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

Announcement – Date: November 25th , 2025:

We are pleased to announce the publication of the finalized versions of LGVP Modules I, II, V, and XVI, together with the introductory note and definitions.

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: 25/11/2025

 
Module I: Pharmacovigilance systems and their quality systems
Module I: Pharmacovigilance systems and their quality systems
First published: 25/11/2025
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: 25/11/2025
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: 25/11/2025
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

Consultation dates: from 16/10/2023 to 16/01/2024
 
Module VII: Periodic Safety Update Report (PSUR)
Module VII: Periodic Safety Update Report (PSUR)

Consultation dates: from 16/12/2023 to 16/03/2024
 
Module VIII: Post-Authorization Safety Study(PASS)
Module VIII: Post-Authorization Safety Study(PASS)


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

 
Module XV: Safety Communication 
Module XV: Safety Communication

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: 25/11/2025
Consultation dates: from 16/11/2023 to 16/02/2024
 

 
Definitions
LGVP Annex I: Definitions
First published: 25/11/2025
 
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ATC Name B/G Ingredients Dosage Form Price
C10AA07 SINLIP G Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 563,070 L.L
D10AF02 ERYTHROMYCIN 1.5 % G Erythromycin - 15mg/ml 1.5 % Solution 501,701 L.L
G04BX14 DEPOJOY G Dapoxetine (hydrochloride) - 30mg 30mg Tablet, film coated 1,565,577 L.L
J01MA12 PILOQ G Levofloxacin - 500mg/100ml 500mg/100ml Injectable solution 980,365 L.L
M01AC02 REUTENOX G Tenoxicam - 20mg 20mg Tablet, coated 576,508 L.L
N01BB54 PRILA G Prilocaine - 2.5% w/w, Lidocaine - 2.5% w/w Cream 1,057,604 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 300mg 300mg Capsule 1,342,499 L.L
N05CM18 PROXIDA G Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable concentrate for solution 1,771,184 L.L
P03AB02 GAMMA BENZENE HEXACHLORIDE G Lindane - 1% 1% Lotion 167,660 L.L
A11CC05 ALTUM G Vitamin D3 - 50,000IU 50,000IU Capsule, hard 712,620 L.L
C09CA07 TOLURA G Telmisartan - 40mg 40mg Tablet 532,162 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 20mg 20mg Tablet, coated 517,379 L.L
D10AF02 SPOTEX G Erythromycin - 4% 4% Gel 854,684 L.L
G04BX14 LEJAM G Dapoxetine (hydrochloride) - 30mg 30mg Tablet, film coated 1,269,931 L.L
J01MA12 VLOFINOX G Levofloxacin (hemihydrate) - 500mg/100ml 500mg/100ml Injectable solution 814,369 L.L
M01AC02 SORAL G Tenoxicam - 20mg/2ml 20mg/2ml Injectable lyophilised powder for solution+solvent 588,603 L.L
N01BB54 PRILA G Prilocaine - 2.5% w/w, Lidocaine - 2.5% w/w Cream 1,163,768 L.L
N03AX12 GABATREX G Gabapentin - 300mg 300mg Capsule 1,585,734 L.L
N05CM18 DEXMEDETOMIDINE EVER PHARMA G Dexmedetomidine HCl - 400mcg/4ml 400mcg/4ml Injectable concentrate for solution 15,543,897 L.L
P03AC04 PERMACARE G Permethrin - 1% 1% Lotion 590,011 L.L
R06AB54 DRAUDEX G Chlorphenamine maleate - 4mg, Phenylephrine - 5mg Tablet, sugar coated 166,381 L.L
V03AE07 PHOSPHOLOW G Calcium acetate - 660mg 660mg Tablet 1,118,077 L.L
A02BC05 ESO TAD G Esomeprazole - 20mg 20mg Capsule, hard, gastro-resistant 299,677 L.L
A11CC05 BIODAL G Vitamin D3 - 50,000IU 50,000IU Tablet, film coated 1,110,014 L.L
B03AC FER PANPHARMA G Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable solution 2,315,441 L.L
C05CA03 DIOSMINE BIOGARAN CONSEIL G Diosmin - 600mg 600mg Tablet, coated 761,959 L.L
C10AA07 UBSATOR-CA G Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 499,142 L.L
D10AF05 NADIXA G Nadifloxacin - 1% 1% Cream 850,652 L.L
G04BX14 PRIXETIN 30 G Dapoxetine (hydrochloride) - 30mg 30mg Tablet, film coated 2,105,353 L.L
J01DC02 AXETINE G Cefuroxime sodium - 750mg 750mg Injectable powder for solution 1,193,332 L.L
    ...
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