韩国口罩KF80 KF94 KF99标准英文原文.docx
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韩国口罩KF80 KF94 KF99标准英文原文.docx
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韩国口罩KF80KF94KF99标准英文原文
RegulationsontheApproval,Notification,andEvaluationofQuasi-Drugs
MinistryofFoodandDrugSafety(MFDS)NoticeNo.2010–65(Establishedon09/15/2010)
MFDSNoticeNo.2011–5(Revisedon02/01/2011)MFDSNoticeNo.2012–129(Revisedon12/27/2012)MFDSNoticeNo.2013–2(Revisedon01/16/2013)MFDSNoticeNo.2013–9(Revisedon03/08/2013)MFDSNoticeNo.2013–33(Revisedon04/05/2013)MFDSNoticeNo.2014–76(Revisedon02/12/2014)MFDSNoticeNo.2014–153(Revisedon09/04/2014)MFDSNoticeNo.2014–169(Revisedon10/15/2014)MFDSNoticeNo.2014–177(Revisedon10/29/2014)MFDSNoticeNo.2015–69(Revisedon09/25/2015)
Article1(Purpose)
Chapter1GeneralProvisions
ThepurposeofthisNoticeistoprovidedetailedproceduresandrequirementsformanufacturingorimportingapproval(notification)ofquasi-drugs,andproductssubjecttothesafetyandefficacyevaluationandscientificreviewofspecificationsandtestingmethodsforquasi-drugs,datarequirements(scope,descriptionandwaiver),andrelevantcriteriaandmanagementofdatapursuanttoArticles31,42,and76ofthePharmaceuticalAffairsActandArticles4,5,8to13,39,40,and57to59oftheRulesontheSafetyofDrugs,etc.
Article2(Definitions)
ThetermsusedinthisNoticeshallbedefinedasfollows:
1.“Activeingredient”meansasubstanceoragroupofsubstances(includingherbalmedicines,ofwhichpharmacologicallyactiveingredient,etc.havenotbeenidentifiedyet)expectedtomanifest,directlyorindirectly,theindicationsofquasi-drugs.
2.“Newmaterial”meansasubstanceoragroupofsubstancesthathavenotbeenuseddomesticallyasanactiveingredientofdrugsorquasi-drugs;however,forquasi-drugsfallingundersubparagraph7(a)ofArticle2ofthePharmaceuticalAffairsAct,italsomeansasubstanceoragroupofsubstancesthathavenotbeenuseddomesticallyasanexcipientofquasi-drugs.
3.“Herbalmedicinalproduct”,asseenfromthewesternmedicinepointofview,meansapreparationmadewithrawmaterialsorsubstancesderivedfromnaturalmaterialsthatisnotusedfortreatmentpurposesintheorientalmedicine.However,apreparation,thoughoriginatedfromanaturalmaterial,madebyextractingandrefiningaparticularingredient,shallnotbeconsideredasherbalmedicinalproduct.
4.“Combinationproducts”meansquasi-drugscontainingtwoormoreactiveingredientsincludingextracts(suchas
herbalmedicinalproducts)fromtwoormoreplantsandextractsfromtwoormoreorgansofthesameanimal(e.g.:
anextractfromliverandstomachofapig),etc.Syntheticmaterialsthataredifficulttoseparateorrefineindividualingredient,orunnecessarytoprocesssuchoperations(e.g.:
o-,m-,orp-Cresol),oranextractfromthesameplant(provided,thatevenifextractedfromthesameplant,iftheactiveingredientsextractedfromdifferentpartsarenoticeablydifferent,asScopoliaeRhozomaextract,itshallbeexcluded.)andanextractfromthesameorganofthesameanimal(e.g.:
gastricmucousmembraneextractofapig)shallbeconsideredasasingle-componentproduct.
5.“Sample”meansmaterialscollectedinareasonablemanner,suchasrandomsampling.
6.“Actualvalue”meansavalueobtainedfromactualmeasurementtobeusedforactualstatisticalanalysiswithoutliersexcluded.
7.“Actualstatisticalvalue”meansavalueobtainedfromstatisticalanalysisofactualvalues
8.“Disinfectantsandinsecticidesforpreventinginfectiousdisease”meansoneofthefollowingproducts:
(a)Productsusedforthepurposeofexpellingorcontrollingharmfulpathogencarryinginsects(includinglarvaandimagoofmosquitoes,ants,flies,fleas,lice,andcockroaches)causingdiseasesandsanitaryhazardsforpeople.
(b)Productsusedforthepurposeofsterilizationanddisinfection,notdirectlyappliedtopeople,animalsormedicaldevices.
(c)“Rodenticides”meansproductsusedforthepurposeofcontrollingpathogencarryingrodentscausingdiseasesinpeople.
9.“Booster”meansasubstanceoragroupofsubstancesthatenhancestheactionofactiveingredients,thoughitdoesnothaveinherentlysterilizing,insecticidalandrodenticidaleffects.
10.“Inhalableproducts”meansproducts,suchascigarette-typeproductsspecifiedinsubparagraph2(e)oftheDesignationoftheScopeofQuasi-Drugs(MFDSNotice),thatareusedthroughrepeatedanddirectinhalationorproductsspecifiedinsubparagraph2(j)oftheDesignationoftheScopeofQuasi-Drugsthatmaybeusedthroughprolongedorrepeatedandindirectinhalation.
Chapter2ApplicationforApprovalorNotificationofQuasi-drugsandDataRequirements
Article3(ApprovalorNotificationProcess)
(1)Quasi-drugsthataresubjecttonotificationpursuanttoArticles31(4)and42
(1)ofthePharmaceuticalAffairsActshallbeasfollows;howeverproductssubjecttosafetyandefficacyevaluationpursuanttoArticles21and44shallbeexcluded:
1.ProductslistedintheKoreanPharmacopoeia(NoticeofMFDS),compendiaordrugformulariesrecognizedbytheMinisterofMinistryofFoodandDrugSafety(hereinafterreferredtoastheMinisterofMFDS);however,productsthathavenotbeenapproveddomesticallyshallbeexcluded.
2.ProductsforwhichspecificationsandtestmethodsarenotifiedbytheMinisterofMFDS.
3.ProductsthatcomplywiththemanufacturingstandardsnotifiedbytheMinisterofMFDS.
(2)Manufacturersorimporterswhofiledforapproval(notification)ofquasi-drugsshallbeapprovedordeclareasspecifiedbelow:
1.Forproductswiththesamespecificationsandquantitiesofactiveingredient(s),dosageform,androuteofadministration(orapplication),theyshallberegardedas,andapproved(notified)asoneproduct;however,itis
notapplied,iftheuniquenatureofaproductisrecognizedwithinascopeofthesamespecificationsorifaproductisintendedforexportonly.Also,approval(notification)formanufactureandimportshallberegardedasseparatecasesand,thus,shallbeappliedwithdifferentproductnames.
2.Notwithstandingsubparagraph1,forproductstobemixeduppriortouse(e.g.:
adoublebatchofadeveloperanddyeforhaircoloringproducts)orwhenamix-basedmanufacturingisjustifiable,theymaybeapproved(ornotified)asapackage.Ifonlythetaste(flavor),color,orshapediffer,theymaybeapproved(ornotified)asoneproductwithonecertificateofapproval(notification).
3.Notwithstandingsubparagraphs1and2,quasi-drugsfallingundersubparagraphs1and2(a),(b),(f),and(i)oftheDesignationoftheScopeofQuasi-Drugs(MFDSNotice)maybeapproved(notified)asapackagewithdifferentproductnames,eveniftheyhavethesameactiveingredient.However,insuchacase,ifthetype,quantitiesanddosageformoftheactiveingredientarethesame,eventhoughtherestoftheingredientsaredifferent,theymaybeapproved(ornotified)withonecertificateofapproval(notification).
(3)Forquasi-drugsintendedforexportonly,theapplicationforproductapproval(notification)maybesubmittedonlywithspecifications,etc.requiredbytheimporteroftheproduct,insteadofinformationonsafetyandefficacy,specifications,andtestmethodspursuanttoArticle4
(1)1and2oftheRulesontheSafetyofDrugs,etc.Insuchacase,theMinisterofMFDSmaygrantapproval(oracceptnotification)onthebasisofthosedocumentsetc.
(4)Quasi-drugsfallingundersubparagraph7(c)ofArticle2ofthePharmaceuticalAffairsActshallcomplywithChapter5Approval,NotificationandReviewofDisinfectantsandInsecticides,etcforpreventingInfectiousDiseases
Article4(ProcessingofChangestoApprovalorNotificationofQuasi-Drugs)
(1)Ifapprovedornotifiedquasi-drugsspecifiedinArticle3areintendedtobechangedinaccordancewithArticle8
(1)oftheRulesontheSafetyofDrugs,etc.,suchchangesshallcomplywithprovisionsofArticles7to18oftheRules.
(2)Notwithstandingparagraph
(1),forthefollowingminorchanges,dossiers(includingelectronicdocuments)describingsuchchangesmaybeprovidedforapprovalornotificationpursuanttoArticle8(4)oftheRulesontheSafetyofDrugs,etc:
1.Changestotheproductname(applicableonlyforsingle-componentproducts,forwhichtheactiveingredientorprescriptioninformationisusedastheproductname),drugsubstancesandtheirquantities,ortermsusedinspecificationsandtestmethods,etc.inaccordancewithchangestotermsofsubstancesorpreparationslistedintheKoreanPharmacopoeia,KoreanPharmaceuticalCodex,SpecificationsandTestMethodsforQuasi-DrugsandothersasnotifiedbytheMinisterofMFDS,andforeigncompendiaaslistedintheDesignationofCompendiaandMonographs(MFDSNotice);
2.Inthesectionofmanufacturingmethod,changestothecontainersorpackaging(exceptforimmediatecontainerorpackaging)thatdonotaffectthestability;
3.Inthesectionofmanufacturingmethod,changestothemanufacturer’saddressduetochangeofadministrativedistrict.
4.Inthesectionofindications(efficacyandeffects),dosageandadministrationandprecautions,useofeasytermsdesignatedandnotifiedbytheMinisterofMFDS.
5.Inthesectionofdrugsubstancesandtheirquantities,changestothetypeoftarcolorant
6.ChangetothespecificationsofadditiveswithinthescopeofthestandardsandcompendianotifiedbytheMinisterofMFDSpursuanttosubparagraph1.
(3)Forchangespursuanttoeachsubparagraphofparagraph
(2),themanufacturerorimporterofthequasi-drugshallspecifythedateandchangesin“ChangesandRegulatoryActions,etc.”onthebacksideoftheapproval(ornotification)certificate..
(4)Forchangesaslistedintheab
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