Details
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Comment
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Resolution: Considered - No action required
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Medium
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FHIR Core (FHIR)
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R5
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Biomedical Research & Regulation
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MedicinalProductDefinition
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Description
R4B received a ballot comment for PackagedProductDefinition that different jurisdictions may want different legal statuses on the same resource. This makes sense and was accepted.
This also makes sense for the product itself, and in fact this is necessary for an EMA use case for the DADI (eAF variation form) system under development.
The PPD change was not mirrored to the MPD, in the spirit of minimizing changes, but it seems sensible to add this to R5.
Proposal:
MedicinalProductDefinition.legalStatusOfSupply currently 0..1
make it a backbone, 0..*
and have .code 0..1 (correspondng to the current legalStatusOfSupply code)
and jurisdiction 0...1 value set LegalStatusOfSupply (Example)
essentially a mirror of http://build.fhir.org/packagedproductdefinition-definitions.html#PackagedProductDefinition.legalStatusOfSupply