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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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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) successfully conducted a two-day training program on “Ensuring Regulatory Compliance in Clinical Trials: GCP and Inspections for Regulators”on 9th and 10th September 2025 at SLF. The program was designed to strengthen the capacity of regulators, inspectors, and clinical research professionals in ensuring compliance with international standards for ethical and high-quality clinical trials. Throughout the training, participants gained valuable insights into the latest updates on ICH-GCP E6(R3) guidelines, the conduct of GCP inspections, and both theoretical knowledge and essential soft skills such as communication and critical thinking. Sessions also focused on regulatory expectations, inspection readiness, and practical approaches to enhancing clinical trial oversight. In addition, case studies and interactive discussions with experienced experts provided participants with practical, real-world perspectives.

The training brought together a diverse group of professionals, including Prof. Asita de Silva, Madeline Ducatte (USA), Dr.Chamini Kanatiwela, and ACRP-certified auditors P. Ellawala and S. Ajanthan,fostering collaboration and knowledge sharing to strengthen the conduct of clinical trials in Sri Lanka. Renowned clinical trial experts Prof. Channa Ranasinghe, Dr. Ananda Wijewickrama, Dr. Rajiva de Silva, Dr. Nadeeka Chandrarathne, and Dr. Nuradh Joseph further enriched the sessions by sharing their extensive expertise and practical experience, fostering meaningful discussions and deeper understanding among participants. The program concluded with positive feedback, highlighting NMRA’s strong commitment to ensuring GCP compliance and readiness for future inspections.

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