EFPIA _使用欧洲药典药品和电子信息(ePI)试点概述（英）.pdfVIP

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TableofContents

Executivesummary3

Introduction5

MethodologyoftheSurvey6

Results7

Somegraphicsaboutthemainresultsofthesurvey7

SummaryoftheePIpilotstatusineachrespondingcountry11

Generalconclusion30

Annex1:listofquestionsinthesurvey32

Caveat:.Thecut-offdatefortheresultsofthesurveypresentedinthisdocumentistheendofQ22025.Sincethat

date,therehavebeensomedevelopmentandevolutionabouttheePIpilotsinIreland,inGermany,…However,these

havenotbeentakenintoaccountinthepresentedresultsinordertohaveonesinglecut-offdateforthestatistical

analysisoftheresultsandacomprehensiveinterpretationoftheseresults.Thisillustrateshowfastthesituationabout

ePIisevolvingacrossEurope.

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Executivesummary

InaccordancewiththecurrentEuropeanlegislation,apaperleafletmustbeincludedineachpackofa

medicinalproduct.Thisleafletcontainsimportantinformationandguidanceontheproperuseofthe

respectivemedicinalproduct,approvedbythecompetentregulatoryauthorities.

TheEuropeanpharmaceuticallegislationiscurrentlyunderreview.Theproposedrevisionincludesthe

introductionofelectronicpatientinformation(ePI)andcreatesthepossibilityforthefuturetransitionfrom

paperleafletstoelectronicproductinformation,drivenbyMemberStatesreadiness.

TheInterAssociationTaskForceonePI(IATF-ePI:AESGP,Efpia,MedicinesforEurope)conductedasurveyon

thestatusofePIpilotprojectsacrossEurope.Thesepilotsarerunbythenationalcompetentauthorities,

approvedb