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Variations in eCTD format Q&A document - Europa
esubmission.ema.europa.euVariations in MRP, Chapter 1 (e.g. AT/H/0234/II/003/G). Q 3.2: How should a grouped variation of different types, for a single MA, be presented? A 3.2: The diagram below shows an example for a Centralised Procedure variation for a grouping of a Type IB and a Type II variation for the same MA. Submission type = the highest submission type within ...
BEST PRACTICE GUIDE For Type IB Variations CMDv/BPG/005 ...
www.hma.eu1.4 Type IB variations may be grouped together with other variations in a single notification. If the highest ranking variation is a Type IB variation,
BEST PRACTICE GUIDE For Type II Variations CMDv/BPG/006 ...
www.hma.eu1.5 A MAH may also submit several Type IB and/or Type II variations to one or more of their products in a single application; this will be dealt with in