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الدليل الوطني حول الممارسات الجيدة لليقظة الدوائية

 
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
A10BH01 SITAVITAE G Sitagliptin - 100mg 100mg Tablet, film coated 1,412,378 L.L
B01AF01 VAROXA G Rivaroxaban - 20mg 20mg Tablet, film coated 1,343,843 L.L
B05BC01 SERUFLEX MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
C01EB15 CARMETADIN G Trimetazidine - 35mg 35mg Tablet, film coated, modified release 631,606 L.L
C09AA05 ACURIL G Ramipril - 5mg 5mg Tablet 614,136 L.L
C10AA05 ATOR MEDIS G Atorvastatin - 10mg 10mg Tablet, film coated 305,052 L.L
J01BA01 CHLORAMPHENICOL PALMITATE G Chloramphenicol (palmitate) - 125mg/5ml 125mg/5ml Suspension 159,981 L.L
J01DH03 ERTANZ G Ertapenem - 1g 1g Injectable powder 2,521,049 L.L
J05AB11 VALACICLOVIR ARROW G Valaciclovir - 500mg 500mg Tablet, film coated, breakable 2,889,261 L.L
L01CD01 EBETAXEL G Paclitaxel - 150mg/25ml 150mg/25ml Injectable concentrated solution 15,457,059 L.L
N02BE51 ADOL EXTRA G Paracetamol - 500mg, Caffeine - 65mg Caplet 122,290 L.L
N05AH03 ZOLAPINE G Olanzapine - 5mg 5mg Tablet, orodispersible 1,186,165 L.L
N06BA09 APO-ATOMOXETINE G Atomoxetine (HCl) - 40mg 40mg Capsule 4,114,846 L.L
R03BA02 AERONIDE G Budesonide - 400mcg 400mcg Capsule, inhalation 2,116,552 L.L
C02KX01 BOSENTAN ARROW G Bosentan (monohydrate) - 125mg 125mg Tablet, film coated L.L
A02BC01 OMEPRAZOLE PHARMADEX G Omeprazole - 20mg 20mg Capsule 15,757,784 L.L
A07AX03 FUROXYL G Nifuroxazide - 200mg 200mg Capsule 366,037 L.L
A10BH01 SITAXIA 100 G Sitagliptin - 100mg 100mg Tablet, film coated 2,003,470 L.L
B01AF01 XAVIRAN G Rivaroxaban - 20mg 20mg Tablet, film coated 952,208 L.L
B05BC01 SOLUFLEX MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 603,320 L.L
C09AA05 APO-RAMIPRIL G Ramipril - 5mg 5mg Capsule 794,211 L.L
C10AA05 ATORLIP 10 G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 1,052,037 L.L
J01BA01 CHLORAMPHENICOL G Chloramphenicol - 250mg 250mg Capsule 166,381 L.L
J01DH03 ERTAPENEM ARROW G Ertapenem - 1g 1g Injectable concentrate for solution 2,650,057 L.L
J05AB11 VALCYK BENTA G Valaciclovir - 500mg 500mg Tablet, film coated 4,318,214 L.L
L01CD01 PACLITAXEL NEAPOLIS G Paclitaxel - 150mg/25ml 150mg/25ml Injectable concentrate for solution 15,665,972 L.L
L01XA01 CISPLATINE VIATRIS 1MG/ML G Cisplatin - 10mg/10ml 10mg/10ml Injectable concentrated solution 412,655 L.L
L04AD02 ROLITAC XR G Tacrolimus - 0.5mg 0.5mg Capsule, hard, prolonged release 6,329,498 L.L
N02BE51 SICADOL EXTRA G Paracetamol - 500mg, Caffeine - 65mg Tablet 147,823 L.L
N05AH03 ZYRWAN OD G Olanzapine - 5mg 5mg Tablet, orodispersible 831,391 L.L
    ...
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