Administration Method

Definition and Purpose

General method by which a pharmaceutical product is intended to be administered to the patient.
Source: EDQM

Examples

Solution for injection; tablet; hard-capsule powder for inhalation.
For more examples, see Administration Method Examples

Usage

Current usage: As part of the Pharmaceutical Dose Form in Profile: Medicinal Product
Future usage: As part of the Pharmaceutical Dose Form in Manufactured Item and Administrable Product

Code system source

EDQM via SPOR

Basic Dose Form

Definition and Purpose

Generalised version of the pharmaceutical dose form, used to group together related pharmaceutical dose forms.
Source: EDQM

Examples

Capsule; tablet; powder; solution.
For more examples, see Basic Dose Form Examples

Usage

Current usage: As part of the Pharmaceutical Dose Form in Profile: Medicinal Product
Future usage: As part of the Pharmaceutical Dose Form in Manufactured Item and Administrable Product

Code system source

EDQM via SPOR

Combination Pack

Definition and Purpose

The combination pack is used to combine two or more pharmaceutical dose forms (or combined pharmaceutical dose forms, or combined terms) to describe products that are packaged together but are administered separately as independent pharmaceutical products.
Source: EDQM

Examples

Soral solution in satchet, Solution for infusion in pre-filled syringe
For more examples, see Combination Pack Examples

Usage

Current usage: As a type of Authorised Pharmaceutical Dose Form in Profile: Medicinal Product and as potential part of a Combined Term
Future usage: See above

Code system source

EDQM via SPOR

Combined Pharmaceutical Dose Form

Definition and Purpose

The combined pharmaceutical dose form is used to combine two or more pharmaceutical dose forms into a single term, in order to describe a medicinal product that consists of two or more manufactured items that are intended to be combined to produce a single pharmaceutical product for administration to the patient.
It is not used to combine pharmaceutical dose forms with other classes of term such as containers or administration devices (see instead Combined Term). It is not used to combine pharmaceutical dose forms that are packaged together but administered separately rather than being combined to produce a single pharmaceutical product (see instead Combination Pack).
Source: EDQM

Examples

Powder and solvent for solution for injection.
For more examples, see Combined Pharmaceutical Dose Form Examples
and supplement (internal NOMA codes) Combined Pharmaceutical Dose Form Supplement Examples

Usage

Current usage: As a type of Authorised Pharmaceutical Dose Form in Profile: Medicinal Product and as potential part of a Combined Term
Future usage: See above

Code system source

EDQM via SPOR

Combined Term

Definition and Purpose

Single term to describe a pharmaceutical dose form (or combined pharmaceutical dose form) and an item of packaging, either for the purpose of distinguishing between marketed products that differ only in the container or administration device, or where the item of packaging has special characteristics that are relevant to the use of the medicinal produc
Source: EDQM

Examples

Oral solution in satchet, Solution for infusion in pre-filled syringe
For more examples, see Combined Term Examples
and supplement (internal NOMA codes) Combined Term Supplement Examples

Usage

Current usage: As a type of Authorised Pharmaceutical Dose Form in Profile: Medicinal Product Future usage: See above

Code system source

EDQM via SPOR

Intended Site

Definition and Purpose

General body site at which a pharmaceutical product is intended to be administered. Source: EDQM

Examples

Nasal, Oral, Pulmonary
For more examples, see Intended Site Examples

Usage

Current usage: As part of the Pharmaceutical Dose Form in Profile: Medicinal Product
Future usage: As part of the Pharmaceutical Dose Form in Manufactured Item and Administrable Product

Code system source

EDQM via SPOR

Pharmaceutical Dose Form

Definition and Purpose

The pharmaceutical dose form is used to describe the manufactured item (i.e. the item as presented in the packaging by the manufacturer) or the pharmaceutical product (i.e. the item as intended to be administered to the patient, after any necessary transformation has been carried out). When used to describe the manufactured item, it may be referred to as the manufactured dose form; when describing the pharmaceutical product, it may be referred to as the administrable dose form.
The Standard Terms database does not explicitly distinguish between manufactured dose forms and administrable dose forms other than by use of the tagging system However, for a term representing a manufactured dose form such as ‘Powder for solution for injection’, the words‘for solution for injection’ indicate that a reconstitution is required, and that the resulting administrable dose form is ‘Solution for injection’. Source: EDQM

Examples

Dispersible tablet, powder for solution for injection, prolonged-release capsule, hard
For more examples, see Pharmaceutical Dose Form Examples
and supplement (internal NOMA codes) Pharmaceutical Dose Form Supplement Examples

Usage

Current usage: As a type of Authorised Pharmaceutical Dose Form in Profile: Medicinal Product, and as potential part of a Combined Term, Combination Pack or Combined Pharmaceutical Dose Form.
Future usage: As the Manufacured Dose Form in the Manufactured Item and the Administrable Dose form in the Administrable Product.

Code system source

EDQM via SPOR

Release Characteristics

Definition and Purpose

Description of the timing by which an active ingredient is made available in the body after administration of the pharmaceutical product, in comparison with a conventional, direct release of the active ingredient.
Similar to a combined pharmaceutical dose form, a combination pack is built up from the manufactured dose forms, combined pharmaceutical dose forms or combined terms that describe the products in the package. It may have links to the manufactured dose form(s), administrable dose forms, combined pharmaceutical dose forms, combined dose forms, and packaging item(s) with which it is associated. Source: EDQM

Examples

Delayed; prolonged; conventional
For more examples, see Release Characteristics Examples

Usage

Current usage: As part of the Pharmaceutical Dose Form in Profile: Medicinal Product
Future usage: As part of the Pharmaceutical Dose Form in Manufactured Item and Administrable Product

Code system source

EDQM via SPOR

State of Matter

Definition and Purpose

Physical condition describing the molecular form of a product.
Source: EDQM

Examples

Gas; liquid; semi-solid; solid
For more examples, see State of Matter Examples

Usage

Current usage: As a classification for the Basic Dose Form TODO pagelink{pagelink:Home/FHIR-Artifacts/Profile-Medicinal-Product.page.md}} Future usage: See above

Code system source

EDQM via SPOR

Transformation

Definition and Purpose

Procedure that is carried out in order to convert a manufactured item that requires such a procedure into a pharmaceutical product, i.e. from its manufactured dose form to its administrable dose form.
Source: EDQM

Example for a transformation: Powder for Solution for Injection can be trnsformed (reconstituted) into Solution for Injection by the transformation "Dissolution"

"Transformation" is one of five attributes of a Pharmaceutical Dose Form (todo link)

Examples

Dilution; dispersion; dissolution
For more examples, see Transformation Examples

Usage

Current usage: As part of the Pharmaceutical Dose Form in Profile: Medicinal Product
Future usage: As part of the Pharmaceutical Dose Form in Manufactured Item and Administrable Product

Code system source

EDQM via SPOR