GUIDELINE-ON-PLASTIC-IMMEDIATE-PACKAGING-MATERIALS

EuropeanMedicinesAgencyInspectionsPublic7WestferryCircus,CanaryWharf,London,E144HB,UKTel.(44-20)74188400Fax[phone]E-mail:[e-mail]@EMEA2005Reproductionand/ordistributionofthisdocumentisauthorisedfornon-commercialpurposesonlyprovidedtheEMEAisacknowledgedLondon,19May2005CPMP/QWP/4359/03EMEA/CVMP/205/04COMMITTEEFORMEDICINALPRODUCTSFORHUMANUSE(CHMP)COMMITTEEFORMEDICINALPRODUCTSFORVETERINARYUSE(CVMP)GUIDELINEONPLASTICIMMEDIATEPACKAGINGMATERIALSDRAFTAGREEDBYQUALITYWORKINGPARTYOctober2003ADOPTIONBYCPMP/CVMPFORRELEASEFORCONSULTATIONFebruary2004ENDOFCONSULTATION(DEADLINEFORCOMMENTS)31August2004AGREEDBYQUALITYWORKINGPARTYFebruary2005ADOPTIONBYCHMP/CVMPApril/May2005DATEFORCOMINGINTOEFFECT1December2005ThisguidelinereplacestheGuidelineonPlasticPrimaryPackagingMaterials(RulesGoverningMedicinalProducts3AQ10a).CPMP/QWP/4359/03andEMEA/CVMP/205/04EMEA2005Page2/11GUIDELINEONPLASTICIMMEDIATEPACKAGINGMATERIALSTABLEOFCONTENTS1INTRODUCTION............................................................................................................................31.1ObjectiveoftheGuideline.....................................................................................................31.2ScopeoftheGuideline..........................................................................................................31.3GeneralPrinciples..................................................................................................................42LOCATIONOFDOCUMENTATIONTOBEPROVIDEDINTHEMARKETINGAUTHORISATIONAPPLICATION.............................................................................................43DATATOBESUBMITTED...........................................................................................................53.1Generalinformation...............................................................................................................53.2Specifications.........................................................................................................................54EXTRACTIONSTUDIES...............................................................................................................65INTERACTIONSTUDIES.............................................................................................................65.1MigrationStudies..................................................................................................................75.2SorptionStudies.....................................................................................................................76TOXICOLOGICALINFORMATION/DOCUMENTATION.....................................................77GLOSSARY......................................................................................................................................8APPENDIXI:DECISIONTREEONTHEPRESENTATIONOFTHEDOCUMENTATION......9APPENDIXII:DECISIONTREEONTHEPRESENTATIONOFTHEDOCUMENTATIONOFPLASTICPACKAGINGMATERIAL........................................................................................10APPENDIXIII:CORRELATIONTABLEFORPRESENTINGTHEINFORMATION...............11CPMP/QWP/4359/03andEMEA/CVMP/205/04EMEA2005Page3/11GUIDELINEONPLASTICIMMEDIATEPACKAGINGMATERIALS1INTRODUCTION1.1ObjectiveoftheGuidelineThisGuidelinesupersedestheGuidelineonPlasticPrimaryPackagingMaterialspublishedintheRulesGoverningMedicinalProducts3AQ10aandaddressestheinformationonplasticmaterialsbeingusedasimmediatepackagingforactivesubstancesandmedicinalproductstobesubmittedinmarketingauthorisationapplications.ItconcernstheapplicationofPart1,Module3,sections3.2.1.6,3.2.2.2and3.2.2.7ofAnnexItoDirective2003/63/EC,amendingDirective2001/83/ECforhumanmedicinalproducts,andPart2,sectionsA,CandGofAnnex1toDirective2001/82/ECforveterinarymedicinalproducts,respectively,toplasticimmediatepackagingmaterials.1.2ScopeoftheGuidelineTheguidelinecoversthespecificrequirementsforplasticimmediatepackagingmaterials.Itisnotintendedtooutlinegeneralrequirementsalsoapplicabletoothertypesofpackagingmaterialsortopropertiesofthecontainerclosuresystem,e.g.performance.Theguidelineislimitedtoplasticimmediatepackagingmaterials,i.e.packagingmaterialsintendedtobeindirectcontactwiththeactivesubstanceormedicinalproduct.Thematerialsmaybepartofthecontainer,theclosureorsealorofotherpartsofthecontainerclosuresystem(s).Elastomeresandnaturalandsyntheticrubberarenotwithinthescopeofthisguideline.Thisguidelineshouldnotbeappliedretrospectivelytoalreadymarketedproductsintheirauthorisedpackagingmaterial.However,innewregistrationapplicationsorinvariationapplicationstointroduceanewimmediateplasticpack,plasticimmediatepackagingmaterialsforactiveingredientsandmedicinalproductshavetocomplywiththerequirementsoutlinedinthisdocument,regardlesswhetherthematerialisgoingtobeusedforthefirsttimeorhasalreadybeenusedforpackagingofactivesubstancesormedicinalproducts.CPMP/QWP/4359/03andEMEA/CVMP/205/04EMEA2005Page4/111.3GeneralPrinciplesThedatatobeprovidedforplasticpackagingmaterialsdependonthephysical