To Local Manufacturers.

You are hereby informed that after reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to extend the validity of Manufacturing Licenses and GMP Certificates for a period of one year. This extension can be considered for the Manufacturing licenses and GMP Certificates expired after 30th of June 2019 and would be expired up to 31st December 2021.

1.    Following conditions shall be applied.

     i.    Local Manufacturers should apply for extension of each Manufacturing License and GMP Certificate before 31st August 2021. No request for extension under this scheme will be entertained after this date.
    ii.    Applicant will be charged relevant fees for the Manufacturing Licenses and GMP Certificates including any arrears payments.  

2.    Procedure of extension shall be as follows.  
    i.    Applications will be accepted through online via following email.
exlm.nmra@gmail.com
    ii.    Following documents should be submitted by the applicant.

•     Request for extension (Click here to download the format)
•     Copy of latest Certificate of Registration (for Manufacturing Licenses) / copy of latest GMP report (for GMP Certificates)
•    Copy of latest Manufacturing License / GMP Certificate.
•    Copy of acknowledgement for Manufacturing License / GMP Certificate request submission.

   iii.    Heading of the email should clearly mentioned “Request for extension – Manufacturing License Number / GMP Certificate Number.”
   iv.    After screening of the request, the applicant will be informed to submit original certificate with payment to NMRA. A seal will be placed in the original License / Certificate indicating the period of extension and other relevant conditions.  
  v.    NMRA may reject any request for extension for a product which is not complying to NMRA Act and Regulations.

(Date: 14 June 2021)