Here : Notice to Local Manufacturers - Manufacturing data Submission

Click Here : Excel Sheet

All market authorization holders for imported Medicines, Medical Devices, Cosmetics and Borderline Products are kindly requested to submit their import/consignment data using the provided Excel template, effective from 1^st of April 2026

Click here : Import Consigment Data Submission - Amendment 1

Click here : Excel sheet

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The grace period for renewal of expired retail pharmacy licenses was over the 28th of February, 2026. The attached notice is applied to all applications that are submitted after the 1st of March, 2026.

Click Here : Notice to all retail pharmacy owners and responsible pharmacists.

In view of the prevailing crisis situation in the Middle East region and with the objective of minimizing fuel consumption, the Government has declared every Wednesday as a public holiday with effect from 18.03.2026, until further notice.

Accordingly, this is to kindly inform you that every Wednesday will be treated as a holiday for the operations of the Authority until further notice.

However, the Public Day of the Pharmacies Regulatory Division scheduled for Wednesday, 18.03.2026, will be held as previously arranged. Thereafter, necessary arrangements will be made to conduct the Public Day on other weekdays, and the relevant parties will be informed in due course.

We kindly seek your understanding and cooperation in this matter.

Click Here : Public Notice

Chief Executive Officer

National Medicines Regulatory Authority

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Submission of manual applications for foreign manufacturing site registrations (Previous online approvals)

Please be advised that, for all foreign manufacturing site registrations previously approved via the online system, a manual dossier should be submitted.

Following supporting document submission is mandatory with the manual dossier.

• Copy of the e-NMRA manufacturing site approval certificate issued by the National Medicines Regulatory Authority
• Previous payment receipt
• Copy of the previously issued approval letter for the manufacturing site (if available)

Deadline for the submission-05/09/2026

CEO/NMRA

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The public is hereby informed that the Online Appointment System used to reserve dates and times for public days at the National Medicines Regulatory Authority (NMRA) will be
temporarily unavailable starting from 01 April 2026 due to essential maintenance work.

However, appointments for public days with the divisions listed below can still be reserved by completing the relevant Google Form through the link provided each respective division.

• Pharmacy Regulatory Division
• Medicine Regulatory Division
• Medical Device Regulatory Division
• Borderline Product Regulatory Division
• Cosmetic Regulatory Division
• Manufacturing Regulatory Division
• Pricing Regulatory Division

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For more information, please here : Web Notice

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All Marketing Authorization Holders of Medicines are kindly requested to submit following details of variation in separate Excel sheets as follows.

Excel Sheet 01 –Already Evaluated Variation Applications with renewal and re-registration applications

Please provide the application numbers and relevant details of variation applications submitted and that have already been evaluated and finalized,together with any renewal or re-registration applications.

Kindly send us an Excel sheet with the subject “Already evaluated variations with renewal and re-registration applications” including following details.

Include the following details:

1.     Application Number

2.     Submitted Date

3.     Product Name

4.     Manufacturer

5.     Local Agent

6.     Type of Variation (Major / Minor / Notification)

7.     Small Description of Variation

8.     Evaluated date

9.     Decision of the variation

Click Here : Sample Excel Sheet 01

Excel Sheet 02 –Pending Variation Applications with New, Renewal or Re-Registration Applications

Please provide details of variation applications where both the variation and new, renewal, or re-registration applications have been submitted but are still awaiting evaluation.

Kindly email Excel sheets with the subject of “Pending Variations Applications with New, Renewal or Re-Registration Applications”

Include the following details:

1.     Application Number

2.     Submitted Date

3.     Manufacturer

4.     Local Agent

5.     Type of Variation (Major / Minor / Notification)

6.     Small Description of Variation

Click Here : Sample Excel Sheet 02

Please ensure that the completed Excel Sheets (01 and 02, as applicable) are submitted on or before 13th March 2026 to aa19@nmra.gov.lk copying to pa8@nmra.gov.lk.Send your email with the heading of “Details of Variation Applications”

Your cooperation and timely response are greatly appreciated.

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To inform all marketing authorization holders of medicines to print or place a non-peelable Sticker on each commercial pack indicating the wording "NMRA Registered Product" and MRP as per discussion on MRM held on 7/1/2026 (as amendment the previous notice published 5/3/2026)

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Click Here : Notice on Labelling Requirement

Click Here: General instructions for submission of applications for orthopaedic implants and instrument set

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All Marketing Authorization Holders of Medical Devices

All Medical Device Marketing Authorization Holders (MAHs)are hereby informed that the National Medicines Regulatory Authority (NMRA) has decided to collect data relating to pending files of the following applications submitted up to 31st December 2024.

• New Applications
• Renewal Applications
• Re-registration Applications
• Variation Applications
• FMSA Applications

 All relevant MAHs are kindly requested to review your records and provide the required details for all pending applications submitted within the above-mentioned period.

Please ensure that the requested information is submitted on or before 31st March 2026.

The details must be entered through the Google form using the link provided below

Click Here: Collecting Data relating to pending files Google form

Average US Dollar Rate March -2026 for Price Approvals of MRP’s by NMRA

Notice to all Authorized Local Agents, This is to kindly inform all authorized local agents that the USD rate considered for the month of March -2026  for processing price details of medicines/ medical devices is 312.95.

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

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The National Medicines Regulatory Authority hereby informs all medicine importers and local manufacturers in Sri Lanka that registration applications are accepted for the extended release formulations of Methylphenidate, Lisdexamfetamine and other related stimulant medicines used in the management of Attention Deficit Hyperactivity Disorder (ADHD).

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Click Here: Prohibition on Registration and Use of Glutathione and Vitamin C Intravenous Preparations for Skin Lightening in Sri Lanka

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Click Here: Notice for all Importers of Cosmetic - Instructions for ASYCUDA document

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All Marketing Authorization Holders of Cosmetics are hereby informed that acceptance of cosmetic dossiers will be conducted only on Wednesday, 18th February 2026, from 9.00 a.m. to 2.00 p.m.,due to unavoidable circumstances

Please make the necessary arrangements to submit your dossiers within the above specified date and time.

Click Here : Policy Decisions Taken by the Medicines Evaluation Committee in Year 2025

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Attached is a list of retail pharmacies with valid license

Click Here :Retail Pharmacy Licenses Valid from 06th of February 2026

As per the fee gazette (No. 2452/39), published on the 4th of September 2025, the processing fee for applications of retail pharmacies and wholesale establishments should be paid by the mentioned applicants in the attachment to issue your licenses. All applicants can attend NMRA on any public day (Monday, Wednesday, or Friday) without an appointment only for the purpose of this payment.
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Click Here: The details of retail pharmacies and wholesale establishments with outstanding processing fees.

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Average US Dollar Rate February-2026 for Price Approvals of MRP’s by NMRA

Notice to all Authorized Local Agents,This is to kindly inform all authorized local agents that the USD rate considered for the month of February-2026  for processing price details of medicines/ medical devices is 311.25
Please ensure that all price submissions for MRP approvals are prepared accordingly.

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To all importers,

Please find the Google Form (via the link/QR code provided) for the submission of price details relevant to import license applications that expire on or after 1^st of   February 2026.

Please note that applicants who have already submitted price details are also required to resubmit the information through this Google Form.

A printed copy of the completed Google Form must be submitted together with the Application for License to Import a Registered Medicine [Regulation 48(3), Schedule VIII] and the Submission of Price Details for Dossiers(New/RR/Renewal/Variation) & Import Licenses Form (F-PD-001/ Effective Date: 04.09.2025 / Version 1.0 / Revision No. 0), along with the relevant supporting documents.

Thank you.

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All Market Authorization Holders of medicines are hereby informed that if any new medicine application was submitted to the NMRA on or before 30 September 2024 and the initial evaluation has not yet been received, you are kindly requested to inform the  NMRA accordingly.
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Please send the required information to the following email address:
pa15@nmra.gov.lk
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When submitting the information, please:

• Use the email subject as:
  “Pending evaluations : Medicine applications submitted before 30 September 2024”
• Provide all relevant details of the application using the attached Excel template.

Please note that the completed Excel template and related information needs to be submitted on or before 4.00 p.m. on Wednesday, 28 January 2026.
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Click Here:  Excel template

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Thank you.
National Medicines Regulatory Authority
Sri Lanka

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This web notice is published to avoid inconvenience during customs importation, in accordance with the web notice issued on 51th March 2025. Relevant classification reports will be issued as early as possible.

[This publication has been initiated from 91th (06/01/2026) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 06/01/2026

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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 90th (31/12/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 31/12/2025

Notice regarding the distance criteria exemption for new pharmacies of owner pharmacists.

Click Here : Distance Criteria Exemption for Owner Pharmacists

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The National Medicines Regulatory Authority (NMRA) requests the support of the public to ensure that all registered medicines are sold strictly at or below the officially approved Maximum Retail Prices (MRP).

If you observe any pharmacy, private hospital, or other outlet selling medicines at prices higher than those listed in the NMRA Maximum Retail Price List, you are kindly requested to submit a complaint using the QR code provided below or by emailing the details to complaints@nmra.gov.k
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When submitting a complaint, please include the following information where possible:

• Name and address of the pharmacy/outlet
• Date of purchase or observation
• Name of the medicine, strength, and pack size
• Price charged (attach a photo of the bill/receipt if available)
• Photo of the product pack (optional)
• Your contact details (optional, for clarification)

Your cooperation helps us safeguard patient rights and maintain fair pricing across the country.

CEO,
NMRA

Notice to all Authorized Local Agents,

This is to kindly inform all authorized local agents that the USD rate considered for the month of January-2026  for processing price details of medicines/ medical devices is 308.74
Please ensure that all price submissions for MRP approvals are prepared accordingly.

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This is to inform all Marketing Authorization Holders (MAHs) and stakeholders that the status of pricing review of the following applications can now be checked online:

·       Medicine Dossiers

·       Medicine Import Licence Applications

The updated status is available through the following Google Sheet: Status of the Pricing Applications

https://docs.google.com/spreadsheets/d/1LcjNqvQO9N9b3o85VGeutHz8RfQS9eznZRGuqWhanz0/edit?gid=0#gid=0

Applicants are kindly requested to refer to this sheet to obtain the current status of their pricing review.

This initiative is introduced to improve transparency, access to information, and timely communication with stakeholders.

CEO, NMRA

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Description: 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 89th (29/12/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 29/12/2025

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All importers are requested to fill in the following Google Form and submit the required details of their currently functioning manufacturers.
Data Collection Period:19/12/2025 to 05/01/2026

Timely submission of accurate information is requested.‍

https://forms.gle/FioW5ZpwtQgZi7r3A

CEO/NMRA

It is hereby notified that new applications for pharmacies established within Private Hospitals and Channelling Centres will be accepted from all districts, provided that the
respective Private Hospital or Channelling Centre is duly registered with the Private Health Services Regulatory Council (PHSRC).

Click Here : Notice Regarding Acceptance of New Pharmacy Applications from Private Hospitals and Channelling Centres

The National Medicines Regulatory Authority (NMRA) hereby informs all licensed retail pharmacy owners that, considering the prevailing situation in the country and other acceptable reasons, the renewal of expired retail pharmacy licences will be accepted up to 28 February 2026.

Click Here : Notice Regarding Renewal of Expired Retail Pharmacy Licences

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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 between the period of 2000 and 2010 will be required to submit applications for renewal. NMRA may 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 foreign manufacturing premises, with the required documents.
• A six-months grace period with effect from 1st of January 2026 will be given for the submission of renewal applications.
• The format of the application and the list of required documents is attached with this notice.
• 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.
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Note that, If the renewal of manufacturing site is not completed, the product registration will not be r enewed and new product applications (Sample import license and product registration) will not be accepted.

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CEO/NMRA

Click Here : Application for Renewal of an Overseas Manufacturer of Medicines

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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 88th (22/12/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 22/12/2025

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All importers are requested to fill in the following Google form and submit the required details of their currently functioning foreign manufacturers.
Data Collection Period: 19/12/2025 to 26/12/2025
Timely submission of accurate information is requested.
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Click Here : https://forms.gle/DzAbLEDhGZdsfVe86
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CEO/NMRA

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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.

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[This publication has been initiated from 87th (16/12/2025) Subcommittee of BPEC]

‍Click Here : Rejected Borderline Product Classification Applications

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New applications are not accepted and renewal of existing applications will not be continued for the 0.2% w/v strength of Olopatadine Hydrochloride Ophthalmic Solution under "Need" clause

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Effective December 15, 2025, all applicants for new transport licenses and for the renewal of existing transport licenses are required to use the new application
format and submit all necessary documentation strictly according to the newly published checklists.

• ‍Application for license to transport therapeutic goods for distribution
• ‍Transport New Check list
• ‍Transport Renewal Check list

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According to the recommendations of the National Language Commission, all information and instructions displayed on dispensing envelopes and containers for medicines must be provided in Sinhala, Tamil, and English, in compliance with the National Language Policy.

Click Here:

• Notice
• Label

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This web notice is published to avoid inconvenience during custom 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 initiated from 86th Subcommittee of BPEC)

Click Here : Rejected Borderline Product Classification Applications

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• The safe and effective amount of “Collagen” - 2.5 to 15 grams of hydrolyzed collagen peptides.
• The final decision (on collagen containing products) will be the committee decision.

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Current updates in regulatory requirements of Borderline Products” to be published in the NMRA website on following matters;

Click here : Current updates in regulatory requirements of Borderline Products

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The National Medicines Regulatory Authority (NMRA) is pleased to announce that the Public Appointment System will be implemented starting from 8th December, to streamline and enhance public engagement on scheduled public days.

Members of the public are required to make an appointment prior to visiting the NMRA for matters related to the relevant divisions listed in the attachment.  Furthermore, from 8th December 2025 on wards, it will not be possible to visit or meet at the NMRA for public days without a prior appointment

Click Here : For more information

Effective December 2, 2025, all resignations from the position of Responsible Pharmacist must be submitted using the new official resignation form. Any submission using an alternative form or following a different procedure will not be considered a valid resignation.

• Notice
• New official resignation form

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Notice to all authorized local agents,

‍Average US dollar rate December 2025 for price approvals of MRPs calculations by NMRA.

This is kindly inform all authorized local agents that the USFD rate considered for the month of December 2025 for processing price details of medicines/ medical devices is 306.85 LKR.

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

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

[This publication has been initiated from 85^th (26/11/2025) Subcommittee of BPEC]

Click Here: Rejected Borderline Product Classification Applications as at 01/12/2025

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රටේ පවතින තත්වය හමුවේ ජාතික ඖෂධ නියාමන අධිකාරියේ 2025/11/28 ප.ව 2 ට විවෘත කිරීමට තිබූ සියලු ටෙන්ටර්, 2025/ 12/01 ප.ව 2 දක්වා දීර්ඝ කරන බව දන්වා සිටිමු .

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In accordance with the National Medicines Regulatory Authority Act, No. 05of 2015, the National Medicines Regulatory Authority (NMRA) hereby informs the public of the maximum retail prices (MRP) of the medicines that have been approved by the Authority.

If any individual or institution sells these medicines at a price higher than the approved MRP, please report such instances to the National Medicines Regulatory Authority via email at complaints@nmra.gov.lk

Click Here: Maximum Retail Prices of Medicines

This publicly accessible database provides official information on medicines recall and revocation notifications that are taken to remove unsafe / ineffective/ substandard medicines from the market. This database is continuously updated and please find the current updated version of the database as of 2025.11.14

Click Here : Medicines Recall and Revocation Database - Upto 14.11.2025‍

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All Market Authorization Holders (MAH) are here by informed that the Prioritization Request Form (Form No: F-MR-030) shall be used for requesting prioritization of new medicine applications and sample import license.

Effective 15 November 2025, a hard copy of the completed form must be submitted by the respective local agents together with all relevant supporting documents.

In addition to the hard copy submission, the corresponding Google Form must also be duly completed and submitted.

Your cooperation in ensuring compliance with this updated submission procedure is highly appreciated.

Link to Form: Prioritization Request Form [F-MR-030]
Link to Google Form: Prioritization Request Form

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The National Medicines Regulatory Authority (NMRA) has granted a grace period until December 31, 2025, for all licensed retail pharmacies to renew their expired licenses.

This concession is crucial because, effective January 1, 2026, the NMRA will strictly enforce Clause 101 (2) of its regulations. This clause stipulates that a license will be

automatically cancelled if the renewal application is not submitted within three months of the current license's expiry date. Pharmacy owners are therefore advised to submit

renewals promptly to avoid cancellation.

Click Here for more : Notice to all retail and wholesale pharmacy owners

The National Medicines Regulatory Authority (NMRA) announces that the temporary suspension of accepting new retail pharmacy applications, which was in effect from 01 April 2025 to 01 October 2025, has been extended from 01 October 2025 until further notice.

‍Click Here : Notice

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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 83rd (27/10/2025) and 84th (31/10/2025) Subcommittees of BPEC.]

Click Here : Rejected Borderline Product Classification Applications

Notice to All Authorized Local Agents,

This is to kindly inform all authorized local agents that the USD rate considered for the month of November 2025 for processing price details of medicines / medical devices is 306.11.
Please ensure that all price submission for MRP approvals are prepared accordingly.

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Click Here : Reliance Pathway for Registration of New Medical Device Applications

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, 30th October 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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Registration and Licensing of Medicines (Fees) Regulations 2025 - Gazette Notification No. 2452/39 - English / Sinhala / Tamil

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Additional Guideline for Active Ingredients-Borderline Products Regulatory Division

Click Here : Guideline

Certificate of Analysis - New Format Update
The previous Certificate of Quality has been replaced with a revised new report format, which includes four copies printed in four different colours.

Click Here: Certificate of Analysis - New Format

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This publicly accessible database provides official information on medicines recall and revocation notifications that are taken to remove unsafe / ineffective/ substandard medicines from the market. This database is continuously updated. Find the current updated version of the database as of 2025.10.14

Click Here : Medicines Recall and Revocation Database - Upto 14.10.2025

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All Marketing Authorization Holders (MAHs) of medicines are hereby informed that the following categories of applications, which remain pending at the Pricing Division due to non-response from applicants within three months from the initial communication from the NMRA, will be considered for rejection from both the Pricing Review Process and the Registration Process at the NMRA:

·       Applications where applicants have not submitted there quested price details.

·       Applications where applicants have not responded to the MRP determinations officially communicated by the NMRA.

A notification letter will be issued to inform the withdrawal and closure of these applications and applicants can submit any concerns or clarifications regarding this decision within one month of this letter. Failure to respond within this period will result in the permanent rejection of your application by the NMRA.  

Please note that, after rejection,if the applicants wish to proceed further, these product registration applications must be resubmitted as a new application to the NMRA.

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This publicly accessible database provides official information on medicines recall and revocation notifications-taken to remove unsafe / ineffective / substandard medicines from the market. This initiative has taken as per the provisions of NMRA Act, No. 5 of 2015 and is implemented as recommended by the WHO Global Bencharking tool to achieve and maintain international standards for public health protection and supply chain intergity.

‍Click Here : Medicines Recall and Revocation Database. (since 2020)

NMRA decisions based on the MEC recommendation for the new molecular entities submitted for stage 1. (Need assessment), the corrected list is attached.

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Click Here for corrected list

Notice to All Authorized Local Manufacturers and Importers,

This is to formally inform all authorized local Manufacturers and Importers of the following regulatory requirements regarding submissions for New, Renewal, and Re-registration applications with decisions of "Awaiting Additional Documents" or "Rejected."

• For applications under "Awaiting Additional Documents," the required documents may be submitted within one (1) year from the date of the CEO's approval of the latest evaluation, along with the applicable data evaluation fee.
• After one (1) year from the above decisions, the application will be considered a new application, and a new dossier with a sample license must be submitted.
• No appeals will be accepted for such cases beyond the one-year period.

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As per the Fees Gazette (No. 2452/39) published on 4th of September 2025, the Application Fee for a Retail and Wholesale License is valid for a three-year period from 4 th of September 2025.

Notice

Notice to All Authorized Local Agents,

This is to kindly inform all authorized local agents that the USD rate considered for the month of October 2025 for processing price details of medicines / medical devices is 305.40

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

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NMRA Decisions based on the MEC recomendation for the new molecular entities submitted for stage 1. (Need assessment)

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Click Here : Decisions for New Molecular Entities

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Effective from 1st of October 2025, all regulatory matters pertaining to pharmacies (receiving applications to start/renew/make changes to a wholesale/retail pharmacy, interviews for responsible pharmacists, etc.) will require a prior appointment to visit the Pharmacy Regulation Division on public days (Mondays, Wednesdays, and Fridays). You can now book a date and time through the link available on the official NMRA website.

Click Here for More (Notice)

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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 82th Subcommittee of BPЕС.)

Rejected Borderline Product Classification Applications

New Format of Excel Sheet for Submitting Price Details

This is to kindly inform all authorized local agents that the format of the Excel sheet to be used for submitting price details of import licenses has been revised.

The updated format of the Excel sheet is published together with this notice. Please note that all other instructions pertaining to the submission process will remain unchanged.

Click here - New Format of Excel Sheet

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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 Wednesday, 24th September 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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We wish to inform about the regulatory approach concerning the use of N-acetylcysteine (NAC) as an ingredient in borderline products.

Based on safety concerns and lack of conclusive evidence supporting the benefits of NAC, it has been determined that: N-acetylcysteine (NAC) should not be permitted for use in borderline products.

This decision reflects a precautionary approach to safeguard public health and ensure regulatory compliance.

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The NMRA has identified a shortage of Lignocaine Throat Spray in the country. In order to ensure continued availability of this essential medicine for patients, NMRA will be accepting and evaluating product registration applications for Lignocaine Throat Spray with immediate effect.

Applicants are kindly requested to:

·       Submit complete dossiers in accordance with the applicable regulatory guidelines.

·       Ensure that product quality, safety, and efficacy data are provided as per NMRA requirements.

All submissions will be subject to the standard regulatory review process with priority attention due to the shortage situation.

For further information or clarification, applicants may contact the Medicines Regulatory Division, NMRA.

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All marketing authorization holders of medicine are here by informed that NMRA has decided to prioritize sample import license applications of reliance products having less than five registered products. Please inform them with evidence for reliance.

For further clarification on any of the above points, please contact Medicine Regulatory Division, NMRA

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It is hereby informed to all stakeholders, including manufacturers, importers,distributors, healthcare providers, and end-users, about updates related to medical devices within our jurisdiction.

Any instrument, apparatus, appliance, software, material or any other article, whether used single or in combination, including the software necessary for its proper application intended by the manufacturer used in or on human beings for the purpose of Laser procedures, Micro needling, Thread lifting, Cavitation, Electro muscle stimulation, High intensity ultrasound tightening and Fraxel radio frequency technology for skin tightening should be registered under the medical devices.

For further information or clarification on any of the above points, please contact Medical Device Regulatory Division, NMRA.

ChiefExecutive Officer-NMRA

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Notice

Designated Officer - Dr. K.M.G.K Bandara (CEO (Acting)) - 0112 695173, ceo@nmra.gov.lk

Information Officer - Mrs. O.P. Assalaarachchi (Legal Officer - NMRA) - 0112 698896, lo@nmra.gov.lk

All Marketing Authorization Holders of medicines are hereby informed that the updated NMRA Pricing Format (F-PD-001, Effective Date: 04.09.2025, Version 1.0,Revision No. 0) should be used when submitting/emailing  price details to the NMRA for medicine dossiers (including New, Re-Registration (RR), Renewal, and Variation) and import licenses.

This requirement will be effective from 09th September 2025.

NMRA Pricing Format- F-PD-001

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All marketing authorization holders of medicine are hereby informed that as informed earlier, the price determination process for import licences will commence for all import licences that expire and are renewed after 1st November 2025.

To ensure timely processing and avoid delays,all applicants are advised to submit their import licence applications at least twelve (12) weeks in advance to the National Medicines Regulatory Authority(NMRA).

Applicants are required to:

Submission of Import Licence Applications

1. Import licence applications must be submitted to the NMRA accepting counter with all required documents in hard copy.
2. A signed hard copy of the price details format must also be submitted together with the import licence application.

Email Submission of Price Details

Applicants need to complete the attached Excel format and the format for Submission of price details for Dossiers (New/ RR/ Renewal/Variation) & Import Licenses (F-PD-001 Effective date 04.09.2025/V1.0/RevNo 0), and email to: pricing@nmra.gov.lk at the time of submitting the import licence application.

           Subject of the email:IL[Dossier number] [generic name of the product]

2.  Format of the Excel Sheet

3. Submission of Price Details for Dossiers (New/ RR/ Renewal/ Variation) & Import Licenses
(Document Reference: F-PD-001 | Effective Date: 04.09.2025 | Version: 1.0 | Rev. No: 0)

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The National Medicines Regulatory Authority (NMRA) of Sri Lanka has implemented anew security feature to enhance the integrity and authenticity of all certificates and licenses issued by NMRA.

Implementation Timeline

• From 01 August 2025: Hologram stickers are applied to all Registration Certificates, Import Licenses, Sample Import Licenses and Manufacturing Licenses covering:
  • Medicines
  • Medical Devices
  • Borderline Products
  • Cosmetics
• From 01 September 2025: Hologram stickers are extended to:

• Retail Pharmacy Licenses
• Wholesale Licenses
• Transport Licenses

All documents issued on or after the respective dates will include the official NMRA hologram sticker.

Benefits of the Hologram Sticker

• Provides robust protection against forgery and unauthorized duplication
• Facilitates quick and reliable visual verification of authenticity
• Reinforces stakeholder trust in NMRA’s regulatory processes

Required Actions for Stakeholders

All importers, manufacturers, and license holders are advised to:

1. Confirm that all active certificates and licenses in your possession bear the NMRA hologram sticker.
2. Immediately report any document issued on or after the above dates that does not include the hologram sticker to the Licensing Division.

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Contact for Assistance

For further information or clarification, please reach out to:

‍ Licensing Division
National Medicines Regulatory Authority

And

Pharmacy Division

National Medicines Regulatory Authority

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The National Medicines Regulatory Authority (NMRA) wishes to inform the public of the updated list of licensed retail pharmacies in Sri Lanka. This list includes all pharmacies that have been granted a valid license to operate as of September 2025.

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List of Licensed Retail Pharmacies in Sri Lanka

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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 September 2025 for processing price details of medicines / medical devices is 304.57

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

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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 Wednesday,27th August 2025 at 10.00 A.M. To participate please schedule an appointment by entering your details in the book available with the Security Officer on the 2nd Floor. Please ignore the previous notice and sorry for any inconvenience if occurred.

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

(This publication has been initiated from 81st Subcommittee of BPEC)

Click Here: Rejected Borderline Product Classification Applications

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.