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This Guidance is directly referenced in legislation and must be presented in its original publication format.
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General dossier requirements
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Page history
v1.5 Minor update
v1.4 Amendments to Part C to update the reference for dossier requirements for biologicals.
v1.3 Amendments to Part C to update dossier requirements for Registered Complementary and Assessed Listed Medicine.
v1.2
- Part E deleted section: Paper dossier from NeeS or eCTD format
- Added email submission of electronic dossiers
- Other minor updates.
v1.1. Minor updates.
v1.0 Original publication.
v1.5 Minor update
v1.4 Amendments to Part C to update the reference for dossier requirements for biologicals.
v1.3 Amendments to Part C to update dossier requirements for Registered Complementary and Assessed Listed Medicine.
v1.2
- Part E deleted section: Paper dossier from NeeS or eCTD format
- Added email submission of electronic dossiers
- Other minor updates.
v1.1. Minor updates.
v1.0 Original publication.