annex ii - application form for marketing authorization of a pharmaceutical product for human use

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1、APPLICATIONFORMFORMARKETINGAUTHORIZATIONOFAPHARMACEUTICALPRODUCTFORHUMANUSETheapplicationformistobeusedforanapplicationforamarketingauthorisationofapharmaceuticalproductforhumanusesubmittedtoNationalDrugAuthority.Theapplicationformshouldbedulyfilledwithrelevantinforma

2、tion,datedsignedandstampedappropriately.Aseparateapplicationformisrequiredforeachproduct.Forthepurposeofregistrationthefollowingproductswillberegardedaseitherbeingthesameproductorseparateproductapplications.TYPEOFAPPLICATIONSApplicationSameSeparate1.Eachindividualdosa

3、geformofaparticularmedicineX2.Variationsoftheactivepharmaceuticalingredient(API)ofaproductX3.Tablets/Capsules/Suppositories/Lozengesa)Differentpack-sizesofexactlythesamestrengthandformulation.Xb)Differentstrengthsandformulations.Xc)Uncoatedandcoatedtabletsofthesamestr

4、engthandformulation.X4.Syrups/Liquids/Solutions(excludingparenterals)/Creams/Ointmentsa)Differentcontainersizesofthesamestrengthandformulation.Xb)Thesamecontainersizeofdifferentstrengthsandformulations.X5.AmpoulesandVialsandLargeVolumeParenteralsa)Ampoulesorsingledose

5、vialscontainingidenticalsolutionsofthesamestrengthbutofdifferentvolumes(i.e.resultingindifferenttotaldoses).Xb)Ampoulescontainingsolutionsofdifferentstrengths.Xc)Ampoulesandsingledosevialscontaininge.g.drypowder,crystalsofdifferentmass.Xd)Ampoulesandsingledosevialscon

6、tainingthesamerespectivemassesofe.g.drypowder,crystals.Xe)Ampoules,singledosevials,aswellaspre-filleddisposablesyringesandcartridgescontainingidenticalsolutionsofthesamestrengthandsamevolumeofliquid.Xf)Dentalcartridgescontainingdifferentvolumesoffluidsofthesamestrengt

7、h(providedthedoseremainsconstant).Xg)Ampoulescontaining“waterforinjection”,butofdifferentvolumes.X8/8a)Specialampoulesofdrypowderand“waterforinjections”containedinthesameunit,butintendedformixingatthetimeofinjectionifwaterforinjectionsisfullydescribedindossier.Xb)Ampo

8、ulescontainingidenticalsolutionsofdifferentvolumesusedonlyasdiluentinthereconstitutionofapreparationforparenteraluse.Xc)Mult