| Item | DT | Card | Conf | Description | Label |
|---|
| | 0 … * | R | | (IPS...uct) |
| |  | | hl7ips-dataelement-2 |  Medicinal Product | CEN/TC 251 prEN 17269 |
|
 | @classCode
|
| cs | 0 … 1 | F | MANU |
| hl7:templateId
|
| II | 1 … 1 | M | | (IPS...uct) |
 | | @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 | | (IPS...uct) |
| | @classCode
|
| cs | 0 … 1 | F | MMAT |
| | @determinerCode
|
| cs | 0 … 1 | F | KIND |
| | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...uct) |
| oid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.3 |
| Choice | 0 … 1 | | Elements to choose from:- hl7:code
- hl7:code[@codeSystem='2.16.840.1.113883.6.96']
|
| CE.IPS | 0 … 1 | R | This element is generally used to identify a medicinal product.
When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID).
For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code. | (IPS...uct) |
| | | | hl7ips-dataelement-105 | Product Code | CEN/TC 251 prEN 17269 |
|
| CE.IPS | 0 … 1 | R | Non IDMP codes from SNOMED CT value set | (IPS...uct) |
| where [@codeSystem='2.16.840.1.113883.6.96'] | |
| | CONF | | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.71 IPS Medications Products (DYNAMIC) |
|
| | hl7:name
|
| EN | 0 … 1 | R | This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction.
The name may be applicable in one or more country/language combinations.
| (IPS...uct) |
| | | | hl7ips-dataelement-117 | Brand Name | CEN/TC 251 prEN 17269 | | hl7ips-dataelement-171 | Product Common Name (and Strength) | CEN/TC 251 prEN 17269 |
|
| | 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.
| (IPS...uct) |
| | | | hl7ips-dataelement-227 | Pharmaceutical dose form | CEN/TC 251 prEN 17269 |
|
| | CONF | | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC) |
|
| | Example | <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode> |
| | pharm:asContent
|
| | 0 … * | | This structure describes the packaging of the medication.
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.
| (IPS...uct) |
| 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> </code> </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"/> </code> </containerPackagedProduct></asContent> |
| PQ | 0 … 1 | | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) |
| cs | 0 … 1 | | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
|
| | 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. | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| cs | 1 … 1 | F | KIND |
| | 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".
| (IPS...uct) |
| 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.
| (IPS...uct) |
| | Example | <name>AMOXIFEN(R) 20 compresse 20 mg</name> |
| 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. | (IPS...uct) |
| | CONF | | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
|
| | Example | <formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode> |
| PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...uct) |
| cs | 0 … 1 | | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
|
| | 1 … 1 | R | |
| | 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.
| (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) |
| cs | 0 … 1 | | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
|
| | 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 | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| cs | 1 … 1 | F | KIND |
| 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".
| (IPS...uct) |
| 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.
| (IPS...uct) |
| | Example | <name>...</name> |
| 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. | (IPS...uct) |
| | CONF | | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
|
| PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...uct) |
| cs | 0 … 1 | | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
|
| | 1 … 1 | R | |
| | 0 … * | R | In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the Packaged Medicinal Product.
| (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) |
| cs | 0 … 1 | | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
|
| | 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 | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| cs | 1 … 1 | F | KIND |
| 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). | (IPS...uct) |
| ST | 0 … 1 | R | When present, it can be used for the representing the brand name. | (IPS...uct) |
| 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. | (IPS...uct) |
| | CONF | | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
|
| PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...uct) |
| cs | 0 … 1 | | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
|
| | 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.
| (IPS...uct) |
| where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] | |
| cs | 1 … 1 | F | GRIC |
| | Example | <asSpecializedKind classCode="GRIC">
<generalizedMaterialKind classCode="MMAT">
<!-- Pharmaceutical Substance (ATC Code)-->
<code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/> </generalizedMaterialKind></asSpecializedKind> |
| | | pharm:generalizedMaterialKind
|
| | 1 … 1 | M | | (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| CD.IPS | 1 … 1 | R | The <code> element contains the ATC code of this medicine. | (IPS...uct) |
| | CONF | | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 IPS WHO ATC (DYNAMIC) |
|
| | Example | <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> |
| | 0 … * | | | (IPS...uct) |
| | 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. | (IPS...uct) |
| 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/> </code> </generalizedMaterialKind></asSpecializedKind> |
| | | pharm:generalizedMaterialKind
|
| | | R | | (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| 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.
| (IPS...uct) |
| | 0 … * | R | | (IPS...uct) |
| | 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.
| (IPS...uct) |
| cs | 1 … 1 | R | |
| | CONF | | The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) |
|
| | 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.</quantity>
| (IPS...uct) |
| | Example | <quantity>...</quantity> |
| PQ | 1 … 1 | R | | (IPS...uct) |
| cs | 1 … 1 | R | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC) |
|
| | 1 … 1 | R | |
| PQ | 1 … 1 | R | | (IPS...uct) |
| cs | 1 … 1 | R | |
| | CONF | | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC) |
|
| | 1 … 1 | R | |
| | | pharm:ingredientSubstance
|
| | 1 … 1 | R | | (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| 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. | (IPS...uct) |
| | CONF | | The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 IPS Medicine Active Substances (DYNAMIC) |
|
| ED | 0 … * | | | (IPS...uct) |
| TEL | 0 … * | | | (IPS...uct) |
| CD | 0 … * | | This element can be used to provide alternative identifications for the described substance. | (IPS...uct) |
| | 0 … 1 | C | Name of the substance | (IPS...uct) |
| | 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 | |
Under pre-publication review
