hl7:manufacturedProduct
|
|
0 … * |
R |
|
(IPS uct) |
@classCode
|
cs |
0 … 1 |
F |
MANU |
hl7:templateId
|
II |
1 … 1 |
M |
|
(IPSuct) |
@root
|
uid |
1 … 1 |
F |
2.16.840.1.113883.10.22.4.2 |
| Included |
1 … 1 |
R |
from 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (DYNAMIC)
|
hl7:manufacturedMaterial
|
|
1 … 1 |
R |
|
(IPSuct) |
@classCode
|
cs |
0 … 1 |
F |
MMAT |
@determinerCode
|
cs |
0 … 1 |
F |
KIND |
hl7:templateId
|
II |
1 … 1 |
M |
|
(IPSuct) |
@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.
|
(IPSuct) |
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.
|
(IPSuct) |
pharm:formCode
|
CE.IPS |
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.
|
(IPSuct) |
| |
CONF |
|
| |
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.
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:capacityQuantity> 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.
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.
|
(IPSuct) |
@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 |
0 … 1 |
|
The quantity which specified how many inner packaged content entities are in an outer
packaging container entity.
|
(IPSuct) |
@unit
|
cs |
0 … 1 |
|
|
| |
CONF |
|
@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. |
(IPSuct) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
pharm:code
|
|
0 … 1 |
|
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".
|
(IPSuct) |
pharm:name
|
ST |
0 … 1 |
|
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.
|
(IPSuct) |
| |
Example |
<name>AMOXIFEN(R) 20 compresse 20 mg</name> |
pharm:formCode
|
CE.IPS |
0 … 1 |
R |
This element encodes the type of the most inner package item or of the or the Packaged
Medicinal Product.
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; Packages and Route of Administration.
|
(IPSuct) |
| |
CONF |
|
| |
Example |
<formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode> |
pharm:capacityQuantity
|
PQ |
0 … 1 |
|
It represents the functional capacity of the container: e.g. bottle containing up
to 20 tablets or ampule of 10 ml.
|
(IPSuct) |
@unit
|
cs |
0 … 1 |
|
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
pharm:asContent
|
|
0 … * |
R |
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.
|
(IPSuct) |
@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.
|
(IPSuct) |
@unit
|
cs |
0 … 1 |
|
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
| |
Example |
<quantity value="20" unit="{tablet}"/> |
| |
Example |
<quantity value="10" unit="mL"/> |
pharm:containerPackagedProduct
|
|
1 … 1 |
R |
It represents the intermediate Package Item or the Packaged Medicinal Product |
(IPSuct) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
pharm:code
|
CD.IPS |
0 … 1 |
|
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".
|
(IPSuct) |
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 inner <pharm:containerPackagedProduct> than this element
can be used for the brand name.
|
(IPSuct) |
| |
Example |
<name>...</name> |
pharm:formCode
|
CE.IPS |
1 … 1 |
R |
This element encodes the type of the most inner package item or of the or the Packaged
Medicinal Product.
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 reference terminology
for representing Pharmaceutical Dose forms; Packages and Route of Administration.
|
(IPSuct) |
| |
CONF |
|
pharm:capacityQuantity
|
PQ |
0 … 1 |
|
It represents the functional capacity of the container: e.g. bottle containing up
to 20 tablets or ampule of 10 ml.
|
(IPSuct) |
@unit
|
cs |
0 … 1 |
|
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
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.
|
(IPSuct) |
@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.
|
(IPSuct) |
@unit
|
cs |
0 … 1 |
|
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
| |
Example |
<quantity value="20" unit="{tablet}"/> |
| |
Example |
<quantity value="10" unit="mL"/> |
pharm:containerPackagedProduct
|
|
1 … 1 |
R |
When present, it represents the Packaged Medicinal Product |
(IPSuct) |
@classCode
|
cs |
1 … 1 |
F |
CONT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
pharm:code
|
CD.IPS |
0 … 1 |
|
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).
|
(IPSuct) |
pharm:name
|
ST |
0 … 1 |
R |
When present, it can be used for the representing the brand name. |
(IPSuct) |
pharm:formCode
|
CE.IPS |
1 … 1 |
R |
When present, it encodes the type of the outer package.
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; Packages and Route of Administration.
|
(IPSuct) |
| |
CONF |
|
pharm:capacityQuantity
|
PQ |
0 … 1 |
|
It represents the functional capacity of the container: e.g. bottle containing up
to 20 tablets or ampule of 10 ml.
|
(IPSuct) |
@unit
|
cs |
0 … 1 |
|
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
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.
|
(IPSuct) |
| 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 |
|
(IPSuct) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
pharm:code
|
CD.IPS |
1 … 1 |
R |
The element contains the ATC code of this medicine.
|
(IPSuct) |
| |
CONF |
|
| |
Example |
<code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> |
pharm:name
|
|
0 … * |
|
|
(IPSuct) |
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.
|
(IPSuct) |
@classCode
|
cs |
1 … 1 |
F |
GRIC |
| |
Example |
<asSpecializedKind classCode="GRIC">
<generalizedMaterialKind classCode="MMAT">
<code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"/> <name/> </generalizedMaterialKind></asSpecializedKind> |
pharm:generalizedMaterialKind
|
|
|
R |
|
(IPSuct) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
pharm:code
|
CD.IPS |
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.
|
(IPSuct) |
pharm:name
|
|
0 … * |
R |
|
(IPSuct) |
pharm:ingredient
|
|
0 … * |
R |
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.
|
(IPSuct) |
@classCode
|
cs |
1 … 1 |
R |
|
| |
CONF |
|
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.
|
(IPSuct) |
| |
Example |
<quantity>...</quantity> |
hl7:numerator
|
PQ |
1 … 1 |
R |
|
(IPSuct) |
@unit
|
cs |
1 … 1 |
R |
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
hl7:denominator
|
PQ |
1 … 1 |
R |
|
(IPSuct) |
@unit
|
cs |
1 … 1 |
R |
|
| |
CONF |
|
@value
|
|
1 … 1 |
R |
|
pharm:ingredientSubstance
|
|
1 … 1 |
R |
|
(IPSuct) |
@classCode
|
cs |
1 … 1 |
F |
MMAT |
@determinerCode
|
cs |
1 … 1 |
F |
KIND |
pharm:code
|
CD.IPS (extensible) |
0 … 1 |
C |
The IDMP ISO 11238 standard addresses the identification and exchange of regulated
information on substances.
The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances
globally consistent with this standard.
Those identifiers however are yet available for concrete usage, therefore in this
version of the template, SNOMED CT has been chosen as reference terminology also for
the active substances.
This choice will be revised based on the availability and the maturity of GInAS.
|
(IPSuct) |
| |
CONF |
|
hl7:originalText
|
ED |
0 … * |
|
|
(IPSuct) |
hl7:reference
|
TEL |
0 … * |
|
|
(IPSuct) |
hl7:translation
|
CD |
0 … * |
|
This element can be used to provide alternative identifications for the described
substance.
|
(IPSuct) |
pharm:name
|
|
0 … 1 |
C |
Name of the substance |
(IPSuct) |
| |
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 |
|
Template IPS Medication Information (detail)
IPS Medication Statement (2021)
