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  • 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
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