| 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 |
| | 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. | (IPS...uct) |
| | | | hl7ips-dataelement-105 | Product Code | CEN/TC 251 prEN 17269 |
|
| | 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 (preferred) | 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 comes preferably from value set 2.16.840.1.113883.11.22.25 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. It represents the primary description of the packaging of the medicine (e.g., the medicine is packaged in ampoules of 50ml volume each) and may include additional packaging information of how many of the primary packaged items are within an outer package (e.g., 5 ampoules are packaged in a box).
The primary description of the package should be consistent with the given pharmaceutical dose form (pharm:formCode of the medication). Example: a consistent pharmaceutical dose form to the package form “Ampoules” would be e.g., “Solution for injection”.
In case the package describes a product, the pharm:code element provides the code for the product.
In case the package describes a product, and the package has a brand name, it should be described in the pharm:name element (e.g., Xylocaine 1% with Adrenaline Inj, 5 injections package).
The pharm:formCode element represents the form of the product/contaner (e.g., tablet container, bottle, ...).
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.
| (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| | Example | Packaged Medicinal Product with formCode <asContent classCode="CONT">
<containerPackagedProduct classCode="CONT" determinerCode="KIND">
<!-- 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> |
| | Example | General example <asContent classCode="CONT">
<quantity value=" " unit=" "/> <containerPackagedProduct classCode="CONT" determinerCode="KIND">
<!-- Medicinal product code (package-level) -->
<code code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <!-- Brand name (package) -->
<name> . . . </name> <formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <capacityQuantity value=" " unit=" "/> <asContent>
<containerPackagedProduct classCode="CONT" determinerCode="KIND">
<capacityQuantity value=" " unit=" "/> </containerPackagedProduct> </asContent> </containerPackagedProduct></asContent> |
| | Example | Medicinal product with pharmaceutical dose form ”Tablets”, available as a “Tablet container” with 30 tablets <asContent classCode="CONT">
<!-- 30 tablets in the package -->
<quantity value="30" unit="{tablet}"/> <containerPackagedProduct classCode="CONT" determinerCode="KIND">
<!-- .. -->
<formCode code=" " displayName="Tablet container" codeSystem=" " codeSystemName=" "/> </containerPackagedProduct></asContent> |
| | Example | Medicinal product with pharmaceutical dose form 'Solution for injection', available as “Ampoules” with 50ml volume, packaged as 5 ampoules per box <asContent classCode="CONT">
<quantity value="50" unit="ml"/> <!-- 50ml per ampoule -->
<containerPackagedProduct classCode="CONT" determinerCode="KIND">
<!-- .. -->
<formCode code=" " displayName="Ampoules" codeSystem=" " codeSystemName=" "/> <asContent>
<!-- 5 ampoules in a box -->
<quantity value="5"/> <containerPackagedProduct classCode="CONT" determinerCode="KIND">
<!-- .. -->
</containerPackagedProduct> </asContent> </containerPackagedProduct></asContent> |
| | Example | Packaged Medicinal Product with multiple layers packaging <asContent classCode="CONT">
<containerPackagedProduct>
<!-- Inner Package -->
<code codeSystem="..." code="..." displayName="..."/> <asContent>
<containerPackagedProduct>
<!-- Intermediate Package -->
<asContent>
<containerPackagedProduct>
<!-- Outer Package / Packaged Medicinal Product -->
</containerPackagedProduct> </asContent> </containerPackagedProduct> </asContent> </containerPackagedProduct></asContent> |
| Included | | | from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) |
| PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) |
| | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| cs | 1 … 1 | F | KIND |
| CE | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (IPS...uct) |
| EN | 0 … * | |
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) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | 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) |
| | | | | 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 | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (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 outer <pharm:containerPackagedProduct> than this element can be used for the brand name. | (IPS...uct) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 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 | | (IPS...uct) |
| | | | | | | 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 | 0 … 1 | | When present, it can be used to convey the Packaged Medicinal Product ID.
| (IPS...uct) |
| ST | 0 … 1 | R | | (IPS...uct) |
| CE | 1 … 1 | R | | (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 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 |
| cs | 1 … 1 | F | KIND |
| CD.IPS | 1 … 1 | R | The 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 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 as for example the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) when it will be available for use.
The generalizedMaterialKind/code element is used to covey these codes.
| (IPS...uct) |
| cs | 1 … 1 | F | GRIC |
| | Example | <asSpecializedKind classCode="GRIC">
<generalizedMedicineClass classCode="MMAT">
<code code=" " displayName=" " codeSystem=" " codeSystemName=" "/> </generalizedMedicineClass></asSpecializedKind> |
| Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| | pharm:part
|
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | PART |
| II | 0 … 1 | | | (IPS...uct) |
| PQ | 0 … 1 | | | (IPS...uct) |
| | 1 … 1 | R | | (IPS...uct) |
| CE | 0 … 1 | | | (IPS...uct) |
| EN | 0 … 1 | | | (IPS...uct) |
| ED | 0 … 1 | | | (IPS...uct) |
| CE | 0 … 1 | | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| Included | | | from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) |
| PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) |
| | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| cs | 1 … 1 | F | KIND |
| CE | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (IPS...uct) |
| EN | 0 … * | |
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) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | 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) |
| | | | | | | 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 | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (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 outer <pharm:containerPackagedProduct> than this element can be used for the brand name. | (IPS...uct) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 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 | | (IPS...uct) |
| | | | | | | | | 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 | 0 … 1 | | When present, it can be used to convey the Packaged Medicinal Product ID.
| (IPS...uct) |
| ST | 0 … 1 | R | | (IPS...uct) |
| CE | 1 … 1 | R | | (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | GRIC |
| Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | PART |
| II | 0 … 1 | | | (IPS...uct) |
| PQ | 0 … 1 | | | (IPS...uct) |
| | 1 … 1 | R | | (IPS...uct) |
| CE | 0 … 1 | | | (IPS...uct) |
| EN | 0 … 1 | | | (IPS...uct) |
| ED | 0 … 1 | | | (IPS...uct) |
| CE | 0 … 1 | | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| Included | | | from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) |
| PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) |
| | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| cs | 1 … 1 | F | KIND |
| CE | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (IPS...uct) |
| EN | 0 … * | |
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) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | 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) |
| | | | | | | | | 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 | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (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 outer <pharm:containerPackagedProduct> than this element can be used for the brand name. | (IPS...uct) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 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 | | (IPS...uct) |
| | | | | | | | | | | 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 | 0 … 1 | | When present, it can be used to convey the Packaged Medicinal Product ID.
| (IPS...uct) |
| ST | 0 … 1 | R | | (IPS...uct) |
| CE | 1 … 1 | R | | (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | GRIC |
| Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | | | | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | PART |
| II | 0 … 1 | | | (IPS...uct) |
| PQ | 0 … 1 | | | (IPS...uct) |
| | 1 … 1 | R | | (IPS...uct) |
| CE | 0 … 1 | | | (IPS...uct) |
| EN | 0 … 1 | | | (IPS...uct) |
| ED | 0 … 1 | | | (IPS...uct) |
| CE | 0 … 1 | | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| Included | | | from 2.16.840.1.113883.10.21.4.17 UV Content (DYNAMIC) |
| PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) |
| | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (IPS...uct) |
| cs | 1 … 1 | F | CONT |
| cs | 1 … 1 | F | KIND |
| CE | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (IPS...uct) |
| EN | 0 … * | |
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) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | 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) |
| | | | | | | | | | | 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 | 0 … 1 | |
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 Packaged Medicinal Product ID.
| (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 outer <pharm:containerPackagedProduct> than this element can be used for the brand name. | (IPS...uct) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 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 | | (IPS...uct) |
| | | | | | | | | | | | | 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 | 0 … 1 | | When present, it can be used to convey the Packaged Medicinal Product ID.
| (IPS...uct) |
| ST | 0 … 1 | R | | (IPS...uct) |
| CE | 1 … 1 | R | | (IPS...uct) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (IPS...uct) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | GRIC |
| Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | | | | | | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| | 0 … * | | | (IPS...uct) |
| cs | 1 … 1 | F | PART |
| | 0 … * | | | (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) |
|
| Included | | | from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) |
| RTO_PQ_PQ | 0 … 1 | | | (IPS...uct) |
| | Example | 10 mg of the ingredient per ml <pharm:quantity>
<cda:numerator xsi:type="PQ" value="10" unit="mg"/> <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity> |
| | Example | 2% of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="2" unit="%"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| | Example | 5mg of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="5" unit="mg"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| PQ | 0 … 1 | | | (IPS...uct) |
| PQ | 0 … 1 | | | (IPS...uct) |
| | | | | | | | | pharm:ingredientSubstance
|
| | 0 … 1 | | The substance used for this product plying the role indicated in the ingredient classCode.
The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
| (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (IPS...uct) |
| EN | 0 … 1 | C | | (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 | |
| | 0 … * | | | (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) |
|
| Included | | | from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) |
| RTO_PQ_PQ | 0 … 1 | | | (IPS...uct) |
| | Example | 10 mg of the ingredient per ml <pharm:quantity>
<cda:numerator xsi:type="PQ" value="10" unit="mg"/> <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity> |
| | Example | 2% of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="2" unit="%"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| | Example | 5mg of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="5" unit="mg"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| PQ | 0 … 1 | | | (IPS...uct) |
| PQ | 0 … 1 | | | (IPS...uct) |
| | | | | | | pharm:ingredientSubstance
|
| | 0 … 1 | | The substance used for this product plying the role indicated in the ingredient classCode.
The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
| (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (IPS...uct) |
| EN | 0 … 1 | C | | (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 | |
| | 0 … * | | | (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) |
|
| Included | | | from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) |
| RTO_PQ_PQ | 0 … 1 | | | (IPS...uct) |
| | Example | 10 mg of the ingredient per ml <pharm:quantity>
<cda:numerator xsi:type="PQ" value="10" unit="mg"/> <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity> |
| | Example | 2% of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="2" unit="%"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| | Example | 5mg of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="5" unit="mg"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| PQ | 0 … 1 | | | (IPS...uct) |
| PQ | 0 … 1 | | | (IPS...uct) |
| | | | | pharm:ingredientSubstance
|
| | 0 … 1 | | The substance used for this product plying the role indicated in the ingredient classCode.
The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
| (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (IPS...uct) |
| EN | 0 … 1 | C | | (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 | |
| | pharm:ingredient
|
| | 0 … * | |
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) |
|
| | Example | <pharm:ingredient classCode="ACTI">
<pharm:quantity>
<cda:numerator type="PQ" value=" " unit=" "/> <cda:denominator type="PQ" value=" " unit=" "/> </pharm:quantity> <ingredientSubstance classCode="MMAT" determinerCode="KIND">
<code code=" " displayName=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="ATC WHO"/> </ingredientSubstance></pharm:ingredient> |
| Included | | | from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) |
| RTO_PQ_PQ | 0 … 1 | | | (IPS...uct) |
| | Example | 10 mg of the ingredient per ml <pharm:quantity>
<cda:numerator xsi:type="PQ" value="10" unit="mg"/> <cda:denominator xsi:type="PQ" value="1" unit="ml"/></pharm:quantity> |
| | Example | 2% of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="2" unit="%"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| | Example | 5mg of the ingredient <pharm:quantity>
<cda:numerator xsi:type="PQ" value="5" unit="mg"/> <cda:denominator xsi:type="PQ" value="1"/></pharm:quantity> |
| PQ | 0 … 1 | | | (IPS...uct) |
| PQ | 0 … 1 | | | (IPS...uct) |
| | | pharm:ingredientSubstance
|
| | 0 … 1 | | The substance used for this product plying the role indicated in the ingredient classCode.
The <code> element contains the coded representation of the ingredient and the <name> element may be used for the plain text representation.
| (IPS...uct) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (IPS...uct) |
| EN | 0 … 1 | C | | (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
