ectd baseline
- Guideline or reference source
- TIGES Harmonised guidance for ectd submissions in the eu
- Definition
- A baseline submission is a compiled submission of the current status of the dossier, i.e. resubmission of currently valid documents that have already been provided to an agency but in another format. The sections provided to make up a baseline can be defined by the applicant, but any omissions should not render the submitted content misleading. A baseline would typically consist of the Module 3 documents that tend to change over time during the lifecycle of the product.
- Used For
- technical baseline application
- Related Term
- ectd application
- reformatting
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