Details
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Change Request
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Resolution: Persuasive
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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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(NA)
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Jean Duteau / Catherine Hosage-Norman : 11-0-0
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Clarification
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Non-substantive
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Yes
Description
General
- Add an introductive paragraph describing what the semantic annotation is used for in the ePI
- Titles "Technical Section" and "Focusing Section" seems not be so descriptive of what these sections are about. Please use better titles
Section 4.1 Focusing Section
- Please revise this section in order to improve its understandability: what we're trying to achieve, how; what are the technical details to realize it,...
Section 4.1.1 Introduction to Focusing
- Please improve the clarity of this section, I don't think that a first reader understand what we are talking about....
- It would be good to have a description of what "focusing" tries to achieve and then how technically is done.
Section 4.1.2 Focus Attributes
- Revise the sentence "The following attributes are identified as the key focus points of the product information. Some attribute options may vary between countries (e.g., Age to be considered an Adult). For information on these, refer to the Country Appendixes." There are no "The following attributes" nor "Country Appendixes."
Section 4.1.3 Text with No Attribute
- This section seems to be out of context... please revise
Attachments
Issue Links
- is voted on by
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BALLOT-46246 Negative - Giorgio Cangioli : 2023-Jan-FHIR IG EMEDICINAL PRODUCT INFO R1 STU
- Withdrawn
- relates to
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FHIR-39961 In section 4.1.4.1 Examples - there is a note to "INSERT TABLE" but there is no table
- Published