Gravitate Health FHIR Implementation Guide (FHIR R4)
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide (FHIR R4), published by . 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-ips/ and changes regularly. See the Directory of published versions

Connections

How to connect IPS and ePI resources

The following unique identifiers are used as connection points between the IPS bundle, the ePI Master List and the ePI document (e.g., PIL or SmPC).

Market Authorization Number (MAN) A marketing authorisation number is used to uniquely identify a medicinal product. it is allocated to a specific strength and pharmaceutical form of the medicinal product.

The marketing authorisation number, assigned by the European Medicines Agency to a centrally authorised medicinal product, indicates whether it is a product for human or veterinary use, the year of authorisation of the first presentation of the product, the sequence number of the authorisation of the first presentation of the product and the number distinguishing subsequently authorised presentations of the product (pharmaceutical form, strength, pack size and type of packaging). It has the following format: EU/A/BB/CCC/DDD:

EU – identification of a centrally authorised medicinal product

A – distinction of the medicinal product (1 – human medicine, 2 – veterinary medicine)

BB – year of authorisation

CCC – serial number of the authorisation

DDD – number of the product presentation

This type of the marketing authorisation number allows for the tracing of links between individual product presentations assigned to the global authorisation; however, it does not allow for the distinguishing of the year in which the individual presentations were authorised, and it does not even indicatively point to the therapeutic area of the use of the product.

The marketing authorisation number of a product which is subject to parallel distribution, comprises of the marketing authorisation number of a centrally authorised medicinal product complemented with the letters “PD”, meaning parallel distribution, the sequential number of the parallel distribution authorisation in the respective year, and the year of issuance of such authorisation; prior to 1 January 2017, the letters “PD” were complemented with the sequential number of the parallel distribution authorisation issued for the concerned medicinal product and the year of issuance of the parallel distribution authorisation. The data after the letters PD serve solely for the Institute’s internal purposes, they do not form part of the marketing authorisation number and in the search database they are provided on a separate line under the marketing authorisation number.

Substance Identifier (SID) for the active ingredient(s)

IPS

Within the IPS bundle, the medicinal product identifiers are found in the MedicationIPS section.

Path Description
Medication.language Language of the content
Medication.code Medication that was administered or was to be administered (medication code from any code system)
Medication.code:atcClass WHO ATC classification
Medication.code:snomed SNOMED CT medications
Medication.code:man Unique medicinal product identifier issued by the national competant authority. The MAN is the only identifier that definitively connects the IPS bundle to the ePI Master List and the ePI document bundles
Medication.status States whether the medicinal product is available for use (active) or not available for use (inactive)
Medication.form Form of the medicinal product
Medication.ingredient Active substance (or ingredient) of the medicinal product
Medication.ingredient.itemCodeableConcept Unique identifier for the active ingredient in the medicinal product
Medication.ingredient.itemCodeableConcept.text Plain text representation of the active ingredients name
Medication.ingredient.strength The strength of the medicinal product expressed as a ratio of two quantity values - a numerator and a denominator

ePI - Master List

The ePI Master List is a List resource and serves as an index of all ePI documents associated to a given medicinal product. For example, all SmPCs and all PILs for a given medicinal product.

Within the ePI Master List, the medicinal product identifiers are found here:

Path Description
list.identifier.system:medicine-name Plain text brand name of the medicinal product
list.identifier.system:marketing-authorisation-numbers Unique medicinal product identifier issued by the national competant authority. The MAN is the only identifier that definitively connects the ePI Master List to the IPS bundle and the ePI document bundles

Within the ePI Master List, the identifier for the individual ePI document bundles are found here:

Path Description
list.code.coding.system:example-pi-list-types Identifies the type of list
list.code.coding.code:00000021213 code for the ePI Master List type
list.code.coding.display:ePI Master List display name for the List type code
list.subject.extension.valueCoding.system:medicine-name branded name of the medicinal product
list.subject.extension.valueCoding.system:marketing-authorization-holder Unique medicinal product identifier issued by the national competant authority. The MAN is the only identifier that definitively connects the IPS bundle to the ePI Master List and the ePI document bundles
list.subject.extension.valueCoding.system:active-substance Active substance (or ingredient) of the medicinal product
list.subject.extension.valueCoding.system:domain Identifies whether the medicinal product is intended for human (H) or veterinary(V) use
list.entry.item.extension:documentType Identifies the type of ePI document bundle (e.g., SmPC or PIL)
list.entry.item.extension:language Identifies the language of the content in the ePI document bundle
list.entry.item.reference Unique identifier to a specific version of a ePI document bundle (e.g., version 1.0 of a PIL for this medicinal product

ePI Document Bundle

the ePI document bundle serves as the logical regulatory document. E.g., SmPC or PIL.

Within the ePI document bundle, the medicinal product identifiers are found here:

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