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Since NMRA is not in a position to carry out onsite GMP inspections of overseas manufacturers in the near future due to prevailing COVID 19 pandemic situations , accepting of applications for new foreign manufacturing sites will be restricted with effect from 9th October 2020 .Applications for new foreign manufacturing sites will be accepted only from the manufacturers who fulfill one of the following criteria, until further notice.

Manufacturing sites located in a reference country, i.e. PIC / S member

Manufacturers who have expressed interest to apply for marketing authorization through the WHO collaborative registration procedure. Manufacturing sites that manufacture products identified as in need of ( more ) sources of supply . E.g. COVID 19 related products , orphan drugs , breakthrough therapies, products having less than three registered manufacturers .

When manufacturing of an existing product is transferred to anew site.

Your corporation on the matter would be much appreciated.

(Date: 08 October 2020) 

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