To all Market Authorization Holders of Medicines,
You are hereby informed that NMRA will initiate a renewal process for overseas manufacturing sites with effect from 1st August 2025. Initially, manufacturing sites approved between the period of 2000 and 2010 will be required to submit applications for renewal. NMRA may carry out an onsite GMP inspection if the site has not been inspected by NMRA reference authority.

The following conditions will be applied for the renewal process:

• The local agent would require submitting an application for renewal of the foreign manufacturing premises, with the required documents.
• A six-months grace period with effect from 1st of January 2026 will be given for the submission of renewal applications.
• The format of the application and the list of required documents is attached with this notice.
• A renewal application fee as prescribed in the fees regulations will be charged.
• A fee for GMP inspection - Foreign, as prescribed in the fees regulations will be charged, if decided to carry out an onsite inspection.
• Manufacturing sites for which renewal applications are not submitted within the announced deadline will be discontinued.
• The renewed approvals will be valid for a period of five years.

You may contact Manufacturing Regulatory Division, NMRA for further clarifications.
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Note that, If the renewal of manufacturing site is not completed, the product registration will not be r enewed and new product applications (Sample import license and product registration) will not be accepted.

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CEO/NMRA

Click Here : Application for Renewal of an Overseas Manufacturer of Medicines

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