National Medicines Regulatory Authority

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.