hl7:manufacturedMaterial
|
|
0 … 1 |
R |
This element describes the IDMP Medicinal Product.
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
| |
Example |
<hl7:manufacturedMaterial>
<!-- Example with all the IDMP Levels (PhPID,MPID, PCID) and other attributes used in
epSOS (e.g. ingredients, ATC, strengths) -->
<hl7:code codeSystem="" code="MPID" displayName="" CodeSystemName="MP EMA"/> <hl7:name>Medicinal Product Name</hl7:name> <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code="10219000" displayName="tablet" CodeSystemName="EDQM"/> <cpm:asContent>
<!-- Packaged Medicinal Product (PC) -->
<cpm:containerPackagedProduct>
<!-- PC ID-->
<cpm:code codeSystem=" " code="PCID" displayName=" "/> <cpm:name>...</cpm:name> <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code="" displayName="" CodeSystemName="EDQM"/> </cpm:containerPackagedProduct> </cpm:asContent> <cpm:asSpecializedKind classCode="GRIC">
<!-- Pharmaceutical Substance (ATC Code)-->
<cpm:generalizedMaterialKind classCode="MMAT">
<!-- Pharmaceutical Substance (ATC Code)-->
<cpm:code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/> </cpm:generalizedMaterialKind> </cpm:asSpecializedKind> <cpm:asSpecializedKind>
<!-- Pharmaceutical Product (PhP)-->
<cpm:generalizedMaterialKind classCode="MMAT">
<cpm:code code="PhPID" codeSystem=" " displayName=" " codeSystemName="PhP EMA"/> <cpm:name>....</cpm:name> </cpm:generalizedMaterialKind> </cpm:asSpecializedKind> <!-- list of active ingredients -->
<cpm:ingredient classCode="ACTI" determinerCode="KIND">
<cpm:quantity>
<!-- strength -->
<cpm:numerator unit="mg" value="20" xsi:type="PQ"/> <cpm:denominator unit="1" value="{tablet}" xsi:type="PQ"/> </cpm:quantity> <cpm:ingredientSubstance>
<cpm:code codeSystem=" " code="SubstanceID" displayName=" " CodeSystemName="G-SRS"/> <cpm:name>...</cpm:name> </cpm:ingredientSubstance> </cpm:ingredient></hl7:manufacturedMaterial> |
hl7:code
|
CE.EPSOS |
0 … 1 |
R |
IDMP Medicinal Product ID (MPID)
< used in of epSOS to convey the “Country A Cross-border/regional/national medicinal
product code. >
< REMOVE ? => 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. >
< ADD binding with the EMA MPID >
|
(ope…ial) |
hl7:name
|
EN |
0 … 1 |
R |
IDMP Medicinal Product Name.
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.
< clarify if we should provide only the full name or also the parts >
< In an epSOS ePrescriprion or eDispensation document, the <name> element should contain
the brand name of the medication. [NB: check if this still applies.. ]>
|
(ope…ial) |
cpm:formCode
|
CE.EPSOS |
1 … 1 |
R |
Pharmaceutical dose form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
|
(ope…ial) |
| |
CONF |
|
| |
Example |
<cpm:formCode code="10211000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2015" displayName="Capsule, soft">...</cpm:formCode> |
cpm:asContent
|
|
0 … * |
R |
This structure describes the packaging of the product. |
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
| |
Example |
<cpm:asContent>
<cpm:containerPackagedProduct>
<!-- Inner Package -->
<cpm:code codeSystem=" " code="" displayName=""/> <cpm:asContent>
<cpm:containerPackagedProduct>
<!-- Intermediate Package -->
<cpm:asContent>
<cpm:containerPackagedProduct>
<!-- Outer Package / Packaged Medicinal Product -->
</cpm:containerPackagedProduct> </cpm:asContent> </cpm:containerPackagedProduct> </cpm:asContent> </cpm:containerPackagedProduct></cpm:asContent> |
| |
Example |
<cpm:asContent>
<cpm:containerPackagedProduct>
<!-- Packaged Medicinal Product -->
<cpm:code codeSystem=" " code="MPID" displayName="MP name"/> <cpm:name>..</cpm:name> <cpm:formCode codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" code=".." displayName="MP name" CodeSystemName="EDQM"/> </cpm:containerPackagedProduct></cpm:asContent> |
cpm:containerPackagedProduct
|
|
1 … * |
R |
It shall be used for describing the IDMP Packaged Medicinal Product and - when needed
- the Package Items.
The most inner (nested) item represent the most outer package item.
The presence of the PCID indicates that that element represents the "Packaged Medicinal
Product".
If the package has a brand name, it can be described in the <name> element. [TO BE
CHECKED]
[ To be evaluated what to use or not the capacityQuantity the SPL uses the quantity
element .... ]
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
@determinerCode
|
cs |
1 … 1 |
F |
INSTANCE |
cpm:code
|
|
0 … 1 |
|
|
(ope…ial) |
cpm:name
|
ST |
0 … 1 |
|
Name of the Packaged Medicinal Product / Package Item |
(ope…ial) |
| |
Example |
<cpm:name>...</cpm:name> |
cpm:formCode
|
CE.EPSOS |
0 … 1 |
R |
|
(ope…ial) |
| |
CONF |
|
| |
Example |
<cpm:formCode code="30007000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</cpm:formCode> |
cpm:capacityQuantity
|
PQ |
1 … 1 |
M |
|
(ope…ial) |
@unit
|
cs |
1 … 1 |
R |
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
| |
Example |
<cpm:capacityQuantity unit="1" value="700">...</cpm:capacityQuantity> |
cpm:asContent
|
|
0 … * |
R |
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
| |
Example |
<cpm:asContent classCode="CONT">
<cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
<cpm:name/> <cpm:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <cpm:capacityQuantity value=" " unit=" "/> </cpm:containerPackagedMedicine></cpm:asContent> |
cpm:containerPackagedProduct
|
|
1 … * |
R |
Used in this context for describing the Packaged Medicinal Product and or the Packaged Medicinal Product Item
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
@determinerCode
|
cs |
1 … 1 |
F |
INSTANCE |
| |
Example |
<cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</cpm:containerPackagedMedicine> |
cpm:code
|
|
0 … * |
|
|
(ope…ial) |
cpm:name
|
ST |
0 … * |
R |
|
(ope…ial) |
| |
Example |
<cpm:name>...</cpm:name> |
cpm:formCode
|
CE.EPSOS |
1 … 1 |
R |
|
(ope…ial) |
| |
CONF |
|
| |
Example |
<cpm:formCode code="30007000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</cpm:formCode> |
cpm:asContent
|
|
0 … * |
R |
This structure describes the packaging of the medication. The <cpm:formCode> element
provides the code for the particular package. If the package has a brand name, it
can be described in the <cpm:name> element.. The <cpm:capacityQuantity> element described
the capacity of the packaging. For example, to represent 30 tablets, the <cpm:formCode>
element at the <manufacturedMaterial> level must indicate tablets as the form, value
attribute of the <cpm:capacityQuantity> 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.
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
| |
Example |
<cpm:asContent classCode="CONT">
<cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">
<cpm:name/> <cpm:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <cpm:capacityQuantity value=" " unit=" "/> </cpm:containerPackagedMedicine></cpm:asContent> |
cpm:containerPackagedProduct
|
|
1 … * |
R |
Used in this context for describing the Packaged Medicinal Product and or the Packaged Medicinal Product Item
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
@determinerCode
|
cs |
1 … 1 |
F |
INSTANCE |
| |
Example |
<cpm:containerPackagedMedicine classCode="CONT" determinerCode="INSTANCE">...</cpm:containerPackagedMedicine> |
cpm:code
|
|
0 … * |
|
|
(ope…ial) |
cpm:name
|
ST |
0 … * |
R |
|
(ope…ial) |
| |
Example |
<cpm:name>...</cpm:name> |
cpm:formCode
|
CE.EPSOS |
1 … 1 |
R |
|
(ope…ial) |
| |
CONF |
|
| |
Example |
<cpm:formCode code="30007000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</cpm:formCode> |
cpm:quantity
|
PQ |
0 … * |
|
|
(ope…ial) |
cpm:asSpecializedKind
|
|
1 … 1 |
R |
This module is used for Representing the Pharmaceutical Substance according to the
WHO Anatomical Therapeutic Chemical (ATC) Classification System.
The <code> element contains the ATC code, the <name> element may be used for the plain
text representation. The classCode of "GRIC" identifies this structure as the representation
of a generic equivalent of the medication described in the current Medicine entry.
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
GRIC |
| |
Example |
<cpm:asSpecializedKind classCode="GRIC">
<cpm:generalizedMaterialKind classCode="MMAT">
<!-- Pharmaceutical Substance (ATC Code)-->
<cpm:code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/> </cpm:generalizedMaterialKind></cpm:asSpecializedKind> |
cpm:generalizedMaterialKind
|
|
|
R |
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
cpm:code
|
CD.EPSOS |
1 … 1 |
R |
|
(ope…ial) |
@codeSystem
|
CONF |
0 … 1 |
F |
2.16.840.1.113883.6.73 (WHO ATC) |
| |
Example |
<cpm:code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> |
cpm:name
|
|
0 … 1 |
R |
|
(ope…ial) |
cpm:asSpecializedKind
|
|
0 … * |
R |
This module can be used to represent the Pharmaceutical Product (Ids Set)
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.
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
GRIC |
| |
Example |
<cpm:asSpecializedKind classCode="GRIC">
<cpm:generalizedMaterialKind classCode="MMAT">
<cpm:code code=" " codeSystem=" " displayName=" " codeSystemName="WHO ATC"/> <cpm:name/> </cpm:generalizedMaterialKind></cpm:asSpecializedKind> |
cpm:generalizedMaterialKind
|
|
|
R |
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
cpm:code
|
CD.EPSOS |
1 … 1 |
R |
IDMP PhP Id. The level and the startum of the PhPID is distiguished by the codeSystem
OID <to be verified>
|
(ope…ial) |
cpm:name
|
|
0 … 1 |
R |
|
(ope…ial) |
cpm:ingredient
|
|
0 … * |
R |
This module proivdes the list of active ingredients used for this product. One or
more active ingredients may be present.
The classCode of "ACTI" indicates that this is an active ingredient.
Note: In this version the Pharmaceutical Substance ATC is no more provided as an ingredient
but as a class of products (asSpecializedKind.generalizedMaterialKind.code element).
|
(ope…ial) |
@classCode
|
cs |
1 … 1 |
F |
ACTI |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
| |
Example |
<cpm:ingredient classCode="ACTI">...</cpm:ingredient> |
cpm:quantity
|
|
1 … 1 |
M |
The medication strength is represented as the ratio of the active ingredient(s) to
a unit of medication. The <quantity> element contains the numerator and denominator
of the strength ratio.
|
(ope…ial) |
| |
Example |
<cpm:quantity>...</cpm:quantity> |
cpm:numerator
|
PQ |
1 … 1 |
R |
|
(ope…ial) |
@unit
|
cs |
1 … 1 |
R |
|
@value
|
|
1 … 1 |
R |
|
| |
Example |
<cpm:numerator unit="mg" value="20" xsi:type="PQ">...</cpm:numerator> |
cpm:denominator
|
PQ |
1 … 1 |
R |
|
(ope…ial) |
@unit
|
cs |
1 … 1 |
R |
|
@value
|
|
1 … 1 |
R |
|
| |
Example |
<cpm:denominator unit="1" value="1" xsi:type="PQ">...</cpm:denominator> |
cpm:ingredientSubstance
|
|
1 … 1 |
R |
Active ingredient used for this product.
The <code> element contains the coded representation of the ingredient and the <name>
element may be used for the plain text representation.
|
(ope…ial) |
cpm:code
|
|
1 … 1 |
R |
Identifier of the
substance. <binding with the vocabulary to be added likely the G-SRS (2.16.840.1.113883.4.9
SRS OID>
|
(ope…ial) |
cpm:name
|
|
0 … 1 |
|
Name of the substance
|
(ope…ial) |
Template OpenMed Material
Draft