Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions

International

The ePI project aims primarily at European format of the SMPC, but the relationship with other projects is vital. Especially the USA and Japanese counterparts.

There has been a work on the mapping between the 3:

SmPC JPI USPI
1. Name of the medicinal product beginning of document beginning of document
2. Qualitative and quantitative composition 3.1 Composition 11. Description + 3 dosage forms and strengths
3. Pharmaceutical form N/A 11. Description
4. Clinical particulars - -
4.1 Therapeutic indications 4. Indications 1. Indications and usage
4.2 Posology and method of administration 6. Dosage and administration 2. Dosage and administration
4.3 Contraindications 9. Precautions concerning patients with specific backgrounds 4. Contraindications
4.4 Special warnings and precautions for use 9. Precautions concerning patients with specific backgrounds 5. Warnings and precautions
4.5 Interaction with other medicinal products and other forms of interaction 10. Interactions 7. Drug interactions
4.6 Fertility, pregnancy and lactation 9. Precautions concerning patients with specific backgrounds 8. Use in specific populations
4.7 Effects on ability to drive and use machines 9.Precautions concerning patients with specific backgrounds N/A
4.8 Undesirable effects 11. Adverse reactions 6. Adverse reactions
4.9 Overdose 13. Overdosage 10. Overdosage
5. Pharmacological properties - -
5.1 Pharmacodynamic properties 18. Pharmacology 12.1 Mechanism of Action + 12.2 Pharmacodynamics
5.2 Pharmacokinetic properties 16. Pharmacokinetics 12.3 Pharmacokinetics
5.3 Preclinical safety data 17. Clinical studies 14. Clinical studies
6. Pharmaceutical particulars - -
6.1 List of excipients 3.1 Composition N/A
6.2 Incompatibilities N/A N/A
6.3 Shelf life beginning of document N/A
6.4 Special precautions for storage beginning of document 16. How supplied/storage and handling
6.5 Nature and contents of container N/A 16. How supplied/storage and handling
6.6 Special precautions for disposal and other handling N/A N/A
7. Marketing authorisation holder 26. Marketing authorization holder, etc. N/A
8. Marketing authorisation number(s) 26. Marketing authorization holder, etc. N/A
9. Date of first authorisation/renewal of the authorisation N/A N/A
10. Date of revision of the text beginning of document N/A

USPI - FHIR SPL

The data for the SPL related IG is present here

So in terms of FHIR document, is also possible to create a mapping between sections in the Composition.

So..