Preferred Label : EDQM Health Care Terminology;
NCIt synonyms : European Directorate for the Quality of Medicines and HealthCare Controlled Vocabularies;
NCIt related terms : EDQM HC; EDQM HealthCare Controlled Vocabularies;
NCIt definition : A terminology developed by the European Directorate for the Quality of Medicines and
HealthCare to provide the basis for global harmonization of pharmaceutical products
in marketing authorization applications, labelling, and electronic communications
in pharmacovigilance and adverse reporting. For more information, please visit: https://standardterms.edqm.eu;
Alternative definition : EDQM-HC: 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. For more information,
please visit: https://standardterms.edqm.eu;
NCI Metathesaurus CUI : CL552437;
Origin ID : C148636;
UMLS CUI : C4725177;
Semantic type(s)
subset_includes_concept