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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".
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The "has product name" 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.
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The has supplier attribute will be available from the Concept model attribute hierarchy; values for the Has Supplier attribute will be authored in the national extension, using the root of 77416004 | Supplier (supplier)| from the Qualifier hierarchy.
Contains clinical drug
Definition: The Clinical Drug contained in the packaged product.
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For Combination (Packaged Medicinal) Products, there will be one Clinical Drug for each of the components in the packaged product that is placed into the supply chain. When a non-therapeutically active component such as a diluent is provided in a packaged medicinal product placed into the supply chain, extensions may choose whether to describe the diluent as a separate Clinical Drug or whether to manage the inclusion of the diluent in the product name only (see below in section 11).
Has pack size and
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Has pack size unit
Definition: The amount or quantity of clinical drug present in the package. For clinical drugs described with a unit of presentation, 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 clinical drugs with a continuous presentation, this is the amount of the clinical drug present in the package with pack size units of either weight or volume.
The following table describes some patterns and gives examples:
| Product type | CD strength type | Unit of presentation | Pack size | Pack size unit |
|---|---|---|---|---|
| Discrete dose forms: tablets, capsules, pessaries, suppositories etc. | presentation strength | basic dose form | number of units of presentation present in package | same as unit of presentation |
| Bendroflumethiazide 5mg conventional release oral tablet 28 pack | tablet | 28 | tablet(s) | |
| Discrete dose forms: sachets, ampoules, vials containing powders, granules etc | presentation strength | "intimate container" | number of units of presentation present in package | same as unit of presentation |
| Cefotaxime 2g (per vial) powder for solution for injection 10 vial pack | vial | 10 | vial(s) | |
| Metered dose forms: pressurised inhalers, cutaneous sprays, nasal sprays etc. with a metered dose valve | presentation strength | actuation | number of units of presentation present in package | same as unit of presentation |
| Beclometasone dipropionate 100 mcg per actuation pressurised inhalation 200 actuation inhaler | actuation | 200 | actuation(s) | |
| Liquid dose forms: parenteral liquids, unit dose nebuliser solutions etc. in an "intimate container" | presentation strength (with concentration strength) | "intimate container" | number of units of presentation present in package | same as unit of presentation |
| Metoclopramine hydrochloride 100 mg per 20 mL solution for injection ampoule 5 ampoule pack | ampoule | 5 | ampoule(s) | |
| Liquid products described using concentration strength but which have a unit of presentation | concentration strength | "intimate container" | number of units of presentation present in package | same as unit of presentation |
| Insulin human soluble 100 unit per mL solution for injection 5 cartridges | cartridge | 5 | cartridge(s) | |
| Continuous preparation No unit of presentatation exists | concentration strength | NA | Quantity of product in package | unit of measure for quantity (volume or weight) |
| Hydrocortisone 10mg/1g cutaneous cream 30g tube | NA | 30 | grammes |
Note for those liquid products described using concentration strength, the size of the intimate container is not described (a 1.5mL cartridge or a 3 mL cartridge). For liquid products presented in an intimate container described using a concentration strength, the volume of clinical drug present in the intimate container may need to be described separately. This could be achieved using "unit of presentation volume" and "unit of presentation volume units" attributes and values if this were required.
Count of
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clinical drug type
Packs of medicinal products must be represented using the closed world view; they contain only the clinical drug type(s) content stated. In order to ensure that pack concepts classify correctly, so that packs that contain more than one (type of) clinical drug (i.e. combination packs) do not classify as children of packs that contain only one type of clinical drug, a "count of clinical drug type" attribute is used.
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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.
(Outer) Container
Description of the container that forms the outer package (the box, bottle, tube or jar) is not considered to be a definitional attribute for the Packaged Clinical Drug or Real Packaged Clinical Drug classes; no use cases have been presented to date to require this as a definitional attribute. However, national extensions may have a use for the information, possibly even with dimensions, to support robotic dispensing and supply chain use cases, using reference sets and/or additional axiom functionality.
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