" /> EDQM Health Care Terminology - CISMeF





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;

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11/05/2024


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