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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

 

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ATC Name B/G Ingredients Dosage Form Price
J01CA01 ANTALPEN FORTE G Ampicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 206,056 L.L
J01CA01 AMPICILLIN G Ampicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 206,056 L.L
J01CA04 AMOXYDIL G Amoxicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 142,063 L.L
J01FA10 AZOMYNE G Azithromycin (dihydrate) - 200mg/5ml 200mg/5ml Powder for suspension 237,860 L.L
J01CA04 AMOXYCILLIN G Amoxicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 166,381 L.L
J01CA04 AMOXIDREX G Amoxicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 284,127 L.L
J01FA10 AZOMYCIN G Azithromycin (dihydrate) - 200mg/5ml 200mg/5ml Powder for suspension 693,423 L.L
J01CA04 AMOXYDIL G Amoxicillin (trihydrate) - 500mg/5ml 500mg/5ml Powder for suspension 218,854 L.L
M01AE01 ALGIFAST 400 B Ibuprofen Lysine - 400mg 400mg Powder for suspension 473,033 L.L
J01CR02 AUGMENTIN B Amoxicillin (trihydrate) - 125mg/5ml, Clavulanic Acid (potassium) - 31.25mg/5ml 156.25mg/5ml Powder for suspension 302,365 L.L
J01CR02 AMOCLAN G Amoxicillin (trihydrate) - 125mg/5ml, Clavulanic Acid (potassium) - 31.25mg/5ml 156mg/5ml Powder for suspension 159,917 L.L
J01CR02 AUGMENTIN B Amoxicillin (trihydrate) - 250mg/5ml, Clavulanic Acid (potassium) - 62.5mg/5ml 312.5mg/5ml Powder for suspension 542,912 L.L
J01CR02 AMOCLAN FORTE G Amoxicillin (trihydrate) - 250mg/5ml, Clavulanic Acid (potassium) - 62.5mg/5ml 312mg/5ml Powder for suspension 288,926 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 200mg/5ml, Clavulanic Acid (potassium) - 28.5mg/5ml 228.5mg/5ml Powder for suspension 345,368 L.L
J01CR02 AUGMENTIN B Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Powder for suspension 524,099 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57.1mg/5ml 457mg/5ml Powder for suspension 278,175 L.L
J01CR02 AUGMENTIN ES B Amoxicillin (trihydrate) - 600mg/5ml, Clavulanic Acid (potassium) - 42.9mg/5ml 642.9mg/5ml Powder for suspension 846,621 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 600mg/5ml, Clavulanic Acid (potassium) - 42.9mg/5ml 642.9mg/5ml Powder for suspension 507,972 L.L
S02CA06 AURICULARUM G Dexamethasone (sodium phosphate) - 10mg, Nystatin - 1,000,000IU, Oxytetracycline HCl - 90,000IU, Polymyxin B sulfate - 100,000IU Powder for suspension + solvent 755,239 L.L
J01FA10 AZOMYCIN G Azithromycin (dihydrate) - 200mg/5ml 200mg/5ml Powder for suspension + solvent 365,525 L.L
D11AX01 ALOPEXY G Minoxidil - 20mg/ml 2% Solution 532,162 L.L
D11AX01 ALOPEXY G Minoxidil - 50mg/ml 5% Solution 896,343 L.L
D11AX01 ALOPEXY G Minoxidil - 5% 5% Solution 896,343 L.L
R05X ACTISOUFRE B Sulfure de Sodium - 13mg, Saccharomyces Cerevisiae - 500mg Solution 740,457 L.L
R06AX27 AERIUS B Desloratadine - 0.5mg/ml 0.5mg/ml Solution 403,153 L.L
N01BB02 AVOCAINE G Lidocaine - 10% 10% Spray 620,855 L.L
R01AD09 AVOCOM G Mometasone furoate - 0.05% 0.05% Spray 419,279 L.L
R02A ANGINOVAG G Lidocaine HCl - 100mg/100ml, Hydrocortisone acetate - 60mg/100ml, Tyrothricin - 400mg/100ml, Dequalinium chloride - 100mg/100ml, ?-Glycerrhetinic acid - 60mg/100ml Spray 651,764 L.L
R01AC03 ALLERGODIL NASAL B Azelastine HCl - 0.14mg/dose 0.14mg/dose Spray, solution 657,139 L.L
A07EC02 ASACOL B Mesalazine - 500mg 500mg Suppository 1,703,992 L.L
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