Extension of the Submission Deadline for the Foreign Medicine Manufacturing Site Renewal Application

To All Market Authorization Holders of Medicines,

Please be informed that the implementation of the renewal process for overseas Pharmaceutical manufacturing site approvals by the National Medicines Regulatory Authority (NMRA) has been extended until1 January 2027.

Initially, Manufacturing sites approved before the year 2010 will be required to submit applications for renewal.

NMRA may conduct an onsite GMP inspection of the manufacturing site, where deemed necessary, as part of the renewal process,irrespective of whether the site has previously been inspected by NMRA or an NMRA-recognized reference regulatory authority.

Please note that from 1^stJanuary 2027, if the renewal application of a foreign manufacturing site has not been submitted, the following regulatory actions will apply:

·        Renewal of the registration of products manufactured at that site will not be granted.

·        New product applications, including applications for Sample Import Licences and Product Registration,for products manufactured at that site will not be accepted.

This extension is granted to provide Market Authorization Holders with additional time to prepare and submit the required documentation for the renewal of foreign Pharmaceutical manufacturing site approvals.

Updated Application form and the checklist for accepting renewal dossier submission are attached herewith.

Click here :

• ‍Checklist for Accepting Application for Renewal of an Overseas Manufacturer of Medicines
• ‍Application for Renewal of an Overseas Manufacturer of Medicines

CEO/NMRA