All local manufacturers are hereby requested to submit data related to second brand/generic applications for pharmaceutical products that are already registered with the National Medicines Regulatory Authority.

This information is being collected to support regulatory evaluation and database updates.

Kindly fill in the Google Form using the link below and attached the mandatory documents listed.

Click here to access the Google Form :

https://forms.gle/4t9PJwBErcN2ZgPY9

Mandatory Documents (to be uploaded for each product and each strength):

1.   Copy of the previous Registration Certificate

2.  Copy of the last Evaluation Report

3.  Duly filled Declaration Format declaring the sameness of the product (separate declaration required for each product an each strength)

Instructions:

• Submit separate entries for product/strength.
• Ensure that all attached documents are clear, complete and legible.

Your timely cooperation in this matter is highly appreciated.