Item | DT | Card | Conf | Description | Label |
---|
| | | | | (UVM...ail) |
| @classCode
|
| cs | 1 … 1 | F | MANU |
| hl7:templateId
|
| II | 1 … 1 | M | | (UVM...ail) |
| | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.21.4.11 |
| hl7:manufacturedMaterial
|
| | | | | (UVM...ail) |
| | @classCode
|
| cs | 0 … 1 | F | MMAT |
| | @determinerCode
|
| cs | 0 … 1 | F | KIND |
| | hl7:code
|
| CE | 0 … 1 | R | The code describes the code of the medication. The medication may be either
- a brand/product or
- described as a generic/scientific name or
- a descriptor of a magistral preparation/compound medicine
| (UVM...ail) |
| ED | 0 … 1 | R | The originalText shoud contain a reference whose URI value points to the name and strength of the medication in the corresponding section.text, or just the name alone if strength is not relevant. | (UVM...ail) |
| TEL | 1 … 1 | R | | (UVM...ail) |
| CE | 0 … * | | Product code(s) from any organizational or juristdictional system | (UVM...ail) |
| CONF | shall be drawn from concept domain "Product Code" |
|
| | hl7:name
|
| EN | 0 … 1 | R | The element SHOULD contain the name of the medication (e.g., "Adol 500mg Caplet"). The medication may be either
- a brand/product or
- described as a generic/scientific name or
- a descriptor of a magistral preparation/compound medicine
| (UVM...ail) |
| | pharm:formCode
|
| CE | 0 … 1 | | This code represents the pharmaceutical dose form (e.g., tablet, capsule, liquid) and SHOULD be present, if not implied by the product. It MAY be present if implied by the product. The value of this code may affect the units used in the substance administration quantity element. | (UVM...ail) |
| | hl7:lotNumberText
|
| ST | 0 … 1 | | The lotNumberText element MAY be present and is a string representation of a lot number of this specific instance of the product. The provided lot number SHALL refer to the primary packaged item described in the Packaging element. | (UVM...ail) |
| | pharm:expirationTime
|
| TS | 0 … 1 | | The pharm:expirationTime element MAY be present and SHALL contain a value attribute containing the date (e.g., specific date, specific date including time) of expiration of this specific instance of the product. The value given in the pharm:expirationTime element SHALL refer to the primary packaged item described in the Medicine Packaging
element. | (UVM...ail) |
| | 1 … 1 | R | |
| | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | CONT |
| Example | Packaged Medicinal Product with formCode <pharm:asContent classCode="CONT"> <pharm:containerPackagedProduct classCode="CONT" determinerCode="KIND"> <!-- Packaged Medicinal Product --> <pharm:code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"/> <pharm:name>100 MIRACLE PILLS(TM)</pharm:name> <pharm:formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/> </pharm:containerPackagedProduct></pharm:asContent> |
| Example | General example <pharm:asContent classCode="CONT"> <pharm:quantity value=" " unit=" "/> <pharm:containerPackagedProduct classCode="CONT" determinerCode="KIND"> <!-- Medicinal product code (package-level) --> <pharm:code code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <!-- Brand name (package) --> <pharm:name> . . . </pharm:name> <pharm:formCode code=" " displayName=" " codeSystem=" " codeSystemName=" "/> <pharm:capacityQuantity value=" " unit=" "/> <pharm:asContent> <pharm:containerPackagedProduct classCode="CONT" determinerCode="KIND"> <pharm:capacityQuantity value=" " unit=" "/> </pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct></pharm:asContent> |
| Example | Medicinal product with pharmaceutical dose form ”Tablets”, available as a “Tablet container” with 30 tablets <pharm:asContent classCode="CONT"> <!-- 30 tablets in the package --> <pharm:quantity value="30" unit="{tablet}"/> <pharm:containerPackagedProduct classCode="CONT" determinerCode="KIND"> <!-- .. --> <pharm:formCode code=" " displayName="Tablet container" codeSystem=" " codeSystemName=" "/> </pharm:containerPackagedProduct></pharm:asContent> |
| Example | Medicinal product with pharmaceutical dose form 'Solution for injection', available as “Ampoules” with 50ml volume, packaged as 5 ampoules per box <pharm:asContent classCode="CONT"> <pharm:quantity value="50" unit="ml"/> <!-- 50ml per ampoule --> <pharm:containerPackagedProduct classCode="CONT" determinerCode="KIND"> <!-- .. --> <pharm:formCode code=" " displayName="Ampoules" codeSystem=" " codeSystemName=" "/> <pharm:asContent> <!-- 5 ampoules in a box --> <pharm:quantity value="5"/> <pharm:containerPackagedProduct classCode="CONT" determinerCode="KIND"> <!-- .. --> </pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct></pharm:asContent> |
| Example | Packaged Medicinal Product with multiple layers packaging <pharm:asContent classCode="CONT"> <pharm:containerPackagedProduct> <!-- Inner Package --> <pharm:code codeSystem="..." code="..." displayName="..."/> <pharm:asContent> <pharm:containerPackagedProduct> <!-- Intermediate Package --> <pharm:asContent> <pharm:containerPackagedProduct> <!-- Outer Package / Packaged Medicinal Product --> </pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct> </pharm:asContent> </pharm:containerPackagedProduct></pharm: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.
| (UVM...ail) |
| | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (UVM...ail) |
| 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.
| (UVM...ail) |
| 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.
| (UVM...ail) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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. | (UVM...ail) |
| 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.
| (UVM...ail) |
| | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the intermediate Package Item or the Packaged Medicinal Product
| (UVM...ail) |
| 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.
| (UVM...ail) |
| 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. | (UVM...ail) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | CONT |
| PQ | 0 … 1 | R | | (UVM...ail) |
| | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | When present, it represents the Packaged Medicinal Product | (UVM...ail) |
| 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.
| (UVM...ail) |
| ST | 0 … 1 | R | | (UVM...ail) |
| CE | 1 … 1 | R | | (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 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 WHO ATC drug code, or 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.
| (UVM...ail) |
| cs | 1 … 1 | F | GRIC |
| Example | <pharm:asSpecializedKind classCode="GRIC"> <pharm:generalizedMedicineKind classCode="MMAT" determinerCode="KIND"> <pharm:code code=" " displayName=" " codeSystem=" " codeSystemName=" "/> </pharm:generalizedMedicineKind></pharm:asSpecializedKind> |
Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| | pharm:part
|
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | PART |
| II | 0 … 1 | | | (UVM...ail) |
| PQ | 0 … 1 | | | (UVM...ail) |
| | 1 … 1 | | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| 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.
| (UVM...ail) |
| | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (UVM...ail) |
| 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.
| (UVM...ail) |
| 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.
| (UVM...ail) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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. | (UVM...ail) |
| 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.
| (UVM...ail) |
| | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the intermediate Package Item or the Packaged Medicinal Product
| (UVM...ail) |
| 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.
| (UVM...ail) |
| 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. | (UVM...ail) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | CONT |
| PQ | 0 … 1 | R | | (UVM...ail) |
| | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | When present, it represents the Packaged Medicinal Product | (UVM...ail) |
| 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.
| (UVM...ail) |
| ST | 0 … 1 | R | | (UVM...ail) |
| CE | 1 … 1 | R | | (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | GRIC |
Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | PART |
| II | 0 … 1 | | | (UVM...ail) |
| PQ | 0 … 1 | | | (UVM...ail) |
| | 1 … 1 | | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| 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.
| (UVM...ail) |
| | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (UVM...ail) |
| 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.
| (UVM...ail) |
| 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.
| (UVM...ail) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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. | (UVM...ail) |
| 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.
| (UVM...ail) |
| | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the intermediate Package Item or the Packaged Medicinal Product
| (UVM...ail) |
| 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.
| (UVM...ail) |
| 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. | (UVM...ail) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | CONT |
| PQ | 0 … 1 | R | | (UVM...ail) |
| | | | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | When present, it represents the Packaged Medicinal Product | (UVM...ail) |
| 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.
| (UVM...ail) |
| ST | 0 … 1 | R | | (UVM...ail) |
| CE | 1 … 1 | R | | (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | GRIC |
Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | | | | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | PART |
| II | 0 … 1 | | | (UVM...ail) |
| PQ | 0 … 1 | | | (UVM...ail) |
| | 1 … 1 | | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| 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.
| (UVM...ail) |
| | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | | (UVM...ail) |
| 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.
| (UVM...ail) |
| 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.
| (UVM...ail) |
| CE | 0 … 1 | | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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. | (UVM...ail) |
| 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.
| (UVM...ail) |
| | | | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the intermediate Package Item or the Packaged Medicinal Product
| (UVM...ail) |
| 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.
| (UVM...ail) |
| 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. | (UVM...ail) |
| CE | 1 … 1 | R | This element encodes the type of the intermediate package item or of the or the Packaged Medicinal Product.
| (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | CONT |
| PQ | 0 … 1 | R | | (UVM...ail) |
| | | | | | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | When present, it represents the Packaged Medicinal Product | (UVM...ail) |
| 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.
| (UVM...ail) |
| ST | 0 … 1 | R | | (UVM...ail) |
| CE | 1 … 1 | R | | (UVM...ail) |
| PQ | 0 … 1 | | Captures the number of product units the package would contain if fully loaded.
| (UVM...ail) |
| | 1 … 1 | R | |
| cs | 0 … 1 | | |
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | GRIC |
Included | | | from 2.16.840.1.113883.10.21.4.19 UV Generalized Medicine Class (DYNAMIC) |
| | | | | | | | | pharm:generalizedMedicineKind
|
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| | 1 … 1 | R | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| | 0 … * | | | (UVM...ail) |
| cs | 1 … 1 | F | PART |
| | 0 … * | | | (UVM...ail) |
| 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 | | | (UVM...ail) |
| 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 | | | (UVM...ail) |
| PQ | 0 … 1 | | | (UVM...ail) |
| | | | | | | | | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (UVM...ail) |
| EN | 0 … 1 | C | | (UVM...ail) |
| 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 … * | | | (UVM...ail) |
| 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 | | | (UVM...ail) |
| 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 | | | (UVM...ail) |
| PQ | 0 … 1 | | | (UVM...ail) |
| | | | | | | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (UVM...ail) |
| EN | 0 … 1 | C | | (UVM...ail) |
| 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 … * | | | (UVM...ail) |
| 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 | | | (UVM...ail) |
| 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 | | | (UVM...ail) |
| PQ | 0 … 1 | | | (UVM...ail) |
| | | | | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (UVM...ail) |
| EN | 0 … 1 | C | | (UVM...ail) |
| 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.
| (UVM...ail) |
| 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 xsi:type="PQ" value=" " unit=" "/> <cda:denominator xsi:type="PQ" value=" " unit=" "/> </pharm:quantity> <pharm:ingredientSubstance classCode="MMAT" determinerCode="KIND"> <pharm:code code=" " displayName=" " codeSystem="2.16.840.1.113883.6.73" codeSystemName="ATC WHO"/> </pharm:ingredientSubstance></pharm:ingredient> |
Included | | | from 2.16.840.1.113883.10.21.4.18 UV Ingredient (DYNAMIC) |
| RTO_PQ_PQ | 0 … 1 | | | (UVM...ail) |
| 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 | | | (UVM...ail) |
| PQ | 0 … 1 | | | (UVM...ail) |
| | | 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.
| (UVM...ail) |
| cs | 1 … 1 | F | MMAT |
| cs | 1 … 1 | F | KIND |
| CD | 0 … 1 | C | | (UVM...ail) |
| EN | 0 … 1 | C | | (UVM...ail) |
| 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 | |
| hl7:manufacturerOrganization
|
| | 0 … 1 | R | Contains 2.16.840.1.113883.10.12.151 CDA Organization (DYNAMIC) | (UVM...ail) |