Page History

Active ingredient substance

The substance that provides the intended therapeutic effect of the medicinal product, described usually but not always without modifiers such as esters, salts or other non-covalent derivatives

Administrable dose form

The (pharmaceutical) dose form of a medicinal product for administration to a patient, after any necessary transformation (from the manufactured dose form) has been carried out

Basis of strength substance

(BoSS)

The substance against which the strength quantity of a medicinal product is measured

Clinical Drug

(CD)

A representation of a medicinal product based on description of 1) its precise active ingredient substances only and explicitly, 2) the stated basis of strength substance(s) with strength, expressed as presentation strength with unit of presentation or as concentration strength as appropriate, and 3) with its manufactured dose form

Clinical Drug presentation

(CD presentation)

A representation of a medicinal product based on description of 1) its precise active ingredient substances only and explicitly,

2)

the stated basis of strength substance(s) with strength, expressed

as presentation strength with unit of presentation

, and 3) with its manufactured dose form

Clinical Drug concentration

(CD concentration)

A representation of a medicinal product based on description of 1) its precise active ingredient substances only and explicitly, 2) the stated basis of strength substance(s) with strength, expressed as concentration strength and 3) with its manufactured dose form

Combination Grouper

A concept grouping together medicinal products based on both the chemical structure and behaviour (mechanism of action) of their active ingredient substance(s)

Concentration strength

A type of strength description where the amount of the basis of strength substance present per unitary amount (volume, mass) of the single clinical drug being represented

Disposition Grouper

A concept grouping together medicinal products based on the behaviour (mechanism of action) of their active ingredient substance(s)

Dose form

(Pharmaceutical dose form)

The physical manifestation or formulation of a medicinal product that contains the active ingredient substance(s) intended to be delivered to a patient; the pharmaceutical dose form may be a manufactured dose form or an administrable dose form

IDMP

Identification of Medicinal Products
A suite of ISO standards concerned with the unique identification of medicinal products, primarily within the regulatory domain of use

The suite includes:
ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

ISO 11238:2018 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances

ISO 11239:2012 Health informatics - Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

ISO 11240: 2012 Health informatics - Identification of medicinal products -- Data elements and structures for the unique identification and exchange of units of measurement

Intimate container

The receptacle or vessel used to contain (or bound) liquid medicinal products into countable entities

Manufactured dose form

The (pharmaceutical) dose form of a medicinal product as it is presented by the manufacturer into the supply chain, before any transformation into an administrable dose form

Medicinal Product

(MP)

An abstract representation of a medicinal product based on description of active ingredient substance(s) that it contains (regardless of any modification of those active ingredient substance(s)), but not exclusively limited by those substances, in that other substances may be present

Medicinal Product only

(MP only)

An abstract representation of a medicinal product based on description of only and exclusively the active ingredient substance(s) that it contains but regardless of any modification of those active ingredient substance(s)

Medicinal Product precisely

(MP precisely)

An abstract representation of a medicinal product based on description of only and exclusively the precise active ingredients it contains

Medicinal Product Form

(MPF)

An abstract representation of a medicinal product based on description of active ingredients it contains, but not limited by that description, and on the (generalised) intended site of use for the product

Medicinal Product Form Only

(MPF only)

 An abstract representation of a medicinal product based on description of only and exclusively the active ingredient(s) it contains and on the (generalised) intended site of use for the product

Structural Grouper

A concept grouping together medicinal products based on the chemical structure of their active ingredient substance(s)

Precise active ingredient

The substance that provides the therapeutic effect of the medicinal product, described using the fullest and most specific description of the substance as it is used in the product(s) being represented.  This may include various modifiers, such as salts, esters, polymers (e.g. pegylation), and/or solvates

Presentation strength

A type of strength description where the amount of the basis of strength substance present in the unit of presentation of or in the volume (or mass) of the single clinical drug being represented

Therapeutic Role Grouper

A concept grouping together medicinal products based on a broad description of their use in treatment of disease

Unit of presentation

A qualitative concept that describes a countable entity in which the clinical drug is presented, or in which it is bounded