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:

|Path|Description| |———|———|