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Fake medicines are "medicine" that try to imitate the appearance of real ones.

becarefulupdated

Details: Published: 23 April 2021

It is a shared responsibility.

Please report medicine related problems to the NMRA.

SafteyUpdated

Details: Published: 23 April 2021

COVID-19-Vaccine-1

Covid 19 Vaccines Procedures and Reports

Guideline on procedure for expedited Marketing Authorization for Emergency use permission, Registration/Licensing of COVID 19 vaccines in Sri Lanka

Emergency use authorization / registration of COVID 19 vaccines

The National Medicines Regulatory Authority accepts applications of vaccines against COVID 19 to be considered for emergency use authorization / registration. COVID 19 vaccines are eligible for rapid regulatory review under section 109 of the NMRA Act No. 5 of 2015 and related guidelines.

Manufacturers / importers of candidate COVID 19 vaccines for emergency use authorization or registration of such vaccines in Sri Lanka should as an initial step submit an expression of interest (EOI) to the NMRA. The EOI should be submitted in the prescribed format and sent to the attention of the Chief Executive Officer, National Medicines Regulatory Authority, No. 120, Norris Canal Road, Colombo 10, Sri Lanka or by email to This email address is being protected from spambots. You need JavaScript enabled to view it.
Once the EOI submitted by the manufacturer / importer is accepted by the NMRA, an application for emergency use authorization / registration should be made in the prescribed format with all documents requested in the checklist.
All such applications for emergency use authorization / registration should be accompanied by the mandatory recommendation of the Ministry of Health.

Expression of Interest (EOI) to National Medicines Regulatory Authority by Applicant of COVID-19 vaccines

Application format for Expedited Marketing Authorisation

Vaccines evaluation reports

AZ Vaccine (Covishield) evaluation report

Sputnik V vaccine evaluation report

Details: Published: 12 March 2021

Safety of medicines is a shared responsibility of all the parties concerned. Timely reporting of adverse reactions facilitates identifying problems, taking appropriate remedial measures and gathering novel information on medicines. Hence sharing the information on incidents of adverse events that you encounter in your practice is of immense value.

We have made reporting convenient by introducing the WHITE CARD as a Google form. Please send your report to the Pharmacovigilance division and contribute to safety of medicines. Do not hesitate to report if some details are not known. The identities of Reporter, Patient and Institution will remain confidential

Details: Published: 20 November 2020

Important safety concerns on the use of Cyproterone Acetate and Ethinylestradiol

The National Medicines Regulatory Authority wishes to draw your attention to recent reviews on the safety of combination product Cyproterone Acetate and Ethinylestradiol.

Serious adverse thromboembolic events have been reported from France following extensive off-label use of Cyproterone Acetate 2mg and Ethinylestradiol 35mcg Tablets (Diane 35 and its generic products). At the request of the French National Agency of Medicines and Health Products Safety (ANSM), Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA) has reviewed the safety of the product and had concluded that the benefits of the drug outweigh the risks provided that several measures are taken to minimize the risk of thromoembolism.

Details: Published: 20 November 2020

Be aware of fake medicines

Medicine safety

Covid 19 Vaccines Procedures and Reports

Share information on adverse reactions with the NMRA

Important safety concerns on the use of Cyproterone Acetate & Ethinyl Estradiol

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