EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

EMA Write API ActivityDefinition

Defines the rule a ActivityDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

EMA Write API Marketing Regulated Authorization

Defines the rule a Marketing RegulatedAuthorization resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

EMA Write API MedicinalProductDefinition

Profiled resource containing data about a Medicinal Product.

EMA Write API PackagedProductDefinition

Defines the rule a PackagedProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

EMA Write PMS API Bundle

EMA Write PMS API Bundle

Structures: Data Type Profiles

These define constraints on FHIR data types for systems conforming to this implementation guide.

EMA ATC Coding

EMA ATC Coding

EMA AdditionalMonitoringIndicator boolean CodeableConcept

EMA AdditionalMonitoringIndicator boolean CodeableConcept

EMA Application Identifier Number

EMA Application Identifier Number

EMA Coding

EMA Coding

EMA Coding Restrictions

EMA Coding Restrictions

EMA Data Carrier Identifier

EMA Data Carrier Identifier

EMA Duration

EMA Duration

EMA EURD Identifier

EMA EURD Identifier

EMA Generic ReferentialTerm CodeableConcept

EMA Generic ReferentialTerm CodeableConcept

EMA Generic ReferentialTerm CodeableConcept restrictions

EMA Generic ReferentialTerm CodeableConcept restrictions

EMA Genetically Modified Organisms CodeableConcept

EMA Genetically Modified Organisms CodeableConcept

EMA Identifier Restrictions

EMA Identifier Restrictions

EMA Identifier Restrictions

EMA Identifier Restrictions

EMA Legal Basis CodeableConcept

EMA Legal Basis CodeableConcept

EMA Light ATC CodeableConcept

EMA Light ATC CodeableConcept

EMA MP Identifier

EMA MP Identifier

EMA Manufacturing Authorization Number Identifier

EMA Manufacturing Authorization Number Identifier

EMA Marketing Authorization Identifier

EMA Marketing Authorization Identifier

EMA Master File Identifier

EMA Master File Identifier

EMA PC Identifier

EMA PC Identifier

EMA Period

EMA Period

EMA Period restrictions

EMA Period restrictions

EMA Product Category CodeableConcept

EMA Product Category CodeableConcept

EMA Qualified Person Type CodeableConcept

EMA Qualified Person Type CodeableConcept

EMA Quantity

EMA Quantity

EMA Ratio

EMA Ratio

EMA Subject Restrictions

EMA Subject Restrictions

EMA Subject Restrictions

EMA Subject Restrictions

EMA XEVMPD Product CodeableConcept

EMA XEVMPD Product CodeableConcept

The MPD Name Part Type Coding

The MPD Name Part Type Coding

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Authorised Dose Form

Authorised Dose Form

CodeSystemName

Name of the coding system the 'coding' element belongs to

Date of Update extension

Date of Update extension

Language

Language using the EMA SPOR codes

Marketing Status Reason

Marketing Status Reason

MedicinalProductDefiniton - MasterFile

The MedicinalProductDefinition's Master File

Regulated Authorization - Date of First Authorisation

The Regulated Authorization's Date of First Authorisation

Regulated Authorization - International Birth Date

The Regulated Authorization's International Birth Date

Regulated Authorization - Paediatric - Reference Country

The Paediatric Regulated Authorization's Reference Country

Risk of Supply Shortage

Risk of Supply Shortage

Risk of Supply Shortage Comment

Risk of Supply Shortage Comment

Submission Date extension

Submission Date extension

TermVersion

Version of a term from RMS

The ATC Pending Extension

The ATC pending Extension

The Comparator Extension

The Comparator Extension

The Complies with directive Extension

The Complies with directive Extension

The Ingredient Annex 5.10 Extension

The Ingredient Annex 5.10 Extension

The Ingredient Annex 5.11 Extension

The Ingredient Annex 5.11 Extension

The Ingredient Annex 5.20 Extension

The Ingredient Annex 5.20 Extension

The Ingredient Annex 5.23 Extension

The Ingredient Annex 5.23 Extension

The Ingredient Documentation Extension

The Ingredient Documentation Extension

The Ingredient's Origin of Substance Extension

The Ingredient's Origin of Substance Extension

The Operation Extension

The Operation Extension

The Package Shelf Life Duration Extension

The Package Shelf Life Duration Extension

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Additional Monitoring Indicator

Additional Monitoring Indicator

Application Submission Type

Application Submission Type

Authorised Dose Form

Authorised Dose Form

Combined Pharmaceutical Dose Form

Combined Pharmaceutical Dose Form

Country

Country

Data Classification

Data Classification

Documentation

Documentation

Domain

Domain

Genetically Modified Organism

Genetically Modified Organism

Ingredient Role

Ingredient Role

Language

Language

Legal Status of Supply

Legal Status of Supply

Manufacturing Activity

Manufacturing Activity

Marketing Status

Marketing Status

Marketing Status Reason

Marketing Status Reason

Marketing and Manufacturing types

Marketing and Manufacturing types

Master File Identifier Type

Master File Identifier Type

Master File Type

Master File Type

Master File Type + DocumentType

Master File Type + DocumentType

Material

Material

Medicinal Product Name Part Type

Medicinal Product Name Part Type

Medicinal Product Type

Medicinal Product Type

Packaging

Packaging

Paediatric Use Indicator

Paediatric Use Indicator

Pharmaceutical Dose Form

Pharmaceutical Dose Form

Product Category

Product Category

Product Cross Reference Type

Product Cross Reference Type

Promotion

Promotion

Quantity Operator

Quantity Operator

Regulatory Authorization Registration Procedure

Regulatory Authorization Registration Procedure

Regulatory Entitlement Status

Regulatory Entitlement Status

Regulatory Entitlement Type

Regulatory Entitlement Type

Shelf Life Type

Shelf Life Type

Special Precautions For Storage

Special Precautions For Storage

Substance Origin

Substance Origin

Supply

Supply

Unit of Measurement

Unit of Measurement

Units of Presentation

Units of Presentation

XEVMPD medicinal product type

XEVMPD medicinal product type

XEVMPD medicinal product type

XEVMPD medicinal product type

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

Additional Monitoring Indicator

Additional Monitoring Indicator

Application Submission Type

Application Submission Type

Combination Package

Combination Package

Combined Pharmaceutical Dose Form

Combined Pharmaceutical Dose Form

Combined Term

Combined Term

Contact Type

Contact Type

Country

Country

Data Classification

Data Classification

Document Type

Document Type

Documentation

Documentation

Domain

Domain

Domain

Domain

Domain

Domain

Genetically Modified Organism

Genetically Modified Organism

Ingredient Role

Ingredient Role

Legal Status From the Supply

Legal Status From the Supply

Manufacturing Activity Value Set

Manufacturing Activity Value Set

Marketing Authorisation Application Legal Basis

Marketing Authorisation Application Legal Basis

Marketing Status

Marketing Status

Master File Identifier Type

Master File Identifier Type

Master File Type

Master File Type

Material

Material

Medicinal Product Name Part Type

Medicinal Product Name Part Type

Medicinal Product Type

Medicinal Product Type

Paediatric Use Indicator

Paediatric Use Indicator

Pharmaceutical Dose Form

Pharmaceutical Dose Form

Product Category

Product Category

Product Cross Reference Type

Product Cross Reference Type

Promotion

Promotion

Quantity Operator

Quantity Operator

Reason for Marketing Unavailability

Reason for Marketing Unavailability

Record Status

Record Status

Regulatory Authorization Registration Procedure

Regulatory Authorization Registration Procedure

Regulatory Entitlement

Regulatory Entitlement

Regulatory Entitlement Status

Regulatory Entitlement Status

Shelf Life Type

Shelf Life Type

Special Precautions for Storage

Special Precautions for Storage

Substance Origin

Substance Origin

Supply

Supply

Unit Of Measurement Value Set

Unit Of Measurement Value Set

Units Of Presentation

Units Of Presentation

XEVMPD Medicinal Product Type

XEVMPD Medicinal Product Type

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

1. Get Product Bundle

An example of the response from GET $everthing

2. Change pack size

An example of the submission to $merge to change a package size

3. Change pack size (response)

Example resonse data from a packge size change

4. Add manufacturing operation

An example of the submission to $merge to add a manufacturing operation

5. Add manufacturing operation (response)

Example resonse data from adding a manufacturing operation

ActivityDefinition

n/a (These are dummy resources to represent data instances not currently available from the API)

DocumentReference

n/a

DocumentReference

n/a

Organization

n/a

PractitionerRole

n/a