All Market Authorization Holders of medicines are hereby informed that, with effect from 01^stAugust 2025 applications for the renewal and re-registration will not be considered for registration unless the following documentation is submitted at the time of application submission, in accordance with the provisions of Section 65(d) of the National Medicines Regulatory Authority Act, No.5 of 2015.

1.    Imported Medicines:

Application must be included;

•   Evidence of Importation during the past two (02) years,

•   Proof of participation in tenders, or

•   A written clarification for the absence of importation or non-participation in tenders during the specific period.

2.    Locally Manufactured Medicines:

Application must be included;

·     Evidence of production within the past two (02) years,

·     Proof of participation in tenders,or

·     A written explanation if the product has not been manufactured or has not participated in tenders during the specific period.

Important:

Applications submitted without the above mandatory information will not be accepted for evaluation. This requirement is enforced under the authority of Section 65(d) of the NMRA Act, which empowers the Authority to ensure the continuous availability of registered medicinal products in the market.

Additionally, for applications already submitted without the required documentation, evaluators are instructed to request the necessary information via email prior to granting registration.

Your strict compliance with this directive is expected.