Reminder on the working documents provided within the eCTD submissions

As per the structure of the eCTD, the product information should be provided in pdf format within Module 1.1.3. However it is occasionally necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate folder called xxxx-workingdocuments on the same submission zip package as the eCTD.