Details
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Change Request
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Resolution: Persuasive with Modification
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Very High
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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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MedicinalProductDefinition (ePI)
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Jean Duteau / Catherine Hosage-Norman : 11-0-0
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Correction
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Non-compatible
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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
- Is http://hl7.org/fhir/ValueSet/publication-status the value set to be used in this profile ?
- consider in any case to add alternative value sets as needed (e.g. SPOR).
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
- should this be fixed to SPOR#220000000001 ?
- in any case check the used https://spor.ema.europa.eu/rmswi/220000000000 url, an official url is needed
name.part.type
- should this be fixed to SPOR concepts ?
- in any case check the used https://spor.ema.europa.eu/rmswi/220000000000 url, an official url is needed
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.
Attachments
Issue Links
- is voted on by
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BALLOT-46287 Negative - Giorgio Cangioli : 2023-Jan-FHIR IG EMEDICINAL PRODUCT INFO R1 STU
- Withdrawn