National Medicines Regulatory Authority

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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සෞඛ්‍ය අමාත්‍යාංශ ගොඩනැගිල්ල තුළ ජාතික ඖෂධ  නියාමන අධිකාරිය ස්ථාපිත කිරීමට අදාළ මූල්‍ය කටයුතු සහ අනෙකුත් අත්‍යාවශ්‍ය සියලු කටයුතු සිදු කිරීම සම්බන්ධයෙන් අදාළ සියලු පාර්ශව සම්බන්ධ කරගනිමින්  අවබෝධතා  ගිවිසුමකට එලඹිය යුතුව ඇත.

ජාතික ඖෂධ නියාමන  අධිකාරිය වෙනුවෙන් අවබෝධතා ගිවිසුම සකස් කිරීම සම්බන්ධයෙන් උනන්දුවක් දක්වන සිවිල් නීති ක්ෂේත්‍රයේ(ගිවිසුම් නීතිය) සම්බන්ධ වසර  දහයක පළපුරැද්ද සහිත නීතිඥවරැන්ගෙන්  අයඳුම්පත් කැඳවනු ලැබේ.රාජ්‍ය අංශයට ඉහත අවබෝධතා  ගිවිසුම් සකස් කිරීමේ සේවා සපයා  තිබීම විශේෂ සුදුසුකමක් වේ.

ඔබගේ සියලු තොරතුරු  ඇතුළත් ජීව දත්ත පත්‍රිකාව සමඟ මිල ගණන් අප වෙත 2024.10.09 දින පස්වරු 02.00ට පෙර පහත ලිපිනයට ගෙනැවිත්  භාරදීමට හෝ ලියාපදිංචි තැපෑලෙන් යොමු කිරීමට  කටයුතු කරන්න.

ප්‍රධාන විධායක නිලධාරි,

ජාතිකඖෂධ නියාමන අධිකාරිය,

2 වනමහළ,

රාජ්‍ය ඉංජිනේරු සංස්ථා ගොඩනැගිල්ල,

ඩබ්.ඒ.ඩී.රාමනායක මාවත,

කොළඹ 02.

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A memorandum of understanding should be reached involving all the relevant parties regarding the financial and other necessary activities related to the establishment of the National Drug Regulatory Authority in the Ministry of Health building.

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Applications are invited from lawyers with ten years of experience in the field of civil law(contract law) who are interested in preparing MOUs on behalf of the National Drug Regulatory Authority. Having provided similar MOU preparation services to the public sector is a special qualification.

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Submit your curriculum vitae with all the details and the price to us before 02.00 pm on 09.10.2024 to the address below or send it by registered post.

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Chief Executive Officer

National Medicines Regulatory Authority

2 nd Floor

State Engineering Corporation

W.A.D.Ramanayake Mawatha

Colombo 02

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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.

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We appreciate your corporation in this matter.

NMRA welcomes your comments & feedback on the guidelines for the Waivers of Registration (WOR) of Pharmaceutical products imported to Sri Lanka

This will be started from 19^th of September 2024 to 30^th of September 2024.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to p35@nmra.gov.lk & aa14@nmra.gov.lk by 30^th of  September 2024

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