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  1. FHIR Specification Feedback
  2. FHIR-39810

Revise the PackagedProductDefinition-uv-epi profile

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • Electronic Medicinal Product Information (FHIR)
    • 1.0.0-ballot
    • Biomedical Research & Regulation
    • STU
    • PackagedProductDefinition (ePI)
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      Proceed as requested, in particular

      • revise the referred value sets
      • no alternative value sets
      • legalStatusOfSupply use SPOR as example
      • marketingStatus: align legalStatusOfSupply and marketingStatus. Use jurisdiciton for both with the same value set.
      • marketingStatus.status, shelfLifeStorage.type, packaging.shelfLifeStorage.specialPrecautionsForStorage : use SPOR as example
      • packaging.material: use EDQM as example
      • packaging.packaging: leave as it is
      Show
      Proceed as requested, in particular revise the referred value sets no alternative value sets legalStatusOfSupply use SPOR as example marketingStatus: align legalStatusOfSupply and marketingStatus. Use jurisdiciton for both with the same value set. marketingStatus.status, shelfLifeStorage.type, packaging.shelfLifeStorage.specialPrecautionsForStorage : use SPOR as example packaging.material: use EDQM as example packaging.packaging: leave as it is
    • Jean Duteau / Catherine Hosage-Norman : 11-0-0
    • Correction
    • Compatible, substantive
    • Yes

    Description

      identifier.system

      • revise the packagedProductIdSystems value set

      type

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

      status

      • add alternative value sets as needed

      legalStatusOfSupply.code

      • revise the legalStatusOfSupply value set
      • should the preferred value set be based on SPOR ?
      • add alternative value sets as needed (e.g. SPOR)

      1.1.1.5      marketingStatus

      • Why in the legalStatusOfSupply is used the jurisdiction and in the marketingStatus the country (or only the country) ? (both country and jurisdiction are present in the resource). Harmonize the choice if there are no specific reasons for having these differences. 

      1.1.1.6      marketingStatus.status

      • revise the marketingStatus value set
      • should the preferred value set be based on SPOR ?
      • add alternative value sets as needed (e.g. SPOR)

      1.1.1.7      packaging.identifier.system

      • fix the dataCarrierIdSystem value set

      1.1.1.8      packaging.type

      • fix the secondaryPrimaryPackType value set
      • add alternative value sets as needed

      1.1.1.9      packaging.material

      • revise the packageMaterial value set
      • should the preferred value set be based on SPOR ?
      • add alternative value sets as needed (e.g. SPOR)

      1.1.1.10   shelfLifeStorage.type

      • revise the shelfLifeType value set
      • should the preferred value set be based on SPOR ?
      • add alternative value sets as needed (e.g. SPOR)

      1.1.1.11   shelfLifeStorage.periodDuration.code

      • fix the unitofMeasure value set
      • add alternative value sets as needed

      1.1.1.12   packaging.shelfLifeStorage.specialPrecautionsForStorage

      • revise the specialPrecautionsForStorage value set
      • should the preferred value set be based on SPOR ?
      • add alternative value sets as needed (e.g. SPOR)

      1.1.1.13   packaging.packaging

      • if the same rules apply for all the nesting levels, make them explicit

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            giorgio Giorgio Cangioli
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              Created:
              Updated:
              Resolved: