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retired Template  eHDSI eP/eD Manufactured Material

Id 1.3.6.1.4.1.12559.11.10.1.3.1.3.30 Effective Date 2022‑07‑12 12:23:25
Other versions this id:
Status retired Retired Version Label
Name eHDSIePeDManufacturedMaterial Display Name eHDSI eP/eD Manufactured Material
Classification CDA Entry Level Template
Open/Closed Open (other than defined elements are allowed)
Associated with
Associated with 14 concepts
Id Name Data Set
ehdsi-dataelement-205 draft Medicinal Product Classification draft eHDSI Data Set
ehdsi-dataelement-271 draft Medicinal Product Package description draft eHDSI Data Set
ehdsi-dataelement-273 draft Medicinal Product Classification draft eHDSI Data Set
ehdsi-dataelement-206 draft Medicinal Product Brand Name draft eHDSI Data Set
ehdsi-dataelement-266 draft Strength(s) draft eHDSI Data Set
ehdsi-dataelement-197 draft Pharmaceutical Dose Form draft eHDSI Data Set
ehdsi-dataelement-198 draft Active Ingredient Strenght(s) draft eHDSI Data Set
ehdsi-dataelement-270 draft Medicinal Product Package identifier draft eHDSI Data Set
ehdsi-dataelement-275 draft Medicinal Product Identifier draft eHDSI Data Set
ehdsi-dataelement-267 draft Active Ingredient(s) draft eHDSI Data Set
ehdsi-dataelement-274 draft Medicinal Product Brand Name draft eHDSI Data Set
ehdsi-dataelement-202 draft Medicinal Product Package identifier draft eHDSI Data Set
ehdsi-dataelement-199 draft Active Ingredient(s) draft eHDSI Data Set
ehdsi-dataelement-207 draft Medicinal Product identifier draft eHDSI Data Set
Used by / Uses
Used by 0 transactions and 0 templates, Uses 3 templates
Uses as Name Version
1.3.6.1.4.1.12559.11.10.1.3.1.3.38 Include active eHDSI asContent DYNAMIC
1.3.6.1.4.1.12559.11.10.1.3.1.3.36 Include active eHDSI asSpecializedKind DYNAMIC
1.3.6.1.4.1.12559.11.10.1.3.1.3.37 Include active eHDSI ingredient DYNAMIC
Relationship Version: template 1.3.6.1.4.1.12559.11.10.1.3.1.3.30 eHDSI eP/eD Manufactured Material (2022‑06‑23 07:12:23)
Version: template 1.3.6.1.4.1.12559.11.10.1.3.1.3.30 eHDSI eP/eD Manufactured Material (2022‑02‑04 17:30:00)
Generalization: template 2.16.840.1.113883.10.12.311 CDA Material (2005‑09‑07)
ref
ad1bbr-
Item DT Card Conf Description Label
hl7:manufacturedMaterial
0 … * R (eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
hl7:templateId
II.EPSOS 1 … 1 M (eHDdotsial)
@root
uid 1 … 1 F 1.3.6.1.4.1.12559.11.10.1.3.1.3.30
hl7:code
CE.EPSOS 0 … 1 R The element is used to convey a regional/national medicinal product code or MPID compliant with the IDMP system.
The element MUST NOT be used to convey:
  • ATC code (see generalizedMaterialKind instead)
  • PCID code compliant with the IDMP system (see containerPackagedProduct.code instead)
The <originalText> under the code MAY be included, but is not expected to be processed by the recipient of the document. If included, it 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.

If the code is not available, the whole field SHOULD be skipped.
(eHDdotsial)
 
target
ehdsi-dataelement-275 draft Medicinal Product Identifier draft eHDSI Data Set
ehdsi-dataelement-207 draft Medicinal Product identifier draft eHDSI Data Set
  Example
Acceptable 1
<code code="036772010" codeSystem="2.16.840.1.113883.2.9.6.1.5" codeSystemName="AIC" displayName="TIARTAN*28CPR RIV 600+12,5MG"/>
  Example
Acceptable 2
<code code="014094" codeSystem="1.2.246.537.6.55" codeSystemName="VNR" codeSystemVersion="2017.012" displayName="FORSTEO"/>
  Example
Acceptable 3
<code code="1008368" codeSystem="1.3.6.1.4.1.28284.6.2.4.44" codeSystemName="Ravimipreparaadi kood" displayName="MAREVAN FORTE">
  <originalText>
    <reference value="#ORIGNAME"/>  </originalText>
</code>
  Example
Unacceptable
<code code="C09BX01" codeSystem="2.16.840.1.113883.6.88" displayName="Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161"/>
hl7:name
EN 1 … 1 R
If present in the document, the element SHALL contain the brand name (invented name) of the medicinal product according to its marketing authorization. No additional information about the product (such as strength, dose form, package type, etc) is normally permitted, unless it is an inseparable part of the brand name, as authorized by a Medicines Agency.

If the information about the brand name is not available (for example it cannot be extracted from the long textual description of the medicinal product or the prescription is active ingredient based), the whole field SHOULD be skipped.
(eHDdotsial)
 
target
ehdsi-dataelement-206 draft Medicinal Product Brand Name draft eHDSI Data Set
ehdsi-dataelement-274 draft Medicinal Product Brand Name draft eHDSI Data Set
  Example
Acceptable 1
<name>TIARTAN</name>
  Example
Acceptable 3
<name>FUROSEMIDA APOTEX 40 mg COMPRIMIDOS EFG</name>
  Example
Unacceptable 1
<name>LIPITOR F.C.TAB 20MG/TAB ΒTx 14 (BLIST 2x 7)</name>
  Example
Unacceptable 2
<name>TIARTAN*28CPR RIV 600+12,5MG</name>
  Example
Unacceptable 3
<name>Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161</name>
  Example
Unacceptable 4
<name>amoxicillin</name>
  Example
Unacceptable 5
<name>FUROSEMIDA APOTEX 40 mg COMPRIMIDOS EFG, 10 comprimidos</name>
pharm:desc
EN 0 … 1 R Free-text representation of the strength. (eHDdotsial)
  Example <desc>20/12,5 mg</desc>
pharm:formCode
CE.EPSOS 1 … 1 R This 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 eHDSIDoseForm, OID: 1.3.6.1.4.1.12559.11.10.1.3.1.42.2.
(eHDdotsial)
 
target
ehdsi-dataelement-197 draft Pharmaceutical Dose Form draft eHDSI 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 eHDSIDoseForm (DYNAMIC)
  Example <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2017-04-14" displayName="Capsule, soft">...</formCode>
pharm:asContent
1 … 1 M This structure describes the packaging of the medication.
The <pharm:formCode> element provides the code for the particular package. If the package has a brand name, it can be described in the <pharm:name> element. The <pharm:quantity> represents 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.

When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
pharm:quantity
PQ 1 … 1 M This element describes how many content items are present in the package.

The preferred way is to provide the quantity in a coded form using the @unit and @value attributes.
If no coded information is available and even the use of UCUM annotations is not sufficient and more information is available within the national infrastructure, the originalText element can be used to add additional information:

<hl7:translation>
<hl7:originalText>tablets</hl7:originalText>
</hl7:translation>
To improve understanding for the receiver, the additional information has to be provided in English.
(eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example <quantity value="10" unit="mL"/>
  Example <quantity value="20" unit="{Tablet}"/>
  Example <quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
 
target
ehdsi-dataelement-270 draft Medicinal Product Package identifier draft eHDSI Data Set
ehdsi-dataelement-202 draft Medicinal Product Package identifier draft eHDSI Data Set
pharm:name
ST 0 … * R
If present, the element SHALL contain a sufficiently detailed description of the prescribed medicinal product/package. The description may contain information on the brand name, dose form, package (including its type or brand name), strength, etc.

If the detailed description of the product is not available, the element SHALL be skipped.
(eHDdotsial)
 
target
ehdsi-dataelement-271 draft Medicinal Product Package description draft eHDSI Data Set
  Example
Acceptable 1
<name>LIPITOR F.C.TAB 20MG/TAB ΒTx 14 (BLIST 2x 7)</name>
  Example
Acceptable 2
<name>TIARTAN*28CPR RIV 600+12,5MG</name>
  Example
Acceptable 3
<name>Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161</name>
  Example
Unacceptable 1
<name>EASYHALER</name>
  Example
Unacceptable 2
<name>amoxicillin</name>
  Example
Unacceptable 3
<name>TIARTAN</name>
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
  Example
Packaged Medicinal Product with multiple layers packaging
<asContent>
  <containerPackagedProduct>
    <!-- Inner Package -->
    <code codeSystem="..." code="..." displayName="..."/>    <asContent>
      <containerPackagedProduct>
        <!-- Intermediate Package -->
        <asContent>
          <containerPackagedProduct>
            <!-- Outer Package / Packaged Medicinal Product -->
          </containerPackagedProduct>
        </asContent>
      </containerPackagedProduct>
    </asContent>
  </containerPackagedProduct>
</asContent>
  Example
Packaged Medicinal Product with formCode
<asContent>
  <containerPackagedProduct>
    <!-- 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>
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
(eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example
unit value is a UCUM annotation
<quantity value="20" unit="{Tablet}"/>
  Example
unit value is from the eHDSIUnit value set
<quantity value="10" unit="mL"/>
  Example
unit value is set to 1
<quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
If this is also the most inner  <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
pharm:name
ST 0 … * R
It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example <quantity value="20" unit="{tablet}"/>
  Example <quantity value="10" unit="mL"/>
  Example <quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R When present, it represents the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
(eHDdotsial)
pharm:name
ST 0 … * R When present, it can be used for the representing the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R When present, it encodes the type of the outer package.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
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.

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

(eHDdotsial)
where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73']
@classCode
cs 1 … 1 F GRIC
  Example <asSpecializedKind classCode="GRIC">
  <generalizedMaterialKind classCode="MMAT">
    <code code=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName=" "/>    <name/>  </generalizedMaterialKind>
</asSpecializedKind>
pharm:generalizedMaterialKind
1 … 1 M (eHDdotsial)
@determinerCode
cs 0 … 1  
@classCode
cs 1 … 1 F MMAT
pharm:code
CD.EPSOS 1 … 1 R The element contains the ATC code of this medicine.
(eHDdotsial)
  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 eHDSIActiveIngredient (DYNAMIC)
pharm:name
0 … 1
The element SHALL be skipped if the generalizedMaterialKind/code element is present and contains a valid value (not a nullFlavor).

If present, the element SHALL contain a textual description of the generic equivalent of the medication described in the current Medicine entry.

If the prescription is generic (based on one or more active ingredients), the element, if present, SHALL contain the INN or a similar description of the prescribed medicine.
(eHDdotsial)
pharm:asSpecializedKind
0 … * R The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international.

The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified.

When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element.

(eHDdotsial)
@classCode
cs 1 … 1 F GEN
  Example <asSpecializedKind classCode="GEN">
  <generalizedMaterialKind classCode="MMAT">
    <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"/>    <name/>  </generalizedMaterialKind>
</asSpecializedKind>
pharm:generalizedMaterialKind
1 … 1 M (eHDdotsial)
@classCode
cs 1 … 1 F MMAT
pharm:code
CD.EPSOS 1 … 1 R When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id. The level and the stratum of the PhPID will be distiguished by the OID of the code system.
(eHDdotsial)
 
target
ehdsi-dataelement-205 draft Medicinal Product Classification draft eHDSI Data Set
ehdsi-dataelement-273 draft Medicinal Product Classification draft eHDSI Data Set
pharm:name
0 … * (eHDdotsial)
pharm:part
0 … * R (eHDdotsial)
@classCode
cs 1 … 1 F PART
pharm:id
II.EPSOS 0 … 1 (eHDdotsial)
pharm:quantity
PQ 0 … 1 (eHDdotsial)
pharm:partProduct
1 … 1 R (eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
pharm:asContent
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F CONT
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.38 eHDSI asContent (DYNAMIC)
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity.

The preferred way is to provide the quantity in a coded form using the @unit and @value attributes.
If no coded information is available and even the use of UCUM annotations is not sufficient and more information is available within the national infrastructure, the originalText element can be used to add additional information:

<hl7:translation>
<hl7:originalText>tablets</hl7:originalText>
</hl7:translation>
To improve understanding for the receiver, the additional information has to be provided in English.
(eHDdotsial)
@unit
cs 1 … 1 R The value of the unit attibute should come from the eHDSIUnit value set. There is no constraint since we also want to enable the use of UCUM annotations, that are not part of the value set.
@value
1 … 1 R
  Example <quantity value="20" unit="{tablet}"/>
  Example <quantity value="10" unit="mL"/>
pharm:containerPackagedProduct
1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
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 (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
pharm:name
ST 0 … * 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.

If the detailed description of the product is not available, the element SHALL be skipped.
(eHDdotsial)
  Example
Acceptable 1
<name>LIPITOR F.C.TAB 20MG/TAB ΒTx 14 (BLIST 2x 7)</name>
  Example
Acceptable 2
<name>TIARTAN*28CPR RIV 600+12,5MG</name>
  Example
Acceptable 3
<name>Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161</name>
  Example
Unacceptable 1
<name>EASYHALER</name>
  Example
Unacceptable 2
<name>amoxicillin</name>
  Example
Unacceptable 3
<name>TIARTAN</name>
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
  Example
Packaged Medicinal Product with multiple layers packaging
<asContent>
  <containerPackagedProduct>
    <!-- Inner Package -->
    <code codeSystem="..." code="..." displayName="..."/>    <asContent>
      <containerPackagedProduct>
        <!-- Intermediate Package -->
        <asContent>
          <containerPackagedProduct>
            <!-- Outer Package / Packaged Medicinal Product -->
          </containerPackagedProduct>
        </asContent>
      </containerPackagedProduct>
    </asContent>
  </containerPackagedProduct>
</asContent>
  Example
Packaged Medicinal Product with formCode
<asContent>
  <containerPackagedProduct>
    <!-- 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>
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
(eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example
unit value is a UCUM annotation
<quantity value="20" unit="{tablet}"/>
  Example
unit value is from the eHDSIUnit value set
<quantity value="10" unit="mL"/>
  Example
unit value is set to 1
<quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
If this is also the most inner  <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
pharm:name
ST 0 … * R
It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example <quantity value="20" unit="{Tablet}"/>
  Example <quantity value="10" unit="mL"/>
  Example <quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R When present, it represents the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
(eHDdotsial)
pharm:name
ST 0 … * R When present, it can be used for the representing the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R When present, it encodes the type of the outer package.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asSpecializedKind
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F GRIC
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.36 eHDSI asSpecializedKind (DYNAMIC)
pharm:generalizedMaterialKind
0 … * (eHDdotsial)
@determinerCode
cs 1 … 1 F KIND
@classCode
cs 1 … 1 F MMAT
hl7:code
1 … 1 R (eHDdotsial)
hl7:name
0 … * (eHDdotsial)
pharm:part
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F PART
pharm:id
II.EPSOS 0 … 1 (eHDdotsial)
pharm:quantity
PQ 0 … 1 (eHDdotsial)
pharm:partProduct
1 … 1 R (eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
pharm:asContent
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F CONT
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.38 eHDSI asContent (DYNAMIC)
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity.

The preferred way is to provide the quantity in a coded form using the @unit and @value attributes.
If no coded information is available and even the use of UCUM annotations is not sufficient and more information is available within the national infrastructure, the originalText element can be used to add additional information:

<hl7:translation>
<hl7:originalText>tablets</hl7:originalText>
</hl7:translation>
To improve understanding for the receiver, the additional information has to be provided in English.
(eHDdotsial)
@unit
cs 1 … 1 R The value of the unit attibute should come from the eHDSIUnit value set. There is no constraint since we also want to enable the use of UCUM annotations, that are not part of the value set.
@value
1 … 1 R
  Example <quantity value="20" unit="{tablet}"/>
  Example <quantity value="10" unit="mL"/>
pharm:containerPackagedProduct
1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
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 (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
pharm:name
ST 0 … * 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.

If the detailed description of the product is not available, the element SHALL be skipped.
(eHDdotsial)
  Example
Acceptable 1
<name>LIPITOR F.C.TAB 20MG/TAB ΒTx 14 (BLIST 2x 7)</name>
  Example
Acceptable 2
<name>TIARTAN*28CPR RIV 600+12,5MG</name>
  Example
Acceptable 3
<name>Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161</name>
  Example
Unacceptable 1
<name>EASYHALER</name>
  Example
Unacceptable 2
<name>amoxicillin</name>
  Example
Unacceptable 3
<name>TIARTAN</name>
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
  Example
Packaged Medicinal Product with multiple layers packaging
<asContent>
  <containerPackagedProduct>
    <!-- Inner Package -->
    <code codeSystem="..." code="..." displayName="..."/>    <asContent>
      <containerPackagedProduct>
        <!-- Intermediate Package -->
        <asContent>
          <containerPackagedProduct>
            <!-- Outer Package / Packaged Medicinal Product -->
          </containerPackagedProduct>
        </asContent>
      </containerPackagedProduct>
    </asContent>
  </containerPackagedProduct>
</asContent>
  Example
Packaged Medicinal Product with formCode
<asContent>
  <containerPackagedProduct>
    <!-- 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>
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
(eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example
unit value is a UCUM annotation
<quantity value="20" unit="{tablet}"/>
  Example
unit value is from the eHDSIUnit value set
<quantity value="10" unit="mL"/>
  Example
unit value is set to 1
<quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
If this is also the most inner  <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
pharm:name
ST 0 … * R
It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example <quantity value="20" unit="{Tablet}"/>
  Example <quantity value="10" unit="mL"/>
  Example <quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R When present, it represents the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
(eHDdotsial)
pharm:name
ST 0 … * R When present, it can be used for the representing the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R When present, it encodes the type of the outer package.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asSpecializedKind
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F GRIC
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.36 eHDSI asSpecializedKind (DYNAMIC)
pharm:generalizedMaterialKind
0 … * (eHDdotsial)
@determinerCode
cs 1 … 1 F KIND
@classCode
cs 1 … 1 F MMAT
hl7:code
1 … 1 R (eHDdotsial)
hl7:name
0 … * (eHDdotsial)
pharm:part
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F PART
pharm:id
II.EPSOS 0 … 1 (eHDdotsial)
pharm:quantity
PQ 0 … 1 (eHDdotsial)
pharm:partProduct
1 … 1 R (eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
pharm:asContent
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F CONT
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.38 eHDSI asContent (DYNAMIC)
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity.

The preferred way is to provide the quantity in a coded form using the @unit and @value attributes.
If no coded information is available and even the use of UCUM annotations is not sufficient and more information is available within the national infrastructure, the originalText element can be used to add additional information:

<hl7:translation>
<hl7:originalText>tablets</hl7:originalText>
</hl7:translation>
To improve understanding for the receiver, the additional information has to be provided in English.
(eHDdotsial)
@unit
cs 1 … 1 R The value of the unit attibute should come from the eHDSIUnit value set. There is no constraint since we also want to enable the use of UCUM annotations, that are not part of the value set.
@value
1 … 1 R
  Example <quantity value="20" unit="{tablet}"/>
  Example <quantity value="10" unit="mL"/>
pharm:containerPackagedProduct
1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
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 (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
pharm:name
ST 0 … * 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.

If the detailed description of the product is not available, the element SHALL be skipped.
(eHDdotsial)
  Example
Acceptable 1
<name>LIPITOR F.C.TAB 20MG/TAB ΒTx 14 (BLIST 2x 7)</name>
  Example
Acceptable 2
<name>TIARTAN*28CPR RIV 600+12,5MG</name>
  Example
Acceptable 3
<name>Triplixam, perindopril + indapamid + amlodipin / tbl. film obl. 30x(5 mg+1,25 mg+5 mg), C09BX01161</name>
  Example
Unacceptable 1
<name>EASYHALER</name>
  Example
Unacceptable 2
<name>amoxicillin</name>
  Example
Unacceptable 3
<name>TIARTAN</name>
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
  Example
Packaged Medicinal Product with multiple layers packaging
<asContent>
  <containerPackagedProduct>
    <!-- Inner Package -->
    <code codeSystem="..." code="..." displayName="..."/>    <asContent>
      <containerPackagedProduct>
        <!-- Intermediate Package -->
        <asContent>
          <containerPackagedProduct>
            <!-- Outer Package / Packaged Medicinal Product -->
          </containerPackagedProduct>
        </asContent>
      </containerPackagedProduct>
    </asContent>
  </containerPackagedProduct>
</asContent>
  Example
Packaged Medicinal Product with formCode
<asContent>
  <containerPackagedProduct>
    <!-- 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>
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
(eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example
unit value is a UCUM annotation
<quantity value="20" unit="{tablet}"/>
  Example
unit value is from the eHDSIUnit value set
<quantity value="10" unit="mL"/>
  Example
unit value is set to 1
<quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R
If this is also the most inner  <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
 
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
(eHDdotsial)
pharm:name
ST 0 … * R
It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asContent
0 … 1
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. 
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
pharm:quantity
PQ 1 … 1 M The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example <quantity value="20" unit="{Tablet}"/>
  Example <quantity value="10" unit="mL"/>
  Example <quantity value="10" unit="1">
  <translation>
    <originalText>Tablet</originalText>  </translation>
</quantity>
pharm:containerPackagedProduct
1 … 1 R When present, it represents the Packaged Medicinal Product.
(eHDdotsial)
@classCode
cs 1 … 1 F CONT
@determinerCode
cs 1 … 1 F KIND
  Example <containerPackagedProduct classCode="CONT" determinerCode="KIND">...</containerPackagedProduct>
pharm:code
CE.EPSOS 0 … 1 R When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
(eHDdotsial)
pharm:name
ST 0 … * R When present, it can be used for the representing the brand name.
(eHDdotsial)
pharm:formCode
CE.EPSOS 1 … 1 R When present, it encodes the type of the outer package.
(eHDdotsial)
  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 eHDSIDoseForm (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 eHDSIPackage (DYNAMIC)
  Example <formCode code="10100500" codeSystem="0.4.0.127.0.16.1.1.2.1" displayName="Concentrate for oral suspension"/>
pharm:asSpecializedKind
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F GRIC
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.36 eHDSI asSpecializedKind (DYNAMIC)
pharm:generalizedMaterialKind
0 … * (eHDdotsial)
@determinerCode
cs 1 … 1 F KIND
@classCode
cs 1 … 1 F MMAT
hl7:code
1 … 1 R (eHDdotsial)
hl7:name
0 … * (eHDdotsial)
pharm:part
0 … * (eHDdotsial)
@classCode
cs 1 … 1 F PART
pharm:ingredient
0 … * (eHDdotsial)
@classCode
cs 1 … 1 R
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.37 eHDSI ingredient (DYNAMIC)
pharm:quantity
0 … 1 (eHDdotsial)
  Example
10 mg of the ingredient per ml
<quantity>
  <numerator type="PQ" value="10" unit="mg"/>  <denominator type="PQ" value="1" unit="ml"/></quantity>
  Example
2% of the ingredient
<quantity>
  <numerator type="PQ" value="2" unit="%"/>  <denominator type="PQ" value="1"/></quantity>
  Example
5mg of the ingredient
<quantity>
  <numerator type="PQ" value="5" unit="mg"/>  <denominator type="PQ" value="1"/></quantity>
hl7:numerator
0 … 1 (eHDdotsial)
hl7:denominator
0 … 1

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
(eHDdotsial)
pharm:ingredientSubstance
0 … 1 The substance used for this product plying the role indicated in the ingredient classCode.

The element <code> contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
(eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
pharm:code
CD.EPSOS 1 … 1 R (eHDdotsial)
  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 eHDSIActiveIngredient (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.61 eHDSISubstance (DYNAMIC)
pharm:name
0 … 1 Name of the substance. (eHDdotsial)
pharm:ingredient
0 … * (eHDdotsial)
@classCode
cs 1 … 1 R
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.37 eHDSI ingredient (DYNAMIC)
pharm:quantity
0 … 1 (eHDdotsial)
  Example
10 mg of the ingredient per ml
<quantity>
  <numerator type="PQ" value="10" unit="mg"/>  <denominator type="PQ" value="1" unit="ml"/></quantity>
  Example
2% of the ingredient
<quantity>
  <numerator type="PQ" value="2" unit="%"/>  <denominator type="PQ" value="1"/></quantity>
  Example
5mg of the ingredient
<quantity>
  <numerator type="PQ" value="5" unit="mg"/>  <denominator type="PQ" value="1"/></quantity>
hl7:numerator
0 … 1 (eHDdotsial)
hl7:denominator
0 … 1

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
(eHDdotsial)
pharm:ingredientSubstance
0 … 1 The substance used for this product plying the role indicated in the ingredient classCode.

The element <code> contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
(eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
pharm:code
CD.EPSOS 1 … 1 R (eHDdotsial)
  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 eHDSIActiveIngredient (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.61 eHDSISubstance (DYNAMIC)
pharm:name
0 … 1 Name of the substance. (eHDdotsial)
pharm:ingredient
0 … * (eHDdotsial)
@classCode
cs 1 … 1 R
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.37 eHDSI ingredient (DYNAMIC)
pharm:quantity
0 … 1 (eHDdotsial)
  Example
10 mg of the ingredient per ml
<quantity>
  <numerator type="PQ" value="10" unit="mg"/>  <denominator type="PQ" value="1" unit="ml"/></quantity>
  Example
2% of the ingredient
<quantity>
  <numerator type="PQ" value="2" unit="%"/>  <denominator type="PQ" value="1"/></quantity>
  Example
5mg of the ingredient
<quantity>
  <numerator type="PQ" value="5" unit="mg"/>  <denominator type="PQ" value="1"/></quantity>
hl7:numerator
0 … 1 (eHDdotsial)
hl7:denominator
0 … 1

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
(eHDdotsial)
pharm:ingredientSubstance
0 … 1 The substance used for this product plying the role indicated in the ingredient classCode.

The element <code> contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
(eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
pharm:code
CD.EPSOS 1 … 1 R (eHDdotsial)
  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 eHDSIActiveIngredient (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.61 eHDSISubstance (DYNAMIC)
pharm:name
0 … 1 Name of the substance. (eHDdotsial)
pharm:ingredient
0 … * (eHDdotsial)
@classCode
cs 1 … 1 R
Included from 1.3.6.1.4.1.12559.11.10.1.3.1.3.37 eHDSI ingredient (DYNAMIC)
pharm:quantity
0 … 1 (eHDdotsial)
  Example
10 mg of the ingredient per ml
<quantity>
  <numerator type="PQ" value="10" unit="mg"/>  <denominator type="PQ" value="1" unit="ml"/></quantity>
  Example
2% of the ingredient
<quantity>
  <numerator type="PQ" value="2" unit="%"/>  <denominator type="PQ" value="1"/></quantity>
  Example
5mg of the ingredient
<quantity>
  <numerator type="PQ" value="5" unit="mg"/>  <denominator type="PQ" value="1"/></quantity>
hl7:numerator
0 … 1 (eHDdotsial)
hl7:denominator
0 … 1

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
(eHDdotsial)
pharm:ingredientSubstance
0 … 1 The substance used for this product plying the role indicated in the ingredient classCode.

The element <code> contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
(eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
pharm:code
CD.EPSOS 1 … 1 R (eHDdotsial)
  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 eHDSIActiveIngredient (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.61 eHDSISubstance (DYNAMIC)
pharm:name
0 … 1 Name of the substance. (eHDdotsial)
pharm:ingredient
0 … * R One 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. (eHDdotsial)
 
target
ehdsi-dataelement-267 draft Active Ingredient(s) draft eHDSI Data Set
ehdsi-dataelement-199 draft Active Ingredient(s) draft eHDSI Data Set
@classCode
cs 1 … 1 F ACTI
pharm:quantity
1 … 1 M 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.

The denominator element should contain an amount with its corresponding unit. Only when the numerator comes in a fractional form and cannot be separated into the numerator and denominator form, or is related to a unit of administration, a unit of '1' in the denominator is allowed.

The units used must come from the eHDSIUnit Value Set. 

The preferred way is to provide the medication strength in a coded form using the @numerator and @denominator attributes. If no coded information is available and even the use of UCUM annotations is not sufficient and more information is available within the national infrastructure, the originalText element can be used to add additional information:
<hl7:translation> <hl7:originalText>mg/dose</hl7:originalText> </hl7:translation>
To improve understanding for the receiver, the additional information has to be provided in English.
(eHDdotsial)
 
target
ehdsi-dataelement-266 draft Strength(s) draft eHDSI Data Set
ehdsi-dataelement-198 draft Active Ingredient Strenght(s) draft eHDSI Data Set
  Example
Strength in normal representation
<quantity>
  <numerator value="5" unit="mg" type="PQ"/>  <denominator value="1" unit="mL" type="PQ"/></quantity>
  Example
Strength when fractional numerator unit not convertible
<quantity>
  <numerator value="5" unit="mg/mL" type="PQ"/>  <denominator value="1" unit="1" type="PQ"/></quantity>
  Example
Strength per unit of administration
<quantity>
  <numerator value="500" unit="mg" type="PQ"/>  <denominator value="1" unit="1" type="PQ"/></quantity>
  Example
Strength per unit of presentation which is not a unit of administration
<quantity>
  <numerator value="2" unit="g" type="PQ"/>  <denominator value="1" unit="{Tube}" type="PQ"/></quantity>
hl7:numerator
PQ 1 … 1 R (eHDdotsial)
@unit
cs 1 … 1 R
@value
1 … 1 R
  Example <numerator unit="mg" value="20" type="PQ"/>
hl7:denominator
PQ 1 … 1 R (eHDdotsial)
@unit
cs 1 … 1 R

3 possible uses for the @unit attribute are allowed:

  1. The preferred situation where value of the unit attibute comes from the eHDSIUnit value set.
  2. A UCUM annotation can be used in the unit attribute. In the case of countable items, the content between curly brackets must be a concept from the eHDSIQuantityUnit value set.
  3. For countable units, the unit attribute can also be set to '1', and the translation element can be used to convey the type of content item.
@value
1 … 1 R
  Example <denominator unit="1" value="1" type="PQ"/>
pharm:ingredientSubstance
1 … 1 R (eHDdotsial)
@classCode
cs 1 … 1 F MMAT
@determinerCode
cs 1 … 1 F KIND
  Example <ingredientSubstance classCode="MMAT" determinerCode="KIND">
  <code code="C09CA02" codeSystem="2.16.840.1.113883.6.73" codeSystemName="Anatomical Therapeutic Chemical" displayName="Eprosartan"/>  <name>EPROSARTAN</name></ingredientSubstance>
pharm:code
CD.EPSOS 1 … 1 R (eHDdotsial)
  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 eHDSIActiveIngredient (DYNAMIC)
or
The value of @code shall be drawn from value set 1.3.6.1.4.1.12559.11.10.1.3.1.42.61 eHDSISubstance (DYNAMIC)
hl7:originalText
ED 0 … * (eHDdotsial)
hl7:reference
TEL 0 … * (eHDdotsial)
hl7:translation
CD 0 … * This element can be used to provide alternative identifications for the described substance. (eHDdotsial)
pharm:name
0 … 1 Name of the substance (eHDdotsial)