12 July 2012

Apex Regulatory's Blog: eCTD: Literature in the Article 8(3) Mixed Application (EU)


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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