All Marketing authorization holders / Local manufacturers of medicine are hereby informed that the e-mail address for the notification of Drug Master File (DMF) of Active Pharmaceuticl Agent (API) is "This email address is being protected from spambots. You need JavaScript enabled to view it.".
The hard copy of e-mail sent by the manufacturer should be attached with the relevant dossier of the product.
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To all Market Authorization Holders of Medicines,
NMRA is publishing herewith a link to obtain Manufacturing site changed dossier (Sterile & Non-sterile medicines) details pending at NMRA. (Please note that if you already submitted these details via the link which was published in Feb 2024, no need to fill this form again.)
Please provide required details on or before 15 th May 2024.
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To all Marketing Authorization Holders of Medical Devices,
It is here by informed that all dossiers and other applications for medical device registration will be accepted after applying by filling out the Google form linked below or scanning the provided QR code
Please fill out the following relevant checklist and submit two copies along with the dossier to the accepting point
CEO / NMRA
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To All Marketing Authorization Holders of Medical Devices
All importers of Medical Devices are hereby informed that NMRA will terminate the email confirmation process for the foreign manufacturing site application (FMSA). Hence, you can submit FMSA application without the email confirmation which is issued by the Head of Medical Device Division/NMRA with effect from 22nd of April 2024.
This applies for pending email confirmations as well.
Chief Executive Officer
NMRA
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Dear Local Agents / Importers,
In accordance with the regulations outlined in the NMRA Act, it is mandatory to submit import details of medicines to the National Medicines Regulatory Authority. To facilitate this process and ensure compliance, we kindly request all local agents and importers to provide accurate information regarding the medicines imported between January 2023 and the present date.
To steamline the data collection process, we have created a Google Form for your convenience. Please take a few minues to fill out the form (https://docs.google.com/forms/d/e/1FAIpQLSf9cRIDzWL1HE-ZgqmT5RCDL7H7QjjxlVwR1dCYQzCWwBRlHQ/viewform?usp=sf_link) with details for each medicine imported within the specified period. Thank you for your prompt attention to this matter.
Click on the above link or scan the QR code to fill the Google Form on or before 31st March 2024.
Cheif Executive Officer / NMRA
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