Guideline on Good PharmacovigilancePractices ( GVP)for Arab countries

Done by :-Dr./ Nahla Raafat

Outlines of the presentation• Introduction• Module I– Pharmacovigilance systems and their quality systems• Module II- Pharmacovigilance system master file (PSMF)• Module III – Pharmacovigilance inspections• Module IV – Pharmacovigilance audits• Module V – Risk Management Systems• Module VI –Management and reporting of adverse reactions to

medicinal products• Module VII - Periodic safety update report (PSUR)• Module VIII – Post authorization safety studies• Module IX – Signal management• Module X– Additional monitoring• Module XV – Safety communication

Introduction

Background

• Arab world comprises 22 countries and territories

• Under the umbrella of Arab League, ministers of healthestablished a higher technical committee for medicineswith representatives from most of the Arab countries &lead by the head of Egyptian PV center (Dr.Amr Saad)

• Common PV& bioequivalence guidelines: ''GoodPharmacovigilance Practice for Arab Countries'' (GVP-Arab) & Harmonized Arab Guideline on Bioequivalenceof Generic Pharmaceutical Products

• This guideline is greatly adopted from the EuropeanGood Pharmacovigilance Practices (EU GVP)

Current Situation in Arab World

• Egypt, Saudi Arabia and Jordan already have very strong regulations inpharmacovigilance based in their drug regulatory authorities

• Morocco has a collaborating PV center with the WHO.• Tunisia has pharmacovigilance centers located outside drug regulatory

authorities.• United Arab Emirates, Oman, Kuwait, Iraq, Sudan and Syria has

pharmacovigilance centers located within drug regulatory authorities.

16 different modules, together withsome product/population specificconsiderations as well as annexes andtemplates of submission

Each GVP module represents onemajor PV process

The guideline version I was publishedin March 2014 and version II waspublished in December 2014 and theeffective date will be 1stJuly 2015

ModulesModule I Pharmacovigilance systems and their quality systemsModule II Pharmacovigilance system master fileModule III Pharmacovigilance inspectionsModule IV Pharmacovigilance auditsModule V Risk Management SystemsModule VI Management and reporting of adverse reactions to medicinal productsModule VII Periodic safety update report (PSUR)Module VIII Post authorization safety studiesModule IX Signal managementModule X Additional monitoringModule XI Public participation in pharmacovigilanceModule XII Continuous pharmacovigilance, ongoing benefit-risk evaluation,

regulatory action and planning of public communicationModule XIV International cooperationModule XV Safety communicationModule XVI Risk minimization measures: selection tools and effectiveness indicators

Recent developments &Change in ideology

From To

Assessment of whether MAHs haveinfrastructures or not(described in Detailed Description ofPharmacovigilance System (DDPS)

Assessing the intelligence of such infrastructures(described now in Pharmacovigilance systemmaster file (PSMF)

Assessing only Periodic Safety (described inPSURs)

Assessing Benefit/Risk ratio (described inPeriodic Benefit Risk Evaluation reports (PBRER)

Assessing only submitted documents Performing pharmacovigilance audits andinspections.

Relying on Standard Operating Procedure(SOPs) of performance

Assessing quality systems as a whole.

Depending only on DDL for urgent safetyevaluation

Make use of recent revolution of internetconnection.

Acting reactively Acting proactively by adding more weight toRMPs and risk minimization activities

Adding more weight on Public participation and international co- operation.

Module I– Pharmacovigilancesystems and their quality systems

• Ensuring that the organization documents the quality system• Ensuring that the documents describing the quality system are

subject to document control• Ensuring that adequate resources are available and that

training is provided• Ensuring that suitable and sufficient premises, facilities and

equipment are available• Ensuring adequate compliance management• Ensuring adequate record management• Auditing: reviewing the pharmacovigilance system including

its quality system at regular intervals in risk- based manner toverify its effectiveness & introducing corrective and preventivemeasures where necessary

• Ensuring that mechanisms exist for timely and effectivecommunication, including escalation the non-adherence tothe requirements of the quality and pharmacovigilancesystems and taking corrective, preventive and escalationaction as necessary

Responsibilities for the quality system

• Continuous benefit-risk evaluation of medicinal products• Establishing, assessing and implementing risk management systems and

evaluating their effectiveness• Collection, processing, management, quality control, follow-up for missing

information, coding, classification, duplicate detection, evaluation andtimely electronic transmission of (ICSRs) from any source

• Signal management• Scheduling, preparation, submission and assessment of PSURs• Meeting commitments and responding to requests from national medicines

authorities• Interaction between the PV and product quality defect systems• Communicating safety changes with RA• Communicating information to patients and healthcare professionals about

changes to the risk-benefit balance of products• Keeping product information up-to-date with the current scientific

knowledge• Implementation of variations to marketing authorizations for safety reasons

Critical pharmacovigilance processes

Module II- Pharmacovigilance systemmaster file (PSMF)

• The PSMF is a detailed description of thepharmacovigilance system used by the MAH withrespect to one or more authorized medicinal products.

• Location PSMF shall be located either at the site where the main

pharmacovigilance activities of the marketing authorizationholder are performed or at the site where the qualifiedperson responsible for pharmacovigilance operates.

Details about the location of the PSMF are required to benotified to the national medicines authority, and any changeto the location shall be notified immediately to the nationalmedicines authority

• There is NO requirement for variations for changes inthe content of the PSMF.

• The PSMF shall be maintained in a current state and bepermanently available to the QPPV

• Change control, logbook, versions and archiving:Changes to the PSMF should be recorded, such that a history ofchanges is available (specifying the date and the nature of thechange), descriptive changes to the PSMF must be recorded in alogbook

• PSMF Registration:Each national medicines authority in the Arab Countriesshould manage a national list/database which provides apractical mechanism for maintaining up-to-date informationabout:

the MAH's (or contractual partner) PSMF

its status

its location

the QPPV &/or LSR contact information

the products relevant to the pharmacovigilance system described in the PSMF

Information to be contained in the PSMF (Sections of the PSMF)

1 • Qualified person responsible for pharmacovigilance (QPPV)• Qualified person responsible for pharmacovigilance (QPPV)

2 • Organizational structure of the marketing authorization holder (MAH)• Organizational structure of the marketing authorization holder (MAH)

3 • Sources of safety data• Sources of safety data

4 • Computerized systems and databases• Computerized systems and databases

5 • Pharmacovigilance processes• Pharmacovigilance processes

6 • Pharmacovigilance system performance• Pharmacovigilance system performance

7 • Quality system• Quality system

8 • Annex to the PSMF• Annex to the PSMF

Special considerations for the multinationalMAHs/applicants

Two documents are required

The PSMF (according to European GoodPharmacovigilance Practice which is the

base for this guideline)

National pharmacovigilance sub-systemfile (national PSSF) which describes the

key elements of pharmacovigilanceactivities in the Arab County concerned

Module III – Pharmacovigilanceinspections

1. Determine that the marketing authorization holder has personnel,systems and facilities in place to meet their pharmacovigilance obligations

2. identify, record and address non-compliance which may pose a risk to publichealth

3. Use the inspection results as a basis for enforcement action, where considerednecessary.

1. Determine that the marketing authorization holder has personnel,systems and facilities in place to meet their pharmacovigilance obligations

2. identify, record and address non-compliance which may pose a risk to publichealth

3. Use the inspection results as a basis for enforcement action, where considerednecessary.

When non-compliance with pharmacovigilance obligations is detected themedicines authority shall take the necessary regulatory action. What action is takenwill depend on the potential negative public health impact of the non-compliance(s)

When non-compliance with pharmacovigilance obligations is detected themedicines authority shall take the necessary regulatory action. What action is takenwill depend on the potential negative public health impact of the non-compliance(s)

Cooperation and Sharing of information:The national medicines authorities in Arab Countries are encouraged to cooperateregarding pharmacovigilance inspections and in particular the following asapplicable:

–Training–Joint pharmacovigilance inspection–Exchange of information

Cooperation and Sharing of information:The national medicines authorities in Arab Countries are encouraged to cooperateregarding pharmacovigilance inspections and in particular the following asapplicable:

–Training–Joint pharmacovigilance inspection–Exchange of information

Inspection types• System and product-related inspections• Routine and “for cause”

pharmacovigilance inspections• Pre-authorization inspections• Post-authorization inspections• Announced and unannounced

inspections• Re-inspections• Remote inspections (This approach may

also be taken where there are logisticalchallenges to an on-site inspection (e.g. apandemic outbreak)

Module IV – Pharmacovigilanceaudits

The MAH in the Arab Countries is required to perform regularrisk- based audit(s) of their pharmacovigilance system,including audit(s) of its quality system to ensure that thequality system complies with the quality system requirements.

The MAH in the Arab Countries is required to perform regularrisk- based audit(s) of their pharmacovigilance system,including audit(s) of its quality system to ensure that thequality system complies with the quality system requirements.

The MAH shall place a note concerning critical and majoraudit findings of any audit relating to the pharmacovigilancesystem in the PSMF.

The MAH shall place a note concerning critical and majoraudit findings of any audit relating to the pharmacovigilancesystem in the PSMF.

Based on the audit findings, the MAH shall ensure that anappropriate plan detailing corrective and preventative actionis prepared and implemented.

Based on the audit findings, the MAH shall ensure that anappropriate plan detailing corrective and preventative actionis prepared and implemented.

Module V – Risk Management

Systems

It is recognized that at the time of authorization, information on the safety of a medicinalproduct is relatively limited.

A medicinal product is authorized on the basis that in the specified indication(s), at thetime of authorization, the benefit-risk balance is judged to be positive for the targetpopulation.

Historically, risk management systems for medicinal products for human use was basedsolely on managing risks. However, when considering how to maximize, or indeed assess,the risk-benefit balance, risks need to be understood in the context of benefit.

Both post-authorization safety studies and post-authorization efficacy studies may be acondition of the marketing authorization in certain circumstances and for these studiesthey shall be included in the risk management plan (RMP).

Risk management is a global activity. However, because of differences in indication andhealthcare systems, target populations may be different across the world and riskminimization activities will need to be tailored to the system in place in a particularcountry

Risk management, is applicable to medicinal products at any point in their lifecycle.

Risk management has three stages which are inter-related and re- iterative:

Characterization of thesafety profile of the

medicinal product includingwhat is known and not

known.

Planning ofpharmacovigilance

activities tocharacterize risks andidentify new risks and

increase theknowledge in general

about the safetyprofile of the

medicinal product.

Planning andimplementation ofrisk minimization

and mitigation andassessment of the

effectiveness ofthese activities.

Structure of the risk management plan

• 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 SVI Additional requirements for the safety specification Module SVII Identified and potential risks 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 risk management plan• Part VII Annexes

Formats for risk-management plans

• with all of the modules in one document(e.g. for innovators not having EU RMP,biosimilars….etc.)Integrated RMP

• suitable for use for generic medicinesAbridged format

• format suitable for any MAH/Applicants havingEU RMP in place (whether innovators, genericsor importers), submitted altogether with mostupdated version EU RMP.

National Displayof RMP

Module VI –Management andreporting of adverse reactions to

medicinal products

collection, data management and reporting ofsuspected adverse reactions (serious and non-serious)

associated with medicinal products for human use

collection, data management and reporting ofsuspected adverse reactions (serious and non-serious)

associated with medicinal products for human use

Only valid ICSRs should be reportedOnly valid ICSRs should be reported

Serious domestic valid ICSRs 15 days from the dateof receipt of the reports

Non-serious domestic valid ICSRs 90 days from thedate of receipt of the reports.

Reporting of serious international valid ICSRs by MAHsmay be required in some Arab Countries

Serious domestic valid ICSRs 15 days from the dateof receipt of the reports

Non-serious domestic valid ICSRs 90 days from thedate of receipt of the reports.

Reporting of serious international valid ICSRs by MAHsmay be required in some Arab Countries

Each MAH shall have in place a system for the collection andrecording of all reports of suspected adverse reactions which arebrought to its attention, whether reported spontaneously oroccurring in the context of a post-authorization study

MAH shall establish mechanisms enabling the traceability andfollow-up of adverse reaction reports. Pharmacovigilance data anddocuments shall be retained as long as the product is authorized andfor at least 10 years after the marketing authorization has ceased toexist.

MAH responsibilities apply to reports related to medicinal productsfor which ownership cannot be excluded on the basis of one thefollowing criteria: medicinal product name, active substance name,pharmaceutical form, batch number or route of administration.

MAH shall ensure that any information on adverse reactions,suspected to be related to at least one of the active substances of itsmedicinal products authorized in the Arab Country concerned, isbrought to its attention by any company outside this Arab countrybelonging to the same mother company (or group of companies).

Reporting models of ICSRsReporting models of ICSRs

Full electronicreporting:

the nationalmedicines authority

has an electronicregulatory submission

environment,Gateway. To be

compatible, the MAHmust have a fully ICHE2B (R2) compliantpharmacovigilancesystem and ICH M2ESTRI gateway; (i.e.

MAH submit the validICSRs through ESTRI

gateway)

Full electronicreporting:

the nationalmedicines authority

has an electronicregulatory submission

environment,Gateway. To be

compatible, the MAHmust have a fully ICHE2B (R2) compliantpharmacovigilancesystem and ICH M2ESTRI gateway; (i.e.

MAH submit the validICSRs through ESTRI

gateway)

Partial electronicreporting:

The MAH submit thevalid ICSRs as an XML

file (e.g. throughsecured email or onCD…etc.; check the

national requirements)to the

pharmacovigilancedepartment at thenational medicinesauthority who willthen import this

submitted XML fileinto the “National

Pharmacovigilance andSafety reports

database” i.e. nogateway

Partial electronicreporting:

The MAH submit thevalid ICSRs as an XML

file (e.g. throughsecured email or onCD…etc.; check the

national requirements)to the

pharmacovigilancedepartment at thenational medicinesauthority who willthen import this

submitted XML fileinto the “National

Pharmacovigilance andSafety reports

database” i.e. nogateway

Web-based reportingtool:

the national medicinesauthority provides such

tool which has onlinefunctions enable theMAH to generate andsubmit a fully ICH E2B

and M2 compliant SafetyMessages (ICSRs). This ismost beneficial for Small

and Medium SizeEnterprises (SMEs), which

do not have thenecessary IT in-house

tools available (i.e. do nothave a fully ICH E2B (R2)

compliantpharmacovigilance

system and/or ESTRIgateway in place)

Web-based reportingtool:

the national medicinesauthority provides such

tool which has onlinefunctions enable theMAH to generate andsubmit a fully ICH E2B

and M2 compliant SafetyMessages (ICSRs). This ismost beneficial for Small

and Medium SizeEnterprises (SMEs), which

do not have thenecessary IT in-house

tools available (i.e. do nothave a fully ICH E2B (R2)

compliantpharmacovigilance

system and/or ESTRIgateway in place)

Noneelectronicreporting:

MAH submitthe valid ICSRson CIOMs form(whether hardor soft copy)

Noneelectronicreporting:

MAH submitthe valid ICSRson CIOMs form(whether hardor soft copy)

Module VII - Periodic safety updatereport (PSUR)

Periodic safety update report (PSUR)

Are pharmacovigilance documents intended to provide an evaluation of therisk-benefit balance of a medicinal product for submission by marketingauthorization holders at defined time points during the post- authorizationphase.

The required format and content of PSURs in the Arab Countries are based onthose for PSUR described in the European Good Pharmacovigilance Practice aswell as for the Periodic Benefit Risk Evaluation Report (PBRER) described in theICH-E2C(R2) guideline. In line with the national legislation, the report isdescribed as PSUR in the GVP Modules in the Arab countries

The “modular approach” of PSUR enables the common content ofparticular sections to be utilized interchangeably in PSURs andRMPs, hence, minimizes duplication during the preparation

Dates and frequency of PSUR submission: According to the "list ofEU reference dates“ which is adopted in the guidelineDates and frequency of PSUR submission: According to the "list ofEU reference dates“ which is adopted in the guideline

PSUR submission timelines:within 70 calendar days of the data lock point (day 0) for PSURs coveringintervals up to 12 months (including intervals of exactly 12 monthswithin 90 calendar days of the data lock point (day 0) for PSURs coveringintervals in excess of 12 months;the timeline for the submission of ad hoc PSURs requested by nationalmedicines authorities will normally be specified in the request, otherwise thead hoc PSURs should be submitted within 90 calendar days of the data lockpoint.

PSUR submission timelines:within 70 calendar days of the data lock point (day 0) for PSURs coveringintervals up to 12 months (including intervals of exactly 12 monthswithin 90 calendar days of the data lock point (day 0) for PSURs coveringintervals in excess of 12 months;the timeline for the submission of ad hoc PSURs requested by nationalmedicines authorities will normally be specified in the request, otherwise thead hoc PSURs should be submitted within 90 calendar days of the data lockpoint.

To avoid duplication of efforts a single assessment of PSURs fordifferent authorized medicinal products containing the same activesubstance should be performed in each Arab Country.

To avoid duplication of efforts a single assessment of PSURs fordifferent authorized medicinal products containing the same activesubstance should be performed in each Arab Country.

Contents of the PSUR:Part I: Title page including signaturePart II: Executive SummaryPart III: Table of Contents1. Introduction2. Worldwide marketing authorization status3. Actions taken in the reporting interval for safety

reasons3.1 Actions related to investigational uses (not

applicable for generics)3.2 Actions related to marketing experience

4. Changes to reference safety information5. Estimated exposure and use patterns

5.1 Cumulative subject exposure in clinical trials(not applicable for generics)

5.2 Cumulative & interval patient exposure frommarketing experience

6. Data in summary tabulations6.1 Reference information6.2 Cumulative summary tabulations of serious

adverse events from clinical trials (not applicable forgenerics)

6.3 Cumulative and interval summary tabulations frompost-marketing data sources

7. Summaries of significant findings from clinicaltrials during the reporting interval (notapplicable for generics)

8. Findings from non-interventional studies9. Information from other clinical trials and

sources10. Non-clinical Data (not applicable for generics)11. Literature12. Other periodic reports13. Lack of efficacy in controlled clinical trials (not

applicable for generics)14. Late-breaking information15. Overview of signals: new, ongoing or closed16. Signal and risk evaluation17. Benefit evaluation18. Integrated benefit-risk analysis for authorized

indications19. Conclusions and actions20. Appendices to the PSUR

Module VIII – Post authorizationsafety studies

any study relating to an authorized medicinalproduct 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 riskmanagement measures.

any study relating to an authorized medicinalproduct 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 riskmanagement measures.

This guidance applies to non-interventional PASSwhich are initiated, managed or financed by a

marketing authorization holder and conducted inthe Arab Country concerned.

This guidance applies to non-interventional PASSwhich are initiated, managed or financed by a

marketing authorization holder and conducted inthe Arab Country concerned.

Following the review of the final study report, thenational medicines authority may decide:

VariationSuspension

Revocation of the marketing authorizationThe decision shall mention any divergent positions and thegrounds on which they are based and include a timetablefor the implementation of this agreed action

Following the review of the final study report, thenational medicines authority may decide:

VariationSuspension

Revocation of the marketing authorizationThe decision shall mention any divergent positions and thegrounds on which they are based and include a timetablefor the implementation of this agreed action

• Develop a study protocol and submit it to the national medicines authority• Ensure the fulfillment of its pharmacovigilance obligations in relation to the

study and that this can be audited, inspected and verified. (Adversereactions/adverse events should be reported to medicines authorities inaccordance with the provisions of Module VI. Procedures for the collection,management (including a review by the marketing authorization holder ifappropriate) and reporting of suspected adverse reactions/adverse eventsshould be put in place and summarized in the study protocol.

• Submit any substantial amendments to the protocol, before theirimplementation, to the national medicines authority/national scientificresearch ethics committee

• MAH may be requested to submit the study progress reports to themedicines authorities

• Submit a final study report, including a public abstract, to the nationalmedicines authority/ national scientific research ethics committee as soonas possible and not later than 12 months after the end of data collection

• Evaluate whether the study results have an impact on the marketingauthorization and if necessary, submit to the national medicines authoritiesan application to vary the MA

Roles and responsibilities of the MAH, for imposed non- interventionalPASS as a condition to the marketing authorization:

Module IX – Signal management

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 isjudged to be of sufficient likelihood to justify verificatory action. For the purpose of GVP, only new

information related to adverse effects will be considered.

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 isjudged to be of sufficient likelihood to justify verificatory action. For the purpose of GVP, only new

information related to adverse effects will be considered.

Signal management process can be defined:The set of activities performed to determine whether, based on an examination of

individual case safety reports (ICSRs), aggregated data from active surveillance systemsor studies, literature information or other data sources, there are new risks associatedwith an active substance or a medicinal product or whether known risks have changed.

Signal management process can be defined:The set of activities performed to determine whether, based on an examination of

individual case safety reports (ICSRs), aggregated data from active surveillance systemsor studies, literature information or other data sources, there are new risks associatedwith an active substance or a medicinal product or whether known risks have changed.

Signal management process steps:signal detectionsignal validationsignal analysis & prioritizationsignal assessmentrecommendation of actionexchange of information

Signal management process steps:signal detectionsignal validationsignal analysis & prioritizationsignal assessmentrecommendation of actionexchange of information

• Monitor the data in its ADRs database; as well as monitor thedata in “National Pharmacovigilance and Safety reportsdatabase” to the extent of their accessibility (accessible in onlysome Arab Countries)

• Validate any signal detected and shall forthwith inform theresponsible medicines authority for signal detection with specialattention to those in the list as published by the nationalmedicines authority.

• Notify in writing as an Emerging Safety Issue to the medicinesauthorities in Arab Countries where the medicinal product isauthorized, any safety issue arising from its signal detectionactivity which could have a significant impact on the benefit-riskbalance for a medicinal product and/or have implications forpublic health.

• Collaborate with the national medicines authority for theassessment of the signals by providing additional informationupon request.

• Keep an audit trail of its signal detection activities

Roles and responsibilities of MAH

Module X– Additional monitoring

National Medicines Authorities, shall set up, maintain and makepublic a list of medicinal products that are subject to additionalmonitoring. European list is adopted.

These medicinal products will be readily identifiable by an invertedequilateral black triangle . That triangle will be followed by anexplanatory statement in the summary of product characteristics(SmPC) as follows:“This medicinal product is subject to additional monitoring. Thiswill allow quick identification of new safety information.Healthcare professionals are asked to report any suspectedadverse reactions. See section ....... for how to report adversereactions.”

A similar statement will also be included in the packageleaflet

This explanatory statement should encourage healthcareprofessionals and patients to report all suspected adversereactions.

Module XV – Safety communication

Objectives of safety communication :-providing timely, evidence-based information on the safe and effective use of medicinesfacilitating changes to healthcare practices (including self- medication practices) where necessarychanging attitudes, decisions and behaviors in relation to the use of medicines;Supporting risk minimization behaviorfacilitating informed decisions on the rational use of medicines.

Objectives of safety communication :-providing timely, evidence-based information on the safe and effective use of medicinesfacilitating changes to healthcare practices (including self- medication practices) where necessarychanging attitudes, decisions and behaviors in relation to the use of medicines;Supporting risk minimization behaviorfacilitating informed decisions on the rational use of medicines.

Means of safety communication– Direct healthcare professional communication (DHPC)– Documents in lay language

– Press communication– Website– Other web-based communications– Bulletins and newsletters– Responding to enquiries from the public

Means of safety communication– Direct healthcare professional communication (DHPC)– Documents in lay language

– Press communication– Website– Other web-based communications– Bulletins and newsletters– Responding to enquiries from the public

Processing of DHPCs, MAH should submit the following to the medicines authority (s) in the ArabCountry (s) where the products are authorized:– Draft DHPC; and– The dissemination list– Timetable for disseminating the DHPC– Dissemination mechanism

Processing of DHPCs, MAH should submit the following to the medicines authority (s) in the ArabCountry (s) where the products are authorized:– Draft DHPC; and– The dissemination list– Timetable for disseminating the DHPC– Dissemination mechanism

Modules Underdevelopment

Module XI - Public participation in pharmacovigilance

Module XII - Continuous pharmacovigilance, ongoing benefit-riskevaluation, regulatory action and planning of public communication

Module XIV - International cooperation

Module XVI – Risk minimization measures: selection tools andeffectiveness indicators