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 ceonmra2@gmail.com
• 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 Authorization

AZ Vaccine (Covishield) evaluation report

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(Date: 05 February 2021)