Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Example Bundle: Bundle - ePI Type 2 Paracetamol Example

Document Subject

identifier: http://ema.europa.eu/identifier/WONDERDRUG-500MG

domain: Human use

status: Active

legalStatusOfSupply: Medicinal product subject to medical prescription

Contacts

-Contact
*Organization Acme Pharma Inc.

name

productName: WonderDrug 500 mg tablets

part

part: WonderDrug

type: Invented name part

part

part: 500 mg

type: Strength part

part

part: tablets

type: Pharmaceutical dose form part

Usages

-CountryLanguage
*EstoniaEstonian

Document Content

Package Leaflet: Information for the user - Paracetamol Tablets

Package Leaflet

Package Leaflet

1. What is in this leaflet

1. What is in this leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Additional Resources Included in Document

Entry 2 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Organization/org-epi-type2-example-acme

Resource Organization:

Language: en

Profile: Organization (ePI)

identifier: https://spor.ema.europa.eu/omswi/LOC-100000000

active: true

type: Marketing authorisation holder

name: Acme Pharma Inc.

Contacts

-Address
*123 Pharma Way, 102 37 Prague 10, Czech Republic

Entry 3 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/MedicinalProductDefinition/mpd-epi-type2-example-paracetamol

Resource MedicinalProductDefinition:

identifier: http://ema.europa.eu/identifier/WONDERDRUG-500MG

domain: Human use

status: Active

legalStatusOfSupply: Medicinal product subject to medical prescription

Contacts

-Contact
*Organization Acme Pharma Inc.

name

productName: WonderDrug 500 mg tablets

part

part: WonderDrug

type: Invented name part

part

part: 500 mg

type: Strength part

part

part: tablets

type: Pharmaceutical dose form part

Usages

-CountryLanguage
*EstoniaEstonian

Entry 4 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/RegulatedAuthorization/ra-epi-type2-example-paracetamol

Resource RegulatedAuthorization:

Language: en

Profile: RegulatedAuthorization (ePI)

identifier: http://ema.europa.eu/identifier/MA-123456789

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription

type: Marketing Authorisation

region: Estonia

status: Active

holder: Organization Acme Pharma Inc.

Entry 5 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/PackagedProductDefinition/ppd-epi-type2-example-paracetamol

Resource PackagedProductDefinition:

Language: en

Profile: PackagedProductDefinition (ePI)

identifier: http://example.org/identifier/ppd-epi-type2-example-paracetamol

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription

status: Active

packaging

type: Box

quantity: 1

packaging

type: Blister

containedItem

Items

-Reference
*ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

amount: 30 Tablet

Entry 6 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/ManufacturedItemDefinition/mid-epi-type2-example-paracetamol

Resource ManufacturedItemDefinition:

identifier: http://example.org/identifier/mid-epi-type2-example-paracetamol

status: Active

manufacturedDoseForm: Tablet

unitOfPresentation: Tablet

property

type: Shape

value: Round

property

type: Color

value: White

property

type: Size

value: 10 mm

property

type: Score

value: Scored

property

type: Imprint

value:

WD500

Entry 7 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/AdministrableProductDefinition/apd-epi-type2-example-paracetamol

Resource AdministrableProductDefinition:

identifier: http://example.org/identifier/apd-epi-type2-example-paracetamol

status: Active

formOf: MedicinalProductDefinition: identifier = http://ema.europa.eu/identifier#WONDERDRUG-500MG; domain = Human use; status = Active; legalStatusOfSupply = Medicinal product subject to medical prescription

administrableDoseForm: Tablet

unitOfPresentation: Tablet

producedFrom: ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

property

type: Shape

value: Round

property

type: Color

value: White

property

type: Flavor

value: None

property

type: Image

value: Tablet Image

RouteOfAdministrations

-Code
*Oral use

Entry 8 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-active

Resource Ingredient:

Language: en

Profile: Ingredient (ePI)

identifier: http://example.org/identifier/ingredient-epi-type2-example-paracetamol-active

status: Active

for: ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Active

function: API

group: Chemical

substance

Codes

-Concept
*Paracetamol

Strengths

-Presentation[x]
*500 mg (Details: UCUM codemg = 'mg')/1 tablet (Details: EDQM Standard Terms code10219000 = 'Tablet')

Entry 9 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-excipient-1

Resource Ingredient:

Language: en

Profile: Ingredient (ePI)

identifier: http://example.org/identifier/ingredient-epi-type2-example-paracetamol-excipient-1

status: Active

for: ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

substance

Codes

-Concept
*Pregelatinised starch

Entry 10 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-excipient-2

Resource Ingredient:

Language: en

Profile: Ingredient (ePI)

identifier: http://example.org/identifier/ingredient-epi-type2-example-paracetamol-excipient-2

status: Active

for: ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

substance

Codes

-Concept
*Maize starch

Entry 11 - fullUrl = http://hl7.org/fhir/uv/emedicinal-product-info/Ingredient/ingredient-epi-type2-example-paracetamol-excipient-3

Resource Ingredient:

Language: en

Profile: Ingredient (ePI)

identifier: http://example.org/identifier/ingredient-epi-type2-example-paracetamol-excipient-3

status: Active

for: ManufacturedItemDefinition: identifier = http://example.org/identifier#mid-epi-type2-example-paracetamol; status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet

role: Excipient

substance

Codes

-Concept
*Magnesium stearate