EU GDP Guideline

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1、8.3.2013OfficialENJournaloftheEuropeanUnionC68/1II(Information)INFORMATIONFROMEUROPEANUNIONINSTITUTIONS,BODIES,OFFICESANDAGENCIESOTHERACTSGuidelinesof7March2013onGoodDistributionPracticeofMedicinalProductsforHumanUse(2013/C68/01)INTRODUCTIONPossessionofamanufacturing

2、authorisationincludesauthorisationtodistributethemedicinalproductscoveredbytheauTheseguidelinesarebasedonArticle84andArticle85(b)(3)ofthorisation.ManufacturersperforminganydistributionactivitiesDirective2001/83/ECoftheEuropeanParliamentandofthewiththeirownproductsmus

3、tthereforecomplywithGDP.Councilof6November2001ontheCommunitycoderelatingtomedicinalproductsforhumanuse(1)(Directive2001/83/EC).ThedefinitionofwholesaledistributiondoesnotdependonwhetherthatdistributorisestablishedoroperatinginspecificThewholesaledistributionofmedicin

4、alproductsisancustomsareas,suchasinfreezonesorinfreewarehouses.Allimportantactivityinintegratedsupplychainmanagement.obligationsrelatedtowholesaledistributionactivities(suchasToday’sdistributionnetworkformedicinalproductsisexporting,holdingorsupplying)alsoapplytothes

5、edistributors.increasinglycomplexandinvolvesmanyplayers.TheseRelevantsectionsoftheseguidelinesshouldalsobeadheredtoguidelineslaydownappropriatetoolstoassistwholesalebyotheractorsinvolvedinthedistributionofmedicinaldistributorsinconductingtheiractivitiesandtopreventpr

6、oducts.falsifiedmedicinesfromenteringthelegalsupplychain.Compliancewiththeseguidelineswillensurecontrolofthedistributionchainandconsequentlymaintainthequalityandtheintegrityofmedicinalproducts.Otheractorssuchasbrokersmayalsoplayaroleinthedistributionchannelformedicin

7、alproducts.AccordingtoArticle85(b),personsbrokeringmedicinalproductsmustbesubjecttocertainprovisionsapplicabletowholesaleAccordingtoArticle1(17)ofDirective2001/83/EC,wholesaledistributors,aswellasspecificprovisionsonbrokering.distributionofmedicinalproductsisallactiv

8、itiesconsistingofprocuring,holding,supplyingorexportingmedicinalproducts,apartfromsupplyingmedicinalproductstothepublic.Suchactivit