submission mode
- Guideline or reference source
- TIGES Harmonised guidance for ectd submissions in the eu
- Definition
- This is an element of the eCTD envelope and should only contain a value in variation or line extension regulatory activities and must be included in every sequence of that activity. The value can be set to ‘single’, ‘grouping’ or ‘worksharing’
- Broader Term
- envelope, ectd
- Narrower Term
- grouped regulatory activity
- regulatory activity subject to a worksharing agreement
- single regulatory activity
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