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  1. FHIR Specification Feedback
  2. FHIR-28432

Add subject[x] reference to MedicinalProductDefinition and SubstanceDefinition

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R5
    • Clinical Decision Support
    • DomainResource
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      Add a choice of canonical to subject choices to allow a PlanDefinition to have a definitional item as the subject.

      Document the allowed reference resources:

      • MedicinalProductDefinition
      • SubstanceDefinition
      • AdministrableProductDefinition
      • ManufacturedItemDefinition
      • PackagedProductDefinition
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      Add a choice of canonical to subject choices to allow a PlanDefinition to have a definitional item as the subject. Document the allowed reference resources: MedicinalProductDefinition SubstanceDefinition AdministrableProductDefinition ManufacturedItemDefinition PackagedProductDefinition
    • Floyd Eisenberg/Kensaku Kawamoto: 19-0-0
    • Enhancement
    • Compatible, substantive
    • R5

    Description

      Request to add subject[x] reference to the MedicinalProductDefinition and SubstanceDefinition resource.

      In PQ/CMC project, we are leveraging PlanDefinition for a Drug Product and Drug Substance quality specification.  A Quality Specification is a series of tests that will be performed on a drug product or a drug substance where each test has set of acceptance criteria defined in the specification.  

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            bryn.rhodes Bryn Rhodes
            shastak Smita Hastak
            Catherine Hosage Norman, Rik Smithies, Vivek Desai (Inactive)
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            Dates

              Created:
              Updated:
              Resolved: