Guidelines-on-good-pharmacovigilance-practices-(GV

8January2014EMA/781168/2013Guidelinesongoodpharmacovigilancepractices(GVP)Introductorycovernote,lastupdatedwithfinaldefinitionannexrevision2BackgroundtoGVP.........................................................................................2HistoryoftheGVPdevelopmentprocessandlastupdates...................................2Objectivesofpharmacovigilance.......................................................................3PharmacovigilanceintheEU:rolesofdifferentactors.........................................3Legalbasis,scopeandprocessforGVP.............................................................3MaintenanceandfurtherdevelopmentofGVP....................................................4StructureofGVP............................................................................................5ReferencingoflegalrequirementsinGVP..........................................................5Practicaladviceforthepublicconsultation.........................................................57WestferryCircus●CanaryWharf●LondonE144HB●UnitedKingdomAnagencyoftheEuropeanUnionTelephone+44(0)2074188400Facsimile+44(0)[e-mail]©EuropeanMedicinesAgency,2014.Reproductionisauthorisedprovidedthesourceisacknowledged.BackgroundtoGVPNewlegislationforpharmacovigilanceappliesintheEuropeanUnion(EU)sinceJuly2012,andtosupportitsimplementation,anewsetofguidelinesfortheconductofpharmacovigilanceintheEUhasbeendevelopedwhich,astheyareadopted,replacetheprevioussetinVolume9AoftheRulesGoverningMedicinalProductsintheEU.Thisnewguidanceongoodpharmacovigilancepractices(GVP)isorganisedintotwotypesofchapters,namelyModulesonpharmacovigilanceprocessesandProduct-orPopulation-SpecificConsiderations.HistoryoftheGVPdevelopmentprocessandlastupdatesThefirstsevenModulesonprioritisedprocesseswereconsultedbetween21Februaryand18April2012andrevised,takingintoaccountthecommentsreceivedfromstakeholders.Theyareavailableintheirfinalversionswhichcameintoforceon2July2012.ModuleIIIonpharmacovigilanceinspectionsandModuleXonprocessesforadditionalmonitoringofmedicinalproductswerereleasedon27June2012forpublicconsultationuntil24August2012,andModuleIVonpharmacovigilanceauditsandModuleXVonsafetycommunicationwerereleasedon26July2012forpublicconsultationuntil21September2012.ModulesIIIandIVwerepublishedintheirfinalversions,togetherwiththeupdatedGVPAnnexIondefinitions,on13December2012.ThefinalModuleXVwaspublishedon24January2013,togetherwithatemplateforDirectHealthcareProfessionalLettersintheGVPAnnexII.On25April2013,thefinalModuleXonadditionalmonitoringwaspublishedasfinal,takingintoaccountlatestadditionallegislation.Sincetheirfirstreleaseasfinal,someModuleshavebeenrevisedasfinal:ModuleIIwaspublishedinitsfirstrevision,mainlytoprovideclarificationsforherbalmedicinalproducts,on12April2013.ModuleVIIIRevision1anditsAddendumRevision1aswellasinAnnexII–TemplateforthePSURCoverPageRevision1werepublishedon25April2013.On7June2013,thedraftrevision1ofModuleVIonthemanagementandreportingofadversereactionswasreleasedforpublicconsultation,inordertoprovidemoreguidanceontheclockstateforreportingofvalidcasereports,reportingfrompost-authorisationsafetystudiesaswellasthehandlingoflanguages.Alsoon7June2013,draftModuleXVIonriskminimisationmeasureswasreleasedforpublicconsultation.Bothconsultationsclosedon5August2013andthefinalisationprocessisongoing.On12December2013,thefirstchapterwithProduct-orPopulation-SpecificConsiderationswasprovidedinitsfinalversion,i.e.thechapterP.Ionvaccines,followingitspublicconsultationlaunchedon12April2013.Also,revision1ofModuleVIIonperiodicsafetyupdatereportswasprovidedinitsfinalversionfollowingpublicconsultationlaunchedon25April2013.ThisrevisionincludedupdatesforconsistencywiththerecentlyfinalisedICH-E2C(R2)guidelineandontheoperationsintheEU.Today,thedefinitionsrelatingtovaccinepharmacovigilance,launchedforpublicconsultationon12April2013,arepublishedwithoutanychange,togetherwithotheramendmentstodefinitionsandexplanatorynotesasdetailedonpage2oftheGVPAIondefinitioninitsrevision2.FortimelineswhentheremainingModulesandnewConsiderationswillbepublishedforpublicconsultation,pleaseseetheGVPwebpageoftheAgency’swebsite.Guidelinesongoodpharmacovigilancepractices(GVP)–IntroductorycovernoteEMA/781168/2013Page2/6ObjectivesofpharmacovigilancePharmacovigilancehasbeendefinedbytheWorldHealthOrganization(WHO)asthescienceandactivitiesrelatingtothedetection,assessment,understandingandpreventionofadverseeffectsoranyothermedicine-relatedproblem.Inlinewiththisgeneraldefinition,underlyingobjectivesoftheapplicableEUlegislationforpharmacovigilanceare:•preventingharmfromadversereactionsinhumansarisingfromtheuseofauthorisedmedicinalproductswithinoroutsidethetermsofmarketingauthorisationorfromoccupationalexposure;and•promotingthesafeandeffectiveuseofmedicinalproducts,inparticularthroughprovidingtimelyinformationaboutthesafetyofmedicinalproductstopatients,healthcareprofessionalsandthepublic.Pharmacovigilanceisthereforeanactivitycontributingtotheprotectiono