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Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization

Where can you Report your Adverse Drug Reactions or Adverse Events Following Immunization

This section provides a comprehensive overview of the procedures and tools available to Healthcare Professionals, Market Authorization Holders and the General Public to report adverse events associated with medicinal products and vaccines in Lebanon.

How to report

You can send the case reports using the following tools:

A. For Healthcare Professionals and Public
We have developed two user-friendly tools for ADR reporting: The Med Safety App and the e-reporting link, both accessible to healthcare professionals and the general public.

Med Safety Mobile Application:

The Med Safety Mobile Application is the latest tool that the Lebanese National Pharmacovigilance Program adopted to report adverse drug reactions. It was launched on September 2022. By downloading the app, you can easily report adverse events, adverse drug reactions and adverse events following immunization.

How do I get the App?

Search App Store or Google Play for Med Safety
Install the App to your device
When opening the App for the 1st time, the user must select Lebanon
The user is asked to select the language

For further information, you may watch the full tutorial on how to use the app on the below link:
https://www.youtube.com/watch?v=kRFaiDVzDz4&t=1s

Electronic Reporting: by clicking the link below, you will be directed to the main reporting page.

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=LB

Direct Contact with the Lebanese National Pharmacovigilance Program:

You may contact us using:

Email Address:
pv@moph.gov.lb
pv.moph@gmail.com
Phone number of the Quality Assurance of Pharmaceutical Products Program: 01-830254

B. For Market Authorization Holders:

Based on the Ministerial Resolution MR #181 issued in 2021, MAHs should adhere to the internationally agreed ICH guidelines and standards and send the reports in XML format as specified in ICH E2B (R2 or R3) guidelines
(https://www.moph.gov.lb/userfiles/files/Quality%26Safety/PharmacovigilanceSystemInLebanon/Karar%20181-2021.pdf).

All XML files should be sent to the following emails: pv@moph.gov.lb, and pv.moph@gmail.com.

As for what to report or report type you can refer to Module VI:
https://moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon#/en/view/70479/lebanese-guideline-on-good-pharmacovigilance-practices-lgvp-