EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) 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 ActivityDefinition Restrictions |
Defines restrictive rules 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 |
Defines the rules a MedicinalProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application |
| EMA Write API MedicinalProductDefinition Restrictions |
Defines the restrictive rules a MedicinalProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application |
| EMA Write API PackagedProductDefinition |
Defines the rules a PackagedProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application |
| EMA Write API PackagedProductDefinition |
Defines the restrictive rules a PackagedProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application |
| EMA Write API Regulated Authorization |
Defines the rules a Marketing or Manufacturing RegulatedAuthorization 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 |
| EMA Write PMS API Bundle Restrictions |
EMA Write PMS API Bundle Restrictions |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| EMA API V2 Identifier |
EMA API V2 Identifier |
| 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 Duration |
EMA Duration |
| EMA EURD Identifier |
EMA EURD Identifier |
| EMA Eudra GMP Number Identifier |
EMA Eudra GMP Number 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 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 Master File Identifier Restrictions |
EMA Master File Identifier Restrictions |
| EMA Master Identifier |
EMA Master Identifier |
| EMA PC Identifier |
EMA PC Identifier |
| EMA Period |
EMA Period |
| EMA Period restrictions |
EMA Period restrictions |
| EMA Pharmacovigilance Qualified Person Type CodeableConcept |
EMA Pharmacovigilance Qualified Person Type CodeableConcept |
| EMA Pharmacovigilance Qualified Person Type CodeableConcept |
EMA Pharmacovigilance Qualified Person Type CodeableConcept |
| EMA Product Category CodeableConcept |
EMA Product Category CodeableConcept |
| EMA Quantity |
EMA Quantity |
| EMA Ratio |
EMA Ratio |
| EMA Reference Restrictions |
EMA Reference 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 |
| Code System Name |
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 |
| Term Version |
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 |
| Record Status |
Record Status |
| 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 |
| Genetically Modified Organism |
Genetically Modified Organism |
| Ingredient Role |
Ingredient Role |
| Language |
Language |
| 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 |
| 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 |
| 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 |