药品包装说明书en文档格式.docx

药品包装说明书en文档格式.docx

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（II）Theinnerpackagelabelshall,dependingonthesize,address,asfaraspossible,thedrugname,indicationsorfunctions,dosageandadministration,strength,manufacturingdate,lotnumber,shelflife,manufacturer,etc.Thedrugname,strengthandlotnumberareitemsthatmustbecovered.

（III）Themiddlepackagelabelshalladdressthedrugname,mainingredients,description,indicationsorfunctions,dosageandadministration,contraindications,strength,storage,manufacturingdate,lotnumber,shelflife,approvalnumber,manufacturer,etc.

（IV）Thelargepackagelabelshalladdressthedrugname,strength,storage,manufacturingdate,lotnumber,shelflife,approvalnumber,manufacturerandothernecessaryinformationbeyondthedescriptionsuchasquantityinthepackage,announcementsabouttransportationorothermarks.（V）Theshelflifeonthelabelsshallbeexpressedas:

Validto:

（year）（month）

（VI）Wherealladversereactions,contraindicationsandannouncementscannotbeindicatedinthemiddlepackagelabelduetosizerestriction,words“Seethedescriptionfordetails”shallbeindicated.

Article10Forpackagesofdrugsubstances,paragraph（I）ofArticle8shallbereferredtoforimplementationandlabelsshallbemadeasperprovisionsforlargepackagelabelsofdrugproducts.

Article11Thepackageofeachminimummarketingunitofdrugproductsshallbeprintedorpastedwiththelabelaccordingtotherequirementsandattachedwiththedirection.

Article12Pharmaceuticaldirectionsshallcoverbasicscientificinformationaboutthedrugproductssuchassafetyandefficacy.

Pharmaceuticaldirectionsshalladdressthefollowingitems:

drugnames（genericname,Englishname,Chinesepinyin,chemicalname）,chemicalformula,molecularweight,structureformulae（ingredientsshallbespecifiedforcompoundproductsandbiologicalproducts））,description,

pharmacology,toxicology,pharmacokinetics,indications,dosageandadministration,adversereactions,contraindications,announcements（administrationinpregnantandlactatingwomen,administrationinchildren,druginteractionsandothertypesofinteractionswith,e.g.smoking,drinking,etc.）,overdose（symptoms,emergencymeasures,detoxicants）,shelflife,storage,approvalnumber,manufacturer（includingaddressandcontacttelephone）.Ifanitemisnotclearlyknown,words“Notclearlyknown”shallbeindicated;

ifindeednoinfluencemaybeproduced,“None”shallbeindicated.

Pharmaceuticalmanufacturersshallinitiativelyfollowpost-marketingsafetyandefficacyinformationofdrugproducts.Wherethepharmaceuticaldirectionistoberevised,anapplicationshallbemadeintime.Directionsshallbeprintedintheunifiedformat（seeAnnexIandAnnexIIfortheformatofdirections）andthecontentsshallbeconsistentwiththatapprovedbyStateFoodandDrugAdministration.

Article13Exceptunitsandcontents,dosageandadministrationofdrugproductsshallbedescribedusingexpressionsthatcanbeeasilyunderstoodsuchas“×

tabletspertime,×

timesdaily”,“×

vesselspertime,×

timesdaily”,etc.forguidingcorrectdruguse.

Article14Fordrugsunderparticularmanagementsuchasnarcotics,psychotropics,toxicdrugsformedicaluseandradioactivedrugs,drugsforexternaluse,OTCdrugs,etc.,markscomplyingwiththerelatedrequirementsshallbeprintedonthemiddlepackage,largepackage,labelanddirection;

particularrequirementsforstorage,ifany,shallbeindicatedataneye-catchingplaceonthepackagesandlabelandalsointhedirection.

Article15Toapplyforregistrationofadrugproduct,thereviewandapprovalprocedureofthepackage,labelanddirectionshallbecarriedoutaccordingtothemanagementregulationsdependingonthedrugcategory.Forrevisingorchangingpackages,labelsordirectionsofmarketeddrugproducts,applicationandapprovalshallbeperformedaspertheoriginalapplicationprocedure.

Article16Pharmaceuticalmanufacturersviolatingtheseprovisionsshallbeorderedbythedrugregulatoryauthorityordepartmenttochangethepackage,labelordirectionandrecallmarketednon-conformingdrugsand,atthesametime,punishedaccordingtoapplicableprovisionsofPharmaceuticalAdministrationLawofthePeople’sRepublicofChinaandRegulationfortheImplementationofPharmaceuticalAdministrationLawofthePeople’sRepublicofChina.

Article17StateFoodandDrugAdministrationshallberesponsibleforinterpretingtheseprovisions.

Article18TheseprovisionsshallenterintoforceasofJanuary1,2001.

AnnexI:

FormatofDirectionsofChemicalDrugsandBiologicalProducts

Directionof×

×

[DrugName]

Genericname:

Tradename:

Englishname:

Chinesespelling:

Theprincipalingredientandchemicalnameofthisdrug:

Structuralformula:

Molecularformula:

Molecularweight:

（Notes:

1.Forcompounddrugproducts,itshallbedescribedas:

“Thisdrugisacompoundproductanditiscomposedof”;

2.Forbiologicalproducts,thisitemshallbe“Principalingredients”.）

[Description]

[Pharmacology&

Toxicology]

[Pharmacokinetics]

[Dosageandadministration]

[Adversereactions]

[Contraindications]

[Administrationinpregnantandlactatingwomen]

[Administrationinchildren]

[Administrationinsenilepatients]

[Druginteractions]

[Overdose]

[Strength]

[Shelflife]

[Storage]

[Approvalnumber]

[Manufacturer（address,contacttelephone）]

ProvisionsontheAdministrationofPharmaceuticalDirectionsandLabels

（SFDAOrderNo.24）

ChapterIIPharmaceuticalDirections

Article9Pharmaceuticaldirectionsshallcoverimportantscientificdata,conclusionsandinformationaboutsafetyandefficacyofdrugstoguidesafeandrationaldruguse.Detailedformat,contentandexpressionrequirementsofpharmaceuticaldirectionsareformulatedandissuedbytheStateFoodandDrugAdministration.

Article10Forexpressionofdiseasenames,pharmaceuticalterms,drugnames,andnamesandresultsofclinicaltests,officiallyissuedornormalizedspecialwordsandphasesshallbeused,andweightsandmeasuresshallcomplywithprovisionsofnationalstandards.

Article11PharmaceuticaldirectionsshallindicateallactiveingredientsorallTCMingredientsintheprescription.ForinjectionsandOTCdrugs,namesofallexcipientsusedshallalsobeindicated.

Wherethepharmaceuticalprescriptioncontainsingredientsorexcipientsthatmaycauseseriousadversereactions,theinformationshallbeindicated.

Article12Pharmaceuticalmanufacturersshallinitiativelyfollowpost-marketingsafetyandefficacyinformationofdrugs.Wherethepharmaceuticaldirectionistoberevised,anapplicationshallbemadeintime.

Accordingtodataonadversedrugreactionmonitoring,drugrevaluationresults,etc.,theStateFoodandDrugAdministrationmayalsorequestpharmaceuticalmanufacturerstorevisepharmaceuticaldirections.

Article13Afterrevisionofapharmaceuticaldirectionisapproved,thepharmaceuticalmanufacturershallnotifyimmediatelyrelateddrugbusinesses,usersandotherdepartmentsoftherevisionsanduserevisedpharmaceuticaldirectionandlabeltimelyfollowingtherequirements.Article14Pharmaceuticaldirectionsshallfullycoverinformationaboutadversedrugreactionsandspecifyadversedrugreactions.Wherethepharmaceuticalmanufacturerhasnottimelyrevisedthepharmaceuticaldirectionaccordingtopost-marketingsafetyandefficacyinformationofthedrugorspecifiedadversedrugreactionsinthepharmaceuticaldirection,adverseresultsincurredtherebyshallbeassumedbythemanufacturer.

Article15Approvaldateandrevisiondateofpharmaceuticaldirectionsshallbeclearlyindicatedinthepharmaceuticaldirections.

ChapterIIIPharmaceuticalLabels

Article16Apharmaceuticallabelmeanscontentprintedorpastedonapharmaceuticalpackageandmaybeaninnerlabeloranouterlabel.Aninnerlabelmeansthelabelinimmediatecontactwiththepharmaceuticalpackage,andanouterlabelmeansalabelofthepackageotherthantheinnerlabel.

Article17Aninnerpharmaceuticallabelshallcoveritemssuchasgenericname,indicationsorfunctions,strength,dosageandadministration,manufacturedate,productlotnumber,shelflife,manufacturer,etc.ofthedrug.

Wherethepackagesizeistoosmalltospecifyalloftheaboveitems,atleastgenericname,strength,productlotnumber,shelflife,etc.shallbeindicated.

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