عربي
English
روابط سريعة
مواقع ذات صلة
الخط الساخن للخدمات الصحية للنازحين اللبنانيين 1787   
الخط الساخن لدخول المرضى الى المستشفيات 01/832700   
التسجيل لأخذ لقاح الكورونا covax.moph.gov.lb   
الخط الساخن لوزارة الصحّة العامة 1214   
هل أنت مستخدم جديد؟ قم بالتسجيل الآن
 
تسجيل الدخول | إنشاء حساب
هل نسيت كلمة السرّ؟
دعنا نساعدك
للوصول إلى هدفك.
حمّل تطبيق وزارة الصحة العامة بنسخته الجديدة
لمعرفة آخر المستجدات عن فيروس كورونا

 
وصّل صوتك
# كون قدّ المسؤولية
أرسل أي شكوى او استفسار وساهم في التغيير

الدليل الوطني حول الممارسات الجيدة لليقظة الدوائية

 
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
 
    1
    2
    3
    4
    5
    6
    7
    ...
    14
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
الكل
التصنيف العلاجي الاسم أساسي / جنيسي التركيبة العلمية العيار الشكل الصيدلاني سعر المبيع من العموم
B05CX01 DEXTROSE 7.5% INJECTION USP G Glucose - 7.5% 7.5% Injectable solution 148,566 L.L
B05CX01 DEXTROSE 7.5% INJECTION USP G Glucose - 7.5% 7.5% Injectable solution 179,456 L.L
B05CX01 DEXTROSE 7.5% INJECTION USP G Glucose - 7.5% 7.5% Injectable solution 163,184 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 33g/100ml 33g/100ml Injectable solution 287,295 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 50g/100ml 50g/100ml Injectable solution 329,815 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 20g/100ml 20g/100ml Injectable solution 807,874 L.L
B02BX01 DICYNONE B Etamsylate - 250mg/2ml 250mg Injectable solution 482,439 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 300mg 300mg Injectable solution 123,001,362 L.L
B05DB DIANEAL PD4 1.36% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l 1.36% Injectable solution 1,163,270 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 300mg 300mg Injectable solution 123,001,362 L.L
B05DB DIANEAL PD4 CYCLER 1.36% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l Injectable solution 1,150,329 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 200mg 200mg Injectable solution 123,001,362 L.L
B05DB DIANEAL PD4 2.27% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l Injectable solution 1,163,270 L.L
D11AH05 DUPIXENT BioTech Dupilumab - 200mg 200mg Injectable solution 123,001,362 L.L
B05DB DIANEAL PD4 CYCLER 2.27% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l Injectable solution 1,150,329 L.L
B05DB DIANEAL PD4 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 1,111,506 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
H02AB02 DEXAMED G Dexamethasone - 8mg/2ml 8mg/2ml Injectable solution 2,998,113 L.L
H02AB02 DEXAMED G Dexamethasone - 8mg/2ml 8mg/2ml Injectable solution 338,648 L.L
H02AB02 DEXAMEDIS FORT G Dexamethasone Phosphate - 8mg/2ml 8mg/2ml Injectable solution 43,003 L.L
H02AB02 DEXAMETHASONE SODIUM PHOSPHATE USP - EIPICO G Dexamethasone (sodium phosphate) - 8mg/2ml 8mg/2ml Injectable solution 185,450 L.L
H02AB02 DEXASINA G Dexamethasone Phosphate - 8mg/2ml 8mg/2ml Injectable solution 3,471,145 L.L
H02AB02 DEXAMETHASON-PANPHARMA G Dexamethasone - 5mg/1ml 5mg/1ml Injectable solution 368,213 L.L
H02AB02 DEXAMETHASONE MEDIS G Dexamethasone Phosphate - 4mg/1ml 4mg/1ml Injectable solution 1,154,361 L.L
A11CC05 DIBASE G Vitamin D3 - 100,000IU/ml 100,000IU/ml Injectable solution 354,774 L.L
L01CD02 DOCETAXEL EBEWE G Docetaxel - 80mg/8ml 80mg/8ml Injectable solution 19,518,281 L.L
L01CD02 DOCETAXEL EBEWE G Docetaxel - 20mg/2ml 20mg/2ml Injectable solution 5,313,553 L.L
N05BA01 DIAZEPAM RENAUDIN G Diazepam - 10mg/2ml 10mg/2ml Injectable solution 514,692 L.L
R06AA02 DIPHENIST G Diphenhydramine HCl - 50mg/ml 50mg/ml Injectable solution 6,977,230 L.L
L01DB01 DOXO-CELL G Doxorubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 1,794,030 L.L
    1
    2
    3
    4
    5
    6
    7
    ...
    14
Sitemap
حقوق الطبع والنشر محفوظة ل وزارة الصحة العامة ©2025