All applicants submitting Re-Registration (RR) dossiers to the National Medicines Regulatory Authority are hereby informed that a Declaration of the Product must be submitted along with the application, with effect from 1st April 2026.

Applicants are required to confirm that:

• There are no changes to the product as per the existing registration approved by NMRA;

           or

• Where applicable, provide details of any changes made in accordance with the relevant variation guidelines.

A standard declaration format is attached to this notice. Applicants are required to duly complete and sign the declaration by the authorized signatory of the Marketing Authorization Holder (MAH) and submit it together with the RR dossier.

Click Here : standard declaration format

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