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Specification:

Electronic Medicinal Product Information (FHIR)
Raised in Version:

1.0.0-ballot
Work Group:

Biomedical Research & Regulation
Outstanding Negatives:
STU
Related Page(s):

(many)
Grouping:
- voted-by-BRR
Resolution Description:

Hide

proceed as requested

Show
proceed as requested
Resolution Vote:
Craig Anderson / Norman Gregory : 7-0-0
Change Category:
Clarification
Change Impact:
Non-substantive

change "This model is meant as a demonstration. Refer to national or regional guidance for local rules about what resources are in or out of scope." Into something like "This section, included only for demonstration purposes, provides a general guidance on how to create an ePI by using this guide. Refer however to national or regional guidelines to fulfill the rules specified by each jurisdiction."
I recommend to use only one picture summarizing all the phases and describe the steps in the text. In any case revise the figures used in this page e.g. in the first one all the boxes are empty.
remove "Step 3: Create List (of ePIs)", no lists are defined in this guide

is voted on by

BALLOT-46247 Negative - Giorgio Cangioli : 2023-Jan-FHIR IG EMEDICINAL PRODUCT INFO R1 STU