Ennov InSight RIM Publisher 7.1

Repeatable Assembly Sections

The eCTD assembly contains repeatable sections and captures section-specific metadata for their associated extended type.
Assembly section number Assembly section name Associated extended type
1.15.2.1 Material Promotional Material Type
N/A Galenic Form CH Galenic Form
2.3.S Drug Substance Drug Substance
2.3.P Drug Product Drug Product
2.7.3 Clinical Indication Clinical Indication
3.2.S Drug Substance Drug Substance
3.2.P Drug Product Drug Product
3.2.P.4 Excipient Excipient
3.2.A.1 Quality Appendix Quality Appendix
3.2.A.2 Quality Appendix Quality Appendix
3.2.A.3 Excipient Excipient
5.3.5 Clinical Indication Clinical Indication