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To All Stakeholders, Manufacturers, Importers, Distributors, and Users of Medical Devices

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.

Details

To all market Authorization Holders of Medicines,

NMRA is publishing herewith a link to obtain renewal dossier details which will expire in January, February and March 2024. Please provide required details on or before 17th January 2024.

https://docs.google.com/forms/d/e/1FAIpQLSfT4987PKSvQNE1PikfC5H7Vy6zF8gR4QMw3ai3VxyhAnvlzw/viewform?usp=sf_link

qr code for google forms 2

Details

All local manufacturers and marketing authorization holders of medicine are hereby informed that NMRA has decided to temporary stop accepting new medicines applications, new site master files, formulation applications and new foreign site registration applications from published date of this notice to 1st of February, 2024.

However, new medicines applications, which are having less than five registered products in NMRA will be accepted as per the routine procedures and proceeded on priority basis. New foreign site registration applications on site transfers of already approved sites in NMRA will proceed as per the routine procedures.

Details

To All Importers of Medicine

Extension of registration for Pharmaceuticals up to 30th June 2024

All marketing authorization holders of medicine are hereby informed that NMRA has decided to extend registrations of Pharmaceuticals of which the registration expires on or before 31st December 2023 up to 30th June 2024, if there are no reports of quality failures.

For this purpose please provide

1. The original certificate of registration of a Medicine and License to import a registered Medicine.

2. Acknowledgment of submitted additional documents for relevant certificate / license.

 

Details

To all importers of Medicines

All authroized agents for medicine are hereby informed that priority registration will be granted for the following products. 

  1. Zidovudine 300 mg + Lamivudine 150 mg Tablets
  2. Efavirenz Capsules / Tablets 600 mg
  3. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg Tablets
  4. Lopinavir 200 mg + Ritonavir 50 mg Tablets
  5. Abacavir Sulfate Capsules / Tablets 300 mg
  6. Lamivudine Tablets 150 mg
  7. Atazanavir Sulfate 300 mg + Ritonovir 100 mg Tablets
  8. Darunavir Ethanolate 600 mg + Ritonovir 100 mg Tablets
  9. Raltegravir Tablets 400 mg
  10. Dolutegravir Tablets 50 mg
  11. Tenofovir Disproxil 300 mg + Lamivudine 300 mg + Dolutegravir 50 mg Tablets
  12. Tenofovir Alafenamide 25 mg + Emtricitabine 200 mg + Dolutegravir 50 mg Tablets
  13. Abacavir 60 mg + Lamivudine 30 mg Tablets
  14. Abacavir Sulfate 120 mg + Lamivudine 60 mg Dispersible Tablets
  15. Zidovudine 60 mg + Lamivudine 30 mg Dispersible Tablets
  16. Lopinavir 100 mg + Ritonavir 25 mg Tablets
  17. Efavirenz Capsules / Tablets 200 mg
  18. Nevirapine Oral Suspension 50 mg / 5 ml - 100 ml
  19. Dolutegravir Tablets 10 mg
  20. Zidoviduine Syrup 5 mg / 5 ml
  21. Lamivudine Syrup 5 mg / 5 ml
Details
120, Norris Canal Road, Colombo 10
 011-2687743
 info@nmra.gov.lk
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