Id1.3.6.1.4.1.12559.11.10.1.3.1.3.1Effective Date2013‑12‑20
Statusdraft DraftVersion Label
NameepSOSCDAManufacturedProductDisplay NameepSOS CDA ManufacturedProduct
Description
Template CDA ManufacturedProduct (prototype, directly derived from POCD_RM000040 MIF) The medicine entry content module describes a medication used in a <substanceAdministration> or <supply> act. This entry uses the structure of the HL7 V3 R_Medication Universal Common Message Element (CMET), Release 2.

This structure is part of the HL7 V3 2009 Normative Edition (COCT_RM230100UV). The incorporation of this structure is done according to section 1.4 CDA Extensibility of the HL7 CDA standard. Such an extension of the base CDA standard is an accepted practice in IHE (e.g. in the XD* Lab specification).

For the purposes of WP 3.5 this extension is necessary to satisfy the requirements for eP and eD data elements to represent a generic equivalent and ingredients.
The rules of section 1.4 CDA Extensibility require the designation of a new XML namespace for the XML elements in this structure. For the purposes of documentation, the namespace urn:epsos-org:ep:medication shall be used.

The following specification and constraints are applied to the structures of the CMET.

The example uses Pyrimon, Chloramphenicol/ Dexamethasone 1% w/v/ 0.1% w/v 5 ml Eye Drops as the medication. The structure is further explained in the following subsections.
ClassificationCDA Entry Level Template
Open/ClosedOpen (other than defined elements are allowed)
Associated with
Associated with 7 concepts
IdNameData Set
epsos-dataelement-105draft Strength draft epSOS Data Set
epsos-dataelement-137draft Brand name draft epSOS Data Set
epsos-dataelement-106draft Pharmaceutical dose form draft epSOS Data Set
epsos-dataelement-135draft Medicinal product code draft epSOS Data Set
epsos-dataelement-103draft Active ingredient draft epSOS Data Set
epsos-dataelement-104draft Active ingredient code draft epSOS Data Set
epsos-dataelement-138draft Medicinal product package size draft epSOS Data Set
Used by / Uses
Used by 5 transactions and 62 templates, Uses 1 template
Used by as NameVersion
2.16.840.1.113883.3.1937.777.11.4.23Transactiondraft Return MRO2013‑11‑02
2.16.840.1.113883.3.1937.777.11.4.12Transactiondraft Return PS of country A2012‑05‑02
2.16.840.1.113883.3.1937.777.11.4.19Transactiondraft Return eP from country A2013‑11‑02
2.16.840.1.113883.3.1937.777.11.4.21Transactiondraft Send HCER to country A2013‑11‑02
2.16.840.1.113883.3.1937.777.11.4.25Transactiondraft Send eD to country A2013‑11‑02
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkdraft epSOS-ePrescription2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkretired epSOS-ePrescription2018‑11‑14 10:49:44
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkretired eHDSI ePrescription2020‑04‑16 10:42:14
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkretired eHDSI ePrescription2020‑06‑17 09:25:30
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkretired eHDSI ePrescription2020‑09‑09 12:19:36
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkretired eHDSI ePrescription2020‑09‑09 12:22:47
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkretired eHDSI ePrescription2022‑09‑12 13:39:27
1.3.6.1.4.1.12559.11.10.1.3.1.1.1linkactive eHDSI ePrescription2024‑04‑19 09:57:14
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkdraft epSOS-eDispensation2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkretired epSOS-eDispensation2018‑11‑14 10:49:04
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkretired epSOS-eDispensation2019‑11‑11 14:43:22
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkretired epSOS-eDispensation2020‑04‑06 19:20:14
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkretired eHDSI eDispensation2020‑04‑16 10:41:22
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkretired eHDSI eDispensation2020‑08‑31 08:12:35
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkretired eHDSI eDispensation2020‑09‑09 12:09:23
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkretired eHDSI eDispensation2022‑09‑12 13:38:46
1.3.6.1.4.1.12559.11.10.1.3.1.1.2linkactive eHDSI eDispensation2024‑04‑19 09:56:20
1.3.6.1.4.1.12559.11.10.1.3.1.1.3linkdraft epSOS-Patient Summary2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.3linkretired epSOS-Patient Summary2018‑11‑14 10:53:50
1.3.6.1.4.1.12559.11.10.1.3.1.1.3linkretired eHDSI Patient Summary2020‑04‑14 13:03:47
1.3.6.1.4.1.12559.11.10.1.3.1.1.3linkretired eHDSI Patient Summary2020‑09‑02 10:19:44
1.3.6.1.4.1.12559.11.10.1.3.1.1.3linkretired eHDSI Patient Summary2022‑09‑12 13:44:19
1.3.6.1.4.1.12559.11.10.1.3.1.1.3linkactive eHDSI Patient Summary2024‑04‑19 10:03:32
1.3.6.1.4.1.12559.11.10.1.3.1.1.4linkdraft epSOS-Health Care Encounter Report2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.4linkretired epSOS-Health Care Encounter Report2018‑11‑14 09:02:41
1.3.6.1.4.1.12559.11.10.1.3.1.1.5linkdraft epSOS-Medication Related Overview2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.1.5linkretired epSOS-Medication Related Overview2018‑11‑14 09:03:13
1.3.6.1.4.1.12559.11.10.1.3.1.2.1linkdraft Section Prescription2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.1linkretired eHDSI Prescription2020‑04‑16 12:20:48
1.3.6.1.4.1.12559.11.10.1.3.1.2.1linkretired eHDSI Prescription2020‑09‑07 10:11:58
1.3.6.1.4.1.12559.11.10.1.3.1.2.1linkactive eHDSI Prescription2023‑07‑05 12:36:43
1.3.6.1.4.1.12559.11.10.1.3.1.2.2linkdraft Section Dispensation2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.2linkretired Section Dispensation2020‑01‑09 11:41:03
1.3.6.1.4.1.12559.11.10.1.3.1.2.2linkretired eHDSI Dispensation2020‑04‑16 12:15:19
1.3.6.1.4.1.12559.11.10.1.3.1.2.2linkactive eHDSI Dispensation2020‑09‑04 15:39:09
1.3.6.1.4.1.12559.11.10.1.3.1.2.3linkdraft Section Medication Summary2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.2.3linkretired Section Medication Summary2019‑04‑08 12:31:22
1.3.6.1.4.1.12559.11.10.1.3.1.2.3linkretired eHDSI Medication Summary2020‑04‑16 12:19:40
1.3.6.1.4.1.12559.11.10.1.3.1.2.3linkactive eHDSI Medication Summary2020‑09‑07 09:56:57
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentdraft epSOS CDA substanceAdministration2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentretired epSOS CDA substanceAdministration2019‑03‑21 13:51:15
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentretired epSOS CDA substanceAdministration2019‑11‑07 16:15:52
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentretired epSOS CDA substanceAdministration2020‑03‑30 13:06:06
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentretired eHDSI Substance Administration2020‑04‑14 14:55:37
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentretired eHDSI Substance Administration2020‑07‑02 13:56:15
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentretired eHDSI Substance Administration2020‑09‑03 12:24:41
1.3.6.1.4.1.12559.11.10.1.3.1.3.2Containmentcancelled eHDSI Substance Administration2021‑12‑23 14:16:45
1.3.6.1.4.1.12559.11.10.1.3.1.3.3Containmentdraft epSOS CDA Supply2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.3.3Containmentretired epSOS CDA Supply2019‑02‑11 15:06:51
1.3.6.1.4.1.12559.11.10.1.3.1.3.3Containmentretired epSOS CDA Supply2019‑11‑11 14:18:44
1.3.6.1.4.1.12559.11.10.1.3.1.3.3Containmentretired eHDSI Supply2020‑04‑16 13:03:23
1.3.6.1.4.1.12559.11.10.1.3.1.3.3Containmentretired eHDSI Supply2020‑08‑31 08:23:17
1.3.6.1.4.1.12559.11.10.1.3.1.3.3Containmentretired eHDSI Supply2020‑09‑08 10:07:41
1.3.6.1.4.1.12559.11.10.1.3.1.3.4Containmentdraft Medication Item2013‑12‑20
1.3.6.1.4.1.12559.11.10.1.3.1.3.4Containmentretired Medication Item2019‑04‑08 12:46:30
1.3.6.1.4.1.12559.11.10.1.3.1.3.4Containmentretired Medication Item2019‑12‑03 08:26:05
1.3.6.1.4.1.12559.11.10.1.3.1.3.4Containmentretired Medication Item2020‑03‑24 15:58:29
1.3.6.1.4.1.12559.11.10.1.3.1.3.4Containmentretired eHDSI Medication Item2020‑04‑15 15:15:45
1.3.6.1.4.1.12559.11.10.1.3.1.3.4Containmentretired eHDSI Medication Item2020‑09‑03 12:38:20
2.16.840.1.113883.3.1937.777.11.10.144Containmentretired eHDSI Related Prescription2019‑11‑11 14:27:16
2.16.840.1.113883.3.1937.777.11.10.144Containmentretired eHDSI Related Prescription2020‑08‑31 08:24:36
2.16.840.1.113883.3.1937.777.11.10.144Containmentretired eHDSI Related Prescription2020‑09‑09 14:42:37
Uses as NameVersion
2.16.840.1.113883.3.1937.777.11.10.143Includedraft epSOS CDA MaterialDYNAMIC
RelationshipSpecialization: template 2.16.840.1.113883.10.12.312 CDA ManufacturedProduct (2005‑09‑07)
ref
ad1bbr-
Example
Example
<manufacturedProduct classCode="MANU">
  <templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.1"/>  <manufacturedMaterial classCode="MMAT" determinerCode="KIND">
    <!-- National medicinal product code -->
    <code code=" " displayName="Pyrimon" codeSystem=" " codeSystemName=" "/>    <!-- Brand name -->
    <name>Pyrimon</name>    <epsos:formCode code="10604000" displayName="Eye drops, solution" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM"/>    <!-- Container information -->
    <epsos:asContent classCode="CONT">
      <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
        <epsos:name>Pyrimon 5 ml Eye Drops</epsos:name>        <epsos:formCode code="30008000" displayName="Bottle" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM"/>        <epsos:capacityQuantity value="5" unit="ml"/>        <epsos:capTypeCode code="30022000" codeSystem=" 1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="Dropper applicator" codeSystemName="EDQM"/>      </epsos:containerPackagedMedicine>
    </epsos:asContent>
    <!-- This is the generic equivalent -->
    <epsos:asSpecializedKind classCode="GRIC">
      <epsos:generalizedMedicineClass classCode="MMAT">
        <epsos:code nullFlavor="NA"/>        <epsos:name>Chloramphenicol/ Dexamethasone</epsos:name>      </epsos:generalizedMedicineClass>
    </epsos:asSpecializedKind>
    <!-- This is the list of active ingredients -->
    <epsos:ingredient classCode="ACTI">
      <!-- Strength 1% w/v -->
      <epsos:quantity>
        <epsos:numerator xsi:type="epsos:PQ" value="10" unit="mg"/>        <epsos:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>      </epsos:quantity>
      <epsos:ingredient classCode="MMAT" determinerCode="KIND">
        <epsos:code code="S01AA01" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="chloramphenicol"/>        <epsos:name>Chloramphenicol</epsos:name>      </epsos:ingredient>
    </epsos:ingredient>
    <epsos:ingredient classCode="ACTI">
      <!-- Strength 0.1% w/v -->
      <epsos:quantity>
        <epsos:numerator xsi:type="epsos:PQ" value="1" unit="mg"/>        <epsos:denominator xsi:type="epsos:PQ" value="1" unit="ml"/>      </epsos:quantity>
      <epsos:ingredient classCode="MMAT" determinerCode="KIND">
        <epsos:code code="D07CB04" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="dexamethasone and antibiotics"/>        <epsos:name>Dexamethasone</epsos:name>      </epsos:ingredient>
    </epsos:ingredient>
  </manufacturedMaterial>
</manufacturedProduct>
ItemDTCardConfDescriptionLabel
hl7:manufacturedProduct
0 … 1RepSOdotsduct
@classCode
cs0 … 1FMANU
hl7:templateId
II.EPSOS1 … 1R In an epSOS ePrescription or eDispensation document, the name and coding of the medication are specified in the elements under the <manufacturedProduct> element. The templateId element is required and identifies this as a Medicine entry. epSOdotsduct
@root
uid1 … 1F1.3.6.1.4.1.12559.11.10.1.3.1.3.1
 Example<templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.1">...</templateId>
hl7:templateId
II.EPSOS0 … *RepSOdotsduct
Included1 … 1R from 2.16.840.1.113883.3.1937.777.11.10.143 epSOS CDA Material (DYNAMIC)
hl7:manufacturedMaterial
1 … 1RepSOdotsrial
@classCode
cs1 … 1FMMAT
@determinerCode
cs1 … 1FKIND
hl7:code
CE.EPSOS0 … 1R The <code> element of the <manufacturedMaterial> describes the medication.
For the scope of epSOS this is used to convey the “Country A Cross-border/regional/national medicinal product code.

In a CDA document, the <originalText> shall contain a <reference> whose URI value points to the generic name and strength of the medication in the narrative, or just the generic name alone if strength is not relevant.

Note: When the text is supplied from the narrative, the implication is that if the components of a combination medication are supplied in an entry, these must also be displayed in narrative text; the combination medication will not be able to be broken down into its component parts. This is entirely consistent with the CDA Release 2.0 requirements that the narrative supply the necessary and relevant human readable information content.
epSOdotsrial
 
target
epsos-dataelement-135draft Medicinal product code draft epSOS Data Set
hl7:name
EN0 … 1R In an epSOS ePrescriprion or eDispensation document, the element should contain the brand name of the medication.epSOdotsrial
 
target
epsos-dataelement-137draft Brand name draft epSOS Data Set
epsos:desc
EN0 … 1R Free-text representation of the strength. epSOdotsrial
 Example<epsos:desc>20/12,5 mg</epsos:desc>
epsos:formCode
CE.EPSOS1 … 1RThis code represents the form of the medication (e.g. tablet, capsule, liquid). The value of this code affects the units used in the substance administration quantity element – if the form is a tablet, for example, the unit is 1; if the form is a liquid, the unit will be part of UCUM. The value set is epSOSDoseForm, OID: 1.3.6.1.4.1.12559.11.10.1.3.1.42.2.
epSOdotsrial
 
target
epsos-dataelement-106draft Pharmaceutical dose form draft epSOS Data Set
 CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.2 epSOSDoseForm (DYNAMIC)
 Example<epsos:formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2017-04-14" displayName="Capsule, soft">...</epsos:formCode>
epsos:asContent
0 … *R This structure describes the packaging of the medication. The element provides the code for the particular package. If the package has a brand name, it can be described in the element. The element described the capacity of the packaging. For example, to represent 30 tablets, the element at the level must indicate tablets as the form, value attribute of the element must have the value of 30, and the unit attribute must be 1. In the cases where the unit attribute is not 1, UCUM units shall be used. The value set is epSOSUnits, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 and epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2.epSOdotsrial
@classCode
cs1 … 1FCONT
 Example<epsos:asContent classCode="CONT">
  <epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
    <epsos:name/>    <epsos:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/>    <epsos:capacityQuantity value=" " unit=" "/>  </epsos:containerPackagedMedicine>
</epsos:asContent>
epsos:containerPackagedMedicine
1 … *RepSOdotsrial
@classCode
cs1 … 1FCONT
@determinerCode
cs1 … 1FINSTANCE
 Example<epsos:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</epsos:containerPackagedMedicine>
epsos:name
ST0 … *RepSOdotsrial
 Example<epsos:name>...</epsos:name>
epsos:formCode
CE.EPSOS1 … 1RepSOdotsrial
 CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.2 epSOSDoseForm (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.3 epSOSPackage (DYNAMIC)
 Example<epsos:formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
epsos:capacityQuantity
PQ1 … 1MepSOdotsrial
 
target
epsos-dataelement-138draft Medicinal product package size draft epSOS Data Set
@unit
cs1 … 1R
 CONF
The value of @unit shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 epSOSUnits (DYNAMIC)
@value
1 … 1R
 Example<epsos:capacityQuantity unit="1" value="700"/>
epsos:asSpecializedKind
0 … 1RThis module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System. 

The classCode of "GEN" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.

The <epsos:code> element contains the ATC code, and the <epsos:name> element may be used for the plain text representation.

epSOdotsrial
@classCode
cs1 … 1FGEN
 Example<epsos:asSpecializedKind classCode="GEN">
  <epsos:generalizedMedicineClass classCode="MMAT">
    <epsos:code code=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName=" "/>    <epsos:name/>  </epsos:generalizedMedicineClass>
</epsos:asSpecializedKind>
epsos:generalizedMedicineClass
RepSOdotsrial
@classCode
cs1 … 1FMMAT
epsos:code
CD.EPSOS1 … 1RepSOdotsrial
 CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 epSOSActiveIngredient (DYNAMIC)
epsos:name
0 … 1epSOdotsrial
epsos:ingredient
0 … *ROne or more active ingredients may be represented with this structure. The classCode of "ACTI" indicates that this is an active ingredient. The element contains the coded representation of the ingredient and the element may be used for the plain text representation.epSOdotsrial
@classCode
cs1 … 1FACTI
@determinerCode
cs1 … 1FKIND
 Example<epsos:ingredient classCode="ACTI">...</epsos:ingredient>
epsos:quantity
1 … 1M The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The element contains the numerator and denominator of the strength ratio. epSOdotsrial
 
target
epsos-dataelement-105draft Strength draft epSOS Data Set
 Example<epsos:quantity>...</epsos:quantity>
epsos:numerator
epsos:PQ1 … 1RepSOdotsrial
@unit
cs1 … 1R
@value
1 … 1R
 Example<epsos:numerator unit="mg" value="20" xsi:type="epsos:PQ"/>
epsos:denominator
epsos:PQ1 … 1RepSOdotsrial
@unit
cs1 … 1R
@value
1 … 1R
 Example<epsos:denominator unit="1" value="1" xsi:type="epsos:PQ"/>
epsos:ingredient
CD.EPSOS1 … 1RepSOdotsrial
epsos:code
CD.EPSOS1 … 1RepSOdotsrial
 
target
epsos-dataelement-104draft Active ingredient code draft epSOS Data Set
 CONF
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 epSOSActiveIngredient (DYNAMIC)
epsos:originalText
ED0 … *epSOdotsrial
epsos:reference
TEL0 … *epSOdotsrial
epsos:translation
CD0 … *This element can be used to provide alternative identifications for the described substance.epSOdotsrial
epsos:name
0 … 1Name of the substanceepSOdotsrial
 
target
epsos-dataelement-103draft Active ingredient draft epSOS Data Set