This short post concerns the submission of Literature
References in "Full Mixed" applications under Article 8(3). I don't
think it is discussed in any eCTD specific guidance (or if it is, I couldn't
find it!) so I thought it might be useful to share this information with you.
Article 8(3) applications are full MAA applications detailed
in Directive 2001/83/EC. This type of application normally requires the
submission of the results of both pre-clinical and clinical trials in Modules 4
and 5.
There does exist, however, the option to submit what is
described as a "full mixed" application which contains literature
references in place of (rather than to supplement) Study Reports. The content
of these references must therefore fulfil the requirements of the Directive:
To find more information please use the below mentioned link
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