Module 12 Presentations

Option1

• Current versions of the EU validation criteria for NeeS and eCTD do not allow for files to be placed directly into 3.2.P.4. This will be changed the next time the criteria are updated. • In the meantime, applicants should note that the criterion governing file names for eCTD, 15.BP3, is a Best Practice criterion only, and, as such, applicants are able to use the structures recommended by ICH in Q&A 73 • However, for NeeS, the equivalent criterion (2.11) is a Pass/Fail criterion, and, until the validation criteria are updated, applicants submitting NeeS will have to adhere to the current EU file naming rules, which do not allow a single file in 3.2.P.4

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