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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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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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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

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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

Please ensure that the completed Excel Sheets (01 and 02, as applicable) are submitted on or before 8th 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 approved product" and MRP as per discussion on MRM held on 7/1/2026

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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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