2.16.840.1.113883.10.22.4.3/static-2021-08-02T165227

Id	2.16.840.1.113883.10.22.4.3	Effective Date	2021‑08‑02 16:52:27 Other versions this id: IPSMedMaterial as of 2024‑08‑04 10:47:30 IPSMedMaterial as of 2016‑11‑10
Status	Draft	Version Label	2021
Name	IPSMedMaterial	Display Name	IPS Manufactured Material
Description This entry provides details about the medicinal product. Due to the current absence of global product identifiers the product is described through a set of identification and descriptive attributes (e.g. active substances, strength, unit of presentation,...)  that may be used to integrate jurisdictional product codes. This shortage will be likely overcome when the ISO IDMP identifiers will be available for concrete usage in the next years, as well as the globally used value sets for products attributes agreed by the ISO IDMP implemention guides. (e.g. GInAs for substances). Even though there is a quite common consensus about the attributes that should be provided in order to describe a medicine in the context of the international patient summary (e.g. the list of active substances, the strength(s); the administrable pharmaceutical forms;..), this template doesn't require any of them, recommending, above all for cross-borders services, to provide all the available information that could be helpful for the identification of medications Jurisdictions could specialize this template making some ofthese attributes required. It is also recognized that in many contexts structured information about the product, might not be available, and only textual information for describing products (e.g. the product scientific name "amoxicillin 400mg/5mL suspension”) or some of their attributes (e.g. textual strength "875 mg + 125 mg" ; "amoxycillin and clavulanic acid") could be used. This template attempts to provide a solution that takes in account this current complexity being also ready for including the future IDMP-based solution as soon as they will become available for concrete use. Since the CDA R2.0 model support only a very limited set of information about the products, extensions based on the R_ProductList (Common Product Model) CMET have been used for conveying such information, aiming to align this solution with that that will be likely used for the IDMP implementation Guide.
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 4 concepts Id Name Data Set hl7ips-data​element-105  Product Code  CEN/TC 251 prEN 17269 hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269 hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 hl7ips-data​element-227  Pharmaceutical dose form  CEN/TC 251 prEN 17269
Uses	Uses 3 templates Uses as Name Version 2.16.840.1.113883.10.21.4.17 Include UV Content (R1-STU2-ballot) DYNAMIC 2.16.840.1.113883.10.21.4.19 Include UV Generalized Medicine Class (2023) DYNAMIC 2.16.840.1.113883.10.21.4.18 Include UV Ingredient (R1-STU2-ballot) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.311 CDA Material (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.147 OpenMed Material (2016‑05‑10 22:43:03) ref epsos-
Example	Example <manufacturedMaterial>   <!-- Example with all the IDMP Levels (PhPID,MPID, PCID) and other product attributes (e.g. ingredients, ATC Code, strengths) -->   <templateId root="2.16.840.1.113883.10.22.4.3"/>  <code codeSystem="" code="MPID" displayName="" CodeSystemName="MP EMA"/>  <name>Medicinal Product Name</name>  <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="10219000" displayName="tablet" CodeSystemName="EDQM"/>  <asContent>     <!-- Packaged Medicinal Product (PC) -->     <containerPackagedProduct>       <!-- PC ID-->       <code codeSystem=" " code="PCID" displayName=" "/>      <name>...</name>      <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="" displayName="" CodeSystemName="EDQM"/>    </containerPackagedProduct>  </asContent>  <asSpecializedKind classCode="GRIC">     <!-- Pharmaceutical Substance (ATC Code)-->     <generalizedMaterialKind classCode="MMAT">       <!-- Pharmaceutical Substance (ATC Code)-->       <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>    </generalizedMaterialKind>  </asSpecializedKind>  <asSpecializedKind>     <!-- Pharmaceutical Product (PhP)-->     <generalizedMaterialKind classCode="MMAT">       <code code="PhPID" codeSystem=" " displayName=" " codeSystemName="PhP EMA"/>      <name>....</name>    </generalizedMaterialKind>  </asSpecializedKind>  <!-- list of active ingredients -->   <ingredient classCode="ACTI" determinerCode="KIND">     <quantity>       <!-- strength -->       <numerator type="PQ" value="20" unit="mg"/>      <denominator type="PQ" value="1" unit="{tablet}"/>    </quantity>    <ingredientSubstance>       <code codeSystem=" " code="SubstanceID" displayName=" " CodeSystemName="G-SRS"/>      <name>...</name>    </ingredientSubstance>  </ingredient></manufacturedMaterial>
Example	Example <manufacturedMaterial classCode="MMAT" determinerCode="KIND">   <templateId root="2.16.840.1.113883.10.22.4.3"/>  <code code="..." codeSystem="1.2.3.999"/>  <name>name</name>  <formCode code="10101000" displayName="Oral drops, solution" codeSystem="0.4.0.127.0.16.1.1.2.1"/>  <asContent classCode="CONT">     <containerPackagedProduct classCode="CONT" determinerCode="KIND">       <code/>      <name/>      <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>      <capacityQuantity value="..." unit="..."/>      <asContent classCode="CONT">         <containerPackagedProduct classCode="CONT" determinerCode="KIND">           <code/>          <name/>          <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>          <asContent classCode="CONT">             <containerPackagedProduct classCode="CONT" determinerCode="KIND">               <code/>              <name/>              <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>            </containerPackagedProduct>          </asContent>        </containerPackagedProduct>      </asContent>    </containerPackagedProduct>  </asContent>  <asSpecializedKind classCode="GRIC">     <generalizedMaterialKind classCode="MMAT">       <code code="..." codeSystem="2.16.840.1.113883.6.73"/>      <name/>    </generalizedMaterialKind>  </asSpecializedKind>  <asSpecializedKind classCode="GRIC">     <generalizedMaterialKind classCode="MMAT">       <code/>      <name/>    </generalizedMaterialKind>  </asSpecializedKind>  <ingredient classCode="ACTI" determinerCode="KIND">     <quantity>       <numerator value="20" unit="mg"/>      <denominator value="100" unit="mL"/>    </quantity>    <ingredientSubstance>       <code/>      <name/>    </ingredientSubstance>  </ingredient></manufacturedMaterial>
Item DT Card Conf Description Label hl7:manufactured​Material 0 … * R (IPS...ial) @classCode cs 0 … 1 F MMAT @determiner​Code cs 0 … 1 F KIND hl7:templateId II 1 … 1 M (IPS...ial) @root oid 1 … 1 F 2.16.840.1.113883.10.22.4.3 hl7:code CE.IPS 0 … 1 R This element is generally used to identify a medicinal product. When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID). For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code. (IPS...ial)   hl7ips-data​element-105  Product Code  CEN/TC 251 prEN 17269 hl7:name EN 0 … 1 R This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction. The name may be applicable in one or more country/language combinations. (IPS...ial)   hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269 hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 pharm:formCode CE.IPS (preferred) 0 … 1 R Administrable Pharmaceutical Dose Form. This code represents the form of the medication (e.g. tablet, capsule, liquid) Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration. It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT. (IPS...ial)   hl7ips-data​element-227  Pharmaceutical dose form  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC)   Example <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode> pharm:asContent 0 … * This structure describes the packaging of the medication. It represents the primary description of the packaging of the medicine (e.g., the medicine is packaged in ampoules of 50ml volume each) and may include additional packaging information of how many of the primary packaged items are within an outer package (e.g., 5 ampoules are packaged in a box). The primary description of the package should be consistent with the given pharmaceutical dose form (pharm:formCode of the medication). Example: a consistent pharmaceutical dose form to the package form “Ampoules” would be e.g., “Solution for injection”. In case the package describes a product, the pharm:code element provides the code for the product. In case the package describes a product, and the package has a brand name, it should be described in the pharm:name element (e.g., Xylocaine 1% with Adrenaline Inj, 5 injections package). The pharm:formCode element represents the form of the product/contaner (e.g., tablet container, bottle, ...). The <pharm:capacity​Quantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container. The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging. In the latter case, the most inner (nested) item represents the most outer package item. For example the case    \--Box    \-----2 blisters    \--------20 tablets  is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box. The most inner package represents the Packaged Medicinal Product. (IPS...ial) @classCode cs 1 … 1 F CONT   Example Packaged Medicinal Product with formCode <asContent classCode="CONT">   <containerPackagedProduct classCode="CONT" determinerCode="KIND">     <!-- Packaged Medicinal Product -->     <code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"/>    <name>100 MIRACLE PILLS(TM)</name>    <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/>  </containerPackagedProduct></asContent>   Example General example <asContent classCode="CONT">   <quantity value=" " unit=" "/>  <containerPackagedProduct classCode="CONT" determinerCode="KIND">     <!-- Medicinal product code (package-level) -->     <code code=" " displayName=" " codeSystem=" " codeSystemName=" "/>    <!-- Brand name (package) -->     <name> . . . </name>    <formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/>    <capacityQuantity value=" " unit=" "/>    <asContent>       <containerPackagedProduct classCode="CONT" determinerCode="KIND">         <capacityQuantity value=" " unit=" "/>      </containerPackagedProduct>    </asContent>  </containerPackagedProduct></asContent>   Example Medicinal product with pharmaceutical dose form ”Tablets”, available as a “Tablet container” with 30 tablets <asContent classCode="CONT">   <!-- 30 tablets in the package -->   <quantity value="30" unit="{tablet}"/>  <containerPackagedProduct classCode="CONT" determinerCode="KIND">     <!-- .. -->     <formCode code=" " displayName="Tablet container" codeSystem=" " codeSystemName=" "/>  </containerPackagedProduct></asContent>   Example Medicinal product with pharmaceutical dose form 'Solution for injection', available as “Ampoules” with 50ml volume, packaged as 5 ampoules per box <asContent classCode="CONT">   <quantity value="50" unit="ml"/>  <!-- 50ml per ampoule -->   <containerPackagedProduct classCode="CONT" determinerCode="KIND">     <!-- .. -->     <formCode code=" " displayName="Ampoules" codeSystem=" " codeSystemName=" "/>    <asContent>       <!-- 5 ampoules in a box -->       <quantity value="5"/>      <containerPackagedProduct classCode="CONT" determinerCode="KIND">         <!-- .. -->       </containerPackagedProduct>    </asContent>  </containerPackagedProduct></asContent>   Example Packaged Medicinal Product with multiple layers packaging <asContent classCode="CONT">   <containerPackagedProduct>     <!-- Inner Package -->     <code codeSystem="..." code="..." displayName="..."/>    <asContent>       <containerPackagedProduct>         <!-- Intermediate Package -->         <asContent>           <containerPackagedProduct>             <!-- Outer Package / Packaged Medicinal Product -->           </containerPackagedProduct>        </asContent>      </containerPackagedProduct>    </asContent>  </containerPackagedProduct></asContent> Included from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CE 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name EN 0 … * It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 0 … 1 This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the "2 blisters"  In the case of    \--Box    \-----5 vials it represents the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 1 … 1 R This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * R In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R (IPS...ial) pharm:containerPackagedProduct 1 … 1 R When present, it represents the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 When present, it can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R (IPS...ial) pharm:formCode CE 1 … 1 R (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asSpecializedKind 0 … 1 R This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System. The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry. (IPS...ial) where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] @classCode cs 1 … 1 F GRIC   Example <asSpecializedKind classCode="GRIC">   <generalizedMaterialKind classCode="MMAT">     <!-- Pharmaceutical Substance (ATC Code)-->     <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>  </generalizedMaterialKind></asSpecializedKind> pharm:generalizedMaterialKind 1 … 1 M (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS 1 … 1 R The <code> element contains the ATC code of this medicine. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 IPS WHO ATC (DYNAMIC)   Example <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> pharm:name 0 … * (IPS...ial) pharm:asSpecializedKind 0 … * R The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international as for example the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) when it will be available for use. The generalizedMaterialKind/code element is used to covey these codes. (IPS...ial) @classCode cs 1 … 1 F GRIC   Example <asSpecializedKind classCode="GRIC">   <generalizedMedicineClass classCode="MMAT">     <code code=" " displayName=" " codeSystem=" " codeSystemName=" "/>  </generalizedMedicineClass></asSpecializedKind> Included from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) pharm:generalizedMedicineKind 0 … * (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code 1 … 1 R (IPS...ial) pharm:name 0 … * (IPS...ial) pharm:part 0 … * (IPS...ial) @classCode cs 1 … 1 F PART pharm:id II 0 … 1 (IPS...ial) pharm:quantity PQ 0 … 1 (IPS...ial) pharm:partProduct 1 … 1 R (IPS...ial) pharm:code CE 0 … 1 (IPS...ial) pharm:name EN 0 … 1 (IPS...ial) pharm:desc ED 0 … 1 (IPS...ial) pharm:formCode CE 0 … 1 (IPS...ial) pharm:asContent 0 … * (IPS...ial) @classCode cs 1 … 1 F CONT Included from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CE 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name EN 0 … * It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 0 … 1 This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the "2 blisters"  In the case of    \--Box    \-----5 vials it represents the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 1 … 1 R This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * R In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R (IPS...ial) pharm:containerPackagedProduct 1 … 1 R When present, it represents the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 When present, it can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R (IPS...ial) pharm:formCode CE 1 … 1 R (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asSpecializedKind 0 … * (IPS...ial) @classCode cs 1 … 1 F GRIC Included from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) pharm:generalizedMedicineKind 0 … * (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code 1 … 1 R (IPS...ial) pharm:name 0 … * (IPS...ial) pharm:part 0 … * (IPS...ial) @classCode cs 1 … 1 F PART pharm:id II 0 … 1 (IPS...ial) pharm:quantity PQ 0 … 1 (IPS...ial) pharm:partProduct 1 … 1 R (IPS...ial) pharm:code CE 0 … 1 (IPS...ial) pharm:name EN 0 … 1 (IPS...ial) pharm:desc ED 0 … 1 (IPS...ial) pharm:formCode CE 0 … 1 (IPS...ial) pharm:asContent 0 … * (IPS...ial) @classCode cs 1 … 1 F CONT Included from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CE 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name EN 0 … * It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 0 … 1 This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the "2 blisters"  In the case of    \--Box    \-----5 vials it represents the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 1 … 1 R This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * R In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R (IPS...ial) pharm:containerPackagedProduct 1 … 1 R When present, it represents the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 When present, it can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R (IPS...ial) pharm:formCode CE 1 … 1 R (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asSpecializedKind 0 … * (IPS...ial) @classCode cs 1 … 1 F GRIC Included from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) pharm:generalizedMedicineKind 0 … * (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code 1 … 1 R (IPS...ial) pharm:name 0 … * (IPS...ial) pharm:part 0 … * (IPS...ial) @classCode cs 1 … 1 F PART pharm:id II 0 … 1 (IPS...ial) pharm:quantity PQ 0 … 1 (IPS...ial) pharm:partProduct 1 … 1 R (IPS...ial) pharm:code CE 0 … 1 (IPS...ial) pharm:name EN 0 … 1 (IPS...ial) pharm:desc ED 0 … 1 (IPS...ial) pharm:formCode CE 0 … 1 (IPS...ial) pharm:asContent 0 … * (IPS...ial) @classCode cs 1 … 1 F CONT Included from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CE 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name EN 0 … * It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 0 … 1 This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the "2 blisters"  In the case of    \--Box    \-----5 vials it represents the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) pharm:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 It represents the code of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial) pharm:formCode CE 1 … 1 R This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product. (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asContent 0 … * R In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R (IPS...ial) pharm:containerPackagedProduct 1 … 1 R When present, it represents the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 When present, it can be used to convey the Packaged Medicinal Product ID. (IPS...ial) pharm:name ST 0 … 1 R (IPS...ial) pharm:formCode CE 1 … 1 R (IPS...ial) pharm:capacity​Quantity PQ 0 … 1 Captures the number of product units the package would contain if fully loaded. (IPS...ial) @value 1 … 1 R @unit cs 0 … 1   pharm:asSpecializedKind 0 … * (IPS...ial) @classCode cs 1 … 1 F GRIC Included from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) pharm:generalizedMedicineKind 0 … * (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code 1 … 1 R (IPS...ial) pharm:name 0 … * (IPS...ial) pharm:part 0 … * (IPS...ial) @classCode cs 1 … 1 F PART pharm:ingredient 0 … * (IPS...ial) @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) Included from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) pharm:quantity RTO_PQ_PQ 0 … 1 (IPS...ial)   Example 10 mg of the ingredient per ml <pharm:quantity>   <cda:numerator xsi:type="PQ" value="10" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity>   Example 2% of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="2" unit="%"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity>   Example 5mg of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="5" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> cda:numerator PQ 0 … 1 (IPS...ial) cda:denominator PQ 0 … 1 (IPS...ial) pharm:ingredientSubstance 0 … 1 The substance used for this product plying the role indicated in the ingredient classCode. The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation. (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 C (IPS...ial) pharm:name EN 0 … 1 C (IPS...ial)   Schematron assert role  error     test pharm:code or pharm:name     Message Either the name or the code of the substance (or both) shall be provided   pharm:ingredient 0 … * (IPS...ial) @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) Included from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) pharm:quantity RTO_PQ_PQ 0 … 1 (IPS...ial)   Example 10 mg of the ingredient per ml <pharm:quantity>   <cda:numerator xsi:type="PQ" value="10" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity>   Example 2% of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="2" unit="%"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity>   Example 5mg of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="5" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> cda:numerator PQ 0 … 1 (IPS...ial) cda:denominator PQ 0 … 1 (IPS...ial) pharm:ingredientSubstance 0 … 1 The substance used for this product plying the role indicated in the ingredient classCode. The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation. (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 C (IPS...ial) pharm:name EN 0 … 1 C (IPS...ial)   Schematron assert role  error     test pharm:code or pharm:name     Message Either the name or the code of the substance (or both) shall be provided   pharm:ingredient 0 … * (IPS...ial) @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) Included from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) pharm:quantity RTO_PQ_PQ 0 … 1 (IPS...ial)   Example 10 mg of the ingredient per ml <pharm:quantity>   <cda:numerator xsi:type="PQ" value="10" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity>   Example 2% of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="2" unit="%"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity>   Example 5mg of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="5" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> cda:numerator PQ 0 … 1 (IPS...ial) cda:denominator PQ 0 … 1 (IPS...ial) pharm:ingredientSubstance 0 … 1 The substance used for this product plying the role indicated in the ingredient classCode. The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation. (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 C (IPS...ial) pharm:name EN 0 … 1 C (IPS...ial)   Schematron assert role  error     test pharm:code or pharm:name     Message Either the name or the code of the substance (or both) shall be provided   pharm:ingredient 0 … * This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present. The classCode of "ACTI" indicates that this is an active ingredient. (IPS...ial) @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC)   Example <pharm:ingredient classCode="ACTI">   <pharm:quantity>     <cda:numerator type="PQ" value=" " unit=" "/>    <cda:denominator type="PQ" value=" " unit=" "/>  </pharm:quantity>  <ingredientSubstance classCode="MMAT" determinerCode="KIND">     <code code=" " displayName=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="ATC WHO"/>  </ingredientSubstance></pharm:ingredient> Included from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) pharm:quantity RTO_PQ_PQ 0 … 1 (IPS...ial)   Example 10 mg of the ingredient per ml <pharm:quantity>   <cda:numerator xsi:type="PQ" value="10" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity>   Example 2% of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="2" unit="%"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity>   Example 5mg of the ingredient <pharm:quantity>   <cda:numerator xsi:type="PQ" value="5" unit="mg"/>  <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> cda:numerator PQ 0 … 1 (IPS...ial) cda:denominator PQ 0 … 1 (IPS...ial) pharm:ingredientSubstance 0 … 1 The substance used for this product plying the role indicated in the ingredient classCode. The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation. (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code CD 0 … 1 C (IPS...ial) pharm:name EN 0 … 1 C (IPS...ial)   Schematron assert role  error     test pharm:code or pharm:name     Message Either the name or the code of the substance (or both) shall be provided