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 on or before 31st December 2005 will be required to submit applications for renewal. NMRA will 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 manufacturing premises foreign, with the required documents. 
• NMRA will publish the format of the application and the list of required documents, in due course. A deadline to submit renewal applications will also be announced.
• 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. 

Note that, If the renewal of manufacturing site is not completed, the product registration will not be renewed and new product applications (Sample import license and product registration) will not be accepted. 

CEO/NMRA

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