UAE MOH GVP Guidlines Ver 1.2.pdf - Aspx

UAE MOH Guidelines in Good Vigilance Practice (GVP)
For Marketing Authorization Holders / Pharmaceutical

Manufacturers
In UAE
Drug Department
Public Health Policies and Licensing Sector
Ministry of Health and Prevention UAE
2018
UAE MOH Guidelines in Good Vigilance Practice (GVP) For Marketing Authorization Holders /
Pharmaceutical Manufacturers In UAE Page 1
Contents
Contents Page
1.Introduction 4
2. Pharmaceutical Manufacturer/ Marketing Authorization Holder (MAH)

and qualified Person Responsible for Pharmacovigilance (QPPV)
5
responsibilities ‫ت‬:
3. Pharmacovigilance System Master File (PSMF)
6
4. Risk Management System (RMS)
8
5. Reporting of adverse reactions to medicinal products ‫ة‬
10
6. Periodic Safety Update Reports (PSURs)
16
7. Post-authorization Safety Study (PASS)
18
8. Signal Management
19
9. Safety communication
20
10. Risk Minimization Measures (RMM)
22
11. References
27
ACRONYMS
MOHaP Ministry of Health and Prevention
DD Drug Department
PVMD Pharmacovigilance and Medical Device Section

EMA European Medicine Agency
EURD European Union reference dates
ICH International Conference for Harmonization
ICSR Individual Case Safety Report
LSR Local Safety Responsible
MAH Marketing Authorization Holder
PASS Post Authorization Safety Study
PBRER Periodic Benefit Risk Evaluation Report
PL Package Leaflet
PSMF Pharmacovigilance System Master File
PSUR Periodic Safety Update Report
PV Pharmacovigilance
QPPV Qualified Person Responsible for Pharmacovigilance
RMM Risk Minimization Measures
RMP Risk Minimization Plan
RMS Risk Management System
SmPC Summary of Product Characteristics
WHO World Health Organization
Introduction
Pharmacovigilance (PV) has been defined by the World health Organization (WHO) as the
science and activities relating to the detection, assessment, understanding and prevention
of adverse effects or any other medicine related problem.
This guideline was prepared as a result of the discussions and recommendations of the
National Pharmacovigilance committee of the Ministry of Health and Prevention and other
Local Health Authorities in UAE.
Since the national program for the vigilance of pharmaceutical drug information and
poison, seeks to identify the side effects of drug, categorize, analyze, monitor, control, and
assess the risks to find solutions to avoid them and to protect members of the community,
as well as to identify the adverse interactions between them and chemical medicines or
herbal and complementary medicines or food. And the program also seeks to promote
continuing education for drug safety and monitoring side effects and educate pharmacists,
doctors and community on the medicine safety reporting.
All pharmaceutical companies/ Marketing Authorization Holder (MAH) whose products

are registered and marketed in UAE must have a system in place for documenting following
Objectives:
 Pharmacovigilance systems and their quality systems
 Pharmacovigilance System Master File (PSMF)
 Pharmacovigilance Inspections
 Pharmacovigilance audits
 Risk management systems
 Management and reporting adverse reactions to medicinal
 Products Periodic safety update reports (PSURs)
 Post authorization safety studies
 Signal management
 Safety communication
 Risk minimization measures
Pharmaceutical Manufacturer/ Marketing Authorization Holder (MAH) and qualified Person
Responsible for Pharmacovigilance (QPPV) responsibilities:
A pharmacovigilance system is defined as a system used by an organization to fulfill its

legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor
the safety of authorized medicinal products and detect any change to their risk-benefit
balance.
A pharmacovigilance system, like any system, is characterized by its structures, processes
and outcomes. For each specific pharmacovigilance process, including its necessary
structures, a dedicated Module is included in GVP.
The MAH should ensure that it has an appropriate Pharmacovigilance System in place in
order to assume responsibility and liability for its products on the market and to ensure
that appropriate action may be taken when necessary. The MAH should therefore ensure
that all information relevant to the risk‐benefit balance of a medicinal product is reported
to the PV section/ Drug Department/ UAE MOHAP in accordance to these guidelines.
When submitting an application for new Pharmaceutical Product registration, the

Applicant, should submit a description of the pharmacovigilance System and submit proof
that the services of a Qualified Person Responsible for Pharmacovigilance (QPPV),
hereafter referred to as the QPPV, are in place.
The MAH shall have permanently and continuously at its disposal an appropriately QPPV
resident in UAE. For multinational MAHs a local safety responsible (LSR) may be accepted
Based in UAE. For local MAHs there should be a dedicated QPPV and he/she should be
resident in UAE. The names and 24 hours contact details of the nominated QPPV and his
alternate during absence should be submitted to PV section /Drug Department.
The MAH shall ensure that the QPPV has acquired adequate theoretical and practical
knowledge for the performance of PV activities. The QPPVs should have a minimum of
bachelor degree in pharmacy or medicine, a basic training in epidemiology and biostatistics
is desirable.
The QPPV shall be responsible for the establishment and maintenance of the marketing
authorization holder‘s Pharmacovigilance System and therefore shall have sufficient
authority to influence the performance of the quality system and the pharmacovigilance
activities and to promote, maintain and improve compliance with the legal requirements.
The applicant/MAH should provide the following requirements in order to get QPPV
approval:
1. Letter of appointment from the company not the agent
2. Training certificate in PV
3. Experience certificate in PV
4. List of products covered by the company
5. ADR case reports submitted in UAE. (Local companies to report ADR cases of their
products to the department within one year of the appointment)
6. SOP of the PV officer.
7. Graduation certificate ( minimum Bachelor Degree in Pharmacy or Medicine)
Pharmacovigilance System Master File (PSMF)
What is PSMF?
The Pharmacovigilance System Master File (PSMF) is a detailed description of the

Pharmacovigilance System used by the marketing authorization holder with respect to one
or more authorized medicinal products.
The content of the pharmacovigilance system master file should reflect global availability
of safety information for medicinal products authorized for the MAH, with information
on the pharmacovigilance system to the local or regional activities. Despite this fact,
pharmacovigilance activities on the national level as described in the PSMF may not be
applied to the same extent by all the MAH's national offices/ affiliates, furthermore, some
additional national requirements and details may also apply. Accordingly, multinational
MAHs/Applicants should provide clear illustration of the key elements of both global
pharmacovigilance system and national pharmacovigilance sub-system, highlighting the
role of QPPV, which pharmacovigilance activities are carried out in the KSA, which are
carried out in the headquarter/globally and how they integrate together.
For the Multinational MAH/Applicant the following two documents are required to have
1. The PSMF (according to European Good Pharmacovigilance Practice) and/ or,
2. National pharmacovigilance system file (national PVSF) which describes the key
elements of pharmacovigilance activities in the UAE.
The content of National PVSF is as follow:
 Roles and Responsibilities of the Marketing Authorization Holder
 Monitoring of Compliance and Pharmacovigilance Inspections
 Qualified Person Responsible for Pharmacovigilance (QPPV)
 Pharmacovigilance Plan
 Organizational chart
 Quality Management System
 Requirements for Risk Management Systems: Clinical & Non-clinical Part of the
Safety Specification
 Adverse Events/Adverse Reactions
 Identified and Potential Interactions including Food-Drug and Drug-Drug

interactions
 Epidemiology
 The Risk Minimization Plan.
 Requirements for Expedited Reporting of Individual Case Safety Reports
 Requirements for Reporting in Special Situations
 Requirements for Periodic Safety Update Reports
 Training
 Documentation
Location of PSMF
The PSMF shall be located (physically) either at the site where the main
Pharmacovigilance activities of the marketing authorization holder are performed or at
the site where the QPPV operates.
PSMF and product registration:

Only a summary of the MAH pharmacovigilance system is required to be included in the
marketing authorization application.
Changes to PSMF and Variations Applications

There is no requirement for variations for changes in the content of the pharmacovigilance
system master file. PSMF will be kept up to date by the MAH, without the need of
submitting variation applications. Only a notification letter and the updates should be
submitted to PV section/ Drug Department.
Risk Management System (RMS)
What is a Risk Management System (RMS)?

It is a set of pharmacovigilance activities and interventions designed to identify,
characterise, prevent or minimize risks relating to medicinal products including the
assessment of the effectiveness of those activities and interventions.
What is a Risk Management Plan (RMP)?

A detailed description of the risk management system.
What is Risk minimization activity?
An intervention intended to prevent or reduce the probability of the occurrence of an
adverse reaction associated with the exposure to a medicine or to reduce its severity
should it occur.
What are the obligations of MAHs for minimizing risk of medicines?

 Ensuring that they constantly monitor the risks of their medicines in compliance
with relevant legislation and report the results of this, as required, to PV & DID.
 Taking all appropriate actions to minimize the risks of their medicines and
maximize the benefits including ensuring the accuracy of all information produced
by the company in relation to its medicines, and actively updating and
communicating it when new information becomes available.
Overview of the parts and modules of the RMP
The RMP is divided into several parts, with the safety specifications of the RMP organized
into modules to increase flexibility.
Part I Product(s) Overview

Part II Safety Specification
Module SI: Epidemiology of the indication(s) and target population(s)
Module SII: Non‐clinical part of the Safety Specification
Module SIII: Clinical trial exposure
Module SIV: Populations not studied in clinical trials
Module SV: Post‐Authorization Experience
Module SVII: Identified and potential risks
Module SVI: Additional requirements for the Safety Specification in UAE
Module SVIII: Summary of the safety concerns
Part III Pharmacovigilance Plan
Part IV Plans for post‐authorization efficacy studies
Part V Risk minimization measures (including evaluation of the effectiveness of risk
minimization measures)
Part VI Summary of the RMP
Part VII Annexes
Submission and updates for the RMP
 RMP for new molecules should be submitted with the registration application.
 RMP for new innovator, biological, and biosimilar should be submitted with the
registration application.
 RMP for other registration status may be requested upon registration application.
Reporting of adverse reactions to medicinal products
This guide addresses the requirements which are applicable to the PV Section , Drug
Department, MOHAP, UAE, as regards the collection, data management and reporting of
suspected adverse reactions (serious and non‐serious) associated with medicinal
products for human use authorized in UAE. However, this guide does not address the
collection, management and reporting of events or patterns of use, which do not result
in suspected adverse reactions (e.g. asymptomatic overdose, abuse, off‐label use, and
misuse or medication error) or which do not require to be reported as individual case
safety report or as Emerging Safety Issues. This information may however need to be
collected and presented in periodic safety update reports for the interpretation of
safety data or for the benefit risk evaluation of medicinal products.
Reporting time frames:

In general, the reporting of serious valid ICSRs is required as soon as possible, but in no
case later than 5 working days after initial receipt of the information by any personnel of
the marketing authorization holder, including medical representatives and contractors.
This applies to initial information while follow‐up information should be submitted
within 15 calendar days. Where a case initially reported as serious becomes non‐serious,
based on new follow‐up information, this information should still be reported within 15
days; the reporting time frame for non‐ serious reports should then be applied for the
subsequent follow‐up reports.
 Reporting of non‐serious valid ICSRs is required within 09 days from the date of
receipt of the reports marketing authorization holders.
 Direct report of Counterfeit cases is requested.
Collection of reports:
A. Pharmacovigilance & Drug Information Department responsibilities

Pharmacovigilance & Drug Information Department has in place a system for the
collection and recording of unsolicited and solicited reports of suspected adverse
reactions that occur in its territory and which are brought to its attention by healthcare
professionals, consumers, or MAHs.
In this context, the reporting of suspected adverse drug reactions is possible by all health
care providers, consumers and MAH by means of:
 Straightforward paper based reporting forms, reporting to PV @moh.gov.ae
 Online reporting system
 Smart phone application
B. Marketing authorization holders’ responsibilities:

1. Each MAH shall have in place a system for the collection and recording of all
reports of suspected adverse reactions which are brought to its attention, whether
reported spontaneously by healthcare professionals or consumers or occurring in
the context of a post‐authorization study.
2. MAH shall establish mechanisms enabling the traceability and follow‐up of adverse
reaction reports while complying with the data protection legislation.
Pharmacovigilance data and documents relating to individual authorized
medicinal products shall be retained as long as the product is authorized and for
at least 10 years after the marketing authorization has ceased to exist.
Spontaneous reports
MAHs shall record all reports of suspected adverse reactions originating from within or
outside UAE, which are brought to their attention spontaneously by healthcare
professionals, or consumers. This includes reports of suspected adverse reactions
received electronically or by any other appropriate means.
Solicited reports
MAHs shall record all reports of suspected adverse reactions originating from within or
outside UAE, which occur in post‐authorization studies, initiated, managed, or financed
by them.
Case reports published in the scientific and medical literature

MAHs should monitor all the active substances for which they hold a marketing
authorization by accessing a widely used systematic literature review and reference
database.
Suspected adverse reactions related to quality defect or falsified

medicinal products
When a report of suspected adverse reactions is associated with a suspected or
confirmed counterfeit or falsified medicinal product or quality defect of a medicinal
product, a valid ICSR should be reported. The seriousness of the ICSR is linked to the
seriousness of the reported suspected adverse reactions.
MAHs should have a system in place to ensure that reports of suspected adverse reactions
related to falsified medicinal products or to quality defects of a medicinal product are
investigated in a timely fashion and that confirmed quality defects are notified separately
to the manufacturer and to PV section, Drug Department, MOHAP, UAE.
Suspected transmission via a medicinal product of an infectious agent

For the purposes of reporting, any suspected transmission of an infectious agent via a
medicinal product should be considered as a serious adverse reaction and such cases
should be reported within 15 days. If no other criterion is applicable, the seriousness of this
ICSR should be considered as important medical event .This also applies to vaccines.
In the case of medicinal products derived from human blood or human plasma,
haemovigilance procedures may also apply. Therefore the MAH should have a system in
place to communicate suspected transmission via a medicinal product of an infectious
agent to the manufacturer, the relevant blood establishment(s) and PVMD / DD in UAE
MOHaP.
Emerging safety issues
Events may occur, which do not fall within the definition of reportable valid ICSRs, and thus
are not subject to the reporting requirements, even though they may lead to changes in the
known risk‐benefit balance of a medicinal product and/or impact on public health.
Therefore, they should be notified as Emerging Safety Issues in writing to the PVMD / DD in
UAE MOHaP, where the medicinal product is authorized; this should be done immediately
when becoming aware of them.
Period between the submission of the marketing authorization application and the granting
of the marketing authorization:
In the period between the submission of the marketing authorization application and the
granting of the marketing authorization, information (quality, non‐clinical, clinical) that
could impact on the risk‐benefit balance of the medicinal product under evaluation may
become available to the applicant. It is the responsibility of the applicant to ensure that this
information is immediately submitted in accordance with the modalities described to
PVMD / DD in UAE MOHaP when the application is under assessment.
Reporting time frames:

The general rules in relation to the reporting of initial and follow‐up reports, including
those for defining the clock start are detailed. Reporting timeframes are as follows:
 Serious domestic valid ICSRs shall be reported to PVMD / DD in UAE MOHaP, by

MAHs within 15 days from the date of receipt of the reports;
 Non-serious domestic valid ICSRs shall be reported to DPV&DI, DGPA&DC, UAE
by MAHs within 09 days from the date of receipt of the reports.
 Reporting of international cases is required to be reported through the

PSUR/PBRER.
Periodic Safety Update Reports (PSURs)
What is Periodic Safety Update Reports (PSURs)
Periodic safety update reports (PSURs) are PV documents intended to provide an

evaluation of the risk‐benefit balance of a medicinal product for submission by MAHs at
defined time points during the post‐authorization phase.
The PSUR should focus on summary information, scientific safety assessment and
integrated benefit‐risk evaluation.
The obligations imposed in respect of PSURs should be proportionate to the risks posed
by medicinal products. PSUR reporting should therefore be linked to the risk
management systems of a medicinal product. As part of the assessment, it should be
considered whether further investigations need to be carried out and whether any action
concerning the marketing authorizations of products containing the same active
substance or the same combination of active substances, and their product information is
necessary.
The main objective of a PSUR is to present a comprehensive, concise and critical analysis
of the risk‐benefit balance of the medicinal product taking into account new or emerging
information in the context of cumulative information on risks and benefits. The PSUR is
therefore a tool for post‐authorization evaluation at defined time points in the lifecycle of
a product. For the purposes of lifecycle benefit‐risk management, it is necessary to
continue evaluating the risks and benefits of a medicine in everyday medical practice and
long‐term use in the post‐authorization phase.
Format and contents of the PSUR:
The required format and content of PSURs are based on those for PSUR described in the
European Good Pharmacovigilance Practice as well as for the Periodic Benefit Risk
Evaluation Report (PBRER) described in the ICH‐E2C (R2) guideline. The PBRER format
replaces the PSUR format previously described in the ICH‐E2C (R1). In UAE, the report
shall be described and named as either as PSUR or PBRER.
Timelines for PSUR submission:

 Within 70 calendar days of the data lock point (day 0) for PSURs covering
intervals up to 12 months (including intervals of exactly 12 months); and
 Within 90 calendar days of the data lock point (day 0) for PSURs covering
intervals in excess of 12 months; ad hoc PSURs should be submitted
within 90 calendar days of the data lock point.
 PSUR Frequencies to be harmonized with EURD calendar.
Training of staff members related to the PSUR process:

For all organizations, it is the responsibility of the person responsible for the
pharmacovigilance system to ensure that the personnel, including pharmacovigilance,
quality personnel involved in the preparation, review, quality control, submission and
assessment of PSURs are adequately qualified, experienced and trained according to the
applicable guidelines.
Post-authorization Safety Study (PASS)
What is PASS?
A post authorization safety study (PASS) is defined as any study relating to an

authorized medicinal product conducted with the aim of identifying, characterizing or
quantifying a safety hazard, confirming the safety profile of the medicinal product, or of
measuring the effectiveness of risk management measures.
A PASS may be initiated, managed or financed by a MAH voluntarily, or pursuant to an

obligation imposed by PVMD / DD in UAE MOHAP.
 The Module concerns PASS which are clinical trials or non‐interventional studies
and does not address non‐clinical safety studies. A PASS is non‐interventional if
the following requirements are cumulatively fulfilled:
 the medicinal product is prescribed in the usual manner in accordance with the
terms of the marketing authorizations;
 the assignment of the patient to a particular therapeutic strategy is not decided in

advance by a trial protocol but falls within current practice and the prescription of
the medicine is clearly separated from the decision to include the patient in the
study; and
 No additional diagnostic or monitoring procedures are applied to the patients and

epidemiological methods are used for the analysis of collected data.
Non‐interventional studies are defined by the methodological approach used and not by Its
scientific objectives. Non‐interventional studies include database research or review of
records where all the events of interest have already happened (this may include case‐
control, cross‐sectional, cohort or other study designs making secondary use of data). Non‐
interventional studies also include those involving primary data collection (e.g. prospective
observational studies and registries in which the data collected derive from routine clinical
care), provided that the conditions set out above are met. In these studies, interviews,
questionnaires and blood samples may be performed as part of normal clinical practice.
Signal Management
A signal is defined as information that arises from one or multiple sources (including
observations and experiments), which suggests a new potentially causal association, or a
new aspect of a known association, between an intervention and an event or set of related
events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify an
action.
The signal management process can be defined as the set of activities performed to
determine whether, based on an examination of individual case safety reports (ICSRs),
aggregated data from active surveillance systems or studies, literature information or
other data sources, there are new risks associated with an active substance or a
medicinal product or whether known risks have changed.
The signal management process concerns all stakeholders involved in the safety
monitoring of medicinal products including patients, healthcare professionals, MAHs,
regulatory authorities, scientific committees. Whereas the ADRs database will be a major
source of pharmacovigilance information, the signal management process covers signals
arising from any source, only signals related to an adverse reaction shall be considered.
The signal management process covers all steps from detecting signals to recommending
action(s) as follows:
 signal detection;
 signal validation;
 signal analysis and prioritization;
 signal assessment;
 recommendation for action;
 Exchange of information.
Safety communication
Safety communication module provides guidance to MAH), national medicines authorities

on how to communicate and coordinate safety information. Communicating safety
information to patients and healthcare professionals is a public health responsibility and is
essential for achieving the objectives of pharmacovigilance in terms of promoting the
rational, safe and effective use of medicines, preventing harm from adverse reactions and
contributing to the protection of patients‘ and public health. Safety communication is a
broad term covering different types of information on medicines, including statutory
information as contained in the product information (i.e. the Summary of Product
Characteristics (SmPC), Package Leaflet (PL) and the labeling of the packaging).
The primary target audiences for safety communication issued by regulatory authorities
and marketing authorization holders should be patients and healthcare professionals
who use (i.e. prescribe, handle, dispense, administer or take) medicinal products
As primary target audiences, healthcare professionals play an essential role. Effective

safety communication enables them to give clear and useful information to their patients,
thereby promoting patient safety and confidence in the regulatory system. Both
healthcare professionals in clinical practice and those involved in clinical trials should be
provided with appropriate information on any safety concern at the same time.
Patient, consumer and healthcare professional organizations can play a role as

multipliers as they can disseminate important safety information to target audiences.
The media is also a target audience for safety communication. The capacity of the media
to reach out to patients, healthcare professionals and the general public is a critical
element for amplifying new and important information on medicines. The way safety
information is communicated through the media will influence the public perception and
it is therefore important that the media receives safety information directly from the
national medicines authorities in addition to the information they receive from other
sources, such as from the MAHs.
Means of Safety Communication
 Direct healthcare professional communication (DHPC)

 Documents in lay language
 Press communication
 Website
 Other web based communications
 Bulletins and newsletter
 Inter authorities communication
 Responding to enquiries from the public
Risk Minimization Measures (RMM)
What is RMM?
Risk Since the national program for the vigilance of pharmaceutical drug information and
poison, and seeks to identify the side effects of drug and categorized and analyzed, and
ways to monitor and control, as well as pharmaceutical and error how to assess the risks
and find solutions to avoid them and to protect members of the community solutions and
sick of the negative effects, as well as to identify the adverse interactions between them and
chemical medicines or herbal and complementary medicines or food. And the program also
seeks to promote continuing education for drug safety and monitoring side effects to him
and educate pharmacists, doctors, community awareness of the reports of the safety of
medicines measures are interventions intended to prevent or reduce the occurrence of
adverse reactions associated with the exposure to a medicine, or to reduce their severity or
impact on the patient should adverse reactions occur. Planning and implementing risk
minimization measures and assessing their effectiveness are key elements of risk
management. Risk minimization measures may consist of routine risk minimization or
additional risk minimization measures. Routine risk minimization is applicable to all
medicinal products, and involves the use of the following tools.
 the Summary of Product Characteristics (SmPC);
 the Package Leaflet (PL);
 the labeling;
 the pack size and design;
 The legal (prescription) status of the product.
Risk minimization measures aim to optimize the safe and effective use of a medicinal
product throughout its life cycle. The risk‐benefit balance of a medicinal product can be
improved by reducing the burden of adverse reactions or by optimizing benefit, through
targeted patient selection and/or exclusion and through treatment management (e.g.
specific dosing regimen, relevant testing, patient follow‐up). Risk minimization measures
should therefore guide optimal use of a medicinal product in medical practice with the
goal of supporting the provision of the right medicine, at the right dose, at the right time,
to the right patient and with the right information and monitoring. Additional risk
minimization activities should only be introduced when they are deemed to be essential
for the safe and effective use of the medicinal product and should be developed and
provided by suitably qualified people.
Educational programs
Are based on targeted communication with the aim to supplement the information in the
summary product characteristics (SmPC) and package leaflet. Any educational material
should focus on actionable goals and should provide clear and concise messages
describing actions to be taken in order to prevent and minimize selected safety concerns.
The aim of an educational program

Is to improve the use of a medicine by positively influencing the actions of healthcare
professionals and patients towards minimizing risk. Educational materials should
therefore be built on the premise that there is an actionable recommendation for
targeted education and that applying this measure is considered essential for minimizing
an important risk and/or for optimization of the risk‐benefit balance. Ideally,
educational materials should be available in a range of formats so as to ensure that access
is not limited by disability or access to the internet. When feasible the appropriateness of
the tool and media for the target audience (e.g. suitable language, pictures, diagrams, or
other graphical support) should be user tested in advance, in order to optimize the
success of the implementation phase.
The content of any educational material

Should be fully aligned with the currently approved product information for a medicinal
product, such as the SmPC and package leaflet, and should add rather than duplicate
SmPC and package leaflet information. Promotional elements, either direct or veiled (e.g.
logos, product brand colors, suggestive images and pictures), should not be included and
the focus of the educational material should be on the risk(s) related to the product and
the management of those risk(s) requiring additional risk minimization.
Educational tools
Should focus on clearly defined actions related to specific safety concerns described in
the RMP and should not be unnecessarily diluted by including information that is not
immediately relevant to the safety concern and that is adequately presented in the SmPC
or package leaflet. Educational tools should refer the reader to the SmPC and the package
leaflet. In addition to an introductory statement that the educational material is essential
to ensure the safe and effective use and appropriately manage important selected risks,
elements for inclusion in an educational tool could provide:
 guidance on prescribing, including patient selection, testing and monitoring;

 guidance on the management of such risks (to healthcare professionals and patients or
carers);
 Guidance on how and where to report adverse reaction of special interest.
Educational tools targeting healthcare professionals:
The aim of any educational tool targeting a healthcare professional should be to deliver
specific recommendation(s) on the use (what to do) and/or contraindication(s) (what not
to do) and/or warnings (how to manage adverse reactions) associated with the medicine
and the specific important risks needing additional risk minimization measures, including:
 selection of patients;
 treatment management such as dosage, testing and monitoring;
 special administration procedures, or the dispensing of a medicinal product;
 Details of information which needs to be given to patients.
The format of a particular tool will depend upon the message to be delivered. For example,
where a number of actions are needed before writing a prescription for an individual
patient, a checklist may be the most suitable format. A brochure may be more appropriate
to enhance awareness of specific important risks with a focus on the early recognition and
management of adverse reactions, while posters for display in certain clinical
environments can include helpful treatment or dosage reference guides. Other formats may
be preferable, depending on the scope of the tool.
Educational tools targeting patients and/or carers:
The aim of tools targeting patients should be to enhance the awareness of patients or their
carers on the early signs and symptoms of specific adverse reactions causing the need for
additional risk minimization measures and on the best course of action to be taken should
any of those symptoms occur. If appropriate, a patient‘s educational tool could be used to
provide information on the correct administration of the product and to remind the patient
about an important activity, for example a diary for posology or diagnostic procedures that
need to be carried out and recorded by the patient and eventually discussed with healthcare
professionals, to ensure that any steps required for the effective use of the product are
adhered to.
Patient alert card

The aim of this tool should be to ensure that special information regarding the patient‘s
current therapy and its important risks (e.g. potential life‐threatening interactions with
other therapies) is held by the patient at all times and reaches the relevant healthcare
professional as appropriate. The information should be kept to the minimum necessary
to convey the key minimization message(s) and the required mitigating action, in any
circumstances, including emergency. Ability to carry with ease (e.g. can be fitted in a
wallet) should be a key feature of this tool.
References
1. Pharmacovigilance Practice (GVP) for Arab Countries for Medicinal Products for
Human Use (Version 3),
2. International Conference for Harmonization (ICH)
3. European Medicine Agency (EMA) guidelines.

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UAE MOH Guidelines in Good Vigilance Practice (GVP)

For Marketing Authorization Holders / Pharmaceutical

2. Pharmaceutical Manufacturer/ Marketing Authorization Holder (MAH)

MOHaP Ministry of Health and Prevention

PVMD Pharmacovigilance and Medical Device Section

All pharmaceutical companies/ Marketing Authorization Holder (MAH) whose products

A pharmacovigilance system is defined as a system used by an organization to fulfill its

When submitting an application for new Pharmaceutical Product registration, the

Pharmacovigilance System Master File (PSMF)

The Pharmacovigilance System Master File (PSMF) is a detailed description of the

1. The PSMF (according to European Good Pharmacovigilance Practice) and/ or,

The content of National PVSF is as follow:

 Roles and Responsibilities of the Marketing Authorization Holder

 Monitoring of Compliance and Pharmacovigilance Inspections

 Qualified Person Responsible for Pharmacovigilance (QPPV)

 Quality Management System

 Adverse Events/Adverse Reactions

 Identified and Potential Interactions including Food-Drug and Drug-Drug

 The Risk Minimization Plan.

 Requirements for Expedited Reporting of Individual Case Safety Reports

 Requirements for Reporting in Special Situations

PSMF and product registration:

Changes to PSMF and Variations Applications

Risk Management System (RMS)

What is a Risk Management System (RMS)?

What is a Risk Management Plan (RMP)?

What is Risk minimization activity?

What are the obligations of MAHs for minimizing risk of medicines?

Overview of the parts and modules of the RMP

Part I Product(s) Overview

Submission and updates for the RMP

Reporting of adverse reactions to medicinal products

Reporting time frames:

 Direct report of Counterfeit cases is requested.

A. Pharmacovigilance & Drug Information Department responsibilities

B. Marketing authorization holders’ responsibilities:

Case reports published in the scientific and medical literature

Suspected adverse reactions related to quality defect or falsified

Suspected transmission via a medicinal product of an infectious agent

Emerging safety issues

Reporting time frames:

 Serious domestic valid ICSRs shall be reported to PVMD / DD in UAE MOHaP, by

 Reporting of international cases is required to be reported through the

What is Periodic Safety Update Reports (PSURs)

Periodic safety update reports (PSURs) are PV documents intended to provide an

Timelines for PSUR submission:

 PSUR Frequencies to be harmonized with EURD calendar.

Training of staff members related to the PSUR process:

A post authorization safety study (PASS) is defined as any study relating to an

A PASS may be initiated, managed or financed by a MAH voluntarily, or pursuant to an

 the assignment of the patient to a particular therapeutic strategy is not decided in

 No additional diagnostic or monitoring procedures are applied to the patients and

Safety communication module provides guidance to MAH), national medicines authorities

As primary target audiences, healthcare professionals play an essential role. Effective

Patient, consumer and healthcare professional organizations can play a role as

Means of Safety Communication

 Direct healthcare professional communication (DHPC)

The aim of an educational program

The content of any educational material