ePI Elements

ePI IG for APAC markets, 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/cander2/aseanepi/ and changes regularly. See the Directory of published versions

The base FHIR specification describes a set of base resources used in many different use cases.

A FHIR profile is a customized version of a resource. It defines specific rules and constraints for how a resource should be used in a particular context (ePI in this case). This customization ensures ßthat the data exchanged is consistent and meets the specific needs of different organizations or systems.

As noted in the Use Cases/Recommendations section, ePI Type 2 (A, B, C, and D) is recommended as the ideal approach for countries in the APAC region to benefit from FHIR ePI.

The following content serves as a business friendly version of the recommended ePI Type 2 profile. The real ePI profile (i.e., the structured version) can be found on the Artifacts page; along with sample data.

ePI Type 2 Resources and Elements

Bundle

The Bundle resource is a container for all resources with an ePI. There are different types of Bundle but for ePI, the Bundle type is always "Document". There can only be one Bundle per ePI.

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
Version	Incremental version number for this ePI document (e.g., 1, 2, 3, 4, 5)
Date of last update	Date of last revision for this version of the authorized ePI document.
Identifier	Business assigned identifier to uniquely identify this version of the ePI
Type	Defines the type of Bundle. For ePI, the type must always be “Document”.
Time Stamp	Original date of approval for this ePI. This date remains the same across all versions of the ePI.

Composition

The Composition resource is the basic structure for an ePI document since it carries the section headings, images, and narrrative content (e.g., text, tables, bulleted/numbered lists). There can only be one Composition per ePI Document Bundle

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
Language	The language of this ePI’s narrative text. ISO two letter language code.
Text	Narrative description of this ePI
Version	Incremental version number for this Composition (e.g., 1, 2, 3, 4, 5)
contained	Images are included as contained binary resources. One contained element per image.
Binary	Binary resource for encoded images.
Id value	Unique identifier for this image.
Content Type value	File type for the binary content (e.g., SVG, PNG, JPEG).
Data	Actual base64 encoded content for the image.
Extension	This extension is an implementation work around to avoid unnecessary validator errors, and expected to be drop in future profile releases, and is used to ensure that images used in ePI sections are properly referenced in the FHIR resource.
Value Reference
Reference value	The use of the imageReference extension avoids warning and error messages in common FHIR validators.
identifier	Unique business identifier for this version of the Composition.
status	Status of this resource (e.g., Active, retired).
Type	The type of ePI document template (e.g., healthcare professional, patient information, instruction for use, pack label)
coding
system	Reference to the terminology system where document type codes and display values are stored.
code	Health authority assigned code for this document type.
display	Human readable text for this document type.
Subject	Cross-reference to the Medicinal Product Definition(s) associated with this ePI.
Date	Date of last revision for this version of the authorized EPI document.
Author	Cross-reference to the Organization resource representing the Market Authorization Holder
Title	Simple title for this ePI document.
Section
Title	Section heading defined by the market authorization holder.
coding	Section heading defined by the health authority. Cannot be changed by the market authorization holder
system	Reference to the terminology system where section heading codes and display values are stored.
code	Health authority assigned code for this section heading.
display	Human readable text for this section.
text	Narrative text for this section (e.g., paragraphs, bulleted lists, tables).
Status value	The status of the narrative (i.e., always “generated”).
div	Defines a division or a section of the XHTML narrative.
paragraph	Paragraph text
Bulleted list	Ordered or unordered bulleted list
Table	Tables

Regulated Authorization

The Regulated Authorization resource describes a regulatory approval or licence related to a regulated medicinal product (E.g., a Market Authorization). There must be one or more Regulated Authorizations in an ePI.

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
identifier	Business assigned unique identifier(s) for this authorization. E.g., health authority assigned market authorization or license.
subject	Cross-reference to the Medicinal Product Definition(s) associated with this ePI.
type	Type of authorization
description	Narrative description of the authorization
region	ISO two letter country code for the country in which the authorization was assigned.
status	Status of this resource (e.g., Active, retired).
statusDate	The date the status was assigned
validityPeriod	Period in which the authorization is valid.
basis	The legal/regulatory framework or reasons under which this authorization is granted.
holder	Cross-reference to the Organization resource associated with the market authorization holder
regulator	Cross-reference to the Organization resource associated with the regulator

Organization

The Organization Resource describes the company name, identifier, address, and type. There must be one or more Organizations in an ePI.

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
identifier	Business assigned unique identifier(s) for this organization. E.g., health authority assigned identifier
Active	Whether this Organization Resource is still in active use.
Type	Type of organization. E.g., marketing authorization holder, manufacturer.
Name	Legal name of the organization
alias	Alternative name(s) for this organization. E.g., if Legal name is in Thai language, the alias could be the English name.
description	Narrative description of this organization
contact	Phone, email, website details for this organization related to the ePI
telecom: phone	Organization’s phone number(s) for
telecom: email	Organization’s email address for
telecom: url	Organization’s websites related to
Address	Organizations address
type	Defines whether this is a mailing address (i.e., postal); or a physical address that can be visited (i.e., physical); or both.
text	Full address
line	Street name and number
City	City in which the organization is physically located
state	State, province, or prefecture in which the organization is physically located
postal code	Postal code for the area
Country	ISO two letter country code for the country in which the organization is located.

Medicinal Product Definition

The Medicinal Product Definition resource describes regulatory details about the product (e.g., name, route of administration, legal/marketing status). There must be one or more Medicinal Product Definition.

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
identifier	Business assigned unique identifier(s) for this organization. E.g., product license number or market authorization number for the product.
subject	Cross-reference to the Medicinal Product Definition(s) associated with this ePI.
type	Type of authorization
description	Narrative description of what the authorization is for.
region	Jurisdiction in which the authorization was granted (i.e., ISO two letter country code)
status	Status of this resource (e.g., Active, retired).
statusDate	The date the status was assigned
holder	Cross-reference to the Organization Resource related to the Market Authorization Holder.
Route	Authorized route of administration
coding
system	Reference to the terminology system where codes and display values are stored.
code	Code for the route of administration
display	Display text for the route of administration
Version	Incremental version number for this ePI document (e.g., 1, 2, 3, 4, 5)
Status	Status of this resource (e.g., Active, retired).
Status date	The date the status was assigned
Legal Status of Supply	Product category or product type
coding
system	Reference to the terminology system where product category/type codes and display values are stored.
code	Code for the product type/category
display	Display text for the product type/category
Name
Product name	Full name of the medicinal product
Part	A fragment of the product name
Part	Editable text for the proprietary name
Type	Proprietary Name
coding
system	Reference to the terminology system where codes and display values are stored.
code	Code for the proprietary name
display	Display text for the proprietary name
Part	A fragment of the product name
Part	Editable text for the non-proprietary name
Type	Non-proprietary name
coding
system	Reference to the terminology system where codes and display values are stored.
code	Code for the Non-proprietary name part
display	Display text for the Non-proprietary name part
Part	Editable text for the strength part
Part	Editable values for the strength
Type	Strength part
coding
system	Reference to the terminology system where codes and display values are stored.
code	Code for the strength part
display	Display text for the strength part
Part	Editable text for the pharmaceutical dose form
Part	Editable text for the pharmaceutical dose form
Type	Pharmaceutical dose form
coding
system	Reference to the terminology system where codes and display values are stored.
code	Code for the pharmaceutical dose form
display	Display text for the pharmaceutical dose form part
Usage	Country and language
Country	Country code for where this name applies
coding
system	Reference to the terminology system where country codes and display values are stored.
code	Code for the ISO two-letter country
display	Display name for the country
language	Language code for this name
coding
system	Reference to the terminology system where language codes and display values are stored.
code	ISO two-letter language code
display	Display name for the language

Manufactured Item Definition

The Manufactured Item Definition resource describes the physical properties of the pharmaceutical dose form in its primary package (e.g., strength, ingredients, size, colour, shape). There must be one or more Manufactured Item Definitions in an ePI.

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
identifier	Business assigned unique identifier(s) for this Manufactured Item.
status	Status of this resource (e.g., Active, retired).
Manufactured dose form	Dose form of the product in its primary packaging
coding
system	Reference to the terminology system where pharmaceutical dose form codes and display values are stored.
code	Code for the pharmaceutical dose form
display	Display text for the pharmaceutical dose form
Unit of presentation	Unit of presentation for the product
coding
system	Reference to the terminology system where unit of presentation codes and display values are stored.
code	Code for the unit of presentation
display	Display text for the unit of presentation
manufacturer	Cross-reference to the Organization resource for the manufacturer or market authorization holder.
properties	Physical attributes of the medicinal product
colour	Colour of the medicinal product
flavour	Flavour of the medicinal product
score	Describes whether the medicinal product is scored
shape	Describes the shape of the medicinal product
surface form	Describes whether the medicinal product’s surface is convex or concave
size	Describes the dimensions of the medicinal product
image	Cross-reference to the Binary resource for the encoded version of the image
imprint	Describes whether the medicinal product has an imprint
text	Narrative description of the medicinal product

Ingredient

The Ingredient resource uniquely describes all ingredients contained in the Manufactured Item. This includes ingredient name, identifier, role (active, inactive, adjuvant), manufacturer, and strength. There must be at least one or more Ingredients in an ePI.

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
identifier	Business assigned unique identifier(s) for this ingredient.
status	Status of this resource (e.g., Active, retired).
for	Cross-reference to the Manufactured Item this ingredient is associated with.
role	Whether the ingredient is active or inactive
allergenic indicator	Flags if the ingredient is a known allergen
substance	The substance that comprises this ingredient
system	Reference to the terminology system substance codes and display values are stored.
code	Code for this substance.
display	Human readable text for this substance.
strength (Presentation - quantity)	The presentation quantity of the substance expressed per unit of presentation
presentationQuantity
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
strength (Presentation - ratio)	The presentation quantity of the substance expressed as a ratio
numerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
denominator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
strength (Presentation - RatioRange)	The presentation quantity of the substance expressed as a range
lowNumerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
highNumerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
denominator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
strength (Concentration - quantity)	The concentrationquantity of the substance expressed per unit of presentation
presentationQuantity
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
strength (Concentration - ratio)	The concentrationquantity of the substance expressed as a ratio
numerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
denominator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
strength (Concentration - RatioRange)	The concentrationquantity of the substance expressed as a range
lowNumerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
highNumerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
denominator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
basis
referenceStrength	Describes moiety as the quantity of substance.
substance	Cross-reference to the substance identifier
strength	Quantity of substance
strengthQuanitity	The quantity of the substance expressed per unit of measure.
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
strengthRatio	The quantity of the substance expressed as a ratio.
numerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
denominator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
strengthRatioRange	The quantity of the substance expressed as a range.
lowNumerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
highNumerator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit
denominator
value	Numeric quantity
unit	Unit of measure
system	Reference to the terminology system where unit of measure codes and display values are stored.
code	Code for this unit

Substance Definition

The Substance Definition resource describes an ingredient in more detail (e.g., molecular weight, chemical structure). There must be one or more Substance Definitions in an ePI.

FHIR Resource and Data Element	Description
id	System generated UUID used uniquely identify this resource
identifier	Business assigned unique identifier(s) for this substance.
version	Incremental version number for this ePI document (e.g., 1, 2, 3, 4, 5)
status	Status of this resource (e.g., Active, retired).
name	Human readable name for this substance.