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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