# Medication (EU core) - HL7 Europe Base and Core FHIR IG v2.0.0

* [**Table of Contents**](toc.md)
* [**Artifacts Summary**](artifacts.md)
* **Medication (EU core)**

## Resource Profile: Medication (EU core) 

| | | |
| :--- | :--- | :--- |
| *Official URL*:http://hl7.eu/fhir/base-r5/StructureDefinition/medication-eu-core | *Version*:2.0.0 | |
| * Standards status: *[Trial-use](http://hl7.org/fhir/R5/versions.html#std-process) | [Maturity Level](http://hl7.org/fhir/versions.html#maturity): 2 | *Computable Name*:MedicationEuCore |
| **Copyright/Legal**: Copyright HL7 Europe. Licensed under creative commons public domain (CC0 1.0). | | |

 
This profile introduces essential constraints and extensions for the Medication resource that apply across multiple use cases. 

**Usages:**

* Refer to this Profile: [Medication (EU core)](StructureDefinition-medication-eu-core.md), [MedicationRequest (EU core)](StructureDefinition-medicationRequest-eu-core.md), [MedicationStatement (EU core)](StructureDefinition-medicationStatement-eu-core.md) and [Procedure (EU core)](StructureDefinition-procedure-eu-core.md)
* Examples for this Profile: [Medication/01A-Cefuroxime1500GenericExplicit](Medication-01A-Cefuroxime1500GenericExplicit.md)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/hl7.fhir.eu.base-r5|current/StructureDefinition/medication-eu-core)

### Formal Views of Profile Content

 [Description of Profiles, Differentials, Snapshots and how the different presentations work](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#structure-definitions). 

 

Other representations of profile: [CSV](StructureDefinition-medication-eu-core.csv), [Excel](StructureDefinition-medication-eu-core.xlsx), [Schematron](StructureDefinition-medication-eu-core.sch) 

### Notes:

#### Characteristics Extension

 The `characteristic` extension is a loosely defined key–value pair that allows implementations to add any other information about the medicinal product. Such information may include details relevant to requests (for example lactose-free = true) or additional data about the product actually dispensed (for example special precaution for storage = "Store in a refrigerator (2°C – 8°C)"). The data type of the value depends on the type of the characteristic. 

 Availability of this information depends on its presence in the source data. In FHIR, ` MedicationKnowledge` and resources in the Medication Definition module include elements for characteristics or properties, which allow medicinal product dictionaries to communicate this type of data when necessary. Other elements in detailed product descriptions may also be conveyed using this extension. 

#### Strength Representation with basisOfStrengthSubstance Extension

 The `basisOfStrengthSubstance` extension is used when the substance listed as the ingredient differs from the substance on which the strength is expressed. 

 In many medicinal products, the ingredient may be represented as a precise substance (for example a salt form), while the strength is expressed in terms of the active moiety. When the ingredient substance and the strength reference substance do not match, the `basisOfStrengthSubstance` extension indicates which substance the strength value refers to. 

 The following examples represent different representations of the concept: 

 *1193768007 | Product containing precisely cefuroxime (as cefuroxime sodium) 750 milligram/1 vial powder for conventional release solution for injection (clinical drug)|* 

 Depending on the medicinal product dictionary, the substance and strength provided may differ. 

 If the ingredient substance and the strength refer to the same substance, the extension can be used for explicit clarity, but it does not add additional information. 

* Data element: Ingredient
  * Example 1: cefuroxime
  * Example 2: cefuroxime sodium
* Data element: Strength
  * Example 1: 750 mg
  * Example 2: 789 mg

 If the ingredient is a different form of the substance (for example a salt), but the strength is expressed for another substance (typically the active moiety), the extension is needed to remove this ambiguity. 

* Data element: Ingredient
  * Example 3: cefuroxime
  * Example 4: cefuroxime sodium
* Data element: Strength
  * Example 3: 789 mg
  * Example 4: 750 mg
* Data element: basisOfStrengthSubstance
  * Example 3: cefuroxime sodium
  * Example 4: cefuroxime

 The approach described here aligns with the SNOMED CT medicinal product concept model and can be derived from the ISO IDMP representation. 

#### Medicinal Product Name

 The `Medication` resource does not include an explicit element for the medicinal product name. In countries where medication information is distributed as a code system, the de facto elements used for holding the medication name have been ` Medication.code.text` or `Medication.code.coding.display`. This is also the recommendation of HL7 Pharmacy. 

 However, analysis of extensions in national implementation guides showed that many countries prefer to extend the `Medication` resource in order to include an explicit element for the authorised name of the product. It is also evident that countries often add multiple codings to the `.code` element, which makes it difficult to understand which coding is associated with the official product name. 

 Therefore, this implementation guide includes a simple extension for the authorised medicinal product name. National implementations are not required to use this extension when their functional requirements are covered by the `.code` element. 

#### Identifier vs Code

 In case of medications, the line between `.identifier` and `.code` is not always clear, and the practice of using these elements differs between countries. 

 This implementation guide allows the use of the `.identifier` element for non-instance identifiers such as IDMP identifiers or product codes from a national product registry or EMA PMS. It should be noted that identifiers do not have display names, which requires the consumer of the data to have lookup access to the source system of the identifier or the producer of the data to populate additional descriptive elements describing the product. 

#### Code vs Classification (e.g. ATC)

 The `classification` extension was introduced after reviewing how different countries implement medication classifications. Some implementations include ATC codes in `Medication.code.coding`, while others use extensions. 

 Because classifications such as ATC represent a categorisation of a medication rather than the medication itself, the preferred approach is to convey them in a separate classification element. 

 National implementations that currently include ATC as an additional coding may continue to do so, but should maintain the ability to map it to the classification extension, particularly for cross-border use. 

 If ATC itself is used as the medication code (for example in certain ` MedicationStatement` contexts), it should remain in `Medication.code`. ATC is not recommended for ingredient representation, as the code system lacks the required granularity. 

#### Additional Information and Examples

 Additional information and example instances can be found in the HL7 Europe Medication Prescription and Dispense Implementation Guide. 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "medication-eu-core",
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 2
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "trial-use"
  }],
  "url" : "http://hl7.eu/fhir/base-r5/StructureDefinition/medication-eu-core",
  "version" : "2.0.0",
  "name" : "MedicationEuCore",
  "title" : "Medication (EU core)",
  "status" : "active",
  "date" : "2026-04-27T22:41:19+03:00",
  "publisher" : "HL7 Europe",
  "contact" : [{
    "name" : "HL7 Europe",
    "telecom" : [{
      "system" : "url",
      "value" : "http://hl7.eu"
    }]
  }],
  "description" : "This profile introduces essential constraints and extensions for the Medication resource that apply across multiple use cases.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "code" : "150",
      "display" : "Europe"
    }]
  }],
  "copyright" : "Copyright HL7 Europe. Licensed under creative commons public domain (CC0 1.0).",
  "fhirVersion" : "5.0.0",
  "mapping" : [{
    "identity" : "script10.6",
    "uri" : "http://ncpdp.org/SCRIPT10_6",
    "name" : "Mapping to NCPDP SCRIPT 10.6"
  },
  {
    "identity" : "w5",
    "uri" : "http://hl7.org/fhir/fivews",
    "name" : "FiveWs Pattern Mapping"
  },
  {
    "identity" : "rim",
    "uri" : "http://hl7.org/v3",
    "name" : "RIM Mapping"
  },
  {
    "identity" : "v2",
    "uri" : "http://hl7.org/v2",
    "name" : "HL7 V2 Mapping"
  }],
  "kind" : "resource",
  "abstract" : false,
  "type" : "Medication",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Medication",
  "derivation" : "constraint",
  "differential" : {
    "element" : [{
      "id" : "Medication",
      "path" : "Medication"
    },
    {
      "id" : "Medication.extension",
      "path" : "Medication.extension",
      "slicing" : {
        "discriminator" : [{
          "type" : "value",
          "path" : "url"
        }],
        "ordered" : false,
        "rules" : "open"
      }
    },
    {
      "id" : "Medication.extension:productName",
      "path" : "Medication.extension",
      "sliceName" : "productName",
      "short" : "Current trade name (authorised name) of the medicinal product.",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "Extension",
        "profile" : ["https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-medication-productname"]
      }]
    },
    {
      "id" : "Medication.extension:classification",
      "path" : "Medication.extension",
      "sliceName" : "classification",
      "short" : "Classifications of the product, e.g ATC, narcotic/psychotropic, orphan drug, etc",
      "min" : 0,
      "max" : "*",
      "type" : [{
        "code" : "Extension",
        "profile" : ["https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-medication-classification"]
      }]
    },
    {
      "id" : "Medication.extension:sizeOfItem",
      "path" : "Medication.extension",
      "sliceName" : "sizeOfItem",
      "short" : "Size of one item (for example, in a pack of 5 vials, this would represent the size of 1 vial)",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "Extension",
        "profile" : ["https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-medication-sizeofitem"]
      }]
    },
    {
      "id" : "Medication.extension:characteristic",
      "path" : "Medication.extension",
      "sliceName" : "characteristic",
      "short" : "Specifies other descriptive properties of the medication.",
      "min" : 0,
      "max" : "*",
      "type" : [{
        "code" : "Extension",
        "profile" : ["https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-medication-characteristic"]
      }]
    },
    {
      "id" : "Medication.extension:unitOfPresentation",
      "path" : "Medication.extension",
      "sliceName" : "unitOfPresentation",
      "short" : "Unit of presentation of the product (e.g. tablet, vial, ampoule, etc)",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "Extension",
        "profile" : ["https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-medication-unitofpresentation"]
      }]
    },
    {
      "id" : "Medication.extension:packageType",
      "path" : "Medication.extension",
      "sliceName" : "packageType",
      "short" : "Type of container. This information is more relevant in cases when the packaging has an impact on administration of the product (e.g. pre-filled syringe)",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "Extension",
        "profile" : ["http://hl7.eu/fhir/StructureDefinition/medication-package-type"]
      }]
    },
    {
      "id" : "Medication.extension:device",
      "path" : "Medication.extension",
      "sliceName" : "device",
      "short" : "Device, typically an administration device, included in the product.",
      "min" : 0,
      "max" : "*",
      "type" : [{
        "code" : "Extension",
        "profile" : ["https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-medication-device"]
      }]
    },
    {
      "id" : "Medication.extension:device.extension:device",
      "path" : "Medication.extension.extension",
      "sliceName" : "device"
    },
    {
      "id" : "Medication.extension:device.extension:device.value[x]",
      "path" : "Medication.extension.extension.value[x]",
      "binding" : {
        "strength" : "example",
        "valueSet" : "http://terminology.ehdsi.eu/ValueSet/eHDSIPackage"
      }
    },
    {
      "id" : "Medication.identifier",
      "path" : "Medication.identifier",
      "short" : "Identifier for the medicinal product, its generic representation, or packaged product (e.g. EMA PMS ID on product or package level)"
    },
    {
      "id" : "Medication.code",
      "path" : "Medication.code",
      "short" : "A terminology-based code for the product (e.g. SNOMED CT code)"
    },
    {
      "id" : "Medication.marketingAuthorizationHolder",
      "path" : "Medication.marketingAuthorizationHolder",
      "short" : "Marketing authorisation holder of the medicinal product. If the product does not have a marketing authorisation, the manufactured information may be used. It is sufficient to populate only name and optionally an identifier of the organisation."
    },
    {
      "id" : "Medication.doseForm",
      "path" : "Medication.doseForm",
      "short" : "Dose form. For a branded product, this would most likely be authorised dose form, but it could also be administrable dose form. For package items, it could be item's individual dose form.",
      "binding" : {
        "extension" : [{
          "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
          "valueString" : "MedicationForm"
        }],
        "strength" : "example",
        "description" : "A coded concept defining the form of a medication.",
        "valueSet" : "http://hl7.org/fhir/ValueSet/medication-form-codes",
        "additional" : [{
          "purpose" : "preferred",
          "valueSet" : "http://terminology.ehdsi.eu/ValueSet/eHDSIDoseForm",
          "documentation" : "MyHealth@EU crossborder value set for dose forms. Based on EDQM Standard Terms."
        }]
      }
    },
    {
      "id" : "Medication.totalVolume",
      "path" : "Medication.totalVolume",
      "short" : "Total volume or number of package items inside a package. This element should not contain overall prescribed amount, but describe the product itself. In case of complex packages, this element could be left empty, and number of different items could be indicated in the nested Medications."
    },
    {
      "id" : "Medication.ingredient",
      "path" : "Medication.ingredient",
      "short" : "Ingredient or a part product. For combination packs, each ingredient can be a separate manufactured item with its own ingredients, dose form, and strength"
    },
    {
      "id" : "Medication.ingredient.item",
      "path" : "Medication.ingredient.item",
      "short" : "Substance (Substance resource or concept from terminology) or a medicinal product (Medication resource or concept from terminology). Medicinal product can be an ingredient in case of extemporal medications or combination packs (e.g Creme + 6 tablets)",
      "type" : [{
        "code" : "CodeableReference",
        "targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Substance",
        "http://hl7.eu/fhir/base-r5/StructureDefinition/medication-eu-core"]
      }],
      "binding" : {
        "strength" : "example",
        "valueSet" : "http://hl7.org/fhir/ValueSet/substance-codes",
        "additional" : [{
          "purpose" : "preferred",
          "valueSet" : "http://terminology.ehdsi.eu/ValueSet/eHDSISubstance",
          "documentation" : "MyHealth@EU crossborder value set for substances. Based on EMA SPOR SMS."
        }]
      }
    },
    {
      "id" : "Medication.ingredient.isActive",
      "path" : "Medication.ingredient.isActive",
      "short" : "Active ingredient indicator. By default, only active ingredients are expected - therefore, the default value is true."
    },
    {
      "id" : "Medication.ingredient.strength[x]",
      "path" : "Medication.ingredient.strength[x]",
      "short" : "Amount of substance in product (presentation or concentration strength)",
      "definition" : "Definitional resources should be used for specifying the different types of strengths: presentation, concentration."
    },
    {
      "id" : "Medication.ingredient.strength[x].extension:basisOfStrengthSubstance",
      "path" : "Medication.ingredient.strength[x].extension",
      "sliceName" : "basisOfStrengthSubstance",
      "short" : "Basis of strength substance - substance for which the strength is provided (this could be different from the precise active ingredient).",
      "min" : 0,
      "max" : "1",
      "type" : [{
        "code" : "Extension",
        "profile" : ["https://profiles.ihe.net/PHARM/MPD/StructureDefinition/ihe-ext-medication-strengthsubstance"]
      }]
    },
    {
      "id" : "Medication.batch.lotNumber",
      "path" : "Medication.batch.lotNumber",
      "short" : "Lot Number"
    },
    {
      "id" : "Medication.batch.expirationDate",
      "path" : "Medication.batch.expirationDate",
      "short" : "Expiration Date"
    }]
  }
}

```
