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


Announcement – January 30th, 2026
Public Consultation on New LGVP Modules


The Lebanese Ministry of Public Health (MoPH), through the Lebanese National Pharmacovigilance Program (LNPVP), is pleased to announce the release of two additional modules of the Lebanese Good Pharmacovigilance Practices (LGVP) Guideline for public consultation:

Module III: Pharmacovigilance Inspections
Module IV: Pharmacovigilance Audits

In line with the MoPH’s commitment to transparency, regulatory strengthening, and continuous improvement of pharmacovigilance systems in Lebanon, all Marketing Authorization Holders (MAHs) and stakeholders involved in pharmacovigilance activities are invited to review these modules and submit their comments, suggestions, or questions.

Public Consultation Period
February 1st to April 30th, 2026

How to Participate

The modules are available under the relevant section of the Lebanese National Pharmacovigilance Program webpage.
Proposals for corrections, revisions, or additions should be submitted using the official Excel consultation template provided below.

Comments should be sent within the consultation period to the following email addresses:
lgvp@moph.gov.lb
lgvp.moph@gmail.com


Each Excel file should be named according to the following convention:
“Module [Module Number] – [Company Name].xls”
(e.g., Module III – CompanyName.xls)


An acknowledgment email will be sent to confirm receipt of the submitted comments.

Important Clarification
To ensure appropriate follow-up, the following reviewer details must be included in the body of the submission email:
Reviewer’s full name
Reviewer’s contact information (email and phone number)
Reviewer’s current country of residence

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

The Lebanese Ministry of Public Health extends its sincere appreciation to all stakeholders for their continued collaboration and active participation in strengthening pharmacovigilance and medication safety in Lebanon.

Announcement – Date: January 15th , 2026:

We are pleased to announce the publication of the finalized versions of LGVP Modules I, II, V, VI, VII, VIII, XV 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: 15/1/2026

 
Module I: Pharmacovigilance systems and their quality systems
Module I: Pharmacovigilance systems and their quality systems
First published: 15/1/2026
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: 15/1/2026
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: 15/1/2026
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: 15/1/2026
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: 15/1/2026
Consultation dates: from 16/12/2023 to 16/03/2024
 
Module VIII: Post Authorization Safety Studies (PASS)
Module VIII: Post Authorization Safety Studies (PASS)

First published: 15/1/2026
Consultation dates: from 16/12/2023 to 16/03/2024

 
Module XV: Safety Communication 
Module XV: Safety Communication
First published: 15/1/2026
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: 15/1/2026
Consultation dates: from 16/11/2023 to 16/02/2024

 
Definitions
LGVP Annex I: Definitions
First published: 15/1/2026
 
Module III - Pharmacovigilance Inspections
Module III - Pharmacovigilance Inspections
Released for Public Consultation: February 2nd ,2026
End of Public Consultation: April 30th, 2026
 
Module IV - audit
Module IV - audit
Released for Public Consultation: February 2nd ,2026
End of Public Consultation: April 30th, 2026
 
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ATC Name B/G Ingredients Dosage Form Price
C05BX51 DOXIPROCT B Calcium dobesilate - 4%, Lidocaine HCl - 2% Ointment 610,104 L.L
C09CA07 MICARDIS B Telmisartan - 80mg 80mg Tablet 998,475 L.L
D10AX03 SKINOREN B Azelaic acid - 0.2g/g 0.2g/g Cream 722,987 L.L
J07AL02 PREVENAR 13 B Polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 23F (2.2mcg)Polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 6,352,343 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 50mg 50mg Injectable suspension, prolonged release 9,661,754 L.L
R05CB06 MUCOSOLVAN LA B Ambroxol HCl - 75mg 75mg Capsule 345,368 L.L
B05DB DIANEAL PD4 CYCLER 3.86% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 38.6g/l Injectable solution 1,150,329 L.L
C05BX51 DOXIPROCT PLUS B Calcium dobesilate - 4%, Dexamethasone acetate - 0.0025%, Lidocaine HCl - 2% Ointment 489,159 L.L
D10BA01 ROACCUTANE B Isotretinoin - 10mg 10mg Capsule 1,353,249 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
M01AB05 FLECTOR E.P B Diclofenac (epolamine) - 50mg 50mg Granules 503,941 L.L
N01AX10 PROPOFOL-LIPURO B Propofol - 10mg/ml 1% Injectable emulsion 1,411,035 L.L
N05AX13 INVEGA SUSTENNA B Paliperidone palmitate - 150mg 150mg Injectable suspension, prolonged release 27,480,894 L.L
S02CA02 VIOCORTENE B Clioquinol - 10mg/ml, Flumetasone pivalate - 0.2mg/ml Drops 568,253 L.L
A02BD08 PYLERA B Bismuth subcitrate potassium - 140mg, Tetracycline HCl - 125mg, Metronidazole - 125mg Capsule 6,156,142 L.L
B03AE10 TOT'HEMA B Copper (gluconate) - 0.70mg/10ml, Manganese (gluconate) - 1.33mg/10ml, Iron (gluconate) - 50mg/10ml Solution 604,729 L.L
B05XA PEDITRACE B Sodium selenite 5H2O (anhydrous) - 6.66mcg/ml, Sodium fluoride - 126mcg/ml, Potassium iodide - 1.31mcg/ml, Zinc chloride - 521mcg/ml, Copper chloride - 53.7mcg/ml, Manganese chloride 4H2O - 3.6mcg/ml Injectable concentrated solution 4,749,139 L.L
C05CA03 DIOVENOR 600 B Diosmin - 600mg 600mg Tablet, film coated 1,089,856 L.L
M01AB05 CATAFLAM B Diclofenac potassium - 50mg 50mg Tablet, sugar coated 262,049 L.L
N05AX13 TREVICTA B Paliperidone - 175mg 175mg Injectable suspension, prolonged release 35,006,803 L.L
C05CA03 DIOVENOR 600 B Diosmin - 600mg 600mg Tablet 544,256 L.L
C10AA07 CRESTOR B Rosuvastatin (calcium) - 5mg 5mg Tablet 589,947 L.L
G04BE30 LIF-DOL B Yohimbin HCl - 3.3mg, Thiamine - 5.5mg, Cyanocobalamine - 0.015mg, Ferrous fumarate - 50mg, Sildenafil citrate - 10mg Tablet, coated 231,653 L.L
J07AL02 PREVENAR 20 B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F,8, 9V,10A, 11A, 12F, 14, 15B, 18C, 19A, 19F,22F, 23F, 33F (2.2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein (approximately 51mcg) adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 7,415,107 L.L
N05AX13 TREVICTA B Paliperidone - 263mg 263mg Injectable suspension, prolonged release 40,713,289 L.L
A02BX13 GAVISCON B Sodium alginate - 500mg/10ml, Sodium bicarbonate - 267mg/10ml, Calcium (carbonate) - 160mg/10ml Liquid 295,645 L.L
A11DB NEUROBION B Vitamin B12 - 1000mcg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 545,600 L.L
G04BX ROWATINEX B Olive oil - 33mg, Cineol - 3mg, Fenchone - 4mg, Anethol - 4mg, Borneol - 10mg, Camphene - 15mg, ?-Pinene - 6.2mg, ?-Pinene - 24.8mg Capsule 255,330 L.L
J07AL02 VAXNEUVANCE B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 22F, 23F,33F (2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg) Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate adjuvant - Injectable suspension 6,988,413 L.L
L01EB04 TAGRISSO B Osimertinib - 80mg 80mg Tablet, film coated 603,192,941 L.L
    ...
    168
    ...
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