The lists of Standard Terms were initially drawn up by the European Pharmacopoeia (Ph. Eur.) Commission further to a request of the EU Commission, for use in marketing authorisation applications (MAAs), labelling (including the summary of product characteristics (SmPC)), and electronic communications. The European Directorate for the Quality of Medicines & HealthCare (EDQM), a Directorate of the Council of Europe based in Strasbourg, France, is responsible continuing this work. Standard Terms have the double purpose of bringing information to the patient/user/prescriber and distinguishing medicinal products having the same trade-name. Because of the labelling purposes it is imperative that any Standard Term is constructed with a view to the patient and the prescriber. It conveys essential information on the properties and uses of the particular medicinal products. To avoid a proliferation of over-complicated terms, complete information cannot always be included in a Standard Term, and should instead appear elsewhere in the labelling, in particular the package leaflet and SMPC.
The data is from the EDQM Standard Terms database, and is reproduced with the permission of the European Directorate for the Quality of Medicines & HealthCare, Council of Europe (EDQM). For more information, please visit: https://standardterms.edqm.eu EDQM-HealthCare Standard Terms web page.
EDQM-HC terminology files are available for download from this NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/EDQM-HealthCare/) in two formats:
|Subset Code||The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.|
|NCIt Subset Name||The name of the subset.|
|NCIt Concept Code||The NCIt concept code attached to the PT concept.|
|NCIt Preferred Term||The preferred term chosen by the NCIt to represent the concept.|
|EDQM-HC Preferred Term||The preferred term chosen by the EDQM-HC to represent the concept.|
|EDQM-HC Source Code||The unique code attached to the concept assigned by the EDQM-HC.|
|EDQM-HC Definition||A text definition of the term created by an EDQM-HC subject matter expert.|
|NCIt Definition||A text definition of the term.|
EDQM-HealthCare terminology is bundled into subsets, identified by code and name in the second and third columns of each row. These are the names and definitions of the subsets.
Subset Name Subset Description EDQM-HC Closure Terminology Terminology subset about items used to close a container for the purpose of the correct storage and (where appropriate) use of the product. EDQM-HC Container Terminology Terminology subset about items of packaging that is part of a medicinal product and is used for storage, identification and/or transport of the components of the medicinal product. Note: 'Container' is a general concept that groups together the concepts of immediate container, intermediate packaging and outer packaging. EDQM-HC Transformation Terminology Terminology subset about procedures that are 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. Note: A transformation is not required when the manufactured item is equal to the pharmaceutical product. EDQM-HC Administration Device Terminology Terminology subset about devices that are used to administer a pharmaceutical product. EDQM-HC Combined Term Terminology Terminology subset about single terms to describe a pharmaceutical dose form (or combined pharmaceutical dose for) 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 product. EDQM-HC Release Characteristics Terminology Terminology subset about descriptions 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. EDQM-HC Combined Pack Terminology Terminology subset about single terms to describe two or more medicinal products that are packaged together and marketed under a single license, and which are intended to be administered independently, as separate pharmaceutical products. EDQM-HC Administration Method Terminology Terminology subset about general methods by which a pharmaceutical product is intended to be administered to the patient. EDQM-HC State of Matter Terminology Terminology subset about physical conditions describing the molecular form of a product. Note: State of matter is used to group basic dose forms according to their physical properties. EDQM-HC Intended Site of Administration Terminology Terminology subset about general body sites at which a pharmaceutical product is intended to be administered. EDQM-HC Basic Dose Form Terminology Terminology subset about generalized versions of the pharmaceutical dose form, used to group together related pharmaceutical dose forms. EDQM-HC Pharmaceutical Dosage Form Terminology Terminology subset about the physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient. Note: 'Pharmaceutical dose form' and 'Dosage form' are synonyms. 'Pharmaceutical dose form' can refer to the administrable dose form or the manufactured dose form, depending on the product that it is describing. EDQM-HC Combined Pharmaceutical Dose Form Terminology Terminology subset about single terms to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product, and which includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. Note: in the example 'Powder and solvent for solution for injection', the medicinal product contains two manufactured items: (i) a powder for solution for injection, and (ii) a solvent; the pharmaceutical product that is prepared form the two manufactured items is a solution for injection; the combined pharmaceutical dose form for the medicinal product is therefore 'powder and solvent for solution for injection'. EDQM-HC Units of Presentation Terminology Terminology subset about qualitative terms describing the discrete countable entity in which a pharmaceutical product or manufactured item is presented, in cases where strength or quantity is expressed referring to one instance of this countable entity. Note: A unit of presentation will often have the same name as a concept in another controlled vocabulary list, such as a basic dose form or a container, but the two concepts are not equivalent, and each has its own definition and identifier. EDQM-HC Routes and Methods of Administration Terminology Terminology subset about the paths by which the pharmaceutical product is taken into or makes contact with the body.
Also included on the NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/EDQM-HealthCare/) are the following additional files:
Archived files are available at:
Help requests on these files should go to NCIThesaurus@mail.nih.gov