Through our consultation papers, NMRA invites feedback & comments from our stakeholders to further improve our policies and services.

Guidelines for monitoring & reporting adverse drug reactions for Healthcare Professionals & patients

NMRA welcomes your comments & feedback on the proposed Guidelines for monitoring & reporting adverse drug reactions for Healthcare Professionals & Patients.

This will be started from 29^th of February 2024 to 29^th of March 2024.

Please provide your name, the organization you represnt, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it. by 29^th of  March 2024.

Amendments for Published Guideline on variation for Medicine ( May 17, 2022)

NMRA welcomes your comments & feedback on the proposed amendments for the Published Guideline on Variation for Medicine May 17, 2022.

This will be started from 27^th of February 2024 to 05^th of March 2024

Please provide your name, the organization you represnt, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it. by 5^th of  March 2024.
 

Guideline for renewal of registration of medicines in Sri Lanka (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline for Renewal of registration of Medicines in Sri Lanka.

This will start from  10th September 2022 to 10th October 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 10th October 2022.

Guideline on pharmacovigilance system master file (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on pharmacovigilance system master file.

This will start from  08th February 2022 to 08th March 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 08th March 2022.

Guideline on periodic benefit risk evaluation report (PBRER) (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on periodic benefit risk evaluation report (PBRER)

This will start from  16th December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on pharmacovigilance audit (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on pharmacovigilance audit.

This will start from  16th December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on safety communication  (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on safety communication. 

This will start from  16th December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on additional monitoring (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on additional monitoring. 

This will start from  16th December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on pharmacovigilance inspections (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on pharmacovigilance inspections. 

This will start from  16th December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on pharmacovigilance system & quality system (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on pharmacovigilance system and quality system. 

This will start from  16th December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline for monitoring & reporting adverse drug reactions for healthcare professionals & patients  (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline for monitoring & reporting adverse drug reactions for healthcare professionals & patients.

This will start from  16th December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on Borderline Product (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on Borderline Products.

This will start from  15th December 2021 to 15th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. by 15th January 2022.

Guideline on Risk Management System (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on Risk Management System.

This will start from  13rd December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on Post Authorization Safety Studies (PASS) (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on Post Authorization Safety Studies (PASS).

This will start from  13rd December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Guideline on Signal Management & Emerging Safety Issues (Closed)

NMRA welcomes your comments & feedback on the proposed Guideline on Signal Management and Emerging Safety Issues.

This will start from  13rd December 2021 to 25th January 2022.

Please provide your name, the organization you represent, mailing address and contact number to follow up with you to clarify any issue if necessary. Please email your feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. & This email address is being protected from spambots. You need JavaScript enabled to view it.  by 25th January 2022.

Details

Published: 18 August 2019