National Medicines Regulatory Authority

All Marketing Authorization Holders (MAHs) of medicines are hereby informed that the following categories of applications, which remain pending at the Pricing Division due to non-response from applicants within three months from the initial communication from the NMRA, will be considered for rejection from both the Pricing Review Process and the Registration Process at the NMRA:

·       Applications where applicants have not submitted there quested price details.

·       Applications where applicants have not responded to the MRP determinations officially communicated by the NMRA.

A notification letter will be issued to inform the withdrawal and closure of these applications and applicants can submit any concerns or clarifications regarding this decision within one month of this letter. Failure to respond within this period will result in the permanent rejection of your application by the NMRA.  

Please note that, after rejection,if the applicants wish to proceed further, these product registration applications must be resubmitted as a new application to the NMRA.

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This publicly accessible database provides official information on medicines recall and revocation notifications-taken to remove unsafe / ineffective / substandard medicines from the market. This initiative has taken as per the provisions of NMRA Act, No. 5 of 2015 and is implemented as recommended by the WHO Global Bencharking tool to achieve and maintain international standards for public health protection and supply chain intergity.

‍Click Here : Medicines Recall and Revocation Database. (since 2020)

NMRA decisions based on the MEC recommendation for the new molecular entities submitted for stage 1. (Need assessment), the corrected list is attached.

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Click Here for corrected list

Notice to All Authorized Local Manufacturers and Importers,

This is to formally inform all authorized local Manufacturers and Importers of the following regulatory requirements regarding submissions for New, Renewal, and Re-registration applications with decisions of "Awaiting Additional Documents" or "Rejected."

• For applications under "Awaiting Additional Documents," the required documents may be submitted within one (1) year from the date of the CEO's approval of the latest evaluation, along with the applicable data evaluation fee.
• After one (1) year from the above decisions, the application will be considered a new application, and a new dossier with a sample license must be submitted.
• No appeals will be accepted for such cases beyond the one-year period.

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As per the Fees Gazette (No. 2452/39) published on 4th of September 2025, the Application Fee for a Retail and Wholesale License is valid for a three-year period from 4 th of September 2025.

Notice