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Lebanese Guideline on Good Pharmacovigilance Practices (LGVP)

Lebanese Good Pharmacovigilance Practices (LGVP) Guideline - Invite for Public Consultation

Announcement – Date: January 31th, 2023
We are pleased to announce the extension to LGVP public consultation deadlines.
Phase II (Modules II, V, and XVI): Extended from February 16th, 2024 to March 16th, 2024.
Phase III (Modules VII, VIII, and XV): Extended from March 16th, 2024 to April 16th, 2024.

Clarification – Date: October 17th , 2023
As an addition to the instructions outlined above, kindly note that the following details pertaining to the reviewer are obligatory and must be incorporated within the body of the submitted email:

Reviewer's full name
Reviewer's contact information, including phone number and email
Reviewer's current country of residence

Beirut, October 16, 2023 — The Lebanese Ministry of Public Health (MoPH) is pleased to announce the official release of Version 1 of the Lebanese Good Pharmacovigilance Practices Guideline (LGVP) for public consultation.
In alignment with our commitment to transparency, safety, and continuous improvement, we invite all Marketing Authorization Holders and any party or individual involved in pharmacovigilance activities in Lebanon to actively participate in the public consultation phase for this guideline. Your valuable input, comments, and questions will contribute to the refinement of the guideline.

Guideline Overview:
The LGVP outlines essential standards and best practices in pharmacovigilance, ensuring that all pharmaceutical products available in Lebanon meet the highest safety and quality standards. This guideline will play a pivotal role in strengthening our nation's pharmaceutical sector and, most importantly, safeguarding public health.

Public Consultation Details:
The public consultation period will follow a sequential release of Modules to be organized into three distinct phases, each extending for a duration of three months, with a one-month interval between phases. These phases are outlined as follows:

Phase	Start Date	End Date	Modules
Phase I	October 16, 2023	January 16, 2024	Introductory Note: Legal basis and structure of pharmacovigilance guideline* Module I: Pharmacovigilance systems and their quality systems Module VI: Collection, management and submission of reports of suspected adverse reactions to medicinal products
Phase II	November 16, 2023	March 16, 2024	Module II: Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Sub-System File (PSSF) Module V: Risk management systems Module XVI: Risk minimization measures-selection of tools and effectiveness indicators
Phase III	December 16, 2023	April 16, 2024	Module VII: Periodic Safety Update Report (PSUR) Module VIII: Post-Authorization Safety Studies (PASS) Module XV: Safety communication

*The introductory note is not concerned with the public consultation; you are therefore not required to submit comments on it.

As of the date of the present announcement, the MoPH is proud to initiate Phase I of the public consultation for the concerned Modules.

How to Participate:
To access the guideline and participate in the public consultation, kindly access the links for the Modules provided under the relevant section of the present Lebanese National Pharmacovigilance Program webpage.

Proposals for corrections, revision, or addition suggested to any section of the released Modules are to be shared through the provided link for the Excel sheet and sent to both of the following emails within the specified timeframe: lgvp@moph.gov.lb, and lgvp.moph@gmail.com.

We kindly request that you use the provided Excel sheet for each respective Module. The Excel file should be named according to the following convention: “Module [Module number]-[Company name].xls”, for instance, "Module I-Mersaco.xls." Your compliance with this naming convention is greatly appreciated.

An acknowledgment email will be sent to confirm the receipt pf the suggested comments.

For further information and inquiries, please contact the Pharmacovigilance Team through the above email.

Remarks:
The Lebanese MoPH extends its gratitude to all stakeholders for their cooperation and commitment to the advancement of pharmacovigilance in Lebanon. Your engagement in the public consultation is invaluable, and together, we will set new standards for pharmaceutical safety and efficacy.

Copyright Notice ©
This Guideline on Good Pharmacovigilance Practices (GVP) for Lebanon is the property of the Lebanese Ministry of Public Health (MoPH). All rights are reserved. Do not copy without permission. Permission may be requested from the Quality Assurance for Pharmaceutical Products Program - Ministry of Public Health, Lebanon by sending an email to: pv@moph.gov.lb, or pv.moph@gmail.com

Introductory Note: Legal basis and structure of pharmacovigilance guideline

Introductory Note: Legal basis and structure of pharmacovigilance guideline

First published: 16/10/2023

Module I: Pharmacovigilance systems and their quality systems

Module I: Pharmacovigilance systems and their quality systems
First published: 16/10/2023
Consultation dates: from 16/10/2023 to 16/01/2024

Module II: Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Sub-System File (PSSF)

Module II: Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Sub-System File (PSSF)
First published: 16/11/2023
Consultation dates: from 16/11/2023 to 16/02/2024

Module V: Risk Management System

Module V: Risk Management System
Module V – Annex: Template of the National Display of the Risk Management Plan in Lebanon
First published: 16/11/2023
Consultation dates: from 16/11/2023 to 16/02/2024

Module VI: Collection, management, and submission of reports of suspected adverse reactions to medicinal products

Module VI: Collection, management, and submission of reports of suspected adverse reactions to medicinal products
First published: 16/10/2023
Consultation dates: from 16/10/2023 to 16/01/2024

Module VII: Periodic Safety Update Report (PSUR)

Module VII: Periodic Safety Update Report (PSUR)
First published: 16/12/2023
Consultation dates: from 16/12/2023 to 16/03/2024

Module VIII: Post-Authorization Safety Study(PASS)

Module VIII: Post-Authorization Safety Study(PASS)

First published: 16/12/2023
Consultation dates: from 16/12/2023 to 16/03/2024

Module XV: Safety Communication

Module XV: Safety Communication
First published: 16/12/2023
Consultation dates: from 16/12/2023 to 16/03/2024

Module XVI: Risk Minimization Measures: Selection of Tools and Effectiveness Indicators

Module XVI: Risk Minimization Measures: Selection of Tools and Effectiveness Indicators

First published: 16/11/2023
Consultation dates: from 16/11/2023 to 16/02/2024