药品包装说明书en文档格式.docx
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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.
Ar
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