To all marketing authorization holders of medicines and medical devices

Extension of certificates of registration, import licenses and manufacturing licenses

Revised Closing Date for applying for extension of certificates of registration, import licenses and manufacturing licenses for medicines

This is to bring to your notice that at the meeting held with the Sri Lanka Chamber of Pharmaceutical Industry and Hon. State Minister of Pharmaceutical Production, Supplies and Regulation which was held on 15th July 2021, a decision was taken to bring forward the closing date for applications for extension of registration certificates and licenses for medicines, by one month.

As such, the applications which are entertained through the email exm.nmra@gmail.com will be closed on 31st July 2021 at 12 a.m.

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 certificates of registration, manufacturing and import licenses pertaining to Medicines and Medical Devices for a period of one year. This extension can be considered for the certificates of registration and licences expired after 30th of June 2019 and would be expired up to 31st December 2021.

1.    Following conditions shall be applied.

• This extension is applicable for re registration and renewal applications only.
• Marketing authorization holders should apply for extension of each certificate of registration and licence before 31st August 2021. No request for extension of certificate of registration and licence under this scheme will be entertained after this date.
• Applicant will be charged relevant fees for the certificates and licences including any arrears payments.  

2.    Procedure of extension shall be as follows.

i.    Applications will be accepted through online via following emails.
     For medicines – exm.nmra@gmail.com                  

     For medical devices - exd.nmra@gmail.com

ii.    Following documents should be attached with the email.
a.    Request for extension (Click here to download the request form)
b.    Copy of previous (latest) evaluation report
c.    Copy of last registration certificate / import license
d.    Copy of acknowledgement and payment receipt for re registration/ additional data submission

iii.    Heading of the email should clearly mentioned “Request for extension - dossier 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 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.

Special Notes:

• For medical devices marketing authorization holder should apply for re registration/ renewal through automation system before six month on the expiry of above extension.
• Please do not reapply repeatedly for the same application.

(Date: 21 May 2021)

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