| Version 1.0.0-ballot |
Current Build |
Difference |
Notes |
| CodeSystems |
| Organization Management Services CodeSystem | | Removed | |
| Products Management Services CodeSystem | | Removed | |
| Referentials Management Services CodeSystem | | Removed | |
| Substances Management Services CodeSystem | | Removed | |
| eMedicinal Product Information Code System | Added | |
| eMedicinal Product Information Code System | | Removed | |
| ValueSets |
| Country ValueSet | ISO Country two letter code | Comparison | 2 Breaking Changes, 1 Change, 256 Notes |
| Common Languages | All Languages | Comparison | 1 Breaking Change, 0 Changes, 168 Notes |
| Combined Pharmaceutical Dose Form | | Removed | |
| Combined Pharmaceutical Dose Form | Administrable Pharmaceutical Dose Form | Comparison | 2 Breaking Changes, 0 Changes, 5 Notes |
| Combined Pharmaceutical Dose Form | Dose Form | Comparison | 2 Breaking Changes, 0 Changes, 5 Notes |
| Combined Pharmaceutical Dose Form | Manufactured Dose Form | Comparison | 2 Breaking Changes, 0 Changes, 5 Notes |
| Regulated Authorization Type identifier systems | Regulated Authorization Type | Comparison | 2 Breaking Changes, 1 Change, 12 Notes |
| Regulated Authorization Type identifier systems | | Removed | |
| MedicinalProductDefinition identifier systems | | Removed | |
| Surface form of the product | | Removed | |
| Type of Regulated Authorization | | Removed | |
| Additional Monitoring Indicator | Additional Monitoring | Comparison | 2 Breaking Changes, 1 Change, 7 Notes |
| Additional Monitoring Indicator | | Removed | |
| AdministrableProductDefinition identifier systems | | Removed | |
| Administrable Pharmaceutical Dose Form | Added | |
| WHO ATC | WHO ATC | Comparison | 1 Breaking Change, 0 Changes, 2 Notes |
| Authorization Status | PublicationStatus | Comparison | 2 Breaking Changes, 0 Changes, 6 Notes |
| Authorization Status | | Removed | |
| Case System Identifiers | | Removed | |
| ISO Country two letter code | Country ValueSet | Comparison | 2 Breaking Changes, 1 Change, 257 Notes |
| ISO Country two letter code | Jurisdiction ValueSet | Comparison | 2 Breaking Changes, 1 Change, 512 Notes |
| ISO Country two letter code | ISO Country two letter code | Comparison | 1 Breaking Change, 0 Changes, 3 Notes |
| Data Carrier Identifiers | | Removed | |
| Dose Form | Added | |
| ePI document types | FHIR Document Type Codes | Comparison | 2 Breaking Changes, 0 Changes, 11 Notes |
| ePI document types | ePI document types | Comparison | 1 Breaking Change, 0 Changes, 3 Notes |
| The topic of this list | | Removed | |
| General Status used across ePI resources | PublicationStatus | Comparison | 2 Breaking Changes, 0 Changes, 12 Notes |
| General Status used across ePI resources | | Removed | |
| Ingredient Role | Added | |
| Legal Status for the Supply | Legal Status Of Supply | Comparison | 2 Breaking Changes, 1 Change, 7 Notes |
| Legal Status for the Supply | | Removed | |
| Manufactured Dose Form | Added | |
| ManufacturedItemDefinition identifier systems | | Removed | |
| Marketing Status | | Removed | |
| Medicinal Product Type | Medicinal Product Type | Comparison | 2 Breaking Changes, 1 Change, 6 Notes |
| Medicinal Product Type | | Removed | |
| MedDRA Terms for clinical diseases and symptoms | MedDRA Terms for clinical diseases and symptoms | Comparison | 1 Breaking Change, 0 Changes, 2 Notes |
| Non-proprietary Name of the active ingredient(s) | | Removed | |
| Type of operation | | Removed | |
| Organization identifier systems | | Removed | |
| Type of organization | Organization Type | Comparison | 2 Breaking Changes, 1 Change, 6 Notes |
| Type of organization | | Removed | |
| Package Material | Package Material | Comparison | 2 Breaking Changes, 1 Change, 6 Notes |
| Package Material | | Removed | |
| High level Pack Type | Medicinal Product Package Type | Comparison | 2 Breaking Changes, 1 Change, 22 Notes |
| High level Pack Type | Package Type | Comparison | 2 Breaking Changes, 1 Change, 7 Notes |
| High level Pack Type | | Removed | |
| PackagedProductDefinition identifier systems | | Removed | |
| Part Type | | Removed | |
| Pediatric Use Indicator | Pediatric Use | Comparison | 2 Breaking Changes, 1 Change, 7 Notes |
| Pediatric Use Indicator | | Removed | |
| Pharmaceutical Dose Form of the medicinal product | | Removed | |
| Product Confidentiality | | Removed | |
| Product Name Part Type | | Removed | |
| Color of the product | Color of the product | Comparison | 1 Breaking Change, 0 Changes, 15 Notes |
| Flavor of the product | Flavor of the product | Comparison | 1 Breaking Change, 0 Changes, 74 Notes |
| Score on the product | | Removed | |
| Shape of the product | Shape of the product | Comparison | 1 Breaking Change, 0 Changes, 22 Notes |
| Proprietary Name of the medicinal product | | Removed | |
| Regulatory Activity Type | Regulated Authorization Case Type | Comparison | 2 Breaking Changes, 1 Change, 31 Notes |
| Regulatory Activity Type | | Removed | |
| Ingredient Role; e.g., inactive, active base, active moiety | | Removed | |
| Route Of Administration | Route Of Administration | Comparison | 1 Breaking Change, 0 Changes, 5 Notes |
| Pack Type | Packaging Type | Comparison | 2 Breaking Changes, 1 Change, 7 Notes |
| Pack Type | | Removed | |
| Section Codes | Section Codes | Comparison | 1 Breaking Change, 0 Changes, 113 Notes |
| Shelf Life Type | | Removed | |
| Special Precautions For Storage | | Removed | |
| Strength of the medicinal product name | | Removed | |
| Substances | SNOMED CT Substance Codes | Comparison | 2 Breaking Changes, 1 Change, 8 Notes |
| Substances | Substances | Comparison | 1 Breaking Change, 0 Changes, 2 Notes |
| Units of Measure | | Removed | |
| Units of Presentation | Units of Presentation | Comparison | 1 Breaking Change, 0 Changes, 60 Notes |
| Country2 | ISO Country two letter code | Comparison | 2 Breaking Changes, 0 Changes, 8 Notes |
| RoleClassIngredientEntity | Ingredient Role | Comparison | 2 Breaking Changes, 0 Changes, 32 Notes |
| StructureDefinitions |
| OperationOutcome | OperationOutcome | Failed | StructureDefinition is not for an profile - can't be compared (left: OperationOutcome) |
| AdministrableProductDefinition (ePI) | AdministrableProductDefinition (ePI) | Comparison | 1 Breaking Change, 16 Changes, 4 Notes |
| Bundle - ePI | Bundle - ePI | Failed | class org.hl7.fhir.r5.comparison.ResourceComparer$PlaceHolderComparison cannot be cast to class org.hl7.fhir.r5.comparison.ProfileComparer$ProfileComparison (org.hl7.fhir.r5.comparison.ResourceComparer$PlaceHolderComparison and org.hl7.fhir.r5.comparison.ProfileComparer$ProfileComparison are in unnamed module of loader 'app') |
| ClinicalUseDefinition Contraindication (ePI) | ClinicalUseDefinition Contraindication (ePI) | Comparison | 1 Breaking Change, 28 Changes, 5 Notes |
| ClinicalUseDefinition Indication (ePI) | ClinicalUseDefinition Indication (ePI) | Comparison | 1 Breaking Change, 28 Changes, 5 Notes |
| ClinicalUseDefinition Interaction (ePI) | ClinicalUseDefinition Interaction (ePI) | Comparison | 1 Breaking Change, 28 Changes, 5 Notes |
| ClinicalUseDefinition Undesirable Effect (ePI) | ClinicalUseDefinition Undesirable Effect (ePI) | Comparison | 1 Breaking Change, 28 Changes, 5 Notes |
| ClinicalUseDefinition Warning (ePI) | ClinicalUseDefinition Warning (ePI) | Comparison | 1 Breaking Change, 28 Changes, 5 Notes |
| Composition (ePI) | Composition (ePI) | Comparison | 1 Breaking Change, 30 Changes, 8 Notes |
| Ingredient (ePI) | Ingredient (ePI) | Comparison | 1 Breaking Change, 14 Changes, 6 Notes |
| ManufacturedItemDefinition (ePI) | ManufacturedItemDefinition (ePI) | Comparison | 1 Breaking Change, 24 Changes, 5 Notes |
| MedicinalProductDefinition (ePI) | MedicinalProductDefinition (ePI) | Comparison | 1 Breaking Change, 59 Changes, 11 Notes |
| Organization (ePI) | Organization (ePI) | Comparison | 1 Breaking Change, 15 Changes, 3 Notes |
| PackagedProductDefinition (ePI) | PackagedProductDefinition (ePI) | Comparison | 2 Breaking Changes, 36 Changes, 11 Notes |
| RegulatedAuthorization (ePI) | RegulatedAuthorization (ePI) | Comparison | 1 Breaking Change, 22 Changes, 5 Notes |
| SubstanceDefinition (ePI) | SubstanceDefinition (ePI) | Comparison | 1 Breaking Change, 41 Changes, 6 Notes |