Transcription of Compilation Quality Review - Europa
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Compilation Quality Review - Europa
30 October 2020. EMA/25090/2002 *. Human Medicines Division Compilation of QRD decisions on stylistic matters in product information Issues Connected problems QRD Suggestions Abbreviations Subscript and superscript Acronyms must be written in their standard form; Cmax are sometimes not used correctly in acronyms; Cmax, Cmax Abbreviations and Not always understood, Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full. In acronyms particularly in the package cases where this is not possible, at its first occurrence the term should be spelled out in full followed by the leaflet. The approach acronym/abbreviation in brackets. The acronym/abbreviation can then be used thereafter. See also the most varies across languages, frequently used non-standard abbreviations published on the Agency's website, Table of non-standard so acronyms/abbreviations abbreviations . may be either in the language of the translation or derived from English.
product. On the outer carton it is recommended to give prominence to the term ‘concentrate’. A statement reflecting critical steps prior to administration of the product should also be included (section 5 of Annex IIIA). For instance, in case the pharmaceutical form is “concentrate for solution for infusion” the following statements
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