IMS剂型缩写2018版指导.pdf

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1、NEWFORMCODECLASSIFICATIONGUIDELINESVERSION2018PUBLICATIONDATEJANUARY2018NewFormCodeClassificationGuidelinesCONTENTSPageINTRODUCTION4GENERALCLASSIFICATIONRULES5-Rule1.LevelofDetail5-Rule2.Long-ActingandOrdinaryForms5-Rule3.AlphabeticalRule6-Rule4.OralSystemicFormsWhichRequireModi

2、fication6BeforeUseTHEHIERARCHIESWITHINTHESYSTEM7DEFINITONOFTHEFIRSTLETTER8THEVALIDFIRSTLETTERCODES9A..OralSolidOrdinary10B..OralSolidLong-Acting10D..OralLiquidOrdinary10E..OralLiquidLong-Acting10F..ParenteralOrdinary10G..ParenteralLong-Acting11H..RectalSystemic11I..NasalSystemic

3、11J..OtherSystemic11K..OralTopical11M..Topical,Dermatological,Haemorrhoidal,External12N..Ophthalmic12P..Otic12Q..NasalTopical13R..LungAdministration13T..Vaginal/Intra-uterine14V..Non-humanUseandOthers14Z..Unknown14DEFINITIONOFTHESECONDLETTER15THEVALIDSECONDLETTERCODES15DEFINITIO

4、NOFTHETHIRDLETTER16VERSION2018PageAmendmentDate:©EphMRA2NewFormCodeClassificationGuidelinesVALIDCOMBINATIONSOFSECONDANDTHIRDLETTERSANDDEFINITIONS17.A.Tablets17.B.CoatedTablets19.C.Capsules21.D.SolidSpecialForms23.E.Powders/Granules25.F.Gases27.G.Liquids28.H.PressurisedAerosols31

5、.J.BathPreparations33.K.Teas35.L.Suppositories36.M.Ampoules37.N.Pre-filledSyringes39.P.Vials42.Q.Infusions45.S.Ointments47.T.Creams48.V.GelsandSols49.W.MedicatedDressings51.Y.OtherSpecialForms54.Z.MedicalAids57VALIDCOMBINATIONSOFFIRST,SECONDANDTHIRD60LETTERSLISTOFVALIDNEWFORMCOD

6、ESANDTHEIRABBREVIATED84DESCRIPTIONSVERSION2018PageAmendmentDate:©EphMRA3NewFormCodeClassificationGuidelinesINTRODUCTIONTheTHREELETTERCODE(TLC)wasintroducedasadosageFormCodeintheauditsduringthemiddleofthe1960s.Alargenumberofnewdosageformshaveappearedsincethattimeanditwasconsidere

7、dthatrevisionofthesystemwasrequiredinorderthataunified,worldwideclassificationcouldbedeveloped.TheAnnualGeneralMeetingoftheEphMRAin1984decidedtocreateaWorkingPartytodiscusssuggestedimprovementstotheclassification,andmemberswereappointedfromrepresentativecountriesandIMS.Thisgroup

8、basedtheirworkuponproposals,whichwerealreadyund