| PORP_HD000001UV02 Submisson MessageHMD |
Description: Description (Link to Excel View) Derived from RMIM: PORP_RM000001UV02 |
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| SubmissionUnit |
Design Comments: Codes for all ACTs will be different based on the Regulatory Authority and type of product. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| statusCode [0..1] Act (CS) {CNE:D:ActStatus} |
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| component [0..*] (Component) |
Design Comments: Priority number will only be used for Context of Use that share the same code and have the same KeywordGroup |
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| pertainsTo [1..*] (PertinentInformation) | |||||||||
| Component |
Design Comments: Priority number will only be used for Context of Use that share the same code and have the same KeywordGroup |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| priorityNumber [0..1] ActRelationship (INT) |
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| contextOfUse [1..1] (ContextOfUse) | |||||||||
| ContextOfUse | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassDocument, root= "DOC"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| title [0..1] Act (ST) |
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| statusCode [1..1] (M) Act (CS) {CNE:V:x_DocumentStatus} |
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| setId [0..1] ContextStructure (II) |
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| versionNumber [0..1] ContextStructure (INT) |
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| sequelTo [0..*] (SequelTo) | |||||||||
| referencedBy1 [0..1] (Reference8) | |||||||||
| referencedBy2 [0..*] (Reference5) | |||||||||
| SequelTo | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipSequel, root= "SEQL"} |
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| relatedContextOfUse [1..1] (RelatedContextOfUse) | |||||||||
| RelatedContextOfUse | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassDocument, root= "DOC"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| versionNumber [0..1] ContextStructure (INT) |
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| Reference8 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipRefersTo, root= "REFR"} |
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| fileReference [1..1] (FileReference) |
Design Comments: A FileReference is a pointer (or reference) to a file. |
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| FileReference |
Design Comments: A FileReference is a pointer (or reference) to a file. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| Reference5 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipRefersTo, root= "REFR"} |
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| keyword [1..1] (Keyword) |
Design Comments: A keyword is a pointer (or reference) to a keyword definition. |
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| Keyword |
Design Comments: A keyword is a pointer (or reference) to a keyword definition. |
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| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] Act (II) |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| PertinentInformation | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipPertains, root= "PERT"} |
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| sequenceNumber [1..1] (M) ActRelationship (INT) |
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| choice [1..1] (Choice) | |||||||||
| Choice | |||||||||
| choice of ReviewableUnit | |||||||||
| or Submission | |||||||||
| ReviewableUnit | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| code [1..1] (M) Act (CD) {CNE:D:ActCode} |
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| statusCode [0..1] Act (CS) {CNE:D:ActStatus} |
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| pertainsTo [1..*] (PertinentInformation4) | |||||||||
| PertinentInformation4 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipPertains, root= "PERT"} |
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| submission [1..1] (Submission) | |||||||||
| Submission | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| code [1..1] (M) Act (CD) {CNE:D:ActCode} |
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| statusCode [0..1] Act (CS) {CNE:D:ActStatus} |
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| pertainsTo [1..1] (PertinentInformation2) | |||||||||
| PertinentInformation2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipPertains, root= "PERT"} |
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| application [1..1] (Application) | |||||||||
| Application | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| code [1..1] (M) Act (CD) {CNE:D:ActCode} |
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| component [0..*] (Component2) | |||||||||
| referencedBy [0..*] (Reference4) | |||||||||
| Component2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| file [1..1] (File) | |||||||||
| File | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [1..1] (M) Act (II) |
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| title [0..1] Act (ST) |
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| text [1..1] (M) Act (ED) |
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| Reference4 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipRefersTo, root= "REFR"} |
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| keywordDefinition [1..1] (KeywordDefinition) | |||||||||
| KeywordDefinition | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| id [1..1] (M) Act (II) |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| statusCode [1..1] (M) Act (CS) {CNE:D:ActStatus, default= "active"} |
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| value [0..1] Observation (DSET<CV>) {CWE:D:ObservationValue} |
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| replacementOf [0..1] (ReplacementOf) | |||||||||
| ReplacementOf | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipReplaces, root= "RPLC"} |
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| previousKeywordDefinition [1..1] (PreviousKeywordDefinition) | |||||||||
| PreviousKeywordDefinition | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| id [1..1] (M) Act (II) |
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