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