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  1. FHIR Specification Feedback
  2. FHIR-39808

Revise the MedicinalProductDefinition-uv-epi profile

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Very High Very High
    • Electronic Medicinal Product Information (FHIR)
    • 1.0.0-ballot
    • Biomedical Research & Regulation
    • STU
    • MedicinalProductDefinition (ePI)
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      Proceed as requested, including 

      • revise the referred value sets as requested (see FHIR-39822, FHIR-39824)
      • define  value sets for  combinedPharmaceuticalDoseForm, routeOfAdministration based on EDQM
      • legalStatusOfSupply: use the value set used in the base resource
      • status: same value set, change the binding to example
      • no alternative value sets
      • marketingStatus.status: SPOR as example
      • name.type and name.part.type: remove the slices and revert to the base resource
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      Proceed as requested, including  revise the referred value sets as requested (see FHIR-39822 , FHIR-39824 ) define  value sets for  combinedPharmaceuticalDoseForm, routeOfAdministration based on EDQM legalStatusOfSupply: use the value set used in the base resource status: same value set, change the binding to example no alternative value sets marketingStatus.status: SPOR as example name.type and name.part.type: remove the slices and revert to the base resource
    • Jean Duteau / Catherine Hosage-Norman : 11-0-0
    • Correction
    • Non-compatible
    • Yes

    Description

      identifier.system

      • revise the manufacturedItemIdSystems value set

       type

      • revise the medProductType value set

      domain

      • add alternative value sets as needed (e.g. SPOR)

      status

      combinedPharmaceuticalDoseForm

      • Revise the PharmaceuticalDoseForm value set
      • the preferred value set should not be based on SPOR but on EDQM;
      • add alternative value sets as needed (e.g. SPOR)
      • evaluate if it is correct to have a single value set for the Pharmaceutical Dose Form (not sure that in all the cases the combined Pharmaceutical Dose Form applies..)

      route

      • revise the routeOfAdministration value set
      • the preferred value set should not be based on SPOR but on EDQM;
      • add alternative value sets as needed (e.g. SPOR)

      legalStatusOfSupply

      • revise the legalStatusOfSupply value set
      • not sure that the preferred value set be based on SPOR..
      • add alternative value sets as needed (e.g. SPOR)

      additionalMonitoringIndicator

      • Fix the additionalMonitoringIndicator value set
      • add alternative value sets as needed

      pediatricUseIndicator

      • Fix the pediatricUseIndicator value set
      • add alternative value sets as needed

      classification

      • add  alternative value sets as needed

      marketingStatus.status

      • revise the marketingStatus value set
      • not sure that the preferred value set be based on SPOR..
      • add alternative value sets as needed (e.g. SPOR)

      packagedMedicinalProduct

      • revise the packageType value set
      • add as alternative value sets as needed

      name.type

      name.part.type

      usage.country

      • add alternative value sets as needed

      usage.jurisdiction

      • add alternative value sets as needed

      crossReference

      • make explicit the 1.. product element, CodeableReference(MedicinalProductDefinitionUvEpi)

      crossReference.type

      • change the binding from extensible to preferred (in the base resource this value set is experimental / example)
      • add alternative value sets as needed

      operation.type.concept

      • fix the operationType value set
      • add alternative value sets as needed.

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            giorgio Giorgio Cangioli
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              Created:
              Updated:
              Resolved: