Stream: europe
Topic: ePI
Jens Villadsen (Jun 29 2021 at 08:37):
FYI - draft spec comming up on ePI: https://github.com/EuropeanMedicinesAgency/ePI-consultation - anyone else involved?
Jens Villadsen (Jun 29 2021 at 08:37):
More up to date information also listed on https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information-requirements#electronic-product-information-initiative-section
Rik Smithies (Jun 29 2021 at 11:12):
Hi Jens, I am involved
Jens Villadsen (Jun 29 2021 at 17:24):
You know if they plan to make an IG as well?
Rik Smithies (Jun 29 2021 at 19:16):
The team tend to prefer IGs in the form of documents (i.e. word/pdf) I think because of some documentation standards and ease of review in the early stages before the details are concrete. But I can imagine - and will push for - actual FHIR profiles and IGs at some stage.
Jens Villadsen (Jun 29 2021 at 20:44):
Good to know
Jens Villadsen (Aug 10 2021 at 06:53):
@Rik Smithies - FYI - http://build.fhir.org/ig/hl7-eu/gravitate-health/
Jens Villadsen (Aug 25 2021 at 10:03):
Now moved to https://hl7-eu.github.io/gravitate-health/ in order to support R4B
Last updated: Apr 12 2022 at 19:14 UTC
