Transcription of Standard Terms - EDQM
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Standard Terms - EDQM
2018 EDQM, Council of Europe. All rights reserved. Standard Terms Introduction and Guidance for Use Version 5 June 2018 GENERAL PRINCIPLES AND INSTRUCTIONS FOR USE OF THE LISTS OF Standard Terms 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 for continuing this work.
Standard Terms: Introduction and Guidance for Use – v.2.1.2 –5 June 2018 iii 3.2.2. Combined pharmaceutical dose form: links to other terms ..... 11
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