Medication Scheme Implementation Guide
1.0.0 - draft Estonia flag

Medication Scheme Implementation Guide, published by TEHIK. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/TEHIK-EE/ig-ee-medication-scheme/ and changes regularly. See the Directory of published versions

Extension: ExtensionEETISUnauthorizedProductRequest

Official URL: https://fhir.ee/StructureDefinition/ee-tis-unauthorized-product-request Version: 1.0.0
Draft as of 2024-02-21 Computable Name: ExtensionEETISUnauthorizedProductRequest

Müügiloata ravimi taotlus. Used for requesting marketing permit for unauthorized medication.

Context of Use

This extension may be used on the following element(s):

  • Element ID MedicationRequest
  • Element ID MedicationStatement

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Complex Extension: Müügiloata ravimi taotlus. Used for requesting marketing permit for unauthorized medication.

  • requestNumber: id: An Extension
  • requestReason: CodeableConcept: Müügiloata ravimi taotluse põhjus
  • requestStatus: CodeableConcept: An Extension
  • requestDate: dateTime: Müügiloata ravimi taotluse kuupäev.
  • requestNegDecision: CodeableConcept: An Extension
  • requestReasonText: string: An Extension

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Müügiloata ravimi taotlus.
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:requestNumber 0..1 Extension Request number for unauthorized medication marketing request
..... extension 0..0
..... url 1..1 uri "requestNumber"
..... value[x] 0..1 id Marketing request decision number given by Ravimiamet. Every marketing request has its own unique number.
.... extension:requestReason 1..1 Extension Reason for unauthorized medication marketing request
..... extension 0..0
..... url 1..1 uri "requestReason"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ER_Müügiloata taotluse põhjendus (preferred): Myygiloata ravimi pohjendus. LOEND

.... extension:requestStatus 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "requestStatus"
..... value[x] 0..1 CodeableConcept Unauthorized medication marketing request ststus Positiivne | Negatiivne
Binding: Müügiloata ravimi kasutamise taotluse staatus (preferred): Müügiloata ravimi taotluse staatuse loend

.... extension:requestDate 1..1 Extension Date when the request was made.
..... extension 0..0
..... url 1..1 uri "requestDate"
..... value[x] 0..1 dateTime Value of extension
.... extension:requestNegDecision 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "requestNegDecision"
..... value[x] 0..1 CodeableConcept Reason for a declining the request.
Binding: Müügiloata ravimi kasutamise taotluse negatiivse otsuse põhjendus (required): Müügiloata ravimi taotluse keelduva otsuse põhjendused

.... extension:requestReasonText 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "requestReasonText"
..... value[x] 0..1 string Reason in free form text. If the reason for requesting unauthorized medicine is not in the valueset there must be free form explanation for the request.
... url 1..1 uri "https://fhir.ee/StructureDefinition/ee-tis-unauthorized-product-request"

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Müügiloata ravimi taotlus.
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:requestNumber 0..1 Extension Request number for unauthorized medication marketing request
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestNumber"
..... value[x] 0..1 id Marketing request decision number given by Ravimiamet. Every marketing request has its own unique number.
.... extension:requestReason 1..1 Extension Reason for unauthorized medication marketing request
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestReason"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ER_Müügiloata taotluse põhjendus (preferred): Myygiloata ravimi pohjendus. LOEND

.... extension:requestStatus 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestStatus"
..... value[x] 0..1 CodeableConcept Unauthorized medication marketing request ststus Positiivne | Negatiivne
Binding: Müügiloata ravimi kasutamise taotluse staatus (preferred): Müügiloata ravimi taotluse staatuse loend

.... extension:requestDate 1..1 Extension Date when the request was made.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestDate"
..... value[x] 0..1 dateTime Value of extension
.... extension:requestNegDecision 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestNegDecision"
..... value[x] 0..1 CodeableConcept Reason for a declining the request.
Binding: Müügiloata ravimi kasutamise taotluse negatiivse otsuse põhjendus (required): Müügiloata ravimi taotluse keelduva otsuse põhjendused

.... extension:requestReasonText 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestReasonText"
..... value[x] 0..1 string Reason in free form text. If the reason for requesting unauthorized medicine is not in the valueset there must be free form explanation for the request.
... url 1..1 uri "https://fhir.ee/StructureDefinition/ee-tis-unauthorized-product-request"

doco Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Müügiloata ravimi taotlus. Used for requesting marketing permit for unauthorized medication.

  • requestNumber: id: An Extension
  • requestReason: CodeableConcept: Müügiloata ravimi taotluse põhjus
  • requestStatus: CodeableConcept: An Extension
  • requestDate: dateTime: Müügiloata ravimi taotluse kuupäev.
  • requestNegDecision: CodeableConcept: An Extension
  • requestReasonText: string: An Extension

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Müügiloata ravimi taotlus.
... extension 2..* Extension Extension
... Slices for extension Content/Rules for all slices
.... extension:requestNumber 0..1 Extension Request number for unauthorized medication marketing request
..... extension 0..0
..... url 1..1 uri "requestNumber"
..... value[x] 0..1 id Marketing request decision number given by Ravimiamet. Every marketing request has its own unique number.
.... extension:requestReason 1..1 Extension Reason for unauthorized medication marketing request
..... extension 0..0
..... url 1..1 uri "requestReason"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ER_Müügiloata taotluse põhjendus (preferred): Myygiloata ravimi pohjendus. LOEND

.... extension:requestStatus 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "requestStatus"
..... value[x] 0..1 CodeableConcept Unauthorized medication marketing request ststus Positiivne | Negatiivne
Binding: Müügiloata ravimi kasutamise taotluse staatus (preferred): Müügiloata ravimi taotluse staatuse loend

.... extension:requestDate 1..1 Extension Date when the request was made.
..... extension 0..0
..... url 1..1 uri "requestDate"
..... value[x] 0..1 dateTime Value of extension
.... extension:requestNegDecision 0..1 Extension Extension
..... extension 0..0
..... url 1..1 uri "requestNegDecision"
..... value[x] 0..1 CodeableConcept Reason for a declining the request.
Binding: Müügiloata ravimi kasutamise taotluse negatiivse otsuse põhjendus (required): Müügiloata ravimi taotluse keelduva otsuse põhjendused

.... extension:requestReasonText 0..* Extension Extension
..... extension 0..0
..... url 1..1 uri "requestReasonText"
..... value[x] 0..1 string Reason in free form text. If the reason for requesting unauthorized medicine is not in the valueset there must be free form explanation for the request.
... url 1..1 uri "https://fhir.ee/StructureDefinition/ee-tis-unauthorized-product-request"

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Müügiloata ravimi taotlus.
... id 0..1 id Unique id for inter-element referencing
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:requestNumber 0..1 Extension Request number for unauthorized medication marketing request
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestNumber"
..... value[x] 0..1 id Marketing request decision number given by Ravimiamet. Every marketing request has its own unique number.
.... extension:requestReason 1..1 Extension Reason for unauthorized medication marketing request
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestReason"
..... value[x] 0..1 CodeableConcept Value of extension
Binding: ER_Müügiloata taotluse põhjendus (preferred): Myygiloata ravimi pohjendus. LOEND

.... extension:requestStatus 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestStatus"
..... value[x] 0..1 CodeableConcept Unauthorized medication marketing request ststus Positiivne | Negatiivne
Binding: Müügiloata ravimi kasutamise taotluse staatus (preferred): Müügiloata ravimi taotluse staatuse loend

.... extension:requestDate 1..1 Extension Date when the request was made.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestDate"
..... value[x] 0..1 dateTime Value of extension
.... extension:requestNegDecision 0..1 Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestNegDecision"
..... value[x] 0..1 CodeableConcept Reason for a declining the request.
Binding: Müügiloata ravimi kasutamise taotluse negatiivse otsuse põhjendus (required): Müügiloata ravimi taotluse keelduva otsuse põhjendused

.... extension:requestReasonText 0..* Extension Extension
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... url 1..1 uri "requestReasonText"
..... value[x] 0..1 string Reason in free form text. If the reason for requesting unauthorized medicine is not in the valueset there must be free form explanation for the request.
... url 1..1 uri "https://fhir.ee/StructureDefinition/ee-tis-unauthorized-product-request"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:requestReason.value[x]preferredMyygiloataRavimiPohjendus (a valid code from ER_Müügiloata taotluse põhjendus)
https://fhir.ee/ValueSet/myygiloata-ravimi-pohjendus
from this IG
Extension.extension:requestStatus.value[x]preferredMyygiloataRavimiTaotluseStaatus (a valid code from Müügiloata ravimi kasutamise taotluse staatus)
https://fhir.ee/ValueSet/myygiloata-ravimi-taotluse-staatus
from this IG
Extension.extension:requestNegDecision.value[x]requiredMyygiloataRavimiNegOtsusePohjendus (a valid code from Müügiloata ravimi kasutamise taotluse negatiivse otsuse põhjendus)
https://fhir.ee/ValueSet/myygiloata-ravimi-neg-otsuse-pohjendus
from this IG

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()