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Type:
Change Request
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Resolution: Unresolved
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Priority:
Medium
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FHIR Core (FHIR)
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R5
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Biomedical Research & Regulation
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RegulatedAuthorization
The eAF Electronic Application Form standard (currently in use across 27 countries in the EU, when products are being approved or altered) is being converted to FHIR and has the concept of an approval of a manufacturer for the ingredient of a product.
This requires a reference from RegulatedAuthorization to Ingredient.
This is neither the authorisation of the product as a whole, or the authorisation of the substance as an abstract concept.