UnicomIG
0.1.0 - ci-build
UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. This is not an authorized publication; it is the continuous build for version 0.1.0). 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.
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 Medicinal Product profile |
Medicinal Product as defined in ISO IDMP |
| PPL Organization |
Organization |
| PPL Packaged Product profile |
Packaged Product |
| PPL Marketing Authorisation profile |
Regulated Authorization profile defines the Marketing Authorisation on product or package level |
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 - 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 |
| Processing Profile - Marketing Authorisation |
Intermediate profile for processing PPL Marketing Authorisation (Regulated Authorization) data |
These define data models that represent the domain covered by this implementation guide in more business-friendly terms than the underlying FHIR resources.
| Medicinal Product |
Medicinal Product |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| CD |
Concept descriptor |
| DT |
Date |
| II |
Instance Identifier |
| QT |
Quantity |
| ST |
String |
| TS |
Time stamp |
| class |
Class of data elements |
| untyped |
No data type defined |
These define sets of codes used by systems conforming to this implementation guide.
| All Units Combined |
Value set for presentation strength denominator unit, combines units of measurement and units of presentation. |
| 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. |
| Country (EMA SPOR RMS) |
Countries. EMA SPOR RMS list. |
| Country (ISO 3166-1-2) |
Countries |
| Domain |
Domain of the medicinal product. EMA SPOR RMS list. |
| Language (FHIR) |
All languages |
| Language (EMA SPOR RMS) |
Languages. EMA SPOR RMS list. |
| Legal Status for the Supply |
EMA SPOR RMS list |
| Material |
Package material. EMA SPOR RMS LIST. |
| Dummy value set |
Dummy value set for suppressing QA errors caused by FHIR R4B broken value set bindings |
| Pharmaceutical Dose Form |
Pharmaceutical dose form. Does not include combination dose forms. |
| Routes and Methods of Administration |
Routes and methods of medication administration. EMA SPOR RMS list. |
| Anatomical Therapeutic Chemical classification system |
Value set for Anatomical Therapeutic Chemical classification system Human and Veterinary. It combines 2 SPOR/WHO lists |
| Marketing Status |
Marketing Status |
| Packaging |
Packaging |
| Record Status |
Value set for record status. |
| Regulatory Entitlement Status |
Regulatory Entitlement Status |
| Shelf Life Type |
Shelf Life Type |
| EMA SPOR SMS Substances |
Value set for substances, PPL subset from SMS. |
| Unit of Measurement EMA |
Units of measurement. EMA SPOR RMS list based on UCUM. |
| Unit of Presentation EMA |
Units of presentation. EMA SPOR RMS list based on EDQM. |
| 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. |
| Filter-label |
ValueSet Filter label from EDQM, FIL, see https://standardterms.edqm.eu/# |
| administration-device |
ValueSet Administration device from EDQM, DEV, see https://standardterms.edqm.eu/# |
| administration-method |
ValueSet Administration method from EDQM, AME, see https://standardterms.edqm.eu/# |
| basic-dose-form |
ValueSet Basic dose form from EDQM, BDF, see https://standardterms.edqm.eu/# |
| closure |
ValueSet Closure from EDQM, CLO, see https://standardterms.edqm.eu/# |
| combination-pack |
ValueSet Combination pack from EDQM, CMP, see https://standardterms.edqm.eu/# |
| combined-pharmaceutical-dose-form |
ValueSet Combined pharmaceutical dose form from EDQM, CDF, see https://standardterms.edqm.eu/# |
| combined-term |
ValueSet Combined term from EDQM, CMT, see https://standardterms.edqm.eu/# |
| container |
ValueSet Container from EDQM, CON, see https://standardterms.edqm.eu/# |
| ehdsi-ucum-unit |
ValueSet for UCUM units to be used in eHDSI |
| intended-site |
ValueSet Intended site from EDQM, ISI, see https://standardterms.edqm.eu/# |
| mapping |
ValueSet Mapping from EDQM, MAP, see https://standardterms.edqm.eu/# |
| packaging-category |
ValueSet Packaging category from EDQM, PAC, see https://standardterms.edqm.eu/# |
| patient-friendly-term |
ValueSet Patient-friendly term from EDQM, PFT, see https://standardterms.edqm.eu/# |
| pharmaceutical-dose-form |
ValueSet Pharmaceutical dose form from EDQM, PDF, see https://standardterms.edqm.eu/# |
| release-characteristics |
ValueSet Release characteristics from EDQM, RCA, see https://standardterms.edqm.eu/# |
| route-of-administration |
ValueSet Route of administration from EDQM, ROA, see https://standardterms.edqm.eu/# |
| state-of-matter |
ValueSet State of matter from EDQM, SOM, see https://standardterms.edqm.eu/# |
| transformation |
ValueSet Transformation from EDQM, TRA, see https://standardterms.edqm.eu/# |
| unit-of-presentation |
ValueSet Unit of presentation from EDQM, UOP, see https://standardterms.edqm.eu/# |
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 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. |
| 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. |
| 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-MPD |
Medicinal Product Definition: combination product of creme and pessaries |
| CanifugCremolum-EE-PPD-1033692 |
Packaged Product Definition: combination package of creme and pessaries |
| 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 |
| 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 4.3.0. Generated 2023-02-03
Links: Table of Contents |
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.
