The section describes the attributes used in the definition of the concepts classes in the national extension model. Descriptions of the attributes used in both the international content and the national extension are given in the international Medicinal Product Hierarchy Specification.

Has product name

Definition

The (authorised) product name for the medicinal product as designated by the license holder (supplier); this may (or may not) be a trademarked name, and is often referred to as the "brand name". 

Discussion

The "has product name" attribute is used in the definition of the real medicinal product and the real clinical drug.  It is not used in the real packaged clinical drug, as this brings the relevant information via the real clinical drug it contains.

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Figure 3750: Diagram of examples of a product name hierarchy

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The 774158006 | Has product name (attribute) | attribute is available from the concept model attribute hierarchy; values for the "has product name" attribute should be authored in the national extension, using the root of 774167006 | Product name (product name) |from the Qualifier hierarchy.

Has supplier

Definition

The (name of the) organisation that holds the authorisation for marketing or supply of the medicinal product. 

Discussion

The "has supplier" attribute is used in the definition of the real medicinal product and the real clinical drug.  It is not used in the real packaged clinical drug, as this brings the relevant information via the real clinical drug it contains.

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Figure 3815: Diagram to show RCDs sharing a single product name associated with different RMPs due to having different suppliers

The 774159003 | Has supplier (attribute) | attribute is available from the concept model attribute hierarchy.  Supplier organisations, by virtue of being corporate bodies and legal entities, are unique to a given nation and must have their representation authored within the national extension using 774164004 | Supplier (supplier) | from the Qualifier hierarchy as the root concept.

Count of clinical drug type

Definition

The number (count) of of distinct clinical drug (concepts) present in the package.  For all non-combination packages, this value should be "one"

Discussion

The "count of clinical drug type" attribute is used in the definition of the packaged clinical drug and the real packaged clinical drug.  

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Combination packs have the appropriate count (always greater than one) for the number of clinical drug types present in the combination pack. If one of the components of a combination pack is a therapeutically inactive diluent, national extensions can choose whether to include this in the "count of clinical drug" and therefore whether the pack containing the diluent will classify as a sibling or as a child of any pack not containing a diluent. See also section 11 below.

Contains clinical drug

Definition

The (real) clinical drug contained in the packaged product.   

Discussion

The "contains clinical drug" attribute is used in the definition of the packaged clinical drug and the real packaged clinical drug.  

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• For clinical drugs : "all products with a dose form, precise ingredient substance and basis of strength substance"
• For real clinical drugs : "all products with a dose form, precise ingredient substance, basis of strength substance, product name and supplier name".

Has pack size and Has pack size unit

Definition

Has pack size: The amount or quantity of clinical drug present in the package

Has pack size unit: The unit of measure appropriate for the pack size

Discussion

For (real) clinical drugs described with a unit of presentation and either a presentation strength or and concentration and presentation strength, the pack size reflects the number of units of presentation present in the package, and the pack size unit relates to the unit of presentation.  For (real) clinical drugs with a continuous dose form, described with  concentration strength, the pack size is the amount of the clinical drug present in the package with pack size units of either weight or volume as appropriate.

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