ECTD Guidance Document - Europa
a specific business process, e.g. an initial MA application or Type II variation. It is a concept used in some review tools to group together several business related sequences. Technical eCTD Guidance v3.0 Page 7 of 60 2. GENERAL CONSIDERATIONS . 2.1 Scope . 2.1.1 Types of Product This guidance covers the submission of electronic regulatory information for all medicinal products human falling within the … ................
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