Sultanate of Oman

Ministry of Health
Directorate General of Pharmaceutical Affairs and Drug Control

Department of Pharmacovigilance and Drug Information

Guideline on Good Pharmacovigilance Practices in Oman

For
MAHs/ Pharmaceutical Companies

Version 1, 2017
Contents

Chapter Page

1. Introduction 3

2. Responsibilities of MAHs/ Pharmaceutical Companies & QPPV 4

3. Pharmacovigilance System Master File (PSMF) 6

4. Pharmacovigilance Inspection 7

5. Risk Management System (RMS) 9

6. Management of adverse reactions to medicinal products 11

7. Periodic Safety Update Report 9PSUR) 16

8. Post-Authorization Safety Study (PASS) 19

9. Signal Management 20

10. Safety Communication 22

11. Risk Minimization Measures (RMM) 24

Acronyms 29

References 30

2 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 1. 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 has been developed to bring guidance on the requirements, procedures,
roles and activities in the field of PV, for Marketing Authorization Holders (MAH) of
medicinal products for human use in Oman. Pharmacovigilance obligations apply to all
products available in Oman, including the registered and non-registered products.

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

are registered and marketed in Oman have to have a system in place for documenting the
objectives laid down in the GVP modules viz.,

1- Pharmacovigilance systems and their quality systems

2- Pharmacovigilance System Master File (PSMF)
3- Pharmacovigilance Inspections
4- Pharmacovigilance audits
5- Risk management systems
6- Management and reporting adverse reactions to medicinal products
7- Periodic safety update reports (PSURs)/ Periodic Benefit Risk Evaluation Report
(PBRER)
8- Post authorization safety studies
9- Signal management
10- Safety communication
11- Risk minimization measures.

The requirements explained in this guideline are based on the Guideline on Good
Pharmacovigilance Practice (GVP) for Arab Countries for Medicinal Products for Human
Use (Version 2), International Conference for Harmonization (ICH) and the European
Medicine Agency (EMA) guidelines.

3 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 2. Responsibilities of Marketing Authorization Holder (MAH)
Pharmaceutical Companies/ and Qualified Person Responsible for
Pharmacovigilance (QPPV):
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 Department of Pharmacovigilance & Drug Information (DPV & DI) fully and on time
in accordance with the guideline.

When submitting an application for a marketing authorisation, the Applicant, in

preparation for the role and responsibilities as MAH, 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 Oman or any other Gulf Cooperation Council (GCC) country. For multinational
MAHs, who do not have a scientific office in any of the GCC countries can designate a local
safety responsible (LSR), on behalf of the local agent in Oman. For local MAHs, there should
be a dedicated QPPV and he/she should be resident in Oman. The names and 24 hours
contact details of the nominated QPPV and his alternate during absence should be
submitted to DPV&DI.

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.

4 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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.

5 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 3. 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.

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.

Summary of the PSMF

Only a summary of the applicant’s pharmacovigilance system is required to be included

in the marketing authorization application.

Contents of PSMF

The PSMF contents and format shall be according to the current version of Arab GVP.

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 for changes to the ‘PSMF Summary’, Variation
Applications should be submitted.

6 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 4. Pharmacovigilance Inspection
In order to determine that marketing authorisation holders comply with
pharmacovigilance obligations, and to facilitate compliance, the DPV & DI will conduct,
pharmacovigilance inspections of MAHs or any firms employed to fulfil marketing
authorisation holder‘s pharmacovigilance obligations.

Pharmacovigilance Inspections will be routine as well as targeted to MAHs suspected of

being non-compliant. The results of an inspection will be provided to the inspected MAH
who will be given the opportunity to comment on the any non-compliance identified. In
case that the outcome of the inspection of the marketing authorization holder does not
comply with the pharmacovigilance obligations, the DGPA & DC shall take the necessary
measures to ensure that a marketing authorization holder is subject to effective,
proportionate and dissuasive penalties.

The objectives of pharmacovigilance inspections are:

 to determine that the marketing authorization holder has personnel, systems and
facilities in place to meet their pharmacovigilance obligations;
 to identify, record and address non-compliance which may pose a risk to public
health;
 To use the inspection results as a basis for enforcement action, where considered
necessary.

For the structure and process of Pharmacovigilance Inspection, refer to the current
version of Arab GVP.
What routine PV inspection may include

 Individual Case Safety Reports (ICSRs)

 Periodic safety update reports (PSURs)
 Ongoing safety evaluation
 Interventional (where appropriate) and non-interventional clinical trials
 Pharmacovigilance system

7 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
The inspection may also include the system for the fulfillment of conditions of a marketing
authorization and the implementation of risk–minimization activities, as they relate to any
of the above safety topics.

Obligations of MAH


Marketing authorization holders with authorized products and applicants who have
submitted new applications are subject to pharmacovigilance inspections. Therefore, both
have responsibilities in relation to inspections, including but not limited to the following:

 Always to be inspection-ready as inspections may be unannounced or in short

notice.

 To maintain and make available to the inspectors on request, no later than 14

calendar days after the receipt of a request, the pharmacovigilance system master
file.

 To ensure that the sites viz., the manufacturing site/the-scientific office responsible
for PV activities/Local agent in the country, selected for inspection, which may
include firms employed by the marketing authorization holder to perform
pharmacovigilance activities, agree to be inspected before the inspection is
performed.

 To make available to the inspectors any information and/or documentation

required for the preparation of the inspection within the deadline given or during
the conduct of the inspection.

 To ensure that relevant staff/ designated person involved in pharmacovigilance

activities or related activities are present and available during the inspection for
interviews or clarification of issues identified.

 To ensure that relevant pharmacovigilance data is accessible from one point.

 To ensure that appropriate and timely corrective and preventive action plans are
implemented to address findings observed during an inspection, with appropriate
prioritization of critical and/or major findings.

8 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 5. 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 minimise risks relating to medicinal products including the
assessment of the effectiveness of those activities and interventions.

The MAHs shall submit global/EU or Core RMP as part of the risk management system.

What is a Risk Management Plan (RMP)?

A detailed description of the risk management system.

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 DPV & DI.

 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 Oman (on request)

9 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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

Note:

Generic products are exempted from submission of RMPs, however on request they need to
adhere to any new safety measures as part of the RMP on request from the DPV & DI.

During New Registration of medicinal products, RMP shall be submitted along with eCTD
dossier. Any RMP updates need shall be submitted to DPV & DI with a copy to Registration
Section in Drug control department. The MAH is obliged to submit RMP on an emerging
safety issue in situations that has particular reference to a region as well, on request from
the DPV & DI.

RMP shall be submitted as EU/ Core or Global.

10 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 6. Management and reporting of adverse reactions to medicinal
products
This guide addresses the requirements, which are applicable to the DPV & DI, 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 Oman. 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 all domestic serious valid ICSRs is required as soon as
possible, but in no case later than 15 calendar days after initial receipt of the information
by any personnel of the marketing authorization holder, including medical
representatives and contractors. This applies to initial and follow-up information. 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 all domestic non-serious valid ICSRs is required within 90 calendar

days from the date of receipt of the reports marketing authorization holders.

11 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
Collection of reports:

A. Department of Pharmacovigilance & Drug Information responsibilities

Department of Pharmacovigilance & Drug Information 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,

 Web-based formats (www.moh.gov.om).

 Mobile Smart Application: Esehaty.

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 that 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 Oman, which are brought to their attention spontaneously by healthcare

12 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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 Oman, 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 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 DPV & DI.

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

13 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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) to DPV & DI, DGPA & DC,
Oman.

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 DPV & DI,
DGPA & DC, Oman where the medicinal product is authorized or available; this should be
done immediately on 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 DPV
& DI, DGPA & DC, Oman, when the application is under assessment.

During this period, the MAH is not mandated to follow any reporting modality unless there
is any emerging safety issue that need to be communicated to DPV & DI either manually or
through the MOH website.

14 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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 DPV & DI, DGPA & DC, Oman, 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, Oman
by MAHs within 90 days from the date of receipt of the reports.

 Reporting of foreign / international cases is not required.

15 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 7. Periodic Safety Update Reports (PSURs)/ PBRER
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.

16 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
Format and contents of the PSUR:

The scope, objectives, format and content of the PSUR are described in current GVP for
Arab countries. The required format and content of PSURs are based on those 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).
The primary objective of the PSUR was to provide a comprehensive picture of the safety of
approved medicinal products. With recognition that the assessment of the risk of a
medicinal product is most meaningful when considered in light of its benefits, the proposed
report would provide greater emphasis on benefit than the PSUR, particularly when risk
estimates change importantly. In such cases there will need to be an overall explicit
evaluation of benefit- risk. Consequently, the name of the proposed report is the “Periodic
Benefit -Risk Evaluation Report” (PBRER). The PBRER would also provide greater
emphasis on the cumulative knowledge regarding a medicinal product, while retaining a
focus on new information.

In Oman, the report shall be described / named and submitted as either PSUR or PBRER,
which is based on the EU/ICH guideline.

Timelines for PSUR /PBRER 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.

 PBRER submissions for newly approved products shall be based on the

EURD reference list.

17 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
Training of staff members related to the PSUR/ PBRER 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.

18 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 8. 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, characterising 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 DPV & DI.

 The Module concerns of PASS 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:

o the medicinal product is prescribed in the usual manner in accordance

with the terms of the marketing authorizations;

o 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

o 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.
19 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical
Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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.

20 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 9. 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.

21 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 10. 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 labelling of the
packaging).

The primary target audiences for safety communication issued by regulatory authorities
and marketing authorisation 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

22 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
it is therefore important that the media receive safety information directly from the
national medicines authorities in addition to the information they receive from other
sources, such as from the MAHs.

Content of safety communication:

Refer to current GVP for Arab countries.

Means of Safety Communication

 Direct healthcare professional communication (DHPC)

 Documents in lay language
 Press communication
 Website
 Other web-based communications
 Bulletins and newsletter
 Inter-authority communication
 Responding to enquiries from the public

Note:
Any safety update in any format, which need to be communicated to healthcare
professionals or public, the same text format, should be approved by DPV & DI before it is
communicated.

23 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
 11. Risk Minimisation Measures (RMM)
What is RMM?
Risk minimisation 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
minimisation measures and assessing their effectiveness are key elements of risk
management. Risk minimisation measures may consist of routine risk minimisation or
additional risk minimisation measures. Routine risk minimisation 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 labelling;
 the pack size and design;
 the legal (prescription) status of the product.
Risk minimisation measures aim to optimise 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 optimising benefit, through
targeted patient selection and/or exclusion and through treatment management (e.g.
specific dosing regimen, relevant testing, and patient follow-up). Risk minimisation
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 minimisation 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.

24 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
Educational programmes

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 programme

Is to improve the use of a medicine by positively influencing the actions of healthcare

professionals and patients towards minimising 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 minimising
an important risk and/or for optimisation of the risk-benefit balance. Ideally,
educational materials should be available in a range of formats 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 optimise 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 colours, 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 minimisation.

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

25 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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 minimisation 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 that 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.

26 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
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 minimisation 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 minimisation 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.
Other risk minimisation measures:

Controlled distribution systems

A controlled distribution system refers to the set of measures implemented to ensure

that the stages of the distribution chain of a medicinal product are tracked up to the
prescription and/or pharmacy dispensing the product.

Pregnancy prevention programme (PPP) is a set of interventions aiming to minimise

pregnancy exposure during treatment with a medicinal product with known or potential

27 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
teratogenic effects. The scope of such a programme is to ensure that female patients are not
pregnant when starting therapy or do not become pregnant during the course and/or soon
after stopping the therapy. It could also target male patients when use of a medicinal
product by the biological father might have a negative effect on pregnancy outcome.

Any additional risk minimization measures introduced on a product should be made

known to the DPV& DI, DGPA & DC, Oman, and the proposal of the plan need to be
submitted and prior approval need to be taken before implementing any such strategy.

28 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
ACRONYMS

DGPA & DC Directorate General of Pharmaceutical Affairs and Drug Information

EMA European Medicine Agency
GCC Gulf Cooperation Council
GVP Good Pharmacovigilance Practice
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
DPV & DI Pharmacovigilance & Drug Information Department
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

29 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017
References
1. Pharmacovigilance Practice (GVP) for Arab Countries for Medicinal Products for Human
Use (Version 2),

2. International Conference for Harmonization (ICH)

3. European Medicine Agency (EMA) guidelines.

30 Guideline on Good Pharmacovigilance Practices in Oman for MAHs/ Pharmaceutical

Companies| Department of Pharmacovigilance & Drug Information, DGPA & DC –MOH,
Oman
Version 1, 2017