eCTD Glossary

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Baseline eCTD
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Baseline eCTD
It is recommended to submit a so-called baseline eCTD with sequence 0000 in case an eCTD lifecycle is started in the middle of the product lifecycle (i.e. not with the initial marketing authorisation application). 
Typically, the baseline includes at least an up to date Module 3 and in Module 1 the latest product information and a cover letter. The submission type (EU envelope) for a baseline eCTD is "reformat". An eCTD baseline should not contain any new information as it will not be subject to review by the drug regulatory agencies.
See also:
eCTD
Module
Sequence



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