UnicomIG
0.1.0 - ci-build
UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. 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/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
Logical data models as FHIR resources
| Medicinal Product Logical Model |
Logical model for a pilot product list's medicinal product |
Profiles for regulatory data, EMA IG and IDMP compliant
| PPL Administrable Product profile |
Administrable product profile defines the ISO IDMP Pharmaceutical Product concept |
| PPL Ingredient profile |
Ingredient for the medicinal product, pharmaceutical product and/or manufactured item |
| PPL Manufactured Item profile |
Manufactured item is the countable element inside the package |
| PPL Marketing Authorisation profile |
Regulated Authorization profile defines the Marketing Authorisation on product or package level |
| PPL Medicinal Product profile |
Medicinal Product as defined in ISO IDMP |
| PPL Organization |
Organization |
| PPL Packaged Product profile |
Packaged Product |
Intermediate data transition profiles, that follow the structure of IDMP, but are less strict
| Processing Profile - Administrable Product |
Intermediate profile for processing PPL Administrable Product data |
| Processing Profile - Ingredient |
Intermediate profile for processing PPL Ingredient data |
| Processing Profile - Manufactured Item |
Intermediate profile for processing PPL Manufactured Item data |
| Processing Profile - Marketing Authorisation |
Intermediate profile for processing PPL Marketing Authorisation (Regulated Authorization) data |
| Processing Profile - Medicinal Product |
Intermediate profile for processing PPL Medicinal Product data |
| Processing Profile - Organization |
Intermediate profile for processing PPL Marketing Authorisation Holder (Organization) data |
| Processing Profile - Packaged Product |
Intermediate profile for processing PPL Packaged Product data |
These are custom operations that can be supported by and/or invoked by systems conforming to this implementation guide.
| Equivalent Look Up |
These define the properties by which a RESTful server can be searched. They can also be used for sorting and including related resources.
| country |
Search for MedicinalProductDefinition by country |
| manufactured-item-packaging-ppd |
Search on manufactured item for PPD inside a nested packaging |
| manufactured-item-ppd |
Search on manufactured item for PPD |
| name-language-correct |
Possiblity to search ingredient for MedicinalProductDefinition.name.usage.language |
| reference-strength-substance |
Possiblity to search ingredient for substance.strength.referenceStrength.substance.concept |
| strength-presentation-quantity |
Possiblity to search for Ingredient.substance.strength.presentation.ofType(Quantity) |
| strength-presentation-ratio |
Possiblity to search for substance and strength at the same time |
| strength-presentation-ratio-denominator |
Possiblity to search for Ingredient.substance.strength.presentation.ofType(Ratio).denominator |
| strength-presentation-ratio-numerator |
Possiblity to search for Ingredient.substance.strength.presentation.ofType(Ratio).numerator |
| strength-quantity-and-substance |
Possiblity to search for substance and strength at the same time |
| strength-ratio-and-substance |
Possiblity to search for substance and strength at the same time |
These define data models that represent the domain covered by this implementation guide in more business-friendly terms than the underlying FHIR resources.
| DRAFT: Medicinal Product in crossborder eP/eD |
DRAFT. Crossborder eP/eD/PS medicinal product as a implementation-agnostic logical model |
| DRAFT: MyHealth@EU medicinal product |
DRAFT. Crossborder eP/eD/PS medicinal product as represented in CDA. |
| Medication for clinical workflows |
DRAFT. eP/eD/PS product |
| SNOMED CT Clinical Drug |
SNOMED CT Clinical Drug concept as logical data model |
These define constraints on FHIR resources for systems conforming to this implementation guide.
| Medication |
Medication for clinical use cases (Medication resource), may be branded or generic |
| Medication as manufactured item |
Manufactured Item as a part of a product for clinical use cases (Medication resource) |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| AD |
Address |
| ANY |
An abstract type |
| BL |
Boolean - true or false |
| CD |
ConceptDescriptor |
| Class |
Class of data elements |
| DT |
Date |
| EN |
EntityName |
| II |
InstanceIdentifier |
| INT |
IntegerNumber |
| PQ |
PhysicalQuantity |
| REAL |
RealNumber |
| RTO |
Ratio |
| ST |
CharacterString |
| TS |
TimeStamp |
| Untyped |
No data type defined |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| AdministrableDoseForm |
Administrable dose form for the product |
| MedicinalProductClassification |
Classification of the product, e.g. ATC. |
| MedicinalProductName |
Registered name for the medicinal product. |
These define sets of codes used by systems conforming to this implementation guide.
| Country (ISO 3166-1-2) |
Countries |
| EDQM Administration Device |
ValueSet Administration device from EDQM, DEV, see https://standardterms.edqm.eu/# |
| EDQM Administration Method |
ValueSet Administration method from EDQM, AME, see https://standardterms.edqm.eu/# |
| EDQM Basic Dose Form |
ValueSet Basic dose form from EDQM, BDF, see https://standardterms.edqm.eu/# |
| EDQM Closure |
ValueSet Closure (for package description) from EDQM, CLO, see https://standardterms.edqm.eu/# |
| EDQM Combination Pack |
ValueSet Combination pack (dose form) from EDQM, CMP, see https://standardterms.edqm.eu/# |
| EDQM Combined Pharmaceutical Dose Form |
ValueSet Combined pharmaceutical dose form from EDQM, CDF, see https://standardterms.edqm.eu/# |
| EDQM Combined Term |
ValueSet Combined term (dose form) from EDQM, CMT, see https://standardterms.edqm.eu/# |
| EDQM Container |
ValueSet Container (package type) from EDQM, CON, see https://standardterms.edqm.eu/# |
| EDQM Intended Site |
ValueSet Intended site from EDQM, ISI, see https://standardterms.edqm.eu/# |
| EDQM Packaging Category |
ValueSet Packaging category from EDQM, PAC, see https://standardterms.edqm.eu/# |
| EDQM Patient-friendly Term |
ValueSet Patient-friendly term (dose forms) from EDQM, PFT, see https://standardterms.edqm.eu/# |
| EDQM Pharmaceutical Dose Form |
ValueSet Pharmaceutical dose form from EDQM, PDF, see https://standardterms.edqm.eu/# |
| EDQM Route of Administration |
ValueSet Route of administration from EDQM, ROA, see https://standardterms.edqm.eu/# |
| EDQM Unit of Presentation |
ValueSet Unit of presentation from EDQM, UOP, see https://standardterms.edqm.eu/# |
| EMA SPOR ATC |
Value set for Anatomical Therapeutic Chemical classification system Human and Veterinary. It combines 2 SPOR/WHO lists |
| EMA SPOR All Units Combined |
Value set for presentation strength denominator unit, combines units of measurement and units of presentation. |
| EMA SPOR Authorised Dose Form |
Value set for authorised dose form. Combines 4 SPOR/EDQM lists: Pharmaceutical dose form, Combined pharmaceutical dose form, Combined term, Combination package. |
| EMA SPOR Country |
Countries. EMA SPOR RMS list. |
| EMA SPOR Domain |
Domain of the medicinal product. EMA SPOR RMS list. |
| EMA SPOR Language |
Languages. EMA SPOR RMS list. |
| EMA SPOR Legal Status for the Supply |
EMA SPOR RMS list |
| EMA SPOR Marketing Status |
Marketing Status |
| EMA SPOR Material |
Package material. EMA SPOR RMS LIST. |
| EMA SPOR Packaging |
Packaging |
| EMA SPOR Pharmaceutical Dose Form |
Pharmaceutical dose form. Does not include combination dose forms. |
| EMA SPOR Record Status |
Value set for record status. |
| EMA SPOR Regulatory Entitlement Status |
Regulatory Entitlement Status |
| EMA SPOR Routes and Methods of Administration |
Routes and methods of medication administration. EMA SPOR RMS list, based on EDQM. |
| EMA SPOR SMS Substances |
Value set for substances, PPL subset from SMS. |
| EMA SPOR Shelf Life Type |
Shelf Life Type |
| EMA SPOR Unit of Measurement |
Units of measurement. EMA SPOR RMS list based on UCUM. |
| EMA SPOR Unit of Presentation |
Units of presentation. EMA SPOR RMS list based on EDQM. |
| Language (FHIR) |
All languages |
| MyHealth@EU Unit of Measurement (UCUM) |
ValueSet for units based on UCUM to be used in MyHealth@EU crossborder services |
| WHO ATC |
World Health Organization Anatomical Therapeutic Chemical (ATC) classification system. Note: The currently implemented code system and the value set expansion contain only a set of example ATC codes, not the complete code system content. |
These define new code systems used by systems conforming to this implementation guide.
| ATC Human EMA |
ATC classification recoded with EMA SPOR RMS codes. Flat list, WHO ATC codes provided in description field for easier use. |
| Combination Package EMA |
Dose forms for combination packages. Based on EDQM. Re-coded with RMS codes. Only used for authorised dose form. |
| Combined Pharmaceutical Dose Form EMA |
Combined Pharmaceutical Dose Form. Based on EDQM. Re-coded with RMS codes. Used only for authorised dose form. |
| Combined Term EMA |
Combined Term. Based on EDQM. Re-coded with RMS codes. Only used for authorised dose form. |
| Country EMA |
Country codes by EMA. Based on ISO 3166-1-2, recoded with RMS codes. |
| Domain EMA |
Domain of the medicinal product (human, veterinary, both) |
| Language EMA |
Language codes by EMA. Based on BCP-47, recoded with RMS codes. |
| Legal Status for the Supply EMA |
Legal status of supply. EMA SPOR RMS list. |
| Marketing Status EMA |
Marketing status of the product in given country. EMA SPOR RMS codes. |
| Material EMA |
Package material. EMA SPOR RMS list. Hierarchical. |
| Packaging EMA SPOR |
Package types, including closures and administration devices. Based on EDQM, recoded with EMA SPOR RMS codes. |
| Pharmaceutical Dose Form EMA |
Pharmaceutical dose form. Based on EDQM, re-coded with RMS codes. |
| Record Status EMA SPOR |
Record Entitlement Status EMA SPOR |
| Regulatory Entitlement Status EMA SPOR |
Regulatory Entitlement Status EMA SPOR |
| Routes and Methods of Administration EMA |
Routes and methods of medication administration. Based on EDQM, re-coded with RMS codes. |
| Substances EMA SPOR SMS |
UNICOM PPL substances from EMA SPOR SMS |
| Unit of Measurement EMA |
Unit of Measurement. Based on UCUM. Re-coded with RMS codes. |
| Unit of Presentation EMA |
Unit of presentation list from EMA SPOR. List id 200000000014. Content based on EDQM, re-coded with RMS codes. |
These define transformations to convert between codes by systems conforming with this implementation guide.
| EDQM-SPOR Pharmaceutical dose forms |
Pharmaceutical dose form value set from EDQM mapped to EMA SPOR codes. |
| SMS-SNOMED CT substances |
EMA SPOR SMS mapped to SNOMED CT concepts. Small example. |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| 001-Agen5mg-EE-FullProduct |
Agen 5mg Tablet. Estonia. Simple example of one full product as a bundle. Packages, PCIDs, differ by material. |
| 002-Agen10mg-EE-FullProduct |
Agen 10mg Tablet. Estonia. Simple example of one full product as a bundle. Packages, PCIDs, differ by material. |
| 003-CefuroximStragen-1-5g-Powder-SE-FullProduct |
Cefuroxim Stragen 1.5g Powder for solution for injection/infusion. Sweden. Strength in grams; man. item quantity unknown; transformation before administration. |
| 004-Cefuroxime-MIP-1500mg-EE-FullProduct |
Cefuroxime MIP 1500mg Powder for solution for injection/infusion. Estonia. Strength in milligrams; man. item quantity unknown; transformation before administration. |
| 005-CanifugCremolum-EE-FullProduct |
Canifug Cremolum. Estonia. Combination package of clotrimazole 10mg/g creme and six 100mg pessaries. |
| 006-Yaz-002mg3mg-tablet-SE-FullProduct |
YAZ ethinylestradiol 0.02mg, drosperinone 3mg, includes placebo tablets. Kingdom of Sweden. Different manufactured items in one container. |
| 007-Jangee-002mg-3mg-Film-coated-tablet-EE-FullProduct |
Jangee ethinylestradiol 0.02mg, drosperinone 3mg. Estonia. Without placebo pills. |
| 008-Jangee-003mg-3mg-Film-coated-tablet-EE-FullProduct |
Jangee ethinylestradiol 0.03mg, drosperinone 3mg. Estonia. Without placebo pills. |
| 009-Paracetamol-Kabi10mg-1ml-EE-FullProduct |
Paracetamol Kabi 10mg/ml solution for infusion. Estonia. One pharmaceutical product for three different manufactured items. |
| 010-Clexane-60mg-06ml-EE-FullProduct |
Clexane, enoxaparine sodium 60mg/0.6ml, 2 pre-filled syringes. Presentation strength per quantity. |
| 011-Betaklav500-125-EE-FullProduct |
Amoxicillin 500mg, clavulanic acid 125mg. Tablets. Estonia. |
| 012-Panodil-500mg-SolutionInSachet-SE-FullProduct |
Paracetamol 500mg. Powder for oral solution in sachet. Sweden. |
| 013-LantusSolostar-EE-FullProduct |
Lantus Solostar, insulin glargine, solution for injection in 3ml pre-filled pens. |
| 014-CanestenKombi-FI-FullProduct |
Canesten Kombi. Finland. Combination package of clotrimazole 20mg/g creme and 500mg pessary with an applicator. |
| 015-CopaliaHCT-EE-FullProduct |
Copalia HCT. Valsartan + amlodipine (besilate) + hydrochlorothiazide tablets. Not a PPL product. |
| 016-Lodipin-10mg-Capsule-GR-FullProduct |
Lodipin 10mg Capsule. Amlodipine (besilate). Greece. |
| 017-ImovaxPolio-EE-FullProduct |
Imovax Polio Suspension for injection. Estonia. |
| AMLHipres-10mg-Tablet-EE-FullProduct |
Hipres amlodipine (maleate) 10mg tablets. Estonia. |
| AMLHipres-5mg-Tablet-EE-FullProduct |
Hipres amlodipine (maleate) 5mg tablet. Estonia. |
| AMLaccord-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablets. Sweden. |
| AMLaccord-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablets. Sweden. |
| AMLaurobindo-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLbluefish-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLbluefish-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| AMLjubilant-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLjubilant-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| AMLkrka-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLkrka-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| AMLmedvalley-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLmedvalley-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| AMLsandoz-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLsandoz-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| AMLteva-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLteva-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| AMLvitabalans-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| AMLvitabalans-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| AT-Curocef-1500-Powder |
Curocef 1500mg Powder for solution for injection/infusion. Austria. |
| Agen-5mg-Tablet-EE-APD |
Administrable/Pharmaceutical Product Definition: simple tablets |
| Agen-5mg-Tablet-EE-I |
Ingredient: amlodipine besilate, presentation strength; amlodipine, reference strength |
| Agen-5mg-Tablet-EE-MID |
Manufactured Item: simple tablet |
| Agen-5mg-Tablet-EE-MPD |
Medicinal Product Definition: simple tablets |
| Agen-5mg-Tablet-EE-PPD-1109887-A |
Packaged Product Definition: simple tablets |
| Agen-5mg-Tablet-EE-PPD-1109887-B |
Packaged Product Definition: simple tablets |
| Agen-5mg-Tablet-EE-RA |
Marketing Authorisation |
| Amlodistad-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| Amlodistad-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
| CanifugCremolum-100mg-Pessary-EE-APD |
Administrable/Pharmaceutical Product Definition: pessaries |
| CanifugCremolum-100mg-Pessary-EE-I |
Ingredient: clotrimazole, presentation strength |
| CanifugCremolum-100mg-Pessary-EE-MID |
Manufactured Item: pessary |
| CanifugCremolum-10mg1g-Cream-EE-APD |
Administrable/Pharmaceutical Product Definition: creme |
| CanifugCremolum-10mg1g-Cream-EE-I |
Ingredient: clotrimazole, concentration strength |
| CanifugCremolum-10mg1g-Cream-EE-MID |
Manufactured Item: cream in tube |
| CanifugCremolum-EE-Cream-Medication-Item |
Clotrimazole cream as part of Canifug Cremolum product (ISO IDMP manufactured item) |
| CanifugCremolum-EE-MPD |
Medicinal Product Definition: combination product of creme and pessaries |
| CanifugCremolum-EE-Medication-Clinical |
Canifug Cremolum in Medication resource as a registered packaged product: combination product of 20g creme and 6 pessaries |
| CanifugCremolum-EE-PPD-1033692 |
Packaged Product Definition: combination package of creme and pessaries |
| CanifugCremolum-EE-Pessary-Medication-Item |
Clotrimazole pessary as part of Canifug Cremolum product (ISO IDMP manufactured item) |
| CanifugCremolum-EE-RA |
Marketing Authorisation |
| Cefuroxime-MIP-1500mg-EE-APD |
Administrable/Pharmaceutical Product Definition: transformed |
| Cefuroxime-MIP-1500mg-EE-I |
Ingredient: cefuroxime sodium, presentation strength; cefuroxime sodium, reference strength |
| Cefuroxime-MIP-1500mg-EE-MID |
Manufactured Item: powder in vial |
| Cefuroxime-MIP-1500mg-EE-MPD |
Medicinal Product Definition: powder for solution |
| Cefuroxime-MIP-1500mg-EE-PPD-1529940 |
Packaged Product Definition: powder for solution in 1 vial |
| Cefuroxime-MIP-1500mg-EE-PPD-1529962 |
Packaged Product Definition: powder for solution in 10 vials |
| Cefuroxime-MIP-1500mg-EE-RA |
Marketing Authorisation |
| Cefuroxime1500-Medication-Clinical |
Cefuroxime 1500mg powder for solution in Medication resource as a generic product |
| Cefuroxime1500-Powder-Medication-Item |
Cefuroxime 1500mg powder in a vial (ISO IDMP manufactured item). Note, that strength can be expressed in grams or milligrams. |
| CefuroximeMIP-EE-Medication-Clinical |
Cefuroxime 1500mg powder for solution in Medication resource as a registered packaged product |
| CefuroximeMIP-EE-Powder-Medication-Item |
Cefuroxime 1500mg powder in a vial (ISO IDMP manufactured item) |
| Clotrimazole-Cream-Generic |
Clotrimazole cream (ISO IDMP manufactured item) |
| Clotrimazole-cream-and-pessaries-Medication-Clinical |
Clotrimazole cream and pessaries as a generic product, Medication resource |
| LOC-100000551-KrkaSverige |
Marketing Authorisation Holder / Organisation |
| LOC-100002580-Zentiva |
Marketing Authorisation Holder / Organisation |
| LOC-100004795-Wolff-Arzneimittel |
Marketing Authorisation Holder / Organisation |
| LOC-100009199-Mip |
Marketing Authorisation Holder / Organisation |
| Norvasc-10mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 10mg tablet. Sweden. |
| Norvasc-5mg-Tablet-SE-IS-MedicinalProductDefinition-BBDL |
Amlodipine (besylate) 5mg tablet. Sweden. |
IG © 2022+ UNICOM. Package hl7.eu.fhir.unicom#0.1.0 based on FHIR 5.0.0. Generated 2024-10-11
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QA Report
The UNICOM Innovation Action has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 875299.
