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". 

It is not essential that the product name be an invented or brand name - it can be a generic name if extensions choose to follow the pattern shown in Figure 4 above. The product name concepts are authored to value the definitional attribute for the real products in the national extension as required by the use cases for that extension. This means that for those extensions that wish to author a hierarchy of product name concepts, they can choose to value the has product name attribute differently for the different levels in the model. 

For example:

Figure 23: Diagram of examples of a product name hierarchy

In a product name hierarchy, the parent product name concept should be authored to reflect the unique set of active ingredient substances for the Real Medicinal Product (see the brand family example in Figure 6 above) and associated Real Clinical Drug and Real Packaged Clinical Drug concepts. It should therefore not include any reference to dose form (e.g. "LA" or "Retard") or to strength (e.g. "Double Strength" of "for Children") or any other information such as indication (e.g. "Shingles Treatment"). Child product name concepts can be authored to include additional information as provided in the authorised name for Real Clinical Drugs and/or Real Packaged Clinical Drugs.  

Product name concepts must be authored in each national extension since the same product name can represent products containing different active ingredients in different jurisdictions, and therefore the product name has a different meaning in different jurisdictions. 

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. 

Medicinal products, like other complex products, are rarely "manufactured" by one single organisation; the substances in a product, including active ingredient substance may be sourced from a range of specialist manufacturers and then assembled into the manufactured dose form by another organisation. The assembling organisation may be a contract manufacturer holding a manufacturing license and working for a variety of clients.  In ISO 11615:2017 the "manufacturer" of a medicinal product is defined as the "organisation that holds the authorisation for the manufacturing process", and it notes that "establishment is a synonym of manufacturer"; establishment is a term that is often used in the USA.  In national terminologies for clinical use however, the term "manufacturer" usually refers to the organisation whose name and details are associated with the public facing information about the product.  This is the organisation responsible for providing the clinical information to support the product use (both for patients and healthcare professionals) and is also responsible for the quality and safety of the product, including for managing all adverse event information relating or possibly relating to the product in use.  Some healthcare cultures allow agreements whereby an organisation may obtain supplies of a medicinal product and then to re-package or re-label that medicinal product and place it into the supply chain, either within a single jurisdiction, or across a group of jurisdictions.  In this case, the organisation is acting as a supplier, and their name and details are likely to be present on the packaging, either exclusively or in addition to the primary organisation.   In these cases, the responsibility for the product information and the product quality and safety is shared in various ways depending on the agreement and jurisdictional regulations.

Nations/affiliates will need to decide the principles under which they will populate the manufacturer/supplier attribute, based on their own regulations and context of practice. The simplest rule is to use the company who holds the authorisation to market the medicinal product, but, as described above, there can be complexities. 

Issues to consider are:

• whether re-packaging or re-labelling is allowed by regulation and whether this is internal to the jurisdiction (as in the USA) or external to the jurisdiction (sometimes known as "parallel importing" or sale of "grey products") or whether both are allowed, and how the authorisations for these are managed and therefore which organisation (the licensed re-packager or the marketing authorisation holder) to designate as the manufacturer/supplier
• the role of the manufacturer/supplier information and the use case(s) to be supported, which may include
  • contact for queries from clinicians and/patients
  • pharmacovigilance and product safety
• whether the national medicines terminology will include medicines not authorised in their jurisdiction, and if so, how they wish to provide manufacturer/supplier information for these
  • for medicinal products licensed outside the jurisdiction, reference to the manufacturer is still likely to be appropriate
  • for compounded specials, to reference a generic "specials manufacturer" concept is possible since most of these will hold an authorisation to undertake specials manufacture

Manufacturer/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.

Due to the nature of the domain where either individual products or whole product sets, with their brand name and authorisation, can be sold from one organisation to another it may be that even within one jurisdiction a single product name will be associated with more than one supplier.  In situations where individual Real Clinical Drugs (or Real Packaged Clinical Drugs, for those products authorised at that level) that share the same product name , but have different supplier organisations, two Real Medicinal Products will exist, as shown in the example below:

Figure 24: Diagram to show RCDs sharing a single product name associated with different RMPs due to having different suppliers

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.   

The contains 'clinical drug attribute' can be valued with either a Clinical Drug from the international release or from the national extension (for example, if a liquid presentation has presentation strength Clinical Drugs in the national extension) .  

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 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:

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 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. 

Standard packs containing a single clinical drug type have a count of "one" for the "count of clinical drug type attribute".

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.  

Currently there are no plans to maintain container concepts that could be used to value a "has outer container" attribute in the international release, but such concepts may exist in the future. EDQM (the European Directorate for the Quality of Medicines and HealthCare) maintains a set of Packaging concepts, including both Container terms and Closure Terms.