Details
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Change Request
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Resolution: Persuasive with Modification
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Medium
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Electronic Medicinal Product Information (FHIR)
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1.0.0-ballot
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Biomedical Research & Regulation
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STU
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PackagedProductDefinition (ePI)
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Jean Duteau / Catherine Hosage-Norman : 11-0-0
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Correction
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Compatible, substantive
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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
Attachments
Issue Links
- is voted on by
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BALLOT-46289 Negative - Giorgio Cangioli : 2023-Jan-FHIR IG EMEDICINAL PRODUCT INFO R1 STU
- Withdrawn