Details
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Change Request
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Resolution: Persuasive with Modification
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Highest
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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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Steps to create ePI Type 2
Steps to create ePI Type 3 -
5.1.9
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Craig Anderson / Norman Gregory : 7-0-0
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Clarification
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Non-substantive
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Yes
Description
There may be a need to characterize warning types – e.g., in the US, black box warnings are the most serious warning type and should be distinguished from other warnings.
Attachments
Issue Links
- is voted on by
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BALLOT-46748 Negative - Celine Lefebvre : 2023-Jan-FHIR IG EMEDICINAL PRODUCT INFO R1 STU
- Balloted