- You are here:
-
Home
-
Announcements
- Regulatory Updates
All importers of Medicines are hereby informed that, in response to your feedback and to facilitate the process, the National Medicines Regulatory Authority decided to offer an alternative method for submitting import data.
Local agents who find it difficult to submit details via the Google form are hereby instructed to utilize the attached format. Please fill out the details according to the given format in an Excel sheet with the necessary details for each Medicine imported during the mentioned period and send the Excel sheet to This email address is being protected from spambots. You need JavaScript enabled to view it. with the subject line : "Collection of Import Data - Medicines."
Important Note :
- Please do not include details of medicines which have already been submitted via the Google Form.
- Each local agent is requested to submit only one Excel sheet containing the import data for all medicines.
Your corperation in this matter is greatly appreciated.
CEO,
NMRA
- Details
To all Marketing Authorization Holders of Medicines,
NMRA is publishing herewith a link to obtain Agency transferred dossier details pending at NMRA.
Please provide the required details on or before 20th of May 2024.
Click on the link below or scan the QR code to fill the Google Form.
- Details
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.
- Details
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.
- Details
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
- Details
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
- Details
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
- Details
To all market Authorization Holders of Medicines,
NMRA is publishing herewith a link to obtain renewal dossier details which will expire in January to July 2024.
Please provide details on or before 10th of April 2024.
- Details
To all Marketing Authorization Holders of Pharmaceuticals,
It is here by informed that all dossiers & related documents for medicine registration will be accepted after applying by filling the Google form through the link or the QR code below.
- Details
All Marketing Authorization Holders of Medicine are here by informed that NMRA has decided to accept sample import license applications only for the Medicines which have less than 5 valid regustrations until further notice.
- Details