No Current Link To VocabularyCoded With ExtensionsCoded No Extensions
PORP_MT000001UV01
Submission Message

Derived from RMIM: PORP_RM000001UV01 and HMD: PORP_HD000001UV01
 
SubmissionUnit

Design Comments: A collection of documents submitted at a particular point in time as part of one or more submissions (or reviewable units that are themselves each part of a submission).

UsageNotes: Both applicants and regulatory authorities send submission units

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..1] (M)
Act (II)

Design Comments: The unique identifier that is used to refer to this act

code [0..1]
Act (CD) {CWE:D:ActCode}

Design Comments: The code specifying the particular kind of submission unit (e.g. Original, Amendment, Supplement).

title [0..1]
Act (ED)

Design Comments: Short description of the submission unit

statusCode [0..1]
Act (CS) {CNE:V:ActStatus}

Design Comments: A submission unit is either active or null.

callBackContact [0..*] (CallBackContact)

Design Comments: At the submission (regulatory activity) and submission unit, there could be many contacts.

subject [0..*] (Subject1)
component [0..*] (Component3)

Design Comments: This associates a CoU with the Submission Unit and carries an optional real-valued priority number to be used in ordering the display of CoU’s bearing identical codes.

componentOf [1..*] (Component2)

Design Comments: A submission unit either pertains to one or more Submissions or pertains to one or more Reviewable Units. For example, an annual report submission unit can apply to multiple applications. Therefore, the applicant will create one submission unit and associate that unit to multiple submissions.

 
CallBackContact

Design Comments: At the submission (regulatory activity) and submission unit, there could be many contacts.

typeCode [1..1] (M)
Participation (CS) {CNE:C:ParticipationType:CALLBCK, fixed value= "CALLBCK"}
contactParty [1..1] (ContactParty)

Design Comments: A person or department to call if there are any questions.

 
ContactParty

Design Comments: A person or department to call if there are any questions.

classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:CON, fixed value= "CON"}
id [1..1] (M)
Role (II)

Design Comments: The unique identifier

code [0..1]
Role (CD) {CWE:D:AssignedRoleType}

Design Comments: The type of contact (e.g. technical, clinical)

statusCode [0..1]
Role (CS) {CNE:V:RoleStatus}

Design Comments: If the contact is still active

contact [0..1] (Contact)
 
Contact
choice of Person
          or Organization
 
Person
classCode [1..1] (M)
Person (CS) {CNE:C:EntityClass:PSN, fixed value= "PSN"}
determinerCode [1..1] (M)
Person (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"}
id [0..*]
Person (DSET<II>)
name [0..*]
Person (COLL<EN>)
telecom [0..*]
Person (COLL<TEL>)
addr [0..*]
Person (COLL<AD>)
asAgent [0..1] (Agent)

Design Comments: An agent is an individual belonging to an organization, e.g a CRO, which is acting on behalf of the sponsor or who is personally acting on behalf of the sponsor or who is as an employee of the sponsor authorized to and responsible for any communication between the applicant and the authority

 
Agent

Design Comments: An agent is an individual belonging to an organization, e.g a CRO, which is acting on behalf of the sponsor or who is personally acting on behalf of the sponsor or who is as an employee of the sponsor authorized to and responsible for any communication between the applicant and the authority

classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:AGNT, fixed value= "AGNT"}
representedOrganization [0..1] (Organization)
 
Organization
classCode [1..1] (M)
Organization (CS) {CNE:C:EntityClass:ORG, fixed value= "ORG"}
determinerCode [1..1] (M)
Organization (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"}
id [0..*]
Organization (DSET<II>)
name [0..*]
Organization (COLL<EN>)
telecom [0..*]
Organization (COLL<TEL>)
addr [0..*]
Organization (COLL<AD>)
 
Subject1
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
categoryEvent [1..1] (CategoryEvent)

Design Comments: A submission unit could be furhtered catagorized. For example, an ammendment (submission unit.code) could be a 30 day waiver. The category can have sub categories

 
CategoryEvent

Design Comments: A submission unit could be furhtered catagorized. For example, an ammendment (submission unit.code) could be a 30 day waiver. The category can have sub categories

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:CATEGORY, fixed value= "CATEGORY"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
code [1..1] (M)
Act (CD) {CNE:D:ActCode}

Design Comments: The type of category

subject [0..*] (Subject2)

Design Comments: A category can have sub categories.

 
Subject2

Design Comments: A category can have sub categories.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
categoryEvent [1..1] (CategoryEvent)
 
Component3

Design Comments: This associates a CoU with the Submission Unit and carries an optional real-valued priority number to be used in ordering the display of CoU’s bearing identical codes.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"}
priorityNumber [0..1]
ActRelationship (REAL)

Design Comments: Sorts the context of use in a review system

contextOfUse [1..1] (ContextOfUse)

Design Comments: A context of use instance associates the document from which it is derived with a position in a pro forma table of contents defined by the controlled vocabulary specified in the code attribute.

UsageNotes: Codes for all ACTs will be different based on the Regulatory Authority and type of product. Regulatory authorities could have different codes than applicants.

 
ContextOfUse

Design Comments: A context of use instance associates the document from which it is derived with a position in a pro forma table of contents defined by the controlled vocabulary specified in the code attribute.

UsageNotes: Codes for all ACTs will be different based on the Regulatory Authority and type of product. Regulatory authorities could have different codes than applicants.

classCode [1..1] (M)
Document (CS) {CNE:C:ActClass:DOC, fixed value= "DOC"}
moodCode [1..1] (M)
Document (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..1] (M)
Document (II)

Design Comments: The unique identifier that is used to refer to this act

code [0..1]
Document (CD) {CWE:D:ActCode}

Design Comments: The code that specifies how the file is to be used within the submission process (e.g. Protocol, Summary Introduction). Note: ContextOfUse codes vary between different product types.

title [0..1]
Document (ST)

Design Comments: The title for the document in the associated assignment. If title is blank, the file title can be used.

statusCode [1..1] (M)
Document (CS) {CNE:V:x_DocumentStatus}

Design Comments: See section "Document Identification, Revisions, and Addenda"

setId [1..1]
Document (II)

Design Comments: See section "Document Identification, Revisions, and Addenda"

versionNumber [0..1]
Document (ST)

Design Comments: See section "Document Identification, Revisions, and Addenda"

primaryInformationRecipient [0..1] (PrimaryInformationRecipient)

Design Comments: A context of use can be targeted to only one regulatory authority.

links [0..*] (Links)

Design Comments: This allows two link correspondance together to make a threaded communication.

sequelTo [0..*] (SequelTo1)

Design Comments: Relates the reference to the CoU version being replaced to the associated new version CoU.

derivedFrom [0..1] (DerivedFrom)

Design Comments: Relates a document reference to the associated context of use.

subjectOf [0..*] (Subject3)
referencedBy [0..*] (Reference3)
 
PrimaryInformationRecipient

Design Comments: A context of use can be targeted to only one regulatory authority.

typeCode [1..1] (M)
Participation (CS) {CNE:C:ParticipationType:PRCP, fixed value= "PRCP"}
territorialAuthority [1..1] (TerritorialAuthority)

Design Comments: The regulatory authority has authority of a region (e.g. country) and is an organization.

 
TerritorialAuthority

Design Comments: The regulatory authority has authority of a region (e.g. country) and is an organization.

classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:TERR, fixed value= "TERR"}
territory [0..1] (Place)
governingAuthority [0..1] (Authority)
 
Place
classCode [1..1] (M)
Place (CS) {CNE:C:EntityClass:PLC, fixed value= "PLC"}
determinerCode [1..1] (M)
Place (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"}
code [1..1] (M)
Place (CD) {CWE:D:PlaceEntityType}
name [0..1]
Place (EN)
addr [0..1]
Place (AD)
 
Authority
classCode [1..1] (M)
Organization (CS) {CNE:C:EntityClass:PUB, fixed value= "PUB"}
determinerCode [1..1] (M)
Organization (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"}
id [0..1]
Organization (II)
name [0..1]
Organization (EN)
 
Links

Design Comments: This allows two link correspondance together to make a threaded communication.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:ELNK, fixed value= "ELNK"}
relatedContextOfUse [1..1] (RelatedContextOfUse)

Design Comments: References the previous version in a set of CoUs when it is being replaced by the associated new version.

 
RelatedContextOfUse

Design Comments: References the previous version in a set of CoUs when it is being replaced by the associated new version.

classCode [1..1] (M)
Document (CS) {CNE:C:ActClass:DOC, fixed value= "DOC"}
moodCode [1..1] (M)
Document (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..1] (M)
Document (II)

Design Comments: Reference to the ContextOfUse.id

versionNumber [0..1]
Document (ST)
 
SequelTo1

Design Comments: Relates the reference to the CoU version being replaced to the associated new version CoU.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:V:ActRelationshipSequel, root= "SEQL"}
relatedContextOfUse [1..1] (RelatedContextOfUse)
 
DerivedFrom

Design Comments: Relates a document reference to the associated context of use.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:DRIV, fixed value= "DRIV"}
documentReference [1..1] (DocumentReference)

Design Comments: A document can be reused, that is filed in multiple places in the table of contents, by being associated with more than one CoU.

 
DocumentReference

Design Comments: A document can be reused, that is filed in multiple places in the table of contents, by being associated with more than one CoU.

classCode [1..1] (M)
Document (CS) {CNE:C:ActClass:DOC, fixed value= "DOC"}
moodCode [1..1] (M)
Document (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..1] (M)
Document (II)

Design Comments: This is the same id that is used in the File Act.

 
Subject3
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
negationInd [0..1]
ActRelationship (BL)
submissionReference [1..1] (SubmissionReference)

Design Comments: The submission is a way to organize an application into discrete units. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. Since the message, at this time, is only from applicant to regulatory authority, submission does not have a date attribute.

 
SubmissionReference

Design Comments: The submission is a way to organize an application into discrete units. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. Since the message, at this time, is only from applicant to regulatory authority, submission does not have a date attribute.

classCode [1..1] (M)
Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"}
moodCode [1..1] (M)
Observation (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..*] (M)
Observation (DSET<II>)

Design Comments: The unique identifier that is used to refer to this act

 
Reference3
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:REFR, fixed value= "REFR"}
keyword [1..1] (Keyword)

Design Comments: A keyword is conceptually a name-value pair, represented as an element of a code set in the code attribute; the code set id and name imply the type (keyword name) and the code value and display name represent the keyword value.

 
Keyword

Design Comments: A keyword is conceptually a name-value pair, represented as an element of a code set in the code attribute; the code set id and name imply the type (keyword name) and the code value and display name represent the keyword value.

classCode [1..1] (M)
Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"}
moodCode [1..1] (M)
Observation (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
code [1..1] (M)
Observation (CD) {CWE:D:ActCode}

Design Comments: referenced by keyword definition value or by the code system

statusCode [0..1]
Observation (CS) {CNE:V:ActStatus}

Design Comments: Being able to remove a keyword for a context of use.

 
Component2

Design Comments: A submission unit either pertains to one or more Submissions or pertains to one or more Reviewable Units. For example, an annual report submission unit can apply to multiple applications. Therefore, the applicant will create one submission unit and associate that unit to multiple submissions.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"}
sequenceNumber [1..1] (M)
ActRelationship (INT.NONNEG)
choice [1..1] (Choice)
 
Choice
choice of ReviewableUnit

Design Comments: The reviewable unit is a way to organize a submission into discrete units. Each reviewable unit can have a status. A reviewable unit performs similar to submission.

          or Submission

Design Comments: The submission is a way to organize an application into discrete units related to a particular regulatory activity. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. Since the message, at this time, is only from applicant to regulatory authority, submission does not have a date attribute .

 
ReviewableUnit

Design Comments: The reviewable unit is a way to organize a submission into discrete units. Each reviewable unit can have a status. A reviewable unit performs similar to submission.

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..*] (M)
Act (DSET<II>)

Design Comments: The unique identifier that is used to refer to this act

code [1..1] (M)
Act (CD) {CNE:D:ActCode}

Design Comments: The code specifying the particular kind of reviewable unit (e.g. CMC, Administration, Tox).

statusCode [0..1]
Act (CS) {CNE:V:ActStatus}

Design Comments: A submission is either active, completed or null.

componentOf [1..*] (Component1)

Design Comments: Organizes information for a single submission. In modular reviews there could be many reviewable units in one submission.

 
Component1

Design Comments: Organizes information for a single submission. In modular reviews there could be many reviewable units in one submission.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"}
submission [1..1] (Submission)

Design Comments: The submission is a way to organize an application into discrete units related to a particular regulatory activity. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. Since the message, at this time, is only from applicant to regulatory authority, submission does not have a date attribute .

 
Submission

Design Comments: The submission is a way to organize an application into discrete units related to a particular regulatory activity. Most typically the submission will be used to organize information based on a review clock. Receipt date from the regulatory authority is important for a submission. Since the message, at this time, is only from applicant to regulatory authority, submission does not have a date attribute .

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..*] (M)
Act (DSET<II>)

Design Comments: The unique identifier that is used to refer to this act

code [1..1] (M)
Act (CD) {CNE:D:ActCode}

Design Comments: The code specifying the particular kind of submission (e.g. Original, Supplement, Annual report).

callBackContact [0..*] (CallBackContact)
subject1 [0..1] (Subject11)
subject2 [0..*] (Subject4)
subject3 [0..1] (Subject7)
subject4 [0..1] (Subject8)
subject5 [0..1] (Subject9)
componentOf [1..*] (Component4)

Design Comments: A submission unit either pertains to one or more Submissions or pertains to one or more Reviewable Units. For example, an annual report submission unit can apply to multiple applications. Therefore, the applicant will create one submission unit and associate that unit to multiple submissions.

 
Subject11
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
mode [1..1] (Mode)

Design Comments: The high-level handling of the information submitted as part of variation(s) and extension applications. The mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. The following are the valid modes: a single regulatory activity (e.g. a Type II variation), a grouped activity (e.g. several variations grouped into a single submission or a periodic report of type IA variations applicable to one or more marketing authorisations), and an activity subject to a worksharing agreement (e.g. a Type II variation applicable to more than one marketing authorisation)

 
Mode

Design Comments: The high-level handling of the information submitted as part of variation(s) and extension applications. The mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. The following are the valid modes: a single regulatory activity (e.g. a Type II variation), a grouped activity (e.g. several variations grouped into a single submission or a periodic report of type IA variations applicable to one or more marketing authorisations), and an activity subject to a worksharing agreement (e.g. a Type II variation applicable to more than one marketing authorisation)

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:POLICY, fixed value= "POLICY"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..1]
Act (II)
code [0..1]
Act (CD) {CWE:D:ActCode}

Design Comments: The high-level handling of the information submitted as part of variation(s) and extension applications. The mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. The following are the valid modes: a single regulatory activity (e.g. a Type II variation), a grouped activity (e.g. several variations grouped into a single submission or a periodic report of type IA variations applicable to one or more marketing authorisations), and an activity subject to a worksharing agreement (e.g. a Type II variation applicable to more than one marketing authorisation)

 
Subject4
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
review [1..1] (Review)
 
Review
classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:REV, fixed value= "REV"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:RQO, fixed value= "RQO"}
id [0..1]
Act (II)
statusCode [0..1]
Act (CS) {CNE:V:ActStatus}
effectiveTime [0..1]
Act (TS)
subject1 [0..*] (Subject6)

Design Comments: The approval is either related to a product or a manufacturing site.

holder [0..*] (Holder)
author [0..*] (Author)
subject2 [0..*] (Subject5)

Design Comments: One submission can have many approvals for one submission. This is true in Europe where one submission is expecting approvals from many countries at different times.

 
Subject6

Design Comments: The approval is either related to a product or a manufacturing site.

typeCode [1..1] (M)
Participation (CS) {CNE:C:ParticipationType:SBJ, fixed value= "SBJ"}
reviewChoice [1..1] (ReviewChoice)
 
ReviewChoice
choice of ManufacturedProduct
          or DedicatedServiceDeliveryLocation

Design Comments: The manufacturing site is based on the organization creating such a product. In other words, if a different organization buys a manufacturing site, it is possible that sites needs to be approved again.

 
ManufacturedProduct
classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:MANU, fixed value= "MANU"}
id [0..1]
Role (II)
manufacturedProduct [1..1] (Product)
 
Product
classCode [1..1] (M)
ManufacturedMaterial (CS) {CNE:C:EntityClass:MMAT, fixed value= "MMAT"}
determinerCode [1..1] (M)
ManufacturedMaterial (CS) {CNE:C:EntityDeterminer:KIND, fixed value= "KIND"}
name [0..*]
ManufacturedMaterial (COLL<EN>)
asNamedEntity [0..*] (NamedEntity)
ingredient [0..*] (Ingredient)
 
NamedEntity
classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:IDENT, fixed value= "IDENT"}
name [0..*]
Role (COLL<EN>)
assigningTerritory [1..1] (Territory)
 
Territory
classCode [1..1] (M)
Organization (CS) {CNE:C:EntityClass:STATE, fixed value= "STATE"}
determinerCode [1..1] (M)
Organization (CS) {CNE:C:EntityDeterminer:INSTANCE, fixed value= "INSTANCE"}
code [1..1] (M)
Organization (CD) {CWE:D:TerritoryEntityType}
name [0..1]
Organization (EN)

Design Comments: territory name if not coded

 
Ingredient
classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:ACTI, fixed value= "ACTI"}
activeIngredientSubstance [1..1] (Substance)
 
Substance
classCode [1..1] (M)
Material (CS) {CNE:C:EntityClass:MAT, fixed value= "MAT"}
determinerCode [1..1] (M)
Material (CS) {CNE:C:EntityDeterminer:KIND, fixed value= "KIND"}
name [1..1]
Material (EN)
 
DedicatedServiceDeliveryLocation

Design Comments: The manufacturing site is based on the organization creating such a product. In other words, if a different organization buys a manufacturing site, it is possible that sites needs to be approved again.

classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:DSDLOC, fixed value= "DSDLOC"}
location [0..1] (Place)
recognizingOrganization [0..1] (Organization)
deviceOf [0..*] (Device)
 
Device
typeCode [1..1] (M)
Participation (CS) {CNE:V:ParticipationTargetDevice, root= "DEV"}
deviceActDefinition [1..1] (A_DeviceActDefinitionUniversal)
 
Author
typeCode [1..1] (M)
Participation (CS) {CNE:C:ParticipationType:AUT, fixed value= "AUT"}
territorialAuthority [1..1] (TerritorialAuthority)
 
Subject5

Design Comments: One submission can have many approvals for one submission. This is true in Europe where one submission is expecting approvals from many countries at different times.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
productCategory [1..1] (ProductCategory)
 
ProductCategory
classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:CATEGORY, fixed value= "CATEGORY"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
code [1..1] (M)
Act (CD) {CNE:D:ActCode}
 
Subject7
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
regulatoryReviewTime [1..1] (RegulatoryReviewTime)

Design Comments: This information is used to determine review timelines and goals and should be captured when the activity is submitted.

 
RegulatoryReviewTime

Design Comments: This information is used to determine review timelines and goals and should be captured when the activity is submitted.

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
code [1..1] (M)
Act (CD) {CWE:D:ActCode}
 
Subject8
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
regulatoryStatus [1..1] (RegulatoryStatus)
 
RegulatoryStatus
classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
code [1..1] (M)
Act (CD) {CWE:D:ActCode}
effectiveTime [0..1]
Act (TS)
 
Subject9
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
submissionGroup [1..1] (SubmissionGroup)
 
SubmissionGroup
classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:GROUPER, fixed value= "GROUPER"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..1] (M)
Act (II)
 
Component4

Design Comments: A submission unit either pertains to one or more Submissions or pertains to one or more Reviewable Units. For example, an annual report submission unit can apply to multiple applications. Therefore, the applicant will create one submission unit and associate that unit to multiple submissions.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"}
application [1..1] (Application)

Design Comments: An application is the highest level of organization of submission content. It is subdivided into submissions, which in turn may be subdivided into reviewable units.

UsageNotes: Id is a set and can be defined by many organizations for tracking purposes

 
Application

Design Comments: An application is the highest level of organization of submission content. It is subdivided into submissions, which in turn may be subdivided into reviewable units.

UsageNotes: Id is a set and can be defined by many organizations for tracking purposes

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..*] (M)
Act (DSET<II>)

Design Comments: The unique identifier that is used to refer to this act

code [1..1] (M)
Act (CD) {CNE:D:ActCode}

Design Comments: The code specifying the particular kind of application (e.g. New Drug Application, 510k, Veterinary New Drug Submission). Each product type will be supported by a different application code.

holder [0..1] (Holder)
informationRecipient [0..*] (InformationRecipient)

Design Comments: A context of use can be targeted to only one regulatory authority.

subject [0..1] (Subject10)
reference [0..*] (Reference2)
component [0..*] (Component5)
referencedBy [0..*] (Reference1)
 
Holder
typeCode [1..1] (M)
Participation (CS) {CNE:C:ParticipationType:HLD, fixed value= "HLD"}
applicant [1..1] (Applicant)
 
Applicant
classCode [1..1] (M)
Role (CS) {CNE:C:RoleClass:SPNSR, fixed value= "SPNSR"}
sponsorOrganization [0..1] (Organization)
 
InformationRecipient

Design Comments: A context of use can be targeted to only one regulatory authority.

typeCode [1..1] (M)
Participation (CS) {CNE:C:ParticipationType:IRCP, fixed value= "IRCP"}
territorialAuthority [1..1] (TerritorialAuthority)
 
Subject10
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:SUBJ, fixed value= "SUBJ"}
reviewProcedure [1..1] (ReviewProcedure)

Design Comments: Defines the procedure in used to review the regulatory activity. The procedures are Centralised, National , Mutual Recognition and Decentralised.

 
ReviewProcedure

Design Comments: Defines the procedure in used to review the regulatory activity. The procedures are Centralised, National , Mutual Recognition and Decentralised.

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:POLICY, fixed value= "POLICY"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
code [0..1]
Act (CD) {CWE:D:ActCode}

Design Comments: Defines the procedure in used to review the regulatory activity. The procedures are Centralised, National , Mutual Recognition and Decentralised.

 
Reference2
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:REFR, fixed value= "REFR"}
applicationReference [1..1] (ApplicationReference)

Design Comments: The id of application that is being referred to.

 
ApplicationReference

Design Comments: The id of application that is being referred to.

classCode [1..1] (M)
Act (CS) {CNE:C:ActClass:ACT, fixed value= "ACT"}
moodCode [1..1] (M)
Act (CS) {CNE:C:ActMood:EVN, fixed value= "EVN"}
id [1..1] (M)
Act (II)

Design Comments: The id of the application.

reasonCode [0..*]
Act (DSET<CD>) {CWE:D:ActReason}
 
Component5
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"}
document [1..1] (Document)

Design Comments: A document instance represents either a simple document, comprising exactly one file identified by means of a text attribute, or a compound document, comprising one or more simple and/or compound documents referenced by their id as components. A document instance may contain either a text attribute or component relationships, but not both.

UsageNotes: Either text or component is used, but not both.

 
Document

Design Comments: A document instance represents either a simple document, comprising exactly one file identified by means of a text attribute, or a compound document, comprising one or more simple and/or compound documents referenced by their id as components. A document instance may contain either a text attribute or component relationships, but not both.

UsageNotes: Either text or component is used, but not both.

classCode [1..1] (M)
Document (CS) {CNE:C:ActClass:DOC, fixed value= "DOC"}
moodCode [1..1] (M)
Document (CS) {CNE:C:ActMood:DEF, fixed value= "DEF"}
id [1..1] (M)
Document (II)

Design Comments: The unique identifier that is used to refer to this act

code [0..1]
Document (CD) {CWE:D:ActCode}
title [0..1]
Document (ST)

Design Comments: The title for the document in the associated assignment. If title is blank, the file title can be used.

text [0..1]
Document (ED)
statusCode [0..1]
Document (CS) {CNE:V:x_DocumentStatus}
setId [0..1]
Document (II)
versionNumber [0..1]
Document (ST)
sequelTo [0..*] (SequelTo2)

Design Comments: Relates the reference to the document version being replaced to the associated new version of the document.

component [0..*] (Component6)

Design Comments: Can reference a Document by Id only.

referencedBy [0..*] (Reference3)
 
SequelTo2

Design Comments: Relates the reference to the document version being replaced to the associated new version of the document.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:V:ActRelationshipSequel, root= "SEQL"}
relatedDocument [1..1] (RelatedDocument)

Design Comments: References the previous version in a set of Documents when it is being replaced by the associated new version.

 
RelatedDocument

Design Comments: References the previous version in a set of Documents when it is being replaced by the associated new version.

classCode [1..1] (M)
Document (CS) {CNE:C:ActClass:DOC, fixed value= "DOC"}
moodCode [1..1] (M)
Document (CS) {CNE:C:ActMood:DEF, fixed value= "DEF"}
id [1..1] (M)
Document (II)

Design Comments: Reference to the ContextOfUse.id

versionNumber [0..1]
Document (ST)
 
Component6

Design Comments: Can reference a Document by Id only.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:COMP, fixed value= "COMP"}
priorityNumber [0..1]
ActRelationship (REAL)
document [1..1] (Document)
 
Reference1
typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:REFR, fixed value= "REFR"}
keywordDefinition [1..1] (KeywordDefinition)

Design Comments: A keyword definition is used to define a set of keywords of a given type; the type is defined from a shared controlled vocabulary in the code attribute, and the keywords are defined as set of complete code entries in the value attribute, including for each entry the code system name and id (OID) and the code value and display name.

 
KeywordDefinition

Design Comments: A keyword definition is used to define a set of keywords of a given type; the type is defined from a shared controlled vocabulary in the code attribute, and the keywords are defined as set of complete code entries in the value attribute, including for each entry the code system name and id (OID) and the code value and display name.

classCode [1..1] (M)
Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"}
moodCode [1..1] (M)
Observation (CS) {CNE:C:ActMood:DEF, fixed value= "DEF"}
code [1..1]
Observation (CD) {CWE:D:ActCode}

Design Comments: The type of Keyword (e.g., Manufacture, Dosage Form, Route of Admin)

statusCode [1..1] (M)
Observation (CS) {CNE:V:ActStatus, default= "active"}

Design Comments: Active or nullified.

value [1..*]
Observation (DSET<CD>) {CWE:D:ObservationValue}

Design Comments: The value of the KeywordDefination.code

replacementOf [0..1] (ReplacementOf)

Design Comments: Relates an existing Keyword Definition to associated new Keyword Definition that is to replace it.

 
ReplacementOf

Design Comments: Relates an existing Keyword Definition to associated new Keyword Definition that is to replace it.

typeCode [1..1] (M)
ActRelationship (CS) {CNE:C:ActRelationshipType:RPLC, fixed value= "RPLC"}
previousKeywordDefinition [1..1] (PreviousKeywordDefinition)

Design Comments: PreviousKeywordDefinition is used to replace an existing KeywordDefination. Once a KeywordDefinition is replaces, that KeywordDefination can no longer be associated with a context of use.

 
PreviousKeywordDefinition

Design Comments: PreviousKeywordDefinition is used to replace an existing KeywordDefination. Once a KeywordDefinition is replaces, that KeywordDefination can no longer be associated with a context of use.

classCode [1..1] (M)
Observation (CS) {CNE:C:ActClass:OBS, fixed value= "OBS"}
moodCode [1..1] (M)
Observation (CS) {CNE:C:ActMood:DEF, fixed value= "DEF"}
code [1..1]
Observation (CD) {CWE:D:ActCode}

Design Comments: Reference to the KeywordDefinition.id.

value [1..*]
Observation (DSET<CD>) {CWE:D:ObservationValue}

Design Comments: Reference to the KeywordDefinition.id.